Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2018 to 31 August 2018 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2018-09-28
Institutions: European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product








C_2018349EN.01001401.xml










28.9.2018   


EN


Official Journal of the European Union


C 349/14






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2018 to 31 August 2018
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))
(2018/C 349/02)






—



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




2.8.2018


Scandonest and associated names


mepivacaine


See Annex


See Annex


3.8.2018






(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.




ANNEX
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
53859 Niederkassel-Mondorf
Germany


SCANDONEST 3 % OHNE VASOKONSTRIKTOR — ZYLINDERAMPULLEN


3 %


Solution for injection


Dental use


30 mg/ml




Belgium


Septodont NV-SA
87 Avenue de la Constitution
B-1083 Bruxelles
Belgium


SCANDONEST 3 % SANS VASOCONSTRICTEUR


3 %


Solution for injection


Dental use


30 mg/ml




Bulgaria


Septodont
58, rue du Pont de Créteil
94100 Saint-Maur-des-Fossés
France


SCANDONEST 30 MG/ML


30 mg/ml


Solution for injection


Dental use


30 mg/ml




Croatia


Apolonia d.o.o.
Dubrova 308
52220 Labin
Croatia


SCANDONEST 30 mg/ml otopina za injekciju


30 mg/ml


Solution for injection


Dental use
Perineural use
Submucosal use


30 mg/ml




Denmark


Spécialités Septodont
58, rue du Pont de Créteil
94100 Saint-Maur-des-Fossés
France


SCANDONEST


30 mg/ml


Solution for injection


Dental use
Perineural use
Submucosal use


30 mg/ml




Estonia


Septodont
58, rue du Pont de Créteil
94100 Saint-Maur-des-Fossés
France


SCANDONEST


30 mg/ml


Solution for injection in cartridge


Dental use
Perineural use
Submucosal use


30 mg/ml




Finland


Septodont
58, rue du Pont de Créteil
94100 Saint-Maur-des-Fossés
France


SCANDONEST


30 mg/ml


Solution for injection


Dental use


30 mg/ml




France


Laboratoires Septodont
58, rue du Pont de Créteil
94107 Saint-Maur-des-Fossés Cedex
France


SCANDONEST 30 MG/ML, SOLUTION INJECTABLE À USAGE DENTAIRE


30 mg/ml


Solution for injection


Dental use
Perineural use
Submucosal use


30 mg/ml




Germany


Septodont GmbH
Felix-Wankel-Str. 9
53859 Niederkassel-Mondorf
Germany


SCANDONEST 3 % OHNE VASOKONSTRIKTOR


3 %


Solution for injection


Dental use
Perineural use


30 mg/ml




Greece


John Tsaprazis SA
157 Michalakopoulou Str.
11527, Athens
Greece


SCANDONEST 3 %


3 %


Solution for injection


Periodontal use


30 mg/ml




Hungary


Septodont
58, rue du Pont de Créteil
94100 Saint-Maur-des-Fossés
France


SCANDONEST 30 MG/ML


30 mg/ml


Solution for injection


Dental use
Perineural use
Submucosal use


30 mg/ml




Ireland


Septodont
58, rue du Pont de Créteil
94100 Saint-Maur-des-Fossés
France


SCANDONEST 3 % W/V SOLUTION FOR INJECTION


3 %


Solution for injection


Dental use


30 mg/ml




Italy


Laboratoires Septodont
58, rue du Pont de Créteil
94100 Saint-Maur-des-Fossés
France


SCANDONEST


3 % without vasoconstrictor


Solution for injection


Dental use


30 mg/ml




Latvia


Septodont
58, rue du Pont de Créteil
94100 Saint-Maur-des-Fossés
France


SCANDONEST 30 MG/ML ŠĶĪDUMS INJEKCIJĀM KĀRTRIDŽĀ


30 mg/ml


Solution for injection in cartridge


Perineural use
Submucosal use


30 mg/ml




Lithuania


Septodont
58, rue du Pont de Créteil
94100 Saint-Maur-des-Fossés
France


SCANDONEST 30 MG/ML, injekcinis tirpalas užtaise


30 mg/ml


Solution for injection in cartridge


Infiltration
Perineural use


30 mg/ml




Luxembourg


Septodont NV-SA
Grondwetlaan
87 Avenue de la Constitution
B-1083 Brussel
Belgium


SCANDONEST 3 % SANS VASOCONSTRICTEUR


3 %


Solution for injection


Dental use


30 mg/ml




Malta


Septodont
58, rue du Pont de Créteil
94100 Saint-Maur-des-Fossés
France


SCANDONEST 30 MG/ML


30 mg/ml


Solution for injection


Dental use
Perineural use
Submucosal use
Infiltration


30 mg/ml




Netherlands


Septodont NV-SA
Grondwetlaan
87 Avenue de la Constitution
B-1083 Brussel
Belgium


SCANDONEST 3 % ZONDER VASOCONSTRICTOR


3 %


Solution for injection


Perineural use


30 mg/ml




Norway


Septodont
58, rue du Pont de Créteil
94100 Saint-Maur-des-Fossés
France


SCANDONEST PLAIN 30 MG/ML


30 mg/ml


Solution for injection


Dental use


30 mg/ml




Poland


Septodont
58, rue du Pont de Créteil
94100 Saint-Maur-des-Fossés
France


SCANDONEST 30 mg/ml


30 mg/ml


Solution for injection


Infiltration
Perineural use


30 mg/ml




Portugal


Septodont, S.A.S.
58, rue du Pont de Créteil
94100 Saint-Maur-des-Fossés
France


SCANDONEST


30 mg/ml


Solution for injection


Gingival use


30 mg/ml




Romania


Laboratoires Septodont
58, rue du Pont de Créteil
94107 Saint-Maur-des-Fossés Cedex
France


SCANDONEST 3 % PLAIN, SOLUŢIE INJECTABILĂ


3 %


Solution for injection


Dental use


30 mg/ml




Slovakia


Septodont
58, rue du Pont de Créteil
94100 Saint-Maur-des-Fossés
France


SCANDONEST 3 %


3 %


Solution for injection


Dental use
Perineural use
Submucosal use


30 mg/ml




Slovenia


Septodont
58, rue du Pont de Créteil
94100 Saint-Maur-des-Fossés
France


SCANDICAINE 30 MG/ML RAZTOPINA ZA INJICIRANJE


30 mg/ml


Solution for injection


Dental use


30 mg/ml




Spain


Septodont
58, rue du Pont de Créteil
94100 Saint-Maur-des-Fossés
France


SCANDONEST 30 mg/ml SOLUCIÓN INYECTABLE


30 mg/ml


Solution for injection


Perineural use
Infiltration


30 mg/ml




Sweden


Septodont
58, rue du Pont de Créteil
94100 Saint-Maur-des-Fossés
France


Scandonest


30 mg/ml


Solution for injection


Dental use


30 mg/ml




United Kingdom


Septodont Ltd
Unit R & S
Orchard Business Centre
St Barnabas Close
Allington Maidstone
Kent ME16 OJZ
England


SCANDONEST 3 % PLAIN
BIOCAINE 3 % PLAIN


3 %


Solution for injection


Dental use
Perineural use
Submucosal use


30 mg/ml