# C_2017208EN.01001001.xml

| 30.6.2017 | EN | Official Journal of the European Union | C 208/10 |
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30.6.2017

EN

Official Journal of the European Union

C 208/10

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2017 to 31 May 2017

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

1

2

(2017/C 208/02)

| — | Issuing, maintenance or modification of a national marketing authorization |
| --- | --- |

—

Issuing, maintenance or modification of a national marketing authorization

Issuing, maintenance or modification of a national marketing authorization

| 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 |
| --- | --- | --- | --- | --- | --- |
| 5.5.2017 | Saroten and associated names | amitriptyline | See Annex | See Annex | 10.5.2017 |

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

5.5.2017

Saroten and associated names

amitriptyline

See Annex

See Annex

10.5.2017

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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

List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, Marketing Authorisation Holders in the Member States

| Member State EU/EEA | Marketing Authorisation Holder | Invented name | Strength | Pharmaceutical Form | Route of administration | Content (concentration) |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Lundbeck Austria GmbH
  Dresdner Strasse 82
  1200 Vienna
  Austria | Saroten | 10 mg | Film-coated tablet | Oral use | |
| Austria | Lundbeck Austria GmbH
  Dresdner Strasse 82
  1200 Vienna
  Austria | Saroten | 25 mg | Film-coated tablet | Oral use | |
| Austria | Lundbeck Austria GmbH
  Dresdner Strasse 82
  1200 Vienna
  Austria | Saroten Retard | 25 mg | Prolonged-release capsule, hard | Oral use | |
| Austria | Lundbeck Austria GmbH
  Dresdner Strasse 82
  1200 Vienna
  Austria | Saroten Retard | 50 mg | Prolonged-release capsule, hard | Oral use | |
| Belgium | Lundbeck S.A.
  Avenue Molière 225
  1050 Brussels
  Belgium | Redomex | 10 mg | Film-coated tablet | Oral use | |
| Belgium | Lundbeck S.A.
  Avenue Molière 225
  1050 Brussels
  Belgium | Redomex | 25 mg | Film-coated tablet | Oral use | |
| Belgium | Lundbeck S.A.
  Avenue Molière 225
  1050 Brussels
  Belgium | Redomex Diffucaps | 25 mg | Prolonged-release capsule, hard | Oral use | |
| Belgium | Lundbeck S.A.
  Avenue Molière 225
  1050 Brussels
  Belgium | Redomex Diffucaps | 50 mg | Prolonged-release capsule, hard | Oral use | |
| Cyprus | C. G. Papaloisou Ltd
  Office address:
  35 Kilkis Avenue
  2234 Latsia
  Cyprus
  Mail address:
  P.O. Box 1711
  2261 Latsia
  Cyprus | Saroten Retard | 25 mg | Prolonged-release capsule, hard | Oral use | |
| Cyprus | C. G. Papaloisou Ltd
  Office address:
  35 Kilkis Avenue
  2234 Latsia
  Cyprus
  Mail address:
  P.O. Box 1711
  2261 Latsia
  Cyprus | Saroten Retard | 50 mg | Prolonged-release capsule, hard | Oral use | |
| Denmark | H. Lundbeck A/S
  Ottiliavej 9
  2500 Valby
  Denmark | Saroten | 10 mg | Film-coated tablet | Oral use | |
| Denmark | H. Lundbeck A/S
  Ottiliavej 9
  2500 Valby
  Denmark | Saroten | 25 mg | Film-coated tablet | Oral use | |
| Denmark | H. Lundbeck A/S
  Ottiliavej 9
  2500 Valby
  Denmark | Saroten Retard | 25 mg | Prolonged-release capsule, hard | Oral use | |
| Denmark | H. Lundbeck A/S
  Ottiliavej 9
  2500 Valby
  Denmark | Saroten Retard | 50 mg | Prolonged-release capsule, hard | Oral use | |
| Estonia | H. Lundbeck A/S
  Ottiliavej 9
  2500 Valby
  Denmark | Saroten Retard | 50 mg | Prolonged-release capsule, hard | Oral use | |
| Germany | Bayer Vital GmbH
  Medizin/Zulassung
  51368 Leverkusen
  Germany | Saroten Tabs | 50 mg | Film-coated tablet | Oral use | |
| Germany | Bayer Vital GmbH
  Medizin/Zulassung
  51368 Leverkusen
  Germany | Saroten retard Tabs | 75 mg | Modified-release tablet | Oral use | |
| Germany | Bayer Vital GmbH
  Medizin/Zulassung
  51368 Leverkusen
  Germany | Saroten 2 ml | 50 mg/2 ml | Solution for injection | Intramuscular use
  intravenous use | 25 mg/ml |
| Greece | PNG GEROLYMATOS MEDICAL AE, ASKLIPIOU 13, KRYONERI 14568 | SAROTEN | 25 mg | Modified-release capsule, hard | Oral use | |
| Greece | PNG GEROLYMATOS MEDICAL AE, ASKLIPIOU 13, KRYONERI 14568 | SAROTEN | 75 mg | Modified-release capsule, hard | Oral use | |
| Greece | PNG GEROLYMATOS MEDICAL AE, ASKLIPIOU 13, KRYONERI 14568 | SAROTEN | 25 mg | Coated tablet | Oral use | |
| Greece | PNG GEROLYMATOS MEDICAL AE, ASKLIPIOU 13, KRYONERI 14568 | SAROTEN | 10 mg | Coated Tablet | Oral use | |
| Luxembourg | Lundbeck S.A.
  Avenue Molière 225
  1050 Brussels
  Belgium | Redomex | 10 mg | Film-coated tablet | Oral use | |
| Luxembourg | Lundbeck S.A.
  Avenue Molière 225
  1050 Brussels
  Belgium | Redomex | 25 mg | Film-coated tablet | Oral use | |
| Luxembourg | Lundbeck S.A.
  Avenue Molière 225
  1050 Brussels
  Belgium | Redomex Diffucaps | 25 mg | Prolonged-release capsule, hard | Oral use | |
| Luxembourg | Lundbeck S.A.
  Avenue Molière 225
  1050 Brussels
  Belgium | Redomex Diffucaps | 50 mg | Prolonged-release capsule, hard | Oral use | |
| Netherlands | Lundbeck B.V.
  Gebouw Jupiter Herikerbergweg 100
  Postbus 12021
  1100 AA Amsterdam
  The Netherlands | Sarotex Retard 25 | 25 mg | Prolonged-release capsule, hard | Oral use | |
| Netherlands | Lundbeck B.V.
  Gebouw Jupiter Herikerbergweg 100
  Postbus 12021
  1100 AA Amsterdam
  The Netherlands | Sarotex Retard 50 | 50 mg | Prolonged-release capsule, hard | Oral use | |
| Norway | H. Lundbeck A/S
  Ottiliavej 9
  2500 Valby
  Denmark | Sarotex | 10 mg | Film-coated tablet | Oral use | |
| Norway | H. Lundbeck A/S
  Ottiliavej 9
  2500 Valby
  Denmark | Sarotex | 25 mg | Film-coated tablet | Oral use | |
| Norway | H. Lundbeck A/S
  Ottiliavej 9
  2500 Valby
  Denmark | Sarotex Retard | 25 mg | Prolonged-release capsule, hard | Oral use | |
| Norway | H. Lundbeck A/S
  Ottiliavej 9
  2500 Valby
  Denmark | Sarotex Retard | 50 mg | Prolonged-release capsule, hard | Oral use | |
| Sweden | H. Lundbeck A/S
  Ottiliavej 9
  2500 Valby
  Denmark | Saroten | 10 mg | Film-coated tablet | Oral use | |
| Sweden | H. Lundbeck A/S
  Ottiliavej 9
  2500 Valby
  Denmark | Saroten | 25 mg | Film-coated tablet | Oral use | |

Member State EU/EEA

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Content (concentration)

Austria

Lundbeck Austria GmbH

Dresdner Strasse 82

1200 Vienna

Austria

Saroten

10 mg

Film-coated tablet

Oral use

Austria

Lundbeck Austria GmbH

Dresdner Strasse 82

1200 Vienna

Austria

Saroten

25 mg

Film-coated tablet

Oral use

Austria

Lundbeck Austria GmbH

Dresdner Strasse 82

1200 Vienna

Austria

Saroten Retard

25 mg

Prolonged-release capsule, hard

Oral use

Austria

Lundbeck Austria GmbH

Dresdner Strasse 82

1200 Vienna

Austria

Saroten Retard

50 mg

Prolonged-release capsule, hard

Oral use

Belgium

Lundbeck S.A.

Avenue Molière 225

1050 Brussels

Belgium

Redomex

10 mg

Film-coated tablet

Oral use

Belgium

Lundbeck S.A.

Avenue Molière 225

1050 Brussels

Belgium

Redomex

25 mg

Film-coated tablet

Oral use

Belgium

Lundbeck S.A.

Avenue Molière 225

1050 Brussels

Belgium

Redomex Diffucaps

25 mg

Prolonged-release capsule, hard

Oral use

Belgium

Lundbeck S.A.

Avenue Molière 225

1050 Brussels

Belgium

Redomex Diffucaps

50 mg

Prolonged-release capsule, hard

Oral use

Cyprus

C. G. Papaloisou Ltd

Office address:

35 Kilkis Avenue

2234 Latsia

Cyprus

Mail address:

P.O. Box 1711

2261 Latsia

Cyprus

Saroten Retard

25 mg

Prolonged-release capsule, hard

Oral use

Cyprus

C. G. Papaloisou Ltd

Office address:

35 Kilkis Avenue

2234 Latsia

Cyprus

Mail address:

P.O. Box 1711

2261 Latsia

Cyprus

Saroten Retard

50 mg

Prolonged-release capsule, hard

Oral use

Denmark

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

Saroten

10 mg

Film-coated tablet

Oral use

Denmark

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

Saroten

25 mg

Film-coated tablet

Oral use

Denmark

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

Saroten Retard

25 mg

Prolonged-release capsule, hard

Oral use

Denmark

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

Saroten Retard

50 mg

Prolonged-release capsule, hard

Oral use

Estonia

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

Saroten Retard

50 mg

Prolonged-release capsule, hard

Oral use

Germany

Bayer Vital GmbH

Medizin/Zulassung

51368 Leverkusen

Germany

Saroten Tabs

50 mg

Film-coated tablet

Oral use

Germany

Bayer Vital GmbH

Medizin/Zulassung

51368 Leverkusen

Germany

Saroten retard Tabs

75 mg

Modified-release tablet

Oral use

Germany

Bayer Vital GmbH

Medizin/Zulassung

51368 Leverkusen

Germany

Saroten 2 ml

50 mg/2 ml

Solution for injection

Intramuscular use

intravenous use

25 mg/ml

Greece

PNG GEROLYMATOS MEDICAL AE, ASKLIPIOU 13, KRYONERI 14568

SAROTEN

25 mg

Modified-release capsule, hard

Oral use

Greece

PNG GEROLYMATOS MEDICAL AE, ASKLIPIOU 13, KRYONERI 14568

SAROTEN

75 mg

Modified-release capsule, hard

Oral use

Greece

PNG GEROLYMATOS MEDICAL AE, ASKLIPIOU 13, KRYONERI 14568

SAROTEN

25 mg

Coated tablet

Oral use

Greece

PNG GEROLYMATOS MEDICAL AE, ASKLIPIOU 13, KRYONERI 14568

SAROTEN

10 mg

Coated Tablet

Oral use

Luxembourg

Lundbeck S.A.

Avenue Molière 225

1050 Brussels

Belgium

Redomex

10 mg

Film-coated tablet

Oral use

Luxembourg

Lundbeck S.A.

Avenue Molière 225

1050 Brussels

Belgium

Redomex

25 mg

Film-coated tablet

Oral use

Luxembourg

Lundbeck S.A.

Avenue Molière 225

1050 Brussels

Belgium

Redomex Diffucaps

25 mg

Prolonged-release capsule, hard

Oral use

Luxembourg

Lundbeck S.A.

Avenue Molière 225

1050 Brussels

Belgium

Redomex Diffucaps

50 mg

Prolonged-release capsule, hard

Oral use

Netherlands

Lundbeck B.V.

Gebouw Jupiter Herikerbergweg 100

Postbus 12021

1100 AA Amsterdam

The Netherlands

Sarotex Retard 25

25 mg

Prolonged-release capsule, hard

Oral use

Netherlands

Lundbeck B.V.

Gebouw Jupiter Herikerbergweg 100

Postbus 12021

1100 AA Amsterdam

The Netherlands

Sarotex Retard 50

50 mg

Prolonged-release capsule, hard

Oral use

Norway

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

Sarotex

10 mg

Film-coated tablet

Oral use

Norway

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

Sarotex

25 mg

Film-coated tablet

Oral use

Norway

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

Sarotex Retard

25 mg

Prolonged-release capsule, hard

Oral use

Norway

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

Sarotex Retard

50 mg

Prolonged-release capsule, hard

Oral use

Sweden

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

Saroten

10 mg

Film-coated tablet

Oral use

Sweden

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

Saroten

25 mg

Film-coated tablet

Oral use

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