30.3.2012

Official Journal of the European Union

C 94/13

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2012 to 29 February 2012

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2) )

2012/C 94/02

— Issuing, maintenance or modification of a national marketing authorization

Date of the decision	Name(s) of the medicinal product	Holder(s) of the marketing authorization	Member State concerned	Date of notification
6.2.2012	Fortekor and associated names -	See Annex I	See Annex I	8.2.2012
27.2.2012	Somatropin	See Annex II	See Annex II	29.2.2012
17.2.2012	Pholcodine-containing medicinal products - Art 31 (maintain)	See Annex III	See Annex III	20.2.2012

— Suspension of a national marketing authorization

Date of the decision	Name(s) of the medicinal product	Holder(s) of the marketing authorization	Member State concerned	Date of notification
13.2.2012	Buflomedil	See Annex IV	See Annex IV	14.2.2012

(1) OJ L 311, 28.11.2001, p. 67.

(2) OJ L 311, 28.11.2001, p. 1.

ANNEX I

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, INDICATIONS, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

Member State

EU/EEA

Marketing authorisation holder

Name

INN

Strengths

Pharmaceutical forms

Animal species

Indications

Austria

Novartis Animal Health GmbH

Biochemiestraße 10

6250 Kundl

Austria

Fortekor 5 mg - Filmtabletten für Hunde und Katzen

Benazepril hydrochloride

5 mg

Film-coated tablets

Dogs and cats

Treatment of heart failure in dogs

Treatment of chronic renal insufficiency in cats

Austria

Novartis Animal Health GmbH

Biochemiestraße 10

6250 Kundl

Austria

Fortekor 20 mg - Filmtabletten für Hunde

Benazepril hydrochloride

20 mg

Film-coated tablets

Dogs

Treatment of heart failure in dogs

Austria

Novartis Animal Health GmbH

Biochemiestraße 10

6250 Kundl

Austria

Fortekor 2,5 mg Gourmet

Benazepril hydrochloride

2,5 mg

Tablets

Dogs and cats

Treatment of heart failure in dogs.

Treatment of chronic renal insufficiency in cats

Belgium

Novartis Consumer Health B.V.

Claudius Prinsenlaan 142

4818 CP Breda

The Netherlands

FORTEKOR 5

Benazepril hydrochloride

5 mg

Film-coated tablets

Dogs and cats

Dog: Treatment of heart failure

Cat: Retardation of chronic renal insufficiency by reducing the blood pressure.

Belgium

Novartis Consumer Health B.V.

Claudius Prinsenlaan 142

4818 CP Breda

The Netherlands

FORTEKOR FLAVOUR 5

Benazepril hydrochloride

5 mg

Tablets

Dogs

Treatment of heart failure

Belgium

Novartis Consumer Health B.V.

Claudius Prinsenlaan 142

4818 CP Breda

The Netherlands

Fortekor 20

Benazepril hydrochloride

20 mg

Film-coated tablets

Dogs

Treatment of heart failure

Belgium

Novartis Consumer Health B.V.

Claudius Prinsenlaan 142

4818 CP Breda

The Netherlands

Fortekor Flavour 20

Benazepril hydrochloride

20 mg

Tablets

Dogs

Treatment of heart failure

Belgium

Novartis Consumer Health B.V.

Claudius Prinsenlaan 142

4818 CP Breda

The Netherlands

Fortekor 2,5

Benazepril hydrochloride

2,5 mg

Tablets

Dogs and cats

Dog: Treatment of heart failure

Cat: Retardation of chronic renal insufficiency by reducing the blood pressure.

Czech Republic

Novartis Animal Health d.o.o.

Verovškova 57

1000 Ljubljana

Slovenia

FORTEKOR 5 mg potahované tablety

Benazepril hydrochloride

5 mg

Film-coated tablets

Dogs and cats

Treatment of heart failure in dogs

Treatment of chronic renal insufficiency in cats

Czech Republic

Novartis Animal Health d.o.o.

Verovškova 57

1000 Ljubljana

Slovenia

FORTEKOR 20 mg potahované tablety

Benazepril hydrochloride

20 mg

Film-coated tablets

Dogs

Treatment of heart failure in dogs

Denmark

Novartis Healthcare A/S Animal Health

Lyngbyvej 172

2100 København Ø

Danmark

Fortekor Vet. 5 mg

Benazepril hydrochloride

5 mg

Tablets

Dogs

Heart diseases in dogs

Denmark

Novartis Healthcare A/S Animal Health

Lyngbyvej 172

2100 København Ø

Danmark

Fortekor Vet. 20 mg

Benazepril hydrochloride

20 mg

Tablets

Dogs

Heart disease in dogs

Denmark

Novartis Healthcare A/S Animal Health

Lyngbyvej 172

2100 København Ø

Danmark

Fortekor Vet. 2,5 mg

Benazepril hydrochloride

2,5 mg

Tablets

Dogs

Heart disease in dogs

Finland

Novartis Healthcare A/S, Animal Health

Lyngbyvej 172

2100 Kööpenhamina

Tanska

Fortekor vet. 5 mg

Benazepril hydrochloride

5 mg

Tablets

Dogs

Heart failure in dogs

Finland

Novartis Healthcare A/S, Animal Health

Lyngbyvej 172

2100 Kööpenhamina

Tanska

Fortekor vet. 20 mg

Benazepril hydrochloride

20 mg

Tablets

Dogs

Heart failure in dogs

Finland

Novartis Healthcare A/S, Animal Health

Lyngbyvej 172

2100 Kööpenhamina

Tanska

Fortekor vet. 2,5 mg

Benazepril hydrochloride

2,5 mg

Tablets

Dogs

Cardiac failure in dogs, chronic renal insufficiency in cats

France

Novartis Sante Animale S.A.S.

14 Boulevard Richelieu

92500 Rueil Malmaison

France

FORTEKOR F 5

Benazepril hydrochloride

5 mg

Tablets

Dogs and cats

For dogs over 5 kg

Treatment of heart failure

For cats over 2,5 kg

Treatment of chronic renal insufficiency

France

Novartis Sante Animale S.A.S.

14 Boulevard Richelieu

92500 Rueil Malmaison

France

FORTEKOR F 20

Benazepril hydrochloride

20 mg

Tablets

Dogs

For dogs over 20 kg

Treatment of heart failure

France

Novartis Sante Animale S.A.S.

14 Boulevard Richelieu

92500 Rueil Malmaison

France

FORTEKOR 2,5

Benazepril hydrochloride

2,5 mg

Tablets

Dogs and cats

For dogs over 2,5 kg

Treatment of heart failure

For cats over 2,5 kg

Treatment of chronic renal insufficiency

Germany

Novartis Tiergesundheit GmbH

Zielstattstr. 40

81379 München

Germany

Fortekor Flavour 2,5 mg

Benazepril hydrochloride

2,5 mg

Tablets

Dogs

Treatment of heart failure in dogs, also in addition to the diuretic furosemide and/or the antiarrhythmic drug digoxin

Germany

Novartis Tiergesundheit GmbH

Zielstattstr. 40

81379 München

Germany

Fortekor 5

Benazepril hydrochloride

5 mg

Film-coated tablets

Dogs

Treatment of heart failure in dogs, also in addition to the diuretic furosemide and/or the antiarrhythmic drug digoxin

Germany

Novartis Tiergesundheit GmbH

Zielstattstr. 40

81379 München

Germany

Fortekor Flavour 5 mg

Benazepril hydrochloride

5 mg

Tablets

Dogs

Treatment of heart failure in dogs, also in addition to the diuretic furosemide and/or the antiarrhythmic drug digoxin

Germany

Novartis Tiergesundheit GmbH

Zielstattstr. 40

81379 München

Germany

Fortekor 20

Benazepril hydrochloride

20 mg

Film-coated tablets

Dogs

Treatment of heart failure in dogs, also in addition to the diuretic furosemide and/or the antiarrhythmic drug digoxin

Germany

Novartis Tiergesundheit GmbH

Zielstattstr. 40

81379 München

Germany

Fortekor Flavour 20 mg

Benazepril hydrochloride

20 mg

Tablets

Dogs

Treatment of heart failure in dogs, also in addition to the diuretic furosemide and/or the antiarrhythmic drug digoxin

Greece

PREMIER SHUKUROGLOU HELLAS

Av.Mesogeion 198

15561 HOLARGOS

GREECE

FORTEKOR 5 mg

Benazepril hydrochloride

5 mg

Film-coated tablets

Dogs

Treatment of heart failure

Greece

PREMIER SHUKUROGLOU HELLAS

Av.Mesogeion 198

15561 HOLARGOS

GREECE

FORTEKOR 20 mg

Benazepril hydrochloride

20 mg

Film-coated tablets

Dogs

Treatment of heart failure

Greece

PREMIER SHUKUROGLOU HELLAS

Av.Mesogeion 198

15561 HOLARGOS

GREECE

FORTEKOR Flavour 5

Benazepril hydrochloride

5 mg

Tablets

Dogs

Treatment of heart failure

Greece

PREMIER SHUKUROGLOU HELLAS

Av.Mesogeion 198

15561 HOLARGOS

GREECE

FORTEKOR Flavour 20

Benazepril hydrochloride

20 mg

Tablets

Dogs

Treatment of heart failure

Hungary

Novartis Animal Health d.o.o.

Verovškova 57

1000 Ljubljana

Slovenia

Fortekor 5 mg ízesített tabletta

Benazepril hydrochloride

5 mg

Tablets

Dogs

For the treatment of heart failure in dogs.

Hungary

Novartis Animal Health d.o.o.

Verovškova 57

1000 Ljubljana

Slovenia

Fortekor 20 mg ízesített tabletta

Benazepril hydrochloride

20 mg

Tablets

Dogs

For the treatment of heart failure in dogs.

Ireland

Novartis Animal Health UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey

GU16 7SR

United Kingdom

FORTEKOR 5 mg film-coated tablets for dogs and cats.

Benazepril hydrochloride

5 mg

Film-coated tablets

Dogs and cats

Treatment of heart failure in dogs. Treatment of chronic renal insufficiency in cats.

Ireland

Novartis Animal Health UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey

GU16 7SR

United Kingdom

Fortekor 20 mg Film-coated tablets for Dogs

Benazepril hydrochloride

20 mg

Tablets

Dogs

Treatment of heart failure in dogs.

Ireland

Novartis Animal Health UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey

GU16 7SR

United Kingdom

Fortekor 2,5 mg tablets for Dogs and Cats

Benazepril hydrochloride

2,5 mg

Tablets

Dogs and cats

Treatment of heart failure in dogs. Treatment of chronic renal insufficiency in cats.

Italy

Novartis Animal Health S.p.A.

largo Boccioni 1

21040 Origgio (VA)

Italy

Fortekor 5

Benazepril hydrochloride

5 mg

Film-coated tablets

Dogs and cats

Dogs: Treatment of heart failure at stages 2,3 and 4. For slowing the renal damage progression in chronic kidney disease with proteinuria. Cats: Treatment of chronic renal insufficiency.

Italy

Novartis Animal Health S.p.A.

largo Boccioni 1

21040 Origgio (VA)

Italy

Fortekor Flavour 5

Benazepril hydrochloride

5 mg

Tablets

Dogs

Treatment of heart failure at 2nd- 3rd and 4th stage. Slow down of the progression of renal damage in chronic kidney disease with proteinuria.

Italy

Novartis Animal Health S.p.A.

largo Boccioni 1

21040 Origgio (VA)

Italy

Fortekor 20

Benazepril hydrochloride

20 mg

Film-coated tablets

Dogs

Dogs: Treatment of heart failure at stages 2,3 and 4. For slowing the renal damage progression in chronic kidney disease with proteinuria.

Italy

Novartis Animal Health S.p.A.

largo Boccioni 1

21040 Origgio (VA)

Italy

Fortekor Flavour 20

Benazepril hydrochloride

20 mg

Tablets

Dogs

Treatment of heart failure at 2nd- 3rd and 4th stage. Slow down of the progression of renal damage in chronic kidney disease with proteinuria.

Italy

Novartis Animal Health S.p.A.

largo Boccioni 1

21040 Origgio (VA)

Italy

Fortekor 2,5

Benazepril hydrochloride

2,5 mg

Tablets

Dogs and cats

Dogs: Treatment of heart failure at stages 2,3 and 4. For slowing the renal damage progression in chronic kidney disease with proteinuria. Cats: Treatment of chronic renal insufficiency.

Luxembourg

Novartis Consumer Health B.V.

Claudius Prinsenlaan 142

4818 CP Breda

The Netherlands

FORTEKOR 5

Benazepril hydrochloride

5 mg

Film-coated tablets

Dogs and cats

Dog: Treatment of heart failure

Cat: Retardation of chronic renal insufficiency by reducing the blood pressure.

Luxembourg

Novartis Consumer Health B.V.

Claudius Prinsenlaan 142

4818 CP Breda

The Netherlands

FORTEKOR Flavour 5

Benazepril hydrochloride

5 mg

Tablets

Dogs

Treatment of heart failure

Luxembourg

Novartis Consumer Health B.V.

Claudius Prinsenlaan 142

4818 CP Breda

The Netherlands

Fortekor 20

Benazepril hydrochloride

20 mg

Film-coated tablets

Dogs

Treatment of heart failure

Luxembourg

Novartis Consumer Health B.V.

Claudius Prinsenlaan 142

4818 CP Breda

The Netherlands

Fortekor Flavour 20

Benazepril hydrochloride

20 mg

Tablets

Dogs

Treatment of heart failure

Luxembourg

Novartis Consumer Health B.V.

Claudius Prinsenlaan 142

4818 CP Breda

The Netherlands

Fortekor 2,5

Benazepril hydrochloride

2,5 mg

Tablets

Dogs and cats

Dog: Treatment of heart failure

Cat: Retardation of chronic renal insufficiency by reducing the blood pressure.

Norway

Novartis Healthcare A/S Animal Health

Lyngbyvej 172

2100 København Ø

Danmark

Fortekor vet 5 mg

Benazepril hydrochloride

5 mg

Tablets

Dogs

Treatment of heart failure, especially dilated cardiomyopathy and mitral failure.

Norway

Novartis Healthcare A/S Animal Health

Lyngbyvej 172

2100 København Ø

Danmark

Fortekor vet 20 mg

Benazepril hydrochloride

20 mg

Tablets

Dogs

Treatment of heart failure, especially dilated cardiomyopathy and mitral failure.

Norway

Novartis Healthcare A/S Animal Health

Lyngbyvej 172

2100 København Ø

Danmark

Fortekor vet 2,5 mg

Benazepril hydrochloride

2,5 mg

Tablets

Dogs and cats

Dog: Treatment of heart failure, especially dilated cardiomyopathy and mitral failure.

Cat: Experimentally to reduce proteinuria in chronic renal failure in which baseline protein/creatinine ratio PCR is > 1.

Poland

Novartis Animal Health d.o.o.

Verovškova 57

1000 Ljubljana

Slovenia

FORTEKOR 5, tabletki powlekane dla pśow i kotów

Benazepril hydrochloride

5 mg

Film-coated tablets

Dogs and cats

For dogs -Treatment of heart failure

For cats -Treatment of chronic renal insufficiency

Poland

Novartis Animal Health d.o.o.

Verovškova 57

1000 Ljubljana

Slovenia

FORTEKOR 20, tabletki powlekane dla pśow

Benazepril hydrochloride

20 mg

Film-coated tablets

Dogs

For dogs -Treatment of heart failure

Portugal

Novartis Farma-Produtos Farmacêuticos, S.A.

Rua do Centro Empresarial, Edifício 8 Quinta da Beloura

2710-444 Sintra

Portugal

FORTEKOR 5 mg comprimidos revestidos para cães e gatos

Benazepril hydrochloride

5 mg

Film-coated tablets

Dogs and cats

Dogs: Treatment of heart failure

Cats: Treatment of renal insufficiency

Portugal

Novartis Farma-Produtos Farmacêuticos, S.A.

Rua do Centro Empresarial, Edifício 8 Quinta da Beloura

2710-444 Sintra

Portugal

FORTEKOR Palatável 5 mg comprimidos para cães e gatos

Benazepril hydrochloride

5 mg

Tablets

Dogs and cats

Dogs: Treatment of heart failure. Indicated in chronic renal insufficiency to slow its progression.

Cats: Treatment of chronic renal insufficiency.

Portugal

Novartis Farma-Produtos Farmacêuticos, S.A.

Rua do Centro Empresarial, Edifício 8 Quinta da Beloura

2710-444 Sintra

Portugal

FORTEKOR 20 mg comprimidos revestidos para cães

Benazepril hydrochloride

20 mg

Film-coated tablets

Dogs

Dogs: Treatment of heart failure

Portugal

Novartis Farma-Produtos Farmacêuticos, S.A.

Rua do Centro Empresarial, Edifício 8 Quinta da Beloura

2710-444 Sintra

Portugal

FORTEKOR Palatável 20 mg comprimidos para cães

Benazepril hydrochloride

20 mg

Tablets

Dogs

Dogs: Treatment of heart failure. Indicated in chronic renal insufficiency to slow its progression.

Portugal

Novartis Farma-Produtos Farmacêuticos, S.A.

Rua do Centro Empresarial, Edifício 8 Quinta da Beloura

2710-444 Sintra

Portugal

FORTEKOR Palatável 2,5 mg comprimidos para cães e gatos

Benazepril hydrochloride

2,5 mg

Tablets

Dogs and cats

Dogs: Treatment of heart failure. Indicated in chronic renal insufficiency to slow its progression.

Cats: Treatment of chronic renal insufficiency.

Romania

Novartis Animal Health d.o.o.

Verovškova 57

1000 Ljubljana

Slovenia

FORTEKOR 5

Benazepril hydrochloride

5 mg

Film-coated tablets

Dogs

For treatment of heart failure in dogs.

Romania

Novartis Animal Health d.o.o.

Verovškova 57

1000 Ljubljana

Slovenia

FORTEKOR 20

Benazepril hydrochloride

20 mg

Film-coated tablets

Dogs

For treatment of heart failure in dogs.

Slovakia

Novartis Animal Health d.o.o.

Verovškova 57

1000 Ljubljana

Slovenia

FORTEKOR 5 mg tbl.ad us.vet

Benazepril hydrochloride

5 mg

Film-coated tablets

Dogs and cats

Treatment of heart failure in dogs. Treatment of chronic kidney insufficiency in cats.

Slovenia

Novartis Veterina d.o.o.

Verovškova 57

1000 Ljubljana

Slovenia

FORTEKOR 5 mg filmsko obložene tablete za pse

Benazepril hydrochloride

5 mg

Film-coated tablets

Dogs

Treatment of heart failure in dogs.

Slovenia

Novartis Veterina d.o.o.

Verovškova 57

1000 Ljubljana

Slovenia

FORTEKOR 20 mg filmsko obložene tablete za pse

Benazepril hydrochloride

20 mg

Film-coated tablets

Dogs

Treatment of heart failure in dogs.

Spain

NOVARTIS SANIDAD ANIMAL, S.L.

Calle de la Marina, 206

08013 Barcelona

Spain

FORTEKOR 5

Benazepril hydrochloride

5 mg

Film-coated tablets

Dogs and cats

Dogs: Treatment of heart failure.

Diuretics and/or antiarrhythmics may be used with benazepril when judged appropriate by the veterinarian, but whenever it is thought to be appropriate benazepril alone may be used.

Cats: Treatment of chronic renal insufficiency.

Spain

NOVARTIS SANIDAD ANIMAL, S.L.

Calle de la Marina, 206

08013 Barcelona

Spain

FORTEKOR SABOR 5 mg

Benazepril hydrochloride

5 mg

Tablets

Dogs

Dogs: Treatment of heart failure in dogs. It is indicated in chronic renal insufficiency to slow down its progression.

Spain

NOVARTIS SANIDAD ANIMAL, S.L.

Calle de la Marina, 206

08013 Barcelona

Spain

FORTEKOR 20

Benazepril hydrochloride

20 mg

Film-coated tablets

Dogs

Dogs: Treatment of heart failure. Diuretics and/or antiarrhythmics may be used with benazepril when judged appropriate by the veterinarian, but whenever it is thought to be appropriate benazepril alone may be used.

Spain

NOVARTIS SANIDAD ANIMAL, S.L.

Calle de la Marina, 206

08013 Barcelona

Spain

FORTEKOR SABOR 20 mg

Benazepril hydrochloride

20 mg

Tablets

Dogs

Dogs: Treatment of heart failure in dogs. It is indicated in chronic renal insufficiency to slow down its progression.

Spain

NOVARTIS SANIDAD ANIMAL, S.L.

Calle de la Marina, 206

08013 Barcelona

Spain

FORTEKOR SABOR 2,5 mg

Benazepril hydrochloride

2,5 mg

Tablets

Dogs and cats

Dogs: Treatment of heart failure in dogs. It is indicated in chronic renal insufficiency to slow down its progression.

Cats: Treatment of chronic renal insufficiency.

Sweden

Novartis Healthcare A/S, Animal Health

Lyngbyvej 172

2100 Köpenhamn

Danmark

Fortekor vet 5 mg

Benazepril hydrochloride

5 mg

Tablets

Dogs

Treatment of heart failure, especially dilated cardiomyopathy and mitral failure.

Sweden

Novartis Healthcare A/S, Animal Health

Lyngbyvej 172

2100 Köpenhamn

Danmark

Fortekor vet 20 mg

Benazepril hydrochloride

20 mg

Tablets

Dogs

Treatment of heart failure, especially dilated cardiomyopathy and mitral failure.

Sweden

Novartis Healthcare A/S, Animal Health

Lyngbyvej 172

2100 Köpenhamn

Danmark

Fortekor vet 2,5 mg

Benazepril hydrochloride

2,5 mg

Tablets

Dogs

Treatment of heart failure, especially dilated cardiomyopathy and mitral failure.

The Netherlands

Novartis Consumer Health BV

Claudius Prinsenlaan 142

4818 CP Breda

The Netherlands

Fortekor 5

Benazepril hydrochloride

5 mg

Film-coated tablets

Dogs and cats

Dogs: For the symptomatic, adjunctive therapy in the treatment with the diuretic furosemide of heart failure caused by mitral failure or congestive cardiomyopathy.

The treatment may improve the effort tolerance and increase survival of dogs with moderate to severe heart failure.

Cats: Treatment of chronic renal failure.

The Netherlands

Novartis Consumer Health BV

Claudius Prinsenlaan 142

4818 CP Breda

The Netherlands

FORTEKOR FLAVOUR 5

Benazepril hydrochloride

5 mg

Tablets

Dogs and cats

Dogs: For the symptomatic, adjunctive therapy in the treatment with the diuretic furosemide of heart failure caused by mitral failure or congestive cardiomyopathy.

The treatment may improve the effort tolerance and increase survival of dogs with moderate to severe heart failure.

Cats: Treatment of chronic renal failure.

The Netherlands

Novartis Consumer Health BV

Claudius Prinsenlaan 142

4818 CP Breda

The Netherlands

Fortekor 20

Benazepril hydrochloride

20 mg

Film-coated tablets

Dogs

Dogs: For the symptomatic, adjunctive therapy in the treatment with the diuretic furosemide of heart failure caused by mitral failure or congestive cardiomyopathy.

The treatment may improve the effort tolerance and increase survival of dogs with moderate to severe heart failure.

The Netherlands

Novartis Consumer Health BV

Claudius Prinsenlaan 142

4818 CP Breda

The Netherlands

Fortekor Flavour 20

Benazepril hydrochloride

20 mg

Tablets

Dogs

Dogs: For the symptomatic, adjunctive therapy in the treatment with the diuretic furosemide of heart failure caused by mitral failure or congestive cardiomyopathy.

The Netherlands

Novartis Consumer Health BV

Claudius Prinsenlaan 142

4818 CP Breda

The Netherlands

Fortekor 2,5

Benazepril hydrochloride

2,5 mg

Tablets

Dogs and cats

Dogs: For the symptomatic, adjunctive therapy in the treatment with the diuretic furosemide of heart failure caused by mitral failure or congestive cardiomyopathy. Cats: Treatment of chronic renal failure.

United Kingdom

Novartis Animal Health UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey

GU16 7SR

United Kingdom

Fortekor 5 mg Film-coated Tablets for Dogs and Cats

Benazepril hydrochloride

5 mg

Film-coated tablets

Dogs and cats

Treatment of heart failure in dogs.

Treatment of chronic renal insufficiency in cats.

United Kingdom

Novartis Animal Health UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey

GU16 7SR

United Kingdom

Fortekor 20 mg Film-coated tablets for Dogs

Benazepril hydrochloride

20 mg

Film-coated tablets

Dogs

Treatment of heart failure in dogs.

United Kingdom

Novartis Animal Health UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey

GU16 7SR

United Kingdom

Fortekor 2,5 mg tablets for Dogs and Cats

Benazepril hydrochloride

2,5 mg

Tablets

Dogs and cats

Treatment of heart failure in dogs.

Treatment of chronic renal insufficiency in cats.

ANNEX II

LIST OF THE INVENTED NAME(S), PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES

Member State

EU/EEA

Marketing authorisaton holder

Product name

Strength

Pharmaceutical form

Route of administration

AT - Austria

Pfizer Corporation Austria Gesellschaft m.b.H.

Floridsdorfer Hauptstraße 1

1210 Wien

Austria

Genotropin 12 mg - Pulver und Lösungsmittel zur Herstellung einer Injektionslösung

12 mg

powder and solvent for solution for injection

Subcutaneous use

AT - Austria

Pfizer Corporation Austria Gesellschaft m.b.H.

Floridsdorfer Hauptstraße 1

1210 Wien

Austria

Genotropin 5,3 mg - Pulver und Lösungsmittel zur Herstellung einer Injektionslösung

5,3 mg

powder and solvent for solution for injection

Subcutaneous use

AT - Austria

Pfizer Corporation Austria Gesellschaft m.b.H.

Floridsdorfer Hauptstraße 1

1210 Wien

Austria

Genotropin MiniQuick 0,2 mg - Pulver und Lösungsmittel zur Herstellung einer Injektionslösung

0,2 mg

powder and solvent for solution for injection

Subcutaneous use

AT - Austria

Eli Lilly GmbH

Kölblgasse 8- 10

1030 Wien

Austria

Humatrope 12 mg - Pulver und Lösungsmittel zur Herstellung einer Injektionslösung

12 mg

powder and solvent for solution for injection

Subcutaneous use

AT - Austria

Eli Lilly GmbH

Kölblgasse 8- 10

1030 Wien

Austria

Humatrope 24 mg - Pulver und Lösungsmittel zur Herstellung einer Injektionslösung

24 mg

powder and solvent for solution for injection

Subcutaneous use

AT - Austria

Eli Lilly GmbH

Kölblgasse 8- 10

1030 Wien

Austria

Humatrope 6 mg - Pulver und Lösungsmittel zur Herstellung einer Injektionslösung

6 mg

powder and solvent for solution for injection

Subcutaneous use

AT - Austria

Novo Nordisk Pharma GmbH

Opernring 3-5

1010 Wien

Austria

Norditropin FlexPro 10 mg/1,5 ml Injektionslösung in einem Fertigpen

10 mg/1,5 ml

solution for injection, in pre-filled pen

Subcutaneous use

AT - Austria

Novo Nordisk Pharma GmbH

Opernring 3-5

1010 Wien

Austria

Norditropin FlexPro 15 mg/1,5 ml Injektionslösung in einem Fertigpen

15 mg/1,5 ml

solution for injection, in pre-filled pen

Subcutaneous use

AT - Austria

Novo Nordisk Pharma GmbH

Opernring 3-5

1010 Wien

Austria

Norditropin FlexPro 5 mg/1,5 ml Injektionslösung in einem Fertigpen

5 mg/1,5 ml

solution for injection, in pre-filled pen

Subcutaneous use

AT - Austria

Novo Nordisk Pharma GmbH

Opernring 3-5

1010 Wien

Austria

Norditropin NordiFlex 10 mg/1,5 ml - Injektionslösung in einem Fertigpen

10 mg/1,5 ml

solution for injection, in pre-filled pen

Subcutaneous use

AT - Austria

Novo Nordisk Pharma GmbH

Opernring 3-5

1010 Wien

Austria

Norditropin NordiFlex 15 mg/1,5 ml - Injektionslösung in einem Fertigpen

15 mg/1,5 ml

solution for injection, in pre-filled pen

Subcutaneous use

AT - Austria

Novo Nordisk Pharma GmbH

Opernring 3-5

1010 Wien

Austria

Norditropin NordiFlex 5 mg/1,5 ml - Injektionslösung in einem Fertigpen

5 mg/1,5 ml

solution for injection, in pre-filled pen

Subcutaneous use

AT - Austria

Novo Nordisk Pharma GmbH

Opernring 3-5

1010 Wien

Austria

Norditropin SimpleXx 10 mg/1,5 ml - Injektionslösung

10 mg/1,5 ml

solution for injection

Subcutaneous use

AT - Austria

Novo Nordisk Pharma GmbH

Opernring 3-5

1010 Wien

Austria

Norditropin SimpleXx 15 mg/1,5 ml - Injektionslösung

15 mg/1,5 ml

solution for injection

Subcutaneous use

AT - Austria

Novo Nordisk Pharma GmbH

Opernring 3-5

1010 Wien

Austria

Norditropin SimpleXx 5 mg/1,5 ml - Injektionslösung

5 mg/1,5 ml

solution for injection

Subcutaneous use

AT - Austria

Merck Gesellschaft mbH

Zimbagasse 5

1147 Wien

Austria

Saizen 8 mg click.easy - Pulver und Lösungsmittel zur Herstellung einer Injektionslösung

8 mg

powder and solvent for solution for injection

Subcutaneous use

AT - Austria

Merck Gesellschaft mbH

Zimbagasse 5

1147 Wien

Austria

Saizen 1,33 mg - Pulver und Lösungsmittel zur Herstellung einer Injektionslösung

1,33 mg

powder and solvent for solution for injection

Subcutaneous use

AT - Austria

Merck Gesellschaft mbH

Zimbagasse 5

1147 Wien

Austria

Saizen 5,83 mg/ml Injektionslösung

5,83 mg/ml

solution for injection

Subcutaneous use

AT - Austria

Merck Gesellschaft mbH

Zimbagasse 5

1147 Wien

Austria

Saizen 8 mg/ml Injektionslösung

8 mg/ml

solution for injection

Subcutaneous use

AT - Austria

Ferring Arzneimittel GmbH

Wienerbergstr. 11, Vienna Twin Tower Turm West 10.OG

1100 Wien,

Austria

Zomacton 10 mg/ml Pulver und Lösungsmittel zur Herstellung einer Injektionslösung in einer Fertigspritze

10 mg/ml

powder and solvent for solution for injection in a prefilled pen

Subcutaneous use

AT - Austria

Ferring Arzneimittel GmbH

Wienerbergstr. 11, Vienna Twin Tower Turm West 10.OG

1100 Wien,

Austria

Zomacton 4 mg - Trockenstechampullen mit Lösungsmittel

4 mg

powder and solvent for solution for injection

Subcutaneous use

BE - Belgium

PFIZER SA

Bld de la Plaine, 17

1050 Brussels

Belgium

Genotonorm

1,3 mg

powder and solvent for solution for injection

Subcutaneous use

BE - Belgium

PFIZER SA

Bld de la Plaine, 17

1050 Brussels

Belgium

Genotonorm

12 mg

powder and solvent for solution for injection

Subcutaneous use

BE - Belgium

PFIZER SA

Bld de la Plaine, 17

1050 Brussels

Belgium

Genotonorm

5 mg

powder and solvent for solution for injection

Subcutaneous use

BE - Belgium

PFIZER SA

Bld de la Plaine, 17

1050 Brussels

Belgium

Genotonorm

5,3 mg

powder and solvent for solution for injection

Subcutaneous use

BE - Belgium

PFIZER SA

Bld de la Plaine, 17

1050 Brussels

Belgium

Genotonorm Miniquick

0,2 mg

powder and solvent for solution for injection

Subcutaneous use

BE - Belgium

PFIZER SA

Bld de la Plaine, 17

1050 Brussels

Belgium

Genotonorm Miniquick

0,4 mg

powder and solvent for solution for injection

Subcutaneous use

BE - Belgium

PFIZER SA

Bld de la Plaine, 17

1050 Brussels

Belgium

Genotonorm Miniquick

0,6 mg

powder and solvent for solution for injection

Subcutaneous use

BE - Belgium

PFIZER SA

Bld de la Plaine, 17

1050 Brussels

Belgium

Genotonorm Miniquick

0,8 mg

powder and solvent for solution for injection

Subcutaneous use

BE - Belgium

PFIZER SA

Bld de la Plaine, 17

1050 Brussels

Belgium

Genotonorm Miniquick

1 mg

powder and solvent for solution for injection

Subcutaneous use

BE - Belgium

PFIZER SA

Bld de la Plaine, 17

1050 Brussels

Belgium

Genotonorm Miniquick

1,2 mg

powder and solvent for solution for injection

Subcutaneous use

BE - Belgium

PFIZER SA

Bld de la Plaine, 17

1050 Brussels

Belgium

Genotonorm Miniquick

1,4 mg

powder and solvent for solution for injection

Subcutaneous use

BE - Belgium

PFIZER SA

Bld de la Plaine, 17

1050 Brussels

Belgium

Genotonorm Miniquick

1,6 mg

powder and solvent for solution for injection

Subcutaneous use

BE - Belgium

PFIZER SA

Bld de la Plaine, 17

1050 Brussels

Belgium

Genotonorm Miniquick

1,8 mg

powder and solvent for solution for injection

Subcutaneous use

BE - Belgium

PFIZER SA

Bld de la Plaine, 17

1050 Brussels

Belgium

Genotonorm Miniquick

2 mg

powder and solvent for solution for injection

Subcutaneous use

BE - Belgium

ELI LILLY BENELUX SA

Rue de l'Etuve 52/1

1000 Brussels

Belgium

Humatrope

6 mg

powder and solvent for solution for injection

Subcutaneous use

BE - Belgium

ELI LILLY BENELUX SA

Rue de l'Etuve 52/1

1000 Brussels

Belgium

Humatrope

12 mg

powder and solvent for solution for injection

Subcutaneous use

BE - Belgium

ELI LILLY BENELUX SA

Rue de l'Etuve 52/1

1000 Brussels

Belgium

Humatrope

24 mg

powder and solvent for solution for injection

Subcutaneous use

BE - Belgium

NOVO NORDISK PHARMA SA

Boulevard international 55

1070 Brussels

Belgium

Norditropin Flexpro

10 mg/1,5 ml

Solution for injection

Subcutaneous use

BE - Belgium

NOVO NORDISK PHARMA SA

Boulevard international 55

1070 Brussels

Belgium

Norditropin Flexpro

15 mg/1,5 ml

Solution for injection

Subcutaneous use

BE - Belgium

NOVO NORDISK PHARMA SA

Boulevard international 55

1070 Brussels

Belgium

Norditropin Flexpro

5 mg/1,5 ml

Solution for injection

Subcutaneous use

BE - Belgium

NOVO NORDISK PHARMA SA

Boulevard international 55

1070 Brussels

Belgium

Norditropin Nordiflex

10 mg/1,5 ml

Solution for injection

Subcutaneous use

BE - Belgium

NOVO NORDISK PHARMA SA

Boulevard international 55

1070 Brussels

Belgium

Norditropin Nordiflex

15 mg/1,5 ml

Solution for injection

Subcutaneous use

BE - Belgium

NOVO NORDISK PHARMA SA

Boulevard international 55

1070 Brussels

Belgium

Norditropin Nordiflex

5 mg/1,5 ml

Solution for injection

Subcutaneous use

BE - Belgium

NOVO NORDISK PHARMA SA

Boulevard international 55

1070 Brussels

Belgium

Norditropin Simplexx

10 mg/1,5 ml

Solution for injection

Subcutaneous use

BE - Belgium

NOVO NORDISK PHARMA SA

Boulevard international 55

1070 Brussels

Belgium

Norditropin Simplexx

15 mg/1,5 ml

Solution for injection

Subcutaneous use

BE - Belgium

NOVO NORDISK PHARMA SA

Boulevard international 55

1070 Brussels

Belgium

Norditropin Simplexx

5 mg/1,5 ml

Solution for injection

Subcutaneous use

BE - Belgium

FERRING NV

Hopmarkt 9 b3

9300 Aalst

Belgium

Zomacton

10 mg/ml

powder and solvent for solution for injection

Subcutaneous use

BE - Belgium

FERRING NV

Hopmarkt 9 b3

9300 Aalst

Belgium

Zomacton

4 mg

powder and solvent for solution for injection

Subcutaneous use

BG - Bulgaria

Ferring GmbH,

Wittland 11,

D-24109 Kiel,

Germany

Zomacton

4 mg

powder and solvent for solution for injection

subcutaneous use

BG - Bulgaria

Pfizer Enterprises SARL,

Rond-point du Kirchberg,

51, Avenue J.F. Kennedy,

L-1855 Luxembourg,

Luxembourg

Genotropin

16 IU (5,3 mg)

powder and solvent for solution for injection

subcutaneous use

BG - Bulgaria

Pfizer Enterprises SARL,

Rond-point du Kirchberg,

51, Avenue J.F. Kennedy,

L-1855 Luxembourg,

Luxembourg

Genotropin

36 IU (12 mg)

powder and solvent for solution for injection

subcutaneous use

BG - Bulgaria

Novo Nordisk A/S,

Novo Alle,

DK-2880 Bagsvaerd,

Denmark

Norditropin Simplex

5 mg/1,5 ml

solution for injection

subcutaneous use

CY - Cyprus

NOVO NORDISK A/S,

Novo Allé,

DK-2880 BAGSVAERD,

DENMARK

NORDITROPIN SIMPLEXx SOLUTION FOR INJECTION 5 MG/1,5 ML

5 mg/1,5 ml

SOLUTION FOR INJECTION

SUBCUTANEOUS INJECTION

CY - Cyprus

NOVO NORDISK A/S,

Novo Allé,

DK-2880 BAGSVAERD,

DENMARK

NORDITROPIN SIMPLEXx SOLUTION FOR INJECTION 10 MG/1,5 ML

10 MG/1,5 ML

SOLUTION FOR INJECTION

SUBCUTANEOUS INJECTION

CY - Cyprus

NOVO NORDISK A/S,

Novo Allé,

DK-2880 BAGSVAERD,

DENMARK

NORDITROPIN SIMPLEXx SOLUTION FOR INJECTION 15 MG/1,5 ML

15 MG/1,5 ML

SOLUTION FOR INJECTION

SUBCUTANEOUS INJECTION

CY - Cyprus

NOVO NORDISK A/S,

Novo Allé,

DK-2880 BAGSVAERD,

DENMARK

NORDITROPIN FLEX PRO 5 mg/1,5 ml PF PEN SOLUTION FOR INJECTION

5 mg/1,5 ml

SOLUTION FOR INJECTION IN A PRE-FILLED PEN

SUBCUTANEOUS INJECTION

CY - Cyprus

NOVO NORDISK A/S,

Novo Allé,

DK-2880 BAGSVAERD,

DENMARK

NORDITROPIN FLEX PRO 10 mg/1,5 ml SOL FOR INJECTION PF PEN

10 MG/1,5 ML

SOLUTION FOR INJECTION IN A PRE-FILLED PEN

SUBCUTANEOUS INJECTION

CY - Cyprus

NOVO NORDISK A/S,

Novo Allé,

DK-2880 BAGSVAERD,

DENMARK

NORDITROPIN FLEX PRO 15 mg/1,5 ml SOL FOR INJECTION PF PEN

15 MG/1,5 ML

SOLUTION FOR INJECTION IN A PRE-FILLED PEN

SUBCUTANEOUS INJECTION

CZ - Czech Republic

Novo Nordisk A/S,

Novo Allé,

2880 Bagsvaerd,

Denmark

Norditropin SimpleXx 15 mg/1,5 ml

10 MG/ML

Solution for injection

subcutaneous use

CZ - Czech Republic

Novo Nordisk A/S,

Novo Allé,

2880 Bagsvaerd,

Denmark

Norditropin SimpleXx 10 mg/1,5 ml

6,7 MG/ML

Solution for injection

subcutaneous use

CZ - Czech Republic

Novo Nordisk A/S,

Novo Allé,

2880 Bagsvaerd,

Denmark

Norditropin SimpleXx 5 mg/1,5 ml

3,3 MG/ML

Solution for injection

subcutaneous use

CZ - Czech Republic

Merck Serono Europe Ltd

56 Marsh Wall

London

N14 9TP

United Kingdom

Saizen 8 mg click.easy

5,83 MG/ML

Powder and solvent for solution for infusion

subcutaneous use

CZ - Czech Republic

Merck Serono Europe Ltd

56 Marsh Wall

London

N14 9TP

United Kingdom

SAIZEN 5,83 MG/ML INJEKČNÍ ROZTOK

5,83 MG/ML

Solution for injection

subcutaneous use

CZ - Czech Republic

Merck Serono Europe Ltd

56 Marsh Wall

London

N14 9TP

United Kingdom

SAIZEN 8 MG/ML INJEKČNÍ ROZTOK

8 MG/ML

Solution for injection

subcutaneous use

CZ - Czech Republic

PFIZER spol. s r.o.,

Stroupežnického 17,

150 00 Praha 5,

Czech Republic

GENOTROPIN 16 m.j. (5,3 mg)

16 UT/ML

Powder and solvent for solution for infusion

subcutaneous use

CZ - Czech Republic

PFIZER spol. s r.o.,

Stroupežnického 17,

150 00 Praha 5,

Czech Republic

GENOTROPIN 36 m.j. (12 mg)

36 UT/ML

Powder and solvent for solution for infusion

subcutaneous use

CZ - Czech Republic

Ferring GmbH,

Wittland 11,

D-24109 Kiel,

Germany

ZOMACTON 4 mg

1,3 mg/ml or 3,3 mg/ml after diluting with water

Powder and solvent for solution for infusion

subcutaneous use

CZ - Czech Republic

ELI LILLY ČR, s.r.o.,

Pobřežní 12,

180 00 Praha 8,

Czech Republic

Humatrope 18 IU (6 mg)

18 UT

Powder and solvent for solution for infusion

subcutaneous use

CZ - Czech Republic

ELI LILLY ČR, s.r.o.,

Pobřežní 12,

180 00 Praha 8,

Czech Republic

Humatrope 36 IU (12 mg)

36 UT

Powder and solvent for solution for infusion

subcutaneous use

CZ - Czech Republic

ELI LILLY ČR, s.r.o.,

Pobřežní 12,

180 00 Praha 8,

Czech Republic

Humatrope 72 IU (24 mg)

72 UT

Powder and solvent for solution for infusion

subcutaneous use

CZ - Czech Republic

Ferring GmbH,

Wittland 11,

D-24109 Kiel,

Germany

ZOMACTON 10 mg

10 MG/1 ML

Powder and solvent for solution for infusion

subcutaneous use

CZ - Czech Republic

Novo Nordisk A/S,

Novo Allé,

2880 Bagsvaerd,

Denmark

Norditropin FlexPro 5 mg/1,5 ml

5 MG/1,5 ML

Solution for injection

subcutaneous use

CZ - Czech Republic

Novo Nordisk A/S,

Novo Allé,

2880 Bagsvaerd,

Denmark

Norditropin FlexPro 10 mg/1,5 ml

10 MG/1,5 ML

Solution for injection

subcutaneous use

CZ - Czech Republic

Novo Nordisk A/S,

Novo Allé,

2880 Bagsvaerd,

Denmark

Norditropin FlexPro 15 mg/1,5 ml

15 MG/1,5 ML

Solution for injection

subcutaneous use

DE - Germany

Ferring GmbH

Wittland 11

D-24109 Kiel

hGH-Ferring 12 (4 mg)

4,32 mg

Powder and solvent for solution for injection

Subcutanous use

DE - Germany

Ferring GmbH

Wittland 11

D-24109 Kiel

ZOMACTON 10 mg/ml Pulver und Lösungsmittel zur Herstellung einer Injektionslösung in einer Fertigspritze

10,0 mg

Powder and solvent for solution for injection

Subcutanous use

DE - Germany

Ferring GmbH

Wittland 11

D-24109 Kiel

Zomacton 4 mg

4,32 mg

Powder and solvent for solution for injection

Subcutanous use

DE - Germany

Lilly Deutschland GmbH

Teichweg 3

D-35396 Gießen

Humatrope für Pen 12 mg Pulver und Lösungsmittel zur Herstellung einer Injektionslösung

12,0 mg

Powder and solvent for solution for injection

Subcutanous use,

intramuscular use

DE - Germany

Lilly Deutschland GmbH

Teichweg 3

D-35396 Gießen

Humatrope für Pen 24 mg Pulver und Lösungsmittel zur Herstellung einer Injektionslösung

24,0 mg

Powder and solvent for solution for injection

Subcutanous use,

intramuscular use

DE - Germany

Lilly Deutschland GmbH

Teichweg 3

D-35396 Gießen

Humatrope für Pen 6 mg Pulver und Lösungsmittel zur Herstellung einer Injektionslösung

6,0 mg

Powder and solvent for solution for injection

Subcutanous use,

intramuscular use

DE - Germany

Merck Serono GmbH

Alsfelder Str. 17

D-64289 Darmstadt

Saizen 8 mg click.easy

8,0 mg

Powder and solvent for solution for injection

Subcutanous use,

intramuscular use

DE - Germany

Novo Nordisk Pharma GmbH

Brucknerstr. 1

D-55127 Mainz

Norditropin FlexPro 10 mg/1,5 ml Injektionslösung in einem Fertigpen

6,7 mg

Solution for injection, in pre-filled pen

Subcutanous use

DE - Germany

Novo Nordisk Pharma GmbH

Brucknerstr. 1

D-55127 Mainz

Norditropin FlexPro 15 mg/1,5 ml Injektionslösung in einem Fertigpen

10,0 mg

Solution for injection, in pre-filled pen

Subcutanous use

DE - Germany

Novo Nordisk Pharma GmbH

Brucknerstr. 1

D-55127 Mainz

Norditropin FlexPro 5 mg/1,5 ml Injektionslösung in einem Fertigpen

3,3 mg

Solution for injection, in pre-filled pen

Subcutanous use

DE - Germany

Novo Nordisk Pharma GmbH

Brucknerstr. 1

D-55127 Mainz

Norditropin NordiFlex 10 mg/1,5 ml Injektionslöung in einem Fertigpen

6,7 mg

Solution for injection

Subcutanous use

DE - Germany

Novo Nordisk Pharma GmbH

Brucknerstr. 1

D-55127 Mainz

Norditropin NordiFlex 15 mg/1,5 ml Injektionslöung in einem Fertigpen

10,0 mg

Solution for injection

Subcutanous use

DE - Germany

Novo Nordisk Pharma GmbH

Brucknerstr. 1

D-55127 Mainz

Norditropin NordiFlex 5 mg/1,5 ml Injektionslöung in einem Fertigpen

3,3 mg

Solution for injection

Subcutanous use

DE - Germany

Novo Nordisk Pharma GmbH

Brucknerstr. 1

D-55127 Mainz

Norditropin Simplexx 10 mg/1,5 ml Injektionslösung

10,0 mg

Solution for injection

Subcutanous use

DE - Germany

Novo Nordisk Pharma GmbH

Brucknerstr. 1

D-55127 Mainz

Norditropin Simplexx 15 mg/1,5 ml Injektionslösung

15,0 mg

Solution for injection

Subcutanous use

DE - Germany

Novo Nordisk Pharma GmbH

Brucknerstr. 1

D-55127 Mainz

Norditropin Simplexx 5 mg/1,5 ml Injektionslösung

5,0 mg

Solution for injection

Subcutanous use

DE - Germany

Pharmacia GmbH

Linkstr. 10

D-10785 Berlin

Genotropin 12 mg

12,0 mg

Powder and solvent for solution for injection

Subcutanous use

DE - Germany

Pharmacia GmbH

Linkstr. 10

D-10785 Berlin

Genotropin 5 mg/ml

5,8 mg

Powder and solvent for solution for injection

Subcutanous use

DE - Germany

Pharmacia GmbH

Linkstr. 10

D-10785 Berlin

Genotropin 5,3 mg

5,3 mg

Powder and solvent for solution for injection

Subcutanous use

DE - Germany

Pharmacia GmbH

Linkstr. 10

D-10785 Berlin

GENOTROPIN MiniQuick 0,2 mg

0,2 mg

Powder and solvent for solution for injection

Subcutanous use

DE - Germany

Pharmacia GmbH

Linkstr. 10

D-10785 Berlin

GENOTROPIN MiniQuick 0,4 mg

0,4 mg

Powder and solvent for solution for injection

Subcutanous use

DE - Germany

Pharmacia GmbH

Linkstr. 10

D-10785 Berlin

GENOTROPIN MiniQuick 0,6 mg

0,6 mg

Powder and solvent for solution for injection

Subcutanous use

DE - Germany

Pharmacia GmbH

Linkstr. 10

D-10785 Berlin

GENOTROPIN MiniQuick 0,8 mg

0,8 mg

Powder and solvent for solution for injection

Subcutanous use

DE - Germany

Pharmacia GmbH

Linkstr. 10

D-10785 Berlin

GENOTROPIN MiniQuick 1,0 mg

1,0 mg

Powder and solvent for solution for injection

Subcutanous use

DE - Germany

Pharmacia GmbH

Linkstr. 10

D-10785 Berlin

GENOTROPIN MiniQuick 1,2 mg

1,2 mg

Powder and solvent for solution for injection

Subcutanous use

DE - Germany

Pharmacia GmbH

Linkstr. 10

D-10785 Berlin

GENOTROPIN MiniQuick 1,4 mg

1,4 mg

Powder and solvent for solution for injection

Subcutanous use

DE - Germany

Pharmacia GmbH

Linkstr. 10

D-10785 Berlin

GENOTROPIN MiniQuick 1,6 mg

1,6 mg

Powder and solvent for solution for injection

Subcutanous use

DE - Germany

Pharmacia GmbH

Linkstr. 10

D-10785 Berlin

GENOTROPIN MiniQuick 1,8 mg

1,8 mg

Powder and solvent for solution for injection

Subcutanous use

DE - Germany

Pharmacia GmbH

Linkstr. 10

D-10785 Berlin

GENOTROPIN MiniQuick 2,0 mg

2,0 mg

Powder and solvent for solution for injection

Subcutanous use

DK - Denmark

Pfizer ApS,

Lautrupvang 8,

DK-2750 Ballerup,

Denmark

Genotropin

1,3 mg

powder and solvens for injection, solution

subcutaneous use

DK - Denmark

Pfizer ApS,

Lautrupvang 8,

DK-2750 Ballerup,

Denmark

Genotropin

5,3 mg

powder and solvens for injection, solution

subcutaneous use

DK - Denmark

Pfizer ApS,

Lautrupvang 8,

DK-2750 Ballerup,

Denmark

Genotropin

5 mg

powder and solvens for injection, solution

subcutaneous use

DK - Denmark

Pfizer ApS,

Lautrupvang 8,

DK-2750 Ballerup,

Denmark

Genotropin

12 mg

powder and solvens for injection, solution

subcutaneous use

DK - Denmark

Pfizer ApS,

Lautrupvang 8,

DK-2750 Ballerup,

Denmark

Genotropin Miniquick

0,2 mg

powder and solvens for injection, solution

subcutaneous use

DK - Denmark

Pfizer ApS,

Lautrupvang 8,

DK-2750 Ballerup,

Denmark

Genotropin Miniquick

0,4 mg

powder and solvens for injection, solution

subcutaneous use

DK - Denmark

Pfizer ApS,

Lautrupvang 8,

DK-2750 Ballerup,

Denmark

Genotropin Miniquick

0,6 mg

powder and solvens for injection, solution

subcutaneous use

DK - Denmark

Pfizer ApS,

Lautrupvang 8,

DK-2750 Ballerup,

Denmark

Genotropin Miniquick

0,8 mg

powder and solvens for injection, solution

subcutaneous use

DK - Denmark

Pfizer ApS,

Lautrupvang 8,

DK-2750 Ballerup,

Denmark

Genotropin Miniquick

1,0 mg

powder and solvens for injection, solution

subcutaneous use

DK - Denmark

Pfizer ApS,

Lautrupvang 8,

DK-2750 Ballerup,

Denmark

Genotropin Miniquick

1,2 mg

powder and solvens for injection, solution

subcutaneous use

DK - Denmark

Pfizer ApS,

Lautrupvang 8,

DK-2750 Ballerup,

Denmark

Genotropin Miniquick

1,4 mg

powder and solvens for injection, solution

subcutaneous use

DK - Denmark

Pfizer ApS,

Lautrupvang 8,

DK-2750 Ballerup,

Denmark

Genotropin Miniquick

1,6 mg

powder and solvens for injection, solution

subcutaneous use

DK - Denmark

Pfizer ApS,

Lautrupvang 8,

DK-2750 Ballerup,

Denmark

Genotropin Miniquick

1,8 mg

powder and solvens for injection, solution

subcutaneous use

DK - Denmark

Pfizer ApS,

Lautrupvang 8,

DK-2750 Ballerup,

Denmark

Genotropin Miniquick

2,0 mg

powder and solvens for injection, solution

subcutaneous use

DK - Denmark

Eli Lilly Danmark A/S,

Nybrovej 110,

DK-2800 Kongens Lyngby,

Denmark

Humatrope

6 mg

powder and solvens for injection, solution

subcutaneous use

DK - Denmark

Eli Lilly Danmark A/S,

Nybrovej 110,

DK-2800 Kongens Lyngby,

Denmark

Humatrope

12 mg

powder and solvens for injection, solution

subcutaneous use

DK - Denmark

Eli Lilly Danmark A/S,

Nybrovej 110,

DK-2800 Kongens Lyngby,

Denmark

Humatrope

24 mg

powder and solvens for injection, solution

subcutaneous use

DK - Denmark

Novo Nordisk A/S,

Novo Allé,

DK-2880 Bagsværd,

Denmark

Norditropin Flexpro

10 mg/1,5 mL

Solution for injection, prefilled pen

subcutaneous use

DK - Denmark

Novo Nordisk A/S,

Novo Allé,

DK-2880 Bagsværd,

Denmark

Norditropin Flexpro

15 mg/1,5 mL

Solution for injection, prefilled pen

subcutaneous use

DK - Denmark

Novo Nordisk A/S,

Novo Allé,

DK-2880 Bagsværd,

Denmark

Norditropin Flexpro

5 mg/1,5 mL

Solution for injection, prefilled pen

subcutaneous use

DK - Denmark

Novo Nordisk A/S,

Novo Allé,

DK-2880 Bagsværd,

Denmark

Norditropin NordiFlex

5 mg/1,5 mL

Solution for injection, prefilled syringe

subcutaneous use

DK - Denmark

Novo Nordisk A/S,

Novo Allé,

DK-2880 Bagsværd,

Denmark

Norditropin NordiFlex

10 mg/1,5 mL

Solution for injection, prefilled syringe

subcutaneous use

DK - Denmark

Novo Nordisk A/S,

Novo Allé,

DK-2880 Bagsværd,

Denmark

Norditropin NordiFlex

15 mg/1,5 mL

Solution for injection, prefilled syringe

subcutaneous use

DK - Denmark

Novo Nordisk A/S,

Novo Allé,

DK-2880 Bagsværd,

Denmark

Norditropin Nordilet

5 mg/1,5 mL

Solution for injection, prefilled syringe

subcutaneous use

DK - Denmark

Novo Nordisk A/S,

Novo Allé,

DK-2880 Bagsværd,

Denmark

Norditropin Nordilet

10 mg/1,5 mL

Solution for injection, prefilled syringe

subcutaneous use

DK - Denmark

Novo Nordisk A/S,

Novo Allé,

DK-2880 Bagsværd,

Denmark

Norditropin Nordilet

15 mg/1,5 mL

Solution for injection, prefilled syringe

subcutaneous use

DK - Denmark

Novo Nordisk A/S,

Novo Allé,

DK-2880 Bagsværd,

Denmark

Norditropin Simplexx

5 mg/1,5 mL

Solution for injection

subcutaneous use

DK - Denmark

Novo Nordisk A/S,

Novo Allé,

DK-2880 Bagsværd,

Denmark

Norditropin Simplexx

10 mg/1,5 mL

Solution for injection

subcutaneous use

DK - Denmark

Novo Nordisk A/S,

Novo Allé,

DK-2880 Bagsværd,

Denmark

Norditropin Simplexx

15 mg/1,5 mL

Solution for injection

subcutaneous use

DK - Denmark

Ferring Lægemidler A/S,

Kay Fiskers Plads 11,

DK-2300 Købenahvn S,

Denmark

Zomacton

4 mg

powder and solvens for solution for injection

subcutaneous use

DK - Denmark

Ferring Lægemidler A/S,

Kay Fiskers Plads 11,

DK-2300 Købenahvn S,

Denmark

Zomacton

10 mg/mL

powder and solvens for solution for injection, prefilled syringe

subcutaneous use

EL - Greece

NOVO NORDISK HELLAS

Panagouli 80 & Agias Triadas 65,

Agia Paraskevi 15343

NORDITROPIN SIMPLEXX

5 MG/1,5 ML CARTRIDGE

Solution for Injection

Subcutaneous

EL - Greece

NOVO NORDISK HELLAS

Panagouli 80 & Agias Triadas 65,

Agia Paraskevi 15343

NORDITROPIN SIMPLEXX

10 MG/1,5 ML CARTRIDGE

Solution for Injection

Subcutaneous

EL - Greece

NOVO NORDISK HELLAS

Panagouli 80 & Agias Triadas 65,

Agia Paraskevi 15343

NORDITROPIN SIMPLEXX

15 MG/1,5 ML CARTRIDGE

Solution for Injection

Subcutaneous

EL - Greece

NOVO NORDISK HELLAS

Panagouli 80 & Agias Triadas 65,

Agia Paraskevi 15343

NORDITROPIN FLEXPRO

5 MG/1,5 ML

Injection Solution Prefilled Syringe

Subcutaneous

EL - Greece

NOVO NORDISK HELLAS

Panagouli 80 & Agias Triadas 65,

Agia Paraskevi 15343

NORDITROPIN FLEXPRO

10 MG/1,5 ML

Injection Solution Prefilled Syringe

Subcutaneous

EL - Greece

NOVO NORDISK HELLAS

Panagouli 80 & Agias Triadas 65,

Agia Paraskevi 15343

NORDITROPIN FLEXPRO

15 MG/1,5 ML

Injection Solution Prefilled Syringe

Subcutaneous

EL - Greece

Pfizer Hellas S.A.

234, Messoghion Ave.,

Neo Psychiko 15451,

Athens,

Greece

GENOTROPIN

5 mg /CARTRIDGE

Powder and Solvent for Solution for Injection in cartridge

Subcutaneous use

EL - Greece

Pfizer Hellas S.A.

234, Messoghion Ave.,

Neo Psychiko 15451,

Athens,

Greece

GENOTROPIN(WITH PRESERVATIVE)

5,3 mg /CARTRIDGE

Powder and Solvent for Solution for Injection in cartridge

Subcutaneous use

EL - Greece

Pfizer Hellas S.A.

234, Messoghion Ave.,

Neo Psychiko 15451,

Athens,

Greece

GENOTROPIN(WITH PRESERVATIVE)

12 mg /CARTRIDGE

Powder and Solvent for Solution for Injection in cartridge

Subcutaneous use

EL - Greece

Pfizer Hellas S.A.

234, Messoghion Ave.,

Neo Psychiko 15451,

Athens,

Greece

GENOTROPIN

1 mg /CARTRIDGE

Powder and Solvent for Solution for Injection in cartridge

Subcutaneous use

EL - Greece

Pfizer Hellas S.A.

234, Messoghion Ave.,

Neo Psychiko 15451,

Athens,

Greece

GENOTROPIN

1,4 mg /CARTRIDGE

Powder and Solvent for Solution for Injection in cartridge

Subcutaneous use

EL - Greece

Pfizer Hellas S.A.

234, Messoghion Ave.,

Neo Psychiko 15451,

Athens,

Greece

GENOTROPIN

2 mg (6IU) /CARTRIDGE

Powder and Solvent for Solution for Injection in cartridge

Subcutaneous use

EL - Greece

Pfizer Hellas S.A.

234, Messoghion Ave.,

Neo Psychiko 15451,

Athens,

Greece

GENOTROPIN

5 mg /CARTRIDGE with preservative

Powder and Solvent for Solution for Injection in cartridge

Subcutaneous use

EL - Greece

Merck A.E. Hellas

Kifisias Avenue 41-45 (Building B)

Marousi 15123

Athens

Greece

SAIZEN

3,33 MG/VIAL (MULTI DO

Powder and Solvent for solution for Injection

Subcutaneous

Intramuscular

EL - Greece

Merck A.E. Hellas

Kifisias Avenue 41-45 (Building B)

Marousi 15123

Athens

Greece

SAIZEN

8 MG/VIAL

Powder and Solvent for solution for Injection

Subcutaneous

Intramuscular

EL - Greece

Merck A.E. Hellas

Kifisias Avenue 41-45 (Building B)

Marousi 15123

Athens

Greece

SAIZEN

5,83 MG/VIAL

Solution for Injection

Subcutaneous

EL - Greece

Merck A.E. Hellas

Kifisias Avenue 41-45 (Building B)

Marousi 15123

Athens

Greece

SAIZEN

8 MG/ML

Solution for Injection

Subcutaneous

EL - Greece

FARMASERV LILLY AEBE

15TH Km NATIONAL HIGHWAY ATHENS-LAMIA

KIFISSIA 14564,

P.O. BOX 51288

HUMATROPE

6 MG/ CARTRIDGE

Powder and Solvent for solution for Injection

Subcutaneous

EL - Greece

FARMASERV LILLY AEBE

15TH Km NATIONAL HIGHWAY ATHENS-LAMIA

KIFISSIA 14564,

P.O. BOX 51288

HUMATROPE

12 MG/ CARTRIDGE

Powder and Solvent for solution for Injection

Subcutaneous

EL - Greece

FARMASERV LILLY AEBE

15TH Km NATIONAL HIGHWAY ATHENS-LAMIA

KIFISSIA 14564,

P.O. BOX 51288

HUMATROPE

24 MG/ CARTRIDGE

Powder and Solvent for solution for Injection

Subcutaneous

EL - Greece

FERRING HELLAS S.A.

GKYZI 3,

MAROUSI 15125

ZOMACTON

4 MG/VIAL

Powder and Solvent for solution for Injection

Subcutaneous

EL - Greece

FERRING HELLAS S.A.

GKYZI 3,

MAROUSI 15125

ZOMACTON

10 MG/VIAL + 1 ML SOLV

Powder and Solvent for solution for Injection

Subcutaneous

ES - Spain

LILLY, S.A.

Avda. de la Industria, 30

Alcobendas

28108 MADRID

HUMATROPE 6 mg polvo y disolvente para solución inyectable

6 mg

powder for solution

Subcutaneous use

ES - Spain

LILLY, S.A.

Avda. de la Industria, 30

Alcobendas

28108 MADRID

HUMATROPE 12 mg polvo y disolvente para solución inyectable

12 mg

powder for solution

Subcutaneous use

ES - Spain

LILLY, S.A.

Avda. de la Industria, 30

Alcobendas

28108 MADRID

HUMATROPE 24 mg polvo y disolvente para solución inyectable

24 mg

powder for solution

Subcutaneous use

ES - Spain

PFIZER, S.A.

Avda. de Europa, 20 B.

Parque Empresarial La Moraleja

Alcobendas

28108 MADRID

GENOTONORM MINIQUICK 0,2 mg polvo y disolvente para solución inyectable

0,2 mg

Powder and solvent for solution for injection

Subcutaneous use

ES - Spain

PFIZER, S.A.

Avda. de Europa, 20 B.

Parque Empresarial La Moraleja

Alcobendas

28108 MADRID

GENOTONORM MINIQUICK 0,4 mg polvo y disolvente para solución inyectable

0,4 mg

Powder and solvent for solution for injection

Subcutaneous use

ES - Spain

PFIZER, S.A.

Avda. de Europa, 20 B.

Parque Empresarial La Moraleja

Alcobendas

28108 MADRID

GENOTONORM MINIQUICK 0,6 mg polvo y disolvente para solución inyectable

0,6 mg

Powder and solvent for solution for injection

Subcutaneous use

ES - Spain

PFIZER, S.A.

Avda. de Europa, 20 B.

Parque Empresarial La Moraleja

Alcobendas

28108 MADRID

GENOTONORM MINIQUICK 0,8 mg polvo y disolvente para solución inyectable

0,8 mg

Powder and solvent for solution for injection

Subcutaneous use

ES - Spain

PFIZER, S.A.

Avda. de Europa, 20 B.

Parque Empresarial La Moraleja

Alcobendas

28108 MADRID

GENOTONORM MINIQUICK 1 mg polvo y disolvente para solución inyectable

1,0 mg

Powder and solvent for solution for injection

Subcutaneous use

ES - Spain

PFIZER, S.A.

Avda. de Europa, 20 B.

Parque Empresarial La Moraleja

Alcobendas

28108 MADRID

GENOTONORM MINIQUICK 1,2 mg polvo y disolvente para solución inyectable

1,2 mg

Powder and solvent for solution for injection

Subcutaneous use

ES - Spain

PFIZER, S.A.

Avda. de Europa, 20 B.

Parque Empresarial La Moraleja

Alcobendas

28108 MADRID

GENOTONORM MINIQUICK 1,4 mg polvo y disolvente para solución inyectable

1,4 mg

Powder and solvent for solution for injection

Subcutaneous use

ES - Spain

PFIZER, S.A.

Avda. de Europa, 20 B.

Parque Empresarial La Moraleja

Alcobendas

28108 MADRID

GENOTONORM MINIQUICK 1,6 mg polvo y disolvente para solución inyectable

1,6 mg

Powder and solvent for solution for injection

Subcutaneous use

ES - Spain

PFIZER, S.A.

Avda. de Europa, 20 B.

Parque Empresarial La Moraleja

Alcobendas

28108 MADRID

GENOTONORM MINIQUICK 1,8 mg polvo y disolvente para solución inyectable

1,8 mg

Powder and solvent for solution for injection

Subcutaneous use

ES - Spain

PFIZER, S.A.

Avda. de Europa, 20 B.

Parque Empresarial La Moraleja

Alcobendas

28108 MADRID

GENOTONORM MINIQUICK 2 mg polvo y disolvente para solución inyectable

2 mg

Powder and solvent for solution for injection

Subcutaneous use

ES - Spain

PFIZER, S.A.

Avda. de Europa, 20 B.

Parque Empresarial La Moraleja

Alcobendas

28108 MADRID

GENOTONORM KABIPEN 5,3 mg polvo y disolvente para solución inyectable

5,3 mg

Powder and solvent for solution for injection

Subcutaneous use

ES - Spain

PFIZER, S.A.

Avda. de Europa, 20 B.

Parque Empresarial La Moraleja

Alcobendas

28108 MADRID

GENOTONORM KABIPEN 12 mg polvo y disolvente para solución inyectable

12 mg

Powder and solvent for solution for injection

Subcutaneous use

ES - Spain

PFIZER, S.A.

Avda. de Europa, 20 B.

Parque Empresarial La Moraleja

Alcobendas

28108 MADRID

GENOTONORM KABIPEN 12 mg polvo y disolvente para solución inyectable

12 mg

powder for solution

Subcutaneous use

ES - Spain

NOVO NORDISK A/S

Novo Alle

DK-2880 Bagsvaerd

NORDITROPIN NORDIFLEX 5 mg / 1,5 ml solución inyectable

5 mg

powder for solution

Subcutaneous use

ES - Spain

NOVO NORDISK A/S

Novo Alle

DK-2880 Bagsvaerd

NORDITROPIN NORDIFLEX 10 mg/1,5 ml solución inyectable

10 mg

powder for solution

Subcutaneous use

ES - Spain

NOVO NORDISK A/S

Novo Alle

DK-2880 Bagsvaerd

NORDITROPIN NORDIFLEX 15 mg/1,5 ml solución inyectable

15 mg

powder for solution

Subcutaneous use

ES - Spain

NOVO NORDISK A/S

Novo Alle

DK-2880 Bagsvaerd

NORDITROPIN SIMPLEXx 5 mg/1,5 ml solución inyectable

5 mg

powder for solution

Subcutaneous use

ES - Spain

NOVO NORDISK A/S

Novo Alle

DK-2880 Bagsvaerd

NORDITROPIN SIMPLEXx 10 mg/1,5 ml solución inyectable

10 mg

powder for solution

Subcutaneous use

ES - Spain

NOVO NORDISK A/S

Novo Alle

DK-2880 Bagsvaerd

NORDITROPIN SIMPLEXx 15 mg/1,5 ml solución inyectable

15 mg

powder for solution

Subcutaneous use

ES - Spain

FERRING, S.A.U

Gobelas, 11.

Urbanización La Florida.

28023 Madrid

ZOMACTON 10 mg/ ml polvo y disolvente en jeringa precargada para solución inyectable

10 mg

powder for solution

Subcutaneous use

ES - Spain

MERCK S.L.

Maria de Molina, 40

28006 Madrid

SAIZEN 8 mg click.easy polvo y disolvente para solución inyectable

8 mg

powder for solution

Subcutaneous use

ES - Spain

FERRING, S.A.U

Gobelas, 11.

Urbanización La Florida.

28023 Madrid

ZOMACTON 4 mg polvo y disolvente en jeringa precargada para solución inyectable

4 mg

powder for solution

Subcutaneous use

ET - Estonia

Ferring GmbH

Wittland 11

D-24109 Kiel

Germany

ZOMACTON

4 mg

Powder and solvent for solution for injection in pre-filled syringe

subcutaneous use

ET - Estonia

Ferring GmbH

Wittland 11

D-24109 Kiel

Germany

ZOMACTON

10 mg

Powder and solvent for solution for injection in pre-filled syringe

subcutaneous use

ET - Estonia

Merck Serono S.p.A.

Via Casilina 125

I-00176 Roma

Italy

SAIZEN 8 MG CLICK.EASY

8 mg

Powder and solvent for solution for injection

subcutaneous use

ET - Estonia

Pfizer Enterprises SARL

Round-Point du Kirchberg

51, Avenue J.F. Kennedy

L-1855

Luxembourg

GENOTROPIN

5,3 mg

Powder and solvent for solution for injection

subcutaneous use

ET - Estonia

Pfizer Enterprises SARL

Round-Point du Kirchberg

51, Avenue J.F. Kennedy

L-1855

Luxembourg

GENOTROPIN

12 mg

Powder and solvent for solution for injection

subcutaneous use

FI - Finland

Ferring Lääkkeet Oy,

Piispansilta 11 A,

PL 23,

02241 Espoo,

Finland

Zomacton

10 mg/ml

Powder and solvent for solution for injection

Subcutaneous use

FI - Finland

Ferring Lääkkeet Oy,

Piispansilta 11 A,

PL 23,

02241 Espoo,

Finland

Zomacton

4 mg

Powder and solvent for solution for injection

Subcutaneous use

FI - Finland

Merck Oy,

Pihatörmä 1 C,

02240 Espoo,

Finland

Saizen click.easy

8 mg

Powder and solvent for solution for injection

Subcutaneous use

FI - Finland

Merck Oy,

Pihatörmä 1 C,

02240 Espoo,

Finland

Saizen

8 mg/ml

Solution for Injection

Subcutaneous use

FI - Finland

Merck Oy,

Pihatörmä 1 C,

02240 Espoo,

Finland

Saizen

5,83 mg/ml

Solution for Injection

Subcutaneous use

FI - Finland

Eli Lilly Finland Oy Ab,

Rajatorpantie 41 C,

PL 16,

01641 Vantaa,

Finland

Humatrope

12 mg

Powder and solvent for solution for injection

Subcutaneous use

FI - Finland

Eli Lilly Finland Oy Ab,

Rajatorpantie 41 C,

PL 16,

01641 Vantaa,

Finland

Humatrope

24 mg

Powder and solvent for solution for injection

Subcutaneous use

FI - Finland

Eli Lilly Finland Oy Ab,

Rajatorpantie 41 C,

PL 16,

01641 Vantaa,

Finland

Humatrope

6 mg

Powder and solvent for solution for injection

Subcutaneous use

FI - Finland

Pfizer Oy,

Tietokuja 4,

00330 Helsinki,

Finland

Genotropin

12 mg

Powder and solvent for solution for injection

Subcutaneous use

FI - Finland

Pfizer Oy,

Tietokuja 4,

00330 Helsinki,

Finland

Genotropin

5 mg

Powder and solvent for solution for injection

Subcutaneous use

FI - Finland

Novo Nordisk A/S,

Novo Allé,

2880 BAGSVAERD,

Denmark

Norditropin Flexpro

5 mg/1,5 ml

Solution for injection in pre-filled pen

Subcutaneous use

FI - Finland

Novo Nordisk A/S,

Novo Allé,

2880 BAGSVAERD,

Denmark

Norditropin Flexpro

10 mg/1,5 ml

Solution for injection in pre-filled pen

Subcutaneous use

FI - Finland

Novo Nordisk A/S,

Novo Allé,

2880 BAGSVAERD,

Denmark

Norditropin Flexpro

15 mg/1,5 ml

Solution for injection in pre-filled pen

Subcutaneous use

FI - Finland

Novo Nordisk A/S,

Novo Allé,

2880 BAGSVAERD,

Denmark

Norditropin Nordiflex

5 mg/1,5 ml

Solution for injection in pre-filled pen

Subcutaneous use

FI - Finland

Novo Nordisk A/S,

Novo Allé,

2880 BAGSVAERD,

Denmark

Norditropin Nordiflex

10 mg/1,5 ml

Solution for injection in pre-filled pen

Subcutaneous use

FI - Finland

Novo Nordisk A/S,

Novo Allé,

2880 BAGSVAERD,

Denmark

Norditropin Nordiflex

15 mg/1,5 ml

Solution for injection in pre-filled pen

Subcutaneous use

FI - Finland

Novo Nordisk A/S,

Novo Allé,

2880 BAGSVAERD,

Denmark

Norditropin Simplexx

5 mg/1,5 ml

Solution for injection

Subcutaneous use

FI - Finland

Novo Nordisk A/S,

Novo Allé,

2880 BAGSVAERD,

Denmark

Norditropin Simplexx

10 mg/1,5 ml

Solution for injection

Subcutaneous use

FI - Finland

Novo Nordisk A/S,

Novo Allé,

2880 BAGSVAERD,

Denmark

Norditropin Simplexx

15 mg/1,5 ml

Solution for injection

Subcutaneous use

FR - France

PFIZER HOLDING France

23-25, avenue du Docteur Lannelongue

75014 Paris-

France

GENOTONORM 12 mg, poudre et solvant pour solution injectable

12 mg

Powder and solvent for solution for injection

subcutaneous use

FR - France

PFIZER HOLDING France

23-25, avenue du Docteur Lannelongue

75014 Paris-

France

GENOTONORM 5 mg, poudre et solvant pour solution injectable

5 mg

Powder and solvent for solution for injection

subcutaneous use

FR - France

PFIZER HOLDING France

23-25, avenue du Docteur Lannelongue

75014 Paris-

France

GENOTONORM 5,3 mg, poudre et solvant pour solution injectable

5,3 mg

Powder and solvent for solution for injection

subcutaneous use

FR - France

PFIZER HOLDING France

23-25, avenue du Docteur Lannelongue

75014 Paris-

France

GENOTONORM MINIQUICK 0,2 mg, poudre et solvant pour solution injectable

0,2 mg

Powder and solvent for solution for injection

subcutaneous use

FR - France

PFIZER HOLDING France

23-25, avenue du Docteur Lannelongue

75014 Paris-

France

GENOTONORM MINIQUICK 0,4 mg, poudre et solvant pour solution injectable

0,4 mg

Powder and solvent for solution for injection

subcutaneous use

FR - France

PFIZER HOLDING France

23-25, avenue du Docteur Lannelongue

75014 Paris-

France

GENOTONORM MINIQUICK 0,6 mg, poudre et solvant pour solution injectable

0,6 mg

Powder and solvent for solution for injection

subcutaneous use

FR - France

PFIZER HOLDING France

23-25, avenue du Docteur Lannelongue

75014 Paris-

France

GENOTONORM MINIQUICK 0,8 mg, poudre et solvant pour solution injectable

0,8 mg

Powder and solvent for solution for injection

subcutaneous use

FR - France

PFIZER HOLDING France

23-25, avenue du Docteur Lannelongue

75014 Paris-

France

GENOTONORM MINIQUICK 1 mg, poudre et solvant pour solution injectable

1 mg

Powder and solvent for solution for injection

subcutaneous use

FR - France

PFIZER HOLDING France

23-25, avenue du Docteur Lannelongue

75014 Paris-

France

GENOTONORM MINIQUICK 1,2 mg, poudre et solvant pour solution injectable

1,2 mg

Powder and solvent for solution for injection

subcutaneous use

FR - France

PFIZER HOLDING France

23-25, avenue du Docteur Lannelongue

75014 Paris-

France

GENOTONORM MINIQUICK 1,4 mg, poudre et solvant pour solution injectable

1,4 mg

Powder and solvent for solution for injection

subcutaneous use

FR - France

PFIZER HOLDING France

23-25, avenue du Docteur Lannelongue

75014 Paris-

France

GENOTONORM MINIQUICK 1,6 mg, poudre et solvant pour solution injectable

1,6 mg

Powder and solvent for solution for injection

subcutaneous use

FR - France

PFIZER HOLDING France

23-25, avenue du Docteur Lannelongue

75014 Paris-

France

GENOTONORM MINIQUICK 1,8 mg, poudre et solvant pour solution injectable

1,8 mg

Powder and solvent for solution for injection

subcutaneous use

FR - France

PFIZER HOLDING France

23-25, avenue du Docteur Lannelongue

75014 Paris-

France

GENOTONORM MINIQUICK 2 mg, poudre et solvant pour solution injectable

2 mg

Powder and solvent for solution for injection

subcutaneous use

FR - France

SANOFI AVENTIS France

1-13, boulevard Romain Rolland

75014 Paris-

France

MAXOMAT 1,3 mg, poudre et solvant pour solution injectable

1,3 mg

Powder and solvent for solution for injection

subcutaneous

FR - France

NOVO NORDISK PHARMACEUTIQUE SAS

Le Palatin

30 rue de Valmy

92800 Puteaux-

France

NORDITROPINE NORDIFLEX 10 mg/1,5 ml, solution injectable en stylo prérempli

10 mg/1,5 ml

Solution for injection

subcutaneous

FR - France

NOVO NORDISK PHARMACEUTIQUE SAS

Le Palatin

30 rue de Valmy

92800 Puteaux-

France

NORDITROPINE NORDIFLEX 15 mg/1,5 ml, solution injectable en stylo prérempli

15 mg/1,5 ml

Solution for injection

subcutaneous

FR - France

NOVO NORDISK PHARMACEUTIQUE SAS

Le Palatin

30 rue de Valmy

92800 Puteaux-

France

NORDITROPINE NORDIFLEX 5 mg/1,5 ml, solution injectable en stylo prérempli

5 mg/1,5 ml

Solution for injection

subcutaneous

FR - France

NOVO NORDISK PHARMACEUTIQUE SAS

Le Palatin

30 rue de Valmy

92800 Puteaux-

France

NORDITROPINE FLEXPRO 10 mg/1,5 ml, solution injectable en stylo prérempli

10 mg/1,5 ml

Solution for injection

subcutaneous

FR - France

NOVO NORDISK PHARMACEUTIQUE SAS

Le Palatin

30 rue de Valmy

92800 Puteaux-

France

NORDITROPINE FLEXPRO 15 mg/1,5 ml, solution injectable en stylo prérempli

15 mg/1,5 ml

Solution for injection

subcutaneous

FR - France

NOVO NORDISK PHARMACEUTIQUE SAS

Le Palatin

30 rue de Valmy

92800 Puteaux-

France

NORDITROPINE FLEXPRO 5 mg/1,5 ml, solution injectable en stylo prérempli

5 mg/1,5 ml

Solution for injection

subcutaneous

FR - France

NOVO NORDISK PHARMACEUTIQUE SAS

Le Palatin

30 rue de Valmy

92800 Puteaux-

France

NORDITROPINE SIMPLEXX 10 mg/1,5 ml, solution injectable

10 mg/1,5 ml

Solution for injection

subcutaneous

FR - France

NOVO NORDISK PHARMACEUTIQUE SAS

Le Palatin

30 rue de Valmy

92800 Puteaux-

France

NORDITROPINE SIMPLEXX 15 mg/1,5 ml, solution injectable

15 mg/1,5 ml

Solution for injection

subcutaneous

FR - France

NOVO NORDISK PHARMACEUTIQUE SAS

Le Palatin

30 rue de Valmy

92800 Puteaux-

France

NORDITROPINE SIMPLEXX 5 mg/1,5 ml, solution injectable

5 mg/1,5 ml

Solution for injection

subcutaneous

FR - France

LILLY France

13, rue Pagès

92158 Suresnes Cedex

UMATROPE 12 mg/3 ml, poudre et solvant pour solution injectable

12 mg/3 ml

Powder and solvent for solution for injection

subcutaneous

FR - France

LILLY France

13, rue Pagès

92158 Suresnes Cedex

UMATROPE 24 mg/3 ml, poudre et solvant pour solution injectable

24 mg/3 ml

Powder and solvent for solution for injection

subcutaneous

FR - France

LILLY France

13, rue Pagès

92158 Suresnes Cedex

UMATROPE 6 mg/3 ml, poudre et solvant pour solution injectable

6 mg/3 ml

Powder and solvent for solution for injection

subcutaneous

FR - France

FERRING SAS

7, rue Jean-Baptiste Clément

94250 Gentilly-

France

ZOMACTON 10 mg/ml, poudre et solvant pour solution injectable en seringue préremplie

10 mg/ml

Powder and solvent for solution for injection

subcutaneous

FR - France

FERRING SAS

7, rue Jean-Baptiste Clément

94250 Gentilly-

France

ZOMACTON 4 mg, poudre et solvant pour solution injectable en multidose

4 mg

Powder and solvent for solution for injection

subcutaneous

FR - France

MERCK SANTE

37, rue Saint-Romain

69008 Lyon

France

SAIZEN 1,33 mg, poudre et solvant pour solution injectable

1,33 mg

Powder and solvent for solution for injection

subcutaneous

FR - France

MERCK SANTE

37, rue Saint-Romain

69008 Lyon

France

SAIZEN 3,33 mg, poudre et solvant pour solution injectable

3,33

Powder and solvent for solution for injection

subcutaneous

FR - France

MERCK SANTE

37, rue Saint-Romain

69008 Lyon

France

SAIZEN 8 mg, poudre et solvant pour solution injectable

Powder and solvent for solution for injection

subcutaneous

FR - France

MERCK SANTE

37, rue Saint-Romain

69008 Lyon

France

SAIZEN CLICKEASY 8 mg, poudre et solvant pour solution injectable

Powder and solvent for solution for injection

subcutaneous

HU - Hungary

Eli Lilly Nederland BV

Grootslag 1-5

3991 RA Houten

Netherlands

HUMATROPE 18 NE (6 mg) injekció patronban

1,9 mg/ml

powder and solvent for injection

subcutaneous use

HU - Hungary

Eli Lilly Nederland BV

Grootslag 1-5

3991 RA Houten

Netherlands

HUMATROPE 36 NE (12 mg) injekció patronban

3,8 mg/ml

powder and solvent for injection

subcutaneous use

HU - Hungary

Eli Lilly Nederland BV

Grootslag 1-5

3991 RA Houten

Netherlands

HUMATROPE 72 NE (24 mg) injekció patronban

7,6 mg/ml

powder and solvent for injection

subcutaneous use

HU - Hungary

Novo Nordisk A/S

Novo Alle

2880 Bagsvaerd

Denmark

NORDITROPIN SimpleXx 5 mg/1,5 ml oldatos injekció

3,3 mg/ml

solution for injection

subcutaneous use

HU - Hungary

Novo Nordisk A/S

Novo Alle

2880 Bagsvaerd

Denmark

NORDITROPIN SimpleXx 10 mg/1,5 ml oldatos injekció

6,7 mg/ml

solution for injection

subcutaneous use

HU - Hungary

Novo Nordisk A/S

Novo Alle

2880 Bagsvaerd

Denmark

NORDITROPIN SimpleXx 15 mg/1,5 ml oldatos injekció

10 mg/ml

solution for injection

subcutaneous use

HU - Hungary

Merck Kft.

Bocskai út 134-146.

1113

Budapest

Hungary

SAIZEN click easy 8 mg por és oldószer oldatos injekcióhoz

8 mg (24 NE) /1,5 ml

powder and solvent for solution for injection

parenteral use

HU - Hungary

Ferring Magyarország Kft.

Váci út 140.

1138

Budapest

Hungary

ZOMACTON 4 mg por és oldószer oldatos injekcióhoz

1,3 mg/ml or 3,3 mg/ml

powder and solvent for solution for injection

subcutaneous use

HU - Hungary

Pfizer Kft.

Alkotás u. 53

1123

Budapest

Hungary

GENOTROPIN 5,3 mg por és oldószer oldatos injekcióhoz

16 NE (5,3 mg/ml)

powder and solvent for solution for injection

subcutaneous use

HU - Hungary

Pfizer Kft.

Alkotás u. 53

1123

Budapest

Hungary

GENOTROPIN 12 mg por és oldószer oldatos injekcióhoz

36 NE (12 mg/ml)

powder and solvent for solution for injection

subcutaneous use

IE - Ireland

Pharmacia Laboratories Limited,

Ramsgate Road,

Sandwich, Kent,

CT13 9NJ,

United Kingdom

Genotropin 5,3 mg powder and solvent for solution for injection

5,3 mg

Powder and solvent for solution

Subcutanous injection

IE - Ireland

Pharmacia Laboratories Limited,

Ramsgate Road,

Sandwich, Kent,

CT13 9NJ,

United Kingdom

Genotropin 12 mg powder and solvent for solution for injection

12 mg

Powder and solvent for solution

Subcutanous injection

IE - Ireland

Pharmacia Laboratories Limited,

Ramsgate Road,

Sandwich, Kent,

CT13 9NJ,

United Kingdom

Genotropin MiniQuick 0,2 mg, powder and solvent for solution for injection

0,2 mg

Powder and solvent for solution

Subcutanous injection

IE - Ireland

Pharmacia Laboratories Limited,

Ramsgate Road,

Sandwich, Kent,

CT13 9NJ,

United Kingdom

Genotropin MiniQuick 0,4 mg, powder and solvent for solution for injection

0,4 mg

Powder and solvent for solution

Subcutanous injection

IE - Ireland

Pharmacia Laboratories Limited,

Ramsgate Road,

Sandwich, Kent,

CT13 9NJ,

United Kingdom

Genotropin MiniQuick 0,6 mg, powder and solvent for solution for injection

0,6 mg

Powder and solvent for solution

Subcutanous injection

IE - Ireland

Pharmacia Laboratories Limited,

Ramsgate Road,

Sandwich, Kent,

CT13 9NJ,

United Kingdom

Genotropin MiniQuick 0,8 mg, powder and solvent for solution for injection

0,8 mg

Powder and solvent for solution

Subcutanous injection

IE - Ireland

Pharmacia Laboratories Limited,

Ramsgate Road,

Sandwich, Kent,

CT13 9NJ,

United Kingdom

Genotropin MiniQuick, 1,0 mg, powder and solvent for solution for injection

1,0 mg

Powder and solvent for solution

Subcutanous injection

IE - Ireland

Pharmacia Laboratories Limited,

Ramsgate Road,

Sandwich, Kent,

CT13 9NJ,

United Kingdom

Genotropin MiniQuick, 1,2 mg, powder and solvent for solution for injection

1,2 mg

Powder and solvent for solution

Subcutanous injection

IE - Ireland

Pharmacia Laboratories Limited,

Ramsgate Road,

Sandwich, Kent,

CT13 9NJ,

United Kingdom

Genetropin MiniQuick, 1,4 mg powder and solvent for Solution for Injection

1,4 mg

Powder and solvent for solution

Subcutanous injection

IE - Ireland

Pharmacia Laboratories Limited,

Ramsgate Road,

Sandwich, Kent,

CT13 9NJ,

United Kingdom

Genotropin MiniQuick, 1,6 mg, powder and solvent for solution for injection

1,6 mg

Powder and solvent for solution

Subcutanous injection

IE - Ireland

Pharmacia Laboratories Limited,

Ramsgate Road,

Sandwich, Kent,

CT13 9NJ,

United Kingdom

Genotropin MiniQuick, 1,8 mg, powder and solvent for solution for injection

1,8 mg

Powder and solvent for solution

Subcutanous injection

IE - Ireland

Pharmacia Laboratories Limited,

Ramsgate Road,

Sandwich, Kent,

CT13 9NJ,

United Kingdom

Genotropin MiniQuick, 2,0 mg, powder and solvent for solution for injection

2,0 mg

Powder and solvent for solution

Subcutanous injection

IE - Ireland

Novo Nordisk A/S,

Novo Alle,

DK-2880, Bagsvaerd,

Denmark

Norditropin SimpleXx 5 mg / 1,5 ml, solution for injection.

5 mg/1,5 ml

solution for injection

Subcutanous injection

IE - Ireland

Novo Nordisk A/S,

Novo Alle,

DK-2880, Bagsvaerd,

Denmark

Norditropin SimpleXx 10 mg / 1,5 ml, solution for injection

10 mg/1,5 ml

solution for injection

Subcutanous injection

IE - Ireland

Novo Nordisk A/S,

Novo Alle,

DK-2880, Bagsvaerd,

Denmark

Norditropin SimpleXx 15 mg / 1,5 ml, solution for injection.

15 mg/1,5 ml

solution for injection

Subcutanous injection

IE - Ireland

Novo Nordisk A/S,

Novo Alle,

DK-2880, Bagsvaerd,

Denmark

Norditropin NordiFlex 5 mg/1,5 ml, solution for injection, in pre-filled pen

5 mg/1,5 ml

solution for injection

Subcutanous injection

IE - Ireland

Novo Nordisk A/S,

Novo Alle,

DK-2880, Bagsvaerd,

Denmark

Norditropin NordiFlex 10 mg/1,5 ml, solution for injection, in pre-filled pen

10 mg/1,5 ml

solution for injection

Subcutanous injection

IE - Ireland

Novo Nordisk A/S,

Novo Alle,

DK-2880, Bagsvaerd,

Denmark

Norditropin NordiFlex 15 mg/1,5 ml, solution for injection, in pre-filled pen

15 mg/1,5 ml

solution for injection

Subcutanous injection

IE - Ireland

Serono Limited,

Bedfont Cross,

Stanwell Road,

Feltham,

Middlesex,

TW14 8NX,

England

Saizen 1,33 mg powder and solvent for solution for injection

1,33 mg

Powder and solvent for solution

Subcutanous injection

IE - Ireland

Serono Limited,

Bedfont Cross,

Stanwell Road,

Feltham,

Middlesex,

TW14 8NX,

England

Saizen 3,33 mg powder and solvent for solution for injection

3,33 mg

Powder and solvent for solution

Subcutanous injection

IE - Ireland

Serono Limited,

Bedfont Cross,

Stanwell Road,

Feltham,

Middlesex,

TW14 8NX,

England

Saizen 8 mg click.easy powder and solvent for solution for injection.

8 mg

solution for injection

Subcutanous injection

IE - Ireland

Merck Serono Limited,

Bedfont Cross,

Stanwell Road,

Feltham,

Middlesex,

TW14 8NX,

England

Saizen 5,83 mg/ml Solution for Injection

5,83 mg

solution for injection

Subcutanous injection

IE - Ireland

Merck Serono Limited,

Bedfont Cross,

Stanwell Road,

Feltham,

Middlesex,

TW14 8NX,

England

Saizen 8 mg/ml Solution for Injection

8 mg

solution for injection

Subcutanous injection

IE - Ireland

Ferring Ireland Ltd.,

United Drug House,

Magna Drive,

Magna Business Park,

Citywest Road,

Dublin 24,

Ireland

Zomacton 4 mg, powder and solvent for solution for injection

4 mg

Powder and solvent for solution

Subcutanous injection

IE - Ireland

Ferring Ireland Ltd.,

United Drug House,

Magna Drive,

Magna Business Park,

Citywest Road,

Dublin 24,

Ireland

Zomacton 10 mg, powder and solvent for solution for injection

10 mg

Powder and solvent for solution

Subcutanous injection

IS - Iceland

Pfizer APS

Lautrupvang 8

DK 2750 Ballerup

Denmark

Genotropin

5 mg

Powder and solvent for solution for injection

s.c.

IS - Iceland

Pfizer APS

Lautrupvang 8

DK 2750 Ballerup

Denmark

Genotropin

12 mg

Powder and solvent for solution for injection

s.c.

IS - Iceland

Pfizer APS

Lautrupvang 8

DK 2750 Ballerup

Denmark

Genotropin

5,3 mg

Powder and solvent for solution for injection

s.c.

IS - Iceland

Eli Lilly Danmark

Nybrovej 110

2800 Lyngby

Denmark

Humatrop 24 mg

24 mg /Cartridge

Powder and solvent for solution for injection

s.c.

IS - Iceland

Eli Lilly Danmark

Nybrovej 110

2800 Lyngby

Denmark

Humatrop 6 mg

6 mg /Cartridge

Powder and solvent for solution for injection

s.c.

IS - Iceland

Novo Nordisk AS

Novo Allé

DK-2880 Bagsværd

Denmark

Norditropin FlexPro

15/1,5 mg/ml Pre-filled pen

Solution for injection

s.c.

IS - Iceland

Novo Nordisk AS

Novo Allé

DK-2880 Bagsværd

Denmark

Norditropin FlexPro

10/1,5 mg/ml Pre-filled pen

Solution for injection

s.c.

IS - Iceland

Novo Nordisk AS

Novo Allé

DK-2880 Bagsværd

Denmark

Norditropin FlexPro

5/1,5 mg/ml Pre-filled pen

Solution for injection

s.c.

IS - Iceland

Novo Nordisk AS

Novo Allé

DK-2880 Bagsværd

Denmark

Norditropin NordiFlex

15/1,5 mg/ml /Cartridge

Solution for injection, prefilled pen

s.c.

IS - Iceland

Novo Nordisk AS

Novo Allé

DK-2880 Bagsværd

Denmark

Norditropin NordiFlex

10/1,5 mg/ml /Cartridge

Solution for injection, prefilled pen

s.c.

IS - Iceland

Novo Nordisk AS

Novo Allé

DK-2880 Bagsværd

Denmark

Norditropin NordiFlex

5/1,5 mg/ml /Cartridge

Solution for injection, prefilled pen

s.c.

IS - Iceland

Novo Nordisk AS

Novo Allé

DK-2880 Bagsværd

Denmark

Norditropin SimplexX

15/1,5 mg/ml/ Cartridge

Solution for injection, Cartridge

s.c.

IS - Iceland

Novo Nordisk AS

Novo Allé

DK-2880 Bagsværd

Denmark

Norditropin SimplexX

10/1,5 mg/ml/ Cartridge

Solution for injection, Cartridge

s.c.

IS - Iceland

Novo Nordisk AS

Novo Allé

DK-2880 Bagsværd

Denmark

Norditropin SimplexX

5/1,5 mg/ml/ Cartridge

Solution for injection, Cartridge

s.c.

IS - Iceland

Merck AB

SE-195 87 Stockholm

Sweden

Saizen click easy 8 mg

8 mg

Powder and solvent for solution for injection

s.c.

IS - Iceland

Merck AB

SE-195 87 Stockholm

Sweden

Saizen 5,83 mg/ml 5,83 mg/ml

5,83 mg/ml 5,8 mg/ml

Solution for injection Single dose container

s.c.

IS - Iceland

Merck AB

SE-195 87 Stockholm

Sweden

Saizen 8 mg/ml 8 mg/ml

Solution for injection Single dose container

s.c.

IT - Italy

Pfizer Italia S.r.l.

Via Valbondione 113

00188 Rome

Italy

Genotropin

5,3 mg

powder and solvent for solution for injection

subcutaneous use

IT - Italy

Pfizer Italia S.r.l.

Via Valbondione 113

00188 Rome

Italy

Genotropin

12 mg

powder and solvent for solution for injection

subcutaneous use

IT - Italy

Pfizer Italia S.r.l.

Via Valbondione 113

00188 Rome

Italy

Genotropin Miniquick

0,2 mg

powder and solvent for solution for injection

subcutaneous use

IT - Italy

Pfizer Italia S.r.l.

Via Valbondione 113

00188 Rome

Italy

Genotropin Miniquick

0,4 mg

powder and solvent for solution for injection

subcutaneous use

IT - Italy

Pfizer Italia S.r.l.

Via Valbondione 113

00188 Rome

Italy

Genotropin Miniquick

0,6 mg

powder and solvent for solution for injection

subcutaneous use

IT - Italy

Pfizer Italia S.r.l.

Via Valbondione 113

00188 Rome

Italy

Genotropin Miniquick

0,8 mg

powder and solvent for solution for injection

subcutaneous use

IT - Italy

Pfizer Italia S.r.l.

Via Valbondione 113

00188 Rome

Italy

Genotropin Miniquick

1 mg

powder and solvent for solution for injection

subcutaneous use

IT - Italy

Pfizer Italia S.r.l.

Via Valbondione 113

00188 Rome

Italy

Genotropin Miniquick

1,2 mg

powder and solvent for solution for injection

subcutaneous use

IT - Italy

Pfizer Italia S.r.l.

Via Valbondione 113

00188 Rome

Italy

Genotropin Miniquick

1,4 mg

powder and solvent for solution for injection

subcutaneous use

IT - Italy

Pfizer Italia S.r.l.

Via Valbondione 113

00188 Rome

Italy

Genotropin Miniquick

1,6 mg

powder and solvent for solution for injection

subcutaneous use

IT - Italy

Pfizer Italia S.r.l.

Via Valbondione 113

00188 Rome

Italy

Genotropin Miniquick

1,8 mg

powder and solvent for solution for injection

subcutaneous use

IT - Italy

Pfizer Italia S.r.l.

Via Valbondione 113

00188 Rome

Italy

Genotropin Miniquick

2 mg

powder and solvent for solution for injection

subcutaneous use

IT - Italy

Merck Serono S.p.A.

Via Casilina, 125

00176 Roma

Italy

SAIZEN

1,33 mg/ml

powder and solvent for solution for injection

subcutaneous use

IT - Italy

Merck Serono S.p.A.

Via Casilina, 125

00176 Roma

Italy

SAIZEN

3,33 mg (0,67 mg/ml)

powder and solvent for solution for injection

subcutaneous use

IT - Italy

Merck Serono S.p.A.

Via Casilina, 125

00176 Roma

Italy

SAIZEN

8 mg (2,96 mg/ml)

powder and solvent for solution for injection

subcutaneous use

IT - Italy

Merck Serono S.p.A.

Via Casilina, 125

00176 Roma

Italy

SAIZEN (CLICK.EASY)

8 mg (5,83 mgml)

powder and solvent for solution for injection

subcutaneous use

IT - Italy

Merck Serono S.p.A.

Via Casilina, 125

00176 Roma

Italy

SAIZEN

5,83 mg/ml

solution for injection

subcutaneous use

IT - Italy

Merck Serono S.p.A.

Via Casilina, 125

00176 Roma

Italy

SAIZEN

8 mg/ml

solution for injection

subcutaneous use

IT - Italy

FERRING SpA

VIA SENIGALLIA, 18/2

20161 MILANO

ZOMACTION

4 mg

powder and solvent for solution for injection

subcutaneous use

IT - Italy

FERRING SpA

VIA SENIGALLIA, 18/2

20161 MILANO

ZOMACTION

10 mg/ml

powder and solvent for solution for injection

subcutaneous use

IT - Italy

ELI LILLY ITALIA SpA

VIA GRAMSCI, 731/733

SESTO FIORENTINO

50019 FIRENZE

HUMATROPE

6 mg

powder and solvent for solution for injection

subcutaneous use

IT - Italy

ELI LILLY ITALIA SpA

VIA GRAMSCI, 731/733

SESTO FIORENTINO

50019 FIRENZE

HUMATROPE

12 mg

powder and solvent for solution for injection

subcutaneous use

IT - Italy

ELI LILLY ITALIA SpA

VIA GRAMSCI, 731/733

SESTO FIORENTINO

50019 FIRENZE

HUMATROPE

24 mg

powder and solvent for solution for injection

subcutaneous use

IT - Italy

NOVO NORDISK A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

NORDITROPIN NORDIFLEX

5 mg/1,5 ml

solution for injection in pre-filled syringe

subcutaneous use

IT - Italy

NOVO NORDISK A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

NORDITROPIN NORDIFLEX

10 mg/1,5 ml

solution for injection in pre-filled syringe

subcutaneous use

IT - Italy

NOVO NORDISK A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

NORDITROPIN NORDIFLEX

15 mg/1,5 ml

solution for injection in pre-filled syringe

subcutaneous use

IT - Italy

NOVO NORDISK A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

NORDITROPIN SIMPLEXX

5 mg/1,5 ml

solution for injection

subcutaneous use

IT - Italy

NOVO NORDISK A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

NORDITROPIN SIMPLEXX

10 mg/1,5 ml

solution for injection

subcutaneous use

IT - Italy

NOVO NORDISK A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

NORDITROPIN SIMPLEXX

15 mg/1,5 ml

solution for injection

subcutaneous use

IT - Italy

BAKER ITALIA SpA

VIA DI PORTA PINCIANA, 6

00187 ROMA

ZIMOSER

1,33 mg/ml

powder and solvent for solution for injection

subcutaneous use

LT - Lithuania

Ferring GmbH,

Wittland 11,

D-24109 Kiel,

Germany

ZOMACTON

10 mg/ml

Powder and solvent for solution for injection in pre-filled syringe

Subcutaneous use

LT - Lithuania

Ferring GmbH,

Wittland 11,

D-24109 Kiel,

Germany

ZOMACTON

4 mg

Powder and solvent for solution for injection

Subcutaneous use

LT - Lithuania

Eli Lilly Holdings Limited,

Lilly House

Priestley Road

Basingstoke

Hampshire

RG24 9NL,

United Kingdom

Humatrope

6 mg

Powder and solvent for solution for injection

Subcutaneous use

LT - Lithuania

Eli Lilly Holdings Limited,

Lilly House

Priestley Road

Basingstoke

Hampshire

RG24 9NL,

United Kingdom

Humatrope

12 mg

Powder and solvent for solution for injection

Subcutaneous use

LT - Lithuania

Novo Nordisk A/S,

Novo Allé

DK-2880 Bagsværd,

Denmark

Norditropin SimpleXx

5 mg/1,5 ml

Solution for injection

Subcutaneous use

LT - Lithuania

Novo Nordisk A/S,

Novo Allé

DK-2880 Bagsværd,

Denmark

Norditropin SimpleXx

10 mg/1,5 ml

Solution for injection

Subcutaneous use

LT - Lithuania

Pfizer Europe MA EEIG.,

Sandwich, Kent,

CT13, 9NJ,

United Kingdom

Genotropin

5,3 mg

Powder and solvent for solution for injection

Subcutaneous use

LT - Lithuania

Pfizer Europe MA EEIG.,

Sandwich, Kent,

CT13, 9NJ,

United Kingdom

Genotropin

12 mg

Powder and solvent for solution for injection

Subcutaneous use

LU - Luxembourg

Pfizer SA

17, BD de la Plaine

B-1050 Bruxelles

Genotorm

1,3 mg

powder and solvent for solution for injection

Subcutaneous use

LU - Luxembourg

Pfizer SA

17, BD de la Plaine

B-1050 Bruxelles

Genotorm

12 mg

Powder and solvent for solution for injection

Subcutaneous use

LU - Luxembourg

Pfizer SA

17, BD de la Plaine

B-1050 Bruxelles

Genotorm

5 mg

Powder and solvent for solution for injection

Subcutaneous use

LU - Luxembourg

Pfizer SA

17, BD de la Plaine

B-1050 Bruxelles

Genotorm

5,3 mg

Powder and solvent for solution for injection

Subcutaneous use

LU - Luxembourg

Pfizer SA

17, BD de la Plaine

B-1050 Bruxelles

Genotonorm Miniquick

0,2 mg

powder for solution for injection

Subcutaneous use

LU - Luxembourg

Pfizer SA

17, BD de la Plaine

B-1050 Bruxelles

Genotonorm Miniquick

0,4 mg

powder for injection

Subcutaneous use

LU - Luxembourg

Pfizer SA

17, BD de la Plaine

B-1050 Bruxelles

Genotonorm Miniquick

0,6 mg

powder for injection

Subcutaneous use

LU - Luxembourg

Pfizer SA

17, BD de la Plaine

B-1050 Bruxelles

Genotonorm Miniquick

0,8 mg

powder for injection

Subcutaneous use

LU - Luxembourg

Pfizer SA

17, BD de la Plaine

B-1050 Bruxelles

Genotonorm Miniquick

1 mg

powder for injection

Subcutaneous use

LU - Luxembourg

Pfizer SA

17, BD de la Plaine

B-1050 Bruxelles

Genotonorm Miniquick

1,4 mg

powder for injection

Subcutaneous use

LU - Luxembourg

Pfizer SA

17, BD de la Plaine

B-1050 Bruxelles

Genotonorm Miniquick

1,5 mg

powder for solution for injection

Subcutaneous use

LU - Luxembourg

Pfizer SA

17, BD de la Plaine

B-1050 Bruxelles

Genotonorm Miniquick

1,6 mg

powder for injection

Subcutaneous use

LU - Luxembourg

Pfizer SA

17, BD de la Plaine

B-1050 Bruxelles

Genotonorm Miniquick

1,8 mg

powder for injection

Subcutaneous use

LU - Luxembourg

Pfizer SA

17, BD de la Plaine

B-1050 Bruxelles

Genotonorm Miniquick

2 mg

powder for injection

Subcutaneous use

LU - Luxembourg

Ferring SA

9 Hopmarkt

B-9300 Aalst

Zomacton

12 UI

powder for solution for injection

subcutaneous

LU - Luxembourg

Novo Nordisk Pharma

Riverside Business Park

B-1070 Bruxelles

Norditropin Simplexx

5 mg

solution for injection

subcutaneous

LU - Luxembourg

Novo Nordisk Pharma

Riverside Business Park

B-1070 Bruxelles

Norditropin Simplexx

15 mg

solution for injection

subcutaneous

LU - Luxembourg

Novo Nordisk Pharma

Riverside Business Park

B-1070 Bruxelles

Norditropin Simplexx

10 mg

solution for injection

subcutaneous

LU - Luxembourg

Novo Nordisk Pharma

Riverside Business Park

B-1070 Bruxelles

Norditropin Simplexx

10 mg/1,5 ml

solution for injection

subcutaneous

LU - Luxembourg

Novo Nordisk Pharma

Riverside Business Park

B-1070 Bruxelles

Norditropin Nordiflex

5 mg/1,5 ml

solution for injection

subcutaneous

LU - Luxembourg

Novo Nordisk Pharma

Riverside Business Park

B-1070 Bruxelles

Norditropin Nordiflex

10 mg/1,5 ml

solution for injection

subcutaneous

LU - Luxembourg

Novo Nordisk Pharma

Riverside Business Park

B-1070 Bruxelles

Norditropin Nordiflex

15 mg/1,5 ml

solution for injection

subcutaneous

LU - Luxembourg

Ferring SA

9 Hopmarkt

B-9300 Aalst

Zomacton-10

10 mg

powder & solvant for solution for injection

subcutaneous

LU - Luxembourg

Ely Lilly Benelux SA

52, rue de l'Etuve

B-1000 Bruxelles

Humatrope

6 mg

powder for injection

subcutaneous & intramuscular

LU - Luxembourg

Ely Lilly Benelux SA

52, rue de l'Etuve

B-1000 Bruxelles

Humatrope

12 mg

powder for injection

subcutaneous & intramuscular

LU - Luxembourg

Ely Lilly Benelux SA

52, rue de l'Etuve

B-1000 Bruxelles

Humatrope

24 mg

powder for injection

subcutaneous & intramuscular

LV - Latvia

Merck Serono S.p.A.,

Via Casilina 125,

I-00176 Roma,

Italy

Saizen 8 mg click.easy powder and solvent for solution for injection

8 mg

powder and solvent for solution for injection

Subcutaneous use

LV - Latvia

Ferring GmbH,

Wittland 11,

24109 Kiel,

Germany

Zomacton 4 mg powder and solvent for solution for injection

4 mg

powder and solvent for solution for injection

Subcutaneous use

LV - Latvia

Ferring GmbH,

Wittland 11,

24109 Kiel,

Germany

Zomacton 10 mg powder and solvent for solution for injection in pre-filled syringe

4 mg

powder and solvent for solution for injection in pre-filled syringe

Subcutaneous use

LV - Latvia

Pfizer Health AB,

Vetenskapsvagen 10,

SE-191 90 Sollentuna,

Sweden

Genotropin 5,3 mg powder and solvent for solution for injection

5,3 mg

powder and solvent for solution for injection

Subcutaneous use

LV - Latvia

Pfizer Health AB,

Vetenskapsvagen 10,

SE-191 90 Sollentuna,

Sweden

Genotropin 12 mg powder and solvent for solution for injection

12 mg

powder and solvent for solution for injection

Subcutaneous use

MT - Malta

Serono Ltd

Bedfont Cross,

Stanwell Road

Feltham,

Middlesex

TW14 8NX0

Saizen 8 mg click.easy

8 MG

Powder and solvent for solution for injection

Subcutaneous

Intramuscular

MT - Malta

Eli Lilly & Co. Ltd.

Lilly House,

Priestley Road,

Basingstoke,

Hampshire

RG24 9NL,

United Kingdom

Humatrope

6 MG

Powder and Solvent for Solution for Injection

Subcutaneous

Intramuscular

MT - Malta

Eli Lilly & Co. Ltd.

Lilly House,

Priestley Road,

Basingstoke,

Hampshire

RG24 9NL,

United Kingdom

Humatrope

12 MG

Powder and Solvent for Solution for Injection

Subcutaneous

Intramuscular

MT - Malta

Eli Lilly & Co. Ltd.

Lilly House,

Priestley Road,

Basingstoke,

Hampshire

RG24 9NL,

United Kingdom

Humatrope

24 MG

Powder and Solvent for Solution for Injection

Subcutaneous

Intramuscular

MT - Malta

NovoNordisk A/S

Novo Alle,

DK - 2880 Bagsvaerd,

Denmark

Norditropin SimpleXx

Somatropin 5 mg/1,5 ml Somatropin 10 mg/1,5 ml

Solution for Injeciton

Subcutaneous

MT - Malta

Pfizer Hellas S.A.

234, Messoghion Ave.,

Neo Psychiko 15451,

Athens,

Greece

Genotropin 5,3 mg powder and solvent for solution for injection

5,3 mg/ml

Powder and Solvent for Solution for Injection in cartridge

Subcutaneous Use

NL - Netherlands

Pfizer BV,

Rivium Westlaan 142,

2909 LD CAPELLE A/D IJSSEL D –

Nederland

Genotropin

5 mg

Powder and solvent for solution for injection (poeder en oplosmiddel voor oplossing voor injectie

Subcutaneous use

NL - Netherlands

Pfizer BV,

Rivium Westlaan 142,

2909 LD CAPELLE A/D IJSSEL D –

Nederland

Genotropin

12 mg

Powder and solvent for solution for injection (poeder en oplosmiddel voor oplossing voor injectie

Subcutaneous use

NL - Netherlands

Eli Lilly Nederland BV

Grootslag 1-5

3991 RA HOUTEN

Nederland

Humatrope

6, 12, 24 mg

Powder and solvent for solution for injection (poeder en oplosmiddel voor oplossing voor injectie

NL - Netherlands

Novo Nordisk B.V.

Flemingweg 18,

2408 AV ALPHEN A/D RIJN

Nederland

Norditropin FlexPro

5 mg/1,5 ml

Solution for injection in pre-filled syringe (oplossing voor injectie in een voorgevulde) pen

NL - Netherlands

Novo Nordisk B.V.

Flemingweg 18,

2408 AV ALPHEN A/D RIJN

Nederland

Norditropin FlexPro

10 mg/1,5 ml

Solution for injection in pre-filled syringe (oplossing voor injectie in een voorgevulde) pen

NL - Netherlands

Novo Nordisk B.V.

Flemingweg 18,

2408 AV ALPHEN A/D RIJN

Nederland

Norditropin FlexPro

15 mg/1,5 ml

Solution for injection in pre-filled syringe (oplossing voor injectie in een voorgevulde) pen

NL - Netherlands

Novo Nordisk B.V.

Flemingweg 18,

2408 AV ALPHEN A/D RIJN

Nederland

Norditropin SimpleXx

5 mg/1,5 ml

Solution for injection (oplossing voor injectie)

NL - Netherlands

Novo Nordisk B.V.

Flemingweg 18,

2408 AV ALPHEN A/D RIJN

Nederland

Norditropin SimpleXx

10 mg/1,5 ml

Solution for injection (oplossing voor injectie)

NL - Netherlands

Novo Nordisk B.V.

Flemingweg 18,

2408 AV ALPHEN A/D RIJN

Nederland

Norditropin SimpleXx

15 mg/1,5 ml

Solution for injection (oplossing voor injectie)

NL - Netherlands

Ferring BV

Polariavenue 132

2132JX Hoofddorp –

Nederland

Zomacton

10 mg/ml

Solution for injection in pre-filled-syringe (oplossing voor injectie in een voorgevulde spuit)

NL - Netherlands

Ferring BV

Polariavenue 132

2132JX Hoofddorp –

Nederland

Zomacton

4 mg/ml

Powder for solution for injection (poeder voor injectievloeistof)

NO - Norway

Pfizer AS,

Postboks 3,

1324 Lysaker,

Norway

Genotropin

0,2 mg

powder and solution for injection

Subcutaneous use

NO - Norway

Pfizer AS,

Postboks 3,

1324 Lysaker,

Norway

Genotropin

0,4 mg

powder and solution for injection

Subcutaneous use

NO - Norway

Pfizer AS,

Postboks 3,

1324 Lysaker,

Norway

Genotropin

0,6 mg

powder and solution for injection

Subcutaneous use

NO - Norway

Pfizer AS,

Postboks 3,

1324 Lysaker,

Norway

Genotropin

0,8 mg

powder and solution for injection

Subcutaneous use

NO - Norway

Pfizer AS,

Postboks 3,

1324 Lysaker,

Norway

Genotropin

1 mg

powder and solution for injection

Subcutaneous use

NO - Norway

Pfizer AS,

Postboks 3,

1324 Lysaker,

Norway

Genotropin

1,2 mg

powder and solution for injection

Subcutaneous use

NO - Norway

Pfizer AS,

Postboks 3,

1324 Lysaker,

Norway

Genotropin

1,4 mg

powder and solution for injection

Subcutaneous use

NO - Norway

Pfizer AS,

Postboks 3,

1324 Lysaker,

Norway

Genotropin

1,6 mg

powder and solution for injection

Subcutaneous use

NO - Norway

Pfizer AS,

Postboks 3,

1324 Lysaker,

Norway

Genotropin

1,8 mg

powder and solution for injection

Subcutaneous use

NO - Norway

Pfizer AS,

Postboks 3,

1324 Lysaker,

Norway

Genotropin

2 mg

powder and solution for injection

Subcutaneous use

NO - Norway

Pfizer AS,

Postboks 3,

1324 Lysaker,

Norway

Genotropin

5 mg

powder and solution for injection

Subcutaneous use

NO - Norway

Pfizer AS,

Postboks 3,

1324 Lysaker,

Norway

Genotropin

12 mg

powder and solution for injection

Subcutaneous use

NO - Norway

Elly Lilly Norge AS,

Grensevien 99,

0663 Oslo,

Norway

Humatrope

6 mg

powder and solution for injection

injection

NO - Norway

Elly Lilly Norge AS,

Grensevien 99,

0663 Oslo,

Norway

Humatrope

12 mg

powder and solution for injection

injection

NO - Norway

Elly Lilly Norge AS,

Grensevien 99,

0663 Oslo,

Norway

Humatrope

24 mg

powder and solution for injection

injection

NO - Norway

NovoNordisk A/S,

Novo Allé,

2880 Bagsværd,

Danmark

Norditropin SimpleXx

5 mg / 1,5 mL

solution for injection

injection

NO - Norway

NovoNordisk A/S,

Novo Allé,

2880 Bagsværd,

Danmark

Norditropin SimpleXx

10 mg / 1,5 mL

solution for injection

injection

NO - Norway

NovoNordisk A/S,

Novo Allé,

2880 Bagsværd,

Danmark

Norditropin SimpleXx

15 mg/ 1,5 mL

solution for injection

injection

NO - Norway

Merck

AB, 195 87 Stockholm,

Sweden

Saizen click easy

8 mg

powder and solution for injection

injection

NO - Norway

Ferring Legemidler AS,

Postboks 4445,

0403 Oslo,

Norway

Zomacton

4 mg

powder and solution for injection

injection

NO - Norway

NovoNordisk A/S,

Novo Allé,

2880 Bagsværd,

Danmark

Norditropin NordiFlex

5 mg/ 1,5 mL,

solution for injection in prefilled syringe

injection

NO - Norway

NovoNordisk A/S,

Novo Allé,

2880 Bagsværd,

Danmark

Norditropin NordiFlex

10 mg/ 1,5 mL

solution for injection in prefilled syringe

injection

NO - Norway

NovoNordisk A/S,

Novo Allé,

2880 Bagsværd,

Danmark

Norditropin NordiFlex

15 mg/ 1,5 mL

solution for injection in prefilled syringe

injection

PL - Poland

Pfizer Europe MA EEIG

Ramsgate Road,

CT13 9 NJ,

Sandwich, Kent,

United Kingdom

Genotropin 5,3

16 j.m. (5,3 mg)

Powder and solvent for solution for injection

Subcutaneous Use

PL - Poland

Pfizer Europe MA EEIG

Ramsgate Road,

CT13 9 NJ,

Sandwich, Kent,

United Kingdom

Genotropin 12

36 j.m. (12 mg)

Powder and solvent for solution for injection

Subcutaneous Use

PL - Poland

Novo Nordisk A/S

Novo Alle,

Bagsvaerd, DK-2880,

Denmark

Norditropin FlexPro

5 g/1,5 ml

Solution for injection in pre-filled pen

Subcutaneous

PL - Poland

Novo Nordisk A/S

Novo Alle,

Bagsvaerd, DK-2880,

Denmark

Norditropin SimpleXx

5 mg/1,5 ml

Solution for injection

Subcutaneous

PL - Poland

Novo Nordisk A/S

Novo Alle,

Bagsvaerd, DK-2880,

Denmark

Norditropin SimpleXx

10 mg/1,5 ml

Solution for injection

Subcutaneous

PL - Poland

Industria Farmaceutica Serono S.p. A

Via Casilina, 125,

Rome, 00176,

Italy

Saizen 8 mg click.easy

24 j.m. (8 mg), [17,5 j.m. (5,83 mg)/ml]

Powder and solvent for solution for injection

Subcutaneous

PT - Portugal

Ferring Portuguesa - Produtos Farmacêuticos, Sociedade Unipessoal, Lda.

Rua Alexandre Herculano - Edifício 1, Piso 6,

2795-240 Linda-a-Velha,

Portugal

Zomacton

4 mg/3,5 ml

Powder and solvent for solution for injection

Subcutaneous use

PT - Portugal

Ferring Portuguesa - Produtos Farmacêuticos, Sociedade Unipessoal, Lda.

Rua Alexandre Herculano - Edifício 1, Piso 6,

2795-240 Linda-a-Velha,

Portugal

Zomacton

10 mg/ml

Powder and solvent for solution for injection in pre-filled syringe

Subcutaneous use

PT - Portugal

Laboratórios Pfizer, Lda.

Lagoas Park, Edifício 10,

2740-271 Porto Salvo

Portugal

Genotropin

12 mg/1 ml

Powder and solvent for solution for injection

Subcutaneous use

PT - Portugal

Laboratórios Pfizer, Lda.

Lagoas Park, Edifício 10,

2740-271 Porto Salvo

Portugal

Genotropin

5,3 mg/1 ml

Powder and solvent for solution for injection

Subcutaneous use

PT - Portugal

Laboratórios Pfizer, Lda.

Lagoas Park, Edifício 10,

2740-271 Porto Salvo

Portugal

Genotropin Miniquick

1 mg/0,25 ml

Powder and solvent for solution for injection

Subcutaneous use

PT - Portugal

Laboratórios Pfizer, Lda.

Lagoas Park, Edifício 10,

2740-271 Porto Salvo

Portugal

Genotropin Miniquick

2 mg/0,25 ml

Powder and solvent for solution for injection

Subcutaneous use

PT - Portugal

Laboratórios Pfizer, Lda.

Lagoas Park, Edifício 10,

2740-271 Porto Salvo

Portugal

Genotropin Miniquick

0,2 mg/0,25 ml

Powder and solvent for solution for injection

Subcutaneous use

PT - Portugal

Laboratórios Pfizer, Lda.

Lagoas Park, Edifício 10,

2740-271 Porto Salvo

Portugal

Genotropin Miniquick

0,4 mg/0,25 ml

Powder and solvent for solution for injection

Subcutaneous use

PT - Portugal

Laboratórios Pfizer, Lda.

Lagoas Park, Edifício 10,

2740-271 Porto Salvo

Portugal

Genotropin Miniquick

0,6 mg/0,25 ml

Powder and solvent for solution for injection

Subcutaneous use

PT - Portugal

Laboratórios Pfizer, Lda.

Lagoas Park, Edifício 10,

2740-271 Porto Salvo

Portugal

Genotropin Miniquick

0,8 mg/0,25 ml

Powder and solvent for solution for injection

Subcutaneous use

PT - Portugal

Laboratórios Pfizer, Lda.

Lagoas Park, Edifício 10,

2740-271 Porto Salvo

Portugal

Genotropin Miniquick

1,2 mg/0,25 ml

Powder and solvent for solution for injection

Subcutaneous use

PT - Portugal

Laboratórios Pfizer, Lda.

Lagoas Park, Edifício 10,

2740-271 Porto Salvo

Portugal

Genotropin Miniquick

1,4 mg/0,25 ml

Powder and solvent for solution for injection

Subcutaneous use

PT - Portugal

Laboratórios Pfizer, Lda.

Lagoas Park, Edifício 10,

2740-271 Porto Salvo

Portugal

Genotropin Miniquick

1,6 mg/0,25 ml

Powder and solvent for solution for injection

Subcutaneous use

PT - Portugal

Laboratórios Pfizer, Lda.

Lagoas Park, Edifício 10,

2740-271 Porto Salvo

Portugal

Genotropin Miniquick

1,8 mg/0,25 ml

Powder and solvent for solution for injection

Subcutaneous use

PT - Portugal

Laboratórios Pfizer, Lda.

Lagoas Park, Edifício 10,

2740-271 Porto Salvo

Portugal

Genotropin

5 mg/1 ml

Powder and solvent for solution for injection

Subcutaneous use

PT - Portugal

Lilly-Portugal, Produtos Farmacêuticos, Lda.

Rua Cesário Verde, no 5, 4o Piso,

Linda-a-Pastora,

2790-326 Queijas,

Portugal

Humatrope

6 mg/3,17 ml

Powder and solvent for solution for injection

Subcutaneous use

PT - Portugal

Lilly-Portugal, Produtos Farmacêuticos, Lda.

Rua Cesário Verde, no 5, 4o Piso,

Linda-a-Pastora,

2790-326 Queijas,

Portugal

Humatrope

12 mg/3,15 ml

Powder and solvent for solution for injection

Subcutaneous use

PT - Portugal

Lilly-Portugal, Produtos Farmacêuticos, Lda.

Rua Cesário Verde, no 5, 4o Piso,

Linda-a-Pastora,

2790-326 Queijas,

Portugal

Humatrope

24 mg/3,15 ml

Powder and solvent for solution for injection

Subcutaneous use

PT - Portugal

Merck, S.A.

Rua Alfredo da Silva, 3 C,

1300-040 Lisboa,

Portugal

Saizen

1,3 mg/1 ml

Powder and solvent for solution for injection

Subcutaneous use;

Intramuscular use

PT - Portugal

Merck, S.A.

Rua Alfredo da Silva, 3 C,

1300-040 Lisboa,

Portugal

Saizen

3,3 mg/5 ml

Powder and solvent for solution for injection

Subcutaneous use;

Intramuscular use

PT - Portugal

Merck, S.A.

Rua Alfredo da Silva, 3 C,

1300-040 Lisboa,

Portugal

Saizen

8 mg/5 ml

Powder and solvent for solution for injection

Subcutaneous use;

Intramuscular use

PT - Portugal

Merck, S.A.

Rua Alfredo da Silva, 3 C,

1300-040 Lisboa,

Portugal

Saizen "Click Easy"

8 mg/1,37 ml

Powder and solvent for solution for injection

Subcutaneous use

PT - Portugal

Novo Nordisk - Comércio de Produtos Farmacêuticos, Lda.

Quinta da Fonte - Edifício D. José - Piso 1,

2780-730 Paço d' Arcos,

Portugal

Norditropin Nordiflex

5 mg/1,5 ml

Solution for injection

Subcutaneous use

PT – Portugal

Novo Nordisk - Comércio de Produtos Farmacêuticos, Lda.

Quinta da Fonte - Edifício D. José - Piso 1,

2780-730 Paço d' Arcos,

Portugal

Norditropin Nordiflex

10 mg/1,5 ml

Solution for injection

Subcutaneous use

PT - Portugal

Novo Nordisk - Comércio de Produtos Farmacêuticos, Lda.

Quinta da Fonte - Edifício D. José - Piso 1,

2780-730 Paço d' Arcos,

Portugal

Norditropin Nordiflex

15 mg/1,5 ml

Solution for injection

Subcutaneous use

PT - Portugal

Novo Nordisk, A/S

Novo Allé,

DK-2880 Bagsvaerd,

Denmark

Norditropin SimpleXx

5 mg/1,5 ml

Solution for injection

Subcutaneous use

PT - Portugal

Novo Nordisk, A/S

Novo Allé,

DK-2880 Bagsvaerd,

Denmark

Norditropin SimpleXx

10 mg/1,5 ml

Solution for injection

Subcutaneous use

PT - Portugal

Novo Nordisk, A/S

Novo Allé,

DK-2880 Bagsvaerd,

Denmark

Norditropin SimpleXx

15 mg/1,5 ml

Solution for injection

Subcutaneous use

PT - Portugal

Novo Nordisk, A/S

Novo Allé,

DK-2880 Bagsvaerd,

Denmark

Norditropin FlexPro

5 mg/1,5 ml

Solution for injection in pre-filled pen

Subcutaneous use

PT - Portugal

Novo Nordisk, A/S

Novo Allé,

DK-2880 Bagsvaerd,

Denmark

Norditropin FlexPro

10 mg/1,5 ml

Solution for injection in pre-filled pen

Subcutaneous use

PT - Portugal

Novo Nordisk, A/S

Novo Allé,

DK-2880 Bagsvaerd,

Denmark

Norditropin FlexPro

15 mg/1,5 ml

Solution for injection in pre-filled pen

Subcutaneous use

RO - Romania

PFIZER EUROPE MA EEIG

Ramsgate Road,

Sandwich, Kent

CT13 9NJ, UK

GENOTROPIN 16 UI (5,3 mg)

16 UI (5,3 mg)

powder and solvent for solution for injection

subcutaneous use

RO - Romania

FERRING GmbH

Wittland 11,

D – 24109 Kiel,

Germany

ZOMACTON 4 mg (12 UI)

4 mg (12 UI)

powder and solvent for solution for injection

subcutaneous use

RO - Romania

NOVO NORDISK A/S

Novo Allé,

DK-2880 Bagsværd,

Denmark

Norditropin SimpleXx 5 mg/1,5 ml

5 mg/1,5 ml

solution for injection in cartridges

subcutaneous use

RO - Romania

NOVO NORDISK A/S

Novo Allé,

DK-2880 Bagsværd,

Denmark

NORDITROPIN FlexPro 5 mg/1,5 ml

5 mg/1,5 ml

solution for injection in pen

subcutaneous use

RO - Romania

NOVO NORDISK A/S

Novo Allé,

DK-2880 Bagsværd,

Denmark

NORDITROPIN FlexPro 10 mg/1,5 ml

10 mg/1,5 ml

solution for injection in pen

subcutaneous use

SE - Sweden

Pfizer

AB 191 90 Sollentuna

Sweden

Genotropin®

5 mg

Powder and solvent for solution for injection

Subcutaneous use

SE - Sweden

Pfizer

AB 191 90 Sollentuna

Sweden

Genotropin®

5,3 mg

Powder and solvent for solution for injection

Subcutaneous use

SE - Sweden

Pfizer

AB 191 90 Sollentuna

Sweden

Genotropin®

12 mg

Powder and solvent for solution for injection

Subcutaneous use

SE - Sweden

Pfizer

AB 191 90 Sollentuna

Sweden

Genotropin Mini Quick

0,2 mg

Powder and solvent for solution for injection

Subcutaneous use

SE - Sweden

Pfizer

AB 191 90 Sollentuna

Sweden

Genotropin Mini Quick

0,4 mg

Powder and solvent for solution for injection

Subcutaneous use

SE - Sweden

Pfizer

AB 191 90 Sollentuna

Sweden

Genotropin Mini Quick

0,6 mg

Powder and solvent for solution for injection

Subcutaneous use

SE - Sweden

Pfizer

AB 191 90 Sollentuna

Sweden

Genotropin Mini Quick

0,8 mg

Powder and solvent for solution for injection

Subcutaneous use

SE - Sweden

Pfizer

AB 191 90 Sollentuna

Sweden

Genotropin Mini Quick

1 mg

Powder and solvent for solution for injection

Subcutaneous use

SE - Sweden

Pfizer

AB 191 90 Sollentuna

Sweden

Genotropin Mini Quick

1,2 mg

Powder and solvent for solution for injection

Subcutaneous use

SE - Sweden

Pfizer

AB 191 90 Sollentuna

Sweden

Genotropin Mini Quick

1,4 mg

Powder and solvent for solution for injection

Subcutaneous use

SE - Sweden

Pfizer

AB 191 90 Sollentuna

Sweden

Genotropin Mini Quick

1,6 mg

Powder and solvent for solution for injection

Subcutaneous use

SE - Sweden

Pfizer

AB 191 90 Sollentuna

Sweden

Genotropin Mini Quick

1,8

Powder and solvent for solution for injection

Subcutaneous use

SE - Sweden

Pfizer

AB 191 90 Sollentuna

Sweden

Genotropin Mini Quick

2 mg

Powder and solvent for solution for injection

Subcutaneous use

SE - Sweden

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin NordiFlex®

5 mg/1,5 ml

Solution for injection, pre-filled pen

Subcutaneous use

SE - Sweden

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin NordiFlex®

10 mg/1,5 ml

Solution for injection, pre-filled pen

Subcutaneous use

SE - Sweden

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin NordiFlex®

15 mg/1,5 ml

Solution for injection, pre-filled pen

Subcutaneous use

SE - Sweden

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin® SimpleXx®

5 mg/1,5 ml

Solution for injection

Subcutaneous use

SE - Sweden

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin® SimpleXx®

10 mg/1,5 ml

Solution for injection

Subcutaneous use

SE - Sweden

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin® SimpleXx®

15 mg/1,5 ml

Solution for injection

Subcutaneous use

SE - Sweden

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Somatropin Novo Nordisk

5 mg/1,5 ml

Solution for injection, pre-filled pen

Subcutaneous use

SE - Sweden

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Somatropin Novo Nordisk

10 mg/1,5 ml

Solution for injection, pre-filled pen

Subcutaneous use

SE - Sweden

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Somatropin Novo Nordisk

15 mg/1,5 ml

Solution for injection, pre-filled pen

Subcutaneous use

SE - Sweden

Ferring Läkemedel

Box 4041

AB 203 11 Malmö

Sweden

Zomacton

4 mg

Powder and solvent for solution for injection

Subcutaneous use

SE - Sweden

Ferring Läkemedel

Box 4041

AB 203 11 Malmö

Sweden

Zomacton

10 mg/ml

Powder and solvent for solution for injection

Subcutaneous use

SE - Sweden

Eli Lilly Sweden

Box 721

AB 169 27 Solna

Sweden

Humatrope®

6 mg

Powder and solvent for solution for injection

Subcutaneous use

SE - Sweden

Eli Lilly Sweden

Box 721

AB 169 27 Solna

Sweden

Humatrope®

12 mg

Powder and solvent for solution for injection

Subcutaneous use

SE - Sweden

Eli Lilly Sweden

Box 721

AB 169 27 Solna

Sweden

Humatrope®

24 mg

Powder and solvent for solution for injection

Subcutaneous use

SE - Sweden

E. Merck

AB 195 87 Stockholm

Sweden

Saizen® click.easy®

8 mg

Powder and solvent for solution for injection

Subcutaneous use

SI - Slovenia

Pfizer Luxembourg SARL,

51 av. J.-F. Kennedy,

1855 Luxembourg

Genotropin 5,3 mg/ml prašek in vehikel za raztopino za injiciranje

5,3 mg/ ml

Powder and solvent for solution for injection

Subcutaneous use

SI - Slovenia

Pfizer Luxembourg SARL,

51 av. J.-F. Kennedy,

1855 Luxembourg

Genotropin 12 mg/ml prašek in vehikel za raztopino za injiciranje

12 mg/ ml

Powder and solvent for solution for injection

Subcutaneous use

SI - Slovenia

Eli Lilly farmacevtska družba, d.o.o.,

Brnčičeva 41g,

1231 Ljubljana- Črnuče,

Slovenia

Humatrope 6 mg prašek in vehikel za raztopino in injiciranje

6 mg

Powder and solvent for solution for injection

Subcutaneous use

SI - Slovenia

Eli Lilly farmacevtska družba, d.o.o.,

Brnčičeva 41g,

1231 Ljubljana- Črnuče,

Slovenia

Humatrope 12 mg prašek in vehikel za raztopino in injiciranje

12 mg

Powder and solvent for solution for injection

Subcutaneous use

SI - Slovenia

Eli Lilly farmacevtska družba, d.o.o.,

Brnčičeva 41g,

1231 Ljubljana- Črnuče,

Slovenia

Humatrope 24 mg prašek in vehikel za raztopino in injiciranje

24 mg

Powder and solvent for solution for injection

Subcutaneous use

SI - Slovenia

NovoNordis A/S,

Novo Alle,

Basvaerd,

Norditropin FlexPro 10 mg/1,5 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku

6,7 mg/1 ml

Solution for injection in pre-filled pen

Subcutaneous use

SI - Slovenia

NovoNordis A/S,

Novo Alle,

Basvaerd,

Norditropin FlexPro 15 mg/1,5 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku

10 mg/1 ml

Solution for injection in pre-filled pen

Subcutaneous use

SI - Slovenia

NovoNordis A/S,

Novo Alle,

Basvaerd,

Norditropin SimpleXx 5 mg/ 1,5 ml raztopina za injiciranje v injekcijskem vložku

3,3 mg/ 1 ml

Solution for injection in cartridge

Subcutaneous use

SI - Slovenia

NovoNordis A/S,

Novo Alle,

Basvaerd,

Norditropin SimpleXx 10 mg/ 1,5 ml raztopina za injiciranje v injekcijskem vložku

6,7 mg/ 1 ml

Solution for injection in cartridge

Subcutaneous use

SI - Slovenia

NovoNordis A/S,

Novo Alle,

Basvaerd,

Norditropin SimpleXx 15 mg/ 1,5 ml raztopina za injiciranje v injekcijskem vložku

10 mg/ 1 ml

Solution for injection in cartridge

Subcutaneous use

SK - Slovakia

Pfizer Europe MA EEIG

Ramsgate Road,

Sandwich Kent

CT13 9NJ

United Kingdom

GENOTROPIN 5,3 mg

5,3 mg

Powder and solvent for solution for injection

Subcutaneous use

SK - Slovakia

Pfizer Europe MA EEIG

Ramsgate Road,

Sandwich Kent

CT13 9NJ

United Kingdom

GENOTROPIN 12 mg

12 mg

Powder and solvent for solution for injection

Subcutaneous use

SK - Slovakia

Eli Lilly ČR, s.r.o.

Pobřežní 394/12

186 00 Praha

Czech Republic

HUMATROPE 18 IU (6 mg)

6 mg

Powder and solvent for solution for injection

Subcutaneous use

SK - Slovakia

Eli Lilly ČR, s.r.o.

Pobřežní 394/12

186 00 Praha

Czech Republic

HUMATROPE 36 IU (12 mg)

12 mg

Powder and solvent for solution for injection

Subcutaneous use

SK - Slovakia

Eli Lilly ČR, s.r.o.

Pobřežní 394/12

186 00 Praha

Czech Republic

HUMATROPE 72 IU (24 mg)

24 mg

Powder and solvent for solution for injection

Subcutaneous use

SK - Slovakia

Novo Nordisk A/S

Novo Allé

2880 Bagsværd

DENMARK

Norditropin FlexPro 10 mg/1,5 ml

10 mg/ 1,5 ml

Solution for injection in pre-filled pen

Subcutaneous use

SK - Slovakia

Novo Nordisk A/S

Novo Allé

2880 Bagsværd

DENMARK

Norditropin FlexPro 5 mg/1,5 ml

5 mg/ 1,5 mg

Solution for injection in pre-filled pen

Subcutaneous use

SK - Slovakia

Novo Nordisk A/S

Novo Allé

2880 Bagsværd

DENMARK

Norditropin SimpleXx 10 mg/1,5 ml

10 mg/1,5 ml

Solution for injection

Subcutaneous use

SK - Slovakia

Novo Nordisk A/S

Novo Allé

2880 Bagsværd

DENMARK

Norditropin SimpleXx 5 mg/1,5 ml

5 mg/1,5 ml

Solution for injection

Subcutaneous use

SK - Slovakia

Merck Serono S.p.A.

Via Casilina 125

00176 Roma

Italy

Saizen 5,83 mg/ ml injekčný roztok

5,83 mg/1 ml

Solution for injection

Subcutaneous use

SK - Slovakia

Merck Serono S.p.A.

Via Casilina 125

00176 Roma

Italy

Saizen 8 mg/ ml injekčný roztok

8 mg/1 ml

Solution for injection

Subcutaneous use

SK - Slovakia

Merck Serono S.p.A.

Via Casilina 125

00176 Roma

Italy

Saizen 8 mg click.easy

8 mg

Powder and solvent for solution for injection

Subcutaneous use

SK - Slovakia

Ferring GmbH

Wittland 11

Kiel

Germany

Zomacton 4 mg

4 mg

Powder and solvent for solution for injection

Subcutaneous use

SK - Slovakia

Ferring GmbH

Wittland 11

Kiel

Germany

Zomacton 10 mg

10 mg

Powder and solvent for solution for injection

Subcutaneous use

UK - United Kingdom

Eli Lilly & Company Limited,

Lilly House,

Priestly Road,

Basingstoke,

Hampshire

RG24 9NL,

Humatrope 6 mg For Injection

6 mg

powder for injection

intramuscular and subcutaneous use

UK - United Kingdom

Eli Lilly & Company Limited,

Lilly House,

Priestly Road,

Basingstoke,

Hampshire

RG24 9NL,

Humatrope 12 mg For Injection

12 mg

powder for injection

subcutaneous use

UK - United Kingdom

Eli Lilly & Company Limited,

Lilly House,

Priestly Road,

Basingstoke,

Hampshire

RG24 9NL,

Humatrope 24 mg For Injection

24 mg

powder for injection

subcutaneous use

UK - United Kingdom

Pfizer Limited,

Ramsgate Road,

Sandwich, Kent,

CT13 9NJ,

United Kingdom

Genotropin 5,3 mg

5,3 mg

powder and solvent for solution for injection

subcutaneous use

UK - United Kingdom

Pfizer Limited,

Ramsgate Road,

Sandwich, Kent,

CT13 9NJ,

United Kingdom

Genotropin 12 mg

12 mg

powder and solvent for solution for injection

subcutaneous use

UK - United Kingdom

Pfizer Limited,

Ramsgate Road,

Sandwich, Kent,

CT13 9NJ,

United Kingdom

Genotropin Miniquick 0,2 mg

0,2 mg

powder and solvent for solution for injection

subcutaneous use

UK - United Kingdom

Pfizer Limited,

Ramsgate Road,

Sandwich, Kent,

CT13 9NJ,

United Kingdom

Genotropin Miniquick 0,4 mg

0,4 mg

powder and solvent for solution for injection

subcutaneous use

UK - United Kingdom

Pfizer Limited,

Ramsgate Road,

Sandwich, Kent,

CT13 9NJ,

United Kingdom

Genotropin Miniquick 0,6 mg

0,6 mg

powder for injection

subcutaneous use

UK - United Kingdom

Pfizer Limited,

Ramsgate Road,

Sandwich, Kent,

CT13 9NJ,

United Kingdom

Genotropin Miniquick 0,8 mg

0,8 mg

powder for injection

subcutaneous use

UK - United Kingdom

Pfizer Limited,

Ramsgate Road,

Sandwich, Kent,

CT13 9NJ,

United Kingdom

Genotropin Miniquick 1 mg

1 mg

powder for injection

subcutaneous use

UK - United Kingdom

Pfizer Limited,

Ramsgate Road,

Sandwich, Kent,

CT13 9NJ,

United Kingdom

Genotropin Miniquick 1,2 mg

1,2 mg

powder for injection

subcutaneous use

UK - United Kingdom

Pfizer Limited,

Ramsgate Road,

Sandwich, Kent,

CT13 9NJ,

United Kingdom

Genotropin Miniquick 1,4 mg

1,4 mg

powder for injection

subcutaneous use

UK - United Kingdom

Pfizer Limited,

Ramsgate Road,

Sandwich, Kent,

CT13 9NJ,

United Kingdom

Genotropin Miniquick 1,6 mg

1,6 mg

powder for injection

subcutaneous use

UK - United Kingdom

Pfizer Limited,

Ramsgate Road,

Sandwich, Kent,

CT13 9NJ,

United Kingdom

Genotropin Miniquick 1,8 mg

1,8 mg

powder for injection

subcutaneous use

UK - United Kingdom

Pfizer Limited,

Ramsgate Road,

Sandwich, Kent,

CT13 9NJ,

United Kingdom

Genotropin Miniquick 2 mg

2 mg

powder for injection

subcutaneous use

UK - United Kingdom

Novo Nordisk Limited,

Broadfield Park,

Brighton Road,

Crawley,

West Sussex

RH11 9RT,

Norditropin Simplexx 5 mg/1,5 ml

5 mg

solution for injection

subcutaneous use

UK - United Kingdom

Novo Nordisk Limited,

Broadfield Park,

Brighton Road,

Crawley,

West Sussex

RH11 9RT,

Norditropin Simplexx 10 mg/1,5 ml

10 mg

solution for injection

subcutaneous use

UK - United Kingdom

Novo Nordisk Limited,

Broadfield Park,

Brighton Road,

Crawley,

West Sussex

RH11 9RT,

Norditropin Simplexx 15 mg/1,5 ml

15 mg

solution for injection

subcutaneous use

UK - United Kingdom

Novo Nordisk Limited,

Broadfield Park,

Brighton Road,

Crawley,

West Sussex

RH11 9RT,

Norditropin Flexpro 5 mg/1,5 ml

5 mg

solution for injection

subcutaneous use

UK - United Kingdom

Novo Nordisk Limited,

Broadfield Park,

Brighton Road,

Crawley,

West Sussex

RH11 9RT,

Norditropin Flexpro 10 mg/1,5 ml

10 mg

solution for injection

subcutaneous use

UK - United Kingdom

Novo Nordisk Limited,

Broadfield Park,

Brighton Road,

Crawley,

West Sussex

RH11 9RT,

Norditropin Flexpro 15 mg/1,5 ml

15 mg

solution for injection

subcutaneous use

UK - United Kingdom

Novo Nordisk Limited,

Broadfield Park,

Brighton Road,

Crawley,

West Sussex

RH11 9RT,

Norditropin Nordiflex 5 mg/1,5 ml

5 mg

solution for injection

subcutaneous use

UK - United Kingdom

Novo Nordisk Limited,

Broadfield Park,

Brighton Road,

Crawley,

West Sussex

RH11 9RT,

Norditropin Nordiflex 10 mg/1,5 ml

10 mg

solution for injection

subcutaneous use

UK - United Kingdom

Novo Nordisk Limited,

Broadfield Park,

Brighton Road,

Crawley,

West Sussex

RH11 9RT,

Norditropin Nordiflex 15 mg/1,5 ml

15 mg

solution for injection

subcutaneous use

UK - United Kingdom

Ferring Phamraceuticals Limited,

The Courtyard,

Waterside Drive,

Langley,

Berkshire

SL3 6EZ,

Zomacton 4 mg injection

4 mg

powder for solution for injection

subcutaneous use

UK - United Kingdom

Ferring Phamraceuticals Limited,

The Courtyard,

Waterside Drive,

Langley,

Berkshire

SL3 6EZ,

Zomacton 10 mg powder for solution for injection (pre-filled syringe)

10 mg

powder for solution for injection

subcutaneous use

UK - United Kingdom

Serono Limted,

Bedfont Cross,

Stanwell Road,

Feltham,

Middlesex

TW14 8NX,

Saizen 4IU

1,33 mg

powder for injection

intramuscular and subcutaneous use

UK - United Kingdom

Serono Limted,

Bedfont Cross,

Stanwell Road,

Feltham,

Middlesex

TW14 8NX,

Saizen 10IU

3,33 mg

powder for injection

intramuscular and subcutaneous use

UK - United Kingdom

Serono Limted,

Bedfont Cross,

Stanwell Road,

Feltham,

Middlesex

TW14 8NX,

Saizen 8 mg ClickEasy

8 mg

powder for solution for injection

subcutaneous use

UK - United Kingdom

Serono Limted,

Bedfont Cross,

Stanwell Road,

Feltham,

Middlesex

TW14 8NX,

Saizen 5,83 mg/ml Solution for Injection

5,83 mg

solution for injection

subcutaneous use

UK - United Kingdom

Serono Limted,

Bedfont Cross,

Stanwell Road,

Feltham,

Middlesex

TW14 8NX,

Saizen 8 mg/ml Solution for Injection

8 mg

solution for injection

subcutaneous use

ANNEX III

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

Member State EU/EEA

Marketing authorisation holder

INN

Strength

Product name

Pharmaceutical form

Route of administration

Belgium

Medgenix Benelux

Vliegveld 21

8560 Wevelgem

Belgium

pholcodine 15 mg/15 ml

Sulfogaiacol 300 mg/15 ml

1,00 mg/ml

(pholcodine)

Broncho-Pectoralis Pholcodine

Syrup

Oral use

Belgium

Medgenix Benelux

Vliegveld 21

8560 Wevelgem

Belgium

pholcodine eucalyptolum

camphora syntheticum

gaiacolum

phenolum

10,00 mg

120 mg

156 mg

50 mg

10 mg

Eucalyptine Pholcodine

(Adult)

Suppository

Rectal use

Belgium

Medgenix Benelux

Vliegveld 21

8560 Wevelgem

Belgium

pholcodine eucalyptolum

camphora syntheticum

gaiacolum

phenolum

5,00 mg

80 mg

100 mg

30 mg

6 mg

Eucalyptine Pholcodine

(Child)

Suppository

Rectal use

Belgium

Novum Pharma

Latem Business Park

Xavier De Cocklaan 66

box 3

9830 Sint-Martens-Latem

Belgium

pholcodine 5 mg/5 ml

Doxylaminii succinas 5 mg/5 ml

Kalii guaiacolsulfonas 47,5 mg/5 ml

Natrii benzoas 50 mg/5 ml

1,00 mg/ml

(pholcodine)

Pholco-mereprine

Syrup

Oral use

Belgium

Sanofi-Aventis Belgium NV

Culliganlaan 1C

1831 Diegem

Belgium

pholcodine 0,12 g

1,20 mg/ml

Cotrane Folcodine

Syrup

Oral use

France

AEROCID

248 bis, rue Gabriel Péri

B.P. 126

94232 Cachan Cedex

FRANCE

myrte (huile essentielle de) (deterpenee); alpha-terpinéol;

pholcodine

0,05 g/100 g;

0,0025 g/100 g;

0,05 g/100 g

Myrtine Enfants, sirop

Syrup

Oral use

France

AMIDO

37, avenue Gabriel Péri

BP 232

92503 Rueil-Malmaison Cedex

FRANCE

coquelicot (petale de) (extrait sec de); pholcodine;

sodium (benzoate de)

0,2/100 g,

0,075 g/100 g

1 g/100 g

Pulmadol Enfants, sirop

Syrup

Oral use

France

BAYER SANTE FAMILIALE

33, rue de l'Industrie

74240 Gaillard

FRANCE

pholcodine

0,075 g/100 g

Broncorinol toux seche enfants, sirop

Syrup

Oral use

France

BAYER SANTE FAMILIALE

33, rue de l'Industrie

74240 Gaillard

FRANCE

pholcodine

0,100 g/100 g

Broncorinol adultes toux seche pholcodine, sirop

Syrup

Oral use

France

BOUCHARA RECORDATI

68, rue Marjolin

92300 Levallois-Perret

FRANCE

biclotymol; chlorphénamine (maléate de); pholcodine

0,2 g/100 ml;

0,012 g/100 ml;

0,120 g/100 ml

Hexapneumine adultes, sirop

Syrup

Oral use

France

BOUCHARA RECORDATI

68, rue Marjolin

92300 Levallois-Perret

FRANCE

biclotymol; chlorphénamine (maléate de); pholcodine

0,15/100 ml;

0,01 g/100 ml

0,1 g/100 ml

Hexapneumine enfants, sirop

Syrup

Oral use

France

BOUCHARA RECORDATI

68, rue Marjolin

92300 Levallois-Perret

FRANCE

biclotymol;

cinéole;

pholcodine

0,0800 g;

0,0700 g;

0,0050 g

Hexapneumine enfants, suppositoire

Suppository

Rectal use

France

BOUCHARA RECORDATI

68, rue Marjolin

92300 Levallois-Perret

FRANCE

biclotymol;

cinéole;

pholcodine

0,160 g;

0,140 g;

0,015 g

Hexapneumine adultes, suppositoire

Suppository

Rectal use

France

BRIDOUX

6, rue Salengro

62160 Bully les Mines

FRANCE

pholcodine;

sodium (benzoate de)

0,0846 g/100 g; 2 g/100 g

Pulmosodyl adulte, sirop

Syrup

Oral use

France

COOPER

Place Lucien-Auvert

77020 Melun Cedex

FRANCE

pholcodine; érysimum (extrait sec d')

1 mg/ml;

1,5 mg/ml

Clarix toux seche pholcodine erysimum adultes, sirop

Syrup

Oral use

France

COOPER

Place Lucien-Auvert

77020 Melun Cedex

FRANCE

pholcodine;

érysimum (extrait sec d')

0,1 g/100 ml;

0,150 g/100 ml

Clarix toux seche pholcodine erysimum adultes sans sucre, sirop édulcoré au maltitol liquide et au cyclamate de sodium

Syrup

Oral use

France

FERLUX

24, avenue d'Aubière

BP 151

63804 Cournon d'Auvergne Cedex

FRANCE

pholcodine

133 mg/100 ml

Dimetane sans sucre 133 mg/100 ml, sirop

Syrup

Oral use

France

GENEVRIER

280, rue de Goa

Les Trois Moulins - Parc de Sophia Antipolis

06600 Antibes

FRANCE

pholcodine

0,0850 g/100 ml

Codotussyl toux seche enfants, sirop

Syrup

Oral use

France

GENEVRIER

280, rue de Goa

Les Trois Moulins - Parc de Sophia Antipolis

06600 Antibes

FRANCE

pholcodine

133 mg/100 ml

Codotussyl toux seche adultes, sirop

Syrup

Oral use

France

GENEVRIER

280, rue de Goa

Les Trois Moulins - Parc de Sophia Antipolis

06600 Antibes

FRANCE

cinéole;

pholcodine

0,05 g

0,005 g

Codotussyl Enfants, suppositoire

Suppository

Rectal use

France

GENEVRIER

280, rue de Goa

Les Trois Moulins - Parc de Sophia Antipolis

06600 Antibes

FRANCE

cinéole;

pholcodine

0,1 g;

0,02 g

Codotussyl adultes, suppositoire

Suppository

Rectal use

France

HEPATOUM

1 bis, rue de Plaisance

94130 Nogent Sur Marne

FRANCE

chlorphénamine (maléate de); pholcodine

0,01300 g/100 ml;

0,08 g/100 ml

Broncalene adultes, sirop

Syrup

Oral use

France

HEPATOUM

1 bis, rue de Plaisance

94130 Nogent Sur Marne

FRANCE

chlorphénamine (maléate de); pholcodine

0,01 g/100 ml;

0,0500 g/100 ml

Broncalene enfants, sirop

Syrup

Oral use

France

HEPATOUM

1 bis, rue de Plaisance

94130 Nogent Sur Marne

FRANCE

chlorphénamine (maléate de); pholcodine

0,0133 g/100 ml

0,08 g/100 ml

Broncalene adultes sans sucre, sirop édulcoré à la saccharine sodique

Syrup

Oral use

France

MEDIFLOR

37, rue St Romain

69008 Lyon

FRANCE

guaïfénésine;

pholcodine

0,200 g/100 ml;

0,100 g/100 ml

Ephedromel, sirop

Syrup

Oral use

France

MEDIFLOR

37, rue St Romain

69008 Lyon

FRANCE

pholcodine; sulfogaïacol

0,050 g/100 g;

3 g/100 g

Pectoral Richelet sans sucre, solution buvable édulcorée à la saccharine sodique

Oral solution

Oral use

France

PIERRE FABRE MEDICAMENT

45, place Abel Gance

92100 Boulogne Billancourt

FRANCE

erysimum (sommite fleurie d') (extrait fluide de);

pholcodine

2,4 g/100 g;

0,082 g/100 g

Polery enfants, sirop

Syrup

Oral use

France

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

FRANCE

pholcodine

0,060 g/100 ml

Rhinathiol enfants toux seche 0,06 % pholcodine, sirop

Syrup

Oral use

France

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

FRANCE

pholcodine

0,060 g/100 ml

Respilene enfants 3 mg/5 ml, sirop

Syrup

Oral use

France

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

FRANCE

pholcodine

0,12 g/100 ml

Pholcodine delalande adultes 0,12 %, sirop

Syrup

Oral use

France

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

FRANCE

pholcodine

0,12 g/100 ml

Pharmakod 0,12 % adultes toux seche, sirop

Syrup

Oral use

France

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

FRANCE

pholcodine

0,12 g/100 ml

Rhinathiol adultes toux seche 0,12 % pholcodine, sirop

Syrup

Oral use

France

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

FRANCE

pholcodine

0,12 g/100 ml

Pholcodine winthrop adultes 0,12 %, sirop

Syrup

Oral use

France

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

FRANCE

pholcodine;

sodium (ténoate de)

0,133 g/100 ml;

1 g

Trophires adultes, sirop

Syrup

Oral use

France

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

FRANCE

pholcodine

0,12 g/100 ml

Respilene adultes 0,12 pour cent, sirop

Syrup

Oral use

France

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

FRANCE

pholcodine;

sodium (ténoate de)

0,06 g/100 ml

1 g/100 ml

Trophires enfants, sirop

Syrup

Oral use

France

UCB PHARMA

420 Avenue Estienne d'Orves

Défense Ouest

92700 Colombes

FRANCE

MYRTE (huile essentielle de) (deterpenee);

pholcodine

20 mg;

18 mg

Atouxx adultes, capsule

Capsule

Oral use

France

URGO

42, rue de Longvic

BP 157

21304 Chenôve Cedex

FRANCE

pholcodine

0,200 g/100 ml

Humex adultes toux seche pholcodine, sirop

Syrup

Oral use

France

URGO

42, rue de Longvic

BP 157

21304 Chenôve Cedex

FRANCE

pholcodine

0,125 g/100 ml

Humex enfants toux seche pholcodine, sirop

Syrup

Oral use

France

ZAMBON FRANCE

13, rue René Jacques

92138 Issy-les-Moulineaux Cedex

FRANCE

pholcodine

1,31 mg/ml

Flucalyptol toux seche pholcodine 1,31 mg/ml, sirop

Syrup

Oral use

France

ZAMBON FRANCE

13, rue René Jacques

92138 Issy-les-Moulineaux Cedex

FRANCE

pholcodine

1,31 mg/ml

Biocalyptol, sirop

Syrup

Oral use

France

ZAMBON FRANCE

13, rue René Jacques

92138 Issy-les-Moulineaux Cedex

FRANCE

pholcodine

131 mg/100 ml

Flucalyptol toux seche pholcodine 1,31 mg/ml sans sucre, sirop edulcoré à la saccharine sodique et au maltitol liquide

Syrup

Oral use

France

ZAMBON FRANCE

13, rue René Jacques

92138 Issy-les-Moulineaux Cedex

FRANCE

gaïacol;

pholcodine

19,750 mg/100 ml;

131 mg/100 ml

Biocalyptol a la pholcodine, sirop

Syrup

Oral use

France

ZAMBON FRANCE

13, rue René Jacques

92138 Issy-les-Moulineaux Cedex

FRANCE

pholcodine

131 mg/100 ml

Biocalyptol 6,55 mg/5 ml sans sucre, sirop édulcoré à la saccharine sodique et au maltitol liquide

Syrup

Oral use

France

ZAMBON FRANCE

13, rue René Jacques

92138 Issy-les-Moulineaux Cedex

FRANCE

pholcodine;

érysimum (extrait sec d')

0,1/100 ml;

0,150/100 ml

Pholcodyl, sirop

Syrup

Oral use

Ireland

GlaxoSmithKline Consumer Healthcare (Ireland) Limited,

Stonemasons Way,

Rathfarnham,

Dublin 16,

Ireland

Paracetamol, Pseudoephedrine hydrochloride, Pholcodine

500 mg,

30 mg,

5 mg

Day Nurse Capsules

Capsule, hard

Oral use

Ireland

GlaxoSmithKline Consumer Healthcare (Ireland) Limited,

Stonemasons Way,

Rathfarnham,

Dublin 16,

Ireland

Paracetamol, Pseudoephedrine hydrochloride, Pholcodine

500 mg,

30 mg,

5 mg

Solpadeine Cold & Flu Capsules

Capsule, hard

Oral use

Ireland

Pinewood Laboratories Ltd,

Ballymacarbry,

Clonmel,

Co. Tipperary,

Ireland

Pholcodine

5 mg

Pholcodex 5 mg/5 ml oral solution

Oral solution

Oral use

Ireland

The Boots Company Plc,

1 Thane Road West,

Nottingham,

NG2 3AA,

United Kingdom

Paracetamol, Pseudoephedrine hydrochloride, Pholcodine

500 mg

30 mg,

5 mg

Nirolex day cold & flu capsules

Capsule, hard

Oral use

Ireland

The Boots Company Plc,

1 Thane Road West,

Nottingham,

NG2 3AA,

United Kingdom

Paracetamol,

Pseudoephedrine hydrochloride,

Pholcodine

1 000 mg/30 ml, 60 mg/30 ml

10 mg/30 ml,

Nirolex day cold & flu oral solution

Oral solution

Oral use

Lithuania

ORIVAS UAB,

J.Jasinskio 16B

LT-01112 Vilnius,

Lithuania

Pholcodine,

Chlorphenamine,

Biclotymol

120 mg

12 mg

200 mg/100 ml

Hexapneumine Adults

Syrup

Oral use

Lithuania

ORIVAS UAB,

J.Jasinskio 16B

LT-01112 Vilnius,

Lithuania

Pholcodine,

Chlorphenamine,

Biclotymolm

100 mg

10 mg

150 mg/100 ml

Hexapneumine Children

Syrup

Oral use

Luxembourg

COOPERATION PHARM.FRANCAISE

PLACE LUCIEN AUVERT

77020 MELUN CEDEX

France

Erysimum extr.sec

Pholcodine

0,150 g

0,100 g

Clarix

Syrup

Oral use

Luxembourg

COOPERATION PHARM.FRANCAISE

PLACE LUCIEN AUVERT

77020 MELUN CEDEX

France

Erysimum extr.sec

Pholcodine

0,150 g

0,100 g

Clarix sans sucre

Syrup

Oral use

Luxembourg

Eurogenerics S.A.

ESPLANADE HEYSEL, B.22

1020 BRUXELLES

Belgium

Pholcodine

phenylephrine hcl

100 mg/100 ml

67 mg/100 ml

Pectorhinyl

Syrup

Oral use

Luxembourg

Eurogenerics S.A.

ESPLANADE HEYSEL, B.22

1020 BRUXELLES

Belgium

Pholcodine

phenylephrine hcl

50 mg/100 ml

pectorhinyl junior

Syrup

Oral use

Luxembourg

MEDGENIX BENELUX S.A

21, VLIEGVELD

8560 WEVELGEM

Belgium

camphre

eucalyptol

gaiacol

phenol

pholcodine

156 mg

120 mg

50 mg

10 mg

Eucalyptine-Pholcodine Adultes

Suppository

Rectal use

Luxembourg

MEDGENIX BENELUX S.A

21, VLIEGVELD

8560 WEVELGEM

Belgium

camphre

eucalyptol

gaiacol

phenol

pholcodine

100 mg

80 mg

30 mg

6 mg

5 mg

Eucalyptine-Pholcodine Enfants

Suppository

Rectal use

Luxembourg

NOVUM PHARMA

66-3, XAVIER DE COCKLAAN

9830 SINT-MARTENS-LATEM

Belgium

doxylamine

pholcodine

benzoate sodique

sulfogaiacol

5 mg

50 mg

47,5 mg

Pholco Mereprine

Syrup

Oral use

Luxembourg

SANOFI-AVENTIS BELGIUM

1C, CULLIGANLAAN

1831 DIEGEM

Belgium

pholcodine

thiophene carboxylate

eucalyptus huile essentielle

parahydroxybenzoate de methyle

parahydroxybenzoate de propyle

0,060 g

1 g

0,250 ml

0,080 g

0,030 g/100 ml

Trophires Enfants

Syrup

Oral use

Luxembourg

SANOFI-AVENTIS BELGIUM

1C, CULLIGANLAAN

1831 DIEGEM

Belgium

pholcodine

thiophene carboxylate

eucalyptus huile essentielle

parahydroxybenzoate de methyle

parahydroxybenzoate de propyle

0,133 g

1 g

0,250 ml

0,080 g

0,030 g

Trophires Adultes

Syrup

Oral use

Luxembourg

SANOFI-AVENTIS BELGIUM

1C, CULLIGANLAAN

1831 DIEGEM

Belgium

Pholcodine

1,2 mg/ml

Cotrane Pholcodine

Syrup

Oral use

Malta

Beecham Group PLC

980, Great West Road

Brentford,

Middlesex

TW 8 9 GS

United Kingdom

Paracetamol,

Pseudoephedrine Hydrochloride,

Pholcodine

500 mg

30 mg

5 mg

Day Nurse

Hard capsules

Oral use

Malta

Beecham Group PLC

980, Great West Road

Brentford,

Middlesex

TW 8 9 GS

United Kingdom

Paracetamol

Pseudoephedrine Hydrochloride

Pholcodine

Active Ingredient per 30 ml

Paracetamol 1 g

Pseudoephedrine Hydrochloride 60 mg

Pholcodine 10 mg

Day Nurse

Oral solution

Oral use

Malta

Thornton & Ross Limited

Linthwaite Huddersfield

West Yorkshire

HD7 5QH

United Kingdom

Pholcodine,

Ephedrine Hydrochloride,

Chlorphenamine Maleate

Pholcodine BP 5,0 mg

Ephedrine Hydrochloride BP 8,0 mg

Chlorphenamine Maleate BP 2,0 mg

Cofsed Liquid

Oral suspension

Oral use

Slovenia

Alkaloid d.o.o.,

Slandrova ulica 4,

1231 Ljubljana,

Slovenia

pholcodine

0,8 mg/ml

Folkodin Alkaloid 0,8 mg/ml peroralna raztopina za otroke

Oral solution

Oral use

Slovenia

Alkaloid d.o.o.,

Slandrova ulica 4,

1231 Ljubljana,

Slovenia

pholcodine

1 mg/ml

Folkodin Alkaloid 1 mg/ml peroralna raztopina

Oral solution

Oral use

Slovenia

Alkaloid d.o.o.,

Slandrova ulica 4,

1231 Ljubljana,

Slovenia

pholcodine

10 mg

Folkodin Alkaloid 10 mg trde kapsule

Capsule, hard

Oral use

Spain

ROTTAPHARM,

S.L.Avda. Diagonal, 67-69

08019 Barcelona

Spain

pholcodine;

cineol;

cherry laurel water;

menthol;

terpineol;

benzocaine

4 mg

3 mg

5 mg

4 mg

2 mg

1 mg

Caltoson Balsamico

Tablets

Oral use

United Kingdom

Alliance Pharmaceuticals Limited,

Avonbridge House, Bath Road, Chippenham,

Wiltshire,

SN15 2BB,

United Kingdom

pholcodine

5 mg

Pavacol-D

Oral liquid

Oral use

United Kingdom

Ayrton Saunders Limited,

North Way,

Walworth Industrial Estate, Andover,

Hampshire,

SP10 5AZ,

United Kingdom

pholcodine

5 mg

Pholcodine Linctus BP

Oral solution

Oral use

United Kingdom

Ayrton Saunders Limited,

North Way,

Walworth Industrial Estate, Andover,

Hampshire,

SP10 5AZ,

United Kingdom

pholcodine

5 mg

Cupal Linctus

Oral liquid

Oral use

United Kingdom

Beecham Group PLC,

980 Great West Road, Brentford,

Middlesex,

TW8 9GS,

United Kingdom

Psedoephedrine Hydrochloride; Pholcodine; Paracetamol

60 mg;

10 mg,

1 000 mg

Day Nurse

Oral solution

Oral use

United Kingdom

Beecham Group PLC,

980 Great West Road, Brentford,

Middlesex,

TW8 9GS,

United Kingdom

Psedoephedrine Hydrochloride;

Pholcodine; Paracetamol

30 mg,

5 mg,

500 mg

Day Nurse

Capsules

Oral use

United Kingdom

Beecham Group PLC,

980 Great West Road, Brentford,

Middlesex,

TW8 9GS,

United Kingdom

Promethazine Hydrochloride, Paracetamol,

Dextromethorphan hydrobromide

Pholcodine;

Pseudoephedrine

10 mg

500 mg

7,5 mg

5 mg

30 mg

Day and Night Nurse capsules

(nb this is a combination of Day Nurse and Night Nurse capsules in one pack)

Capsules

Oral use

United Kingdom

Beecham Group PLC,

980 Great West Road, Brentford,

Middlesex,

TW8 9GS,

United Kingdom

Pholcodine;

Diphenhydramine hydrochloride

3,75 mg/5 ml;

12,5 mg/5 ml

Cough Nurse Night Time Syrup

Oral liquid

Oral use

United Kingdom

Bell Sons & Company Druggist limited.

Gifford House, Slaidburn Crescent, Southport,

Mersyside,

PR9 9AL,

United Kingdom

pholcodine

0,1 % w/w

Bell Pholcodine Linctus

Oral liquid

Oral use

United Kingdom

Bell Sons & Company Druggist limited.

Gifford House, Slaidburn Crescent, Southport,

Mersyside,

PR9 9AL,

United Kingdom

pholcodine

0,2 % w/w

Bell Strong Pholcodine Linctus

Oral liquid

Oral use

United Kingdom

Ernest Jackson and company Limited,

29 High Street, Crediton,

Devon,

EX17 3AP,

United Kingdom

pholcodine

0,12 % w/w

Potter's Pholcodine cough pastilles

Lozenge

Oral use

United Kingdom

LCM Limited,

Linthwaite,Huddersfield,

West Yorkshire,

HD7 5QH,

United Kingdom

pholcodine

5 mg

Pholcodine Linctus BP

Oral solution

Oral use

United Kingdom

Line Range Limited, c/o Orbis consumer products Limited,

Cunard Road, Park Royal,

London

NW10 6PN,

United Kingdom

Pseudoephedrine Hydrochloride; Pholcodine; Diphenhydramine Hydrochloride; Paracetamol;

Ethanol

6,67 mg,

1,67 mg,

100 mg,

96 % 1 ml

Night time Cold relief

Oral solution

Oral use

United Kingdom

Line Range Limited, c/o Orbis consumer products Limited,

Cunard Road, Park Royal,

London

NW10 6PN,

United Kingdom

Pseudoephedrine Hydrochloride; Pholcodine;

Paracetamol

6,67 mg/5 ml,

1,67 mg/5 ml, 100 mg/5 ml

Day time cold relief

Oral liquid

Oral use

United Kingdom

LPC Medical (UK) Limited,

2 Covent Garden Close, Luton,

Bedfordshire,

LU4 8QB,

United Kingdom

pholcodine

10 mg

Hill's Balsam Dry cough liquid

Oral solution

Oral use

United Kingdom

Mcneil Products Limited,

Regulatory Affairs, Dorking Road,

Walton Oaks,

KT20 7NS,

United Kingdom

pholcodine

2 mg

Benylin Children's dry cough

Syrup

Oral use

United Kingdom

Novartis Consumer Health UK Limited,

Wimblehurst Road, Horsham,

West Sussex,

RH12 5AB,

United Kingdom

Promethazine Hydrochloride; Pholcodine

1,5 mg,

1,5 mg

Tixylix night cough oral solution

Oral solution

Oral use

United Kingdom

Novartis Consumer Health UK Limited,

Wimblehurst Road, Horsham,

West Sussex,

RH12 5AB,

United Kingdom

Psedoephedrine Hydrochloride; Chlorpheniramine maleate; Pholcodine

20 mg,

2 mg,

5 mg

Tixylix cough and Cold

Syrup

Oral use

United Kingdom

Novartis Consumer Health UK Limited,

Wimblehurst Road, Horsham,

West Sussex,

RH12 5AB,

United Kingdom

Pholcodine

4 mg

Tixylix Dry cough

Oral solution

Oral use

United Kingdom

Pinewood Laboratories Limited,

Ballymacarbry,

Clonmel,

Co Tipperary,

Ireland

pholcodine

5 mg

Pholcodine Cough Linctus

Syrup

Oral use

United Kingdom

Pinewood Laboratories Limited,

Ballymacarbry,

Clonmel,

Co Tipperary,

Ireland

pholcodine

10 mg

Strong Pholcodine Linctus BP

Oral solution

Oral use

United Kingdom

Sterling Pharmaceuticals Limited,

288 Upper Balsall Heath Road,

Birmingham,

B12 9DR,

United Kingdom

pholcodine

5 mg

Pholcodine Linctus BP.

Oral solution

Oral use

United Kingdom

Sterling Pharmaceuticals Limited,

288 Upper Balsall Heath Road,

Birmingham,

B12 9DR,

United Kingdom

pholcodine

10 mg

Strong Pholcodine Linctus BP.

Oral solution

Oral use

United Kingdom

The Boots company PLC,

1 Thane Road West,

Nottingham,

NG2 3AA

United Kingdom

diphenhydramine Chloride;

Pholcodine

12,5 mg

3,75 mg

Boots cough relief for Adults Liquid

Oral solution

Oral use

United Kingdom

The Boots company PLC,

1 Thane Road West,

Nottingham,

NG2 3AA

United Kingdom

diphenhydramine Chloride;

Pholcodine

12,5 mg,

1,5 mg

Boots cough relief for Children Syrup

Oral solution

Oral use

United Kingdom

The Boots company PLC,

1 Thane Road West,

Nottingham,

NG2 3AA

United Kingdom

Pholcodine

2 mg

Boots Dry Cough Syrup 6 years+

Syrup

Oral use

United Kingdom

The Boots company PLC,

1 Thane Road West,

Nottingham,

NG2 3AA

United Kingdom

Paracetamol, Pseudoephedrine Hydrochloride, Pholcodine

3,333 % w/v,

0,2 % w/v,

0,033 % w/v

Boots Night cough relief oral solution

Oral solution

Oral use

United Kingdom

The Boots company PLC,

1 Thane Road West,

Nottingham,

NG2 3AA

United Kingdom

Paracetamol; Pseudoephedrine Hydrochloride;

Pholcodine

3,333 % w/v,

0,2 % w/v

0,033 % w/v

Boots Day cold and Flu relief oral solution

Oral solution

Oral use

United Kingdom

The Boots company PLC,

1 Thane Road West,

Nottingham,

NG2 3AA

United Kingdom

Paracetamol; Pseudoephedrine Hydrochloride;

Diphenhydramine Hydrochloride; Pholcodine

3,333 % w/v,

0,2 % w/v,

0,083 % w/v,

0,033 % w/v

Boots Pharmacy cold and Flu night liquid

Oral solution

Oral use

United Kingdom

The Boots company PLC,

1 Thane Road West,

Nottingham,

NG2 3AA

United Kingdom

Pholcodine; Paracetamol; Psedoephedrine Hydrochloride

5 mg

500 mg

30 mg

Boots Pharmacy cold and Flu Day capsules

Capsules

Oral use

United Kingdom

The Boots company PLC,

1 Thane Road West,

Nottingham,

NG2 3AA

United Kingdom

Pholcodine; Paracetamol;

Diphenhydramine Psedoephedrine Hydrochloride

5 mg,

500 mg,

12,5 mg

30 mg

Boots Pharmacy Cold and Flu Night Capsules

Capsules

Oral use

United Kingdom

The Boots company PLC,

1 Thane Road West,

Nottingham,

NG2 3AA

United Kingdom

pholcodine

0,1 % w/w

Boots Pholcodine Linctus BP

Oral solution

Oral use

United Kingdom

The Boots company PLC,

1 Thane Road West,

Nottingham,

NG2 3AA

United Kingdom

Pholcodine; Paracetamol; diphenhydramine hydrochloride;

Pseudoephedrine hydrochloride

5 mg

500 mg

12,5 mg

30 mg

Boots Pharmacy Cold and Flu 24 Hour Capsules

(Nb this is a pack containing a combination of Day and Night capsules)

Capsules

Oral use

United Kingdom

Thornton & Ross Limited,

Linthwaite, Huddersfield,

West Yorkshire,

HD7 5QH

United Kingdom

Pholcodine; Ephedrine Hydrochloride; Chlorpheniramine maleate

5 mg,

8 mg,

2 mg

Cofsed Linctus

Oral liquid

Oral use

United Kingdom

Thornton & Ross Limited,

Linthwaite, Huddersfield,

West Yorkshire,

HD7 5QH

United Kingdom

Pholcodine; Ephedrine Hydrochloride;

Chlorpheniramine maleate

2 mg,

4 mg,

1 mg

Cofsed Paediatric Linctus

Oral liquid

Oral use

United Kingdom

Thornton & Ross Limited,

Linthwaite, Huddersfield,

West Yorkshire,

HD7 5QH

United Kingdom

pholcodine

5 mg

Care Pholcodine 5 mg/5 ml Oral solution

Oral liquid

Oral use

United Kingdom

Thornton & Ross Limited,

Linthwaite, Huddersfield,

West Yorkshire,

HD7 5QH

United Kingdom

pholcodine

2 mg

Galenphol Paediatric Linctus oral liquid 2,0 mg/5 ml

Oral liquid

Oral use

United Kingdom

Thornton & Ross Limited,

Linthwaite, Huddersfield,

West Yorkshire,

HD7 5QH

United Kingdom

pholcodine

10 mg

Galenphol Strong Linctus

Oral solution

Oral use

United Kingdom

Thornton & Ross Limited,

Linthwaite, Huddersfield,

West Yorkshire,

HD7 5QH

United Kingdom

pholcodine

5 mg

Covonia Dry cough sugar free formula

Oral liquid

Oral use

United Kingdom

Wise Pharmaceuticals Limited,

7 Oxford Street,

Manchester,

M1 4PB,

United Kingdom

pholcodine

5 mg

Pholcodine Linctus BP

Oral solution

Oral use

United Kingdom

Wise Pharmaceuticals Limited,

7 Oxford Street,

Manchester,

M1 4PB,

United Kingdom

pholcodine

10 mg

Strong Pholcodine Linctus

Oral solution

Oral use

ANNEX IV

LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

Member State EU/EEA

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Austria

S.Med Handels GmbH

Zachgasse1, Vienna

AT-1220

Austria

BufloMed ‧S.Med‧ 300 mg Filmtabletten

300 mg

film-coated tablet

oral use

Austria

S.Med Handels GmbH

Zachgasse1, Vienna

AT-1220

Austria

BufloMed ‧S.Med‧ retard 600 mg Filmtabletten

600 mg

prolonged-release tablet

oral use

Belgium

Amdipharm Limited

Temple Chambers

3 Burlington Road

Dublin 4

Ireland

Loftyl

150 mg

coated tablet

oral use

Belgium

Amdipharm Limited

Temple Chambers

3 Burlington Road

Dublin 4

Ireland

Loftyl

50 mg/5 ml

solution for injection

intramuscular and intravenous use

Cyprus

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street

P.O.Box 51409

3505 Lemesos

Cyprus

Ikelan solution for injection or infusion 50 mg/5 ml

50 mg/5 ml

injection

Intramuscular and intravenous use

France

BIOGARAN

15, boulevard Charles de Gaulle

92700 COLOMBES

FRANCE

BUFLOMEDIL BIOGARAN 150 mg, comprimé pelliculé

150 mg

Film-coated tablet

oral use

France

QUALIMED

117, allée des Parcs

69800 SAINT-PRIEST

France

BUFLOMEDIL QUALIMED 150 mg, comprimé pelliculé

150 mg

Film-coated tablet

oral use

France

TEVA SANTE

Le Palatin 1, 1 cours du Triangle

92936 PARIS LA DEFENSE CEDEX

France

BUFLOMEDIL TEVA 150 mg, comprimé pelliculé

150 mg

Film-coated tablet

oral use

France

ACTAVIS France

La Boursidière Centre d’Affaires

92357 LE PLESSIS ROBINSON

France

BUFLOMEDIL ACTAVIS 150 mg, comprimé

150 mg

Tablet

oral use

France

AMDIPHARM LTD

Temple Chambers 3

Burlington Road

DUBLIN 4

IRELAND

LOFTYL 50 mg/5 ml, solution injectable

50 mg/5 ml

Solution for injection

Intramuscular and intravenous use

France

AMDIPHARM LTD

Temple Chambers 3,

Burlington Road

DUBLIN 4

IRELAND

LOFTYL 150 mg, comprimé pelliculé

150 mg

Film-coated tablet

oral use

France

ARROW GENERIQUES

26, avenue Tony Garnier

69007 LYON

FRANCE

BUFLOMEDIL ARROW 150 mg, comprimé

150 mg

Tablet

oral use

France

CEPHALON FRANCE

20, rue Charles Martigny

94700 MAISONS-ALFORT

FRANCE

FONZYLANE 150 mg, comprimé pelliculé

150 mg

Film-coated tablet

oral use

France

CRISTERS

22 quai Gallieni

92150 SURESNES

FRANCE

BUFLOMEDIL CRISTERS 150 mg, comprimé

150 mg

Tablet

oral use

France

EG LABO - LABORATOIRES EUROGENERICS

"Le Quintet" - bâtiment A

12, rue Danjou

92517 BOULOGNE BILLANCOURT Cedex

FRANCE

BUFLOMEDIL EG 150 mg, comprimé pelliculé

150 mg

Film-coated tablet

oral use

France

LABORATOIRE RATIOPHARM

19, boulevard Paul Vaillant Couturier

94200 IVRY SUR SEINE

France

BUFLOMEDIL RATIOPHARM 150 mg, comprimé pelliculé

150 mg

Film-coated tablet

oral use

France

MYLAN SAS

117, allée des Parcs

69800 SAINT-PRIEST

France

BUFLOMEDIL MYLAN 150 mg, comprimé pelliculé

150 mg

Film-coated tablet

oral use

France

RANBAXY PHARMACIE GENERIQUES

11-15 Quai Dion Bouton

92800 PUTEAUX

France

BUFLOMEDIL RPG 150 mg, comprimé pelliculé

150 mg

Film-coated tablet

oral use

France

RANBAXY PHARMACIE GENERIQUES

11-15 Quai Dion Bouton

92800 PUTEAUX

France

BUFLOMEDIL RPG 150 mg, comprimé

150 mg

Tablet

oral use

France

SANDOZ

49, avenue Georges Pompidou

92300 LEVALLOIS-PERRET

France

BUFLOMEDIL SANDOZ 150 mg, comprimé

150 mg

Tablet

oral use

France

ZYDUS FRANCE

25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d’Activités des Peupliers

92000 NANTERRE

France

BUFLOMEDIL ZYDUS 150 mg, comprimé

150 mg

Tablet

oral use

Germany

Amdipharm Limited

Temple Chamcers, 3

Burlington Road

IRL- DUBLIN 4

Irland

Bufedil long Retardtabletten

600 mg

Prolonged-release tablet

oral use

Germany

AbZ-Pharma GmbH

Dr.Georg-Spohn-Str. 7

D-89143 Blaubeuren

Germany

Buflomedil AbZ, 600 mg Retardtabletten

600 mg

Prolonged-release tablet

oral use

Germany

Actavis Deutschland GmbH & Co. KG

Elisabeth-Selbert-Str. 1

D-40764 Langenfeld

Germany

Buflo-Puren 300

300 mg

Film-coated tablet

oral use

Germany

Actavis Deutschland GmbH & Co. KG

Elisabeth-Selbert-Str. 1

D-40764 Langenfeld

Germany

BUFLO-Puren 600 retard

600 mg

Prolonged-release tablet

oral use

Germany

CT Arzneimittel GmbH

Lengeder Str. 42a

D-13407 Berlin

Buflomedil-CT 150 mg Filmtabletten

150 mg

Film-coated tablet

oral use

Germany

CT Arzneimittel GmbH

Lengeder Str. 42a

D-13407 Berlin

Buflomedil-CT 300 mg Filmtabletten

300 mg

Film-coated tablet

oral use

Germany

CT Arzneimittel GmbH

Lengeder Str. 42a

D-13407 Berlin

Buflomedil-CT 50 mg/5 ml Ampullen

50 mg / 5 ml

Solution for injection, solution for infusion

Intravenous and intramuscular use

Germany

CT Arzneimittel GmbH

Lengeder Str. 42a

D-13407 Berlin

Buflomedil-CT 600 mg Retardtabletten

600 mg

Prolonged-release tablet

oral use

Germany

ratiopharm GmbH

Graf-Arco-STr. 3

D-89079 Ulm

Germany

Buflomedil-ratiopharm 300 mg Filmtabletten

300 mg

Film-coated tablet

oral use

Germany

ratiopharm GmbH

Graf-Arco-STr. 3

D-89079 Ulm

Germany

Buflomedil-ratiopharm 600 mg Retardtabletten

600 mg

Prolonged-release tablet

oral use

Germany

Riemser Arzneimittel AG

An der Wiek 7

D-17493 Greifswald - Insel Riems

Germany

Complamin Buflomedil 600 mg retard

600 mg

Prolonged-release tablet

oral use

Germany

Riemser Arzneimittel AG

An der Wiek 7

D-17493 Greifswald - Insel Riems

Germany

Complamin Buflomedil Injekt

50 mg / 5 ml

Solution for injection

intravenous and intramuscular use

Germany

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst, Gebäude K703

D-65926 Frankfurt am Main

Germany

Defluina peri

300 mg

Film-coated tablet

oral use

Germany

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst, Gebäude K703

D-65926 Frankfurt am Main

Germany

Deflunia peri mite

150 mg

Film-coated tablet

oral use

Germany

Stadapharm GmbH

Stadastr. 2 – 18

D-61118 Bad Vilbel

Buflomedil Stada 150 mg Filmtabletten

150 mg

Film-coated tablet

oral use

Germany

Stadapharm GmbH

Stadastr. 2 – 18

D-61118 Bad Vilbel

Buflomedil Stada 300 mg Filmtabletten

300 mg

Film-coated tablet

oral use

Greece

BROS LTD

AYGIS AND GALINIS 15

KIFISSIA

14564 ATHENS

Greece

THIOCODIN

150 MG/TAB

COATED TABLET

oral use

Greece

BROS LTD

AYGIS AND GALINIS 15

KIFISSIA

14564 ATHENS

Greece

THIOCODIN

300 MG/TAB

COATED TABLET

oral use

Greece

AMDIPHARM LIMITED, IRELAND

Temple Chambers

3 Burlington Road

Dublin 4

Ireland

LOFTYL

150 MG/TAB

FILM COATED TABLET

oral use

Greece

AMDIPHARM LIMITED, IRELAND

Temple Chambers

3 Burlington Road

Dublin 4

Ireland

LOFTYL

300 MG/TAB

FILM COATED TABLET

oral use

Greece

AMDIPHARM LIMITED, IRELAND

Temple Chambers

3 Burlington Road

Dublin 4

Ireland

LOFTYL

150 MG/ML

ORAL DROPS SOLUTION

oral use

Greece

AMDIPHARM LIMITED, IRELAND

Temple Chambers

3 Burlington Road

Dublin 4

Ireland

LOFTYL

50 MG/5 ML

SOLUTION FOR INJECTION

INTRAVENOUS INFUSION, INTRAVENOUS INJECTION, INTRAMUSCULAR

Greece

AMDIPHARM LIMITED, IRELAND

Temple Chambers

3 Burlington Road

Dublin 4

Ireland

LOFTYL

600 MG/TAB

CONTROLLED RELEASE TABLET

oral use

Greece

BIOSPRAY ABEE

18TH KM MARATHONOS AVENUE

PALLINI

15344 Athens

Greece

BOTAMIRAL

300 MG/TAB

FILM COATED TABLET

oral use

Greece

FARAN ABEE PRODUCTION AND DISTRIBUTION OF MEDICINES

ACHAIAS AND TRIZOINIAS

NEA KIFISSIA

14564 Athens

Greece

VANOGEL

150 MG/ML

ORAL DROPS SOLUTION

oral use

Greece

FARAN ABEE PRODUCTION AND DISTRIBUTION OF MEDICINES

ACHAIAS AND TRIZOINIAS

14565 NEA KIFISSIA

Greece

VANOGEL

300 MG/TAB

FILM COATED TABLET

oral use

Greece

HELP ABEE

VALAORITOU 10,

144 52 METAMORFOSI ATTIKIS

Greece

VARDOLIN

150 MG/ML

ORAL DROPS SOLUTION

oral use

Greece

HELP ABEE

VALAORITOU 10,

144 53 METAMORFOSI ATTIKIS

Greece

VARDOLIN

150 MG/TAB

FILM COATED TABLET

oral use

Greece

HELP ABEE

VALAORITOU 10,

144 54 METAMORFOSI ATTIKIS

Greece

VARDOLIN

300 MG/TAB

FILM COATED TABLET

oral use

Greece

HELP ABEE

VALAORITOU 10,

144 55 METAMORFOSI ATTIKIS

Greece

VARDOLIN

600 MG/TAB

CONTROLLED RELEASE TABLET

oral use

Greece

NORMA HELLAS S.A.

MENANDROU 54

10431 ATHENS

Greece

FLUBIR

150 MG/TAB

FILM COATED TABLET

oral use

Greece

NORMA HELLAS S.A.

MENANDROU 54

10432 ATHENS

Greece

FLUBIR

300 MG/TAB

FILM COATED TABLET

oral use

Greece

RAFARM A.E.B.E.

KORINTHOU 12,

15451 NEO PSYCHIKO

Greece

ZELIAN

150 MG/TAB

FILM COATED TABLET

oral use

Greece

RAFARM A.E.B.E.

KORINTHOU 12,

15451 NEO PSYCHIKO

Greece

ZELIAN

300 MG/TAB

FILM COATED TABLET

oral use

Greece

BIOSTAM KAL. MPOUGA AND CO

DIAKRIAS 6

ZOGRAFOU

157 73 Athens

Greece

CHLOROFARM-S

300 MG/TAB

FILM COATED TABLET

oral use

Greece

ANFARM HELLAS

PERIKLEOUS 53-57

105 60 ATHENS

Greece

BLADIRON

300 MG/TAB

FILM COATED TABLET

oral use

Greece

ANFARM HELLAS

PERIKLEOUS 53-57

105 60 ATHENS

Greece

BLADIRON

150 MG/ML

ORAL DROPS SOLUTION

oral use

Greece

A. NIKOLAKOPOULOS AND CO

GALATSIOU AVENUE 115,

11146 ATHENS

Greece

IRRODAN RETARD

600 MG/TAB

SUSTAINED RELEASE TABLET

oral use

Greece

MEDICHROM S.A.

6Km MARKOPOULOU-KOROPI AVENUE

19003 MARKOPOPULO MESOGEIWN

Greece

BUFLODIL

300 MG/TAB

FILM COATED TABLET

oral use

Greece

ELPEN SA PHARMACEUTICAL INDUSTRY

MARATHONOS AVENUE 95

19009 PIKERMI ATTIKIS

Greece

PENPURIN

150 MG/TAB

FILM COATED TABLET

oral use

Greece

ELPEN SA PHARMACEUTICAL INDUSTRY

MARATHONOS AVENUE 95

19010 PIKERMI ATTIKIS

Greece

PENPURIN

300 MG/TAB

FILM COATED TABLET

oral use

Greece

ELPEN SA PHARMACEUTICAL INDUSTRY

MARATHONOS AVENUE 95

19011 PIKERMI ATTIKIS

Greece

PENPURIN

150 MG/ML

ORAL DROPS SOLUTION

oral use

Greece

ELPEN SA PHARMACEUTICAL INDUSTRY

MARATHONOS AVENUE 95

19012 PIKERMI ATTIKIS

Greece

PENPURIN

600 MG/TAB

CONTROLLED RELEASE TABLET

oral use

Greece

VIOFAR LTD

ETHNIKIS ANTISTASEOS AND

TRIFYLLIAS

13671 ACHARNES

Greece

SULODIL

300 MG/TAB

FILM COATED TABLET

oral use

Greece

VIOFAR LTD

ETHNIKIS ANTISTASEOS AND

TRIFYLLIAS

13672 ACHARNES

Greece

SULODIL

600 MG/TAB

CONTROLLED RELEASE TABLET

oral use

Italy

AMDIPHARM LTD

Temple Chambers,

3 Burlington Road,

Dublin 4

IRELAND

LOFTYL

150 mg/ml

oral drop, solution

oral use

Italy

AMDIPHARM LTD

Temple Chambers,

3 Burlington Road,

Dublin 4

IRELAND

LOFTYL

10 mg/ml

solution for injection

intramuscular and intravenous use

Italy

AMDIPHARM LTD

Temple Chambers,

3 Burlington Road,

Dublin 4

IRELAND

LOFTYL

300 mg/10 ml

oral solution

oral use

Italy

AMDIPHARM LTD

Temple Chambers,

3 Burlington Road,

Dublin 4

IRELAND

LOFTYL

600 mg

prolonged-release tablet

oral use

Italy

AMDIPHARM LTD

Temple Chambers,

3 Burlington Road,

Dublin 4

IRELAND

LOFTYL

300 mg

tablet

oral use

Italy

BIOMEDICA FOSCAMA GROUP SpA

Via della Giuliana 73

00195 Roma

Italy

IRRODAN

10 mg/ml

solution for injection

intramuscular and intravenous use

Italy

BIOMEDICA FOSCAMA GROUP SpA

Via della Giuliana 73

00195 Roma

Italy

IRRODAN

150 mg/ml

oral drop, solution

oral use

Italy

BIOMEDICA FOSCAMA GROUP SpA

Via della Giuliana 73

00195 Roma

Italy

IRRODAN

300 mg

tablet

oral use

Italy

LABORATORIO FARMACEUTICO C.T. S.r.l.

Strada Solaro n. 75-77

Villa Sayonara - Sanremo –

18038 IMPERIA

Italy

BUFLOCIT

300 mg

capsule, hard

oral use

Italy

LABORATORIO FARMACEUTICO C.T. S.r.l.

Strada Solaro n. 75-77

Villa Sayonara - Sanremo –

18038 IMPERIA

Italy

BUFLOCIT

150 mg

capsule, hard

oral use

Italy

LABORATORIO FARMACEUTICO C.T. S.r.l.

Strada Solaro n. 75-77

Villa Sayonara - Sanremo –

18038 IMPERIA

Italy

BUFLOCIT

600 mg

prolonged-release tablet

oral use

Luxembourg

AMDIPHARM LIMITED

3, TEMPLE CHAMBERS

IRL DUBLIN

Loftyl

50 mg

solution for injection

Intramuscular and intravenous use

Luxembourg

Amdipharm Limited

Temple Chambers,

3 Burlington Road

Dublin 4

Ireland

Loftyl

150 mg

tablets

oral use

Portugal

Amdipharm Limited

Temple Chambers

3, Burlington Road

Dublin 4

Ireland

Loftyl 300

300 mg

Coated tablet

oral use

Portugal

Amdipharm Limited

Temple Chambers,

3 Burlington Road

Dublin 4

Ireland

Loftyl Forte

600 mg

Prolonged-release tablet

oral use

Netherlands

Amdipharm Limited

Temple Chambers,

3 Burlington Road

Dublin 4

Ireland

Loftyl

150 mg

tablets

oral use

Spain

Amdipharm Limited

Temple Chambers,

3 Burlington Road

Dublin 4

Ireland

LOFTON 150 mg comprimidos recubiertos

150 mg

coated tablet

oral use

Spain

Amdipharm Limited

Temple Chambers,

3 Burlington Road

Dublin 4

Ireland

LOFTON 150 mg/ml gotas orales en solución

150 mg/ml

oral drops solution

oral use

Poland

ICN Polfa Rezszów S.A.

Przemysłowa 2

35-959 Rzeszów,

Poland Office in Warsaw:

ul. Marynarska 15

02-674 Warszawa,

Poland

Buvasodil

150 mg

film coated tablets

oral use

Poland

ICN Polfa Rezszów S.A.

Przemysłowa 2

35-959 Rzeszów,

Poland Office in Warsaw:

ul. Marynarska 15

02-674 Warszawa,

Poland

Buvasodil

300 mg

film coated tablets

oral use

		ISSN 1977-091X doi:10.3000/1977091X.C_2012.094.eng
Official Journal of the European Union		C 94

English edition	Information and Notices	Volume 55 30 March 2012

Notice No	Contents	page
	IV Notices
	NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES
	European Commission
2012/C 094/01	Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2012 to 29 February 2012(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)	1

2012/C 094/02	Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2012 to 29 February 2012(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)	13