EN Official Journal of the European Union C 399/9

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2016 to 30 September 2016

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

(2016/C 399/02)

— 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 8.9.2016 Alkem Art 31 Not applicable See Annex II See Annex II 9.9.2016 22.9.2016 Durogesic and associated names — Art 30 fentanyl See Annex III See Annex III 23.9.2016 22.9.2016 Semler Art 31 Not applicable See Annex IV See Annex IV 23.9.2016

— Refusal 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 22.9.2016 Diclofenac epolamine 50 mg tablets — Art 29 diclofenac See Annex I See Annex I 23.9.2016

— Suspension 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 8.9.2016 Alkem Art 31 Not applicable See Annex II See Annex II 9.9.2016 22.9.2016 Semler Art 31 Not applicable See Annex IV See Annex IV 23.9.2016

(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, applicants in the member states Member State EU/EEA Applicant company name, address Invented Name Strength Pharmaceutical form Route of administration Czech Republic ALTERGON ITALIA S.r.L Via dell’Industria 83030 Pietradefusi, Avellino, ITALY DICLOFENAC ALTERGON 50 MG TABLETY 50 mg tablet Oral use France ALTERGON ITALIA S.r.L Via dell’Industria 83030 Pietradefusi, Avellino, ITALY DICLOFENAC ALTERGON 50 mg tablet Oral use Slovak Republic ALTERGON ITALIA S.r.L Via dell’Industria 83030 Pietradefusi, Avellino, ITALY Diclofenac ALTERGON 50 mg 50 mg tablet Oral use United Kingdom ALTERGON ITALIA S.r.L Via dell’Industria 83030 Pietradefusi, Avellino, ITALY DICLOFENAC EPOLAMINE ALTERGON 50 MG TABLETS 50 mg tablet Oral use

ANNEX II List of nationally authorised medicinal products and marketing authorisation applications Annex IA: Medicinal products recommended for maintenance and marketing authorisation applications for which bioequivalence vis-à-vis the EU reference medicinal product has been established Member State EU/EEA Marketing Authorisation Holder Applicant Invented name Active Substance Strength Pharmaceutical Form Route of Administration Austria Krka d.d., Novo mesto Cefuroxim Krka 250 mg Filmtabletten Cefuroxime 250 mg Film-coated tablet Oral use Austria Krka d.d., Novo mesto Cefuroxim Krka 500 mg Filmtabletten Cefuroxime 500 mg Film-coated tablet Oral use Bulgaria Krka d.d., Novo mesto Furocef 250 mg film-coated tablets Cefuroxime 250 mg Film-coated tablet Oral use Bulgaria Krka d.d., Novo mesto Furocef 500 mg film-coated tablets Cefuroxime 500 mg Film-coated tablet Oral use Croatia Krka — farma d.o.o. Furocef 250 mg film-coated tablets Cefuroxime 250 mg Film-coated tablet Oral use Croatia Krka — farma d.o.o. Furocef 500 mg film-coated tablets Cefuroxime 500 mg Film-coated tablet Oral use Czech Republic Krka d.d., Novo mesto Ricefan 250 mg Cefuroxime 250 mg Film-coated tablet Oral use Czech Republic Krka d.d., Novo mesto Ricefan 500 mg Cefuroxime 500 mg Film-coated tablet Oral use Estonia Krka d.d., Novo mesto FUROCEF Cefuroxime 250 mg Film-coated tablet Oral use Estonia Krka d.d., Novo mesto FUROCEF Cefuroxime 500 mg Film-coated tablet Oral use France Krka d.d., Novo mesto CEFUROXIME KRKA 250 mg, comprimé pelliculé Cefuroxime 250 mg Film-coated tablet Oral use France Krka d.d., Novo mesto CEFUROXIME KRKA 500 mg, comprimé pelliculé Cefuroxime 500 mg Film-coated tablet Oral use Germany Alkem Pharma GmbH Cefuroxim Alkem 250 mg Filmtabletten Cefuroxime axetil 250 mg Film-coated tablet Oral use Germany Alkem Pharma GmbH Cefuroxim Alkem 500 mg Filmtabletten Cefuroxime axetil 500 mg Film-coated tablet Oral use Hungary Krka d.d., Novo mesto Furocef Krka 250 mg tablets Cefuroxime 250 mg Tablet Oral use Hungary Krka d.d., Novo mesto Furocef Krka 500 mg tablets Cefuroxime 500 mg Tablet Oral use Latvia Krka d.d., Novo mesto Ricefan 250 mg film-coated tablets Cefuroxime 250 mg Film-coated tablet Oral use Latvia Krka d.d., Novo mesto Ricefan 500 mg film-coated tablets Cefuroxime 500 mg Film-coated tablet Oral use Lithuania Krka d.d., Novo mesto Ricefan Cefuroxime 250 mg Film-coated tablet Oral use Lithuania Krka d.d., Novo mesto Ricefan Cefuroxime 500 mg Film-coated tablet Oral use Lithuania SIA Ingen Pharma Cefuroxime Ingen Pharma Cefuroxime 250 mg Film-coated tablet Oral use Lithuania SIA Ingen Pharma Cefuroxime Ingen Pharma Cefuroxime 500 mg Film-coated tablet Oral use Poland Krka d.d., Novo mesto Furocef Cefuroxime 250 mg Film-coated tablet Oral use Poland Krka d.d., Novo mesto Furocef Cefuroxime 500 mg Film-coated tablet Oral use Portugal Krka d.d., Novo mesto Cefuroxima Krka Cefuroxime axetil 250 mg Film-coated tablet Oral use Portugal Krka d.d., Novo mesto Cefuroxima Krka Cefuroxime axetil 500 mg Film-coated tablet Oral use Romania Krka d.d., Novo mesto CEFUROXIME KRKA 250 mg, comprimate Cefuroxime 250 mg Film-coated tablet Oral use Romania Krka d.d., Novo mesto CEFUROXIME KRKA 500 mg, comprimate Cefuroxime 500 mg Film-coated tablet Oral use Slovak Republic Krka d.d., Novo mesto Furocef 250 mg filmom obalené tablety Cefuroxime 250 mg Film-coated tablet Oral use Slovak Republic Krka d.d., Novo mesto Furocef 500 mg filmom obalené tablety Cefuroxime 500 mg Film-coated tablet Oral use Slovenia Krka d.d., Novo mesto Ricefan Cefuroxime 250 mg Film-coated tablet Oral use Slovenia Krka d.d., Novo mesto Ricefan Cefuroxime 500 mg Film-coated tablet Oral use Spain Alkem Pharma GmbH Cefuroxima 500 mg comprimidos recubiertos con película Cefuroxime axetil 500 mg Film-coated tablet Oral use Spain Alkem Pharma GmbH Cefuroxima Alkem 250 mg comprimidos recubiertos con película Cefuroxime axetil 250 mg Film-coated tablet Oral use Spain Krka d.d., Novo mesto Cefuroxima KRKA 250 mg comprimidos recubiertos con película Cefuroxime 250 mg Film-coated tablet Oral use Spain Krka d.d., Novo mesto Cefuroxima KRKA 500 mg comprimidos recubiertos con película Cefuroxime 500 mg Film-coated tablet Oral use United Kingdom Alkem Pharma GmbH Cefuroxime 250 mg film-coated tablets Cefuroxime axetil 250 mg Film-coated tablet Oral use United Kingdom Alkem Pharma GmbH Cefuroxime 500 mg film-coated tablets Cefuroxime axetil 500 mg Film-coated tablet Oral use Annex IB: Products for which the marketing authorisations are recommended for suspension and marketing authorisation applications which do not satisfy the criteria for authorisation Member State EU/EEA Marketing Authorisation Holder Applicant Invented name Active Substance Strength Pharmaceutical Form Route of Administration Czech Republic Alkem Pharma GmbH Riluzole Alkem 50 mg potahované tablety Riluzole 50 mg Film-coated tablet Oral use Denmark Orion Corporation Ibuprofen Orion Ibuprofen 200 mg Film-coated tablet Oral use Denmark Orion Corporation Ibuprofen Orion Ibuprofen 400 mg Film-coated tablet Oral use Denmark Orion Corporation Ibuprofen Orion Ibuprofen 600 mg Film-coated tablet Oral use Germany Alkem Pharma GmbH Riluzol Alkem 50 mg Filmtabletten Riluzole 50 mg Film-coated tablet Oral use Spain Alkem Pharma GmbH Riluzole 50 mg comprimidos recubiertos con película EFG Riluzole 50 mg Film-coated tablet Oral use Sweden Orion Corporation Ibuprofen Orion Ibuprofen 200 mg Film-coated tablet Oral use Sweden Orion Corporation Ibuprofen Orion Ibuprofen 400 mg Film-coated tablet Oral use Sweden Orion Corporation Ibuprofen Orion Ibuprofen 600 mg Film-coated tablet Oral use United Kingdom Alkem Pharma GmbH Riluzole alkem 50 mg film-coated tablets Riluzole 50 mg Film-coated tablet Oral use

ANNEX III LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES Member State EU/EEA Marketing authorisation holder (Invented) Name Strength Pharmaceutical form Route of administration Content (concentration) Austria Janssen-Cilag Pharma GmbH, 1020 Vienna, Vorgartenstraße 206B Austria Durogesic 12 μg/h Transdermal patch Transdermal use 2,1 mg/5,25 cm2 which release 12,5 μg fentanyl per hour Austria Janssen-Cilag Pharma GmbH, 1020 Vienna, Vorgartenstraße 206B Austria Durogesic 25 μg/h Transdermal patch Transdermal use 4,2 mg/10,5 cm2 which release 25 μg fentanyl per hour Austria Janssen-Cilag Pharma GmbH, 1020 Vienna, Vorgartenstraße 206B Austria Durogesic 50 μg/h Transdermal patch Transdermal use 8,4 mg/21 cm2 which release 50 μg fentanyl per hour Austria Janssen-Cilag Pharma GmbH, 1020 Vienna, Vorgartenstraße 206B Austria Durogesic 75 μg/h Transdermal patch Transdermal use 12,6 mg/31,5 cm2 which release 75 μg fentanyl per hour Austria Janssen-Cilag Pharma GmbH, 1020 Vienna, Vorgartenstraße 206B Austria Durogesic 100 μg/h Transdermal patch Transdermal use 16,8 mg/42 cm2 which release 100 μg fentanyl per hour Belgium Janssen-Cilag N.V. Antwerpseweg 15-17 B-2340 Beerse Belgium Durogesic 12 μg/h Transdermal patch Transdermal use 2,1 mg/5,25 cm2 which release 12,5 μg fentanyl per hour Belgium Janssen-Cilag N.V. Antwerpseweg 15-17 B-2340 Beerse Belgium Durogesic 25 μg/h Transdermal patch Transdermal use 4,2 mg/10,5 cm2 which release 25 μg fentanyl per hour Belgium Janssen-Cilag N.V. Antwerpseweg 15-17 B-2340 Beerse Belgium Durogesic 50 μg/h Transdermal patch Transdermal use 8,4 mg/21 cm2 which release 50 μg fentanyl per hour Belgium Janssen-Cilag N.V. Antwerpseweg 15-17 B-2340 Beerse Belgium Durogesic 75 μg/h Transdermal patch Transdermal use 12,6 mg/31,5 cm2 which release 75 μg fentanyl per hour Belgium Janssen-Cilag N.V. Antwerpseweg 15-17 B-2340 Beerse Belgium Durogesic 100 μg/h Transdermal patch Transdermal use 16,8 mg/42 cm2 which release 100 μg fentanyl per hour Croatia Johnson & Johnson S.E. d.o.o. Oreškovićeva 6H, 10010 Zagreb, Croatia Durogesic 12 μg/h Transdermal patch Transdermal use 2,1 mg/5,25 cm2 which release 12,5 μg fentanyl per hour Croatia Johnson & Johnson S.E. d.o.o. Oreškovićeva 6H, 10010 Zagreb, Croatia Durogesic 25 μg/h Transdermal patch Transdermal use 4,2 mg/10,5 cm2 which release 25 μg fentanyl per hour Croatia Johnson & Johnson S.E. d.o.o. Oreškovićeva 6H, 10010 Zagreb, Croatia Durogesic 50 μg/h Transdermal patch Transdermal use 8,4 mg/21 cm2 which release 50 μg fentanyl per hour Croatia Johnson & Johnson S.E. d.o.o. Oreškovićeva 6H, 10010 Zagreb, Croatia Durogesic 75 μg/h Transdermal patch Transdermal use 12,6 mg/31,5 cm2 which release 75 μg fentanyl per hour Croatia Johnson & Johnson S.E. d.o.o. Oreškovićeva 6H, 10010 Zagreb, Croatia Durogesic 100 μg/h Transdermal patch Transdermal use 16,8 mg/42 cm2 which release 100 μg fentanyl per hour Cyprus Janssen-Cilag International NV Turnhoutseweg 30 2340 Beerse Belgium Durogesic 25 μg/h Transdermal patch Transdermal use 4,2 mg/10,5 cm2 which release 25 μg fentanyl per hour Cyprus Janssen-Cilag International NV Turnhoutseweg 30 2340 Beerse Belgium Durogesic 50 μg/h Transdermal patch Transdermal use 8,4 mg/21 cm2 which release 50 μg fentanyl per hour Cyprus Janssen-Cilag International NV Turnhoutseweg 30 2340 Beerse Belgium Durogesic 100 μg/h Transdermal patch Transdermal use 16,8 mg/42 cm2 which release 100 μg fentanyl per hour Czech Republic Janssen-Cilag s.r.o., Karla Engliše 3201/6, Prague 5, 150 00 Czech Republic Durogesic 12 mcg/h 12 μg/h Transdermal patch Transdermal use 2,1 mg/5,25 cm2 which release 12,5 μg fentanyl per hour Czech Republic Janssen-Cilag s.r.o., Karla Engliše 3201/6, Prague 5, 150 00 Czech Republic Durogesic 25 mcg/h 25 μg/h Transdermal patch Transdermal use 4,2 mg/10,5 cm2 which release 25 μg fentanyl per hour Czech Republic Janssen-Cilag s.r.o., Karla Engliše 3201/6, Prague 5, 150 00 Czech Republic Durogesic 50 mcg/h 50 μg/h Transdermal patch Transdermal use 8,4 mg/21 cm2 which release 50 μg fentanyl per hour Czech Republic Janssen-Cilag s.r.o., Karla Engliše 3201/6, Prague 5, 150 00 Czech Republic Durogesic 75 mcg/h 75 μg/h Transdermal patch Transdermal use 12,6 mg/31,5 cm2 which release 75 μg fentanyl per hour Czech Republic Janssen-Cilag s.r.o., Karla Engliše 3201/6, Prague 5, 150 00 Czech Republic Durogesic 100 mcg/h 100 μg/h Transdermal patch Transdermal use 16,8 mg/42 cm2 which release 100 μg fentanyl per hour Denmark Janssen Cilag A/S Bregnerødvej 133 3460 Birkerød Denmark Durogesic 12 μg/h Transdermal patch Transdermal use 2,1 mg/5,25 cm2 which release 12,5 μg fentanyl per hour Denmark Janssen Cilag A/S Bregnerødvej 133 3460 Birkerød Denmark Durogesic 25 μg/h Transdermal patch Transdermal use 4,2 mg/10,5 cm2 which release 25 μg fentanyl per hour Denmark Janssen Cilag A/S Bregnerødvej 133 3460 Birkerød Denmark Durogesic 50 μg/h Transdermal patch Transdermal use 8,4 mg/21 cm2 which release 50 μg fentanyl per hour Denmark Janssen Cilag A/S Bregnerødvej 133 3460 Birkerød Denmark Durogesic 75 μg/h Transdermal patch Transdermal use 12,6 mg/31,5 cm2 which release 75 μg fentanyl per hour Denmark Janssen Cilag A/S Bregnerødvej 133 3460 Birkerød Denmark Durogesic 100 μg/h Transdermal patch Transdermal use 16,8 mg/42 cm2 which release 100 μg fentanyl per hour Finland Janssen-Cilag Oy, Vaisalantie 2, 02130 Espoo Finland Durogesic 12 μg/h Transdermal patch Transdermal use 2,1 mg/5,25 cm2 which release 12,5 μg fentanyl per hour Finland Janssen-Cilag Oy, Vaisalantie 2, 02130 Espoo Finland Durogesic 25 μg/h Transdermal patch Transdermal use 4,2 mg/10,5 cm2 which release 25 μg fentanyl per hour Finland Janssen-Cilag Oy, Vaisalantie 2, 02130 Espoo Finland Durogesic 50 μg/h Transdermal patch Transdermal use 8,4 mg/21 cm2 which release 50 μg fentanyl per hour Finland Janssen-Cilag Oy, Vaisalantie 2, 02130 Espoo Finland Durogesic 75 μg/h Transdermal patch Transdermal use 12,6 mg/31,5 cm2 which release 75 μg fentanyl per hour Finland Janssen-Cilag Oy, Vaisalantie 2, 02130 Espoo Finland Durogesic 100 μg/h Transdermal patch Transdermal use 16,8 mg/42 cm2 which release 100 μg fentanyl per hour France JANSSEN-CILAG 1, rue Camille Desmoulins TSA 91003 92787 ISSY-LES-MOULINEAUX Cedex 9 France Durogesic 12 microgrammes/heure, dispositif transdermique 12 μg/h Transdermal patch Transdermal use 2,1 mg/5,25 cm2 which release 12,5 μg fentanyl per hour France JANSSEN-CILAG 1, rue Camille Desmoulins TSA 91003 92787 ISSY-LES-MOULINEAUX Cedex 9 France Durogesic 25 microgrammes/heure, dispositif transdermique 25 μg/h Transdermal patch Transdermal use 4,2 mg/10,5 cm2 which release 25 μg fentanyl per hour France JANSSEN-CILAG 1, rue Camille Desmoulins TSA 91003 92787 ISSY-LES-MOULINEAUX Cedex 9 France Durogesic 50 microgrammes/heure, dispositif transdermique 50 μg/h Transdermal patch Transdermal use 8,4 mg/21 cm2 which release 50 μg fentanyl per hour France JANSSEN-CILAG 1, rue Camille Desmoulins TSA 91003 92787 ISSY-LES-MOULINEAUX Cedex 9 France Durogesic 75 microgrammes/heure, dispositif transdermique 75 μg/h Transdermal patch Transdermal use 12,6 mg/31,5 cm2 which release 75 μg fentanyl per hour France JANSSEN-CILAG 1, rue Camille Desmoulins TSA 91003 92787 ISSY-LES-MOULINEAUX Cedex 9 France Durogesic 100 microgrammes/heure, dispositif transdermique 100 μg/h Transdermal patch Transdermal use 16,8 mg/42 cm2 which release 100 μg fentanyl per hour Germany JANSSEN-CILAG GmbH Johnson & Johnson Platz 1 41470 Neuss, Germany Durogesic SMAT 12 μg/h Transdermal patch Transdermal use 2,1 mg/5,25 cm2 which release 12,5 μg fentanyl per hour Germany JANSSEN-CILAG GmbH Johnson & Johnson Platz 1 41470 Neuss, Germany Durogesic SMAT 25 μg/h Transdermal patch Transdermal use 4,2 mg/10,5 cm2 which release 25 μg fentanyl per hour Germany JANSSEN-CILAG GmbH Johnson & Johnson Platz 1 41470 Neuss, Germany Durogesic SMAT 50 μg/h Transdermal patch Transdermal use 8,4 mg/21 cm2 which release 50 μg fentanyl per hour Germany JANSSEN-CILAG GmbH Johnson & Johnson Platz 1 41470 Neuss, Germany Durogesic SMAT 75 μg/h Transdermal patch Transdermal use 12,6 mg/31,5 cm2 which release 75 μg fentanyl per hour Germany JANSSEN-CILAG GmbH Johnson & Johnson Platz 1 41470 Neuss, Germany Durogesic SMAT 100 μg/h Transdermal patch Transdermal use 16,8 mg/42 cm2 which release 100 μg fentanyl per hour Greece Janssen-Cilag Pharmaceutical S.A.C.I. 56 Eirinis Ave., 151 21, Pefki, Greece Durogesic 12 μg/h Transdermal patch Transdermal use 2,1 mg/5,25 cm2 which release 12,5 μg fentanyl per hour Greece Janssen-Cilag Pharmaceutical S.A.C.I. 56 Eirinis Ave., 151 21, Pefki, Greece Durogesic 25 μg/h Transdermal patch Transdermal use 4,2 mg/10,5 cm2 which release 25 μg fentanyl per hour Greece Janssen-Cilag Pharmaceutical S.A.C.I. 56 Eirinis Ave., 151 21, Pefki, Greece Durogesic 50 μg/h Transdermal patch Transdermal use 8,4 mg/21 cm2 which release 50 μg fentanyl per hour Greece Janssen-Cilag Pharmaceutical S.A.C.I. 56 Eirinis Ave., 151 21, Pefki, Greece Durogesic 75 μg/h Transdermal patch Transdermal use 12,6 mg/31,5 cm2 which release 75 μg fentanyl per hour Greece Janssen-Cilag Pharmaceutical S.A.C.I. 56 Eirinis Ave., 151 21, Pefki, Greece Durogesic 100 μg/h Transdermal patch Transdermal use 16,8 mg/42 cm2 which release 100 μg fentanyl per hour Hungary Janssen-Cilag Kft. 1123 Budapest, Nagyenyed utca 8-14 Magyarország Hungary Durogesic 12 mikrogramm/óra transzdermális tapasz 12 μg/h Transdermal patch Transdermal use 2,1 mg/5,25 cm2 which release 12,5 μg fentanyl per hour Hungary Janssen-Cilag Kft. 1123 Budapest, Nagyenyed utca 8-14 Magyarország Hungary Durogesic 25 mikrogramm/óra transzdermális tapasz 25 μg/h Transdermal patch Transdermal use 4,2 mg/10,5 cm2 which release 25 μg fentanyl per hour Hungary Janssen-Cilag Kft. 1123 Budapest, Nagyenyed utca 8-14 Magyarország Hungary Durogesic 50 mikrogramm/óra transzdermális tapasz 50 μg/h Transdermal patch Transdermal use 8,4 mg/21 cm2 which release 50 μg fentanyl per hour Hungary Janssen-Cilag Kft. 1123 Budapest, Nagyenyed utca 8-14 Magyarország Hungary Durogesic 75 mikrogramm/óra transzdermális tapasz 75 μg/h Transdermal patch Transdermal use 12,6 mg/31,5 cm2 which release 75 μg fentanyl per hour Hungary Janssen-Cilag Kft. 1123 Budapest, Nagyenyed utca 8-14 Magyarország Hungary Durogesic 100 mikrogramm/óra transzdermális tapasz 100 μg/h Transdermal patch Transdermal use 16,8 mg/42 cm2 which release 100 μg fentanyl per hour Iceland Janssen-Cilag AB Box 7073 192 07 Sollentuna Sweden Durogesic 12 μg/h Transdermal patch Transdermal use 2,1 mg/5,25 cm2 which release 12,5 μg fentanyl per hour Iceland Janssen-Cilag AB Box 7073 192 07 Sollentuna Sweden Durogesic 25 μg/h Transdermal patch Transdermal use 4,2 mg/10,5 cm2 which release 25 μg fentanyl per hour Iceland Janssen-Cilag AB Box 7073 192 07 Sollentuna Sweden Durogesic 50 μg/h Transdermal patch Transdermal use 8,4 mg/21 cm2 which release 50 μg fentanyl per hour Iceland Janssen-Cilag AB Box 7073 192 07 Sollentuna Sweden Durogesic 75 μg/h Transdermal patch Transdermal use 12,6 mg/31,5 cm2 which release 75 μg fentanyl per hour Iceland Janssen-Cilag AB Box 7073 192 07 Sollentuna Sweden Durogesic 100 μg/h Transdermal patch Transdermal use 16,8 mg/42 cm2 which release 100 μg fentanyl per hour Ireland Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG United Kingdom Durogesic DTrans 12 μg/h Transdermal patch Transdermal use 2,1 mg/5,25 cm2 which release 12,5 μg fentanyl per hour Ireland Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG United Kingdom Durogesic DTrans 25 μg/h Transdermal patch Transdermal use 4,2 mg/10,5 cm2 which release 25 μg fentanyl per hour Ireland Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG United Kingdom Durogesic DTrans 50 μg/h Transdermal patch Transdermal use 8,4 mg/21 cm2 which release 50 μg fentanyl per hour Ireland Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG United Kingdom Durogesic DTrans 75 μg/h Transdermal patch Transdermal use 12,6 mg/31,5 cm2 which release 75 μg fentanyl per hour Ireland Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG United Kingdom Durogesic DTrans 100 μg/h Transdermal patch Transdermal use 16,8 mg/42 cm2 which release 100 μg fentanyl per hour Italy JANSSEN-CILAG SpA Via M. Buonarroti, 23 20093 COLOGNO MONZESE (MI), Italy Durogesic 12 μg/h Transdermal patch Transdermal use 2,1 mg/5,25 cm2 which release 12,5 μg fentanyl per hour Italy JANSSEN-CILAG SpA Via M. Buonarroti, 23 20093 COLOGNO MONZESE (MI), Italy Durogesic 25 μg/h Transdermal patch Transdermal use 4,2 mg/10,5 cm2 which release 25 μg fentanyl per hour Italy JANSSEN-CILAG SpA Via M. Buonarroti, 23 20093 COLOGNO MONZESE (MI), Italy Durogesic 50 μg/h Transdermal patch Transdermal use 8,4 mg/21 cm2 which release 50 μg fentanyl per hour Italy JANSSEN-CILAG SpA Via M. Buonarroti, 23 20093 COLOGNO MONZESE (MI), Italy Durogesic 75 μg/h Transdermal patch Transdermal use 12,6 mg/31,5 cm2 which release 75 μg fentanyl per hour Italy JANSSEN-CILAG SpA Via M. Buonarroti, 23 20093 COLOGNO MONZESE (MI), Italy Durogesic 100 μg/h Transdermal patch Transdermal use 16,8 mg/42 cm2 which release 100 μg fentanyl per hour Luxembourg Janssen-Cilag N.V. Antwerpseweg 15-17 B-2340 Beerse Belgium Durogesic 12 μg/h Transdermal patch Transdermal use 2,1 mg/5,25 cm2 which release 12,5 μg fentanyl per hour Luxembourg Janssen-Cilag N.V. Antwerpseweg 15-17 B-2340 Beerse Belgium Durogesic 25 μg/h Transdermal patch Transdermal use 4,2 mg/10,5 cm2 which release 25 μg fentanyl per hour Luxembourg Janssen-Cilag N.V. Antwerpseweg 15-17 B-2340 Beerse Belgium Durogesic 50 μg/h Transdermal patch Transdermal use 8,4 mg/21 cm2 which release 50 μg fentanyl per hour Luxembourg Janssen-Cilag N.V. Antwerpseweg 15-17 B-2340 Beerse Belgium Durogesic 75 μg/h Transdermal patch Transdermal use 12,6 mg/31,5 cm2 which release 75 μg fentanyl per hour Luxembourg Janssen-Cilag N.V. Antwerpseweg 15-17 B-2340 Beerse Belgium Durogesic 100 μg/h Transdermal patch Transdermal use 16,8 mg/42 cm2 which release 100 μg fentanyl per hour Malta Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse Belgium Durogesic DTrans 12 μg/h Transdermal patch Transdermal use 2,1 mg/5,25 cm2 which release 12,5 μg fentanyl per hour Malta Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse Belgium Durogesic DTrans 25 μg/h Transdermal patch Transdermal use 4,2 mg/10,5 cm2 which release 25 μg fentanyl per hour Malta Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse Belgium Durogesic DTrans 50 μg/h Transdermal patch Transdermal use 8,4 mg/21 cm2 which release 50 μg fentanyl per hour Malta Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse Belgium Durogesic DTrans 75 μg/h Transdermal patch Transdermal use 12,6 mg/31,5 cm2 which release 75 μg fentanyl per hour Malta Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse Belgium Durogesic DTrans 100 μg/h Transdermal patch Transdermal use 16,8 mg/42 cm2 which release 100 μg fentanyl per hour Netherlands Janssen-Cilag B.V. Dr. Paul Janssenweg 150 5026 RH Tilburg PO Box 90240 5000 LT Tilburg Netherlands Durogesic 12 μg/uur 12 μg/h Transdermal patch Transdermal use 2,1 mg/5,25 cm2 which release 12,5 μg fentanyl per hour Netherlands Janssen-Cilag B.V. Dr. Paul Janssenweg 150 5026 RH Tilburg PO Box 90240 5000 LT Tilburg Netherlands Durogesic 25 μg/uur 25 μg/h Transdermal patch Transdermal use 4,2 mg/10,5 cm2 which release 25 μg fentanyl per hour Netherlands Janssen-Cilag B.V. Dr. Paul Janssenweg 150 5026 RH Tilburg PO Box 90240 5000 LT Tilburg Netherlands Durogesic 50 μg/uur 50 μg/h Transdermal patch Transdermal use 8,4 mg/21 cm2 which release 50 μg fentanyl per hour Netherlands Janssen-Cilag B.V. Dr. Paul Janssenweg 150 5026 RH Tilburg PO Box 90240 5000 LT Tilburg Netherlands Durogesic 75 μg/uur 75 μg/h Transdermal patch Transdermal use 12,6 mg/31,5 cm2 which release 75 μg fentanyl per hour Netherlands Janssen-Cilag B.V. Dr. Paul Janssenweg 150 5026 RH Tilburg PO Box 90240 5000 LT Tilburg Netherlands Durogesic 100 μg/uur 100 μg/h Transdermal patch Transdermal use 16,8 mg/42 cm2 which release 100 μg fentanyl per hour Norway Janssen-Cilag AS Drammensveien 288 NO-0283 Oslo Norway Durogesic 12 μg/h Transdermal patch Transdermal use 2,1 mg/5,25 cm2 which release 12,5 μg fentanyl per hour Norway Janssen-Cilag AS Drammensveien 288 NO-0283 Oslo Norway Durogesic 25 μg/h Transdermal patch Transdermal use 4,2 mg/10,5 cm2 which release 25 μg fentanyl per hour Norway Janssen-Cilag AS Drammensveien 288 NO-0283 Oslo Norway Durogesic 50 μg/h Transdermal patch Transdermal use 8,4 mg/21 cm2 which release 50 μg fentanyl per hour Norway Janssen-Cilag AS Drammensveien 288 NO-0283 Oslo Norway Durogesic 75 μg/h Transdermal patch Transdermal use 12,6 mg/31,5 cm2 which release 75 μg fentanyl per hour Norway Janssen-Cilag AS Drammensveien 288 NO-0283 Oslo Norway Durogesic 100 μg/h Transdermal patch Transdermal use 16,8 mg/42 cm2 which release 100 μg fentanyl per hour Poland Janssen-Cilag International NV Turnhoutseweg 30 B-2340 Beerse Belgium Durogesic 12 μg/h Transdermal patch Transdermal use 2,1 mg/5,25 cm2 which release 12,5 μg fentanyl per hour Poland Janssen-Cilag International NV Turnhoutseweg 30 B-2340 Beerse Belgium Durogesic 25 μg/h Transdermal patch Transdermal use 4,2 mg/10,5 cm2 which release 25 μg fentanyl per hour Poland Janssen-Cilag International NV Turnhoutseweg 30 B-2340 Beerse Belgium Durogesic 50 μg/h Transdermal patch Transdermal use 8,4 mg/21 cm2 which release 50 μg fentanyl per hour Poland Janssen-Cilag International NV Turnhoutseweg 30 B-2340 Beerse Belgium Durogesic 75 μg/h Transdermal patch Transdermal use 12,6 mg/31,5 cm2 which release 75 μg fentanyl per hour Poland Janssen-Cilag International NV Turnhoutseweg 30 B-2340 Beerse Belgium Durogesic 100 μg/h Transdermal patch Transdermal use 16,8 mg/42 cm2 which release 100 μg fentanyl per hour Portugal Janssen Farmacêutica Portugal, Lda. Estrada Consiglieri Pedroso, 69 A Queluz de Baixo 2734-503 Barcarena Portugal Durogesic 12 μg/h Transdermal patch Transdermal use 2,1 mg/5,25 cm2 which release 12,5 μg fentanyl per hour Portugal Janssen Farmacêutica Portugal, Lda. Estrada Consiglieri Pedroso, 69 A Queluz de Baixo 2734-503 Barcarena Portugal Durogesic 25 μg/h Transdermal patch Transdermal use 4,2 mg/10,5 cm2 which release 25 μg fentanyl per hour Portugal Janssen Farmacêutica Portugal, Lda. Estrada Consiglieri Pedroso, 69 A Queluz de Baixo 2734-503 Barcarena Portugal Durogesic 50 μg/h Transdermal patch Transdermal use 8,4 mg/21 cm2 which release 50 μg fentanyl per hour Portugal Janssen Farmacêutica Portugal, Lda. Estrada Consiglieri Pedroso, 69 A Queluz de Baixo 2734-503 Barcarena Portugal Durogesic 75 μg/h Transdermal patch Transdermal use 12,6 mg/31,5 cm2 which release 75 μg fentanyl per hour Portugal Janssen Farmacêutica Portugal, Lda. Estrada Consiglieri Pedroso, 69 A Queluz de Baixo 2734-503 Barcarena Portugal Durogesic 100 μg/h Transdermal patch Transdermal use 16,8 mg/42 cm2 which release 100 μg fentanyl per hour Slovenia Johnson & Johnson d.o.o. Šmartinska cesta 53, 1000 Ljubljana Slovenia Durogesic 12 μg/h Transdermal patch Transdermal use 2,1 mg/5,25 cm2 which release 12,5 μg fentanyl per hour Slovenia Johnson & Johnson d.o.o. Šmartinska cesta 53, 1000 Ljubljana Slovenia Durogesic 25 μg/h Transdermal patch Transdermal use 4,2 mg/10,5 cm2 which release 25 μg fentanyl per hour Slovenia Johnson & Johnson d.o.o. Šmartinska cesta 53, 1000 Ljubljana Slovenia Durogesic 50 μg/h Transdermal patch Transdermal use 8,4 mg/21 cm2 which release 50 μg fentanyl per hour Slovenia Johnson & Johnson d.o.o. Šmartinska cesta 53, 1000 Ljubljana Slovenia Durogesic 75 μg/h Transdermal patch Transdermal use 12,6 mg/31,5 cm2 which release 75 μg fentanyl per hour Slovenia Johnson & Johnson d.o.o. Šmartinska cesta 53, 1000 Ljubljana Slovenia Durogesic 100 μg/h Transdermal patch Transdermal use 16,8 mg/42 cm2 which release 100 μg fentanyl per hour Spain JANSSEN-CILAG, S.A. Paseo de Las Doce Estrellas, 5-7 28042, Madrid Spain Durogesic Matrix 12 μg/h Transdermal patch Transdermal use 2,1 mg/5,25 cm2 which release 12,5 μg fentanyl per hour Spain JANSSEN-CILAG, S.A. Paseo de Las Doce Estrellas, 5-7 28042, Madrid Spain Durogesic Matrix 25 μg/h Transdermal patch Transdermal use 4,2 mg/10,5 cm2 which release 25 μg fentanyl per hour Spain JANSSEN-CILAG, S.A. Paseo de Las Doce Estrellas, 5-7 28042, Madrid Spain Durogesic Matrix 50 μg/h Transdermal patch Transdermal use 8,4 mg/21 cm2 which release 50 μg fentanyl per hour Spain JANSSEN-CILAG, S.A. Paseo de Las Doce Estrellas, 5-7 28042, Madrid Spain Durogesic Matrix 75 μg/h Transdermal patch Transdermal use 12,6 mg/31,5 cm2 which release 75 μg fentanyl per hour Spain JANSSEN-CILAG, S.A. Paseo de Las Doce Estrellas, 5-7 28042, Madrid Spain Durogesic Matrix 100 μg/h Transdermal patch Transdermal use 16,8 mg/42 cm2 which release 100 μg fentanyl per hour Sweden Janssen-Cilag AB Box 7073 192 07 Sollentuna Sweden Durogesic 12 μg/h Transdermal patch Transdermal use 2,1 mg/5,25 cm2 which release 12,5 μg fentanyl per hour Sweden Janssen-Cilag AB Box 7073 192 07 Sollentuna Sweden Durogesic 25 μg/h Transdermal patch Transdermal use 4,2 mg/10,5 cm2 which release 25 μg fentanyl per hour Sweden Janssen-Cilag AB Box 7073 192 07 Sollentuna Sweden Durogesic 50 μg/h Transdermal patch Transdermal use 8,4 mg/21 cm2 which release 50 μg fentanyl per hour Sweden Janssen-Cilag AB Box 7073 192 07 Sollentuna Sweden Durogesic 75 μg/h Transdermal patch Transdermal use 12,6 mg/31,5 cm2 which release 75 μg fentanyl per hour Sweden Janssen-Cilag AB Box 7073 192 07 Sollentuna Sweden Durogesic 100 μg/h Transdermal patch Transdermal use 16,8 mg/42 cm2 which release 100 μg fentanyl per hour United Kingdom Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG United Kingdom Durogesic DTrans 12 μg/h Transdermal patch Transdermal use 2,1 mg/5,25 cm2 which release 12,5 μg fentanyl per hour United Kingdom Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG United Kingdom Durogesic DTrans 25 μg/h Transdermal patch Transdermal use 4,2 mg/10,5 cm2 which release 25 μg fentanyl per hour United Kingdom Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG United Kingdom Durogesic DTrans 50 μg/h Transdermal patch Transdermal use 8,4 mg/21 cm2 which release 50 μg fentanyl per hour United Kingdom Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG United Kingdom Durogesic DTrans 75 μg/h Transdermal patch Transdermal use 12,6 mg/31,5 cm2 which release 75 μg fentanyl per hour United Kingdom Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG United Kingdom Durogesic DTrans 100 μg/h Transdermal patch Transdermal use 16,8 mg/42 cm2 which release 100 μg fentanyl per hour