EUR-Lex Access to European Union law

Back to EUR-Lex homepage

This document is an excerpt from the EUR-Lex website

Document 52019XC0628(02)

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2019 to 31 May 2019(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

OJ C 218, 28.6.2019, p. 8–24 (BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

28.6.2019   

EN

Official Journal of the European Union

C 218/8


Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2019 to 31 May 2019

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

(2019/C 218/02)

Issuing, maintenance or modification of a national marketing authorisation

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorisation

Member State concerned

Date of notification

20.5.2019

Closantel inj 50 mg

closantel

See Annex I

See Annex I

21.5.2019

16.5.2019

Syner-Kinase and associated names

urokinase

See Annex II

See Annex II

17.5.2019

27.5.2019

Septanest and associated names

articaine (hydrochloride)/adrenaline (tartrate)

See Annex III

See Annex III

28.5.2019


(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 form, strengths of the veterinary medicinal products, animal species, route of administration and marketing authorisation holders in the Member States

Member State EU/EEA

Marketing authorisation holder

Name

INN

Strength

Pharmaceutical form

Animal species

Route of administration

Bulgaria

KRKA d.d.

Šmarješka cesta 6

Novo mesto

8501

Slovenia

Сантиола 50 mg/ml инжекционен разтвор за говеда и овце

Closantel

50 mg/ml

solution for injection

cattle, sheep

sheep: subcutaneous

Bulgaria

Industrial Veterinaria, S.A

Esmeralda 19

Esplugues de Llobregat

Barcelona 08950

Spain

Роленол

Closantel

50 mg/ml

solution for injection

cattle, sheep

sheep: subcutaneous

Croatia

KRKA d.d.

Šmarješka cesta 6

Novo mesto

8501

Slovenia

Santiola, 50 mg/mL, otopina za injekciju, za goveda i ovce

Closantel

50 mg/ml

solution for injection

cattle, sheep

sheep: subcutaneous

Czech Republic

KRKA d.d.

Šmarješka cesta 6

Novo mesto

8501

Slovenia

Santiola 50 mg/ml injekční roztok pro skot a ovce

Closantel

50 mg/ml

solution for injection

cattle, sheep

sheep: subcutaneous

Denmark

KRKA d.d.

Šmarješka cesta 6

Novo mesto

8501

Slovenia

Santiola Vet

Closantel

50 mg/ml

solution for injection

cattle, sheep

sheep: subcutaneous

Estonia

KRKA d.d.

Šmarješka cesta 6

Novo mesto

8501

Slovenia

Santiola

Closantel

50 mg/ml

solution for injection

cattle, sheep

sheep: subcutaneous

France

LILLY France

24 Boulevard Vital Bouhot

92200 Neuilly Sur Seine

France

FLUKIVER

Closantel

50 mg/ml

solution for injection

cattle, sheep

sheep: subcutaneous

Hungary

KRKA d.d.

Šmarješka cesta 6

Novo mesto

8501

Slovenia

Santiola 50 mg/ml oldatos injekció szarvasmarhák és juhok részére A.U.V.

Closantel

50 mg/ml

solution for injection

cattle, sheep

sheep: subcutaneous

Ireland

KRKA d.d.

Šmarješka cesta 6

Novo mesto

8501

Slovenia

Santiola 50 mg/ml solution for injection for cattle and sheep

Closantel

50 mg/ml

solution for injection

cattle, sheep

sheep: subcutaneous

Latvia

KRKA d.d.

Šmarješka cesta 6

Novo mesto

8501

Slovenia

Santiola

Closantel

50 mg/ml

solution for injection

cattle, sheep

sheep: subcutaneous

Lithuania

KRKA d.d.

Šmarješka cesta 6

Novo mesto

8501

Slovenia

Santiola 50 mg/ml injekcinis tirpalas galvijams ir avims

Closantel

50 mg/ml

solution for injection

cattle, sheep

sheep: subcutaneous

Romania

KRKA d.d.

Šmarješka cesta 6

Novo mesto

8501

Slovenia

Santiola 50 mg/ml raztopina za injiciranje za govedo in ovce

Closantel

50 mg/ml

solution for injection

cattle, sheep

sheep: subcutaneous

Slovenia

KRKA d.d.

Šmarješka cesta 6

Novo mesto

8501

Slovenia

Santiola 50 mg/ml raztopina za injiciranje za govedo in ovce

Closantel

50 mg/ml

solution for injection

cattle, sheep

sheep: subcutaneous

Spain

Laboratorios e Industrias Iven, S.A.

Luis I, 56.

Poligono Industrial Vallecas

28031 Madrid

Spain

Endoectiven

Closantel

50 mg/ml

solution for injection

cattle, sheep

sheep: subcutaneous

Spain

CENAVISA, S.L.

Cami Pedra Estela s/n

Reus (Tarragona)

43205

Spain

TELCEN

Closantel

50 mg/ml

solution for injection

cattle, sheep

sheep: subcutaneous

Spain

S.P. VETERINARIA, S.A.

Ctra. Reus-Vinyols, KM.4,1

Riudoms (Tarragona)

43330

Spain

ENDOEX 50 mg/ml SOLUCION INYECTABLE

Closantel

50 mg/ml

solution for injection

cattle, sheep

sheep: subcutaneous

Spain

Industrial Veterinaria, S.A

Esmeralda 19

Esplugues de Llobregat

Barcelona 08950

Spain

ROLENOL

Closantel

50 mg/ml

solution for injection

cattle, sheep

sheep: subcutaneous

Sweden

KRKA d.d.

Šmarješka cesta 6

Novo mesto

8501

Slovenia

Santiola vet.

Closantel

50 mg/ml

solution for injection

cattle, sheep

sheep: subcutaneous

United Kingdom

KRKA d.d.

Šmarješka cesta 6

Novo mesto

8501

Slovenia

Santiola 50 mg/ml Solution for Injection for Cattle and Sheep

Closantel

50 mg/ml

solution for injection

sheep

sheep: subcutaneous


ANNEX II

List of medicinal products and presentations

Member State EU/EEA

Marketing authorisation holder

Applicant

(Invented) Name

Strength

Pharmaceutical form

Route of administration

France

 

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

Syner-KINASE

10,000 IU

Powder for solution for injection/infusion

Intravenous Use

France

 

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

Syner-KINASE

25,000 IU

Powder for solution for injection/infusion

Intravenous Use

France

 

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

Syner-KINASE

100,000 IU

Powder for solution for injection/infusion

Intravenous Use

France

 

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

Syner-KINASE

250,000 IU

Powder for solution for injection/infusion

Intravenous Use

France

 

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

Syner-KINASE

500,000 IU

Powder for solution for injection/infusion

Intravenous Use

Germany

 

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

Syner-KINASE

10,000 IU

Powder for solution for injection/infusion

Intravenous Use

Germany

 

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

Syner-KINASE

25,000 IU

Powder for solution for injection/infusion

Intravenous Use

Germany

 

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

Syner-KINASE

100,000 IU

Powder for solution for injection/infusion

Intravenous Use

Germany

 

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

Syner-KINASE

250,000 IU

Powder for solution for injection/infusion

Intravenous Use

Germany

 

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

Syner-KINASE

500,000 IU

Powder for solution for injection/infusion

Intravenous Use

The Netherlands

 

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

Urokinase Devrimed 10.000 IE, poeder voor oplossing voor injectie/infusie

10,000 IU

Powder for solution for injection/infusion

Intravenous Use

The Netherlands

 

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

Urokinase Devrimed 25.000 IE, poeder voor oplossing voor injectie/infusie

25,000 IU

Powder for solution for injection/infusion

Intravenous Use

The Netherlands

 

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

Urokinase Devrimed 100.000 IE, poeder voor oplossing voor injectie/infusie

100,000 IU

Powder for solution for injection/infusion

Intravenous Use

The Netherlands

 

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

Urokinase Devrimed 250.000 IE, poeder voor oplossing voor injectie/infusie

250,000 IU

Powder for solution for injection/infusion

Intravenous Use

The Netherlands

 

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

Urokinase Devrimed 500.000 IE, poeder voor oplossing voor injectie/infusie

500,000 IU

Powder for solution for injection/infusion

Intravenous Use

Spain

 

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

Syner-KINASE

10,000 IU

Powder for solution for injection/infusion

Intravenous Use

Spain

 

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

Syner-KINASE

25,000 IU

Powder for solution for injection/infusion

Intravenous Use

Spain

 

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

Syner-KINASE

100,000 IU

Powder for solution for injection/infusion

Intravenous Use

Spain

 

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

Syner-KINASE

250,000 IU

Powder for solution for injection/infusion

Intravenous Use

Spain

 

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

Syner-KINASE

500,000 IU

Powder for solution for injection/infusion

Intravenous Use

United Kingdom

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

 

Syner-KINASE

10,000 IU

Powder for solution for injection/infusion

Intravenous Use

United Kingdom

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

 

Syner-KINASE

25,000 IU

Powder for solution for injection/infusion

Intravenous Use

United Kingdom

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

 

Syner-KINASE

100,000 IU

Powder for solution for injection/infusion

Intravenous Use

United Kingdom

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

 

Syner-KINASE

250,000 IU

Powder for solution for injection/infusion

Intravenous Use

United Kingdom

Syner-Medica Ltd

Syner-Med House,

120 High Street,

Purley, Surrey,

CR8 2AD,

United Kingdom

 

Syner-KINASE

500,000 IU

Powder for solution for injection/infusion

Intravenous Use


ANNEX III

List of medicinal products and presentations

Member State EU/EEA

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Content

(concentration)

Austria

Septodont GmbH

Felix-Wankel-Str. 9

D - 53859 Niederkassel-Mondorf

Germany

Septanest mit Epinephrin 1:200 000

40 mg/ml + 0,005 mg/ml

Solution for injection

Submucosal use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,005 mg/ml

Austria

Septodont GmbH

Felix-Wankel-Str. 9

D - 53859 Niederkassel-Mondorf

Germany

Septanest mit Epinephrin 1:100 000

40 mg/ml + 0,01 mg/ml

Solution for injection

Submucosal use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,01 mg/ml

Belgium

Septodont Nv-Sa

87 Avenue de la Constitution

B-1083 Brussel

Belgium

Septanest Normal

40 mg/ml + 0,005 mg/ml

Solution for injection

Dental use

Submucosal use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,005 mg/ml

Belgium

Septodont Nv-Sa

87 Avenue de la Constitution

B-1083 Brussel

Belgium

Septanest Special

40 mg/ml + 0,01 mg/ml

Solution for injection

Dental use

Submucosal use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,01 mg/ml

Bulgaria

Laboratories Septodont

58, rue du Pont de Créteil

94107 Saint-Maur-des- Fossés Cedex

France

Септанест с Адреналин 1/200 000

40 mg/ml + 0,005 mg/ml

Solution for injection

Dental use

Submucosal use

Articaine hydrochloride 40 mg/ml

Epinephrine 0,005 mg/ml

Bulgaria

Laboratories Septodont

58, rue du Pont de Créteil

94107 Saint-Maur-des- Fossés Cedex

France

Септанест с Адреналин 1/100 000

40 mg/ml + 0,01 mg/ml

Solution for injection

Dental use

Submucosal use

Articaine hydrochloride 40 mg/ml

Epinephrine 0,01 mg/ml

Croatia

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septanest

40 mg/ml + 0,005 mg/ml

Solution for injection

Dental use

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,005 mg/ml

Croatia

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septanest Forte

40 mg/ml + 0,01 mg/ml

Solution for injection

Dental use

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,01 mg/ml

Cyprus

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septanest

40 mg/ml + 0,005 mg/ml

Solution for injection

Dental use

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,005 mg/ml

Cyprus

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septanest Forte

40 mg/ml + 0,01 mg/ml

Solution for injection

Dental use

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,01 mg/ml

Czech Republic

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des- Fossés

France

Septanest s adrenalinem 1:200 000

40 mg/ml + 0,005 mg/ml

Solution for injection

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,005 mg/ml

Czech Republic

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des- Fossés

France

Septanest s adrenalinem 1:100 000

40 mg/ml + 0,01 mg/ml

Solution for injection

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,01 mg/ml

Denmark

Spécialités Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septanest

40 mg/ml + 0,005 mg/ml

Solution for injection

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,005 mg/ml

Denmark

Spécialités Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septocaine

40 mg/ml + 0,01 mg/ml

Solution for injection

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,01 mg/ml

Estonia

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septanest

40 mg/ml + 0,005 mg/ml

Solution for injection in cartridge

Dental use

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,005 mg/ml

Estonia

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septanest Forte

40 mg/ml + 0,01 mg/ml

Solution for injection in cartridge

Dental use

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,01 mg/ml

Finland

Specialites Septodont.

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septocaine

40 mg/ml + 5 microg/ml

Solution for injection

Dental use

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 5 microg/ml

Finland

Specialites Septodont.

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septocaine Forte

40 mg/ml + 10 microg/ml

Solution for injection

Dental use

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 10 microg/ml

France

Septodont SAS

58, rue du Pont de Créteil

94107 Saint-Maur-Des-Fossés Cedex

France

Septanest 40 mg/ml Adrenalinée au 1/200 000 , solution injectable à usage dentaire

40 mg/ml + 0,005 mg/ml

Solution for injection

Local or regional injection intra-oral

Submucosal use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,005 mg/ml

adrénaline (tartrate d’): non précisé

France

Septodont S.A.S.

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Chlorhydrate d’Articaïne Septodont 40 mg/ml Adrénaline 1/200 000 , solution injectable

40 mg/ml + 0,005 mg/ml

Solution for injection

Dental use

Infiltration and perineural use in the oral cavity

Articaine hydrochloride 40 mg/ml

Adrenaline 0,005 mg/ml

adrénaline (tartrate d’): non précisé

France

Septodont SAS

58, rue du Pont de Créteil

94107 Saint-Maur-Des-Fossés Cedex

France

Septanest 40 mg/ml Adrenalinée au 1/100 000 , solution injectable à usage dentaire

40 mg/ml + 0,01 mg/ml

Solution for injection

Local or regional injection intra-oral

Submucosal use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,01 mg/ml

adrénaline (tartrate d’): non précisé

France

Septodont S.A.S.

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Chlorhydrate d’Articaïne Septodont 40 mg/ml Adrénaline 1/100 000 , solution injectable

40 mg/ml + 0,01 mg/ml

Solution for injection

Dental use

Infiltration and perineural use in the oral cavity

Articaine hydrochloride 40 mg/ml

Adrenaline 0,01 mg/ml

adrénaline (tartrate d’): non précisé

Germany

Septodont GmbH

Felix-Wankel-Str. 9

D-53859 Niederkassel

Germany

Septanest mit Epinephrin 1:200 000 - 40 mg/ml + 0,005 mg/ml Injektionslösung

40 mg/ml + 0,005 mg/ml

Solution for injection

Dental use

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Epinephrine 0,005 mg/ml

Germany

Septodont GmbH

Felix-Wankel-Str. 9

D-53859 Niederkassel

Germany

Septanest mit Adrenalin 1/200 000

40 mg/ml + 0,005 mg/ml

Solution for injection

Submucosal use

Articaine hydrochloride 40 mg/ml

Epinephrine 0,005 mg/ml

Germany

Septodont GmbH

Felix-Wankel-Str. 9

D-53859 Niederkassel

Germany

Septanest mit Epinephrin 1:100 000 - 40 mg/ml + 0,01 mg/ml Injektionslösung

40 mg/ml + 0,01 mg/ml

Solution for injection

Dental use

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Epinephrine 0,01 mg/ml

Germany

Septodont GmbH

Felix-Wankel-Str. 9

D-53859 Niederkassel

Germany

Septanest mit Adrenalin 1/100 000

40 mg/ml + 0,01 mg/ml

Solution for injection

Submucosal use

Articaine hydrochloride 40 mg/ml

Epinephrine 0,01 mg/ml

Greece

John Tsaprazis SA

157 Michalakopoulou Str.

11527, Athens

Greece

Septanest Ενέσιμο διάλυμα 4 % + 1:200 000

40 mg/ml + 0,005 mg/ml

Solution for injection

Infiltration

Periodontal use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,005 mg/ml

Greece

John Tsaprazis SA

157 Michalakopoulou Str.

11527, Athens

Greece

Septanest Ενέσιμο διάλυμα 4 % + 1:100 000

40 mg/ml + 0,01 mg/ml

Solution for injection

Infiltration

Periodontal use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,01 mg/ml

Hungary

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septanest

40 mg/ml + 0,01 mg/ml

Solution for injection

Submucosal use

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,01 mg/ml

Italy

Spécialités Septodont

58 rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septanest

40 mg/ml + 0,005 mg/ml

Solution for injection in cartridge

Infiltration

Articaine hydrochloride 40 mg/ml

Adrenaline 0,005 mg/ml

Italy

Spécialités Septodont

58 rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septanest

40 mg/ml + 0,01 mg/ml

Solution for injection in cartridge

Infiltration

Articaine hydrochloride 40 mg/ml

Adrenaline 0,01 mg/ml

Latvia

Septodont

58 rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

Francija

Septanest 40 mg/5 mikrogrami/ml šķīdums injekcijām kārtridžā

40 mg/ml + 0,005 mg/ml

Solution for injection in cartridge

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,005 mg/ml

Latvia

Septodont

58 rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

Francija

Septanest Forte 40 mg/10 mikrogrami/ml šķīdums injekcijām kārtridžā

40 mg/ml + 0,01 mg/ml

Solution for injection in cartridge

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,01 mg/ml

Lithuania

Septodont

58 rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septanest

40 mg/ml + 0,005 mg/ml

Solution for injection in cartridge

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,005 mg/ml

Lithuania

Septodont

58 rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septanest Forte

40 mg/ml + 0,01 mg/ml

Solution for injection in cartridge

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,01 mg/ml

Luxembourg

Septodont Nv-Sa

87 Avenue de la Constitution

B-1083 Brussel

Belgium

Septanest-N 1*200.000

40 mg/ml + 0,005 mg/ml

Solution for injection

Dental use

Submucosal use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,005 mg/ml

Luxembourg

Septodont Nv-Sa

87 Avenue de la Constitution

B-1083 Brussel

Belgium

Septanest Adrenaline 1:100 000

40 mg/ml + 0,01 mg/ml

Solution for injection

Dental use

Submucosal use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,01 mg/ml

Malta

Septodont

58 rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septanest with adrenaline 1/200 000

40 mg/ml + 0,005 mg/ml

Solution for injection

Dental use

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,005 mg/ml

Malta

Septodont

58 rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septanest with adrenaline 1/100 000

40 mg/ml + 0,01 mg/ml

Solution for injection

Dental use

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,01 mg/ml

Netherlands

Septodont Nv-Sa

87 Avenue de la Constitution

B-1083 Brussel

Belgium

Septanest N

40 mg/ml + 0,005 mg/ml

Solution for injection

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,005 mg/ml

Netherlands

Septodont Nv-Sa

87 Avenue de la Constitution

B-1083 Brussel

Belgium

Septanest SP

40 mg/ml + 0,01 mg/ml

Solution for injection

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,01 mg/ml

Norway

Septodont

58, rue du Pont de Créteil

94107 Saint-Maur-Des-Fossés Cedex

France

Septocaine

40 mg/ml + 0,005 mg/ml

Solution for injection

Dental use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,005 mg/ml

Norway

Septodont

58, rue du Pont de Créteil

94107 Saint-Maur-Des-Fossés Cedex

France

Septocaine Forte

40 mg/ml + 0,01 mg/ml

Solution for injection

Dental use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,01 mg/ml

Poland

Septodont

58 rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septanest Z Adrenaliną 1: 200 000

40 mg/ml + 0,005 mg/ml

Solution for injection

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,005 mg/ml

Poland

Septodont

58 rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septanest Z Adrenaliną 1: 100 000

40 mg/ml + 0,01 mg/ml

Solution for injection

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,01 mg/ml

Portugal

Septodont S.A.S.

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septanest 1/200 000

68 mg/1.7 ml + 0.015 mg/1.7 ml

Solução injetável

Via bucal

Articaína, cloridrato 40 mg/ml

Adrenalina, tartarato 0,0091 mg/ml

Portugal

Septodont S.A.S.

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septanest 1/100 000

68 mg/1.7 ml + 0.031 mg/1.7 ml

Solução injetável

Via bucal

Articaína, cloridrato 40 mg/ml

Adrenalina, tartarato 0,0182 mg/ml

Romania

Septodont

58 rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septanest Cu Adrenalină 1/200 000

40 mg/ml + 0,005 mg/ml

Solution for injection

Dental use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,005 mg/ml

Romania

Septodont

58 rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septanest Cu Adrenalină 1/100 000

40 mg/ml + 0,01 mg/ml

Solution for injection

Dental use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,01 mg/ml

Slovak Republic

Septodont

58, rue du Pont de Créteil,

94100 Saint-Maur-Des-Fossés,

France

Septanest

40 mg/ml + 0,005 mg/ml

Solution for injection

Dental use

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,005 mg/ml

Slovak Republic

Septodont

58, rue du Pont de Créteil,

94100 Saint-Maur-Des-Fossés,

France

Septanest Forte

40 mg/ml + 0,01 mg/ml

Solution for injection

Dental use

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,01 mg/ml

Slovenia

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septanestepi 40 mg/0,005 mg v 1 ml raztopina za injiciranje

40 mg/ml + 0,005 mg/ml

Solution for injection

Dental use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,005 mg/ml

Slovenia

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septanestepi 40 mg/0,01 mg v 1 ml raztopina za injiciranje

40 mg/ml + 0,01 mg/ml

Solution for injection

Dental use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,01 mg/ml

Spain

Septodont

58 rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septanest con adrenalina 1/200 000

40 mg/ml + 0,005 mg/ml

Solution for injection

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline bitartrate 0,005 mg/ml

Spain

Septodont

58 rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septanest con adrenalina 1/100 000

40 mg/ml + 0,01 mg/ml

Solution for injection

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline bitartrate 0,01 mg/ml

Sweden

Specialites Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septocaine

40 mg/ml + 0,005 mg/ml

Solution for injection

Dental use

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,005 mg/ml

Sweden

Specialites Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

Septocaine Forte

40 mg/ml + 0,01 mg/ml

Solution for injection

Dental use

Infiltration and perineural use

Articaine hydrochloride 40 mg/ml

Adrenaline 0,01 mg/ml


Top