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Document 52006XC0930(02)
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 August 2006 to 31 August 2006 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 August 2006 to 31 August 2006 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 August 2006 to 31 August 2006 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
IO C 236, 30.9.2006, p. 7–32
(ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, NL, PL, PT, SK, SL, FI, SV)
|
30.9.2006 |
EN |
Official Journal of the European Union |
C 236/7 |
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 August 2006 to 31 August 2006
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))
(2006/C 236/03)
— Issuing, maintenance or modification of a national marketing authorisation
|
Date of the decision |
Name(s) of the medicinal product |
Holder(s) of the marketing authorization |
Member State concerned |
Date of notification |
|||||
|
4.8.2006 |
Neurontin |
See Annex I |
See Annex I |
8.8.2006 |
|||||
|
10.8.2006 |
Thelin |
|
The Decision is sent to all member States. |
11.8.2006 |
|||||
|
21.8.2006 |
Prozac |
See Annex II |
See Annex II |
23.8.2006 |
|||||
|
21.8.2006 |
Cobactan IV 4;5% |
See Annex III |
See Annex III |
23.8.2006 |
|||||
|
21.8.2006 |
Ceftriaxone Tyrol Pharma |
See Annex IV |
See Annex IV |
23.8.2006 |
|||||
|
28.8.2006 |
Exjade |
|
The Decision is sent to all member States. |
30.8.2006 |
— 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 |
|
28.8.2006 |
Cetirizine Copyfarm |
See Annex V |
See Annex V |
30.8.2006 |
(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 MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
|
Member State |
Marketing Authorisation Holder |
Applicant |
Invented Name |
Strength |
Pharmaceutical Form |
Route of administration |
||||||||||
|
Austria |
|
|
Neurontin |
300 mg |
Capsules, hard |
Oral use |
||||||||||
|
Austria |
|
|
Neurontin |
400 mg |
Capsules, hard |
Oral use |
||||||||||
|
Austria |
|
|
Neurontin |
600 mg |
Film-coated tablets |
Oral use |
||||||||||
|
Austria |
|
|
Neurontin |
800 mg |
Film-coated tablets |
Oral use |
||||||||||
|
Belgium |
|
|
Neurontin |
100 mg |
Capsules, hard |
Oral use |
||||||||||
|
Belgium |
|
|
Neurontin |
300 mg |
Capsules, hard |
Oral use |
||||||||||
|
Belgium |
|
|
Neurontin |
400 mg |
Capsules, hard |
Oral use |
||||||||||
|
Belgium |
|
|
Neurontin |
600 mg |
Film-coated tablets |
Oral use |
||||||||||
|
Belgium |
|
|
Neurontin |
800 mg |
Film-coated tablets |
Oral use |
||||||||||
|
Czech Republic |
|
|
Neurontin |
100 mg |
Capsules, hard |
Oral use |
||||||||||
|
Czech Republic |
|
|
Neurontin |
300 mg |
Capsules, hard |
Oral use |
||||||||||
|
Czech Republic |
|
|
Neurontin |
400 mg |
Capsules, hard |
Oral use |
||||||||||
|
Czech Republic |
|
|
Neurontin |
600 mg |
Film-coated tablets |
Oral use |
||||||||||
|
Czech Republic |
|
|
Neurontin |
800 mg |
Film-coated tablets |
Oral use |
||||||||||
|
Cyprus |
|
|
Neurontin |
300 mg |
Capsules, hard |
Oral use |
||||||||||
|
Cyprus |
|
|
Neurontin |
400 mg |
Capsules, hard |
Oral use |
||||||||||
|
Denmark |
|
|
Gabapentin ‘Pfizer’ |
300 mg |
Capsules, hard |
Oral use |
||||||||||
|
Denmark |
|
|
Gabapentin ‘Pfizer’ |
400 mg |
Capsules, hard |
Oral use |
||||||||||
|
Denmark |
|
|
Gabapentin ‘Pfizer’ |
600 mg |
Film-coated tablets |
Oral use |
||||||||||
|
Denmark |
|
|
Gabapentin ‘Pfizer’ |
800 mg |
Film-coated tablets |
Oral use |
||||||||||
|
Estonia |
|
|
Neurontin |
100 mg |
Capsules, hard |
Oral use |
||||||||||
|
Estonia |
|
|
Neurontin |
300 mg |
Capsules, hard |
Oral use |
||||||||||
|
Estonia |
|
|
Neurontin |
400 mg |
Capsules, hard |
Oral use |
||||||||||
|
Estonia |
|
|
Neurontin |
600 mg |
Film-coated tablets |
Oral use |
||||||||||
|
Estonia |
|
|
Neurontin |
800 mg |
Film-coated tablets |
Oral use |
||||||||||
|
Finland |
|
|
Neurontin |
300 mg |
Capsules, hard |
Oral use |
||||||||||
|
Finland |
|
|
Neurontin |
400 mg |
Capsules, hard |
Oral use |
||||||||||
|
Finland |
|
|
Neurontin |
600 mg |
Film-coated tablets |
Oral use |
||||||||||
|
Finland |
|
|
Neurontin |
800 mg |
Film-coated tablets |
Oral use |
||||||||||
|
France |
|
|
Neurontin |
100 mg |
Capsules, hard |
Oral use |
||||||||||
|
France |
|
|
Neurontin |
300 mg |
Capsules, hard |
Oral use |
||||||||||
|
France |
|
|
Neurontin |
400 mg |
Capsules, hard |
Oral use |
||||||||||
|
France |
|
|
Neurontin |
600 mg |
Film-coated tablets |
Oral use |
||||||||||
|
France |
|
|
Neurontin |
800 mg |
Film-coated tablets |
Oral use |
||||||||||
|
Germany |
|
|
Neurontin |
100 mg |
Capsules, hard |
Oral use |
||||||||||
|
Germany |
|
|
Neurontin |
300 mg |
Capsules, hard |
Oral use |
||||||||||
|
Germany |
|
|
Neurontin |
400 mg |
Capsules, hard |
Oral use |
||||||||||
|
Germany |
|
|
Neurontin |
600 mg |
Film-coated tablets |
Oral use |
||||||||||
|
Germany |
|
|
Neurontin |
800 mg |
Film-coated tablets |
Oral use |
||||||||||
|
Greece |
|
|
Neurontin |
100 mg |
Capsules, hard |
Oral use |
||||||||||
|
Greece |
|
|
Neurontin |
300 mg |
Capsules, hard |
Oral use |
||||||||||
|
Greece |
|
|
Neurontin |
400 mg |
Capsules, hard |
Oral use |
||||||||||
|
Greece |
|
|
Neurontin |
600 mg |
Film-coated tablets |
Oral use |
||||||||||
|
Greece |
|
|
Neurontin |
800 mg |
Film-coated tablets |
Oral use |
||||||||||
|
Iceland |
|
|
Neurontin |
100 mg |
Capsules, hard |
Oral use |
||||||||||
|
Iceland |
|
|
Neurontin |
300 mg |
Capsules, hard |
Oral use |
||||||||||
|
Iceland |
|
|
Neurontin |
400 mg |
Capsules, hard |
Oral use |
||||||||||
|
Iceland |
|
|
Neurontin |
600 mg |
Film-coated tablets |
Oral use |
||||||||||
|
Iceland |
|
|
Neurontin |
800 mg |
Film-coated tablets |
Oral use |
||||||||||
|
Ireland |
|
|
Neurontin |
100 mg |
Capsules, hard |
Oral use |
||||||||||
|
Ireland |
|
|
Neurontin |
300 mg |
Capsules, hard |
Oral use |
||||||||||
|
Ireland |
|
|
Neurontin |
400 mg |
Capsules, hard |
Oral use |
||||||||||
|
Ireland |
|
|
Neurontin |
600 mg |
Film-coated tablets |
Oral use |
||||||||||
|
Ireland |
|
|
Neurontin |
800 mg |
Film-coated tablets |
Oral use |
||||||||||
|
Hungary |
|
|
Neurontin |
100 mg |
Capsules, hard |
Oral use |
||||||||||
|
Hungary |
|
|
Neurontin |
300 mg |
Capsules, hard |
Oral use |
||||||||||
|
Hungary |
|
|
Neurontin |
400 mg |
Capsules, hard |
Oral use |
||||||||||
|
Hungary |
|
|
Neurontin |
600 mg |
Film-coated tablets |
Oral use |
||||||||||
|
Hungary |
|
|
Neurontin |
800 mg |
Film-coated tablets |
Oral use |
||||||||||
|
Italy |
|
|
Neurontin |
100 mg |
Capsules, hard |
Oral use |
||||||||||
|
Italy |
|
|
Neurontin |
300 mg |
Capsules, hard |
Oral use |
||||||||||
|
Italy |
|
|
Neurontin |
400 mg |
Capsules, hard |
Oral use |
||||||||||
|
Latvia |
|
|
Neurontin |
100 mg |
Capsules, hard |
Oral use |
||||||||||
|
Latvia |
|
|
Neurontin |
300 mg |
Capsules, hard |
Oral use |
||||||||||
|
Latvia |
|
|
Neurontin |
400 mg |
Capsules, hard |
Oral use |
||||||||||
|
Latvia |
|
|
Neurontin |
600 mg |
Film-coated tablets |
Oral use |
||||||||||
|
Latvia |
|
|
Neurontin |
800 mg |
Film-coated tablets |
Oral use |
||||||||||
|
Lithuania |
|
|
Neurontin |
100 mg |
Capsules, hard |
Oral use |
||||||||||
|
Lithuania |
|
|
Neurontin |
300 mg |
Capsules, hard |
Oral use |
||||||||||
|
Lithuania |
|
|
Neurontin |
400 mg |
Capsules, hard |
Oral use |
||||||||||
|
Lithuania |
|
|
Neurontin |
600 mg |
Film-coated tablets |
Oral use |
||||||||||
|
Lithuania |
|
|
Neurontin |
800 mg |
Film-coated tablets |
Oral use |
||||||||||
|
Luxembourg |
|
|
Neurontin |
100 mg |
Capsules, hard |
Oral use |
||||||||||
|
Luxembourg |
|
|
Neurontin |
300 mg |
Capsules, hard |
Oral use |
||||||||||
|
Luxembourg |
|
|
Neurontin |
400 mg |
Capsules, hard |
Oral use |
||||||||||
|
Luxembourg |
|
|
Neurontin |
600 mg |
Film-coated tablets |
Oral use |
||||||||||
|
Luxembourg |
|
|
Neurontin |
800 mg |
Film-coated tablets |
Oral use |
||||||||||
|
Malta |
|
|
Neurontin |
100 mg |
Capsules, hard |
Oral use |
||||||||||
|
Malta |
|
|
Neurontin |
300 mg |
Capsules, hard |
Oral use |
||||||||||
|
Malta |
|
|
Neurontin |
400 mg |
Capsules, hard |
Oral use |
||||||||||
|
Malta |
|
|
Neurontin |
600 mg |
Film-coated tablets |
Oral use |
||||||||||
|
Norway |
|
|
Neurontin |
100 mg |
Capsules, hard |
Oral use |
||||||||||
|
Norway |
|
|
Neurontin |
300 mg |
Capsules, hard |
Oral use |
||||||||||
|
Norway |
|
|
Neurontin |
400 mg |
Capsules, hard |
Oral use |
||||||||||
|
Norway |
|
|
Neurontin |
600 mg |
Film-coated tablets |
Oral use |
||||||||||
|
Norway |
|
|
Neurontin |
800 mg |
Film-coated tablets |
Oral use |
||||||||||
|
Poland |
|
|
Neurontin |
100 mg |
Capsules, hard |
Oral use |
||||||||||
|
Poland |
|
|
Neurontin |
300 mg |
Capsules, hard |
Oral use |
||||||||||
|
Poland |
|
|
Neurontin |
400 mg |
Capsules, hard |
Oral use |
||||||||||
|
Poland |
|
|
Neurontin |
600 mg |
Film-coated tablets |
Oral use |
||||||||||
|
Poland |
|
|
Neurontin |
800 mg |
Film-coated tablets |
Oral use |
||||||||||
|
Portugal |
|
|
Neurontin |
100 mg |
Capsules, hard |
Oral use |
||||||||||
|
Portugal |
|
|
Neurontin |
300 mg |
Capsules, hard |
Oral use |
||||||||||
|
Portugal |
|
|
Neurontin |
400 mg |
Capsules, hard |
Oral use |
||||||||||
|
Portugal |
|
|
Neurontin |
600 mg |
Film-coated tablets |
Oral use |
||||||||||
|
Portugal |
|
|
Neurontin |
800 mg |
Film-coated tablets |
Oral use |
||||||||||
|
The Netherlands |
|
|
Neurontin |
100 mg |
Capsules, hard |
Oral use |
||||||||||
|
The Netherlands |
|
|
Neurontin |
300 mg |
Capsules, hard |
Oral use |
||||||||||
|
The Netherlands |
|
|
Neurontin |
400 mg |
Capsules, hard |
Oral use |
||||||||||
|
The Netherlands |
|
|
Neurontin |
600 mg |
Film-coated tablets |
Oral use |
||||||||||
|
The Netherlands |
|
|
Neurontin |
800 mg |
Film-coated tablets |
Oral use |
||||||||||
|
Slovenia |
|
|
Neurontin |
100 mg |
Capsules, hard |
Oral use |
||||||||||
|
Slovenia |
|
|
Neurontin |
300 mg |
Capsules, hard |
Oral use |
||||||||||
|
Slovenia |
|
|
Neurontin |
400 mg |
Capsules, hard |
Oral use |
||||||||||
|
Slovenia |
|
|
Neurontin |
600 mg |
Film-coated tablets |
Oral use |
||||||||||
|
Slovenia |
|
|
Neurontin |
800 mg |
Film-coated tablets |
Oral use |
||||||||||
|
The Slovak Republic |
Contact address:
|
|
Neurontin |
100 mg |
Capsules, hard |
Oral use |
||||||||||
|
The Slovak Republic |
Contact address:
|
|
Neurontin |
300 mg |
Capsules, hard |
Oral use |
||||||||||
|
The Slovak Republic |
Contact address:
|
|
Neurontin |
400 mg |
Capsules, hard |
Oral use |
||||||||||
|
The Slovak Republic |
Contact address:
|
|
Neurontin |
600 mg |
Film-coated tablets |
Oral use |
||||||||||
|
The Slovak Republic |
Contact address:
|
|
Neurontin |
800 mg |
Film-coated tablets |
Oral use |
||||||||||
|
Spain |
|
|
Neurontin |
300 mg |
Capsules, hard |
Oral use |
||||||||||
|
Spain |
|
|
Neurontin |
400 mg |
Capsules, hard |
Oral use |
||||||||||
|
Spain |
|
|
Neurontin |
600 mg |
Film-coated tablets |
Oral use |
||||||||||
|
Spain |
|
|
Neurontin |
800 mg |
Film-coated tablets |
Oral use |
||||||||||
|
Sweden |
|
|
Neurontin |
100 mg |
Capsules, hard |
Oral use |
||||||||||
|
Sweden |
|
|
Neurontin |
300 mg |
Capsules, hard |
Oral use |
||||||||||
|
Sweden |
|
|
Neurontin |
400 mg |
Capsules, hard |
Oral use |
||||||||||
|
Sweden |
|
|
Neurontin |
600 mg |
Film-coated tablets |
Oral use |
||||||||||
|
Sweden |
|
|
Neurontin |
800 mg |
Film-coated tablets |
Oral use |
||||||||||
|
United Kingdom |
|
|
Neurontin |
100 mg |
Capsules, hard |
Oral use |
||||||||||
|
United Kingdom |
|
|
Neurontin |
300 mg |
Capsules, hard |
Oral use |
||||||||||
|
United Kingdom |
|
|
Neurontin |
400 mg |
Capsules, hard |
Oral use |
||||||||||
|
United Kingdom |
|
|
Neurontin |
600 mg |
Film-coated tablets |
Oral use |
||||||||||
|
United Kingdom |
|
|
Neurontin |
800 mg |
Film-coated tablets |
Oral use |
ANNEX II
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
|
Member State |
Marketing Authorisation Holder |
Invented name |
Strength |
Pharmaceutical form |
Route of administration |
|||||||
|
Austria |
|
Fluctine |
20 mg/5 ml |
Oral solution |
Oral use |
|||||||
|
Austria |
|
Fluctine |
20 mg |
Capsule, hard |
Oral use |
|||||||
|
Belgium |
|
Prozac |
20 mg |
Capsule, hard |
Oral use |
|||||||
|
Belgium |
|
Prozac |
20 mg/5 ml |
Oral solution |
Oral use |
|||||||
|
Belgium |
|
Fontex |
20 mg |
Capsule, hard |
Oral use |
|||||||
|
Belgium |
|
Fluoxetine ‘Lilly’ |
20 mg |
Capsule, hard |
Oral use |
|||||||
|
France |
|
Prozac |
20 mg |
Capsule, hard |
Oral use |
|||||||
|
France |
|
Prozac |
20 mg/5 ml |
Oral solution |
Oral use |
|||||||
|
France |
|
Fluoxétine Lilly |
20 mg |
Capsule, hard |
Oral use |
|||||||
|
France |
|
Fluoxétine RPG |
20 mg |
Capsule, hard |
Oral use |
|||||||
|
Germany |
|
Fluctin |
20 mg |
Capsule, hard |
Oral use |
|||||||
|
Germany |
|
Fluctin |
20 mg/5 ml |
Oral solution |
Oral use |
|||||||
|
Greece |
|
Ladose |
20 mg/5 ml |
Oral Solution |
Oral use |
|||||||
|
Greece |
|
Ladose |
20 mg |
Capsule, hard |
Oral use |
|||||||
|
Ireland |
|
Prozac |
20 mg/5 mg |
Oral solution |
Oral use |
|||||||
|
Ireland |
|
Prozac |
20 mg |
Capsule, hard |
Oral use |
|||||||
|
Italy |
|
Prozac |
20 mg/5 ml |
Oral Solution |
Oral use |
|||||||
|
Italy |
|
Prozac |
20 mg |
Capsule, hard |
Oral use |
|||||||
|
Luxembourg |
|
Prozac |
20 mg |
Capsule, hard |
Oral use |
|||||||
|
Luxembourg |
|
Fontex |
20 mg |
Capsule, hard |
Oral use |
|||||||
|
Luxembourg |
|
Prozac |
20 mg/5 ml |
Oral Solution |
Oral use |
|||||||
|
Portugal |
|
Prozac |
20 mg |
Capsule, hard |
Oral use |
|||||||
|
Portugal |
|
Prozac |
20 mg/5 ml |
Oral Solution |
Oral use |
|||||||
|
Spain |
|
Prozac |
20 mg/5 ml |
Oral solution |
Oral use |
|||||||
|
Spain |
|
Prozac |
20 mg |
Capsule, hard |
Oral use |
|||||||
|
Sweden |
|
Fontex |
20 mg/5 ml |
Oral Solution |
Oral use |
|||||||
|
The Netherlands |
|
Prozac |
20 mg/5 ml |
Oral solution |
Oral use |
|||||||
|
The Netherlands |
|
Prozac |
20 mg |
Capsule, hard |
Oral use |
|||||||
|
UK |
|
Prozac |
20 mg/5 ml |
Oral Solution |
Oral use |
|||||||
|
UK |
|
Prozac |
20 mg |
Capsule, hard |
Oral use |
ANNEX III
NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER
|
Member State |
Marketing Authorisation Holder |
Applicant |
Product invented name |
Pharmaceutical form |
Strength |
Animal species |
Frequency and route of administration |
Recommended dose |
||||||
|
Austria |
|
|
Cobactan |
Powder and solvent for solution for injection |
45 mg/ml |
Horse (adult and foal) |
Once or twice daily; Intravenous and intramuscular use |
1mg cefquinome/kg bw (1 ml reconstituted solution/45 kg bw) |
||||||
|
Belgium |
|
|
Cobactan 4.5 % |
Powder and solvent for solution for injection |
45 mg/ml |
Horse (adult and foal) |
Once or twice daily; Intravenous and intramuscular use |
1mg cefquinome/kg bw (1 ml reconstituted solution/45 kg bw) |
||||||
|
Denmark |
|
|
Cobactan Vet. |
Powder and solvent for solution for injection |
45 mg/ml |
Horse (adult and foal) |
Once or twice daily; Intravenous and intramuscular use |
1mg cefquinome/kg bw (1 ml reconstituted solution/45 kg bw) |
||||||
|
Germany |
|
|
Cobactan IV 4.5 % |
Powder and solvent for solution for injection |
45 mg/ml |
Horse (adult and foal) |
Once or twice daily; Intravenous and intramuscular use |
1mg cefquinome/kg bw (1 ml reconstituted solution/45 kg bw) |
||||||
|
Greece |
|
|
Cobactan IV IM 4.5 % |
Powder and solvent for solution for injection |
45 mg/ml |
Horse (adult and foal) |
Once or twice daily; Intravenous and intramuscular use |
1mg cefquinome/kg bw (1 ml reconstituted solution/45 kg bw) |
||||||
|
Spain |
|
|
Cobactan 4.5 % |
Powder and solvent for solution for injection |
45 mg/ml |
Horse (adult and foal) |
Once or twice daily; Intravenous and intramuscular use |
1mg cefquinome/kg bw (1 ml reconstituted solution/45 kg bw) |
||||||
|
France |
|
|
Cobactan IV IM 4.5 % |
Powder and solvent for solution for injection |
45 mg/ml |
Horse (adult and foal) |
Once or twice daily; Intravenous and intramuscular use |
1mg cefquinome/kg bw (1 ml reconstituted solution/45 kg bw) |
||||||
|
Hungary |
|
|
Cobactan IV 4.5 % A.U.V. |
Powder and solvent for solution for injection |
45 mg/ml |
Horse (adult and foal) |
Once or twice daily; Intravenous and intramuscular use |
1mg cefquinome/kg bw (1 ml reconstituted solution/45 kg bw) |
||||||
|
Ireland |
|
|
Cephaguard IV IM 4.5 % |
Powder and solvent for solution for injection |
45 mg/ml |
Horse (adult and foal) |
Once or twice daily; Intravenous and intramuscular use |
1mg cefquinome/kg bw (1 ml reconstituted solution/45 kg bw) |
||||||
|
Italy |
|
|
Cobactan 4.5 % IV IM |
Powder and solvent for solution for injection |
45 mg/ml |
Horse (adult and foal) |
Once or twice daily; Intravenous and intramuscular use |
1mg cefquinome/kg bw (1 ml reconstituted solution/45 kg bw) |
||||||
|
Luxembourg |
|
|
Cobactan 4.5 % |
Powder and solvent for solution for injection |
45 mg/ml |
Horse (adult and foal) |
Once or twice daily; Intravenous and intramuscular use |
1mg cefquinome/kg bw (1 ml reconstituted solution/45 kg bw) |
||||||
|
Netherlands |
|
|
Cobactan 4.5 % |
Powder and solvent for solution for injection |
45 mg/ml |
Horse (adult and foal) |
Once or twice daily; Intravenous and intramuscular use |
1mg cefquinome/kg bw (1 ml reconstituted solution/45 kg bw) |
||||||
|
Poland |
|
|
Cobactan 4.5 % |
Powder and solvent for solution for injection |
45 mg/ml |
Horse (adult and foal) |
Once or twice daily; Intravenous and intramuscular use |
1mg cefquinome/kg bw (1 ml reconstituted solution/45 kg bw) |
||||||
|
Portugal |
|
|
Cobactan 4.5 % |
Powder and solvent for solution for injection |
45 mg/ml |
Horse (adult and foal) |
Once or twice daily; Intravenous and intramuscular use |
1mg cefquinome/kg bw (1 ml reconstituted solution/45 kg bw) |
||||||
|
United Kingdom |
|
|
Cephaguard IV IM 4.5 % |
Powder and solvent for solution for injection |
45 mg/ml |
Horse (adult and foal) |
Once or twice daily; Intravenous and intramuscular use |
1mg cefquinome/kg bw (1 ml reconstituted solution/45 kg bw) |
ANNEX IV
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, APPLICANTS, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
|
Member State |
Marketing Authorisation Holder |
Applicant |
Name |
Strength |
Pharmaceutical Form |
Route of administration |
|||||
|
Germany |
|
— |
Ceftriaxon Tyrol Pharma 1 g Pulver zur Herstellung einer Injektions- oder Infusionslösung |
1 g |
Powder for solution for injection or infusion |
Intramuscular and intravenous use |
|||||
|
Germany |
|
— |
Ceftriaxon Tyrol Pharma 2 g Pulver zur Herstellung einer Infusionslösung |
2 g |
Powder for solution for infusion |
Intravenous use |
|||||
|
Finland |
— |
|
Lendacin 1 g injektio-/infuusiokuiva-aine liuosta varten |
1 g |
Powder for solution for injection or infusion |
Intramuscular and intravenous use |
|||||
|
Finland |
— |
|
Lendacin 2 g infuusiokuiva-aine liuosta varten |
2 g |
Powder for solution for infusion |
Intravenous use |
|||||
|
United Kingdom |
— |
|
Ceftriaxone 1 g powder for solution for injection/infusion |
1 g |
Powder for solution for injection or infusion |
Intramuscular and intravenous use |
|||||
|
United Kingdom |
— |
|
Ceftriaxone 2 g powder for solution for infusion |
2 g |
Powder for solution for infusion |
Intravenous use |
ANNEX V
LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
CETIRIZINE DIHYDROCHLORIDE COPYFARM 10 mg AND ASSOCIATED NAMES
|
Member State |
Marketing Authorisation Holder |
Product Name |
Strength |
Pharmaceutical Form |
Route of administration |
||||
|
Denmark |
|
Cetirizin ‘Copyfarm’ |
10 mg |
Filmcoated tablet |
Oral |
||||
|
Netherlands |
|
Cetirizine dihydrochloride Copyfarm 10 mg |
10 mg |
Filmcoated tablet |
Oral |
||||
|
Norway |
|
Cetirizin Copyfarm |
10 mg |
filmcoated tablet |
Oral |
||||
|
Sweden |
|
Cetirizin Copyfarm |
10 mg |
Filmcoated tablet |
Oral |