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 or Article 38 of Directive 2001/82/EC)
Date: 2017-06-30
Institutions: European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary drug








C_2017208EN.01001001.xml










30.6.2017   


EN


Official Journal of the European Union


C 208/10





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))
(2017/C 208/02)






—



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






(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.


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