# C_2015252EN.01001001.xml

| 31.7.2015 | EN | Official Journal of the European Union | C 252/10 |
| --- | --- | --- | --- |

31.7.2015

EN

Official Journal of the European Union

C 252/10

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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))

1

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 |

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

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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, 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 |

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

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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 |

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

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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 |

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

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