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)
Date: 2019-06-28
Institutions: European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary medicinal product








C_2019218EN.01000801.xml










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