Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2015 to 30 June 2015 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2015-07-31
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2015252EN.01001001.xml










31.7.2015   


EN


Official Journal of the European Union


C 252/10





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2015 to 30 June 2015
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))
(2015/C 252/02)










Date of the decision


Name(s) of the medicinal product


INN (International Non-Proprietary Name)


Holder(s) of the marketing authorization


Member State concerned


Date of notification




5.6.2015


Ikorel and Dancor


See Annex I


See Annex I


See Annex I


6.6.2015




25.6.2015


Merisone


See Annex II


See Annex II


See Annex II


26.6.2015




25.6.2015


Myoson


See Annex III


See Annex III


See Annex III


26.6.2015






(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 medicinal products, route of administration, Marketing Authorisation Holders in the Member States










Member State (in EEA)


Marketing authorisation holder


Invented Name


Strength


Pharmaceutical form


Route of administration




Austria


MERCK Gesellschaft mbH
Zimbagasse 5
1147 Wien
Austria


Dancor 10 mg — Tabletten


10 mg


tablet


oral use




Austria


MERCK Gesellschaft mbH
Zimbagasse 5
1147 Wien
Austria


Dancor 20 mg — Tabletten


20 mg


tablet


oral use




Denmark


Sanofi-Aventis Denmark A/S
Slotsmarken 13
DK-2970 Hørsholm
Denmark


ANGICOR


10 mg


tablet


oral use




Denmark


Sanofi-Aventis Denmark A/S
Slotsmarken 13
DK-2970 Hørsholm
Denmark


ANGICOR


20 mg


tablet


oral use




France


Sanofi-Aventis France
1-13 boulevard Romain Rolland
75014 Paris
France


IKOREL


10 mg


scored tablet


oral use




France


Sanofi-Aventis France
1-13 boulevard Romain Rolland
75014 Paris
France


IKOREL


20 mg


tablet


oral use




France


Sanofi-Aventis France
1-13 boulevard Romain Rolland
75014 Paris
France


NICORANDIL ZENTIVA


10 mg


scored tablet


oral use




France


Sanofi-Aventis France
1-13 boulevard Romain Rolland
75014 Paris
France


NICORANDIL ZENTIVA


20 mg


tablet


oral use




France


Merck Santé
37, Rue Saint-Romain
69379 Lyon Cedex 08
France


Adancor


10 mg


scored tablet


oral use




France


Merck Santé
37, Rue Saint-Romain
69379 Lyon Cedex 08
France


Adancor


20 mg


tablet


oral use




Ireland


Sanofi-Aventis Ireland L Ltd., T/A SANOFI
Citywest Business Campus Dublin 24
Ireland


IKOREL


10 mg


tablet


oral use




Ireland


Sanofi-Aventis Ireland L Ltd., T/A SANOFI
Citywest Business Campus Dublin 24
Ireland


IKOREL


20 mg


tablet


oral use




Netherlands


Sanofi-Aventis Netherlands B.V.
Kampenringweg 45 D-E Gouda
Netherlands


IKOREL 10 mg


10 mg


tablet


oral use




Portugal


Merck, S.A.
Edifício DUO Miraflores
Alameda Fernão Lopes, no 12 — 4o B,
1495-190 Algés
Portugal


Dancor


10 mg


tablet


oral use




Portugal


Merck, S.A.
Edifício DUO Miraflores
Alameda Fernão Lopes, no 12 — 4o B,
1495-190 Algés
Portugal


Dancor


20 mg


tablet


oral use




United Kingdom


Aventis Pharma Limited
One Onslow Street
Guildford
Surrey
GU1 4YS
UK


IKOREL


10 mg


tablet


oral use




United Kingdom


Aventis Pharma Limited
One Onslow Street
Guildford
Surrey
GU1 4YS
UK


IKOREL


20 mg


tablet


oral use







ANNEX II
List of the names, pharmaceutical form, strengths of the medicinal product, route of administration, applicants in the Member States










Member State EU/EEA


Applicant


(Invented) Name


Strength


Pharmaceutical form


Route of administration




Germany


Meditop Pharmaceutical Ltd.,
Ady Endre utca 1.
H2097 Pilisborosjenő,
Hungary


Tolperison-neuraxpharm 50 mg Filmtabletten


50 mg


film-coated tablet


oral use




Germany


Meditop Pharmaceutical Ltd.,
Ady Endre utca 1.
H2097 Pilisborosjenő,
Hungary


Tolperison-neuraxpharm 150 mg Filmtabletten


150 mg


film-coated tablet


oral use




Hungary


Meditop Pharmaceutical Ltd.,
Ady Endre utca 1.
H2097 Pilisborosjenő,
Hungary


MERISONE


50 mg


film-coated tablet


oral use




Hungary


Meditop Pharmaceutical Ltd.,
Ady Endre utca 1.
H2097 Pilisborosjenő,
Hungary


MERISONE


150 mg


film-coated tablet


oral use







ANNEX III
List of the names, pharmaceutical form, strengths of the medicinal product, route of administration, applicants in the Member States










Member State EU/EEA


Applicant


(Invented) Name


Strength


Pharmaceutical form


Route of administration




Belgium


Meditop Pharmaceutical Ltd., Ady Endre utca 1.
H-2097 Pilisborosjenő, Hungary


Tolpermyo 50 mg comprimés pelliculés


50 mg


film-coated tablet


oral use




Belgium


Meditop Pharmaceutical Ltd., Ady Endre utca 1.
H-2097 Pilisborosjenő, Hungary


Tolpermyo 150 mg comprimés pelliculés


150 mg


film-coated tablet


oral use




Hungary


Meditop Pharmaceutical Ltd., Ady Endre utca 1.
H-2097 Pilisborosjenő, Hungary


MYOSON


50 mg


film-coated tablet


oral use




Hungary


Meditop Pharmaceutical Ltd., Ady Endre utca 1.
H-2097 Pilisborosjenő, Hungary


MYOSON


150 mg


film-coated tablet


oral use




Luxembourg


Meditop Pharmaceutical Ltd., Ady Endre utca 1.
H-2097 Pilisborosjenő, Hungary


Epsipam


50 mg


film-coated tablet


oral use




Luxembourg


Meditop Pharmaceutical Ltd., Ady Endre utca 1.
H-2097 Pilisborosjenő, Hungary


Epsipam


150 mg


film-coated tablet


oral use




The Netherlands


Meditop Pharmaceutical Ltd., Ady Endre utca 1.
H-2097 Pilisborosjenő, Hungary


Tolpermyo 50 mg filmomhulde tabletten


50 mg


film-coated tablet


oral use




The Netherlands


Meditop Pharmaceutical Ltd., Ady Endre utca 1.
H-2097 Pilisborosjenő, Hungary


Tolpermyo 150 mg filmomhulde tabletten


150 mg


film-coated tablet


oral use