EN Official Journal of the European Union C 171/11

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2017 to 30 April 2017

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

(2017/C 171/02)

— 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 28.4.2017 Haldol Decanoate and associated names — Art. 30 haloperidol decanoate See Annex I See Annex I 2.5.2017 28.4.2017 Haldol and associated names — Art. 30 haloperidol See Annex II See Annex II 2.5.2017

(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 FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State EU/EEA Marketing authorisation holder Name Strength Pharmaceutical form Route of administration Content (concentration) Austria Janssen-Cilag Pharma GmbH Vorgartenstraße 206B AT-1020 Vienna Austria Haldol Decanoat 50 mg/ml Solution for injection Intramuscular use 50 mg/ml Austria Janssen-Cilag Pharma GmbH Vorgartenstraße 206B AT-1020 Vienna Austria Haldol Decanoat 150 mg/3 ml Solution for injection Intramuscular use 50 mg/ml Belgium Janssen-Cilag NV Antwerpseweg 15-17 B-2340 Beerse Belgium Haldol Decanoas 50 mg/ml Solution for injection Intramuscular use 50 mg/ml Belgium Janssen-Cilag NV Antwerpseweg 15-17 B-2340 Beerse Belgium Haldol Decanoas 150 mg/3 ml Solution for injection Intramuscular use 50 mg/ml Belgium Janssen-Cilag NV Antwerpseweg 15-17 B-2340 Beerse Belgium Haldol Decanoas 100 mg/ml Solution for injection Intramuscular use 100 mg/ml Cyprus Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse Belgium Haldol Decanoate 50 mg/ml Solution for injection Intramuscular use 50 mg/ml Cyprus Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse Belgium Haldol Decanoate 100 mg/ml Solution for injection Intramuscular use 100 mg/ml Denmark Janssen-Cilag A/S Bregnerødvej 133 3460 Birkerød Denmark Serenase Dekanoat 50 mg/ml Solution for injection Intramuscular use 50 mg/ml Denmark Janssen-Cilag A/S Bregnerødvej 133 3460 Birkerød Denmark Serenase Dekanoat 100 mg/ml Solution for injection Intramuscular use 100 mg/ml Finland Janssen-Cilag Oy Vaisalantie 2 02130 Espoo Finland Serenase Depot 50 mg/ml Solution for injection Intramuscular use 50 mg/ml Finland Janssen-Cilag Oy Vaisalantie 2 02130 Espoo Finland Serenase Depot 100 mg/ml Solution for injection Intramuscular use 100 mg/ml France Janssen-Cilag 1, rue Camille Desmoulins, TSA 91003 F-92787 Issy Les Moulineaux, Cedex 9 France Haldol Decanoas 50 mg/ml Solution for injection Intramuscular use 50 mg/ml Germany Janssen-Cilag GmbH Johnson & Johnson Platz 1 41470 Neuss Germany Haldol — Janssen Decanoat Depot 50 mg/ml Solution for injection Intramuscular use 50 mg/ml Germany Janssen-Cilag GmbH Johnson & Johnson Platz 1 41470 Neuss Germany Haldol — Janssen Decanoat Depot 3 ml 150 mg/3 ml Solution for injection Intramuscular use 50 mg/ml Greece Janssen-Cilag Pharmaceutical S.A.C.I. 56 Eirinis Ave, Pefki Athens GR-151 21 Greece Aloperidin Decanoas 50 mg/ml Solution for injection Intramuscular use 50 mg/ml Greece Janssen-Cilag Pharmaceutical S.A.C.I. 56 Eirinis Ave, Pefki Athens GR-151 21 Greece Aloperidin Decanoas 150 mg/3 ml Solution for injection Intramuscular use 50 mg/ml Greece Janssen-Cilag Pharmaceutical S.A.C.I. 56 Eirinis Ave, Pefki, Athens GR-151 21 Greece Aloperidin Decanoas 100 mg/ml Solution for injection Intramuscular use 100 mg/ml Iceland Janssen-Cilag AB Box 4042 16904 Solna Sweden Haldol Depot 100 mg/ml Solution for injection Intramuscular use 100 mg/ml Ireland Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG United Kingdom Haldol Decanoate 50 mg/ml Solution for injection Intramuscular use 50 mg/ml Ireland Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG United Kingdom Haldol Decanoate 100 mg/ml Solution for injection Intramuscular use 100 mg/ml Italy Janssen-Cilag SpA Via M.Buonarroti, 23 I-20093 Cologno Monzese MI, Italy Haldol Decanoas 50 mg/ml Solution for injection Intramuscular use 50 mg/ml Italy Janssen-Cilag SpA Via M.Buonarroti, 23 I-20093 Cologno Monzese MI, Italy Haldol Decanoas 150 mg/3 ml Solution for injection Intramuscular use 50 mg/ml Luxembourg Janssen-Cilag NV Antwerpseweg 15-17 B-2340 Beerse Belgium Haldol Decanoas 50 mg/ml Solution for injection Intramuscular use 50 mg/ml Luxembourg Janssen-Cilag NV Antwerpseweg 15-17 B-2340 Beerse Belgium Haldol Decanoas 150 mg/3 ml Solution for injection Intramuscular use 50 mg/ml Luxembourg Janssen-Cilag NV Antwerpseweg 15-17 B-2340 Beerse Belgium Haldol Decanoas 100 mg/ml Solution for injection Intramuscular use 100 mg/ml The Netherlands Janssen-Cilag BV Dr. Paul Janssenweg 150 5026 RH Tilburg The Netherlands Haldol Decanoas oplossing voor injectie 50 mg/ml 50 mg/ml Solution for injection Intramuscular use 50 mg/ml The Netherlands Janssen-Cilag BV Dr. Paul Janssenweg 150 5026 RH Tilburg The Netherlands Haldol Decanoas oplossing voor injectie 100 mg/ml 100 mg/ml Solution for injection Intramuscular use 100 mg/ml Norway JANSSEN-CILAG AS Drammensveien 288 0283 Oslo Norway Haldol Depot 100 mg/ml Solution for injection Intramuscular use 100 mg/ml Portugal Janssen Farmacêutica Portugal, Lda Estrada Consiglieri Pedroso, 69 A, Queluz de Baixo2734 503 Barcarena Portugal Haldol Decanoato 50 mg/1 ml Solution for injection Intramuscular use 50 mg/ml Portugal Janssen Farmacêutica Portugal, Lda Estrada Consiglieri Pedroso, 69 A, Queluz de Baixo 2734 503 Barcarena Portugal Haldol Decanoato 100 mg/1 ml Solution for injection Intramuscular use 100 mg/ml Sweden Janssen-Cilag AB Box 4042 16904 Solna Sweden Haldol Depot 50 mg/ml Solution for injection Intramuscular use 50 mg/ml Sweden Janssen-Cilag AB Box 4042 16904 Solna Sweden Haldol Depot 100 mg/ml Solution for injection Intramuscular use 100 mg/ml United Kingdom Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG United Kingdom Haldol Decanoate 50 mg/ml Solution for injection Intramuscular use 50 mg/ml United Kingdom Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG, United Kingdom Haldol Decanoate 100 mg/ml Solution for injection Intramuscular use 100 mg/ml