# C_2014467EN.01001101.xml

| 30.12.2014 | EN | Official Journal of the European Union | C 467/11 |
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30.12.2014

EN

Official Journal of the European Union

C 467/11

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2014 to 30 November 2014

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

1

2

(2014/C 467/02)

—   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 |
| --- | --- | --- | --- | --- | --- |
| 28.11.2014 | EMLA cream and associated names | See Annex I | See Annex I | See Annex I | 1.12.2014 |

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

28.11.2014

EMLA cream and associated names

See Annex I

See Annex I

See Annex I

1.12.2014

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

1

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

2

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ANNEX I

List of the names, pharmaceutical form, strength of the medicinal products, route of administration, and marketing authorisation holders in the Member States

| Member State
  in EEA | Marketing authorisation holder | (Invented) Name | INN | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | AstraZeneca Österreich GmbH
  Schwarzenbergplatz 7
  A-1037 Wien
  Austria | Emla 5 % — Creme | lidocaine
  prilocaine | 25 mg/g
  25 mg/g | cream | cutaneous use |
| Belgium | NV AstraZeneca SA
  Egide Van Ophemstraat 110
  1180 Ukkel
  Belgium | Emla 25 mg/25 mg crème | lidocaine
  prilocaine | 25 mg/g
  25 mg/g | cream | cutaneous use |
| Cyprus | AstraZeneca AB
  151 85 Södertälje
  Sweden | Emla Cream 5 % | lidocaine
  prilocaine | 25 mg/g
  25 mg/g | cream | cutaneous use |
| Czech Republic | AstraZeneca UK Limited
  2 Kingdom Street
  W2 6BD London
  United Kingdom | Emla krém 5 % | lidocaine
  prilocaine | 25 mg/g
  25 mg/g | cream | cutaneous use |
| Denmark | AstraZeneca A/S
  Arne Jacobsens Allé 13
  Copenhagen S DK-2300
  Denmark | Emla | lidocaine
  prilocaine | 25 mg/g
  25 mg/g | cream | cutaneous use |
| Finland | AstraZeneca Oy
  Itsehallintokuja 4
  02600 Espoo
  Finland | EMLA | lidocaine
  prilocaine | 25 mg/g
  25 mg/g | cream | cutaneous use |
| France | ASTRAZENECA
  1, place Renault
  92844 Rueil Malmaison Cedex FRANCE | EMLA 5 POUR CENT, crème | lidocaine
  prilocaine | 25 mg/g
  25 mg/g | cream | cutaneous use |
| Germany | AstraZeneca GmbH
  Tinsdaler Weg 183
  22876 Wedel
  Germany | EMLA | lidocaine
  prilocaine | 25 mg/g
  25 mg/g | cream | cutaneous use |
| Greece | AstraZeneca S.A.
  4, Theotokopoulou & Astronafton str
  151 25 Maroussi
  Athens
  Greece | EMLA | lidocaine
  prilocaine | 25 mg/g
  25 mg/g | cream | cutaneous use |
| Iceland | AstraZeneca A/S
  Arne Jacobsens Allé 13
  Copenhagen S DK-2300
  Denmark | Emla | lidocaine
  prilocaine | 25 mg/g
  25 mg/g | cream | cutaneous use |
| Ireland | AstraZeneca UK Limited
  600 Capability Green
  Luton LU1 3LU
  United Kingdom | EMLA 5 % w/w Cream | lidocaine
  prilocaine | 25 mg/g
  25 mg/g | cream | cutaneous use |
| Italy | AstraZeneca S.p.A.
  Palazzo Volta
  Via Francesco Sforza — Basiglio (Milano) 20080
  Italy | EMLA | lidocaine
  prilocaine | 25 mg/g
  25 mg/g | cream | cutaneous use |
| Latvia | AstraZeneca AB
  151 85 Södertälje
  Sweden | Emla 5 % krēms | lidocaine
  prilocaine | 25 mg/g
  25 mg/g | cream | cutaneous use |
| Luxembourg | NV AstraZeneca SA
  Rue Egide Van Ophem 110
  1180 Bruxelles
  Belgium | Emla 25 mg/25 mg crème | lidocaine
  prilocaine | 25 mg/g
  25 mg/g | cream | cutaneous use |
| Malta | AstraZeneca AB, Gartunavagen
  S-151 85 Sodertalje
  Sweden | EMLA 5 % w/w Cream | lidocaine
  prilocaine | 25 mg/g
  25 mg/g | cream | cutaneous use |
| Norway | AstraZeneca AS
  Postboks 6050 Etterstad
  0601 OSLO
  Norway | Emla | lidocaine
  prilocaine | 25 mg/g
  25 mg/g | cream | cutaneous use |
| Poland | AstraZeneca AB
  Sodertalje 151 85 Gartunavagen
  Sweden | EMLA | lidocaine
  prilocaine | 25 mg/g
  25 mg/g | cream | cutaneous use |
| Portugal | AstraZeneca Produtos
  Farmacêuticos, Lda.
  Rua Humberto Madeira 7
  — Queluz de Baixo
  Barcarena 2730-097
  Portugal | Emla | lidocaine
  prilocaine | 25 mg/g
  25 mg/g | cream | cutaneous use |
| Spain | ASTRAZENECA FARMACEUTICA SPAIN, S.A.
  Serrano Galvache 56
  Edificio Roble
  28033 Madrid
  Spain | EMLA 25 mg/g + 25 mg/g crema | lidocaine
  prilocaine | 25 mg/g
  25 mg/g | cream | cutaneous use |
| Sweden | AstraZeneca AB
  151 85 Södertälje
  Sweden | EMLA | lidocaine
  prilocaine | 25 mg/g
  25 mg/g | cream | cutaneous use |
| The Netherlands | AstraZeneca B.V.
  Louis Pasteurlaan 5
  2719 EE ZOETERMEER
  The Netherlands | Emla | lidocaine
  prilocaine | 25 mg/g
  25 mg/g | cream; hydrophilic | cutaneous use |
| United Kingdom | AstraZeneca UK Limited
  600 Capability Green
  Luton LU1 3LU
  United Kingdom | Emla Cream 5 % | lidocaine
  prilocaine | 25 mg/g
  25 mg/g | cream | cutaneous use |

Member State

in EEA

Marketing authorisation holder

(Invented) Name

INN

Strength

Pharmaceutical form

Route of administration

Austria

AstraZeneca Österreich GmbH

Schwarzenbergplatz 7

A-1037 Wien

Austria

Emla 5 % — Creme

lidocaine

prilocaine

25 mg/g

25 mg/g

cream

cutaneous use

Belgium

NV AstraZeneca SA

Egide Van Ophemstraat 110

1180 Ukkel

Belgium

Emla 25 mg/25 mg crème

lidocaine

prilocaine

25 mg/g

25 mg/g

cream

cutaneous use

Cyprus

AstraZeneca AB

151 85 Södertälje

Sweden

Emla Cream 5 %

lidocaine

prilocaine

25 mg/g

25 mg/g

cream

cutaneous use

Czech Republic

AstraZeneca UK Limited

2 Kingdom Street

W2 6BD London

United Kingdom

Emla krém 5 %

lidocaine

prilocaine

25 mg/g

25 mg/g

cream

cutaneous use

Denmark

AstraZeneca A/S

Arne Jacobsens Allé 13

Copenhagen S DK-2300

Denmark

Emla

lidocaine

prilocaine

25 mg/g

25 mg/g

cream

cutaneous use

Finland

AstraZeneca Oy

Itsehallintokuja 4

02600 Espoo

Finland

EMLA

lidocaine

prilocaine

25 mg/g

25 mg/g

cream

cutaneous use

France

ASTRAZENECA

1, place Renault

92844 Rueil Malmaison Cedex FRANCE

EMLA 5 POUR CENT, crème

lidocaine

prilocaine

25 mg/g

25 mg/g

cream

cutaneous use

Germany

AstraZeneca GmbH

Tinsdaler Weg 183

22876 Wedel

Germany

EMLA

lidocaine

prilocaine

25 mg/g

25 mg/g

cream

cutaneous use

Greece

AstraZeneca S.A.

4, Theotokopoulou & Astronafton str

151 25 Maroussi

Athens

Greece

EMLA

lidocaine

prilocaine

25 mg/g

25 mg/g

cream

cutaneous use

Iceland

AstraZeneca A/S

Arne Jacobsens Allé 13

Copenhagen S DK-2300

Denmark

Emla

lidocaine

prilocaine

25 mg/g

25 mg/g

cream

cutaneous use

Ireland

AstraZeneca UK Limited

600 Capability Green

Luton LU1 3LU

United Kingdom

EMLA 5 % w/w Cream

lidocaine

prilocaine

25 mg/g

25 mg/g

cream

cutaneous use

Italy

AstraZeneca S.p.A.

Palazzo Volta

Via Francesco Sforza — Basiglio (Milano) 20080

Italy

EMLA

lidocaine

prilocaine

25 mg/g

25 mg/g

cream

cutaneous use

Latvia

AstraZeneca AB

151 85 Södertälje

Sweden

Emla 5 % krēms

lidocaine

prilocaine

25 mg/g

25 mg/g

cream

cutaneous use

Luxembourg

NV AstraZeneca SA

Rue Egide Van Ophem 110

1180 Bruxelles

Belgium

Emla 25 mg/25 mg crème

lidocaine

prilocaine

25 mg/g

25 mg/g

cream

cutaneous use

Malta

AstraZeneca AB, Gartunavagen

S-151 85 Sodertalje

Sweden

EMLA 5 % w/w Cream

lidocaine

prilocaine

25 mg/g

25 mg/g

cream

cutaneous use

Norway

AstraZeneca AS

Postboks 6050 Etterstad

0601 OSLO

Norway

Emla

lidocaine

prilocaine

25 mg/g

25 mg/g

cream

cutaneous use

Poland

AstraZeneca AB

Sodertalje 151 85 Gartunavagen

Sweden

EMLA

lidocaine

prilocaine

25 mg/g

25 mg/g

cream

cutaneous use

Portugal

AstraZeneca Produtos

Farmacêuticos, Lda.

Rua Humberto Madeira 7

— Queluz de Baixo

Barcarena 2730-097

Portugal

Emla

lidocaine

prilocaine

25 mg/g

25 mg/g

cream

cutaneous use

Spain

ASTRAZENECA FARMACEUTICA SPAIN, S.A.

Serrano Galvache 56

Edificio Roble

28033 Madrid

Spain

EMLA 25 mg/g + 25 mg/g crema

lidocaine

prilocaine

25 mg/g

25 mg/g

cream

cutaneous use

Sweden

AstraZeneca AB

151 85 Södertälje

Sweden

EMLA

lidocaine

prilocaine

25 mg/g

25 mg/g

cream

cutaneous use

The Netherlands

AstraZeneca B.V.

Louis Pasteurlaan 5

2719 EE ZOETERMEER

The Netherlands

Emla

lidocaine

prilocaine

25 mg/g

25 mg/g

cream; hydrophilic

cutaneous use

United Kingdom

AstraZeneca UK Limited

600 Capability Green

Luton LU1 3LU

United Kingdom

Emla Cream 5 %

lidocaine

prilocaine

25 mg/g

25 mg/g

cream

cutaneous use

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