EN Official Journal of the European Union C 243/11

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2014 to 30 June 2014

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

2014/C 243/02

— 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 23.6.2014 Zolpidem See Annex I See Annex I See Annex I 24.6.2014 30.6.2014 Crestor See Annex II See Annex II See Annex II 1.7.2014

(1) OJ L 311, 28.11.01, p. 67.

(2) OJ L 311, 28.11.01, p. 1.

Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, marketing authorisation holders in the Member States Member State in EEA Marketing authorisation holder Product name Strength Pharmaceutical form Route of administration Austria G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria Zoldem 5 mg — Filmtabletten 5 mg film-coated tablet oral use Austria G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria Zoldem 10 mg — Filmtabletten 10 mg film-coated tablet oral use Austria G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria Zolpidem G.L. 10 mg — Filmtabletten 10 mg film-coated tablet oral use Austria Hexal Pharma GmbH, Stella-Klein-Löw-Weg 17, 1020 Wien, Austria Zolpidem ‘Hexal’ — Filmtabletten 10 mg film-coated tablet oral use Austria Meda Pharma GmbH, Guglgasse 15, 1110 Wien, Austria Edluar 5 mg Sublingualtabletten 5 mg sublingual tablet sublingual use Austria Meda Pharma GmbH, Guglgasse 15, 1110 Wien, Austria Edluar 10 mg Sublingualtabletten 10 mg sublingual tablet sublingual use Austria ratiopharm Arzneimittel Vertriebs-GmbH, Albert-Schweitzer-Gasse 3, 1140 Wien, Austria Zolpidem ‘ratiopharm’ 10 mg Filmtabletten 10 mg film-coated tablet oral use Austria sanofi-aventis GmbH, Saturn Tower, Leonard-Bernstein-Straße 10, 1220 Wien, Austria Ivadal — Filmtabletten 10 mg film-coated tablet oral use Austria STADA Arzneimittel GmbH, Muthgasse 36/2, 1190 Wien, Austria Mondeal 10 mg — Filmtabletten 10 mg film-coated tablet oral use Belgium APOTEX NV Av. du Bourg. Etienne Demunter 5 box 8 1090 Jette Belgium Zolpitop 10 mg film-coated tablet oral use Belgium APOTEX NV Av. du Bourg. Etienne Demunter 5 box 8 1090 Jette Belgium Zolpitop 5 mg film-coated tablet oral use Belgium Eurogenerics S.A. Esplanade Heysel, b22 1020 Bruxelles Belgium Zolpidem EG 10 mg film-coated tablet oral use Belgium Eurogenerics S.A. Esplanade Heysel, b22 1020 Bruxelles Belgium Zolpidem EG 10 mg effervescent tablet oral use Belgium Ipca, Produtos Farmaceuticos, Unipessoal Lda Rua Chanceler-Mor 11 R/c Frt. Cacem 2735-615 Portugal Zolpidem IPCA 5 mg film-coated tablet oral use Belgium Ipca, Produtos Farmaceuticos, Unipessoal Lda Rua Chanceler-Mor 11 R/c Frt. Cacem 2735-615 Portugal Zolpidem IPCA 10 mg film-coated tablet oral use Belgium MEDA PHARMA Chaussee de la Hulpe 166 1170 Watermael-Boitsfort Belgium Zolpeduar 5 mg sublingual tablet oral use Belgium MEDA PHARMA Chaussee de la Hulpe 166 1170 Watermael-Boitsfort Belgium Zolpeduar 10 mg sublingual tablet oral use Belgium MYLAN BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart Belgium Zolpidem Mylan 10 mg film-coated tablet oral use Belgium SANDOZ N.V. Telecom Gardens Medialaan 40 1800 1800ilvoorde Belgium Zolpidem Sandoz 10 mg film-coated tablet oral use Belgium SANOFI BELGIUM Airport Plaza, Montreal Building, Leonardo Da Vincilaan 19 1831 Diegem Belgium Stilnoct 10 mg tablet oral use Belgium SANOFI BELGIUM Airport Plaza, Montreal Building, Leonardo Da Vincilaan 19 1831 Diegem Belgium Zolpidem Sanofi-Aventis Belgium 10 mg film-coated tablet oral use Belgium TEVA PHARMA BELGIUM NV Laarstraat 16 2610 Wilrijk Belgium Zolpidem Teva 10 mg film-coated tablet oral use Belgium TEVA PHARMA BELGIUM NV Laarstraat 16 2610 Wilrijk Belgium Zolpidem Ratiopharm 10 mg film-coated tablet oral use Bulgaria ALKALOID-INT d.o.o. Šlandrova ulica 4 1231 Ljubljana-Črnuče Slovenia Adorma 5 mg film-coated tablet oral use Bulgaria ALKALOID-INT d.o.o. Šlandrova ulica 4 1231 Ljubljana-Črnuče Slovenia Adorma 10 mg film-coated tablet oral use Bulgaria Krka, d.d., Novo mesto Šmarješka cesta 6 8000 Novo mesto Slovenia Zolsana 5 mg film-coated tablet oral use Bulgaria Krka, d.d., Novo mesto Šmarješka cesta 6 8000 Novo mesto Slovenia Zolsana 10 mg film-coated tablet oral use Bulgaria Meda Pharma GmbH & Co. KG Benzstrasse 1 Bad Homburg v.d.H 61352 Germany Edluar 5 mg sublingual tablet sublingual use Bulgaria Meda Pharma GmbH & Co. KG Benzstrasse 1 Bad Homburg v.d.H 61352 Germany Edluar 10 mg sublingual tablet sublingual use Bulgaria Sanofi-Aventis Bulgaria EOOD, 103 Alexander Stamboliiski Blvd. Building Sofia Tower Sofia 1303 Bulgaria Stilnox 10 mg film-coated tablet oral use Croatia Alkaloid d.o.o., Ulica grada Vukovara 226 F, Zagreb, Croatia Lunata 5 mg filmom obložene tablete 5 mg film-coated tablet oral use Croatia Alkaloid d.o.o., Ulica grada Vukovara 226 F, Zagreb, Croatia Lunata 10 mg filmom obložene tablete 10 mg film-coated tablet oral use Croatia Krka — farma d.o.o., Radnička cesta 48, Zagreb, Croatia Zolsana 5 mg filmom obložene tablete 5 mg film-coated tablet oral use Croatia Krka — farma d.o.o., Radnička cesta 48, Zagreb, Croatia Zolsana 10 mg filmom obložene tablete 10 mg film-coated tablet oral use Croatia Pliva Hrvatska d.o.o., Prilaz baruna Filipovića 25, Zagreb, Croatia Zonadin 5 mg tablete 5 mg film-coated tablet oral use Croatia Pliva Hrvatska d.o.o., Prilaz baruna Filipovića 25, Zagreb, Croatia Zonadin 10 mg tablete 10 mg film-coated tablet oral use Croatia Sandoz d.o.o., Maksimirska 120, Zagreb, 1000, Croatia Sanval 5 mg filmom obložene tablete 5 mg film-coated tablet oral use Croatia Sandoz d.o.o., Maksimirska 120, Zagreb, 1000, Croatia Sanval 10 mg filmom obložene tablete 10 mg film-coated tablet oral use Cyprus Sanofi-Aventis Cyprus Ltd Charalambou Mouskou 14 Lefkosia 2015 Cyprus Stilnox 10 mg film-coated tablet oral use Czech Republic ALKALOID-INT d.o.o. Šlandrova ulica 4 1231 Ljubljana-Črnuče Slovenia ADORMA 5 MG 5 mg film-coated tablet oral use Czech Republic ALKALOID-INT d.o.o. Šlandrova ulica 4 1231 Ljubljana-Črnuče Slovenia ADORMA 10 MG 10 mg film-coated tablet oral use Czech Republic Apotex Europe B.V. Darwinweg 20 NL 2333 CR Leiden Netherlands APO-ZOLPIDEM 10 MG 10 mg film-coated tablet oral use Czech Republic Generics [UK] Ltd. Station Close EN6 1TL Hertfordshire — Potters Bar United Kingdom ZOLPIDEM MYLAN 10 mg film-coated tablet oral use Czech Republic Krka, d.d., Novo mesto Šmarješka cesta 6 8501 Novo mesto Slovenia ZOLSANA 10 MG 10 mg film-coated tablet oral use Czech Republic MEDA Pharma s.r.o. Kodaňská 1441/46 110 00 Prague 10 Czech Republic EDLUAR 5 MG SUBLINGVÁLNÍ TABLETY 5 mg sublingual tablet sublingual use Czech Republic MEDA Pharma s.r.o. Kodaňská 1441/46 110 00 Prague 10 Czech Republic EDLUAR 10 MG SUBLINGVÁLNÍ TABLETY 10 mg sublingual tablet sublingual use Czech Republic Orion Corporation Orionintie 1/A FI-02200 Espoo Finland ZOLPIDEM ORION 10 MG 10 mg film-coated tablet oral use Czech Republic ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany ZOLPIDEM-RATIOPHARM 10 MG 10 mg film-coated tablet oral use Czech Republic SANDOZ s.r.o. U nákladového nádraží 3265/10 130 00 Prague 3 Czech Republic SANVAL 10 MG 10 mg film-coated tablet oral use Czech Republic sanofi-aventis, s.r.o. Evropská 846/176a 160 00 Prague 6 — Vokovice Czech Republic STILNOX 10 mg film-coated tablet oral use Czech Republic SVUS Pharma a.s., Smetanovo nábřeží 1238/20a 500 02 Hradec Králové Czech Republic ZOLPINOX 10 mg film-coated tablet oral use Czech Republic Takeda GmbH Byk-Gulden-Str. 2 78467 Konstanz Germany HYPNOGEN 10 mg film-coated tablet oral use Czech Republic Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland ZOLPIDEM VITABALANS 10 MG POTAHOVANÉ TABLETY 10 mg film-coated tablet oral use Denmark Actavis Group PTC ehf. Reykjavikurvegur 76-78 IS-220 Hafnarfjördur Iceland Zolpidem ‘Actavis’ 10 mg film-coated tablet oral use Denmark Actavis Group PTC ehf. Reykjavikurvegur 76-78 IS-220 Hafnarfjördur Iceland Zolpidem ‘Actavis’ 5 mg film-coated tablet oral use Denmark Generics [UK] Ltd. Station Close EN6 1TL Hertfordshire — Potters Bar United Kingdom Zolpidem ‘Generics’ 10 mg film-coated tablet oral use Denmark HEXAL A/S, Kanalholmen 8-12, DK-2650 Hvodovre, Denmark Zolpidem ‘Hexal’ 10 mg film-coated tablet oral use Denmark Meda AS, Solvang 8, DK-3450 Allerød, Denmark Edluar 5 mg sublingual tablet sublingual use Denmark Meda AS, Solvang 8, DK-3450 Allerød, Denmark Edluar 10 mg sublingual tablet sublingual use Denmark PharmaCoDane ApS, Marielundvej 46 A, DK-2730 Herlev, Denmark Zonoct 10 mg film-coated tablet oral use Denmark sanofi-aventis Denmark A/S, Slotsmarken 13, DK-2970 Hørsholm, Denmark Stilnoct 10 mg film-coated tablet oral use Denmark Synthon BV, Microweg 22, NL-6545 CM Nijmegen, The Netherlands Zolpidem ‘Genthon’ 5 mg film-coated tablet oral use Denmark Synthon BV, Microweg 22, NL-6545 CM Nijmegen, The Netherlands Zolpidem ‘Genthon’ 10 mg film-coated tablet oral use Denmark Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland Zolpidem ‘Vitabalans’ 10 mg film-coated tablet oral use Estonia Krka, d.d., Novo mesto Šmarješka cesta 6 8000 Novo mesto Slovenia ZOLSANA 5 mg tablet oral use Estonia Krka, d.d., Novo mesto Šmarješka cesta 6 8000 Novo mesto Slovenia ZOLSANA 10 mg tablet oral use Estonia Meda Pharma GmbH & Co. KG Benzstrasse 1 Bad Homburg v.d.H 61352 Germany EDLUAR 5 mg sublingual tablet oral use Estonia Meda Pharma GmbH & Co. KG Benzstrasse 1 Bad Homburg v.d.H 61352 Germany EDLUAR 10 mg sublingual tablet oral use Estonia Sandoz d.d. Verovškova 57, 1000 Ljubljana, Slovenia ZOLPIDEM SANDOZ 10 MG 10 mg tablet oral use Estonia Sanofi-Aventis Estonia OÜ Pärnu mnt 139E/2 11317 Tallinn Estonia STILNOX 10 mg tablet oral use Estonia Takeda GmbH 2 Byk-Gulden Strasse 78467 Konstanz Germany HYPNOGEN 10 mg tablet oral use Estonia Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland ZOLPIDEM VITABALANS 10 MG 10 mg tablet oral use Finland Actavis Group PTC ehf. Reykjavikurvegur 76-78 IS-220 Hafnarfjördur Iceland Stella 5 mg film-coated tablet oral use Finland Actavis Group PTC ehf. Reykjavikurvegur 76-78 IS-220 Hafnarfjördur Iceland Stella 10 mg film-coated tablet oral use Finland Hexal A/S Edvard Thomsens Vej 14 DK-2300 Köpenhamn S Denmark Zolpidem Hexal 10 mg film-coated tablet oral use Finland Meda Oy Vaisalantie 4 02130 Espoo Finland Edluar 5 mg sublingual tablet sublingual use Finland Meda Oy Vaisalantie 4 02130 Espoo Finland Edluar 10 mg sublingual tablet sublingual use Finland Orion Corporation Orionintie 1/A FI-02200 Espoo Finland Somnor 10 mg film-coated tablet oral use Finland ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany Zolpidem-Ratiopharm 10 mg film-coated tablet oral use Finland Sanofi Oy Huopalahdentie 24 P.O.Box 22 00350 Helsinki Finland Stilnoct 10 mg film-coated tablet oral use Finland Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland Zolpidem Vitabalans 10 mg film-coated tablet oral use France LABORATOIRES ALTER 3, avenue de la Baltique ZI de Courtaboeuf 91140 Villebon Sur Yvette France ZOLPIDEM ALTER 10 mg film-coated tablet oral use France Actavis Group PTC ehf. Reykjavikurvegur 76-78 IS-220 Hafnarfjördur Iceland ZOLPIDEM ACTAVIS 10 MG film-coated tablet oral use France ARROW GENERIQUES 26, avenue Tony Garnier 69007 Lyon France ZOLPIDEM ARROW 10 mg film-coated tablet oral use France BIOGARAN 15, boulevard Charles de Gaulle 92700 Colombes FRANCE ZOLPIDEM ALMUS 10 mg film-coated tablet oral use France BIOGARAN 15, boulevard Charles de Gaulle 92700 Colombes FRANCE ZOLPIDEM BIOGARAN 10 mg film-coated tablet oral use France CRISTERS 22 quai Gallieni 92150 Suresnes France ZOLPIDEM CRISTERS 10 mg film-coated tablet oral use France CTRS Route de la Ganne 36170 Saint Benoit du Sault France ZOLPIDEM CTRS 10 mg film-coated tablet oral use France EG LABO — LABORATOIRES EUROGENERICS ‘Le Quintet’ — bâtiment A 12, rue Danjou 92517 Boulogne Billancourt Cedex France ZOLPIDEM EG 10 mg film-coated tablet oral use France EG LABO — LABORATOIRES EUROGENERICS ‘Le Quintet’ — bâtiment A 12, rue Danjou 92517 Boulogne Billancourt Cedex France ZOLPIDEM EG 10 mg coated tablet oral use France Genfarma B.V. Postbus 2062 1500 GB Zaandam The Netherlands ZOLPIDEM RATIOPHARM 10 mg coated tablet oral use France Kiron Pharmaceutica BV Groesbeekseweg 11 Nijmegen, 6524 CK The Netherlands ZOLPIDEM KIRION 5 mg film-coated tablet oral use France MEDA PHARMA 25, boulevard de l'Amiral Bruix 75016 Paris FRANCE EDLUAR 5 mg sublingual tablet oral use France MEDA PHARMA 25, boulevard de l'Amiral Bruix 75016 Paris FRANCE EDLUAR 10 mg sublingual tablet oral use France MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France ZOLPIDEM MYLAN 10 mg film-coated tablet oral use France PHARMACHEMIE BV Swensweg 5 — Haarlem PO Box 552 2003 RN Haarlem PAYS-BAS The Netherlands ZOLPIDEM TEVA 10 mg coated tablet oral use France RANBAXY PHARMACIE GENERIQUES 11-15 Quai Dion Bouton 92800 Puteaux FRANCE ZOLPIDEM RPG 10 mg film-coated tablet oral use France RATIOPHARM GMBH Graf Arco Strasse 3 89079 Ulm ALLEMAGNE ZOLPIDEM RATIOPHARM 10 mg film-coated tablet oral use France SANDOZ 49, avenue Georges Pompidou 92300 Levallois-Perret France ZOLPIDEM GNR 10 mg film-coated tablet oral use France SANDOZ 49, avenue Georges Pompidou 92300 Levallois-Perret France ZOLPIDEM GENERES 10 mg film-coated tablet oral use France SANDOZ 49, avenue Georges Pompidou 92300 Levallois-Perret France ZOLPIDEM SANDOZ 10 mg film-coated tablet oral use France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris France STILNOX 10 mg film-coated tablet oral use France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris France ZOLPIDEM ZENTIVA 10 mg film-coated tablet oral use France Synthon BV, Microweg 22, NL-6545 CM Nijmegen, The Netherlands ZOLPIDEM BAYER 10 mg film-coated tablet oral use France Synthon BV, Microweg 22, NL-6545 CM Nijmegen, The Netherlands ZOLPIDEM BAYER 5 mg film-coated tablet oral use France TEVA SANTE 110, Esplanade du Général de Gaulle 92931 Paris La Défense Cedex FRANCE ZOLPIDEM TEVA 10 mg film-coated tablet oral use France ZYDUS FRANCE 25, rue des Peupliers ZAC Les Hautes Pâtures — Parc d’Activités des Peupliers 92000 Nanterre FRANCE ZOLPIDEM ZYDUS 10 mg film-coated tablet oral use Germany 1 A Pharma Keltenring 1 + 3 82041 Oberhaching Germany Zolpidem 10 — 1A-Pharma 10 mg film-coated tablet oral use Germany AbZ-Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Germany Zolpidem AbZ 10 mg Filmtabletten 10 mg film-coated tablet oral use Germany Actavis Deutschland GmbH & Co. KG Willy-Brandt-Allee 2 81829 München Germany Zolpidem-Actavis 10 mg Filmtabletten 10 mg film-coated tablet oral use Germany Aliud Pharma GmbH Gottlieb-Daimler-Str. 19 89150 Laichingen Germany Zolpidem AL 10 mg Filmtabletten 10 mg film-coated tablet oral use Germany Aliud Pharma GmbH Gottlieb-Daimler-Str. 19 89150 Laichingen Germany Zolpidem AL 5 mg Filmtabletten 5 mg film-coated tablet oral use Germany Aristo Pharma GmbH Wallenroder Str. 8-10 13435 Berlin Germany Zolpidem Aristo 10 mg Filmtabletten 10 mg film-coated tablet oral use Germany AbZ-Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Germany Zolpidem-CT 10 mg Filmtabletten 10 mg film-coated tablet oral use Germany AbZ-Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Germany Zolpidem-CT 5 mg Filmtabletten 5 mg film-coated tablet oral use Germany Dolorgiet GmbH & Co. KG Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany Zolpidem real 10 mg Filmtabletten 10 mg film-coated tablet oral use Germany Heumann Pharma GmbH & Co. Generica KG Südwestpark 50 90449 Nürnberg Germany Zolpidem Heumann 10 mg Filmtabletten 10 mg film-coated tablet oral use Germany Heumann Pharma GmbH & Co. Generica KG Südwestpark 50 90449 Nürnberg Germany Zolpidem Heumann 5 mg Filmtabletten 5 mg film-coated tablet oral use Germany Hexal Aktiengesellschaft Industriestr. 25 83607 Holzkirchen Germany Zolpidem Hexal 10 mg Filmtabletten 10 mg film-coated tablet oral use Germany IPCA — Produtos Farmacêuticos Unipessoal, Lda. Rua José Nogueira Vaz, Lote 104 — Lj Esq 2625-099 Povoa de Santa Iria Portugal Zolpidem IPCA 10 mg Filmtabletten 10 mg film-coated tablet oral use Germany IPCA — Produtos Farmacêuticos Unipessoal, Lda. Rua José Nogueira Vaz, Lote 104 — Lj Esq 2625-099 Povoa de Santa Iria Portugal Zolpidem IPCA 5 mg Filmtabletten 5 mg film-coated tablet oral use Germany Juta Pharma GmbH Gutenbergstr. 13 24941 Flensburg Germany Zolpi-Q 10 mg Filmtabletten 10 mg film-coated tablet oral use Germany Krewel Meuselbach GmbH Krewelstr. 2 53783 Eitorf Germany Zolpinox 10 mg 10 mg film-coated tablet oral use Germany Meda Pharma GmbH & Co. KG Benzstrasse 1 Bad Homburg v.d.H 61352 Germany Edluar 10 mg Sublingualtabletten 10 mg sublingual tablet oral use Germany Meda Pharma GmbH & Co. KG Benzstrasse 1 Bad Homburg v.d.H 61352 Germany Edluar 5 mg Sublingualtabletten 5 mg sublingual tablet oral use Germany Mylan dura GmbH Wittichstr. 6 64295 Darmstadt Germany Zolpidem dura 10 mg Filmtabletten 10 mg film-coated tablet oral use Germany neuraxpharm Arzneimittel GmbH Elisabeth-Selbert-Str. 23 40764 Langenfeld Germany Zolpidem-neuraxpharm 10 mg Filmtabletten 10 mg film-coated tablet oral use Germany neuraxpharm Arzneimittel GmbH Elisabeth-Selbert-Str. 23 40764 Langenfeld Germany Zolpidem-neuraxpharm 5 mg Filmtabletten 5 mg film-coated tablet oral use Germany ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany Zolpidem-ratiopharm 10 mg Filmtabletten 10 mg film-coated tablet oral use Germany ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany Zolpidem-ratiopharm 5 mg Filmtabletten 5 mg film-coated tablet oral use Germany Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 83607 Holzkirchen Germany Zolpidem Sandoz 10 mg Filmtabletten 10 mg film-coated tablet oral use Germany Sanofi-Aventis Deutschland GmbH Industriepark Höchst, Gebäude K703 65926 Frankfurt am Main Germany Bikalm 10 mg film-coated tablet oral use Germany Sanofi-Aventis Deutschland GmbH Industriepark Höchst, Gebäude K703 65926 Frankfurt am Main Germany Stilnox 10 mg film-coated tablet oral use Germany Stadapharm GmbH Stadastr. 2-18 61118 Bad Vilbel Germany Zolpidem STADA 10 mg Filmtabletten 10 mg film-coated tablet oral use Germany Stadapharm GmbH Stadastr. 2-18 61118 Bad Vilbel Germany Zolpidem STADA 5 mg Filmtabletten 5 mg film-coated tablet oral use Germany TAD Pharma GmbH Heinz-Lohmann-Str. 5 27472 Cuxhaven Germany Zolpidem TAD 10 mg 10 mg film-coated tablet oral use Germany Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland Zolpidem Vitabalans 10 mg Filmtabletten 10 mg film-coated tablet oral use Germany Winthrop Arzneimittel GmbH Brüningstr. 50 65926 Frankfurt am Main Germany Zolpi-Lich 10 mg Filmtabletten 10 mg film-coated tablet oral use Greece IOULIA AND IRENE TSETI PHARMACEUTICAL LABORATORIES ABEE, INTERMED ABEE, Kalyftaki 27, Kifissia 14564 Greece HYPNONORM 10 mg film-coated tablet oral use Greece ITF HELLAS S.A. Areos 103 and Ag. Triados 36, Palaio Faliro 17562 Greece ONIRIA 10 mg/ml oral drops, solution oral use Greece ITF PHARMA KERESKEDELMI ES SZOLGALTATO KFT, BUDAPEST, HUNGAR H-1056, Budapest Duna u.1 Hungary KALINICTA 10 mg/ml oral drops, solution oral use Greece SANOFI-AVENTIS AEBE 348 SYNGROU AVENUE, BUILDING A, KALLITHEA 17674 Greece STILNOX 10 mg film-coated tablet oral use Hungary EGIS Gyógyszergyár Nyrt. Keresztúri út 30-38. Budapest 1106 Hungary PIDEZOL 10 mg filmtabletta 10 mg film-coated tablet oral use Hungary ExtractumPharma zRt. Megyeri út 64. Budapest 1044 Hungary ZOLEP 10 mg filmtabletta 10 mg film-coated tablet oral use Hungary Generics (UK) Ltd. Albany Gate, Darkes Lane, Potters bar Herts EN61AG United Kingdom SOMNOGEN 10 mg filmtabletta 10 mg film-coated tablet oral use Hungary ITF Pharma Kft Duna u. 1. Budapest 1056 Hungary ONIRIA 10 mg/ml belsőleges oldatos cseppek 10 mg/ml oral drops, solution oral use Hungary Krka d.d. Novo Mesto Smarjeska cesta 6. Novo Mesto 8501 Slovenia ZOLSANA 5 mg filmtabletta 5 mg film-coated tablet oral use Hungary Krka d.d. Novo Mesto Smarjeska cesta 6. Novo Mesto 8501 Slovenia ZOLSANA 10 mg filmtabletta 10 mg film-coated tablet oral use Hungary LEK Pharmaceuticals d.d. Verovskova 57 Ljubljana Slovenia SANVAL 5 mg filmtabletta 5 mg film-coated tablet oral use Hungary LEK Pharmaceuticals d.d. Verovskova 57 Ljubljana Slovenia SANVAL 10 mg filmtabletta 10 mg film-coated tablet oral use Hungary Meda Pharma Hungary Kft Váci út 91. Budapest 1139 Hungary EDLUAR 5 mg nyelvalatti tabletta 5 mg sublingual tablet sublingual use Hungary Meda Pharma Hungary Kft Váci út 91. Budapest 1139 Hungary EDLUAR 10 mg nyelvalatti tabletta 10 mg sublingual tablet sublingual use Hungary Sanofi-Aventis Magyarország Zrt Tó u. 1-5 Budapest 1045 Hungary STILNOX 10 mg filmtabletta 10 mg film-coated tablet oral use Hungary Teva Magyarország Zrt Repülőtéri út 5. Gödöllő 2100 Hungary ZOLPIDEM-RATIOPHARM 10 mg filmtabletta 10 mg film-coated tablet oral use Hungary Vitabalans Oy Varastokatu 8. Hämeenlinna 13500 Finland ZOLPIDEM VITABALANS 10 mg filmtabletta 10 mg film-coated tablet oral use Hungary Vulm CZ a.s. Olivova 1888 Ricany 25101 Czech Republic INSOM 10 mg pezsgőtabletta 10 mg effervescent tablet oral use Hungary Zentiva k.s. Dolny Mecholupy, U kabelovny 130 Prague 10. 10237 Czech Republic HYPNOGEN 10 mg filmtabletta 10 mg film-coated tablet oral use Iceland LYFIS ehf., Grensásvegur 22, 108 Reykjavík, Iceland Zolpidem LYFIS 10 mg film-coated tablet oral use Iceland Meda AB, Pipers väg 2A, Box 906, SE-170 09, Sweden Edluar 5 mg sublingual tablet oral use Iceland Meda AB, Pipers väg 2A, Box 906, SE-170 09, Sweden Edluar 10 mg sublingual tablet oral use Iceland Mylan AB, Ynglingagatan 14, 10435 Stockholm, Sweden. Zolpidem Mylan 10 mg film-coated tablet oral use Iceland Sanofi Aventis Norge Strandveien 15, 1366 Lysaker, Norway Stilnoct 5 mg film-coated tablet oral use Iceland Sanofi Aventis Norge Strandveien 15, 1366 Lysaker, Norway Stilnoct 10 mg film-coated tablet oral use Ireland Clonmel Healthcare Ltd Waterford Road Clonmel Co. Tipperary Ireland Nytamel 5 mg Film-coated Tablets 5 mg film-coated tablet oral use Ireland Clonmel Healthcare Ltd Waterford Road Clonmel Co. Tipperary Ireland Nytamel 10 mg Film-coated Tablets. 10 mg film-coated tablet oral use Ireland McDermott Laboratories Ltd t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland Zoldem 10 mg film-coated tablets 10 mg film-coated tablet oral use Ireland Meda Health Sales Ireland Limited Unit 34/35 Block A Dunboyne Business Park Dunboyne Co Meath Ireland Edluar 5 mg sublingual tablets 5 mg sublingual tablet oral use Ireland Meda Health Sales Ireland Limited Unit 34/35 Block A Dunboyne Business Park Dunboyne Co Meath Ireland Edluar 10 mg sublingual tablets 10 mg sublingual tablet oral use Ireland Rowex Ltd, Bantry, Co. Cork, Ireland Zolnod 10 mg film-coated tablets 10 mg film-coated tablet oral use Ireland Sanofi-Aventis Ireland Limited T/A Sanofi, Citywest Business Campus, Dublin 24, Ireland Stilnoct 5 mg Film-coated Tablets 5 mg film-coated tablet oral use Ireland Sanofi-Aventis Ireland Limited T/A Sanofi, Citywest Business Campus, Dublin 24, Ireland Stilnoct 10 mg Film-coated Tablets 10 mg film-coated tablet oral use Ireland Teva Pharma B. V. Computerweg 10 3542 DR Utrecht The Netherlands Zolpidem Tartrate Teva 5 mg Film-coated Tablets 5 mg film-coated tablet oral use Ireland Teva Pharma B. V. Computerweg 10 3542 DR Utrecht The Netherlands Zolpidem Tartrate Teva 10 mg Film-coated Tablets 10 mg film-coated tablet oral use Italy Actavis Group PTC ehf. Reykjavikurvegur 76-78 IS-220 Hafnarfjördur Iceland ZOLPIDEM ACTAVIS 10 mg film-coated tablet oral use Italy Doc Generici S.r.l. Turati 40, Milano — 20121 Italy ZOLPIDEM DOC GENERICI 5 mg film-coated tablet oral use Italy Doc Generici S.r.l. Turati 40, Milano — 20121 Italy ZOLPIDEM DOC GENERICI 10 mg film-coated tablet oral use Italy EG S.p.a. Via Scarlatti, 31, Milano — 20124 Italy ZOLPIDEM EG 10 mg film-coated tablet oral use Italy FIDIA Farmaceutici S.p.a. Via Ponte della Fabbrica, 3/a, Abano Terme, Padova — 35031 Italy OPSYCON 10 mg film-coated tablet oral use Italy HEXAL S.p.a. Largo Umberto Boccioni 1 21040 Origgio Varese Italy ZOLPIDEM HEXAL 10 mg film-coated tablet oral use Italy IPCA — Produtos Farmacêuticos Unipessoal, Lda. Rua José Nogueira Vaz, Lote 104 — Lj Esq 2625-099 Povoa de Santa Iria Portugal ZOLPIDEM IPCA 5 mg film-coated tablet oral use Italy IPCA — Produtos Farmacêuticos Unipessoal, Lda. Rua José Nogueira Vaz, Lote 104 — Lj Esq 2625-099 Povoa de Santa Iria Portugal ZOLPIDEM IPCA 10 mg film-coated tablet oral use Italy ITALFARMACO S.p.A. Viale Fulvio Testi 330, 20126 Milano, Italy SONIREM 10 mg/ml oral drops, solution oral use Italy LIFEPHARMA S.P.A. Via dei Lavoratori 54, 20092 Cinisello Balsamo, Milano — Italy ZOLPREM 10 mg/ml oral drops, solution oral use Italy MEDA PHARMA S.P.A., Viale brenta 18, 20139 Milano — Italy ZOLPEDUAR 5 mg sublingual tablet oral use Italy MEDA PHARMA S.P.A., Viale brenta 18, 20139 Milano — Italy ZOLPEDUAR 10 mg sublingual tablet oral use Italy Ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany ZOLPIDEM RATIOPHARM 10 mg film-coated tablet oral use Italy Sandoz S.p.a. Largo Umberto Boccioni, 1, Origgio, Varese — 21040 Italy ZOLPIDEM SANDOZ 10 mg film-coated tablet oral use Italy Sanofi-aventis SpA, Viale Bodio 37/b, 20158 Milano Italy STILNOX 10 mg film-coated tablet oral use Italy Sanofi-aventis SpA, Viale Bodio 37/b, 20158 Milano Italy NOTTEM 10 mg film-coated tablet oral use Italy Teva Italia S.r.l. — via Messina 38 — 20154 Milano Italy ZOLPIDEM TEVA 10 mg film-coated tablet oral use Italy ZENTIVA ITALIA S.R.L. — Viale Bodio 37/b, 20158 Milano Italy ZOLPIDEM ZENTIVA 10 mg film-coated tablet oral use Latvia Krka, d.d., Novo mesto Šmarješka cesta 6 8000 Novo mesto Slovenia Zolsana 5 mg coated tablets 5 mg coated tablet oral use Latvia Krka, d.d., Novo mesto Šmarješka cesta 6 8000 Novo mesto Slovenia Zolsana 10 mg coated tablets 10 mg coated tablet oral use Latvia Meda Pharma GmbH & Co. KG Benzstrasse 1 Bad Homburg v.d.H 61352 Germany Edluar 5 mg sublingual tablets 5 mg sublingual tablet sublingual use Latvia Meda Pharma GmbH & Co. KG Benzstrasse 1 Bad Homburg v.d.H 61352 Germany Edluar 10 mg sublingual tablets 10 mg sublingual tablet sublingual use Latvia Sandoz d.d. Verovškova 57, 1000 Ljubljana, Slovenia Zolpidem Sandoz 10 mg film-coated tablets 10 mg film-coated tablet oral use Latvia sanofi-aventis Latvia SIA, Kr.Valdemara 33-8 Riga, LV 1010, Latvia Stilnox 10 mg film-coated tablets 10 mg film-coated tablet oral use Latvia Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland Zolpidem Vitabalans 10 mg film-coated tablets 10 mg film-coated tablet oral use Latvia Zentiva, k.s. U kabelovny 130 Prague 10, Dolni Mecholupy 10237 Czech Republic Hypnogen 10 mg film-coated tablets 10 mg film-coated tablet oral use Lithuania Krka, d.d., Novo mesto Šmarješka cesta 6 8000 Novo mesto Slovenia Zolsana 10 mg film-coated tablet oral use Lithuania Krka, d.d., Novo mesto Šmarješka cesta 6 8000 Novo mesto Slovenia Zolsana 5 mg film-coated tablet oral use Lithuania Sandoz d.d. Verovškova 57, 1000 Ljubljana, Slovenia Zolpidem Sandoz 10 mg film-coated tablet oral use Lithuania UAB ‘SANOFI-AVENTIS LIETUVA’ A. Juozapavičiaus 6/2 g. LT-09310 Vilnius Lithuania Stilnox 10 mg film-coated tablet oral use Lithuania Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland Zolpidem Vitabalans 10 mg film-coated tablet oral use Lithuania Zentiva, k.s. U kabelovny 130 Prague 10, Dolni Mecholupy 10237 Czech Republic HYPNOGEN 10 mg film-coated tablet oral use Luxembourg MYLAN BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart Belgium Dodorest 10 mg coated tablet oral use Luxembourg SANOFI BELGIUM Airport Plaza, Montreal Building, Leonardo Da Vincilaan 19 1831 Diegem Belgium Stilnoct 10 mg coated tablet oral use Luxembourg Eurogenerics S.A. Esplanade Heysel, b22 1020 Bruxelles Belgium Zolpidem EG cpr.eff. 10 mg effervescent tablet oral use Luxembourg Eurogenerics S.A. Esplanade Heysel, b22 1020 Bruxelles Belgium Zolpidem EG cpr.pellic. 10 mg coated tablet oral use Luxembourg Genthon BV Microweg, 22 6545 Nijmegen The Netherlands Zolpidem Genthion 10 mg coated tablet oral use Luxembourg Genthon BV Microweg, 22 6545 Nijmegen The Netherlands Zolpidem Genthion 5 mg coated tablet oral use Luxembourg Apotex Europe B.V. Darwinweg 20 NL 2333 CR Leiden The Netherlands Zolpitop 10 mg coated tablet oral use Luxembourg Apotex Europe B.V. Darwinweg 20 NL 2333 CR Leiden The Netherlands Zolpitop 5 mg coated tablet oral use Luxembourg MEDA PHARMA Chaussee de la Hulpe 166 1170 Watermael-Boitsfort Belgium Zolpeduar 10 mg sublingual tablet sublingual use Luxembourg MEDA PHARMA Chaussee de la Hulpe 166 1170 Watermael-Boitsfort Belgium Zolpeduar 5 mg sublingual tablet sublingual use Malta Sanofi Malta Ltd. St. Julian’s Rd. San Gwann SGN 2805 Malta Stilnox 10 mg film-coated tablet oral use Malta Pharma MT 103, Stuart Street, Gzira, Malta Nytamel 10 mg film-coated tablet oral use Norway Sanofi Aventis Norge Strandveien 15, 1366 Lysaker, Norway Stilnoct 5 mg film-coated tablet oral use Norway Sanofi Aventis Norge Strandveien 15, 1366 Lysaker, Norway Stilnoct 10 mg film-coated tablet oral use Norway Actavis Norway AS, P.O.BOX 409, 0213 Skoyen, OSLO, Norway Zolpidem Actavis 5 mg film-coated tablet oral use Norway Actavis Norway AS, P.O.BOX 409, 0213 Skoyen, OSLO, Norway Zolpidem Actavis 10 mg film-coated tablet oral use Norway Meda Norge, P.O.BOX 194, 1371 ASKER, Norway Edluar 5 mg sublingual tablet oral use Norway Meda Norge, P.O.BOX 194, 1371 ASKER, Norway Edluar 10 mg sublingual tablet oral use Norway Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland Zolpidem Vitabalans 10 mg film-coated tablet oral use Poland Actavis Group PTC ehf. Reykjavikurvegur 76-78 IS-220 Hafnarfjördur Iceland Noxizol 10 mg film-coated tablet oral use Poland Apotex Europe B.V. Darwinweg 20 NL 2333 CR Leiden The Netherlands Apo-Zolpin 10 mg film-coated tablet oral use Poland Farma-Projekt Sp. z o.o. ul. Józefińska 2 30-529 Kraków Poland Xentic 10 mg film-coated tablet oral use Poland Generics [UK] Ltd. Station Close EN6 1TL Hertfordshire — Potters Bar United Kingdom ZolpiGen 10 mg film-coated tablet oral use Poland Ipca, Produtos Farmaceuticos, Unipessoal Lda Rua Chanceler-Mor 11 R/c Frt. Cacem 2735-615 Portugal Zolpidem IPCA 5 mg film-coated tablet oral use Poland Ipca, Produtos Farmaceuticos, Unipessoal Lda Rua Chanceler-Mor 11 R/c Frt. Cacem 2735-615 Portugal Zolpidem IPCA 10 mg film-coated tablet oral use Poland Italfarmaco S.p.A. Viale Fulvio 330 20126 Milano Italy Sonirem 10 mg/ml oral drops, solution oral use Poland Krka, d.d., Novo mesto Šmarješka cesta 6 8000 Novo mesto Slovenia Zolsana 10 mg film-coated tablet oral use Poland Meda Pharma GmbH & Co. KG Benzstrasse 1 Bad Homburg v.d.H 61352 Germany Edluar 5 mg sublingual tablet oral use Poland Meda Pharma GmbH & Co. KG Benzstrasse 1 Bad Homburg v.d.H 61352 Germany Edluar 10 mg sublingual tablet oral use Poland Orion Corporation Orionintie 1/A FI-02200 Espoo Finland Onirex 10 mg film-coated tablet oral use Poland Pabianickie Zakłady Farmaceutyczne Polfa S.A. ul. Marszałka J. Piłsudskiego 5 95-200 Pabianice Poland Polsen 10 mg film-coated tablet oral use Poland Pfizer Europe MA EEIG Ramsgate Road Kent, Sandwich CT13 9 NJ United Kingdom Zolpidem Pfizer 10 mg film-coated tablet oral use Poland Polfarmex S.A. Józefów 9 99-300 Kutno Poland Nasen 10 mg film-coated tablet oral use Poland Sandoz GmbH ul. Biochemiestrasse 10 Kundli 6250 Austria Sanval 10 mg film-coated tablet oral use Poland Sanofi-Aventis France 1-13 boulevard Romain Rolland 75014 Paris France Stilnox 10 mg film-coated tablet oral use Poland Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland Zolpidem Vitabalans 10 mg film-coated tablet oral use Poland VULM CZ, a.s. Olivova 1888 Ricany 251 01 Czech Republic Insom 10 mg effervescent tablet oral use Poland Zakłady Farmaceutyczne POLPHARMA S.A. Pelplińska 19 83-200 Starogard Gdański Poland Zolpic 10 mg film-coated tablet oral use Poland Zentiva, k.s. U kabelovny 130 Prague 10, Dolni Mecholupy 10237 Czech Republic Hypnogen 10 mg film-coated tablet oral use Portugal Actavis A/S Sucursal Rua Virgílio Correia, 11 — A 1600-219 Lisboa Portugal Zolpidem Actavis 10 mg film-coated tablet oral use Portugal Aurobindo Pharma (Portugal), Unipessoal Lda. Av. do Forte, no 3 — Parque Suécia, Edifício. IV, 2o 2794-038 Carnaxide Portugal Zolpidem Aurobindo 5 mg film-coated tablet oral use Portugal Aurobindo Pharma (Portugal), Unipessoal Lda. Av. do Forte, no 3 — Parque Suécia, Edifício. IV, 2o 2794-038 Carnaxide Portugal Zolpidem Aurobindo 10 mg film-coated tablet oral use Portugal Cinfa Portugal, Lda. Av. Tomás Ribeiro, 43 — Bloco 2, 3o F — Edifício Neopark 2790-221 Carnaxide Portugal Zolpidem Cinfa 10 mg Comprimidos 10 mg film-coated tablet oral use Portugal Generis Farmacêutica, S.A. Rua João de Deus, 19 2700-487 Amadora Portugal Zolpidem Generis 5 mg Comprimidos Revestidos 5 mg film-coated tablet oral use Portugal Generis Farmacêutica, S.A. Rua João de Deus, 19 2700-487 Amadora Portugal Zolpidem Generis 10 mg Comprimidos Revestidos 10 mg film-coated tablet oral use Portugal Genthon GmbH Groesbeeker Weg, 1 D-47559 Kranenburg Germany Zolpidem 5 mg Comprimidos Revestidos 5 mg film-coated tablet oral use Portugal IPCA — Produtos Farmacêuticos Unipessoal, Lda. Rua José Nogueira Vaz, Lote 104 — Lj Esq 2625-099 Povoa de Santa Iria Portugal Zolpidem IPCA 5 mg film-coated tablet oral use Portugal IPCA — Produtos Farmacêuticos Unipessoal, Lda. Rua José Nogueira Vaz, Lote 104 — Lj Esq 2625-099 Povoa de Santa Iria Portugal Zolpidem IPCA 10 mg film-coated tablet oral use Portugal Labesfal Genéricos, S.A Avenida Dr. Afonso Costa, 1370 3465-051 Campo de Besteiros Portugal Zolpidem Labesfal 10 mg film-coated tablet oral use Portugal Laboratórios Azevedos — Indústria Farmacêutica, S.A. Edifícios Azevedos — Estrada Nacional 117-2, Alfragide 2614-504 Amadora Portugal Cymerion 10 mg film-coated tablet oral use Portugal Meda Pharma — Produtos Farmacêuticos, S.A. Rua do Centro Cultural, 13 1749-066 Lisboa Portugal Edluar 5 mg sublingual tablet sublingual use Portugal Meda Pharma — Produtos Farmacêuticos, S.A. Rua do Centro Cultural, 13 1749-066 Lisboa Portugal Edluar 10 mg sublingual tablet sublingual use Portugal Mylan, Lda. Parque Expo, Edifício Atlantis, Avenida D. João II, Lote 1.06.2.2 C — 7.3 e 7.4 1990-095 Lisboa Portugal Zolpidem Mylan 10 mg film-coated tablet oral use Portugal Ratiopharm — Comércio e Indústria de Produtos Farmacêuticos, Lda. Lagoas Park, Edifício 5 A, Piso 2 2740-245 Porto Salvo Portugal Zolpidem Ratiopharm 10 mg Comprimidos Revestidos 10 mg film-coated tablet oral use Portugal Sandoz Farmacêutica, Lda. Alameda da Beloura, Edifício 1, 2o — Escritório 15 2710-693 Sintra Portugal Zolpidem Sandoz 10 mg film-coated tablet oral use Portugal Sanofi — Produtos Farmacêuticos, Lda. Empreendimento Lagoas Park Edifício 7, 3o Piso 2740-244 Porto Salvo Portugal Stilnox 10 mg film-coated tablet oral use Portugal Wynn Industrial Pharma, S.A. Rua Tierno Galvan, Torre 3, 16o Piso, Amoreiras 1070-274 Lisboa Portugal Zolpidem Wynn 10 mg film-coated tablet oral use Romania ALKALOID-INT d.o.o. Šlandrova ulica 4 1231 Ljubljana-Črnuče Slovenia ZADOBRA 5 mg 5 mg film-coated tablet oral use Romania ALKALOID-INT d.o.o. Šlandrova ulica 4 1231 Ljubljana-Črnuče Slovenia ZADOBRA 10 mg 10 mg film-coated tablet oral use Romania ITALFARMACO S.p.A. Viale Fulvio Testi 330, 20126 Milano, Italia ONIRIA 10 mg/ml 10 mg/ml oral drops, solution oral use Romania Krka, d.d., Novo mesto Šmarješka cesta 6 8000 Novo mesto Slovenia ZOLSANA 5 mg 5 mg film-coated tablet oral use Romania Krka, d.d., Novo mesto Šmarješka cesta 6 8000 Novo mesto Slovenia ZOLSANA 10 mg 10 mg film-coated tablet oral use Romania LABORMED PHARMA S.A. B-dul Theodor Pallady nr. 44B Sector 3, Bucureşti, România ZOLPIDEM 10 mg 10 mg film-coated tablet oral use Romania LEK farmacevtska družba d.d. Verovškova 57 1526 Ljubljana Slovenia SANVAL 10 mg 10 mg film-coated tablet oral use Romania Meda Pharma GmbH & Co. KG Benzstrasse 1 Bad Homburg v.d.H 61352 Germany EDLUAR 5 mg 5 mg sublingual tablet oral use Romania Meda Pharma GmbH & Co. KG Benzstrasse 1 Bad Homburg v.d.H 61352 Germany EDLUAR 10 mg 10 mg sublingual tablet oral use Romania S.C. ANTIBIOTICE S.A., Str. Valea Lupului nr.1, Iaşi, România ZOLPIDEM ATB 10 mg 10 mg film-coated tablet oral use Romania SANOFI-AVENTIS ROMÂNIA S.R.L. Str. Izvor, Nr. 80, Et. 6-11 Sector 5, Bucureşti, România STILNOX 10 mg 10 mg film-coated tablet oral use Slovak Republic ALKALOID-INT d.o.o. Šlandrova ulica 4 1231 Ljubljana-Črnuče Slovenia ADORMA 5 mg filmom obalené tablety 5 mg film-coated tablet oral use Slovak Republic ALKALOID-INT d.o.o. Šlandrova ulica 4 1231 Ljubljana-Črnuče Slovenia ADORMA 10 mg filmom obalené tablety 10 mg film-coated tablet oral use Slovak Republic Generics [UK] Ltd. Station Close EN6 1TL Hertfordshire — Potters Bar United Kingdom Zolpidem Mylan 10 mg 10 mg film-coated tablet oral use Slovak Republic Orion Corporation Orionintie 1/A FI-02200 Espoo Finland Zolpidem Orion 10 mg 10 mg film-coated tablet oral use Slovak Republic Sandoz d.d. Verovškova 57, 1000 Ljubljana, Slovenia SANVAL 5 mg 5 mg film-coated tablet oral use Slovak Republic Sandoz d.d. Verovškova 57, 1000 Ljubljana, Slovenia SANVAL 10 mg 10 mg film-coated tablet oral use Slovak Republic sanofi-aventis Slovakia s.r.o. Einsteinova 24 85101 Bratislava Slovak Republic STILNOX 10 mg film-coated tablet oral use Slovak Republic SVUS Pharma a.s., Smetanovo nábřeží 1238/20a 500 02 Hradec Králové Czech Republic ZOLPINOX 10 mg film-coated tablet oral use Slovak Republic Takeda GmbH 2 Byk-Gulden Strasse 78467 Konstanz Germany HYPNOGEN 10 mg film-coated tablet oral use Slovak Republic Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland Zolpidem Vitabalans 10 mg filmom obalené tablety 10 mg film-coated tablet oral use Slovenia ALKALOID-INT d.o.o. Šlandrova ulica 4 1231 Ljubljana-Črnuče Slovenia Perluna 10 mg filmsko obožene tablete 10 mg film-coated tablet oral use Slovenia ALKALOID-INT d.o.o. Šlandrova ulica 4 1231 Ljubljana-Črnuče Slovenia Perluna 5 mg filmsko obožene tablete 5 mg film-coated tablet oral use Slovenia Krka, d.d., Novo mesto Šmarješka cesta 6 8000 Novo mesto Slovenia Zolsana 10 mg filmsko obložene tablete 10 mg film-coated tablet oral use Slovenia Krka, d.d., Novo mesto Šmarješka cesta 6 8000 Novo mesto Slovenia Zolsana 5 mg filmsko obložene tablete 5 mg film-coated tablet oral use Slovenia LEK farmacevtska družba d.d. Verovškova 57 1526 Ljubljana Slovenia Sanval 10 mg filmsko obožene tablete 10 mg film-coated tablet oral use Slovenia LEK farmacevtska družba d.d. Verovškova 57 1526 Ljubljana Slovenia Sanval 5 mg filmsko obložene tablete 5 mg film-coated tablet oral use Slovenia Meda Pharma GmbH & Co. KG Benzstrasse 1 Bad Homburg v.d.H 61352 Germany Edluar 10 mg podjezične tablete 10 mg sublingual tablet sublingual use Slovenia Meda Pharma GmbH & Co. KG Benzstrasse 1 Bad Homburg v.d.H 61352 Germany Edluar 5 mg podjezične tablete 5 mg sublingual tablet sublingual use Slovenia Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland Zolpidem Vitabalans 10 mg filmsko obložene tablete 10 mg film-coated tablet oral use Spain ANGELINI FARMACEUTICA, S.A. Osi, 7-9 Barcelona. 08034. SPAIN DALPARAN 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA 10 mg film-coated tablet oral use Spain Apotex Europe B.V. Darwinweg 20 NL 2333 CR Leiden The Netherlands ZOLPIDEM APOTEX 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG 10 mg film-coated tablet oral use Spain BEXAL FARMACEUTICA, S.A Centro Empresarial Osa Mayor. Avda. Osa Mayor, 4 — Area B, Aravaca (Madrid). 28023. SPAIN ZOLPIDEM BEXALABS 10 mg COMPRIMIDOS CON CUBIERTOS CON PELICULA EFG 10 mg film-coated tablet oral use Spain BEXAL FARMACEUTICA, S.A Centro Empresarial Osa Mayor. Avda. Osa Mayor, 4 — Area B, Aravaca (Madrid). 28023. SPAIN ZOLPIDEM BEXAL 10 mg COMPRIMIDOS RECUBIERTOS EFG 10 mg film-coated tablet oral use Spain FARMALIDER, S.A. Aragoneses, 2, Alcobendas (Madrid). 28108. SPAIN ZOLPIDEM FARMALIDER 10 mg COMPRIMIDOS RECUBIERTOS EFG 10 mg film-coated tablet oral use Spain GENERFARMA, S.L. Ronda Isaac Peral, 6 Parque Tecnológico 46980 Paterna (Valencia) SPAIN ZOLPIDEM DESGEN 5 mg COMPRIMIDOS EFG 5 mg tablet oral use Spain GENERFARMA, S.L. Ronda Isaac Peral, 6 Parque Tecnológico 46980 Paterna (Valencia) SPAIN ZOLPIDEM DESGEN 10 mg COMPRIMIDOS EFG 10 mg tablet oral use Spain GERMED FARMACEUTICA S.L. Chile, 8 — 2a planta. Oficina 203, Las Matas (Madrid). 28290. SPAIN ZOLPIDEM EDIGEN 10 mg COMPRIMIDOS RECUBIERTOS EFG 10 mg film-coated tablet oral use Spain LABORATORIO STADA, S.L. Frederic Mompou, 5 , Sant Just Desvern (Barcelona). 08960 SPAIN ZOLPIDEM STADA 10 mg COMPRIMIDOS RECUBIERTOS EFG 10 mg film-coated tablet oral use Spain LABORATORIOS CINFA, S.A. Olaz-Chipi, 10. Poligono Industrial Areta .Huarte-Pamplona (Navarra) 31620 SPAIN ZOLPIDEM CINFA 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG 10 mg film-coated tablet oral use Spain LABORATORIOS NORMON, S.A. Ronda de Valdecarrizo, 6, Tres Cantos (Madrid). 28760. SPAIN ZOLPIDEM NORMON 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG 10 mg film-coated tablet oral use Spain MEDA PHARMA S.A.U Avda. de Castilla, 2. Edif. Berlin. 2a planta. Parque Empresarial San Fernando, San Fernando de Henares (Madrid).28830. SPAIN EDLUAR 10 MG COMPRIMIDOS SUBLINGUALES 10 mg sublingual tablet oral use Spain MEDA PHARMA S.A.U Avda. de Castilla, 2. Edif. Berlin. 2a planta. Parque Empresarial San Fernando, San Fernando de Henares (Madrid).28830. SPAIN EDLUAR 5 MG COMPRIMIDOS SUBLINGUALES 5 mg sublingual tablet oral use Spain MYLAN PHARMACEUTICALS, S.L. Plom 2-4, 5o Planta, Barcelona. 08038. SPAIN ZOLPIDEM MYLAN 10 mg COMPRIMIDOS RECUBIERTOS EFG 10 mg film-coated tablet oral use Spain PHARMAGENUS, S.A. Avda. Camí Real, 51-57 Palau-solita i Plegamans (Barcelona). 08184. SPAIN ZOLPIDEM PHARMAGENUS 5 mg COMPRIMIDOS 5 mg tablet oral use Spain PHARMAGENUS, S.A. Avda. Camí Real, 51-57 Palau-solita i Plegamans (Barcelona). 08184. SPAIN ZOLPIDEM PHARMAGENUS 10 mg COMPRIMIDOS EFG 10 mg tablet oral use Spain RATIOPHARM ESPAÑA, S.A. C/Anabel Segura 11, Edificio Albatros B 1a Planta, Alcobendas, Madrid. 28108. SPAIN ZOLPIDEM RATIOPHARM 10 mg COMPRIMIDOS RECUBIERTOS EFG 10 mg film-coated tablet oral use Spain RATIOPHARM ESPAÑA, S.A. C/Anabel Segura 11, Edificio Albatros B 1a Planta, Alcobendas, Madrid. 28108. SPAIN ZOLPIDEM TEVAGEN 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG 10 mg film-coated tablet oral use Spain RATIOPHARM ESPAÑA, S.A. C/Anabel Segura 11, Edificio Albatros B 1a Planta, Alcobendas, Madrid. 28108. SPAIN ZOLPIDEM TEVAGEN 5 mg COMPRIMIDOS RECUBIERTOS CON PELICULA 5 mg film-coated tablet oral use Spain SANDOZ FARMACÉUTICA, S.A. Avda. Osa Mayor, 4 28023 Aravaca (Madrid) Spain ZOLPIDEM SANDOZ 10 mg COMPRIMIDOS EFG 10 mg tablet oral use Spain SANOFI AVENTIS, S.A. Josep Plá, 2, Barcelona. 08019 SPAIN STILNOX 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA 10 mg film-coated tablet oral use Spain TEVA GENERICOS ESPAÑOLA S.L.U. C/Anabel Segura, 11 Edificio Albatros B, 1 planta Alcobendas (Madrid). 28108. SPAIN ZOLPIDEM TEVA 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG 10 mg film-coated tablet oral use Spain Zentiva, k.s. U kabelovny 130 Prague 10, Dolni Mecholupy 10237 Czech Republic ZOLPIDEM ZENTIVA 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG 10 mg film-coated tablet oral use Sweden Actavis Group PTC ehf. Reykjavikurvegur 76-78 IS-220 Hafnarfjördur Iceland Zolpidem Actavis 5 mg film-coated tablet oral use Sweden Actavis Group PTC ehf. Reykjavikurvegur 76-78 IS-220 Hafnarfjördur Iceland Zolpidem Actavis 10 mg film-coated tablet oral use Sweden Hexal A/S Edvard Thomsens Vej 14 DK-2300 Köpenhamn S Denmark Zolpidem HEXAL 10 mg film-coated tablet oral use Sweden Ranbaxy (UK) Ltd, Building 4 Chiswick Park London W4 5YE United Kingdom Zolpidem Ranbaxy 5 mg film-coated tablet oral use Sweden Ranbaxy (UK) Ltd, Building 4 Chiswick Park London W4 5YE United Kingdom Zolpidem Ranbaxy 10 mg film-coated tablet oral use Sweden Meda AB, Pipers väg 2A, Box 906, SE-170 09, Sweden Edluar 5 mg sublingual tablet oral use Sweden Meda AB, Pipers väg 2A, Box 906, SE-170 09, Sweden Edluar 10 mg sublingual tablet oral use Sweden Mylan AB Box 23033 104 35 Stockholm Sweden Zolpidem Mylan 10 mg film-coated tablet oral use Sweden Orifarm Generics A/S Energivej 15 POB 69 DK-5260 Odense S Denmark Zolpidem Orifarm 5 mg film-coated tablet oral use Sweden Orifarm Generics A/S Energivej 15 POB 69 DK-5260 Odense S Denmark Zolpidem Orifarm 10 mg film-coated tablet oral use Sweden ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany Zolpidem ratiopharm 5 mg film-coated tablet oral use Sweden ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany Zolpidem ratiopharm 10 mg film-coated tablet oral use Sweden Sandoz A/S Edvard Thomsens Vej 14 DK-2300 Köpenhamn S Denmark Zolpidem Sandoz 5 mg film-coated tablet oral use Sweden Sandoz A/S Edvard Thomsens Vej 14 DK-2300 Köpenhamn S Denmark Zolpidem Sandoz 10 mg film-coated tablet oral use Sweden sanofi-aventis AB Box 14142 167 14 Bromma Sweden Stilnoct 5 mg film-coated tablet oral use Sweden sanofi-aventis AB Box 14142 167 14 Bromma Sweden Stilnoct 10 mg film-coated tablet oral use Sweden STADA Arzneimittel AG Stadastrasse 2-18 DE-61118 Bad Vilbel Germany Zolpidem STADA 5 mg film-coated tablet oral use Sweden STADA Arzneimittel AG Stadastrasse 2-18 DE-61118 Bad Vilbel Germany Zolpidem STADA 10 mg film-coated tablet oral use Sweden Synthon BV, Microweg 22, NL-6545 CM Nijmegen, The Netherlands Zolpidem Genthon 5 mg film-coated tablet oral use Sweden Synthon BV, Microweg 22, NL-6545 CM Nijmegen, The Netherlands Zolpidem Genthon 10 mg film-coated tablet oral use Sweden Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland Zolpidem Vitabalans 10 mg film-coated tablet oral use The Netherlands Actavis B.V. Baarnsche Dijk 1 3741 LN BAARN The Netherlands Zolpidemtartaat Actavis 5 mg, tabletten 5 mg tablet oral use The Netherlands Actavis B.V. Baarnsche Dijk 1 3741 LN BAARN The Netherlands Zolpidemtartraat Actavis 10 mg, tabletten 10 mg tablet oral use The Netherlands ADOH B.V. Godfried Bomansstraat 31 6543 JA NIJMEGEN The Netherlands Zolpidemtartraat ADOH bruistabletten 10 mg, bruistabletten 10 mg effervescent tablet oral use The Netherlands Pharmachemie B.V. Swensweg 5 2031 GA HAARLEM The Netherlands Zolpidemtartraat 5 mg PCH, filmomhulde tabletten 5 mg film-coated tablet oral use The Netherlands Pharmachemie B.V. Swensweg 5 2031 GA HAARLEM The Netherlands Zolpidemtartraat 10 mg PCH, filmomhulde tabletten 10 mg film-coated tablet oral use The Netherlands ratiopharm Nederland B.V. Swensweg 5 2031 GA HAARLEM The Netherlands Zolpidemtartraat ratiopharm 5 mg, tabletten 5 mg tablet oral use The Netherlands ratiopharm Nederland B.V. Swensweg 5 2031 GA HAARLEM The Netherlands Zolpidemtartraat ratiopharm 10 mg, tabletten 10 mg tablet oral use The Netherlands ratiopharm Nederland B.V. Swensweg 5 2031 GA HAARLEM The Netherlands Zolpidemtartraat ratiopharm 5 mg, filmomhulde tabletten 5 mg film-coated tablet oral use The Netherlands ratiopharm Nederland B.V. Swensweg 5 2031 GA HAARLEM The Netherlands Zolpidemtartraat ratiopharm 10 mg, filmomhulde tabletten 10 mg film-coated tablet oral use The Netherlands ratiopharm Nederland B.V. Swensweg 5 2031 GA HAARLEM The Netherlands Zolpidemtartraat ratiopharm 10 mg, filmomhulde tabletten 10 mg film-coated tablet oral use The Netherlands Sandoz B.V. Veluwezoom 22 1327 AH ALMERE The Netherlands Zolpidemtartraat Sandoz 10 mg, filmomhulde tabletten 10 mg film-coated tablet oral use The Netherlands Sandoz B.V. Veluwezoom 22 1327 AH ALMERE The Netherlands Zolpidemtartraat Sandoz 5, filmomhulde tabletten 5 mg 5 mg film-coated tablet oral use The Netherlands Sandoz B.V. Veluwezoom 22 1327 AH ALMERE The Netherlands Zolpidemtartraat Sandoz 10, filmomhulde tabletten 10 mg 10 mg film-coated tablet oral use The Netherlands Synthon B.V. Microweg 22 6545 CM NIJMEGEN The Netherlands Zolpidemtartraat 5 mg, filmomhulde tabletten 5 mg film-coated tablet oral use The Netherlands Synthon B.V. Microweg 22 6545 CM NIJMEGEN The Netherlands Zolpidemtartraat 10 mg, filmomhulde tabletten 10 mg film-coated tablet oral use The Netherlands Synthon B.V. Microweg 22 6545 CM NIJMEGEN The Netherlands Zolpidemtartraat 5 mg, filmomhulde tabletten 5 mg film-coated tablet oral use The Netherlands Synthon B.V. Microweg 22 6545 CM NIJMEGEN The Netherlands Zolpidemtartraat 10 mg, filmomhulde tabletten 10 mg film-coated tablet oral use The Netherlands Synthon B.V. Microweg 22 6545 CM NIJMEGEN The Netherlands Zolpidemtartraat 5 mg, filmomhulde tabletten 5 mg film-coated tablet oral use The Netherlands Synthon B.V. Microweg 22 6545 CM NIJMEGEN The Netherlands Zolpidemtartraat 10 mg, filmomhulde tabletten 10 mg film-coated tablet oral use The Netherlands ADOH B.V. Godfried Bomansstraat 31 6543 JA NIJMEGEN The Netherlands Zolpidemtartraat ADOH 10 mg, bruistabletten 10 mg effervescent tablet oral use The Netherlands Apotex Europe B.V. Darwinweg 20 NL 2333 CR Leiden The Netherlands Zolpidemtartraat Apotex 5 mg, filmomhulde tabletten 5 mg film-coated tablet oral use The Netherlands Apotex Europe B.V. Darwinweg 20 NL 2333 CR Leiden The Netherlands Zolpidemtartraat Apotex 10 mg, filmomhulde tabletten 10 mg film-coated tablet oral use The Netherlands Centrafarm B.V. Nieuwe Donk 3 4879 AC ETTEN LEUR The Netherlands Zolpidemtartraat CF 5 mg, film-omhulde tabletten 5 mg film-coated tablet oral use The Netherlands Centrafarm B.V. Nieuwe Donk 3 4879 AC ETTEN LEUR The Netherlands Zolpidemtartraat CF 10 mg, film-omhulde tabletten 10 mg film-coated tablet oral use The Netherlands Eurogenerics S.A. Esplanade Heysel, b22 1020 Bruxelles Belgium Zolpidem Eurogenerics bruis 10 mg bruistabletten, bruistabletten 10 mg effervescent tablet oral use The Netherlands FIDIA Farmaceutici S.p.a. Via Ponte della Fabbrica, 3/a, Abano Terme, Padova — 35031 Italy Zolpidemtartraat 10 mg, filmomhulde tabletten 10 mg film-coated tablet oral use The Netherlands Genthon BV Microweg, 22 6545 Nijmegen The Netherlands Zolpidemtartraat 5 mg, filmomhulde tabletten 5 mg film-coated tablet oral use The Netherlands Genthon BV Microweg, 22 6545 Nijmegen The Netherlands Zolpidemtartraat 10 mg, filmomhulde tabletten 10 mg film-coated tablet oral use The Netherlands Meda Pharma B.V. Krijgsman 20 1186 DM AMSTELVEEN The Netherlands Edluar 5 mg, tablet voor sublinguaal gebruik 5 mg sublingual tablet sublingual use The Netherlands Meda Pharma B.V. Krijgsman 20 1186 DM AMSTELVEEN The Netherlands Edluar 10 mg, tablet voor sublinguaal gebruik 10 mg sublingual tablet sublingual use The Netherlands Mylan B.V. Dieselweg 25 3752 LB BUNSCHOTEN The Netherlands Zolpidemtartraat Mylan 10 mg, filmomhulde tabletten 10 mg film-coated tablet oral use The Netherlands Pharmachemie B.V. Swensweg 5 2031 GA HAARLEM The Netherlands Zolpidemtartraat 5 PCH, filmomhulde tabletten 5 mg 5 mg film-coated tablet oral use The Netherlands Pharmachemie B.V. Swensweg 5 2031 GA HAARLEM The Netherlands Zolpidemtartraat 10 PCH, filmomhulde tabletten 10 mg 10 mg film-coated tablet oral use The Netherlands Sanofi-Aventis Netherlands B.V. Kampenringweg 45 D-E 2803 PE GOUDA The Netherlands Stilnoct, tabletten 10 mg 10 mg tablet oral use The Netherlands STADA Arzneimittel AG Stadastrasse 2-18 DE-61118 Bad Vilbel Germany Zolpidemtartraat Stada 5 mg, filmomhulde tabletten 5 mg film-coated tablet oral use The Netherlands STADA Arzneimittel AG Stadastrasse 2-18 DE-61118 Bad Vilbel Germany Zolpidemtartraat Stada 10 mg, filmomhulde tabletten 10 mg film-coated tablet oral use The Netherlands Synthon B.V. Microweg 22 6545 CM NIJMEGEN The Netherlands Zolpidemtartraat 10 mg, filmomhulde tabletten 10 mg film-coated tablet oral use United Kingdom Actavis UK Limited, Whiddon Valley, Barnstaple, North Devon EX32 8NS United Kingdom Zolpidem Tartrate 5 mg tablets 5 mg film-coated tablet oral use United Kingdom Actavis UK Limited, Whiddon Valley, Barnstaple, North Devon EX32 8NS United Kingdom Zolpidem Tartrate 10 mg tablets 10 mg film-coated tablet oral use United Kingdom ALKALOID-INT d.o.o. Šlandrova ulica 4 1231 Ljubljana-Črnuče Slovenia Zolpidem Tartrate 5 mg film-coated tablets 5 mg film-coated tablet oral use United Kingdom ALKALOID-INT d.o.o. Šlandrova ulica 4 1231 Ljubljana-Črnuče Slovenia Zolpidem Tartrate 10 mg film-coated tablets 10 mg film-coated tablet oral use United Kingdom Aventis Pharma Limited, One Onslow Street, Guildford, Surrey GU1 4SY United Kingdom Stilnoct 5 mg fiilm-coated tablets 5 mg coated tablet oral use United Kingdom Aventis Pharma Limited, One Onslow Street, Guildford, Surrey GU1 4SY United Kingdom Stilnoct 10 mg film-coated tablets 10 mg coated tablet oral use United Kingdom Bristol Laboratories Limited, Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire HP4 1EG United Kingdom Zolpidem Tartrate 5 mg film-coated tablets 5 mg film-coated tablet oral use United Kingdom Bristol Laboratories Limited, Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire HP4 1EG United Kingdom Zolpidem Tartrate 10 mg film-coated tablets 10 mg film-coated tablet oral use United Kingdom Generics [UK] Ltd. Station Close EN6 1TL Hertfordshire — Potters Bar United Kingdom Zolpidem 10 mg film-coated tablets 10 mg film-coated tablet oral use United Kingdom Meda Pharmaceuticals Limited, Skyway House, Parsonage Road, Takeley, Bishops Stortford CM22 6PU United Kingdom Edluar 5 mg sublingual tablets 5 mg sublingual tablet oral use United Kingdom Meda Pharmaceuticals Limited, Skyway House, Parsonage Road, Takeley, Bishops Stortford CM22 6PU United Kingdom Edluar 10 mg sublingual tablets 10 mg sublingual tablet oral use United Kingdom Amneal Pharma Europe Limited, 70 Sir John Rogerson's Quay, Dublin 2, Ireland Zolpidem Tartrate 5 mg film-coated tablets 5 mg film-coated tablet oral use United Kingdom Amneal Pharma Europe Limited, 70 Sir John Rogerson's Quay, Dublin 2, Ireland Zolpidem Tartrate 10 mg film-coated tablets 10 mg film-coated tablet oral use United Kingdom ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany Zolpidem Tartrate 5 mg film-coated tablets 5 mg film-coated tablet oral use United Kingdom ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany Zolpidem Tartrate 10 mg film-coated tablets 10 mg film-coated tablet oral use United Kingdom Sandoz Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR United Kingdom Zolpidem Tartrate 10 mg tablets 10 mg film-coated tablet oral use United Kingdom Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex BN22 9AG United Kingdom Zolpidem Tartrate 5 mg, film-coated tablets 5 mg film-coated tablet oral use United Kingdom Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex BN22 9AG United Kingdom Zolpidem Tartrate 10 mg, film-coated tablets 10 mg film-coated tablet oral use United Kingdom Tillomed Laboratories Limited, 3 Howard Road, Eaton Socon, St Neots, Cambridgeshire PE19 8ET United Kingdom Zolpidem 10 mg film-coated tablets 10 mg film-coated tablet oral use United Kingdom Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS United Kingdom Zolpidem Tartrate 5 mg tablets 5 mg film-coated tablet oral use United Kingdom Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS United Kingdom Zolpidem Tartrate 10 mg tablets 10 mg film-coated tablet oral use