# C_2018349EN.01001401.xml

| 28.9.2018 | EN | Official Journal of the European Union | C 349/14 |
| --- | --- | --- | --- |

28.9.2018

EN

Official Journal of the European Union

C 349/14

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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 |
| --- | --- |

—

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 |

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

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

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

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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 |

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

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