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 or Article 38 of Directive 2001/82/EC)
Date: 2014-12-30
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2014467EN.01001101.xml










30.12.2014   


EN


Official Journal of the European Union


C 467/11





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))
(2014/C 467/02)
—   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




28.11.2014


EMLA cream and associated names


See Annex I


See Annex I


See Annex I


1.12.2014






(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, 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