Marketing authorisation holder Product name Strength Pharmaceutical form

Transcription

1 Annex I List of the names, pharmaceutical s, strengths of the medicinal products, route of, marketing authorisation holders in the Member States 1

2 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 Austria G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria Zolpidem G.L. 10 mg - Filmtabletten Austria Hexal Pharma GmbH, Stella-Klein- Löw-Weg 17, 1020 Wien, Austria Zolpidem "Hexal" - Filmtabletten 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 2

3 Austria ratiopharm Arzneimittel Vertriebs- GmbH, Albert-Schweitzer-Gasse 3, 1140 Wien, Austria Zolpidem "ratiopharm" 10 mg Filmtabletten Austria sanofi-aventis GmbH, Saturn Tower, Leonard-Bernstein-Straße 10, 1220 Wien, Austria Ivadal - Filmtabletten Austria STADA Arzneimittel GmbH, Muthgasse 36/2, 1190 Wien, Austria Mondeal 10 mg - Filmtabletten Belgium Belgium Belgium APOTEX NV Av. du Bourg. Etienne Demunter 5 box Jette Belgium APOTEX NV Av. du Bourg. Etienne Demunter 5 box Jette Belgium Eurogenerics S.A. Esplanade Heysel, b Bruxelles Belgium Zolpitop Zolpitop 5 mg film-coated tablet oral use Zolpidem EG 3

4 Belgium Belgium Belgium Belgium Belgium Eurogenerics S.A. Esplanade Heysel, b Bruxelles Belgium Ipca, Produtos Farmaceuticos, Unipessoal Lda Rua Chanceler-Mor 11 R/c Frt. Cacem Ipca, Produtos Farmaceuticos, Unipessoal Lda Rua Chanceler-Mor 11 R/c Frt. Cacem MEDA PHARMA Chaussee de la Hulpe Watermael-Boitsfort Belgium MEDA PHARMA Chaussee de la Hulpe Watermael-Boitsfort Belgium Zolpidem EG 10 mg effervescent tablet oral use Zolpidem IPCA 5 mg film-coated tablet oral use Zolpidem IPCA Zolpeduar 5 mg sublingual tablet oral use Zolpeduar 10 mg sublingual tablet oral use 4

5 Belgium Belgium Belgium Belgium Belgium MYLAN BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart Belgium SANDOZ N.V. Telecom Gardens Medialaan ilvoorde Belgium SANOFI BELGIUM Airport Plaza, Montreal Building, Leonardo Da Vincilaan Diegem Belgium SANOFI BELGIUM Airport Plaza, Montreal Building, Leonardo Da Vincilaan Diegem Belgium TEVA PHARMA BELGIUM NV Laarstraat Wilrijk Belgium Zolpidem Mylan Zolpidem Sandoz Stilnoct 10 mg tablet oral use Zolpidem Sanofi-Aventis Belgium Zolpidem Teva 5

6 Belgium Bulgaria Bulgaria Bulgaria Bulgaria Bulgaria TEVA PHARMA BELGIUM NV Laarstraat Wilrijk Belgium ALKALOID-INT d.o.o. Šlandrova ulica Ljubljana-Črnuče ALKALOID-INT d.o.o. Šlandrova ulica Ljubljana-Črnuče Krka, d.d., Novo mesto Šmarješka cesta Novo mesto Krka, d.d., Novo mesto Šmarješka cesta Novo mesto Meda Pharma GmbH & Co. KG Benzstrasse 1 Bad Homburg v.d.h Zolpidem Ratiopharm Adorma 5 mg film-coated tablet oral use Adorma Zolsana 5 mg film-coated tablet oral use Zolsana Edluar 5 mg sublingual tablet sublingual use 6

7 Bulgaria Meda Pharma GmbH & Co. KG Benzstrasse 1 Bad Homburg v.d.h Edluar 10 mg sublingual tablet sublingual use Bulgaria Sanofi-Aventis Bulgaria EOOD, 103 Alexander Stamboliiski Blvd. Building Sofia Tower Sofia 1303 Bulgaria Stilnox 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 Croatia Krka - farma d.o.o., Radnička cesta 48, Zagreb, Croatia Zolsana 5 mg filmom obložene tablete 5 mg film-coated tablet oral use 7

8 Croatia Krka - farma d.o.o., Radnička cesta 48, Zagreb, Croatia Zolsana 10 mg filmom obložene tablete 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 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 Cyprus Sanofi-Aventis Cyprus Ltd Charalambou Mouskou 14 Lefkosia 2015 Cyprus Stilnox 8

9 Czech Republic ALKALOID-INT d.o.o. Šlandrova ulica Ljubljana-Črnuče ADORMA 5 MG 5 mg film-coated tablet oral use Czech Republic Czech Republic Czech Republic Czech Republic ALKALOID-INT d.o.o. Šlandrova ulica Ljubljana-Črnuče Apotex Europe B.V. Darwinweg 20 NL 2333 CR Leiden Generics [UK] Ltd. Station Close EN6 1TL Hertfordshire - Potters Bar United Kingdom Krka, d.d., Novo mesto Šmarješka cesta Novo mesto ADORMA 10 MG APO-ZOLPIDEM 10 MG ZOLPIDEM MYLAN ZOLSANA 10 MG Czech Republic MEDA Pharma s.r.o. Kodaňská 1441/ Prague 10 Czech Republic EDLUAR 5 MG SUBLINGVÁLNÍ TABLETY 5 mg sublingual tablet sublingual use 9

10 Czech Republic MEDA Pharma s.r.o. Kodaňská 1441/ Prague 10 Czech Republic EDLUAR 10 MG SUBLINGVÁLNÍ TABLETY 10 mg sublingual tablet sublingual use Czech Republic Czech Republic Czech Republic Czech Republic Czech Republic Orion Corporation Orionintie 1/A FI Espoo Finland ratiopharm GmbH Graf Arco Strasse 3 D Ulm SANDOZ s.r.o. U nákladového nádraží 3265/ Prague 3 Czech Republic sanofi-aventis, s.r.o. Evropská 846/176a Prague 6 - Vokovice Czech Republic SVUS Pharma a.s., Smetanovo nábřeží 1238/20a Hradec Králové Czech Republic ZOLPIDEM ORION 10 MG ZOLPIDEM-RATIOPHARM 10 MG SANVAL 10 MG STILNOX ZOLPINOX 10

11 Czech Republic Takeda GmbH Byk-Gulden-Str Konstanz HYPNOGEN Czech Republic Vitabalans Oy Varastokatu Hämeenlinna Finland ZOLPIDEM VITABALANS 10 MG POTAHOVANÉ TABLETY Denmark Actavis Group PTC ehf. Reykjavikurvegur IS-220 Hafnarfjördur Iceland Zolpidem "Actavis" Denmark Denmark Denmark Actavis Group PTC ehf. Reykjavikurvegur IS-220 Hafnarfjördur Iceland Generics [UK] Ltd. Station Close EN6 1TL Hertfordshire - Potters Bar United Kingdom HEXAL A/S, Kanalholmen 8-12, DK Hvodovre, Denmark Zolpidem "Actavis" 5 mg film-coated tablet oral use Zolpidem "Generics" Zolpidem "Hexal" 11

12 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 Denmark sanofi-aventis Denmark A/S, Slotsmarken 13, DK-2970 Hørsholm, Denmark Stilnoct Denmark Synthon BV, Microweg 22, NL-6545 CM Nijmegen, Zolpidem "Genthon" 5 mg film-coated tablet oral use Denmark Synthon BV, Microweg 22, NL-6545 CM Nijmegen, Zolpidem "Genthon" 12

13 Denmark Estonia Vitabalans Oy Varastokatu Hämeenlinna Finland Krka, d.d., Novo mesto Šmarješka cesta Novo mesto Zolpidem "Vitabalans" ZOLSANA 5 mg tablet oral use Estonia Estonia Estonia Estonia Krka, d.d., Novo mesto Šmarješka cesta Novo mesto Meda Pharma GmbH & Co. KG Benzstrasse 1 Bad Homburg v.d.h Meda Pharma GmbH & Co. KG Benzstrasse 1 Bad Homburg v.d.h Sandoz d.d. Verovškova 57, 1000 Ljubljana, ZOLSANA 10 mg tablet oral use EDLUAR 5 mg sublingual tablet oral use EDLUAR 10 mg sublingual tablet oral use ZOLPIDEM SANDOZ 10 MG 10 mg tablet oral use 13

14 Estonia Estonia Sanofi-Aventis Estonia OÜ Pärnu mnt 139E/ Tallinn Estonia Takeda GmbH 2 Byk-Gulden Strasse Konstanz STILNOX 10 mg tablet oral use HYPNOGEN 10 mg tablet oral use Estonia Finland Finland Finland Vitabalans Oy Varastokatu Hämeenlinna Finland Actavis Group PTC ehf. Reykjavikurvegur IS-220 Hafnarfjördur Iceland Actavis Group PTC ehf. Reykjavikurvegur IS-220 Hafnarfjördur Iceland Hexal A/S Edvard Thomsens Vej 14 DK-2300 Köpenhamn S Denmark ZOLPIDEM VITABALANS 10MG 10 mg tablet oral use Stella 5 mg film-coated tablet oral use Stella Zolpidem Hexal 14

15 Finland Finland Finland Finland Finland Finland Meda Oy Vaisalantie Espoo Finland Meda Oy Vaisalantie Espoo Finland Orion Corporation Orionintie 1/A FI Espoo Finland ratiopharm GmbH Graf Arco Strasse 3 D Ulm Sanofi Oy Huopalahdentie 24 P.O.Box Helsinki Finland Vitabalans Oy Varastokatu Hämeenlinna Finland Edluar 5 mg sublingual tablet sublingual use Edluar 10 mg sublingual tablet sublingual use Somnor Zolpidem-Ratiopharm Stilnoct Zolpidem Vitabalans 15

16 France France France LABORATOIRES ALTER 3, avenue de la Baltique ZI de Courtaboeuf Villebon Sur Yvette France Actavis Group PTC ehf. Reykjavikurvegur IS-220 Hafnarfjördur Iceland ARROW GENERIQUES 26, avenue Tony Garnier Lyon France ZOLPIDEM ALTER ZOLPIDEM ACTAVIS 10 MG film-coated tablet oral use ZOLPIDEM ARROW France France BIOGARAN 15, boulevard Charles de Gaulle Colombes FRANCE BIOGARAN 15, boulevard Charles de Gaulle Colombes FRANCE ZOLPIDEM ALMUS ZOLPIDEM BIOGARAN France CRISTERS 22 quai Gallieni Suresnes France ZOLPIDEM CRISTERS France CTRS Route de la Ganne Saint Benoit du Sault France ZOLPIDEM CTRS 16

17 France France France France France France EG LABO - LABORATOIRES EUROGENERICS "Le Quintet" - bâtiment A 12, rue Danjou Boulogne Billancourt Cedex France EG LABO - LABORATOIRES EUROGENERICS "Le Quintet" - bâtiment A 12, rue Danjou Boulogne Billancourt Cedex France Genfarma B.V. Postbus GB Zaandam Kiron Pharmaceutica BV Groesbeekseweg 11 Nijmegen, 6524 CK MEDA PHARMA 25, boulevard de l'amiral Bruix Paris FRANCE MEDA PHARMA 25, boulevard de l'amiral Bruix Paris FRANCE ZOLPIDEM EG ZOLPIDEM EG 10 mg coated tablet oral use ZOLPIDEM RATIOPHARM 10 mg coated tablet oral use ZOLPIDEM KIRION 5 mg film-coated tablet oral use EDLUAR 5 mg sublingual tablet oral use EDLUAR 10 mg sublingual tablet oral use 17

18 France France France MYLAN SAS 117, allée des Parcs Saint-Priest France PHARMACHEMIE BV Swensweg 5 - Haarlem PO Box RN Haarlem PAYS-BAS RANBAXY PHARMACIE GENERIQUES Quai Dion Bouton Puteaux FRANCE ZOLPIDEM MYLAN ZOLPIDEM TEVA 10 mg coated tablet oral use ZOLPIDEM RPG France RATIOPHARM GMBH Graf Arco Strasse Ulm ALLEMAGNE ZOLPIDEM RATIOPHARM France SANDOZ 49, avenue Georges Pompidou Levallois-Perret France ZOLPIDEM GNR France SANDOZ 49, avenue Georges Pompidou Levallois-Perret France ZOLPIDEM GENERES 18

19 France SANDOZ 49, avenue Georges Pompidou Levallois-Perret France ZOLPIDEM SANDOZ France France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland Paris France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland Paris France STILNOX ZOLPIDEM ZENTIVA France Synthon BV, Microweg 22, NL-6545 CM Nijmegen, ZOLPIDEM BAYER France Synthon BV, Microweg 22, NL-6545 CM Nijmegen, ZOLPIDEM BAYER 5 mg film-coated tablet oral use France TEVA SANTE 110, Esplanade du Général de Gaulle Paris La Défense Cedex FRANCE ZOLPIDEM TEVA 19

20 France ZYDUS FRANCE 25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d Activités des Peupliers Nanterre FRANCE ZOLPIDEM ZYDUS 1 A Pharma Keltenring Oberhaching AbZ-Pharma GmbH Graf-Arco-Str Ulm Actavis Deutschland GmbH & Co.KG Willy-Brandt-Allee München Aliud Pharma GmbH Gottlieb-Daimler-Str Laichingen Aliud Pharma GmbH Gottlieb-Daimler-Str Laichingen Zolpidem 10-1A-Pharma Zolpidem AbZ 10 mg Filmtabletten Zolpidem-Actavis 10 mg Filmtabletten Zolpidem AL 10 mg Filmtabletten Zolpidem AL 5 mg Filmtabletten 5 mg film-coated tablet oral use 20

21 Aristo Pharma GmbH Wallenroder Str Berlin AbZ-Pharma GmbH Graf-Arco-Str Ulm AbZ-Pharma GmbH Graf-Arco-Str Ulm Dolorgiet GmbH & Co.KG Otto-von-Guericke-Str Sankt Augustin Heumann Pharma GmbH & Co. Generica KG Südwestpark Nürnberg Heumann Pharma GmbH & Co. Generica KG Südwestpark Nürnberg Zolpidem Aristo 10 mg Filmtabletten Zolpidem-CT 10 mg Filmtabletten Zolpidem-CT 5 mg Filmtabletten 5 mg film-coated tablet oral use Zolpidem real 10 mg Filmtabletten Zolpidem Heumann 10 mg Filmtabletten Zolpidem Heumann 5 mg 5 mg film-coated tablet oral use Filmtabletten 21

22 Hexal Aktiengesellschaft Industriestr Holzkirchen IPCA - Produtos Farmacêuticos Unipessoal, Lda. Rua José Nogueira Vaz, Lote Lj Esq Povoa de Santa Iria Zolpidem Hexal 10 mg Filmtabletten Zolpidem IPCA 10 mg Filmtabletten IPCA - Produtos Farmacêuticos Unipessoal, Lda. Rua José Nogueira Vaz, Lote Lj Esq Povoa de Santa Iria Zolpidem IPCA 5 mg Filmtabletten 5 mg film-coated tablet oral use Juta Pharma GmbH Gutenbergstr Flensburg Krewel Meuselbach GmbH Krewelstr Eitorf Zolpi-Q 10 mg Filmtabletten Zolpinox 10 mg 22

23 Meda Pharma GmbH & Co. KG Benzstrasse 1 Bad Homburg v.d.h Meda Pharma GmbH & Co. KG Benzstrasse 1 Bad Homburg v.d.h Mylan dura GmbH Wittichstr Darmstadt neuraxpharm Arzneimittel GmbH Elisabeth-Selbert-Str Langenfeld Edluar 10 mg Sublingualtabletten 10 mg sublingual tablet oral use Edluar 5 mg Sublingualtabletten 5 mg sublingual tablet oral use Zolpidem dura 10 mg Filmtabletten Zolpidem-neuraxpharm 10 mg Filmtabletten neuraxpharm Arzneimittel GmbH Elisabeth-Selbert-Str Langenfeld Zolpidem-neuraxpharm 5 mg Filmtabletten 5 mg film-coated tablet oral use 23

24 ratiopharm GmbH Graf Arco Strasse 3 D Ulm Zolpidem-ratiopharm 10 mg Filmtabletten ratiopharm GmbH Graf Arco Strasse 3 D Ulm Zolpidem-ratiopharm 5 mg Filmtabletten 5 mg film-coated tablet oral use Sandoz Pharmaceuticals GmbH Raiffeisenstr Holzkirchen Zolpidem Sandoz 10 mg Filmtabletten Sanofi-Aventis Deutschland GmbH Industriepark Höchst, Gebäude K Frankfurt am Main Sanofi-Aventis Deutschland GmbH Industriepark Höchst, Gebäude K Frankfurt am Main Stadapharm GmbH Stadastr Bad Vilbel Bikalm Stilnox Zolpidem STADA 10 mg Filmtabletten 24

25 Stadapharm GmbH Stadastr Bad Vilbel TAD Pharma GmbH Heinz-Lohmann-Str Cuxhaven Zolpidem STADA 5 mg Filmtabletten 5 mg film-coated tablet oral use Zolpidem TAD 10 mg Vitabalans Oy Varastokatu Hämeenlinna Finland Zolpidem Vitabalans 10 mg Filmtabletten Greece Greece Winthrop Arzneimittel GmbH Brüningstr Frankfurt am Main IOULIA AND IRENE TSETI PHARMACEUTICAL LABORATORIES ABEE, INTERMED ABEE, Kalyftaki 27, Kifissia Greece ITF HELLAS S.A. Areos 103 and Ag. Triados 36, Palaio Faliro Greece Zolpi-Lich 10 mg Filmtabletten HYPNONORM ONIRIA 10 mg/ml oral drops, solution oral use 25

26 Greece Greece Hungary Hungary Hungary ITF PHARMA KERESKEDELMI ES SZOLGALTATO KFT, BUDAPEST, HUNGAR H-1056, Budapest Duna u.1 Hungary SANOFI-AVENTIS AEBE 348 SYNGROU AVENUE, BUILDING A, KALLITHEA Greece EGIS Gyógyszergyár Nyrt. Keresztúri út Budapest 1106 Hungary ExtractumPharma zrt. Megyeri út 64. Budapest 1044 Hungary Generics (UK) Ltd. Albany Gate, Darkes Lane, Potters bar Herts EN61AG United Kingdom KALINICTA 10 mg/ml oral drops, solution oral use STILNOX PIDEZOL 10 mg filmtabletta ZOLEP 10 mg filmtabletta SOMNOGEN 10 mg filmtabletta 26

27 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 ZOLSANA 5 mg filmtabletta 5 mg film-coated tablet oral use Hungary Krka d.d. Novo Mesto Smarjeska cesta 6. Novo Mesto 8501 ZOLSANA 10 mg filmtabletta Hungary Hungary Hungary LEK Pharmaceuticals d.d. Verovskova 57 Ljubljana LEK Pharmaceuticals d.d. Verovskova 57 Ljubljana Meda Pharma Hungary Kft Váci út 91. Budapest 1139 Hungary SANVAL 5 mg filmtabletta 5 mg film-coated tablet oral use SANVAL 10 mg filmtabletta EDLUAR 5 mg nyelvalatti tabletta 5 mg sublingual tablet sublingual use 27

28 Hungary Meda Pharma Hungary Kft Váci út 91. Budapest 1139 Hungary EDLUAR 10 mg nyelvalatti tabletta 10 mg sublingual tablet sublingual use Hungary Hungary Sanofi-Aventis Magyarország Zrt Tó u. 1-5 Budapest 1045 Hungary Teva Magyarország Zrt Repülőtéri út 5. Gödöllő 2100 Hungary STILNOX 10 mg filmtabletta ZOLPIDEM-RATIOPHARM 10 mg filmtabletta Hungary Vitabalans Oy Varastokatu 8. Hämeenlinna Finland ZOLPIDEM VITABALANS 10 mg filmtabletta Hungary Vulm CZ a.s. Olivova 1888 Ricany Czech Republic INSOM 10 mg pezsgőtabletta 10 mg effervescent tablet oral use 28

29 Hungary Zentiva k.s. Dolny Mecholupy, U kabelovny 130 Prague Czech Republic HYPNOGEN 10 mg filmtabletta Iceland LYFIS ehf., Grensásvegur 22, 108 Reykjavík, Iceland Zolpidem LYFIS Iceland Meda AB, Pipers väg 2A, Box 906, SE , Sweden Edluar 5 mg sublingual tablet oral use Iceland Meda AB, Pipers väg 2A, Box 906, SE , Sweden Edluar 10 mg sublingual tablet oral use Iceland Mylan AB, Ynglingagatan 14, Stockholm, Sweden. Zolpidem Mylan Iceland Sanofi Aventis Norge Strandveien 15, 1366 Lysaker, Norway Stilnoct 5 mg film-coated tablet oral use 29

30 Iceland Sanofi Aventis Norge Strandveien 15, 1366 Lysaker, Norway Stilnoct Ireland Ireland Ireland Ireland Clonmel Healthcare Ltd Waterford Road Clonmel Co. Tipperary Ireland Clonmel Healthcare Ltd Waterford Road Clonmel Co. Tipperary Ireland McDermott Laboratories Ltd t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland Meda Health Sales Ireland Limited Unit 34/35 Block A Dunboyne Business Park Dunboyne Co Meath Ireland Nytamel 5 mg Film-coated Tablets 5 mg film-coated tablet oral use Nytamel 10 mg Film-coated Tablets. Zoldem 10 mg film coated tablets Edluar 5 mg sublingual tablets 5 mg sublingual tablet oral use 30

31 Ireland Ireland Ireland Meda Health Sales Ireland Limited Unit 34/35 Block A Dunboyne Business Park Dunboyne Co Meath Ireland Rowex Ltd, Bantry, Co. Cork, Ireland Sanofi-Aventis Ireland Limited T/A Sanofi, Citywest Business Campus, Dublin 24, Ireland Edluar 10 mg sublingual tablets 10 mg sublingual tablet oral use Zolnod 10mg film-coated tablets Stilnoct 5mg 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 10mg Film-coated Tablets Ireland Teva Pharma B. V. Computerweg DR Utrecht Ireland Teva Pharma B. V. Computerweg DR Utrecht Zolpidem Tartrate Teva 5 mg Filmcoated Tablets Zolpidem Tartrate Teva 10 mg Filmcoated Tablets 5 mg film-coated tablet oral use 31

32 Italy Actavis Group PTC ehf. Reykjavikurvegur IS-220 Hafnarfjördur Iceland ZOLPIDEM ACTAVIS Italy Doc Generici S.r.l. Turati 40, Milano Italy ZOLPIDEM DOC GENERICI 5 mg film-coated tablet oral use Italy Doc Generici S.r.l. Turati 40, Milano Italy ZOLPIDEM DOC GENERICI Italy EG S.p.a. Via Scarlatti, 31, Milano Italy ZOLPIDEM EG Italy FIDIA Farmaceutici S.p.a. Via Ponte della Fabbrica, 3/a, Abano Terme, Padova Italy OPSYCON 32

33 Italy HEXAL S.p.a. Largo Umberto Boccioni Origgio Varese Italy ZOLPIDEM HEXAL Italy IPCA - Produtos Farmacêuticos Unipessoal, Lda. Rua José Nogueira Vaz, Lote Lj Esq Povoa de Santa Iria ZOLPIDEM IPCA 5 mg film-coated tablet oral use Italy Italy IPCA - Produtos Farmacêuticos Unipessoal, Lda. Rua José Nogueira Vaz, Lote Lj Esq Povoa de Santa Iria ITALFARMACO S.p.A. Viale Fulvio Testi 330, Milano, Italy ZOLPIDEM IPCA SONIREM 10 mg/ml oral drops, solution oral use Italy LIFEPHARMA S.P.A. Via dei Lavoratori 54, Cinisello Balsamo, Milano - Italy ZOLPREM 10 mg/ml oral drops, solution oral use 33

34 Italy MEDA PHARMA S.P.A., Viale brenta 18, Milano - Italy ZOLPEDUAR 5 mg sublingual tablet oral use Italy MEDA PHARMA S.P.A., Viale brenta 18, Milano - Italy ZOLPEDUAR 10 mg sublingual tablet oral use Italy Italy Italy Ratiopharm GmbH Graf Arco Strasse 3 D Ulm Sandoz S.p.a. Largo Umberto Boccioni, 1, Origgio, Varese Italy Sanofi-aventis SpA, Viale Bodio 37/b, Milano Italy ZOLPIDEM RATIOPHARM ZOLPIDEM SANDOZ STILNOX Italy Sanofi-aventis SpA, Viale Bodio 37/b, Milano Italy NOTTEM 34

35 Italy Teva Italia S.r.l. - via Messina Milano Italy ZOLPIDEM TEVA Italy ZENTIVA ITALIA S.R.L. - Viale Bodio 37/b, Milano Italy ZOLPIDEM ZENTIVA Latvia Latvia Latvia Latvia Krka, d.d., Novo mesto Šmarješka cesta Novo mesto Krka, d.d., Novo mesto Šmarješka cesta Novo mesto Meda Pharma GmbH & Co. KG Benzstrasse 1 Bad Homburg v.d.h Meda Pharma GmbH & Co. KG Benzstrasse 1 Bad Homburg v.d.h Zolsana 5 mg coated tablets 5 mg coated tablet oral use Zolsana 10 mg coated tablets 10 mg coated tablet oral use Edluar 5 mg sublingual tablets 5 mg sublingual tablet sublingual use Edluar 10 mg sublingual tablets 10 mg sublingual tablet sublingual use 35

36 Latvia Sandoz d.d. Verovškova 57, 1000 Ljubljana, Zolpidem Sandoz 10 mg film-coated tablets Latvia sanofi-aventis Latvia SIA, Kr.Valdemara 33-8 Riga, LV 1010, Latvia Stilnox 10 mg film-coated tablets Latvia Vitabalans Oy Varastokatu Hämeenlinna Finland Zolpidem Vitabalans 10 mg filmcoated tablets Latvia Zentiva, k.s. U kabelovny 130 Prague 10, Dolni Mecholupy Czech Republic Hypnogen 10 mg film-coated tablets Lithuania Lithuania Krka, d.d., Novo mesto Šmarješka cesta Novo mesto Krka, d.d., Novo mesto Šmarješka cesta Novo mesto Zolsana Zolsana 5 mg film-coated tablet oral use 36

37 Lithuania Lithuania Sandoz d.d. Verovškova 57, 1000 Ljubljana, UAB SANOFI-AVENTIS LIETUVA A. Juozapavičiaus 6/2 g. LT Vilnius Lithuania Zolpidem Sandoz Stilnox Lithuania Lithuania Luxembourg Vitabalans Oy Varastokatu Hämeenlinna Finland Zentiva, k.s. U kabelovny 130 Prague 10, Dolni Mecholupy Czech Republic MYLAN BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart Belgium Zolpidem Vitabalans HYPNOGEN Dodorest 10 mg coated tablet oral use 37

38 Luxembourg Luxembourg Luxembourg Luxembourg Luxembourg Luxembourg SANOFI BELGIUM Airport Plaza, Montreal Building, Leonardo Da Vincilaan Diegem Belgium Eurogenerics S.A. Esplanade Heysel, b Bruxelles Belgium Eurogenerics S.A. Esplanade Heysel, b Bruxelles Belgium Genthon BV Microweg, Nijmegen Genthon BV Microweg, Nijmegen Apotex Europe B.V. Darwinweg 20 NL 2333 CR Leiden Stilnoct 10 mg coated tablet oral use Zolpidem EG cpr.eff. 10 mg effervescent tablet oral use Zolpidem EG cpr.pellic. 10 mg coated tablet oral use Zolpidem Genthion 10 mg coated tablet oral use Zolpidem Genthion 5 mg coated tablet oral use Zolpitop 10 mg coated tablet oral use 38

39 Luxembourg Apotex Europe B.V. Darwinweg 20 NL 2333 CR Leiden Zolpitop 5 mg coated tablet oral use Luxembourg Luxembourg Malta Malta Norway MEDA PHARMA Chaussee de la Hulpe Watermael-Boitsfort Belgium MEDA PHARMA Chaussee de la Hulpe Watermael-Boitsfort Belgium Sanofi Malta Ltd. St. Julian s Rd. San Gwann SGN 2805 Malta Pharma MT 103, Stuart Street, Gzira, Malta Sanofi Aventis Norge Strandveien 15, 1366 Lysaker, Norway Zolpeduar 10 mg sublingual tablet sublingual use Zolpeduar 5 mg sublingual tablet sublingual use Stilnox Nytamel Stilnoct 5 mg film-coated tablet oral use 39

40 Norway Sanofi Aventis Norge Strandveien 15, 1366 Lysaker, Norway Stilnoct 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 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 Hämeenlinna Finland Zolpidem Vitabalans 40

41 Poland Poland Poland Poland Poland Actavis Group PTC ehf. Reykjavikurvegur IS-220 Hafnarfjördur Iceland Apotex Europe B.V. Darwinweg 20 NL 2333 CR Leiden Farma-Projekt Sp. z o.o. ul. Józefińska Kraków Poland Generics [UK] Ltd. Station Close EN6 1TL Hertfordshire - Potters Bar United Kingdom Ipca, Produtos Farmaceuticos, Unipessoal Lda Rua Chanceler-Mor 11 R/c Frt. Cacem Noxizol Apo-Zolpin Xentic ZolpiGen Zolpidem IPCA 5 mg film-coated tablet oral use 41

42 Poland Poland Poland Poland Ipca, Produtos Farmaceuticos, Unipessoal Lda Rua Chanceler-Mor 11 R/c Frt. Cacem Italfarmaco S.p.A. Viale Fulvio Milano Italy Krka, d.d., Novo mesto Šmarješka cesta Novo mesto Meda Pharma GmbH & Co. KG Benzstrasse 1 Bad Homburg v.d.h Zolpidem IPCA Sonirem 10 mg/ml oral drops, solution oral use Zolsana Edluar 5 mg sublingual tablet oral use Poland Meda Pharma GmbH & Co. KG Benzstrasse 1 Bad Homburg v.d.h Edluar 10 mg sublingual tablet oral use 42

43 Poland Poland Poland Poland Poland Poland Orion Corporation Orionintie 1/A FI Espoo Finland Pabianickie Zakłady Farmaceutyczne Polfa S.A. ul. Marszałka J. Piłsudskiego Pabianice Poland Pfizer Europe MA EEIG Ramsgate Road Kent, Sandwich CT13 9 NJ United Kingdom Polfarmex S.A. Józefów Kutno Poland Sandoz GmbH ul. Biochemiestrasse 10 Kundli 6250 Austria Sanofi-Aventis France 1-13 boulevard Romain Rolland Paris France Onirex Polsen Zolpidem Pfizer Nasen Sanval Stilnox 43

44 Poland Poland Poland Poland Vitabalans Oy Varastokatu Hämeenlinna Finland VULM CZ, a.s. Olivova 1888 Ricany Czech Republic Zakłady Farmaceutyczne POLPHARMA S.A. Pelplińska Starogard Gdański Poland Zentiva, k.s. U kabelovny 130 Prague 10, Dolni Mecholupy Czech Republic Actavis A/S Sucursal Rua Virgílio Correia, 11 - A Lisboa Zolpidem Vitabalans Insom 10 mg effervescent tablet oral use Zolpic Hypnogen Zolpidem Actavis 44

45 Aurobindo Pharma (), Unipessoal Lda. Av. do Forte, nº 3 - Parque Suécia, Edifício. IV, 2º Carnaxide Aurobindo Pharma (), Unipessoal Lda. Av. do Forte, nº 3 - Parque Suécia, Edifício. IV, 2º Carnaxide Cinfa, Lda. Av. Tomás Ribeiro, 43 - Bloco 2, 3º F - Edifício Neopark Carnaxide Zolpidem Aurobindo 5 mg film-coated tablet oral use Zolpidem Aurobindo Zolpidem Cinfa 10 mg Comprimidos Generis Farmacêutica, S.A. Rua João de Deus, Amadora Zolpidem Generis 5 mg Comprimidos Revestidos 5 mg film-coated tablet oral use Generis Farmacêutica, S.A. Rua João de Deus, Amadora Zolpidem Generis 10 mg Comprimidos Revestidos 45

46 Genthon GmbH Groesbeeker Weg, 1 D Kranenburg Zolpidem 5 mg Comprimidos Revestidos 5 mg film-coated tablet oral use IPCA - Produtos Farmacêuticos Unipessoal, Lda. Rua José Nogueira Vaz, Lote Lj Esq Povoa de Santa Iria Zolpidem IPCA 5 mg film-coated tablet oral use IPCA - Produtos Farmacêuticos Unipessoal, Lda. Rua José Nogueira Vaz, Lote Lj Esq Povoa de Santa Iria Zolpidem IPCA Labesfal Genéricos, S.A Avenida Dr. Afonso Costa, Campo de Besteiros Zolpidem Labesfal 46

47 Laboratórios Azevedos - Indústria Farmacêutica, S.A. Edifícios Azevedos - Estrada Nacional 117-2, Alfragide Amadora Meda Pharma - Produtos Farmacêuticos, S.A. Rua do Centro Cultural, Lisboa Meda Pharma - Produtos Farmacêuticos, S.A. Rua do Centro Cultural, Lisboa Mylan, Lda. Parque Expo, Edifício Atlantis, Avenida D. João II, Lote C e Lisboa Cymerion Edluar 5 mg sublingual tablet sublingual use Edluar 10 mg sublingual tablet sublingual use Zolpidem Mylan Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda. Lagoas Park, Edifício 5 A, Piso Porto Salvo Zolpidem Ratiopharm 10 mg Comprimidos Revestidos 47

48 Sandoz Farmacêutica, Lda. Alameda da Beloura, Edifício 1, 2º - Escritório Sintra Zolpidem Sandoz Romania Romania Sanofi - Produtos Farmacêuticos, Lda. Empreendimento Lagoas Park Edifício 7, 3º Piso Porto Salvo Wynn Industrial Pharma, S.A. Rua Tierno Galvan, Torre 3, 16º Piso, Amoreiras Lisboa ALKALOID-INT d.o.o. Šlandrova ulica Ljubljana-Črnuče ALKALOID-INT d.o.o. Šlandrova ulica Ljubljana-Črnuče Stilnox Zolpidem Wynn ZADOBRA 5 mg 5 mg film-coated tablet oral use ZADOBRA 10 mg 48

49 Romania ITALFARMACO S.p.A. Viale Fulvio Testi 330, Milano, Italia ONIRIA 10 mg/ml 10 mg/ml oral drops, solution oral use Romania Romania Romania Krka, d.d., Novo mesto Šmarješka cesta Novo mesto Krka, d.d., Novo mesto Šmarješka cesta Novo mesto LABORMED PHARMA S.A. B-dul odor Pallady nr. 44B Sector 3, Bucureşti, România ZOLSANA 5 mg 5 mg film-coated tablet oral use ZOLSANA 10 mg ZOLPIDEM 10 mg Romania Romania LEK farmacevtska družba d.d. Verovškova Ljubljana Meda Pharma GmbH & Co. KG Benzstrasse 1 Bad Homburg v.d.h SANVAL 10 mg EDLUAR 5 mg 5 mg sublingual tablet oral use 49

50 Romania Romania Meda Pharma GmbH & Co. KG Benzstrasse 1 Bad Homburg v.d.h S.C. ANTIBIOTICE S.A., Str. Valea Lupului nr.1, Iaşi, România EDLUAR 10 mg 10 mg sublingual tablet oral use ZOLPIDEM ATB 10 mg Romania SANOFI-AVENTIS ROMÂNIA S.R.L. Str. Izvor, Nr. 80, Et Sector 5, Bucureşti, România STILNOX 10 mg Slovak Republic ALKALOID-INT d.o.o. Šlandrova ulica Ljubljana-Črnuče ADORMA 5 mg filmom obalené tablety 5 mg film-coated tablet oral use Slovak Republic ALKALOID-INT d.o.o. Šlandrova ulica Ljubljana-Črnuče ADORMA 10 mg filmom obalené tablety Slovak Republic Generics [UK] Ltd. Station Close EN6 1TL Hertfordshire - Potters Bar United Kingdom Zolpidem Mylan 10 mg 50

51 Slovak Republic Slovak Republic Slovak Republic Slovak Republic Orion Corporation Orionintie 1/A FI Espoo Finland Sandoz d.d. Verovškova 57, 1000 Ljubljana, Sandoz d.d. Verovškova 57, 1000 Ljubljana, sanofi-aventis Slovakia s.r.o. Einsteinova Bratislava Slovak Republic Zolpidem Orion 10 mg SANVAL 5 mg 5 mg film-coated tablet oral use SANVAL 10 mg STILNOX Slovak Republic Slovak Republic SVUS Pharma a.s., Smetanovo nábřeží 1238/20a Hradec Králové Czech Republic Takeda GmbH 2 Byk-Gulden Strasse Konstanz ZOLPINOX HYPNOGEN 51

52 Slovak Republic Vitabalans Oy Varastokatu Hämeenlinna Finland Zolpidem Vitabalans 10 mg filmom obalené tablety ALKALOID-INT d.o.o. Šlandrova ulica Ljubljana-Črnuče Perluna 10 mg filmsko obožene tablete ALKALOID-INT d.o.o. Šlandrova ulica Ljubljana-Črnuče Perluna 5 mg filmsko obožene tablete 5 mg film-coated tablet oral use Krka, d.d., Novo mesto Šmarješka cesta Novo mesto Zolsana 10 mg filmsko obložene tablete Krka, d.d., Novo mesto Šmarješka cesta Novo mesto LEK farmacevtska družba d.d. Verovškova Ljubljana Zolsana 5 mg filmsko obložene tablete 5 mg film-coated tablet oral use Sanval 10 mg filmsko obožene tablete 52

53 LEK farmacevtska družba d.d. Verovškova Ljubljana Meda Pharma GmbH & Co. KG Benzstrasse 1 Bad Homburg v.d.h Meda Pharma GmbH & Co. KG Benzstrasse 1 Bad Homburg v.d.h Sanval 5 mg filmsko obložene tablete 5 mg film-coated tablet oral use Edluar 10 mg podjezične tablete 10 mg sublingual tablet sublingual use Edluar 5 mg podjezične tablete 5 mg sublingual tablet sublingual use Vitabalans Oy Varastokatu Hämeenlinna Finland Zolpidem Vitabalans 10 mg filmsko obložene tablete Spain ANGELINI FARMACEUTICA, S.A. Osi, 7-9 Barcelona SPAIN DALPARAN 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA Spain Apotex Europe B.V. Darwinweg 20 NL 2333 CR Leiden ZOLPIDEM APOTEX 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG 53

54 Spain BEXAL FARMACEUTICA, S.A Centro Empresarial Osa Mayor. Avda. Osa Mayor, 4 - Area B, Aravaca (Madrid) SPAIN ZOLPIDEM BEXALABS 10 mg COMPRIMIDOS CON CUBIERTOS CON PELICULA EFG Spain BEXAL FARMACEUTICA, S.A Centro Empresarial Osa Mayor. Avda. Osa Mayor, 4 - Area B, Aravaca (Madrid) SPAIN ZOLPIDEM BEXAL 10 mg COMPRIMIDOS RECUBIERTOS EFG Spain FARMALIDER, S.A. Aragoneses, 2, Alcobendas (Madrid) SPAIN ZOLPIDEM FARMALIDER 10 mg COMPRIMIDOS RECUBIERTOS EFG Spain GENERFARMA, S.L. Ronda Isaac Peral, 6 Parque Tecnológico Paterna (Valencia) SPAIN ZOLPIDEM DESGEN 5 mg COMPRIMIDOS EFG 5 mg tablet oral use Spain GENERFARMA, S.L. Ronda Isaac Peral, 6 Parque Tecnológico 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) SPAIN ZOLPIDEM EDIGEN 10 mg COMPRIMIDOS RECUBIERTOS EFG 54

55 Spain LABORATORIO STADA, S.L. Frederic Mompou, 5, Sant Just Desvern (Barcelona) SPAIN ZOLPIDEM STADA 10 mg COMPRIMIDOS RECUBIERTOS EFG Spain LABORATORIOS CINFA, S.A. Olaz- Chipi, 10. Poligono Industrial Areta.Huarte-Pamplona (Navarra) SPAIN ZOLPIDEM CINFA 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG Spain LABORATORIOS NORMON, S.A. Ronda de Valdecarrizo, 6, Tres Cantos (Madrid) SPAIN ZOLPIDEM NORMON 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG Spain MEDA PHARMA S.A.U Avda. de Castilla, 2. Edif. Berlin. 2ª planta. Parque Empresarial San Fernando, San Fernando de Henares (Madrid) SPAIN Spain MEDA PHARMA S.A.U Avda. de Castilla, 2. Edif. Berlin. 2ª planta. Parque Empresarial San Fernando, San Fernando de Henares (Madrid) SPAIN EDLUAR 10 MG COMPRIMIDOS SUBLINGUALES EDLUAR 5 MG COMPRIMIDOS SUBLINGUALES 10 mg sublingual tablet oral use 5 mg sublingual tablet oral use 55

56 Spain MYLAN PHARMACEUTICALS, S.L. Plom 2-4, 5º Planta, Barcelona SPAIN ZOLPIDEM MYLAN 10 mg COMPRIMIDOS RECUBIERTOS EFG Spain PHARMAGENUS, S.A. Avda. Camí Real, Palau-solita i Plegamans (Barcelona) SPAIN ZOLPIDEM PHARMAGENUS 5 mg COMPRIMIDOS 5 mg tablet oral use Spain PHARMAGENUS, S.A. Avda. Camí Real, Palau-solita i Plegamans (Barcelona) 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 SPAIN Spain RATIOPHARM ESPAÑA, S.A. C/ Anabel Segura 11, Edificio Albatros B 1ª Planta, Alcobendas, Madrid SPAIN Spain RATIOPHARM ESPAÑA, S.A. C/ Anabel Segura 11, Edificio Albatros B 1ª Planta, Alcobendas, Madrid SPAIN ZOLPIDEM RATIOPHARM 10 mg COMPRIMIDOS RECUBIERTOS EFG ZOLPIDEM TEVAGEN 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG ZOLPIDEM TEVAGEN 5 mg COMPRIMIDOS RECUBIERTOS CON PELICULA 5 mg film-coated tablet oral use 56

57 Spain SANDOZ FARMACÉUTICA, S.A. Avda. Osa Mayor, Aravaca (Madrid) Spain ZOLPIDEM SANDOZ 10 mg COMPRIMIDOS EFG 10 mg tablet oral use Spain SANOFI AVENTIS, S.A. Josep Plá, 2, Barcelona SPAIN STILNOX 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA Spain TEVA GENERICOS ESPAÑOLA S.L.U. C/ Anabel Segura, 11 Edificio Albatros B, 1 planta Alcobendas (Madrid) SPAIN ZOLPIDEM TEVA 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG Spain Zentiva, k.s. U kabelovny 130 Prague 10, Dolni Mecholupy Czech Republic ZOLPIDEM ZENTIVA 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG Sweden Sweden Actavis Group PTC ehf. Reykjavikurvegur IS-220 Hafnarfjördur Iceland Actavis Group PTC ehf. Reykjavikurvegur IS-220 Hafnarfjördur Iceland Zolpidem Actavis 5 mg film-coated tablet oral use Zolpidem Actavis 57

58 Sweden Sweden Sweden Hexal A/S Edvard Thomsens Vej 14 DK-2300 Köpenhamn S Denmark Ranbaxy (UK) Ltd, Building 4 Chiswick Park London W4 5YE United Kingdom Ranbaxy (UK) Ltd, Building 4 Chiswick Park London W4 5YE United Kingdom Zolpidem HEXAL Zolpidem Ranbaxy 5 mg film-coated tablet oral use Zolpidem Ranbaxy Sweden Meda AB, Pipers väg 2A, Box 906, SE , Sweden Edluar 5 mg sublingual tablet oral use Sweden Meda AB, Pipers väg 2A, Box 906, SE , Sweden Edluar 10 mg sublingual tablet oral use Sweden Mylan AB Box Stockholm Sweden Zolpidem Mylan 58

59 Sweden Sweden Sweden Sweden Sweden Sweden Orifarm Generics A/S Energivej 15 POB 69 DK-5260 Odense S Denmark Orifarm Generics A/S Energivej 15 POB 69 DK-5260 Odense S Denmark ratiopharm GmbH Graf Arco Strasse 3 D Ulm ratiopharm GmbH Graf Arco Strasse 3 D Ulm Sandoz A/S Edvard Thomsens Vej 14 DK-2300 Köpenhamn S Denmark Sandoz A/S Edvard Thomsens Vej 14 DK-2300 Köpenhamn S Denmark Zolpidem Orifarm 5 mg film-coated tablet oral use Zolpidem Orifarm Zolpidem ratiopharm 5 mg film-coated tablet oral use Zolpidem ratiopharm Zolpidem Sandoz 5 mg film-coated tablet oral use Zolpidem Sandoz 59

60 Sweden Sweden Sweden Sweden Sweden sanofi-aventis AB Box Bromma Sweden sanofi-aventis AB Box Bromma Sweden STADA Arzneimittel AG Stadastrasse 2-18 DE Bad Vilbel STADA Arzneimittel AG Stadastrasse 2-18 DE Bad Vilbel Synthon BV, Microweg 22, NL-6545 CM Nijmegen, Stilnoct 5 mg film-coated tablet oral use Stilnoct Zolpidem STADA 5 mg film-coated tablet oral use Zolpidem STADA Zolpidem Genthon 5 mg film-coated tablet oral use Sweden Synthon BV, Microweg 22, NL-6545 CM Nijmegen, Zolpidem Genthon 60

61 Sweden Vitabalans Oy Varastokatu Hämeenlinna Finland Zolpidem Vitabalans Actavis B.V. Baarnsche Dijk LN BAARN Zolpidemtartaat Actavis 5 mg, tabletten 5 mg tablet oral use Actavis B.V. Baarnsche Dijk LN BAARN Zolpidemtartraat Actavis 10 mg, tabletten 10 mg tablet oral use ADOH B.V. Godfried Bomansstraat JA NIJMEGEN Zolpidemtartraat ADOH bruistabletten 10 mg, bruistabletten 10 mg effervescent tablet oral use Pharmachemie B.V. Swensweg GA HAARLEM Zolpidemtartraat 5 mg PCH, filmomhulde tabletten 5 mg film-coated tablet oral use Pharmachemie B.V. Swensweg GA HAARLEM Zolpidemtartraat 10 mg PCH, filmomhulde tabletten 61

62 ratiopharm Nederland B.V. Swensweg GA HAARLEM Zolpidemtartraat ratiopharm 5 mg, tabletten 5 mg tablet oral use ratiopharm Nederland B.V. Swensweg GA HAARLEM Zolpidemtartraat ratiopharm 10 mg, tabletten 10 mg tablet oral use ratiopharm Nederland B.V. Swensweg GA HAARLEM Zolpidemtartraat ratiopharm 5 mg, filmomhulde tabletten 5 mg film-coated tablet oral use ratiopharm Nederland B.V. Swensweg GA HAARLEM Zolpidemtartraat ratiopharm 10 mg, filmomhulde tabletten ratiopharm Nederland B.V. Swensweg GA HAARLEM Zolpidemtartraat ratiopharm 10 mg, filmomhulde tabletten Sandoz B.V. Veluwezoom AH ALMERE Zolpidemtartraat Sandoz 10 mg, filmomhulde tabletten 62

63 Sandoz B.V. Veluwezoom AH ALMERE Zolpidemtartraat Sandoz 5, filmomhulde tabletten 5 mg 5 mg film-coated tablet oral use Sandoz B.V. Veluwezoom AH ALMERE Zolpidemtartraat Sandoz 10,filmomhulde tabletten 10 mg Synthon B.V. Microweg CM NIJMEGEN Zolpidemtartraat 5 mg, filmomhulde tabletten 5 mg film-coated tablet oral use Synthon B.V. Microweg CM NIJMEGEN Zolpidemtartraat 10 mg, filmomhulde tabletten Synthon B.V. Microweg CM NIJMEGEN Zolpidemtartraat 5 mg, filmomhulde tabletten 5 mg film-coated tablet oral use Synthon B.V. Microweg CM NIJMEGEN Zolpidemtartraat 10 mg, filmomhulde tabletten 63

64 Synthon B.V. Microweg CM NIJMEGEN Zolpidemtartraat 5 mg, filmomhulde tabletten 5 mg film-coated tablet oral use Synthon B.V. Microweg CM NIJMEGEN Zolpidemtartraat 10 mg, filmomhulde tabletten ADOH B.V. Godfried Bomansstraat JA NIJMEGEN Zolpidemtartraat ADOH 10 mg, bruistabletten 10 mg effervescent tablet oral use Apotex Europe B.V. Darwinweg 20 NL 2333 CR Leiden Zolpidemtartraat Apotex 5 mg, filmomhulde tabletten 5 mg film-coated tablet oral use Apotex Europe B.V. Darwinweg 20 NL 2333 CR Leiden Zolpidemtartraat Apotex 10 mg, filmomhulde tabletten Centrafarm B.V. Nieuwe Donk AC ETTEN LEUR Zolpidemtartraat CF 5 mg, filmomhulde tabletten 5 mg film-coated tablet oral use 64

65 Centrafarm B.V. Nieuwe Donk AC ETTEN LEUR Zolpidemtartraat CF 10 mg, filmomhulde tabletten Eurogenerics S.A. Esplanade Heysel, b Bruxelles Belgium Zolpidem Eurogenerics bruis 10 mg bruistabletten, bruistabletten 10 mg effervescent tablet oral use FIDIA Farmaceutici S.p.a. Via Ponte della Fabbrica, 3/a, Abano Terme, Padova Italy Zolpidemtartraat 10 mg, filmomhulde tabletten Genthon BV Microweg, Nijmegen Zolpidemtartraat 5 mg, filmomhulde tabletten 5 mg film-coated tablet oral use Genthon BV Microweg, Nijmegen Zolpidemtartraat 10 mg, filmomhulde tabletten Meda Pharma B.V. Krijgsman DM AMSTELVEEN Edluar 5 mg, tablet voor sublinguaal gebruik 5 mg sublingual tablet sublingual use 65

66 Meda Pharma B.V. Krijgsman DM AMSTELVEEN Edluar 10 mg, tablet voor sublinguaal gebruik 10 mg sublingual tablet sublingual use Mylan B.V. Dieselweg LB BUNSCHOTEN Zolpidemtartraat Mylan 10 mg, filmomhulde tabletten Pharmachemie B.V. Swensweg GA HAARLEM Zolpidemtartraat 5 PCH, filmomhulde tabletten 5 mg 5 mg film-coated tablet oral use Pharmachemie B.V. Swensweg GA HAARLEM Zolpidemtartraat 10 PCH, filmomhulde tabletten 10 mg Sanofi-Aventis B.V. Kampenringweg 45 D-E 2803 PE GOUDA Stilnoct, tabletten 10 mg 10 mg tablet oral use STADA Arzneimittel AG Stadastrasse 2-18 DE Bad Vilbel Zolpidemtartraat Stada 5 mg, filmomhulde tabletten 5 mg film-coated tablet oral use 66

67 STADA Arzneimittel AG Stadastrasse 2-18 DE Bad Vilbel Zolpidemtartraat Stada 10 mg, filmomhulde tabletten Synthon B.V. Microweg CM NIJMEGEN Zolpidemtartraat 10 mg, filmomhulde tabletten United Kingdom Actavis UK Limited,Whiddon Valley, Barnstaple, North Devon EX32 8NS United Kingdom Zolpidem Tartrate 5mg tablets 5 mg film-coated tablet oral use United Kingdom Actavis UK Limited,Whiddon Valley, Barnstaple, North Devon EX32 8NS United Kingdom Zolpidem Tartrate 10mg tablets United Kingdom ALKALOID-INT d.o.o. Šlandrova ulica Ljubljana-Črnuče Zolpidem Tartrate 5mg film-coated tablets 5 mg film-coated tablet oral use United Kingdom ALKALOID-INT d.o.o. Šlandrova ulica Ljubljana-Črnuče Zolpidem Tartrate 10mg film-coated tablets 67

68 United Kingdom Aventis Pharma Limited, One Onslow Street, Guildford, Surrey GU1 4SY United Kingdom Stilnoct 5mg fiilm-coated tablets 5 mg coated tablet oral use United Kingdom Aventis Pharma Limited, One Onslow Street, Guildford, Surrey GU1 4SY United Kingdom Stilnoct 10mg 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 5mg 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 10mg film-coated tablets United Kingdom United Kingdom Generics [UK] Ltd. Station Close EN6 1TL Hertfordshire - Potters Bar United Kingdom Meda Pharmaceuticals Limited, Skyway House, Parsonage Road, Takeley, Bishops Stortford CM22 6PU United Kingdom Zolpidem 10mg film-coated tablets Edluar 5mg sublingual tablets 5 mg sublingual tablet oral use 68

69 United Kingdom Meda Pharmaceuticals Limited, Skyway House, Parsonage Road, Takeley, Bishops Stortford CM22 6PU United Kingdom Edluar 10mg 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 5mg 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 10mg film-coated tablets United Kingdom ratiopharm GmbH Graf Arco Strasse 3 D Ulm Zolpidem Tartrate 5mg film-coated tablets 5 mg film-coated tablet oral use United Kingdom ratiopharm GmbH Graf Arco Strasse 3 D Ulm Zolpidem Tartrate 10mg film-coated tablets United Kingdom Sandoz Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR United Kingdom Zolpidem Tartrate 10mg tablets 69

70 United Kingdom Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex BN22 9AG United Kingdom Zolpidem Tartrate 5mg, 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 10mg, film-coated tablets United Kingdom United Kingdom United Kingdom Tillomed Laboratories Limited, 3 Howard Road, Eaton Socon, St Neots, Cambridgeshire PE19 8ET United Kingdom Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS United Kingdom Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS United Kingdom Zolpidem 10mg film-coated tablets Zolpidem Tartrate 5mg tablets 5 mg film-coated tablet oral use Zolpidem Tartrate 10mg tablets 70