# Službeni list C 243/25.

| | ISSN 1977-1088 |
| --- | --- |
| Službeni list
  Europske unije | C 243 |
| | |
| Hrvatsko izdanje | Informacije i objave | Svezak 57.25. srpnja 2014. |

ISSN 1977-1088

Službeni list

Europske unije

C 243

Hrvatsko izdanje

Informacije i objave

Svezak 57.25. srpnja 2014.

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| Obavijest br. | Sadržaj | Stranica |
| --- | --- | --- |
| | IV.   Obavijesti |
| | OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE |
| | Europska komisija |
| 2014/C 243/01 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. lipnja 2014. do 30. lipnja 2014.(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća) | 1 |
| 2014/C 243/02 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. lipnja 2014. do 30. lipnja 2014.(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EZ ili člankom 38. Direktive 2001/82/EZ) | 11 |

Obavijest br.

Sadržaj

Stranica

IV.   Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

2014/C 243/01

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. lipnja 2014. do 30. lipnja 2014.(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća)

(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća)

1

2014/C 243/02

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. lipnja 2014. do 30. lipnja 2014.(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EZ ili člankom 38. Direktive 2001/82/EZ)

(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EZ ili člankom 38. Direktive 2001/82/EZ)

11

| HR | |
| --- | --- |

HR

---

IV. Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

| 25.7.2014 | HR | Službeni list Europske unije | C 243/1 |
| --- | --- | --- | --- |

25.7.2014

HR

Službeni list Europske unije

C 243/1

---

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. lipnja 2014. do 30. lipnja 2014.

(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća (1))

2014/C 243/01

—   Izdavanje odobrenja za stavljanje u promet (članak 13 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno

| Datum odluke | Naziv lijeka | INN (međunarodni nezaštićeni naziv lijeka) | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Farmaceutski oblik | Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova) | Datum obavijesti |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 30.6.2014. | Mekinist | trametinib | Glaxo Group Ltd |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |

Datum odluke

Naziv lijeka

INN (međunarodni nezaštićeni naziv lijeka)

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Farmaceutski oblik

Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova)

Datum obavijesti

30.6.2014.

Mekinist

trametinib

Glaxo Group Ltd

980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

EU/1/14/931

Filmom obložena tableta

L01XE25

2.7.2014.

—   Izmjena odobrenja za stavljanje u promet (članak 13 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno

| Datum odluke | Naziv lijeka | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Datum obavijesti |
| --- | --- | --- | --- | --- |
| 3.6.2014. | Adasuve | Alexza UK Ltd. |
| 10 Station Road, Henley-on-Thames, Oxfordshire RG9 1AY, United Kingdom |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

3.6.2014.

Adasuve

Alexza UK Ltd.

10 Station Road, Henley-on-Thames, Oxfordshire RG9 1AY, United Kingdom

EU/1/13/823

5.6.2014.

3.6.2014.

Clopidogrel Krka d.d.

| Krka, d. d., Novo Mesto |
| --- |
| Šmarješka cesta 6, 8501 Novo mesto, Slovenija |

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/562

5.6.2014.

3.6.2014.

Docetaxel Mylan

| Mylan S.A.S |
| --- |
| 117 allée des Parcs, F-69800 Saint Priest, France |

Mylan S.A.S

117 allée des Parcs, F-69800 Saint Priest, France

EU/1/11/748

5.6.2014.

3.6.2014.

Docetaxel Teva

| Teva Pharma B.V. |
| --- |
| Computerweg 10, NL-3542 DR Utrecht, Nederland |

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/09/611

6.6.2014.

3.6.2014.

Efficib

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/08/457

5.6.2014.

3.6.2014.

Ibandronic acid Sandoz

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstraße 11, D-83607 Holzkirchen, Deutschland |

Sandoz Pharmaceuticals GmbH

Raiffeisenstraße 11, D-83607 Holzkirchen, Deutschland

EU/1/11/685

5.6.2014.

3.6.2014.

Janumet

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/08/455

5.6.2014.

3.6.2014.

Kepivance

| Swedish Orphan Biovitrum AB (publ) |
| --- |
| SE-112 76, Stockholm, Sverige |

Swedish Orphan Biovitrum AB (publ)

SE-112 76, Stockholm, Sverige

EU/1/05/314

5.6.2014.

3.6.2014.

Kiovig

| Baxter AG |
| --- |
| Industriestraße 67, A-1221 Wien, Österreich |

Baxter AG

Industriestraße 67, A-1221 Wien, Österreich

EU/1/05/329

5.6.2014.

3.6.2014.

Lysodren

| Laboratoire HRA Pharma |
| --- |
| 15 rue Béranger, F-75003 Paris, France |

Laboratoire HRA Pharma

15 rue Béranger, F-75003 Paris, France

EU/1/04/273

5.6.2014.

3.6.2014.

Macugen

| Pfizer Limited |
| --- |
| Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/05/325

5.6.2014.

3.6.2014.

Memantine LEK

| Pharmathen S.A. |
| --- |
| 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα |

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/13/826

5.6.2014.

3.6.2014.

Nevanac

| Alcon Laboratories (UK) Ltd. |
| --- |
| Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom |

Alcon Laboratories (UK) Ltd.

Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom

EU/1/07/433

5.6.2014.

3.6.2014.

Pradaxa

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim International GmbH

Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/08/442

5.6.2014.

3.6.2014.

Prolia

| Amgen Europe B.V. |
| --- |
| Minervum 7061, NL-4817 ZK Breda, Nederland |

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/10/618

5.6.2014.

3.6.2014.

Ristfor

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/10/620

5.6.2014.

3.6.2014.

Velmetia

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/08/456

5.6.2014.

3.6.2014.

Yondelis

| Pharma Mar S.A. |
| --- |
| Avda de los Reyes 1, Polígono Industrial La Mina, E-28770 Colmenar Viejo, Madrid, España |

Pharma Mar S.A.

Avda de los Reyes 1, Polígono Industrial La Mina, E-28770 Colmenar Viejo, Madrid, España

EU/1/07/417

5.6.2014.

6.6.2014.

Champix

| Pfizer Limited |
| --- |
| Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/06/360

11.6.2014.

6.6.2014.

Edarbi

| Takeda Pharma A/S |
| --- |
| Dybendal Alle 10, 2630 Taastrup, Danmark |

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/11/734

11.6.2014.

6.6.2014.

Gardasil

| Sanofi Pasteur MSD, SNC |
| --- |
| 162 avenue Jean Jaurès, 69007 Lyon, France |

Sanofi Pasteur MSD, SNC

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/06/357

12.6.2014.

6.6.2014.

Resolor

| Shire Pharmaceuticals Ireland Limited |
| --- |
| 5 River Walk, Citywest Business Campus, Dublin 24, Ireland |

Shire Pharmaceuticals Ireland Limited

5 River Walk, Citywest Business Campus, Dublin 24, Ireland

EU/1/09/581

11.6.2014.

6.6.2014.

Silgard

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/06/358

13.6.2014.

6.6.2014.

Telmisartan Teva Pharma

| Teva Pharma B.V. |
| --- |
| Computerweg 10, NL-3542 DR Utrecht, Nederland |

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/11/719

12.6.2014.

6.6.2014.

Topotecan Actavis

| Actavis Group PTC ehf. |
| --- |
| Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland |

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland

EU/1/09/536

11.6.2014.

6.6.2014.

Zutectra

| Biotest Pharma GmbH |
| --- |
| Landsteinerstrasse 5, D-63303 Dreieich, Deutschland |

Biotest Pharma GmbH

Landsteinerstrasse 5, D-63303 Dreieich, Deutschland

EU/1/09/600

11.6.2014.

12.6.2014.

Imatinib Actavis

| Actavis Group PTC ehf. |
| --- |
| Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland |

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland

EU/1/13/825

16.6.2014.

19.6.2014.

Celvapan

| Baxter AG |
| --- |
| Industriestraße 67, A-1221 Wien, Österreich |

Baxter AG

Industriestraße 67, A-1221 Wien, Österreich

EU/1/08/506

23.6.2014.

19.6.2014.

Enurev Breezhaler

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/12/789

23.6.2014.

19.6.2014.

Erivedge

| Roche Registration Limited |
| --- |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/13/848

23.6.2014.

19.6.2014.

GILENYA

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/11/677

23.6.2014.

19.6.2014.

Ilaris

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/564

23.6.2014.

19.6.2014.

Incivo

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30, B-2340 Beerse, België |

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/11/720

23.6.2014.

19.6.2014.

Javlor

| Pierre Fabre Médicament |
| --- |
| 45, place Abel Gance, F-92100 Boulogne, France |

Pierre Fabre Médicament

45, place Abel Gance, F-92100 Boulogne, France

EU/1/09/550

23.6.2014.

19.6.2014.

Osseor

| Les Laboratoires Servier |
| --- |
| 50 rue Carnot, F-92284 Suresnes CEDEX, France |

Les Laboratoires Servier

50 rue Carnot, F-92284 Suresnes CEDEX, France

EU/1/04/287

23.6.2014.

19.6.2014.

Ozurdex

| Allergan Pharmaceuticals Ireland |
| --- |
| Castlebar Road, Westport, County Mayo, Ireland |

Allergan Pharmaceuticals Ireland

Castlebar Road, Westport, County Mayo, Ireland

EU/1/10/638

23.6.2014.

19.6.2014.

Protelos

| Les Laboratoires Servier |
| --- |
| 50 rue Carnot, F-92284 Suresnes CEDEX, France |

Les Laboratoires Servier

50 rue Carnot, F-92284 Suresnes CEDEX, France

EU/1/04/288

23.6.2014.

19.6.2014.

Remicade

| Janssen Biologics B.V. |
| --- |
| Einsteinweg 101, NL-2333 CB Leiden, Nederland |

Janssen Biologics B.V.

Einsteinweg 101, NL-2333 CB Leiden, Nederland

EU/1/99/116

23.6.2014.

19.6.2014.

Repaglinide Teva

| Teva Pharma B.V. |
| --- |
| Computerweg 10, NL-3542 DR Utrecht, Nederland |

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/09/530

23.6.2014.

19.6.2014.

Samsca

| Otsuka Pharmaceutical Europe Ltd. |
| --- |
| Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom |

Otsuka Pharmaceutical Europe Ltd.

Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom

EU/1/09/539

23.6.2014.

19.6.2014.

Seebri Breezhaler

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/12/788

23.6.2014.

19.6.2014.

Simponi

| Janssen Biologics B.V. |
| --- |
| Einsteinweg 101, NL-2333 CB Leiden, Nederland |

Janssen Biologics B.V.

Einsteinweg 101, NL-2333 CB Leiden, Nederland

EU/1/09/546

23.6.2014.

19.6.2014.

Topotecan Teva

| Teva Pharma B.V. |
| --- |
| Computerweg 10, NL-3542 DR Utrecht, Nederland |

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/09/552

23.6.2014.

19.6.2014.

Tovanor Breezhaler

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/12/790

23.6.2014.

19.6.2014.

Valdoxan

| Les Laboratoires Servier |
| --- |
| 50 rue Carnot, F-92284 Suresnes CEDEX, France |

Les Laboratoires Servier

50 rue Carnot, F-92284 Suresnes CEDEX, France

EU/1/08/499

23.6.2014.

19.6.2014.

Votubia

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/11/710

23.6.2014.

23.6.2014.

Angiox

| The Medicines Company UK Ltd |
| --- |
| 115 L Milton Park, Abingdon, Oxfordshire OX14 4SA, United Kingdom |

The Medicines Company UK Ltd

115 L Milton Park, Abingdon, Oxfordshire OX14 4SA, United Kingdom

EU/1/04/289

25.6.2014.

23.6.2014.

Bosulif

| Pfizer Limited |
| --- |
| Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/13/818

25.6.2014.

23.6.2014.

Brilique

| AstraZeneca AB |
| --- |
| SE-151 85 Södertälje, Sverige |

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/10/655

25.6.2014.

23.6.2014.

Diacomit

| Biocodex |
| --- |
| 7 avenue Gallieni, F-94250 Gentilly, France |

Biocodex

7 avenue Gallieni, F-94250 Gentilly, France

EU/1/06/367

25.6.2014.

23.6.2014.

Prevenar 13

| Pfizer Limited |
| --- |
| Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/09/590

25.6.2014.

23.6.2014.

Thymanax

| Servier (Ireland) Industries Limited |
| --- |
| Gorey Road, Arklow, Co. Wicklow, Ireland |

Servier (Ireland) Industries Limited

Gorey Road, Arklow, Co. Wicklow, Ireland

EU/1/08/498

25.6.2014.

23.6.2014.

Vfend

| Pfizer Limited |
| --- |
| Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/02/212

25.6.2014.

23.6.2014.

Yondelis

| Pharma Mar S.A. |
| --- |
| Avda de los Reyes 1, Polígono Industrial La Mina, E-28770 Colmenar Viejo, Madrid, España |

Pharma Mar S.A.

Avda de los Reyes 1, Polígono Industrial La Mina, E-28770 Colmenar Viejo, Madrid, España

EU/1/07/417

25.6.2014.

23.6.2014.

Zeffix

| Glaxo Group Ltd |
| --- |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |

Glaxo Group Ltd

980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

EU/1/99/114

25.6.2014.

27.6.2014.

Amyvid

| Eli Lilly Nederland B.V. |
| --- |
| Grootslag 1-5, NL-3991 RA Houten, Nederland |

Eli Lilly Nederland B.V.

Grootslag 1-5, NL-3991 RA Houten, Nederland

EU/1/12/805

1.7.2014.

27.6.2014.

Cayston

| Gilead Sciences International Limited |
| --- |
| Granta Park, Abington, Cambridge CB21 6GT, United Kingdom |

Gilead Sciences International Limited

Granta Park, Abington, Cambridge CB21 6GT, United Kingdom

EU/1/09/543

1.7.2014.

27.6.2014.

Circadin

| RAD Neurim Pharmaceuticals EEC Limited |
| --- |
| One Forbury Square, The Forbury, Reading, Berkshire RG1 3EB, United Kingdom |

RAD Neurim Pharmaceuticals EEC Limited

One Forbury Square, The Forbury, Reading, Berkshire RG1 3EB, United Kingdom

EU/1/07/392

1.7.2014.

27.6.2014.

Esbriet

| InterMune UK Limited |
| --- |
| Grove House, 2nd Floor, 248A Marylebone Road, London NW1 6JZ, United Kingdom |

InterMune UK Limited

Grove House, 2nd Floor, 248A Marylebone Road, London NW1 6JZ, United Kingdom

EU/1/11/667

1.7.2014.

27.6.2014.

Foclivia

| Novartis Vaccines and Diagnostics S.r.l. |
| --- |
| Via Fiorentina, 1, 53100 Siena, Italia |

Novartis Vaccines and Diagnostics S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

EU/1/09/577

1.7.2014.

27.6.2014.

HALAVEN

| Eisai Europe Limited |
| --- |
| European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom |

Eisai Europe Limited

European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom

EU/1/11/678

1.7.2014.

27.6.2014.

Ibandronic Acid Teva

| Teva Pharma B.V. |
| --- |
| Computerweg 10, NL-3542 DR Utrecht, Nederland |

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/10/642

2.7.2014.

27.6.2014.

Kineret

| Swedish Orphan Biovitrum AB (publ) |
| --- |
| SE-112 76, Stockholm, Sverige |

Swedish Orphan Biovitrum AB (publ)

SE-112 76, Stockholm, Sverige

EU/1/02/203

1.7.2014.

27.6.2014.

Orfadin

| Swedish Orphan Biovitrum International AB |
| --- |
| SE-112 76, Stockholm, Sverige |

Swedish Orphan Biovitrum International AB

SE-112 76, Stockholm, Sverige

EU/1/04/303

1.7.2014.

27.6.2014.

Rasilamlo

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/11/686

9.7.2014.

27.6.2014.

Rasilez

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/07/405

9.7.2014.

27.6.2014.

Rasilez HCT

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/08/491

9.7.2014.

27.6.2014.

Topotecan Hospira

| Hospira UK Limited |
| --- |
| Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom |

Hospira UK Limited

Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom

EU/1/10/633

1.7.2014.

27.6.2014.

Xyrem

| UCB Pharma Ltd. |
| --- |
| 208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom |

UCB Pharma Ltd.

208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom

EU/1/05/312

1.7.2014.

27.6.2014.

ZALTRAP

| Sanofi-Aventis groupe |
| --- |
| 54 rue La Boétie, F-75008 Paris, France |

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/12/814

1.7.2014.

27.6.2014.

Zoledronic acid Teva

| Teva Pharma B.V. |
| --- |
| Computerweg 10, NL-3542 DR Utrecht, Nederland |

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/12/771

2.7.2014.

30.6.2014.

Arzerra

| Glaxo Group Ltd |
| --- |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |

Glaxo Group Ltd

980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

EU/1/10/625

2.7.2014.

30.6.2014.

Avastin

| Roche Registration Limited |
| --- |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/04/300

2.7.2014.

30.6.2014.

Exforge HCT

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/569

9.7.2014.

30.6.2014.

Perjeta

| Roche Registration Limited |
| --- |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/13/813

2.7.2014.

—   Izdavanje odobrenja za stavljanje u promet (članak 38 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća (2)): Prihvaćeno

| Datum odluke | Naziv lijeka | INN (međunarodni nezaštićeni naziv lijeka) | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Farmaceutski oblik | Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova) | Datum obavijesti |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 6.6.2014. | Vectra Felis | dinotefurana, piriproksifena | CEVA SANTE ANIMALE |
| 10 avenue de la Ballastière, F-33500 Libourne, France |

Datum odluke

Naziv lijeka

INN (međunarodni nezaštićeni naziv lijeka)

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Farmaceutski oblik

Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova)

Datum obavijesti

6.6.2014.

Vectra Felis

dinotefurana, piriproksifena

CEVA SANTE ANIMALE

10 avenue de la Ballastière, F-33500 Libourne, France

EU/2/14/165

Otopina za nakapavanje

QP53AX73

11.6.2014.

—   Izmjena odobrenja za stavljanje u promet (članak 38 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno

| Datum odluke | Naziv lijeka | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Datum obavijesti |
| --- | --- | --- | --- | --- |
| 3.6.2014. | Activyl | Intervet International B.V. |
| Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

3.6.2014.

Activyl

Intervet International B.V.

Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland

EU/2/10/118

05.06.2014

6.6.2014.

Cerenia

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/06/062

11.6.2014.

6.6.2014.

Leucofeligen FeLV/RCP

| Virbac |
| --- |
| 1ère Avenue – 2065 m – L.I.D., F-06516 Carros CEDEX, France |

Virbac

1ère Avenue – 2065 m – L.I.D., F-06516 Carros CEDEX, France

EU/2/09/097

11.6.2014.

6.6.2014.

Melovem

| Dopharma Research B.V. |
| --- |
| Zalmweg 24, NL-4941 VX Raamsdonksveer, Nederland |

Dopharma Research B.V.

Zalmweg 24, NL-4941 VX Raamsdonksveer, Nederland

EU/2/09/098

11.6.2014.

6.6.2014.

Metacam

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| D-55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/97/004

11.6.2014.

6.6.2014.

Suvaxyn PCV

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/09/099

11.6.2014.

12.6.2014.

Leucogen

| Virbac |
| --- |
| 1ère Avenue – 2065 m – L.I.D., F-06516 Carros CEDEX, France |

Virbac

1ère Avenue – 2065 m – L.I.D., F-06516 Carros CEDEX, France

EU/2/09/096

16.6.2014.

19.6.2014.

Locatim

| Biokema Anstalt |
| --- |
| Pflugstrasse 12, 9490 Vaduz, Fürstentum Liechtenstein |

Biokema Anstalt

Pflugstrasse 12, 9490 Vaduz, Fürstentum Liechtenstein

EU/2/99/011

23.6.2014.

19.6.2014.

Previcox

| Merial |
| --- |
| 29 avenue Tony Garnier, F-69007 Lyon, France |

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/04/045

23.6.2014.

23.6.2014.

Econor

| Novartis Tiergesundheit GmbH |
| --- |
| Zielstattstrasse 40, D-81379 München, Deutschland |

Novartis Tiergesundheit GmbH

Zielstattstrasse 40, D-81379 München, Deutschland

EU/2/98/010

25.6.2014.

27.6.2014.

Hiprabovis IBR Marker Live

| Laboratorios Hipra, S.A. |
| --- |
| Avda. La Selva, 135, E-17170- Amer (Girona), España |

Laboratorios Hipra, S.A.

Avda. La Selva, 135, E-17170- Amer (Girona), España

EU/2/10/114

1.7.2014.

27.6.2014.

Zulvac 8 Bovis

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/09/105

1.7.2014.

27.6.2014.

Zulvac 8 Ovis

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/09/104

1.7.2014.

30.6.2014.

TruScient

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/11/136

2.7.2014.

Zainteresirane osobe koje žele na uvid dobiti javno izvješće o procjeni predmetnih lijekova i odluka koje se na njih odnose trebale bi se obratiti:

| The European Medicines Agency |
| --- |
| 7, Westferry Circus, Canary Wharf |
| UK – LONDON E14 4H |

The European Medicines Agency

7, Westferry Circus, Canary Wharf

UK – LONDON E14 4H

---

(1)  SL L 136, 30.4.2004., str. 1.

(2)  SL L 136, 30.4.04, str. 1.

---

| 25.7.2014 | HR | Službeni list Europske unije | C 243/11 |
| --- | --- | --- | --- |

25.7.2014

HR

Službeni list Europske unije

C 243/11

---

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. lipnja 2014. do 30. lipnja 2014.

(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EZ (1) ili člankom 38. Direktive 2001/82/EZ (2))

2014/C 243/02

—   Izdavanje, zadržavanje ili izmjena nacionalnog odobrenja za stavljanje u promet

| Datum odluke | Naziv(i) lijeka | INN (međunarodni nezaštićeni naziv lijeka) | Nositelj(i) odobrenja za stavljanje u promet | Država članica na koju se odnosi | Datum obavijesti |
| --- | --- | --- | --- | --- | --- |
| 23.6.2014. | Zolpidem | Vidi Prilog I. | Vidi Prilog I. | Vidi Prilog I. | 24.6.2014. |
| 30.6.2014. | Crestor | Vidi Prilog II. | Vidi Prilog II. | Vidi Prilog II. | 1.7.2014. |

Datum odluke

Naziv(i) lijeka

INN (međunarodni nezaštićeni naziv lijeka)

Nositelj(i) odobrenja za stavljanje u promet

Država članica na koju se odnosi

Datum obavijesti

23.6.2014.

Zolpidem

Vidi Prilog I.

Vidi Prilog I.

Vidi Prilog I.

24.6.2014.

30.6.2014.

Crestor

Vidi Prilog II.

Vidi Prilog II.

Vidi Prilog II.

1.7.2014.

---

(1)  SL L 311, 28.11.2001., str. 67.

(2)  SL L 311, 28.11.2001., str. 1.

---

Dodatak I

Popis naziva, farmaceutskih oblika, jačina lijekova, puta primjene, nositelja odobrenja u državama članicama

| Država članica EU/EGP | Nositelj odobrenja | Zaštićeno ime | Jačina | Farmaceutski oblik | Put primjene |
| --- | --- | --- | --- | --- | --- |
| Austrija | G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria | Zoldem 5 mg – Filmtabletten | 5 mg | filmom obložena tableta | kroz usta |
| Austrija | G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria | Zoldem 10 mg – Filmtabletten | 10 mg | filmom obložena tableta | kroz usta |
| Austrija | G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria | Zolpidem G.L. 10 mg – Filmtabletten | 10 mg | filmom obložena tableta | kroz usta |
| Austrija | Hexal Pharma GmbH, Stella-Klein-Löw-Weg 17, 1020 Wien, Austria | Zolpidem „Hexal” – Filmtabletten | 10 mg | filmom obložena tableta | kroz usta |
| Austrija | Meda Pharma GmbH, Guglgasse 15, 1110 Wien, Austria | Edluar 5 mg Sublingualtabletten | 5 mg | sublingvalna tableta | pod jezik |
| Austrija | Meda Pharma GmbH, Guglgasse 15, 1110 Wien, Austria | Edluar 10 mg Sublingualtabletten | 10 mg | sublingvalna tableta | pod jezik |
| Austrija | ratiopharm Arzneimittel Vertriebs-GmbH, Albert-Schweitzer-Gasse 3, 1140 Wien, Austria | Zolpidem „ratiopharm” 10 mg Filmtabletten | 10 mg | filmom obložena tableta | kroz usta |
| Austrija | sanofi-aventis GmbH, Saturn Tower, Leonard-Bernstein-Straße 10, 1220 Wien, Austria | Ivadal – Filmtabletten | 10 mg | filmom obložena tableta | kroz usta |
| Austrija | STADA Arzneimittel GmbH, Muthgasse 36/2, 1190 Wien, Austria | Mondeal 10 mg – Filmtabletten | 10 mg | filmom obložena tableta | kroz usta |
| Belgija | APOTEX NV
  Av. du Bourg. Etienne Demunter 5 box 8
  1090 Jette
  Belgium | Zolpitop | 10 mg | filmom obložena tableta | kroz usta |
| Belgija | APOTEX NV
  Av. du Bourg. Etienne Demunter 5 box 8
  1090 Jette
  Belgium | Zolpitop | 5 mg | filmom obložena tableta | kroz usta |
| Belgija | Eurogenerics S.A.
  Esplanade Heysel, b22
  1020 Bruxelles
  Belgium | Zolpidem EG | 10 mg | filmom obložena tableta | kroz usta |
| Belgija | Eurogenerics S.A.
  Esplanade Heysel, b22
  1020 Bruxelles
  Belgium | Zolpidem EG | 10 mg | šumeća tableta | kroz usta |
| Belgija | Ipca, Produtos Farmaceuticos, Unipessoal Lda
  Rua Chanceler-Mor 11 R/c Frt.
  Cacem
  2735-615
  Portugal | Zolpidem IPCA | 5 mg | filmom obložena tableta | kroz usta |
| Belgija | Ipca, Produtos Farmaceuticos, Unipessoal Lda
  Rua Chanceler-Mor 11 R/c Frt.
  Cacem
  2735-615
  Portugal | Zolpidem IPCA | 10 mg | filmom obložena tableta | kroz usta |
| Belgija | MEDA PHARMA
  Chaussee de la Hulpe 166
  1170 Watermael-Boitsfort
  Belgium | Zolpeduar | 5 mg | sublingvalna tableta | kroz usta |
| Belgija | MEDA PHARMA
  Chaussee de la Hulpe 166
  1170 Watermael-Boitsfort
  Belgium | Zolpeduar | 10 mg | sublingvalna tableta | kroz usta |
| Belgija | MYLAN BVBA/SPRL
  Terhulpsesteenweg 6A
  1560 Hoeilaart
  Belgium | Zolpidem Mylan | 10 mg | filmom obložena tableta | kroz usta |
| Belgija | SANDOZ N.V.
  Telecom Gardens
  Medialaan 40
  1800 1800ilvoorde
  Belgium | Zolpidem Sandoz | 10 mg | filmom obložena tableta | kroz usta |
| Belgija | SANOFI BELGIUM
  Airport Plaza, Montreal Building, Leonardo Da Vincilaan 19
  1831 Diegem
  Belgium | Stilnoct | 10 mg | tableta | kroz usta |
| Belgija | SANOFI BELGIUM
  Airport Plaza, Montreal Building, Leonardo Da Vincilaan 19
  1831 Diegem
  Belgium | Zolpidem Sanofi-Aventis Belgium | 10 mg | filmom obložena tableta | kroz usta |
| Belgija | TEVA PHARMA BELGIUM NV
  Laarstraat 16
  2610 Wilrijk
  Belgium | Zolpidem Teva | 10 mg | filmom obložena tableta | kroz usta |
| Belgija | TEVA PHARMA BELGIUM NV
  Laarstraat 16
  2610 Wilrijk
  Belgium | Zolpidem Ratiopharm | 10 mg | filmom obložena tableta | kroz usta |
| Bugarska | ALKALOID-INT d.o.o.
  Šlandrova ulica 4
  1231 Ljubljana-Črnuče Slovenia | Adorma | 5 mg | filmom obložena tableta | kroz usta |
| Bugarska | ALKALOID-INT d.o.o.
  Šlandrova ulica 4
  1231 Ljubljana-Črnuče Slovenia | Adorma | 10 mg | filmom obložena tableta | kroz usta |
| Bugarska | Krka, d.d., Novo mesto
  Šmarješka cesta 6
  8000 Novo mesto
  Slovenia | Zolsana | 5 mg | filmom obložena tableta | kroz usta |
| Bugarska | Krka, d.d., Novo mesto
  Šmarješka cesta 6
  8000 Novo mesto
  Slovenia | Zolsana | 10 mg | filmom obložena tableta | kroz usta |
| Bugarska | Meda Pharma GmbH & Co. KG
  Benzstrasse 1
  Bad Homburg v.d.H
  61352
  Germany | Edluar | 5 mg | sublingvalna tableta | pod jezik |
| Bugarska | Meda Pharma GmbH & Co. KG
  Benzstrasse 1
  Bad Homburg v.d.H
  61352
  Germany | Edluar | 10 mg | sublingvalna tableta | pod jezik |
| Bugarska | Sanofi-Aventis Bulgaria EOOD,
  103 Alexander Stamboliiski Blvd. Building Sofia Tower
  Sofia 1303
  Bulgaria | Stilnox | 10 mg | filmom obložena tableta | kroz usta |
| Hrvatska | Alkaloid d.o.o., Ulica grada Vukovara 226 F, Zagreb, Croatia | Lunata 5 mg filmom obložene tablete | 5 mg | filmom obložena tableta | kroz usta |
| Hrvatska | Alkaloid d.o.o., Ulica grada Vukovara 226 F, Zagreb, Croatia | Lunata 10 mg filmom obložene tablete | 10 mg | filmom obložena tableta | kroz usta |
| Hrvatska | Krka – farma d.o.o., Radnička cesta 48, Zagreb, Croatia | Zolsana 5 mg filmom obložene tablete | 5 mg | filmom obložena tableta | kroz usta |
| Hrvatska | Krka – farma d.o.o., Radnička cesta 48, Zagreb, Croatia | Zolsana 10 mg filmom obložene tablete | 10 mg | filmom obložena tableta | kroz usta |
| Hrvatska | Pliva Hrvatska d.o.o., Prilaz baruna Filipovića 25, Zagreb, Croatia | Zonadin 5 mg tablete | 5 mg | filmom obložena tableta | kroz usta |
| Hrvatska | Pliva Hrvatska d.o.o., Prilaz baruna Filipovića 25, Zagreb, Croatia | Zonadin 10 mg tablete | 10 mg | filmom obložena tableta | kroz usta |
| Hrvatska | Sandoz d.o.o., Maksimirska 120, Zagreb, 1000, Croatia | Sanval 5 mg filmom obložene tablete | 5 mg | filmom obložena tableta | kroz usta |
| Hrvatska | Sandoz d.o.o., Maksimirska 120, Zagreb, 1000, Croatia | Sanval 10 mg filmom obložene tablete | 10 mg | filmom obložena tableta | kroz usta |
| Cipar | Sanofi-Aventis Cyprus Ltd
  Charalambou Mouskou 14
  Lefkosia 2015 Cyprus | Stilnox | 10 mg | filmom obložena tableta | kroz usta |
| Češka Republika | ALKALOID-INT d.o.o.
  Šlandrova ulica 4
  1231 Ljubljana-Črnuče Slovenia | ADORMA 5 MG | 5 mg | filmom obložena tableta | kroz usta |
| Češka Republika | ALKALOID-INT d.o.o.
  Šlandrova ulica 4
  1231 Ljubljana-Črnuče Slovenia | ADORMA 10 MG | 10 mg | filmom obložena tableta | kroz usta |
| Češka Republika | Apotex Europe B.V.
  Darwinweg 20
  NL 2333 CR Leiden
  Netherlands | APO-ZOLPIDEM 10 MG | 10 mg | filmom obložena tableta | kroz usta |
| Češka Republika | Generics [UK] Ltd.
  Station Close
  EN6 1TL Hertfordshire – Potters Bar
  United Kingdom | ZOLPIDEM MYLAN | 10 mg | filmom obložena tableta | kroz usta |
| Češka Republika | Krka, d.d., Novo mesto
  Šmarješka cesta 6
  8501 Novo mesto
  Slovenia | ZOLSANA 10 MG | 10 mg | filmom obložena tableta | kroz usta |
| Češka Republika | MEDA Pharma s.r.o.
  Kodaňská 1441/46
  110 00 Prague 10
  Czech Republic | EDLUAR 5 MG SUBLINGVÁLNÍ TABLETY | 5 mg | sublingvalna tableta | pod jezik |
| Češka Republika | MEDA Pharma s.r.o.
  Kodaňská 1441/46
  110 00 Prague 10
  Czech Republic | EDLUAR 10 MG SUBLINGVÁLNÍ TABLETY | 10 mg | sublingvalna tableta | pod jezik |
| Češka Republika | Orion Corporation
  Orionintie 1/A
  FI-02200 Espoo
  Finland | ZOLPIDEM ORION 10 MG | 10 mg | filmom obložena tableta | kroz usta |
| Češka Republika | ratiopharm GmbH
  Graf Arco Strasse 3
  D-89079 Ulm
  Germany | ZOLPIDEM-RATIOPHARM 10 MG | 10 mg | filmom obložena tableta | kroz usta |
| Češka Republika | SANDOZ s.r.o.
  U nákladového nádraží 3265/10
  130 00 Prague 3
  Czech Republic | SANVAL 10 MG | 10 mg | filmom obložena tableta | kroz usta |
| Češka Republika | sanofi-aventis, s.r.o.
  Evropská 846/176a
  160 00 Prague 6 – Vokovice
  Czech Republic | STILNOX | 10 mg | filmom obložena tableta | kroz usta |
| Češka Republika | SVUS Pharma a.s., Smetanovo nábřeží 1238/20a
  500 02 Hradec Králové Czech Republic | ZOLPINOX | 10 mg | filmom obložena tableta | kroz usta |
| Češka Republika | Takeda GmbH
  Byk-Gulden-Str. 2
  78467 Konstanz
  Germany | HYPNOGEN | 10 mg | filmom obložena tableta | kroz usta |
| Češka Republika | Vitabalans Oy
  Varastokatu 8
  13500 Hämeenlinna
  Finland | ZOLPIDEM VITABALANS 10 MG POTAHOVANÉ TABLETY | 10 mg | filmom obložena tableta | kroz usta |
| Danska | Actavis Group PTC ehf.
  Reykjavikurvegur 76-78
  IS-220 Hafnarfjördur
  Iceland | Zolpidem „Actavis” | 10 mg | filmom obložena tableta | kroz usta |
| Danska | Actavis Group PTC ehf.
  Reykjavikurvegur 76-78
  IS-220 Hafnarfjördur
  Iceland | Zolpidem „Actavis” | 5 mg | filmom obložena tableta | kroz usta |
| Danska | Generics [UK] Ltd.
  Station Close
  EN6 1TL Hertfordshire – Potters Bar
  United Kingdom | Zolpidem „Generics” | 10 mg | filmom obložena tableta | kroz usta |
| Danska | HEXAL A/S, Kanalholmen 8-12, DK-2650 Hvodovre, Denmark | Zolpidem „Hexal” | 10 mg | filmom obložena tableta | kroz usta |
| Danska | Meda AS, Solvang 8, DK-3450 Allerød, Denmark | Edluar | 5 mg | sublingvalna tableta | pod jezik |
| Danska | Meda AS, Solvang 8, DK-3450 Allerød, Denmark | Edluar | 10 mg | sublingvalna tableta | pod jezik |
| Danska | PharmaCoDane ApS, Marielundvej 46 A, DK-2730 Herlev, Denmark | Zonoct | 10 mg | filmom obložena tableta | kroz usta |
| Danska | sanofi-aventis Denmark A/S, Slotsmarken 13, DK-2970 Hørsholm, Denmark | Stilnoct | 10 mg | filmom obložena tableta | kroz usta |
| Danska | Synthon BV, Microweg 22, NL-6545 CM Nijmegen, The Netherlands | Zolpidem „Genthon” | 5 mg | filmom obložena tableta | kroz usta |
| Danska | Synthon BV, Microweg 22, NL-6545 CM Nijmegen, The Netherlands | Zolpidem „Genthon” | 10 mg | filmom obložena tableta | kroz usta |
| Danska | Vitabalans Oy
  Varastokatu 8
  13500 Hämeenlinna
  Finland | Zolpidem „Vitabalans” | 10 mg | filmom obložena tableta | kroz usta |
| Estonija | Krka, d.d., Novo mesto
  Šmarješka cesta 6
  8000 Novo mesto
  Slovenia | ZOLSANA | 5 mg | tableta | kroz usta |
| Estonija | Krka, d.d., Novo mesto
  Šmarješka cesta 6
  8000 Novo mesto
  Slovenia | ZOLSANA | 10 mg | tableta | kroz usta |
| Estonija | Meda Pharma GmbH & Co. KG
  Benzstrasse 1
  Bad Homburg v.d.H
  61352
  Germany | EDLUAR | 5 mg | sublingvalna tableta | kroz usta |
| Estonija | Meda Pharma GmbH & Co. KG
  Benzstrasse 1
  Bad Homburg v.d.H
  61352
  Germany | EDLUAR | 10 mg | sublingvalna tableta | kroz usta |
| Estonija | Sandoz d.d.
  Verovškova 57,
  1000 Ljubljana,
  Slovenia | ZOLPIDEM SANDOZ 10 MG | 10 mg | tableta | kroz usta |
| Estonija | Sanofi-Aventis Estonia OÜ Pärnu mnt 139E/2
  11317 Tallinn
  Estonia | STILNOX | 10 mg | tableta | kroz usta |
| Estonija | Takeda GmbH 2 Byk-Gulden Strasse
  78467 Konstanz Germany | HYPNOGEN | 10 mg | tableta | kroz usta |
| Estonija | Vitabalans Oy
  Varastokatu 8
  13500 Hämeenlinna
  Finland | ZOLPIDEM VITABALANS 10 MG | 10 mg | tableta | kroz usta |
| Finska | Actavis Group PTC ehf.
  Reykjavikurvegur 76-78
  IS-220 Hafnarfjördur
  Iceland | Stella | 5 mg | filmom obložena tableta | kroz usta |
| Finska | Actavis Group PTC ehf.
  Reykjavikurvegur 76-78
  IS-220 Hafnarfjördur
  Iceland | Stella | 10 mg | filmom obložena tableta | kroz usta |
| Finska | Hexal A/S
  Edvard Thomsens Vej 14
  DK-2300 Köpenhamn S
  Denmark | Zolpidem Hexal | 10 mg | filmom obložena tableta | kroz usta |
| Finska | Meda Oy
  Vaisalantie 4
  02130 Espoo
  Finland | Edluar | 5 mg | sublingvalna tableta | pod jezik |
| Finska | Meda Oy
  Vaisalantie 4
  02130 Espoo
  Finland | Edluar | 10 mg | sublingvalna tableta | pod jezik |
| Finska | Orion Corporation
  Orionintie 1/A
  FI-02200 Espoo
  Finland | Somnor | 10 mg | filmom obložena tableta | kroz usta |
| Finska | ratiopharm GmbH
  Graf Arco Strasse 3
  D-89079 Ulm
  Germany | Zolpidem-Ratiopharm | 10 mg | filmom obložena tableta | kroz usta |
| Finska | Sanofi Oy
  Huopalahdentie 24
  P.O.Box 22
  00350 Helsinki
  Finland | Stilnoct | 10 mg | filmom obložena tableta | kroz usta |
| Finska | Vitabalans Oy
  Varastokatu 8
  13500 Hämeenlinna
  Finland | Zolpidem Vitabalans | 10 mg | filmom obložena tableta | kroz usta |
| Francuska | LABORATOIRES ALTER
  3, avenue de la Baltique
  ZI de Courtaboeuf
  91140 Villebon Sur Yvette France | ZOLPIDEM ALTER | 10 mg | filmom obložena tableta | kroz usta |
| Francuska | Actavis Group PTC ehf.
  Reykjavikurvegur 76-78
  IS-220 Hafnarfjördur
  Iceland | ZOLPIDEM ACTAVIS | 10 MG | filmom obložena tableta | kroz usta |
| Francuska | ARROW GENERIQUES
  26, avenue Tony Garnier
  69007 Lyon France | ZOLPIDEM ARROW | 10 mg | filmom obložena tableta | kroz usta |
| Francuska | BIOGARAN
  15, boulevard Charles de Gaulle
  92700 Colombes FRANCE | ZOLPIDEM ALMUS | 10 mg | filmom obložena tableta | kroz usta |
| Francuska | BIOGARAN
  15, boulevard Charles de Gaulle
  92700 Colombes FRANCE | ZOLPIDEM BIOGARAN | 10 mg | filmom obložena tableta | kroz usta |
| Francuska | CRISTERS
  22 quai Gallieni
  92150 Suresnes France | ZOLPIDEM CRISTERS | 10 mg | filmom obložena tableta | kroz usta |
| Francuska | CTRS
  Route de la Ganne
  36170 Saint Benoit du Sault France | ZOLPIDEM CTRS | 10 mg | filmom obložena tableta | kroz usta |
| Francuska | EG LABO – LABORATOIRES EUROGENERICS
  „Le Quintet” – bâtiment A
  12, rue Danjou
  92517 Boulogne Billancourt Cedex France | ZOLPIDEM EG | 10 mg | filmom obložena tableta | kroz usta |
| Francuska | EG LABO – LABORATOIRES EUROGENERICS
  „Le Quintet” – bâtiment A
  12, rue Danjou
  92517 Boulogne Billancourt Cedex France | ZOLPIDEM EG | 10 mg | obložena tableta | kroz usta |
| Francuska | Genfarma B.V.
  Postbus 2062
  1500 GB Zaandam
  The Netherlands | ZOLPIDEM RATIOPHARM | 10 mg | obložena tableta | kroz usta |
| Francuska | Kiron Pharmaceutica BV
  Groesbeekseweg 11 Nijmegen, 6524 CK
  The Netherlands | ZOLPIDEM KIRION | 5 mg | filmom obložena tableta | kroz usta |
| Francuska | MEDA PHARMA
  25, boulevard de l'Amiral Bruix
  75016 Paris
  FRANCE | EDLUAR | 5 mg | sublingvalna tableta | kroz usta |
| Francuska | MEDA PHARMA
  25, boulevard de l'Amiral Bruix
  75016 Paris
  FRANCE | EDLUAR | 10 mg | sublingvalna tableta | kroz usta |
| Francuska | MYLAN SAS
  117, allée des Parcs
  69800 Saint-Priest
  France | ZOLPIDEM MYLAN | 10 mg | filmom obložena tableta | kroz usta |
| Francuska | PHARMACHEMIE BV
  Swensweg 5 – Haarlem
  PO Box 552
  2003 RN Haarlem PAYS-BAS
  The Netherlands | ZOLPIDEM TEVA | 10 mg | obložena tableta | kroz usta |
| Francuska | RANBAXY PHARMACIE GENERIQUES
  11-15 Quai Dion Bouton
  92800 Puteaux FRANCE | ZOLPIDEM RPG | 10 mg | filmom obložena tableta | kroz usta |
| Francuska | RATIOPHARM GMBH
  Graf Arco Strasse 3
  89079 Ulm ALLEMAGNE | ZOLPIDEM RATIOPHARM | 10 mg | filmom obložena tableta | kroz usta |
| Francuska | SANDOZ
  49, avenue Georges Pompidou
  92300 Levallois-Perret France | ZOLPIDEM GNR | 10 mg | filmom obložena tableta | kroz usta |
| Francuska | SANDOZ
  49, avenue Georges Pompidou
  92300 Levallois-Perret France | ZOLPIDEM GENERES | 10 mg | filmom obložena tableta | kroz usta |
| Francuska | SANDOZ
  49, avenue Georges Pompidou
  92300 Levallois-Perret France | ZOLPIDEM SANDOZ | 10 mg | filmom obložena tableta | kroz usta |
| Francuska | SANOFI AVENTIS FRANCE
  1-13, boulevard Romain Rolland
  75014 Paris
  France | STILNOX | 10 mg | filmom obložena tableta | kroz usta |
| Francuska | SANOFI AVENTIS FRANCE
  1-13, boulevard Romain Rolland
  75014 Paris France | ZOLPIDEM ZENTIVA | 10 mg | filmom obložena tableta | kroz usta |
| Francuska | Synthon BV, Microweg 22, NL-6545 CM Nijmegen, The Netherlands | ZOLPIDEM BAYER | 10 mg | filmom obložena tableta | kroz usta |
| Francuska | Synthon BV, Microweg 22, NL-6545 CM Nijmegen, The Netherlands | ZOLPIDEM BAYER | 5 mg | filmom obložena tableta | kroz usta |
| Francuska | TEVA SANTE
  110, Esplanade du Général de Gaulle
  92931 Paris La Défense Cedex FRANCE | ZOLPIDEM TEVA | 10 mg | filmom obložena tableta | kroz usta |
| Francuska | ZYDUS FRANCE
  25, rue des Peupliers
  ZAC Les Hautes Pâtures – Parc d’Activités des Peupliers
  92000 Nanterre FRANCE | ZOLPIDEM ZYDUS | 10 mg | filmom obložena tableta | kroz usta |
| Njemačka | 1 A Pharma
  Keltenring 1 + 3
  82041 Oberhaching
  Germany | Zolpidem 10 – 1A-Pharma | 10 mg | filmom obložena tableta | kroz usta |
| Njemačka | AbZ-Pharma GmbH
  Graf-Arco-Str. 3
  89079 Ulm
  Germany | Zolpidem AbZ 10 mg Filmtabletten | 10 mg | filmom obložena tableta | kroz usta |
| Njemačka | Actavis Deutschland GmbH & Co.KG
  Willy-Brandt-Allee 2
  81829 München
  Germany | Zolpidem-Actavis 10 mg Filmtabletten | 10 mg | filmom obložena tableta | kroz usta |
| Njemačka | Aliud Pharma GmbH
  Gottlieb-Daimler-Str. 19
  89150 Laichingen
  Germany | Zolpidem AL 10 mg Filmtabletten | 10 mg | filmom obložena tableta | kroz usta |
| Njemačka | Aliud Pharma GmbH
  Gottlieb-Daimler-Str. 19
  89150 Laichingen
  Germany | Zolpidem AL 5 mg Filmtabletten | 5 mg | filmom obložena tableta | kroz usta |
| Njemačka | Aristo Pharma GmbH
  Wallenroder Str. 8-10
  13435 Berlin
  Germany | Zolpidem Aristo 10 mg Filmtabletten | 10 mg | filmom obložena tableta | kroz usta |
| Njemačka | AbZ-Pharma GmbH
  Graf-Arco-Str. 3
  89079 Ulm
  Germany | Zolpidem-CT 10 mg Filmtabletten | 10 mg | filmom obložena tableta | kroz usta |
| Njemačka | AbZ-Pharma GmbH
  Graf-Arco-Str. 3
  89079 Ulm
  Germany | Zolpidem-CT 5 mg Filmtabletten | 5 mg | filmom obložena tableta | kroz usta |
| Njemačka | Dolorgiet GmbH & Co.KG
  Otto-von-Guericke-Str. 1
  53757 Sankt Augustin
  Germany | Zolpidem real 10 mg Filmtabletten | 10 mg | filmom obložena tableta | kroz usta |
| Njemačka | Heumann Pharma GmbH & Co. Generica KG
  Südwestpark 50
  90449 Nürnberg
  Germany | Zolpidem Heumann 10 mg Filmtabletten | 10 mg | filmom obložena tableta | kroz usta |
| Njemačka | Heumann Pharma GmbH & Co. Generica KG
  Südwestpark 50
  90449 Nürnberg
  Germany | Zolpidem Heumann 5 mg Filmtabletten | 5 mg | filmom obložena tableta | kroz usta |
| Njemačka | Hexal Aktiengesellschaft
  Industriestr. 25
  83607 Holzkirchen
  Germany | Zolpidem Hexal 10 mg Filmtabletten | 10 mg | filmom obložena tableta | kroz usta |
| Njemačka | 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 | filmom obložena tableta | kroz usta |
| Njemačka | 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 | filmom obložena tableta | kroz usta |
| Njemačka | Juta Pharma GmbH
  Gutenbergstr. 13
  24941 Flensburg
  Germany | Zolpi-Q 10 mg Filmtabletten | 10 mg | filmom obložena tableta | kroz usta |
| Njemačka | Krewel Meuselbach GmbH
  Krewelstr. 2
  53783 Eitorf
  Germany | Zolpinox 10 mg | 10 mg | filmom obložena tableta | kroz usta |
| Njemačka | Meda Pharma GmbH & Co. KG
  Benzstrasse 1
  Bad Homburg v.d.H
  61352
  Germany | Edluar 10 mg Sublingualtabletten | 10 mg | sublingvalna tableta | kroz usta |
| Njemačka | Meda Pharma GmbH & Co. KG
  Benzstrasse 1
  Bad Homburg v.d.H
  61352
  Germany | Edluar 5 mg Sublingualtabletten | 5 mg | sublingvalna tableta | kroz usta |
| Njemačka | Mylan dura GmbH
  Wittichstr. 6
  64295 Darmstadt
  Germany | Zolpidem dura 10 mg Filmtabletten | 10 mg | filmom obložena tableta | kroz usta |
| Njemačka | neuraxpharm Arzneimittel GmbH
  Elisabeth-Selbert-Str. 23
  40764 Langenfeld
  Germany | Zolpidem-neuraxpharm 10 mg Filmtabletten | 10 mg | filmom obložena tableta | kroz usta |
| Njemačka | neuraxpharm Arzneimittel GmbH
  Elisabeth-Selbert-Str. 23
  40764 Langenfeld
  Germany | Zolpidem-neuraxpharm 5 mg Filmtabletten | 5 mg | filmom obložena tableta | kroz usta |
| Njemačka | ratiopharm GmbH
  Graf Arco Strasse 3
  D-89079 Ulm
  Germany | Zolpidem-ratiopharm 10 mg Filmtabletten | 10 mg | filmom obložena tableta | kroz usta |
| Njemačka | ratiopharm GmbH
  Graf Arco Strasse 3
  D-89079 Ulm
  Germany | Zolpidem-ratiopharm 5 mg Filmtabletten | 5 mg | filmom obložena tableta | kroz usta |
| Njemačka | Sandoz Pharmaceuticals GmbH
  Raiffeisenstr. 11
  83607 Holzkirchen
  Germany | Zolpidem Sandoz 10 mg Filmtabletten | 10 mg | filmom obložena tableta | kroz usta |
| Njemačka | Sanofi-Aventis Deutschland GmbH
  Industriepark Höchst, Gebäude K703
  65926 Frankfurt am Main
  Germany | Bikalm | 10 mg | filmom obložena tableta | kroz usta |
| Njemačka | Sanofi-Aventis Deutschland GmbH
  Industriepark Höchst, Gebäude K703
  65926 Frankfurt am Main
  Germany | Stilnox | 10 mg | filmom obložena tableta | kroz usta |
| Njemačka | Stadapharm GmbH
  Stadastr. 2-18
  61118 Bad Vilbel
  Germany | Zolpidem STADA 10 mg Filmtabletten | 10 mg | filmom obložena tableta | kroz usta |
| Njemačka | Stadapharm GmbH
  Stadastr. 2-18
  61118 Bad Vilbel
  Germany | Zolpidem STADA 5 mg Filmtabletten | 5 mg | filmom obložena tableta | kroz usta |
| Njemačka | TAD Pharma GmbH
  Heinz-Lohmann-Str. 5
  27472 Cuxhaven
  Germany | Zolpidem TAD 10 mg | 10 mg | filmom obložena tableta | kroz usta |
| Njemačka | Vitabalans Oy
  Varastokatu 8
  13500 Hämeenlinna
  Finland | Zolpidem Vitabalans 10 mg Filmtabletten | 10 mg | filmom obložena tableta | kroz usta |
| Njemačka | Winthrop Arzneimittel GmbH
  Brüningstr. 50
  65926 Frankfurt am Main
  Germany | Zolpi-Lich 10 mg Filmtabletten | 10 mg | filmom obložena tableta | kroz usta |
| Grčka | IOULIA AND IRENE TSETI PHARMACEUTICAL LABORATORIES ABEE, INTERMED ABEE,
  Kalyftaki 27, Kifissia 14564
  Greece | HYPNONORM | 10 mg | filmom obložena tableta | kroz usta |
| Grčka | ITF HELLAS S.A.
  Areos 103 and Ag. Triados 36, Palaio Faliro 17562
  Greece | ONIRIA | 10 mg/ml | oralne kapi, otopina | kroz usta |
| Grčka | ITF PHARMA KERESKEDELMI ES SZOLGALTATO KFT, BUDAPEST, HUNGAR
  H-1056, Budapest
  Duna u.1
  Hungary | KALINICTA | 10 mg/ml | oralne kapi, otopina | kroz usta |
| Grčka | SANOFI-AVENTIS AEBE
  348 SYNGROU AVENUE, BUILDING A, KALLITHEA 17674
  Greece | STILNOX | 10 mg | filmom obložena tableta | kroz usta |
| Mađarska | EGIS Gyógyszergyár Nyrt. Keresztúri út 30-38.
  Budapest
  1106
  Hungary | PIDEZOL 10 mg filmtabletta | 10 mg | filmom obložena tableta | kroz usta |
| Mađarska | ExtractumPharma zRt.
  Megyeri út 64.
  Budapest
  1044
  Hungary | ZOLEP 10 mg filmtabletta | 10 mg | filmom obložena tableta | kroz usta |
| Mađarska | Generics (UK) Ltd.
  Albany Gate, Darkes Lane, Potters bar Herts EN61AG
  United Kingdom | SOMNOGEN 10 mg filmtabletta | 10 mg | filmom obložena tableta | kroz usta |
| Mađarska | ITF Pharma Kft Duna u. 1. Budapest 1056 Hungary | ONIRIA 10 mg/ml belsőleges oldatos cseppek | 10 mg/ml | oralne kapi, otopina | kroz usta |
| Mađarska | Krka d.d. Novo Mesto Smarjeska cesta 6. Novo Mesto 8501 Slovenia | ZOLSANA 5 mg filmtabletta | 5 mg | filmom obložena tableta | kroz usta |
| Mađarska | Krka d.d. Novo Mesto Smarjeska cesta 6. Novo Mesto 8501 Slovenia | ZOLSANA 10 mg filmtabletta | 10 mg | filmom obložena tableta | kroz usta |
| Mađarska | LEK Pharmaceuticals d.d. Verovskova 57
  Ljubljana
  Slovenia | SANVAL 5 mg filmtabletta | 5 mg | filmom obložena tableta | kroz usta |
| Mađarska | LEK Pharmaceuticals d.d. Verovskova 57
  Ljubljana
  Slovenia | SANVAL 10 mg filmtabletta | 10 mg | filmom obložena tableta | kroz usta |
| Mađarska | Meda Pharma Hungary Kft Váci út 91. Budapest 1139 Hungary | EDLUAR 5 mg nyelvalatti tabletta | 5 mg | sublingvalna tableta | pod jezik |
| Mađarska | Meda Pharma Hungary Kft Váci út 91. Budapest 1139 Hungary | EDLUAR 10 mg nyelvalatti tabletta | 10 mg | sublingvalna tableta | pod jezik |
| Mađarska | Sanofi-Aventis Magyarország Zrt
  Tó u. 1-5
  Budapest
  1045
  Hungary | STILNOX 10 mg filmtabletta | 10 mg | filmom obložena tableta | kroz usta |
| Mađarska | Teva Magyarország Zrt
  Repülőtéri út 5.
  Gödöllő 2100
  Hungary | ZOLPIDEM-RATIOPHARM 10 mg filmtabletta | 10 mg | filmom obložena tableta | kroz usta |
| Mađarska | Vitabalans Oy Varastokatu 8. Hämeenlinna 13500
  Finland | ZOLPIDEM VITABALANS 10 mg filmtabletta | 10 mg | filmom obložena tableta | kroz usta |
| Mađarska | Vulm CZ a.s.
  Olivova 1888
  Ricany 25101 Czech Republic | INSOM 10 mg pezsgőtabletta | 10 mg | šumeća tableta | kroz usta |
| Mađarska | Zentiva k.s.
  Dolny Mecholupy,
  U kabelovny 130
  Prague 10. 10237
  Czech Republic | HYPNOGEN 10 mg filmtabletta | 10 mg | filmom obložena tableta | kroz usta |
| Island | LYFIS ehf., Grensásvegur 22, 108 Reykjavík, Iceland | Zolpidem LYFIS | 10 mg | filmom obložena tableta | kroz usta |
| Island | Meda AB, Pipers väg 2A, Box 906, SE-170 09, Sweden | Edluar | 5 mg | sublingvalna tableta | kroz usta |
| Island | Meda AB, Pipers väg 2A, Box 906, SE-170 09, Sweden | Edluar | 10 mg | sublingvalna tableta | kroz usta |
| Island | Mylan AB, Ynglingagatan 14, 10435 Stockholm, Sweden. | Zolpidem Mylan | 10 mg | filmom obložena tableta | kroz usta |
| Island | Sanofi Aventis Norge
  Strandveien 15,
  1366 Lysaker, Norway | Stilnoct | 5 mg | filmom obložena tableta | kroz usta |
| Island | Sanofi Aventis Norge
  Strandveien 15,
  1366 Lysaker, Norway | Stilnoct | 10 mg | filmom obložena tableta | kroz usta |
| Irska | Clonmel Healthcare Ltd
  Waterford Road
  Clonmel
  Co. Tipperary
  Ireland | Nytamel 5 mg Film-coated Tablets | 5 mg | filmom obložena tableta | kroz usta |
| Irska | Clonmel Healthcare Ltd
  Waterford Road
  Clonmel
  Co. Tipperary
  Ireland | Nytamel 10 mg Film-coated Tablets. | 10 mg | filmom obložena tableta | kroz usta |
| Irska | 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 | filmom obložena tableta | kroz usta |
| Irska | Meda Health Sales Ireland Limited
  Unit 34/35 Block A
  Dunboyne Business Park
  Dunboyne
  Co Meath
  Ireland | Edluar 5 mg sublingual tablets | 5 mg | sublingvalna tableta | kroz usta |
| Irska | Meda Health Sales Ireland Limited
  Unit 34/35 Block A
  Dunboyne Business Park
  Dunboyne
  Co Meath
  Ireland | Edluar 10 mg sublingual tablets | 10 mg | sublingvalna tableta | kroz usta |
| Irska | Rowex Ltd,
  Bantry,
  Co. Cork,
  Ireland | Zolnod 10 mg film-coated tablets | 10 mg | filmom obložena tableta | kroz usta |
| Irska | Sanofi-Aventis Ireland Limited T/A Sanofi, Citywest Business Campus, Dublin 24, Ireland | Stilnoct 5 mg Film-coated Tablets | 5 mg | filmom obložena tableta | kroz usta |
| Irska | Sanofi-Aventis Ireland Limited T/A Sanofi, Citywest Business Campus, Dublin 24, Ireland | Stilnoct 10 mg Film-coated Tablets | 10 mg | filmom obložena tableta | kroz usta |
| Irska | Teva Pharma B. V.
  Computerweg 10
  3542 DR Utrecht
  The Netherlands | Zolpidem Tartrate Teva 5 mg Film-coated Tablets | 5 mg | filmom obložena tableta | kroz usta |
| Irska | Teva Pharma B. V.
  Computerweg 10
  3542 DR Utrecht
  The Netherlands | Zolpidem Tartrate Teva 10 mg Film-coated Tablets | 10 mg | filmom obložena tableta | kroz usta |
| Italija | Actavis Group PTC ehf.
  Reykjavikurvegur 76-78
  IS-220 Hafnarfjördur
  Iceland | ZOLPIDEM ACTAVIS | 10 mg | filmom obložena tableta | kroz usta |
| Italija | Doc Generici S.r.l.
  Turati 40, Milano – 20121 Italy | ZOLPIDEM DOC GENERICI | 5 mg | filmom obložena tableta | kroz usta |
| Italija | Doc Generici S.r.l.
  Turati 40, Milano – 20121 Italy | ZOLPIDEM DOC GENERICI | 10 mg | filmom obložena tableta | kroz usta |
| Italija | EG S.p.a. Via Scarlatti, 31, Milano – 20124 Italy | ZOLPIDEM EG | 10 mg | filmom obložena tableta | kroz usta |
| Italija | FIDIA Farmaceutici S.p.a.
  Via Ponte della Fabbrica, 3/a, Abano Terme, Padova – 35031 Italy | OPSYCON | 10 mg | filmom obložena tableta | kroz usta |
| Italija | HEXAL S.p.a.
  Largo Umberto Boccioni 1
  21040 Origgio
  Varese
  Italy | ZOLPIDEM HEXAL | 10 mg | filmom obložena tableta | kroz usta |
| Italija | IPCA – Produtos Farmacêuticos Unipessoal, Lda.
  Rua José Nogueira Vaz, Lote 104 – Lj Esq
  2625-099 Povoa de Santa Iria
  Portugal | ZOLPIDEM IPCA | 5 mg | filmom obložena tableta | kroz usta |
| Italija | IPCA – Produtos Farmacêuticos Unipessoal, Lda.
  Rua José Nogueira Vaz, Lote 104 – Lj Esq
  2625-099 Povoa de Santa Iria
  Portugal | ZOLPIDEM IPCA | 10 mg | filmom obložena tableta | kroz usta |
| Italija | ITALFARMACO S.p.A.
  Viale Fulvio Testi 330,
  20126 Milano, Italy | SONIREM | 10 mg/ml | oralne kapi, otopina | kroz usta |
| Italija | LIFEPHARMA S.P.A. Via dei Lavoratori 54, 20092 Cinisello Balsamo, Milano – Italy | ZOLPREM | 10 mg/ml | oralne kapi, otopina | kroz usta |
| Italija | MEDA PHARMA S.P.A., Viale brenta 18, 20139 Milano – Italy | ZOLPEDUAR | 5 mg | sublingvalna tableta | kroz usta |
| Italija | MEDA PHARMA S.P.A., Viale brenta 18, 20139 Milano – Italy | ZOLPEDUAR | 10 mg | sublingvalna tableta | kroz usta |
| Italija | Ratiopharm GmbH
  Graf Arco Strasse 3
  D-89079 Ulm
  Germany | ZOLPIDEM RATIOPHARM | 10 mg | filmom obložena tableta | kroz usta |
| Italija | Sandoz S.p.a.
  Largo Umberto Boccioni, 1,
  Origgio, Varese – 21040
  Italy | ZOLPIDEM SANDOZ | 10 mg | filmom obložena tableta | kroz usta |
| Italija | Sanofi-aventis SpA, Viale Bodio 37/b, 20158 Milano Italy | STILNOX | 10 mg | filmom obložena tableta | kroz usta |
| Italija | Sanofi-aventis SpA, Viale Bodio 37/b, 20158 Milano Italy | NOTTEM | 10 mg | filmom obložena tableta | kroz usta |
| Italija | Teva Italia S.r.l. – via Messina 38 – 20154 Milano Italy | ZOLPIDEM TEVA | 10 mg | filmom obložena tableta | kroz usta |
| Italija | ZENTIVA ITALIA S.R.L. – Viale Bodio 37/b, 20158 Milano Italy | ZOLPIDEM ZENTIVA | 10 mg | filmom obložena tableta | kroz usta |
| Latvija | Krka, d.d., Novo mesto
  Šmarješka cesta 6
  8000 Novo mesto
  Slovenia | Zolsana 5 mg coated tablets | 5 mg | obložena tableta | kroz usta |
| Latvija | Krka, d.d., Novo mesto
  Šmarješka cesta 6
  8000 Novo mesto
  Slovenia | Zolsana 10 mg coated tablets | 10 mg | obložena tableta | kroz usta |
| Latvija | Meda Pharma GmbH & Co. KG
  Benzstrasse 1
  Bad Homburg v.d.H
  61352
  Germany | Edluar 5 mg sublingual tablets | 5 mg | sublingvalna tableta | pod jezik |
| Latvija | Meda Pharma GmbH & Co. KG
  Benzstrasse 1
  Bad Homburg v.d.H
  61352
  Germany | Edluar 10 mg sublingual tablets | 10 mg | sublingvalna tableta | pod jezik |
| Latvija | Sandoz d.d.
  Verovškova 57,
  1000 Ljubljana,
  Slovenia | Zolpidem Sandoz 10 mg film-coated tablets | 10 mg | filmom obložena tableta | kroz usta |
| Latvija | sanofi-aventis Latvia SIA, Kr.Valdemara 33-8 Riga, LV 1010, Latvia | Stilnox 10 mg film-coated tablets | 10 mg | filmom obložena tableta | kroz usta |
| Latvija | Vitabalans Oy
  Varastokatu 8
  13500 Hämeenlinna
  Finland | Zolpidem Vitabalans 10 mg film-coated tablets | 10 mg | filmom obložena tableta | kroz usta |
| Latvija | Zentiva, k.s.
  U kabelovny 130
  Prague 10, Dolni Mecholupy
  10237
  Czech Republic | Hypnogen 10 mg film-coated tablets | 10 mg | filmom obložena tableta | kroz usta |
| Litva | Krka, d.d., Novo mesto
  Šmarješka cesta 6
  8000 Novo mesto
  Slovenia | Zolsana | 10 mg | filmom obložena tableta | kroz usta |
| Litva | Krka, d.d., Novo mesto
  Šmarješka cesta 6
  8000 Novo mesto
  Slovenia | Zolsana | 5 mg | filmom obložena tableta | kroz usta |
| Litva | Sandoz d.d.
  Verovškova 57,
  1000 Ljubljana,
  Slovenia | Zolpidem Sandoz | 10 mg | filmom obložena tableta | kroz usta |
| Litva | UAB „SANOFI-AVENTIS LIETUVA”
  A. Juozapavičiaus 6/2 g.
  LT-09310 Vilnius
  Lithuania | Stilnox | 10 mg | filmom obložena tableta | kroz usta |
| Litva | Vitabalans Oy
  Varastokatu 8
  13500 Hämeenlinna
  Finland | Zolpidem Vitabalans | 10 mg | filmom obložena tableta | kroz usta |
| Litva | Zentiva, k.s.
  U kabelovny 130
  Prague 10, Dolni Mecholupy
  10237
  Czech Republic | HYPNOGEN | 10 mg | filmom obložena tableta | kroz usta |
| Luksemburg | MYLAN BVBA/SPRL
  Terhulpsesteenweg 6A
  1560 Hoeilaart
  Belgium | Dodorest | 10 mg | obložena tableta | kroz usta |
| Luksemburg | SANOFI BELGIUM
  Airport Plaza, Montreal Building, Leonardo Da Vincilaan 19
  1831 Diegem
  Belgium | Stilnoct | 10 mg | obložena tableta | kroz usta |
| Luksemburg | Eurogenerics S.A.
  Esplanade Heysel, b22
  1020 Bruxelles
  Belgium | Zolpidem EG cpr.eff. | 10 mg | šumeća tableta | kroz usta |
| Luksemburg | Eurogenerics S.A.
  Esplanade Heysel, b22
  1020 Bruxelles
  Belgium | Zolpidem EG cpr.pellic. | 10 mg | obložena tableta | kroz usta |
| Luksemburg | Genthon BV
  Microweg, 22
  6545 Nijmegen
  The Netherlands | Zolpidem Genthion | 10 mg | obložena tableta | kroz usta |
| Luksemburg | Genthon BV
  Microweg, 22
  6545 Nijmegen
  The Netherlands | Zolpidem Genthion | 5 mg | obložena tableta | kroz usta |
| Luksemburg | Apotex Europe B.V.
  Darwinweg 20
  NL 2333 CR Leiden
  The Netherlands | Zolpitop | 10 mg | obložena tableta | kroz usta |
| Luksemburg | Apotex Europe B.V.
  Darwinweg 20
  NL 2333 CR Leiden
  The Netherlands | Zolpitop | 5 mg | obložena tableta | kroz usta |
| Luksemburg | MEDA PHARMA
  Chaussee de la Hulpe 166
  1170 Watermael-Boitsfort
  Belgium | Zolpeduar | 10 mg | sublingvalna tableta | pod jezik |
| Luksemburg | MEDA PHARMA
  Chaussee de la Hulpe 166
  1170 Watermael-Boitsfort
  Belgium | Zolpeduar | 5 mg | sublingvalna tableta | pod jezik |
| Malta | Sanofi Malta Ltd.
  St. Julian’s Rd.
  San Gwann SGN 2805
  Malta | Stilnox | 10 mg | filmom obložena tableta | kroz usta |
| Malta | Pharma MT
  103, Stuart Street,
  Gzira,
  Malta | Nytamel | 10 mg | filmom obložena tableta | kroz usta |
| Norveška | Sanofi Aventis Norge
  Strandveien 15,
  1366 Lysaker, Norway | Stilnoct | 5 mg | filmom obložena tableta | kroz usta |
| Norveška | Sanofi Aventis Norge
  Strandveien 15,
  1366 Lysaker, Norway | Stilnoct | 10 mg | filmom obložena tableta | kroz usta |
| Norveška | Actavis Norway AS, P.O.BOX 409, 0213 Skoyen, OSLO, Norway | Zolpidem Actavis | 5 mg | filmom obložena tableta | kroz usta |
| Norveška | Actavis Norway AS, P.O.BOX 409, 0213 Skoyen, OSLO, Norway | Zolpidem Actavis | 10 mg | filmom obložena tableta | kroz usta |
| Norveška | Meda Norge, P.O.BOX 194, 1371 ASKER, Norway | Edluar | 5 mg | sublingvalna tableta | kroz usta |
| Norveška | Meda Norge, P.O.BOX 194, 1371 ASKER, Norway | Edluar | 10 mg | sublingvalna tableta | kroz usta |
| Norveška | Vitabalans Oy
  Varastokatu 8
  13500 Hämeenlinna
  Finland | Zolpidem Vitabalans | 10 mg | filmom obložena tableta | kroz usta |
| Poljska | Actavis Group PTC ehf.
  Reykjavikurvegur 76-78
  IS-220 Hafnarfjördur
  Iceland | Noxizol | 10 mg | filmom obložena tableta | kroz usta |
| Poljska | Apotex Europe B.V.
  Darwinweg 20
  NL 2333 CR Leiden
  The Netherlands | Apo-Zolpin | 10 mg | filmom obložena tableta | kroz usta |
| Poljska | Farma-Projekt Sp. z o.o.
  ul. Józefińska 2
  30-529 Kraków
  Poland | Xentic | 10 mg | filmom obložena tableta | kroz usta |
| Poljska | Generics [UK] Ltd.
  Station Close
  EN6 1TL Hertfordshire – Potters Bar
  United Kingdom | ZolpiGen | 10 mg | filmom obložena tableta | kroz usta |
| Poljska | Ipca, Produtos Farmaceuticos, Unipessoal Lda
  Rua Chanceler-Mor 11 R/c Frt.
  Cacem
  2735-615
  Portugal | Zolpidem IPCA | 5 mg | filmom obložena tableta | kroz usta |
| Poljska | Ipca, Produtos Farmaceuticos, Unipessoal Lda
  Rua Chanceler-Mor 11 R/c Frt.
  Cacem
  2735-615
  Portugal | Zolpidem IPCA | 10 mg | filmom obložena tableta | kroz usta |
| Poljska | Italfarmaco S.p.A.
  Viale Fulvio 330
  20126 Milano
  Italy | Sonirem | 10 mg/ml | oralne kapi, otopina | kroz usta |
| Poljska | Krka, d.d., Novo mesto
  Šmarješka cesta 6
  8000 Novo mesto
  Slovenia | Zolsana | 10 mg | filmom obložena tableta | kroz usta |
| Poljska | Meda Pharma GmbH & Co. KG
  Benzstrasse 1
  Bad Homburg v.d.H
  61352
  Germany | Edluar | 5 mg | sublingvalna tableta | kroz usta |
| Poljska | Meda Pharma GmbH & Co. KG
  Benzstrasse 1
  Bad Homburg v.d.H
  61352
  Germany | Edluar | 10 mg | sublingvalna tableta | kroz usta |
| Poljska | Orion Corporation
  Orionintie 1/A
  FI-02200 Espoo
  Finland | Onirex | 10 mg | filmom obložena tableta | kroz usta |
| Poljska | Pabianickie Zakłady Farmaceutyczne Polfa S.A.
  ul. Marszałka J. Piłsudskiego 5
  95-200 Pabianice
  Poland | Polsen | 10 mg | filmom obložena tableta | kroz usta |
| Poljska | Pfizer Europe MA EEIG
  Ramsgate Road
  Kent, Sandwich
  CT13 9 NJ
  United Kingdom | Zolpidem Pfizer | 10 mg | filmom obložena tableta | kroz usta |
| Poljska | Polfarmex S.A.
  Józefów 9
  99-300 Kutno
  Poland | Nasen | 10 mg | filmom obložena tableta | kroz usta |
| Poljska | Sandoz GmbH
  ul. Biochemiestrasse 10
  Kundli
  6250
  Austria | Sanval | 10 mg | filmom obložena tableta | kroz usta |
| Poljska | Sanofi-Aventis France
  1-13 boulevard Romain Rolland
  75014 Paris
  France | Stilnox | 10 mg | filmom obložena tableta | kroz usta |
| Poljska | Vitabalans Oy
  Varastokatu 8
  13500 Hämeenlinna
  Finland | Zolpidem Vitabalans | 10 mg | filmom obložena tableta | kroz usta |
| Poljska | VULM CZ, a.s.
  Olivova 1888
  Ricany
  251 01
  Czech Republic | Insom | 10 mg | šumeća tableta | kroz usta |
| Poljska | Zakłady Farmaceutyczne POLPHARMA S.A.
  Pelplińska 19
  83-200 Starogard Gdański
  Poland | Zolpic | 10 mg | filmom obložena tableta | kroz usta |
| Poljska | Zentiva, k.s.
  U kabelovny 130
  Prague 10, Dolni Mecholupy
  10237
  Czech Republic | Hypnogen | 10 mg | filmom obložena tableta | kroz usta |
| Portugal | Actavis A/S Sucursal
  Rua Virgílio Correia, 11 – A
  1600-219 Lisboa
  Portugal | Zolpidem Actavis | 10 mg | filmom obložena tableta | kroz usta |
| Portugal | Aurobindo Pharma (Portugal), Unipessoal Lda.
  Av. do Forte, no 3 – Parque Suécia, Edifício. IV, 2o

  2794-038 Carnaxide
  Portugal | Zolpidem Aurobindo | 5 mg | filmom obložena tableta | kroz usta |
| Portugal | Aurobindo Pharma (Portugal), Unipessoal Lda.
  Av. do Forte, no 3 – Parque Suécia, Edifício. IV, 2o

  2794-038 Carnaxide
  Portugal | Zolpidem Aurobindo | 10 mg | filmom obložena tableta | kroz usta |
| 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 | filmom obložena tableta | kroz usta |
| Portugal | Generis Farmacêutica, S.A.
  Rua João de Deus, 19
  2700-487 Amadora
  Portugal | Zolpidem Generis 5 mg Comprimidos Revestidos | 5 mg | filmom obložena tableta | kroz usta |
| Portugal | Generis Farmacêutica, S.A.
  Rua João de Deus, 19
  2700-487 Amadora
  Portugal | Zolpidem Generis 10 mg Comprimidos Revestidos | 10 mg | filmom obložena tableta | kroz usta |
| Portugal | Genthon GmbH
  Groesbeeker Weg, 1
  D-47559 Kranenburg
  Germany | Zolpidem 5 mg Comprimidos Revestidos | 5 mg | filmom obložena tableta | kroz usta |
| 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 | filmom obložena tableta | kroz usta |
| 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 | filmom obložena tableta | kroz usta |
| Portugal | Labesfal Genéricos, S.A
  Avenida Dr. Afonso Costa, 1370
  3465-051 Campo de Besteiros
  Portugal | Zolpidem Labesfal | 10 mg | filmom obložena tableta | kroz usta |
| Portugal | Laboratórios Azevedos – Indústria Farmacêutica, S.A.
  Edifícios Azevedos – Estrada Nacional 117-2, Alfragide
  2614-504 Amadora
  Portugal | Cymerion | 10 mg | filmom obložena tableta | kroz usta |
| Portugal | Meda Pharma – Produtos Farmacêuticos, S.A.
  Rua do Centro Cultural, 13
  1749-066 Lisboa
  Portugal | Edluar | 5 mg | sublingvalna tableta | pod jezik |
| Portugal | Meda Pharma – Produtos Farmacêuticos, S.A.
  Rua do Centro Cultural, 13
  1749-066 Lisboa
  Portugal | Edluar | 10 mg | sublingvalna tableta | pod jezik |
| 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 | filmom obložena tableta | kroz usta |
| 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 | filmom obložena tableta | kroz usta |
| Portugal | Sandoz Farmacêutica, Lda.
  Alameda da Beloura, Edifício 1, 2o – Escritório 15
  2710-693 Sintra
  Portugal | Zolpidem Sandoz | 10 mg | filmom obložena tableta | kroz usta |
| Portugal | Sanofi – Produtos Farmacêuticos, Lda.
  Empreendimento Lagoas Park Edifício 7, 3o Piso
  2740-244 Porto Salvo
  Portugal | Stilnox | 10 mg | filmom obložena tableta | kroz usta |
| Portugal | Wynn Industrial Pharma, S.A.
  Rua Tierno Galvan, Torre 3, 16o Piso, Amoreiras
  1070-274 Lisboa
  Portugal | Zolpidem Wynn | 10 mg | filmom obložena tableta | kroz usta |
| Rumunjska | ALKALOID-INT d.o.o.
  Šlandrova ulica 4
  1231 Ljubljana-Črnuče Slovenia | ZADOBRA 5 mg | 5 mg | filmom obložena tableta | kroz usta |
| Rumunjska | ALKALOID-INT d.o.o.
  Šlandrova ulica 4
  1231 Ljubljana-Črnuče Slovenia | ZADOBRA 10 mg | 10 mg | filmom obložena tableta | kroz usta |
| Rumunjska | ITALFARMACO S.p.A.
  Viale Fulvio Testi 330, 20126 Milano, Italia | ONIRIA 10 mg/ml | 10 mg/ml | oralne kapi, otopina | kroz usta |
| Rumunjska | Krka, d.d., Novo mesto
  Šmarješka cesta 6
  8000 Novo mesto
  Slovenia | ZOLSANA 5 mg | 5 mg | filmom obložena tableta | kroz usta |
| Rumunjska | Krka, d.d., Novo mesto
  Šmarješka cesta 6
  8000 Novo mesto
  Slovenia | ZOLSANA 10 mg | 10 mg | filmom obložena tableta | kroz usta |
| Rumunjska | LABORMED PHARMA S.A.
  B-dul Theodor Pallady nr. 44B
  Sector 3, Bucureşti, România | ZOLPIDEM 10 mg | 10 mg | filmom obložena tableta | kroz usta |
| Rumunjska | LEK farmacevtska družba d.d. Verovškova 57
  1526 Ljubljana
  Slovenia | SANVAL 10 mg | 10 mg | filmom obložena tableta | kroz usta |
| Rumunjska | Meda Pharma GmbH & Co. KG
  Benzstrasse 1
  Bad Homburg v.d.H
  61352
  Germany | EDLUAR 5 mg | 5 mg | sublingvalna tableta | kroz usta |
| Rumunjska | Meda Pharma GmbH & Co. KG
  Benzstrasse 1
  Bad Homburg v.d.H
  61352
  Germany | EDLUAR 10 mg | 10 mg | sublingvalna tableta | kroz usta |
| Rumunjska | S.C. ANTIBIOTICE S.A.,
  Str. Valea Lupului nr.1, Iaşi, România | ZOLPIDEM ATB 10 mg | 10 mg | filmom obložena tableta | kroz usta |
| Rumunjska | SANOFI-AVENTIS ROMÂNIA S.R.L.
  Str. Izvor, Nr. 80, Et. 6-11
  Sector 5, Bucureşti, România | STILNOX 10 mg | 10 mg | filmom obložena tableta | kroz usta |
| Slovačka Republika | ALKALOID-INT d.o.o.
  Šlandrova ulica 4
  1231 Ljubljana-Črnuče Slovenia | ADORMA 5 mg filmom obalené tablety | 5 mg | filmom obložena tableta | kroz usta |
| Slovačka Republika | ALKALOID-INT d.o.o.
  Šlandrova ulica 4
  1231 Ljubljana-Črnuče Slovenia | ADORMA 10 mg filmom obalené tablety | 10 mg | filmom obložena tableta | kroz usta |
| Slovačka Republika | Generics [UK] Ltd.
  Station Close
  EN6 1TL Hertfordshire – Potters Bar
  United Kingdom | Zolpidem Mylan 10 mg | 10 mg | filmom obložena tableta | kroz usta |
| Slovačka Republika | Orion Corporation
  Orionintie 1/A
  FI-02200 Espoo
  Finland | Zolpidem Orion 10 mg | 10 mg | filmom obložena tableta | kroz usta |
| Slovačka Republika | Sandoz d.d.
  Verovškova 57,
  1000 Ljubljana,
  Slovenia | SANVAL 5 mg | 5 mg | filmom obložena tableta | kroz usta |
| Slovačka Republika | Sandoz d.d.
  Verovškova 57,
  1000 Ljubljana,
  Slovenia | SANVAL 10 mg | 10 mg | filmom obložena tableta | kroz usta |
| Slovačka Republika | sanofi-aventis Slovakia s.r.o. Einsteinova 24
  85101 Bratislava
  Slovak Republic | STILNOX | 10 mg | filmom obložena tableta | kroz usta |
| Slovačka Republika | SVUS Pharma a.s., Smetanovo nábřeží 1238/20a
  500 02 Hradec Králové Czech Republic | ZOLPINOX | 10 mg | filmom obložena tableta | kroz usta |
| Slovačka Republika | Takeda GmbH 2 Byk-Gulden Strasse
  78467 Konstanz Germany | HYPNOGEN | 10 mg | filmom obložena tableta | kroz usta |
| Slovačka Republika | Vitabalans Oy
  Varastokatu 8
  13500 Hämeenlinna
  Finland | Zolpidem Vitabalans 10 mg filmom obalené tablety | 10 mg | filmom obložena tableta | kroz usta |
| Slovenija | ALKALOID-INT d.o.o.
  Šlandrova ulica 4
  1231 Ljubljana-Črnuče Slovenia | Perluna 10 mg filmsko obožene tablete | 10 mg | filmom obložena tableta | kroz usta |
| Slovenija | ALKALOID-INT d.o.o.
  Šlandrova ulica 4
  1231 Ljubljana-Črnuče Slovenia | Perluna 5 mg filmsko obožene tablete | 5 mg | filmom obložena tableta | kroz usta |
| Slovenija | Krka, d.d., Novo mesto
  Šmarješka cesta 6
  8000 Novo mesto
  Slovenia | Zolsana 10 mg filmsko obložene tablete | 10 mg | filmom obložena tableta | kroz usta |
| Slovenija | Krka, d.d., Novo mesto
  Šmarješka cesta 6
  8000 Novo mesto
  Slovenia | Zolsana 5 mg filmsko obložene tablete | 5 mg | filmom obložena tableta | kroz usta |
| Slovenija | LEK farmacevtska družba d.d. Verovškova 57
  1526 Ljubljana
  Slovenia | Sanval 10 mg filmsko obožene tablete | 10 mg | filmom obložena tableta | kroz usta |
| Slovenija | LEK farmacevtska družba d.d. Verovškova 57
  1526 Ljubljana
  Slovenia | Sanval 5 mg filmsko obložene tablete | 5 mg | filmom obložena tableta | kroz usta |
| Slovenija | Meda Pharma GmbH & Co. KG
  Benzstrasse 1
  Bad Homburg v.d.H
  61352
  Germany | Edluar 10 mg podjezične tablete | 10 mg | sublingvalna tableta | pod jezik |
| Slovenija | Meda Pharma GmbH & Co. KG
  Benzstrasse 1
  Bad Homburg v.d.H
  61352
  Germany | Edluar 5 mg podjezične tablete | 5 mg | sublingvalna tableta | pod jezik |
| Slovenija | Vitabalans Oy
  Varastokatu 8
  13500 Hämeenlinna
  Finland | Zolpidem Vitabalans 10 mg filmsko obložene tablete | 10 mg | filmom obložena tableta | kroz usta |
| Španjolska | ANGELINI FARMACEUTICA, S.A. Osi, 7-9 Barcelona. 08034. SPAIN | DALPARAN 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | 10 mg | filmom obložena tableta | kroz usta |
| Španjolska | Apotex Europe B.V.
  Darwinweg 20
  NL 2333 CR Leiden
  The Netherlands | ZOLPIDEM APOTEX 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | 10 mg | filmom obložena tableta | kroz usta |
| Španjolska | 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 | filmom obložena tableta | kroz usta |
| Španjolska | 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 | filmom obložena tableta | kroz usta |
| Španjolska | FARMALIDER, S.A. Aragoneses, 2, Alcobendas (Madrid). 28108.SPAIN | ZOLPIDEM FARMALIDER 10 mg COMPRIMIDOS RECUBIERTOS EFG | 10 mg | filmom obložena tableta | kroz usta |
| Španjolska | GENERFARMA, S.L. Ronda Isaac Peral, 6 Parque Tecnológico 46980 Paterna (Valencia) SPAIN | ZOLPIDEM DESGEN 5 mg COMPRIMIDOS EFG | 5 mg | tableta | kroz usta |
| Španjolska | GENERFARMA, S.L. Ronda Isaac Peral, 6 Parque Tecnológico 46980 Paterna (Valencia) SPAIN | ZOLPIDEM DESGEN 10 mg COMPRIMIDOS EFG | 10 mg | tableta | kroz usta |
| Španjolska | GERMED FARMACEUTICA S.L. Chile, 8 – 2a planta. Oficina 203, Las Matas (Madrid). 28290. SPAIN | ZOLPIDEM EDIGEN 10 mg COMPRIMIDOS RECUBIERTOS EFG | 10 mg | filmom obložena tableta | kroz usta |
| Španjolska | LABORATORIO STADA, S.L. Frederic Mompou, 5 , Sant Just Desvern (Barcelona). 08960
  SPAIN | ZOLPIDEM STADA 10 mg COMPRIMIDOS RECUBIERTOS EFG | 10 mg | filmom obložena tableta | kroz usta |
| Španjolska | 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 | filmom obložena tableta | kroz usta |
| Španjolska | LABORATORIOS NORMON, S.A. Ronda de Valdecarrizo, 6, Tres Cantos (Madrid). 28760. SPAIN | ZOLPIDEM NORMON 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | 10 mg | filmom obložena tableta | kroz usta |
| Španjolska | 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 | sublingvalna tableta | kroz usta |
| Španjolska | 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 | sublingvalna tableta | kroz usta |
| Španjolska | MYLAN PHARMACEUTICALS, S.L. Plom 2-4, 5o Planta, Barcelona. 08038. SPAIN | ZOLPIDEM MYLAN 10 mg COMPRIMIDOS RECUBIERTOS EFG | 10 mg | filmom obložena tableta | kroz usta |
| Španjolska | PHARMAGENUS, S.A. Avda. Camí Real, 51-57 Palau-solita i Plegamans (Barcelona). 08184. SPAIN | ZOLPIDEM PHARMAGENUS 5 mg COMPRIMIDOS | 5 mg | tableta | kroz usta |
| Španjolska | PHARMAGENUS, S.A. Avda. Camí Real, 51-57 Palau-solita i Plegamans (Barcelona). 08184. SPAIN | ZOLPIDEM PHARMAGENUS 10 mg COMPRIMIDOS EFG | 10 mg | tableta | kroz usta |
| Španjolska | 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 | filmom obložena tableta | kroz usta |
| Španjolska | 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 | filmom obložena tableta | kroz usta |
| Španjolska | 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 | filmom obložena tableta | kroz usta |
| Španjolska | SANDOZ FARMACÉUTICA, S.A.
  Avda. Osa Mayor, 4
  28023 Aravaca (Madrid)
  Spain | ZOLPIDEM SANDOZ 10 mg COMPRIMIDOS EFG | 10 mg | tableta | kroz usta |
| Španjolska | SANOFI AVENTIS, S.A.
  Josep Plá, 2,
  Barcelona. 08019
  SPAIN | STILNOX 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | 10 mg | filmom obložena tableta | kroz usta |
| Španjolska | 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 | filmom obložena tableta | kroz usta |
| Španjolska | Zentiva, k.s.
  U kabelovny 130
  Prague 10, Dolni Mecholupy
  10237
  Czech Republic | ZOLPIDEM ZENTIVA 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | 10 mg | filmom obložena tableta | kroz usta |
| Švedska | Actavis Group PTC ehf.
  Reykjavikurvegur 76-78
  IS-220 Hafnarfjördur
  Iceland | Zolpidem Actavis | 5 mg | filmom obložena tableta | kroz usta |
| Švedska | Actavis Group PTC ehf.
  Reykjavikurvegur 76-78
  IS-220 Hafnarfjördur
  Iceland | Zolpidem Actavis | 10 mg | filmom obložena tableta | kroz usta |
| Švedska | Hexal A/S
  Edvard Thomsens Vej 14
  DK-2300 Köpenhamn S
  Denmark | Zolpidem HEXAL | 10 mg | filmom obložena tableta | kroz usta |
| Švedska | Ranbaxy (UK) Ltd,
  Building 4
  Chiswick Park
  London W4 5YE
  United Kingdom | Zolpidem Ranbaxy | 5 mg | filmom obložena tableta | kroz usta |
| Švedska | Ranbaxy (UK) Ltd,
  Building 4
  Chiswick Park
  London W4 5YE
  United Kingdom | Zolpidem Ranbaxy | 10 mg | filmom obložena tableta | kroz usta |
| Švedska | Meda AB, Pipers väg 2A, Box 906, SE-170 09, Sweden | Edluar | 5 mg | sublingvalna tableta | kroz usta |
| Švedska | Meda AB, Pipers väg 2A, Box 906, SE-170 09, Sweden | Edluar | 10 mg | sublingvalna tableta | kroz usta |
| Švedska | Mylan AB
  Box 23033
  104 35 Stockholm
  Sweden | Zolpidem Mylan | 10 mg | filmom obložena tableta | kroz usta |
| Švedska | Orifarm Generics A/S
  Energivej 15 POB 69
  DK-5260 Odense S
  Denmark | Zolpidem Orifarm | 5 mg | filmom obložena tableta | kroz usta |
| Švedska | Orifarm Generics A/S
  Energivej 15 POB 69
  DK-5260 Odense S
  Denmark | Zolpidem Orifarm | 10 mg | filmom obložena tableta | kroz usta |
| Švedska | ratiopharm GmbH
  Graf Arco Strasse 3
  D-89079 Ulm
  Germany | Zolpidem ratiopharm | 5 mg | filmom obložena tableta | kroz usta |
| Švedska | ratiopharm GmbH
  Graf Arco Strasse 3
  D-89079 Ulm
  Germany | Zolpidem ratiopharm | 10 mg | filmom obložena tableta | kroz usta |
| Švedska | Sandoz A/S
  Edvard Thomsens Vej 14
  DK-2300 Köpenhamn S
  Denmark | Zolpidem Sandoz | 5 mg | filmom obložena tableta | kroz usta |
| Švedska | Sandoz A/S
  Edvard Thomsens Vej 14
  DK-2300 Köpenhamn S
  Denmark | Zolpidem Sandoz | 10 mg | filmom obložena tableta | kroz usta |
| Švedska | sanofi-aventis AB
  Box 14142
  167 14 Bromma
  Sweden | Stilnoct | 5 mg | filmom obložena tableta | kroz usta |
| Švedska | sanofi-aventis AB
  Box 14142
  167 14 Bromma
  Sweden | Stilnoct | 10 mg | filmom obložena tableta | kroz usta |
| Švedska | STADA Arzneimittel AG
  Stadastrasse 2-18
  DE-61118 Bad Vilbel
  Germany | Zolpidem STADA | 5 mg | filmom obložena tableta | kroz usta |
| Švedska | STADA Arzneimittel AG
  Stadastrasse 2-18
  DE-61118 Bad Vilbel
  Germany | Zolpidem STADA | 10 mg | filmom obložena tableta | kroz usta |
| Švedska | Synthon BV, Microweg 22, NL-6545 CM Nijmegen, The Netherlands | Zolpidem Genthon | 5 mg | filmom obložena tableta | kroz usta |
| Švedska | Synthon BV, Microweg 22, NL-6545 CM Nijmegen, The Netherlands | Zolpidem Genthon | 10 mg | filmom obložena tableta | kroz usta |
| Švedska | Vitabalans Oy
  Varastokatu 8
  13500 Hämeenlinna
  Finland | Zolpidem Vitabalans | 10 mg | filmom obložena tableta | kroz usta |
| Nizozemska | Actavis B.V.
  Baarnsche Dijk 1
  3741 LN BAARN
  The Netherlands | Zolpidemtartaat Actavis 5 mg, tabletten | 5 mg | tableta | kroz usta |
| Nizozemska | Actavis B.V.
  Baarnsche Dijk 1
  3741 LN BAARN
  The Netherlands | Zolpidemtartraat Actavis 10 mg, tabletten | 10 mg | tableta | kroz usta |
| Nizozemska | ADOH B.V.
  Godfried Bomansstraat 31
  6543 JA NIJMEGEN
  The Netherlands | Zolpidemtartraat ADOH bruistabletten 10 mg, bruistabletten | 10 mg | šumeća tableta | kroz usta |
| Nizozemska | Pharmachemie B.V.
  Swensweg 5
  2031 GA HAARLEM
  The Netherlands | Zolpidemtartraat 5 mg PCH, filmomhulde tabletten | 5 mg | filmom obložena tableta | kroz usta |
| Nizozemska | Pharmachemie B.V.
  Swensweg 5
  2031 GA HAARLEM
  The Netherlands | Zolpidemtartraat 10 mg PCH, filmomhulde tabletten | 10 mg | filmom obložena tableta | kroz usta |
| Nizozemska | ratiopharm Nederland B.V.
  Swensweg 5
  2031 GA HAARLEM
  The Netherlands | Zolpidemtartraat ratiopharm 5 mg, tabletten | 5 mg | tableta | kroz usta |
| Nizozemska | ratiopharm Nederland B.V.
  Swensweg 5
  2031 GA HAARLEM
  The Netherlands | Zolpidemtartraat ratiopharm 10 mg, tabletten | 10 mg | tableta | kroz usta |
| Nizozemska | ratiopharm Nederland B.V.
  Swensweg 5
  2031 GA HAARLEM
  The Netherlands | Zolpidemtartraat ratiopharm 5 mg, filmomhulde tabletten | 5 mg | filmom obložena tableta | kroz usta |
| Nizozemska | ratiopharm Nederland B.V.
  Swensweg 5
  2031 GA HAARLEM
  The Netherlands | Zolpidemtartraat ratiopharm 10 mg, filmomhulde tabletten | 10 mg | filmom obložena tableta | kroz usta |
| Nizozemska | ratiopharm Nederland B.V.
  Swensweg 5
  2031 GA HAARLEM
  The Netherlands | Zolpidemtartraat ratiopharm 10 mg, filmomhulde tabletten | 10 mg | filmom obložena tableta | kroz usta |
| Nizozemska | Sandoz B.V.
  Veluwezoom 22
  1327 AH ALMERE
  The Netherlands | Zolpidemtartraat Sandoz 10 mg, filmomhulde tabletten | 10 mg | filmom obložena tableta | kroz usta |
| Nizozemska | Sandoz B.V.
  Veluwezoom 22
  1327 AH ALMERE
  The Netherlands | Zolpidemtartraat Sandoz 5, filmomhulde tabletten 5 mg | 5 mg | filmom obložena tableta | kroz usta |
| Nizozemska | Sandoz B.V.
  Veluwezoom 22
  1327 AH ALMERE
  The Netherlands | Zolpidemtartraat Sandoz 10,filmomhulde tabletten 10 mg | 10 mg | filmom obložena tableta | kroz usta |
| Nizozemska | Synthon B.V.
  Microweg 22
  6545 CM NIJMEGEN
  The Netherlands | Zolpidemtartraat 5 mg, filmomhulde tabletten | 5 mg | filmom obložena tableta | kroz usta |
| Nizozemska | Synthon B.V.
  Microweg 22
  6545 CM NIJMEGEN
  The Netherlands | Zolpidemtartraat 10 mg, filmomhulde tabletten | 10 mg | filmom obložena tableta | kroz usta |
| Nizozemska | Synthon B.V.
  Microweg 22
  6545 CM NIJMEGEN
  The Netherlands | Zolpidemtartraat 5 mg, filmomhulde tabletten | 5 mg | filmom obložena tableta | kroz usta |
| Nizozemska | Synthon B.V.
  Microweg 22
  6545 CM NIJMEGEN
  The Netherlands | Zolpidemtartraat 10 mg, filmomhulde tabletten | 10 mg | filmom obložena tableta | kroz usta |
| Nizozemska | Synthon B.V.
  Microweg 22
  6545 CM NIJMEGEN
  The Netherlands | Zolpidemtartraat 5 mg, filmomhulde tabletten | 5 mg | filmom obložena tableta | kroz usta |
| Nizozemska | Synthon B.V.
  Microweg 22
  6545 CM NIJMEGEN
  The Netherlands | Zolpidemtartraat 10 mg, filmomhulde tabletten | 10 mg | filmom obložena tableta | kroz usta |
| Nizozemska | ADOH B.V.
  Godfried Bomansstraat 31
  6543 JA NIJMEGEN
  The Netherlands | Zolpidemtartraat ADOH 10 mg, bruistabletten | 10 mg | šumeća tableta | kroz usta |
| Nizozemska | Apotex Europe B.V.
  Darwinweg 20
  NL 2333 CR Leiden
  The Netherlands | Zolpidemtartraat Apotex 5 mg, filmomhulde tabletten | 5 mg | filmom obložena tableta | kroz usta |
| Nizozemska | Apotex Europe B.V.
  Darwinweg 20
  NL 2333 CR Leiden
  The Netherlands | Zolpidemtartraat Apotex 10 mg, filmomhulde tabletten | 10 mg | filmom obložena tableta | kroz usta |
| Nizozemska | Centrafarm B.V.
  Nieuwe Donk 3
  4879 AC ETTEN LEUR
  The Netherlands | Zolpidemtartraat CF 5 mg, film-omhulde tabletten | 5 mg | filmom obložena tableta | kroz usta |
| Nizozemska | Centrafarm B.V.
  Nieuwe Donk 3
  4879 AC ETTEN LEUR
  The Netherlands | Zolpidemtartraat CF 10 mg, film-omhulde tabletten | 10 mg | filmom obložena tableta | kroz usta |
| Nizozemska | Eurogenerics S.A.
  Esplanade Heysel, b22
  1020 Bruxelles
  Belgium | Zolpidem Eurogenerics bruis 10 mg bruistabletten, bruistabletten | 10 mg | šumeća tableta | kroz usta |
| Nizozemska | FIDIA Farmaceutici S.p.a.
  Via Ponte della Fabbrica, 3/a, Abano Terme, Padova – 35031 Italy | Zolpidemtartraat 10 mg, filmomhulde tabletten | 10 mg | filmom obložena tableta | kroz usta |
| Nizozemska | Genthon BV
  Microweg, 22
  6545 Nijmegen
  The Netherlands | Zolpidemtartraat 5 mg, filmomhulde tabletten | 5 mg | filmom obložena tableta | kroz usta |
| Nizozemska | Genthon BV
  Microweg, 22
  6545 Nijmegen
  The Netherlands | Zolpidemtartraat 10 mg, filmomhulde tabletten | 10 mg | filmom obložena tableta | kroz usta |
| Nizozemska | Meda Pharma B.V.
  Krijgsman 20
  1186 DM AMSTELVEEN
  The Netherlands | Edluar 5 mg, tablet voor sublinguaal gebruik | 5 mg | sublingvalna tableta | pod jezik |
| Nizozemska | Meda Pharma B.V.
  Krijgsman 20
  1186 DM AMSTELVEEN
  The Netherlands | Edluar 10 mg, tablet voor sublinguaal gebruik | 10 mg | sublingvalna tableta | pod jezik |
| Nizozemska | Mylan B.V.
  Dieselweg 25
  3752 LB BUNSCHOTEN
  The Netherlands | Zolpidemtartraat Mylan 10 mg, filmomhulde tabletten | 10 mg | filmom obložena tableta | kroz usta |
| Nizozemska | Pharmachemie B.V.
  Swensweg 5
  2031 GA HAARLEM
  The Netherlands | Zolpidemtartraat 5 PCH, filmomhulde tabletten 5 mg | 5 mg | filmom obložena tableta | kroz usta |
| Nizozemska | Pharmachemie B.V.
  Swensweg 5
  2031 GA HAARLEM
  The Netherlands | Zolpidemtartraat 10 PCH, filmomhulde tabletten 10 mg | 10 mg | filmom obložena tableta | kroz usta |
| Nizozemska | Sanofi-Aventis Netherlands B.V.
  Kampenringweg 45 D-E
  2803 PE GOUDA
  The Netherlands | Stilnoct, tabletten 10 mg | 10 mg | tableta | kroz usta |
| Nizozemska | STADA Arzneimittel AG
  Stadastrasse 2-18
  DE-61118 Bad Vilbel
  Germany | Zolpidemtartraat Stada 5 mg, filmomhulde tabletten | 5 mg | filmom obložena tableta | kroz usta |
| Nizozemska | STADA Arzneimittel AG
  Stadastrasse 2-18
  DE-61118 Bad Vilbel
  Germany | Zolpidemtartraat Stada 10 mg, filmomhulde tabletten | 10 mg | filmom obložena tableta | kroz usta |
| Nizozemska | Synthon B.V.
  Microweg 22
  6545 CM NIJMEGEN
  The Netherlands | Zolpidemtartraat 10 mg, filmomhulde tabletten | 10 mg | filmom obložena tableta | kroz usta |
| Velika Britanija | Actavis UK Limited, Whiddon Valley, Barnstaple, North Devon EX32 8NS
  United Kingdom | Zolpidem Tartrate 5 mg tablets | 5 mg | filmom obložena tableta | kroz usta |
| Velika Britanija | Actavis UK Limited, Whiddon Valley, Barnstaple, North Devon EX32 8NS
  United Kingdom | Zolpidem Tartrate 10 mg tablets | 10 mg | filmom obložena tableta | kroz usta |
| Velika Britanija | ALKALOID-INT d.o.o.
  Šlandrova ulica 4
  1231 Ljubljana-Črnuče Slovenia | Zolpidem Tartrate 5 mg film-coated tablets | 5 mg | filmom obložena tableta | kroz usta |
| Velika Britanija | ALKALOID-INT d.o.o.
  Šlandrova ulica 4
  1231 Ljubljana-Črnuče Slovenia | Zolpidem Tartrate 10 mg film-coated tablets | 10 mg | filmom obložena tableta | kroz usta |
| Velika Britanija | Aventis Pharma Limited, One Onslow Street, Guildford, Surrey GU1 4SY
  United Kingdom | Stilnoct 5 mg fiilm-coated tablets | 5 mg | obložena tableta | kroz usta |
| Velika Britanija | Aventis Pharma Limited, One Onslow Street, Guildford, Surrey GU1 4SY
  United Kingdom | Stilnoct 10 mg film-coated tablets | 10 mg | obložena tableta | kroz usta |
| Velika Britanija | Bristol Laboratories Limited, Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire HP4 1EG
  United Kingdom | Zolpidem Tartrate 5 mg film-coated tablets | 5 mg | filmom obložena tableta | kroz usta |
| Velika Britanija | Bristol Laboratories Limited, Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire HP4 1EG
  United Kingdom | Zolpidem Tartrate 10 mg film-coated tablets | 10 mg | filmom obložena tableta | kroz usta |
| Velika Britanija | Generics [UK] Ltd.
  Station Close
  EN6 1TL Hertfordshire – Potters Bar
  United Kingdom | Zolpidem 10 mg film-coated tablets | 10 mg | filmom obložena tableta | kroz usta |
| Velika Britanija | Meda Pharmaceuticals Limited, Skyway House, Parsonage Road, Takeley, Bishops Stortford CM22 6PU
  United Kingdom | Edluar 5 mg sublingual tablets | 5 mg | sublingvalna tableta | kroz usta |
| Velika Britanija | Meda Pharmaceuticals Limited, Skyway House, Parsonage Road, Takeley, Bishops Stortford CM22 6PU
  United Kingdom | Edluar 10 mg sublingual tablets | 10 mg | sublingvalna tableta | kroz usta |
| Velika Britanija | Amneal Pharma Europe Limited, 70 Sir John Rogerson's Quay, Dublin 2, Ireland | Zolpidem Tartrate 5 mg film-coated tablets | 5 mg | filmom obložena tableta | kroz usta |
| Velika Britanija | Amneal Pharma Europe Limited, 70 Sir John Rogerson's Quay, Dublin 2, Ireland | Zolpidem Tartrate 10 mg film-coated tablets | 10 mg | filmom obložena tableta | kroz usta |
| Velika Britanija | ratiopharm GmbH
  Graf Arco Strasse 3
  D-89079 Ulm
  Germany | Zolpidem Tartrate 5 mg film-coated tablets | 5 mg | filmom obložena tableta | kroz usta |
| Velika Britanija | ratiopharm GmbH
  Graf Arco Strasse 3
  D-89079 Ulm
  Germany | Zolpidem Tartrate 10 mg film-coated tablets | 10 mg | filmom obložena tableta | kroz usta |
| Velika Britanija | Sandoz Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR
  United Kingdom | Zolpidem Tartrate 10 mg tablets | 10 mg | filmom obložena tableta | kroz usta |
| Velika Britanija | Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex BN22 9AG
  United Kingdom | Zolpidem Tartrate 5 mg, film-coated tablets | 5 mg | filmom obložena tableta | kroz usta |
| Velika Britanija | Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex BN22 9AG
  United Kingdom | Zolpidem Tartrate 10 mg, film-coated tablets | 10 mg | filmom obložena tableta | kroz usta |
| Velika Britanija | Tillomed Laboratories Limited, 3 Howard Road, Eaton Socon, St Neots, Cambridgeshire PE19 8ET
  United Kingdom | Zolpidem 10 mg film-coated tablets | 10 mg | filmom obložena tableta | kroz usta |
| Velika Britanija | Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS
  United Kingdom | Zolpidem Tartrate 5 mg tablets | 5 mg | filmom obložena tableta | kroz usta |
| Velika Britanija | Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS
  United Kingdom | Zolpidem Tartrate 10 mg tablets | 10 mg | filmom obložena tableta | kroz usta |

Država članica EU/EGP

Nositelj odobrenja

Zaštićeno ime

Jačina

Farmaceutski oblik

Put primjene

Austrija

G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria

Zoldem 5 mg – Filmtabletten

5 mg

filmom obložena tableta

kroz usta

Austrija

G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria

Zoldem 10 mg – Filmtabletten

10 mg

filmom obložena tableta

kroz usta

Austrija

G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria

Zolpidem G.L. 10 mg – Filmtabletten

10 mg

filmom obložena tableta

kroz usta

Austrija

Hexal Pharma GmbH, Stella-Klein-Löw-Weg 17, 1020 Wien, Austria

Zolpidem „Hexal” – Filmtabletten

10 mg

filmom obložena tableta

kroz usta

Austrija

Meda Pharma GmbH, Guglgasse 15, 1110 Wien, Austria

Edluar 5 mg Sublingualtabletten

5 mg

sublingvalna tableta

pod jezik

Austrija

Meda Pharma GmbH, Guglgasse 15, 1110 Wien, Austria

Edluar 10 mg Sublingualtabletten

10 mg

sublingvalna tableta

pod jezik

Austrija

ratiopharm Arzneimittel Vertriebs-GmbH, Albert-Schweitzer-Gasse 3, 1140 Wien, Austria

Zolpidem „ratiopharm” 10 mg Filmtabletten

10 mg

filmom obložena tableta

kroz usta

Austrija

sanofi-aventis GmbH, Saturn Tower, Leonard-Bernstein-Straße 10, 1220 Wien, Austria

Ivadal – Filmtabletten

10 mg

filmom obložena tableta

kroz usta

Austrija

STADA Arzneimittel GmbH, Muthgasse 36/2, 1190 Wien, Austria

Mondeal 10 mg – Filmtabletten

10 mg

filmom obložena tableta

kroz usta

Belgija

APOTEX NV

Av. du Bourg. Etienne Demunter 5 box 8

1090 Jette

Belgium

Zolpitop

10 mg

filmom obložena tableta

kroz usta

Belgija

APOTEX NV

Av. du Bourg. Etienne Demunter 5 box 8

1090 Jette

Belgium

Zolpitop

5 mg

filmom obložena tableta

kroz usta

Belgija

Eurogenerics S.A.

Esplanade Heysel, b22

1020 Bruxelles

Belgium

Zolpidem EG

10 mg

filmom obložena tableta

kroz usta

Belgija

Eurogenerics S.A.

Esplanade Heysel, b22

1020 Bruxelles

Belgium

Zolpidem EG

10 mg

šumeća tableta

kroz usta

Belgija

Ipca, Produtos Farmaceuticos, Unipessoal Lda

Rua Chanceler-Mor 11 R/c Frt.

Cacem

2735-615

Portugal

Zolpidem IPCA

5 mg

filmom obložena tableta

kroz usta

Belgija

Ipca, Produtos Farmaceuticos, Unipessoal Lda

Rua Chanceler-Mor 11 R/c Frt.

Cacem

2735-615

Portugal

Zolpidem IPCA

10 mg

filmom obložena tableta

kroz usta

Belgija

MEDA PHARMA

Chaussee de la Hulpe 166

1170 Watermael-Boitsfort

Belgium

Zolpeduar

5 mg

sublingvalna tableta

kroz usta

Belgija

MEDA PHARMA

Chaussee de la Hulpe 166

1170 Watermael-Boitsfort

Belgium

Zolpeduar

10 mg

sublingvalna tableta

kroz usta

Belgija

MYLAN BVBA/SPRL

Terhulpsesteenweg 6A

1560 Hoeilaart

Belgium

Zolpidem Mylan

10 mg

filmom obložena tableta

kroz usta

Belgija

SANDOZ N.V.

Telecom Gardens

Medialaan 40

1800 1800ilvoorde

Belgium

Zolpidem Sandoz

10 mg

filmom obložena tableta

kroz usta

Belgija

SANOFI BELGIUM

Airport Plaza, Montreal Building, Leonardo Da Vincilaan 19

1831 Diegem

Belgium

Stilnoct

10 mg

tableta

kroz usta

Belgija

SANOFI BELGIUM

Airport Plaza, Montreal Building, Leonardo Da Vincilaan 19

1831 Diegem

Belgium

Zolpidem Sanofi-Aventis Belgium

10 mg

filmom obložena tableta

kroz usta

Belgija

TEVA PHARMA BELGIUM NV

Laarstraat 16

2610 Wilrijk

Belgium

Zolpidem Teva

10 mg

filmom obložena tableta

kroz usta

Belgija

TEVA PHARMA BELGIUM NV

Laarstraat 16

2610 Wilrijk

Belgium

Zolpidem Ratiopharm

10 mg

filmom obložena tableta

kroz usta

Bugarska

ALKALOID-INT d.o.o.

Šlandrova ulica 4

1231 Ljubljana-Črnuče Slovenia

Adorma

5 mg

filmom obložena tableta

kroz usta

Bugarska

ALKALOID-INT d.o.o.

Šlandrova ulica 4

1231 Ljubljana-Črnuče Slovenia

Adorma

10 mg

filmom obložena tableta

kroz usta

Bugarska

Krka, d.d., Novo mesto

Šmarješka cesta 6

8000 Novo mesto

Slovenia

Zolsana

5 mg

filmom obložena tableta

kroz usta

Bugarska

Krka, d.d., Novo mesto

Šmarješka cesta 6

8000 Novo mesto

Slovenia

Zolsana

10 mg

filmom obložena tableta

kroz usta

Bugarska

Meda Pharma GmbH & Co. KG

Benzstrasse 1

Bad Homburg v.d.H

61352

Germany

Edluar

5 mg

sublingvalna tableta

pod jezik

Bugarska

Meda Pharma GmbH & Co. KG

Benzstrasse 1

Bad Homburg v.d.H

61352

Germany

Edluar

10 mg

sublingvalna tableta

pod jezik

Bugarska

Sanofi-Aventis Bulgaria EOOD,

103 Alexander Stamboliiski Blvd. Building Sofia Tower

Sofia 1303

Bulgaria

Stilnox

10 mg

filmom obložena tableta

kroz usta

Hrvatska

Alkaloid d.o.o., Ulica grada Vukovara 226 F, Zagreb, Croatia

Lunata 5 mg filmom obložene tablete

5 mg

filmom obložena tableta

kroz usta

Hrvatska

Alkaloid d.o.o., Ulica grada Vukovara 226 F, Zagreb, Croatia

Lunata 10 mg filmom obložene tablete

10 mg

filmom obložena tableta

kroz usta

Hrvatska

Krka – farma d.o.o., Radnička cesta 48, Zagreb, Croatia

Zolsana 5 mg filmom obložene tablete

5 mg

filmom obložena tableta

kroz usta

Hrvatska

Krka – farma d.o.o., Radnička cesta 48, Zagreb, Croatia

Zolsana 10 mg filmom obložene tablete

10 mg

filmom obložena tableta

kroz usta

Hrvatska

Pliva Hrvatska d.o.o., Prilaz baruna Filipovića 25, Zagreb, Croatia

Zonadin 5 mg tablete

5 mg

filmom obložena tableta

kroz usta

Hrvatska

Pliva Hrvatska d.o.o., Prilaz baruna Filipovića 25, Zagreb, Croatia

Zonadin 10 mg tablete

10 mg

filmom obložena tableta

kroz usta

Hrvatska

Sandoz d.o.o., Maksimirska 120, Zagreb, 1000, Croatia

Sanval 5 mg filmom obložene tablete

5 mg

filmom obložena tableta

kroz usta

Hrvatska

Sandoz d.o.o., Maksimirska 120, Zagreb, 1000, Croatia

Sanval 10 mg filmom obložene tablete

10 mg

filmom obložena tableta

kroz usta

Cipar

Sanofi-Aventis Cyprus Ltd

Charalambou Mouskou 14

Lefkosia 2015 Cyprus

Stilnox

10 mg

filmom obložena tableta

kroz usta

Češka Republika

ALKALOID-INT d.o.o.

Šlandrova ulica 4

1231 Ljubljana-Črnuče Slovenia

ADORMA 5 MG

5 mg

filmom obložena tableta

kroz usta

Češka Republika

ALKALOID-INT d.o.o.

Šlandrova ulica 4

1231 Ljubljana-Črnuče Slovenia

ADORMA 10 MG

10 mg

filmom obložena tableta

kroz usta

Češka Republika

Apotex Europe B.V.

Darwinweg 20

NL 2333 CR Leiden

Netherlands

APO-ZOLPIDEM 10 MG

10 mg

filmom obložena tableta

kroz usta

Češka Republika

Generics [UK] Ltd.

Station Close

EN6 1TL Hertfordshire – Potters Bar

United Kingdom

ZOLPIDEM MYLAN

10 mg

filmom obložena tableta

kroz usta

Češka Republika

Krka, d.d., Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

ZOLSANA 10 MG

10 mg

filmom obložena tableta

kroz usta

Češka Republika

MEDA Pharma s.r.o.

Kodaňská 1441/46

110 00 Prague 10

Czech Republic

EDLUAR 5 MG SUBLINGVÁLNÍ TABLETY

5 mg

sublingvalna tableta

pod jezik

Češka Republika

MEDA Pharma s.r.o.

Kodaňská 1441/46

110 00 Prague 10

Czech Republic

EDLUAR 10 MG SUBLINGVÁLNÍ TABLETY

10 mg

sublingvalna tableta

pod jezik

Češka Republika

Orion Corporation

Orionintie 1/A

FI-02200 Espoo

Finland

ZOLPIDEM ORION 10 MG

10 mg

filmom obložena tableta

kroz usta

Češka Republika

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

ZOLPIDEM-RATIOPHARM 10 MG

10 mg

filmom obložena tableta

kroz usta

Češka Republika

SANDOZ s.r.o.

U nákladového nádraží 3265/10

130 00 Prague 3

Czech Republic

SANVAL 10 MG

10 mg

filmom obložena tableta

kroz usta

Češka Republika

sanofi-aventis, s.r.o.

Evropská 846/176a

160 00 Prague 6 – Vokovice

Czech Republic

STILNOX

10 mg

filmom obložena tableta

kroz usta

Češka Republika

SVUS Pharma a.s., Smetanovo nábřeží 1238/20a

500 02 Hradec Králové Czech Republic

ZOLPINOX

10 mg

filmom obložena tableta

kroz usta

Češka Republika

Takeda GmbH

Byk-Gulden-Str. 2

78467 Konstanz

Germany

HYPNOGEN

10 mg

filmom obložena tableta

kroz usta

Češka Republika

Vitabalans Oy

Varastokatu 8

13500 Hämeenlinna

Finland

ZOLPIDEM VITABALANS 10 MG POTAHOVANÉ TABLETY

10 mg

filmom obložena tableta

kroz usta

Danska

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

IS-220 Hafnarfjördur

Iceland

Zolpidem „Actavis”

10 mg

filmom obložena tableta

kroz usta

Danska

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

IS-220 Hafnarfjördur

Iceland

Zolpidem „Actavis”

5 mg

filmom obložena tableta

kroz usta

Danska

Generics [UK] Ltd.

Station Close

EN6 1TL Hertfordshire – Potters Bar

United Kingdom

Zolpidem „Generics”

10 mg

filmom obložena tableta

kroz usta

Danska

HEXAL A/S, Kanalholmen 8-12, DK-2650 Hvodovre, Denmark

Zolpidem „Hexal”

10 mg

filmom obložena tableta

kroz usta

Danska

Meda AS, Solvang 8, DK-3450 Allerød, Denmark

Edluar

5 mg

sublingvalna tableta

pod jezik

Danska

Meda AS, Solvang 8, DK-3450 Allerød, Denmark

Edluar

10 mg

sublingvalna tableta

pod jezik

Danska

PharmaCoDane ApS, Marielundvej 46 A, DK-2730 Herlev, Denmark

Zonoct

10 mg

filmom obložena tableta

kroz usta

Danska

sanofi-aventis Denmark A/S, Slotsmarken 13, DK-2970 Hørsholm, Denmark

Stilnoct

10 mg

filmom obložena tableta

kroz usta

Danska

Synthon BV, Microweg 22, NL-6545 CM Nijmegen, The Netherlands

Zolpidem „Genthon”

5 mg

filmom obložena tableta

kroz usta

Danska

Synthon BV, Microweg 22, NL-6545 CM Nijmegen, The Netherlands

Zolpidem „Genthon”

10 mg

filmom obložena tableta

kroz usta

Danska

Vitabalans Oy

Varastokatu 8

13500 Hämeenlinna

Finland

Zolpidem „Vitabalans”

10 mg

filmom obložena tableta

kroz usta

Estonija

Krka, d.d., Novo mesto

Šmarješka cesta 6

8000 Novo mesto

Slovenia

ZOLSANA

5 mg

tableta

kroz usta

Estonija

Krka, d.d., Novo mesto

Šmarješka cesta 6

8000 Novo mesto

Slovenia

ZOLSANA

10 mg

tableta

kroz usta

Estonija

Meda Pharma GmbH & Co. KG

Benzstrasse 1

Bad Homburg v.d.H

61352

Germany

EDLUAR

5 mg

sublingvalna tableta

kroz usta

Estonija

Meda Pharma GmbH & Co. KG

Benzstrasse 1

Bad Homburg v.d.H

61352

Germany

EDLUAR

10 mg

sublingvalna tableta

kroz usta

Estonija

Sandoz d.d.

Verovškova 57,

1000 Ljubljana,

Slovenia

ZOLPIDEM SANDOZ 10 MG

10 mg

tableta

kroz usta

Estonija

Sanofi-Aventis Estonia OÜ Pärnu mnt 139E/2

11317 Tallinn

Estonia

STILNOX

10 mg

tableta

kroz usta

Estonija

Takeda GmbH 2 Byk-Gulden Strasse

78467 Konstanz Germany

HYPNOGEN

10 mg

tableta

kroz usta

Estonija

Vitabalans Oy

Varastokatu 8

13500 Hämeenlinna

Finland

ZOLPIDEM VITABALANS 10 MG

10 mg

tableta

kroz usta

Finska

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

IS-220 Hafnarfjördur

Iceland

Stella

5 mg

filmom obložena tableta

kroz usta

Finska

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

IS-220 Hafnarfjördur

Iceland

Stella

10 mg

filmom obložena tableta

kroz usta

Finska

Hexal A/S

Edvard Thomsens Vej 14

DK-2300 Köpenhamn S

Denmark

Zolpidem Hexal

10 mg

filmom obložena tableta

kroz usta

Finska

Meda Oy

Vaisalantie 4

02130 Espoo

Finland

Edluar

5 mg

sublingvalna tableta

pod jezik

Finska

Meda Oy

Vaisalantie 4

02130 Espoo

Finland

Edluar

10 mg

sublingvalna tableta

pod jezik

Finska

Orion Corporation

Orionintie 1/A

FI-02200 Espoo

Finland

Somnor

10 mg

filmom obložena tableta

kroz usta

Finska

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Zolpidem-Ratiopharm

10 mg

filmom obložena tableta

kroz usta

Finska

Sanofi Oy

Huopalahdentie 24

P.O.Box 22

00350 Helsinki

Finland

Stilnoct

10 mg

filmom obložena tableta

kroz usta

Finska

Vitabalans Oy

Varastokatu 8

13500 Hämeenlinna

Finland

Zolpidem Vitabalans

10 mg

filmom obložena tableta

kroz usta

Francuska

LABORATOIRES ALTER

3, avenue de la Baltique

ZI de Courtaboeuf

91140 Villebon Sur Yvette France

ZOLPIDEM ALTER

10 mg

filmom obložena tableta

kroz usta

Francuska

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

IS-220 Hafnarfjördur

Iceland

ZOLPIDEM ACTAVIS

10 MG

filmom obložena tableta

kroz usta

Francuska

ARROW GENERIQUES

26, avenue Tony Garnier

69007 Lyon France

ZOLPIDEM ARROW

10 mg

filmom obložena tableta

kroz usta

Francuska

BIOGARAN

15, boulevard Charles de Gaulle

92700 Colombes FRANCE

ZOLPIDEM ALMUS

10 mg

filmom obložena tableta

kroz usta

Francuska

BIOGARAN

15, boulevard Charles de Gaulle

92700 Colombes FRANCE

ZOLPIDEM BIOGARAN

10 mg

filmom obložena tableta

kroz usta

Francuska

CRISTERS

22 quai Gallieni

92150 Suresnes France

ZOLPIDEM CRISTERS

10 mg

filmom obložena tableta

kroz usta

Francuska

CTRS

Route de la Ganne

36170 Saint Benoit du Sault France

ZOLPIDEM CTRS

10 mg

filmom obložena tableta

kroz usta

Francuska

EG LABO – LABORATOIRES EUROGENERICS

„Le Quintet” – bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex France

ZOLPIDEM EG

10 mg

filmom obložena tableta

kroz usta

Francuska

EG LABO – LABORATOIRES EUROGENERICS

„Le Quintet” – bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex France

ZOLPIDEM EG

10 mg

obložena tableta

kroz usta

Francuska

Genfarma B.V.

Postbus 2062

1500 GB Zaandam

The Netherlands

ZOLPIDEM RATIOPHARM

10 mg

obložena tableta

kroz usta

Francuska

Kiron Pharmaceutica BV

Groesbeekseweg 11 Nijmegen, 6524 CK

The Netherlands

ZOLPIDEM KIRION

5 mg

filmom obložena tableta

kroz usta

Francuska

MEDA PHARMA

25, boulevard de l'Amiral Bruix

75016 Paris

FRANCE

EDLUAR

5 mg

sublingvalna tableta

kroz usta

Francuska

MEDA PHARMA

25, boulevard de l'Amiral Bruix

75016 Paris

FRANCE

EDLUAR

10 mg

sublingvalna tableta

kroz usta

Francuska

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

France

ZOLPIDEM MYLAN

10 mg

filmom obložena tableta

kroz usta

Francuska

PHARMACHEMIE BV

Swensweg 5 – Haarlem

PO Box 552

2003 RN Haarlem PAYS-BAS

The Netherlands

ZOLPIDEM TEVA

10 mg

obložena tableta

kroz usta

Francuska

RANBAXY PHARMACIE GENERIQUES

11-15 Quai Dion Bouton

92800 Puteaux FRANCE

ZOLPIDEM RPG

10 mg

filmom obložena tableta

kroz usta

Francuska

RATIOPHARM GMBH

Graf Arco Strasse 3

89079 Ulm ALLEMAGNE

ZOLPIDEM RATIOPHARM

10 mg

filmom obložena tableta

kroz usta

Francuska

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret France

ZOLPIDEM GNR

10 mg

filmom obložena tableta

kroz usta

Francuska

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret France

ZOLPIDEM GENERES

10 mg

filmom obložena tableta

kroz usta

Francuska

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret France

ZOLPIDEM SANDOZ

10 mg

filmom obložena tableta

kroz usta

Francuska

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

France

STILNOX

10 mg

filmom obložena tableta

kroz usta

Francuska

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris France

ZOLPIDEM ZENTIVA

10 mg

filmom obložena tableta

kroz usta

Francuska

Synthon BV, Microweg 22, NL-6545 CM Nijmegen, The Netherlands

ZOLPIDEM BAYER

10 mg

filmom obložena tableta

kroz usta

Francuska

Synthon BV, Microweg 22, NL-6545 CM Nijmegen, The Netherlands

ZOLPIDEM BAYER

5 mg

filmom obložena tableta

kroz usta

Francuska

TEVA SANTE

110, Esplanade du Général de Gaulle

92931 Paris La Défense Cedex FRANCE

ZOLPIDEM TEVA

10 mg

filmom obložena tableta

kroz usta

Francuska

ZYDUS FRANCE

25, rue des Peupliers

ZAC Les Hautes Pâtures – Parc d’Activités des Peupliers

92000 Nanterre FRANCE

ZOLPIDEM ZYDUS

10 mg

filmom obložena tableta

kroz usta

Njemačka

1 A Pharma

Keltenring 1 + 3

82041 Oberhaching

Germany

Zolpidem 10 – 1A-Pharma

10 mg

filmom obložena tableta

kroz usta

Njemačka

AbZ-Pharma GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Zolpidem AbZ 10 mg Filmtabletten

10 mg

filmom obložena tableta

kroz usta

Njemačka

Actavis Deutschland GmbH & Co.KG

Willy-Brandt-Allee 2

81829 München

Germany

Zolpidem-Actavis 10 mg Filmtabletten

10 mg

filmom obložena tableta

kroz usta

Njemačka

Aliud Pharma GmbH

Gottlieb-Daimler-Str. 19

89150 Laichingen

Germany

Zolpidem AL 10 mg Filmtabletten

10 mg

filmom obložena tableta

kroz usta

Njemačka

Aliud Pharma GmbH

Gottlieb-Daimler-Str. 19

89150 Laichingen

Germany

Zolpidem AL 5 mg Filmtabletten

5 mg

filmom obložena tableta

kroz usta

Njemačka

Aristo Pharma GmbH

Wallenroder Str. 8-10

13435 Berlin

Germany

Zolpidem Aristo 10 mg Filmtabletten

10 mg

filmom obložena tableta

kroz usta

Njemačka

AbZ-Pharma GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Zolpidem-CT 10 mg Filmtabletten

10 mg

filmom obložena tableta

kroz usta

Njemačka

AbZ-Pharma GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Zolpidem-CT 5 mg Filmtabletten

5 mg

filmom obložena tableta

kroz usta

Njemačka

Dolorgiet GmbH & Co.KG

Otto-von-Guericke-Str. 1

53757 Sankt Augustin

Germany

Zolpidem real 10 mg Filmtabletten

10 mg

filmom obložena tableta

kroz usta

Njemačka

Heumann Pharma GmbH & Co. Generica KG

Südwestpark 50

90449 Nürnberg

Germany

Zolpidem Heumann 10 mg Filmtabletten

10 mg

filmom obložena tableta

kroz usta

Njemačka

Heumann Pharma GmbH & Co. Generica KG

Südwestpark 50

90449 Nürnberg

Germany

Zolpidem Heumann 5 mg Filmtabletten

5 mg

filmom obložena tableta

kroz usta

Njemačka

Hexal Aktiengesellschaft

Industriestr. 25

83607 Holzkirchen

Germany

Zolpidem Hexal 10 mg Filmtabletten

10 mg

filmom obložena tableta

kroz usta

Njemačka

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

filmom obložena tableta

kroz usta

Njemačka

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

filmom obložena tableta

kroz usta

Njemačka

Juta Pharma GmbH

Gutenbergstr. 13

24941 Flensburg

Germany

Zolpi-Q 10 mg Filmtabletten

10 mg

filmom obložena tableta

kroz usta

Njemačka

Krewel Meuselbach GmbH

Krewelstr. 2

53783 Eitorf

Germany

Zolpinox 10 mg

10 mg

filmom obložena tableta

kroz usta

Njemačka

Meda Pharma GmbH & Co. KG

Benzstrasse 1

Bad Homburg v.d.H

61352

Germany

Edluar 10 mg Sublingualtabletten

10 mg

sublingvalna tableta

kroz usta

Njemačka

Meda Pharma GmbH & Co. KG

Benzstrasse 1

Bad Homburg v.d.H

61352

Germany

Edluar 5 mg Sublingualtabletten

5 mg

sublingvalna tableta

kroz usta

Njemačka

Mylan dura GmbH

Wittichstr. 6

64295 Darmstadt

Germany

Zolpidem dura 10 mg Filmtabletten

10 mg

filmom obložena tableta

kroz usta

Njemačka

neuraxpharm Arzneimittel GmbH

Elisabeth-Selbert-Str. 23

40764 Langenfeld

Germany

Zolpidem-neuraxpharm 10 mg Filmtabletten

10 mg

filmom obložena tableta

kroz usta

Njemačka

neuraxpharm Arzneimittel GmbH

Elisabeth-Selbert-Str. 23

40764 Langenfeld

Germany

Zolpidem-neuraxpharm 5 mg Filmtabletten

5 mg

filmom obložena tableta

kroz usta

Njemačka

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Zolpidem-ratiopharm 10 mg Filmtabletten

10 mg

filmom obložena tableta

kroz usta

Njemačka

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Zolpidem-ratiopharm 5 mg Filmtabletten

5 mg

filmom obložena tableta

kroz usta

Njemačka

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

83607 Holzkirchen

Germany

Zolpidem Sandoz 10 mg Filmtabletten

10 mg

filmom obložena tableta

kroz usta

Njemačka

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst, Gebäude K703

65926 Frankfurt am Main

Germany

Bikalm

10 mg

filmom obložena tableta

kroz usta

Njemačka

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst, Gebäude K703

65926 Frankfurt am Main

Germany

Stilnox

10 mg

filmom obložena tableta

kroz usta

Njemačka

Stadapharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

Zolpidem STADA 10 mg Filmtabletten

10 mg

filmom obložena tableta

kroz usta

Njemačka

Stadapharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

Zolpidem STADA 5 mg Filmtabletten

5 mg

filmom obložena tableta

kroz usta

Njemačka

TAD Pharma GmbH

Heinz-Lohmann-Str. 5

27472 Cuxhaven

Germany

Zolpidem TAD 10 mg

10 mg

filmom obložena tableta

kroz usta

Njemačka

Vitabalans Oy

Varastokatu 8

13500 Hämeenlinna

Finland

Zolpidem Vitabalans 10 mg Filmtabletten

10 mg

filmom obložena tableta

kroz usta

Njemačka

Winthrop Arzneimittel GmbH

Brüningstr. 50

65926 Frankfurt am Main

Germany

Zolpi-Lich 10 mg Filmtabletten

10 mg

filmom obložena tableta

kroz usta

Grčka

IOULIA AND IRENE TSETI PHARMACEUTICAL LABORATORIES ABEE, INTERMED ABEE,

Kalyftaki 27, Kifissia 14564

Greece

HYPNONORM

10 mg

filmom obložena tableta

kroz usta

Grčka

ITF HELLAS S.A.

Areos 103 and Ag. Triados 36, Palaio Faliro 17562

Greece

ONIRIA

10 mg/ml

oralne kapi, otopina

kroz usta

Grčka

ITF PHARMA KERESKEDELMI ES SZOLGALTATO KFT, BUDAPEST, HUNGAR

H-1056, Budapest

Duna u.1

Hungary

KALINICTA

10 mg/ml

oralne kapi, otopina

kroz usta

Grčka

SANOFI-AVENTIS AEBE

348 SYNGROU AVENUE, BUILDING A, KALLITHEA 17674

Greece

STILNOX

10 mg

filmom obložena tableta

kroz usta

Mađarska

EGIS Gyógyszergyár Nyrt. Keresztúri út 30-38.

Budapest

1106

Hungary

PIDEZOL 10 mg filmtabletta

10 mg

filmom obložena tableta

kroz usta

Mađarska

ExtractumPharma zRt.

Megyeri út 64.

Budapest

1044

Hungary

ZOLEP 10 mg filmtabletta

10 mg

filmom obložena tableta

kroz usta

Mađarska

Generics (UK) Ltd.

Albany Gate, Darkes Lane, Potters bar Herts EN61AG

United Kingdom

SOMNOGEN 10 mg filmtabletta

10 mg

filmom obložena tableta

kroz usta

Mađarska

ITF Pharma Kft Duna u. 1. Budapest 1056 Hungary

ONIRIA 10 mg/ml belsőleges oldatos cseppek

10 mg/ml

oralne kapi, otopina

kroz usta

Mađarska

Krka d.d. Novo Mesto Smarjeska cesta 6. Novo Mesto 8501 Slovenia

ZOLSANA 5 mg filmtabletta

5 mg

filmom obložena tableta

kroz usta

Mađarska

Krka d.d. Novo Mesto Smarjeska cesta 6. Novo Mesto 8501 Slovenia

ZOLSANA 10 mg filmtabletta

10 mg

filmom obložena tableta

kroz usta

Mađarska

LEK Pharmaceuticals d.d. Verovskova 57

Ljubljana

Slovenia

SANVAL 5 mg filmtabletta

5 mg

filmom obložena tableta

kroz usta

Mađarska

LEK Pharmaceuticals d.d. Verovskova 57

Ljubljana

Slovenia

SANVAL 10 mg filmtabletta

10 mg

filmom obložena tableta

kroz usta

Mađarska

Meda Pharma Hungary Kft Váci út 91. Budapest 1139 Hungary

EDLUAR 5 mg nyelvalatti tabletta

5 mg

sublingvalna tableta

pod jezik

Mađarska

Meda Pharma Hungary Kft Váci út 91. Budapest 1139 Hungary

EDLUAR 10 mg nyelvalatti tabletta

10 mg

sublingvalna tableta

pod jezik

Mađarska

Sanofi-Aventis Magyarország Zrt

Tó u. 1-5

Budapest

1045

Hungary

STILNOX 10 mg filmtabletta

10 mg

filmom obložena tableta

kroz usta

Mađarska

Teva Magyarország Zrt

Repülőtéri út 5.

Gödöllő 2100

Hungary

ZOLPIDEM-RATIOPHARM 10 mg filmtabletta

10 mg

filmom obložena tableta

kroz usta

Mađarska

Vitabalans Oy Varastokatu 8. Hämeenlinna 13500

Finland

ZOLPIDEM VITABALANS 10 mg filmtabletta

10 mg

filmom obložena tableta

kroz usta

Mađarska

Vulm CZ a.s.

Olivova 1888

Ricany 25101 Czech Republic

INSOM 10 mg pezsgőtabletta

10 mg

šumeća tableta

kroz usta

Mađarska

Zentiva k.s.

Dolny Mecholupy,

U kabelovny 130

Prague 10. 10237

Czech Republic

HYPNOGEN 10 mg filmtabletta

10 mg

filmom obložena tableta

kroz usta

Island

LYFIS ehf., Grensásvegur 22, 108 Reykjavík, Iceland

Zolpidem LYFIS

10 mg

filmom obložena tableta

kroz usta

Island

Meda AB, Pipers väg 2A, Box 906, SE-170 09, Sweden

Edluar

5 mg

sublingvalna tableta

kroz usta

Island

Meda AB, Pipers väg 2A, Box 906, SE-170 09, Sweden

Edluar

10 mg

sublingvalna tableta

kroz usta

Island

Mylan AB, Ynglingagatan 14, 10435 Stockholm, Sweden.

Zolpidem Mylan

10 mg

filmom obložena tableta

kroz usta

Island

Sanofi Aventis Norge

Strandveien 15,

1366 Lysaker, Norway

Stilnoct

5 mg

filmom obložena tableta

kroz usta

Island

Sanofi Aventis Norge

Strandveien 15,

1366 Lysaker, Norway

Stilnoct

10 mg

filmom obložena tableta

kroz usta

Irska

Clonmel Healthcare Ltd

Waterford Road

Clonmel

Co. Tipperary

Ireland

Nytamel 5 mg Film-coated Tablets

5 mg

filmom obložena tableta

kroz usta

Irska

Clonmel Healthcare Ltd

Waterford Road

Clonmel

Co. Tipperary

Ireland

Nytamel 10 mg Film-coated Tablets.

10 mg

filmom obložena tableta

kroz usta

Irska

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

filmom obložena tableta

kroz usta

Irska

Meda Health Sales Ireland Limited

Unit 34/35 Block A

Dunboyne Business Park

Dunboyne

Co Meath

Ireland

Edluar 5 mg sublingual tablets

5 mg

sublingvalna tableta

kroz usta

Irska

Meda Health Sales Ireland Limited

Unit 34/35 Block A

Dunboyne Business Park

Dunboyne

Co Meath

Ireland

Edluar 10 mg sublingual tablets

10 mg

sublingvalna tableta

kroz usta

Irska

Rowex Ltd,

Bantry,

Co. Cork,

Ireland

Zolnod 10 mg film-coated tablets

10 mg

filmom obložena tableta

kroz usta

Irska

Sanofi-Aventis Ireland Limited T/A Sanofi, Citywest Business Campus, Dublin 24, Ireland

Stilnoct 5 mg Film-coated Tablets

5 mg

filmom obložena tableta

kroz usta

Irska

Sanofi-Aventis Ireland Limited T/A Sanofi, Citywest Business Campus, Dublin 24, Ireland

Stilnoct 10 mg Film-coated Tablets

10 mg

filmom obložena tableta

kroz usta

Irska

Teva Pharma B. V.

Computerweg 10

3542 DR Utrecht

The Netherlands

Zolpidem Tartrate Teva 5 mg Film-coated Tablets

5 mg

filmom obložena tableta

kroz usta

Irska

Teva Pharma B. V.

Computerweg 10

3542 DR Utrecht

The Netherlands

Zolpidem Tartrate Teva 10 mg Film-coated Tablets

10 mg

filmom obložena tableta

kroz usta

Italija

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

IS-220 Hafnarfjördur

Iceland

ZOLPIDEM ACTAVIS

10 mg

filmom obložena tableta

kroz usta

Italija

Doc Generici S.r.l.

Turati 40, Milano – 20121 Italy

ZOLPIDEM DOC GENERICI

5 mg

filmom obložena tableta

kroz usta

Italija

Doc Generici S.r.l.

Turati 40, Milano – 20121 Italy

ZOLPIDEM DOC GENERICI

10 mg

filmom obložena tableta

kroz usta

Italija

EG S.p.a. Via Scarlatti, 31, Milano – 20124 Italy

ZOLPIDEM EG

10 mg

filmom obložena tableta

kroz usta

Italija

FIDIA Farmaceutici S.p.a.

Via Ponte della Fabbrica, 3/a, Abano Terme, Padova – 35031 Italy

OPSYCON

10 mg

filmom obložena tableta

kroz usta

Italija

HEXAL S.p.a.

Largo Umberto Boccioni 1

21040 Origgio

Varese

Italy

ZOLPIDEM HEXAL

10 mg

filmom obložena tableta

kroz usta

Italija

IPCA – Produtos Farmacêuticos Unipessoal, Lda.

Rua José Nogueira Vaz, Lote 104 – Lj Esq

2625-099 Povoa de Santa Iria

Portugal

ZOLPIDEM IPCA

5 mg

filmom obložena tableta

kroz usta

Italija

IPCA – Produtos Farmacêuticos Unipessoal, Lda.

Rua José Nogueira Vaz, Lote 104 – Lj Esq

2625-099 Povoa de Santa Iria

Portugal

ZOLPIDEM IPCA

10 mg

filmom obložena tableta

kroz usta

Italija

ITALFARMACO S.p.A.

Viale Fulvio Testi 330,

20126 Milano, Italy

SONIREM

10 mg/ml

oralne kapi, otopina

kroz usta

Italija

LIFEPHARMA S.P.A. Via dei Lavoratori 54, 20092 Cinisello Balsamo, Milano – Italy

ZOLPREM

10 mg/ml

oralne kapi, otopina

kroz usta

Italija

MEDA PHARMA S.P.A., Viale brenta 18, 20139 Milano – Italy

ZOLPEDUAR

5 mg

sublingvalna tableta

kroz usta

Italija

MEDA PHARMA S.P.A., Viale brenta 18, 20139 Milano – Italy

ZOLPEDUAR

10 mg

sublingvalna tableta

kroz usta

Italija

Ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

ZOLPIDEM RATIOPHARM

10 mg

filmom obložena tableta

kroz usta

Italija

Sandoz S.p.a.

Largo Umberto Boccioni, 1,

Origgio, Varese – 21040

Italy

ZOLPIDEM SANDOZ

10 mg

filmom obložena tableta

kroz usta

Italija

Sanofi-aventis SpA, Viale Bodio 37/b, 20158 Milano Italy

STILNOX

10 mg

filmom obložena tableta

kroz usta

Italija

Sanofi-aventis SpA, Viale Bodio 37/b, 20158 Milano Italy

NOTTEM

10 mg

filmom obložena tableta

kroz usta

Italija

Teva Italia S.r.l. – via Messina 38 – 20154 Milano Italy

ZOLPIDEM TEVA

10 mg

filmom obložena tableta

kroz usta

Italija

ZENTIVA ITALIA S.R.L. – Viale Bodio 37/b, 20158 Milano Italy

ZOLPIDEM ZENTIVA

10 mg

filmom obložena tableta

kroz usta

Latvija

Krka, d.d., Novo mesto

Šmarješka cesta 6

8000 Novo mesto

Slovenia

Zolsana 5 mg coated tablets

5 mg

obložena tableta

kroz usta

Latvija

Krka, d.d., Novo mesto

Šmarješka cesta 6

8000 Novo mesto

Slovenia

Zolsana 10 mg coated tablets

10 mg

obložena tableta

kroz usta

Latvija

Meda Pharma GmbH & Co. KG

Benzstrasse 1

Bad Homburg v.d.H

61352

Germany

Edluar 5 mg sublingual tablets

5 mg

sublingvalna tableta

pod jezik

Latvija

Meda Pharma GmbH & Co. KG

Benzstrasse 1

Bad Homburg v.d.H

61352

Germany

Edluar 10 mg sublingual tablets

10 mg

sublingvalna tableta

pod jezik

Latvija

Sandoz d.d.

Verovškova 57,

1000 Ljubljana,

Slovenia

Zolpidem Sandoz 10 mg film-coated tablets

10 mg

filmom obložena tableta

kroz usta

Latvija

sanofi-aventis Latvia SIA, Kr.Valdemara 33-8 Riga, LV 1010, Latvia

Stilnox 10 mg film-coated tablets

10 mg

filmom obložena tableta

kroz usta

Latvija

Vitabalans Oy

Varastokatu 8

13500 Hämeenlinna

Finland

Zolpidem Vitabalans 10 mg film-coated tablets

10 mg

filmom obložena tableta

kroz usta

Latvija

Zentiva, k.s.

U kabelovny 130

Prague 10, Dolni Mecholupy

10237

Czech Republic

Hypnogen 10 mg film-coated tablets

10 mg

filmom obložena tableta

kroz usta

Litva

Krka, d.d., Novo mesto

Šmarješka cesta 6

8000 Novo mesto

Slovenia

Zolsana

10 mg

filmom obložena tableta

kroz usta

Litva

Krka, d.d., Novo mesto

Šmarješka cesta 6

8000 Novo mesto

Slovenia

Zolsana

5 mg

filmom obložena tableta

kroz usta

Litva

Sandoz d.d.

Verovškova 57,

1000 Ljubljana,

Slovenia

Zolpidem Sandoz

10 mg

filmom obložena tableta

kroz usta

Litva

UAB „SANOFI-AVENTIS LIETUVA”

A. Juozapavičiaus 6/2 g.

LT-09310 Vilnius

Lithuania

Stilnox

10 mg

filmom obložena tableta

kroz usta

Litva

Vitabalans Oy

Varastokatu 8

13500 Hämeenlinna

Finland

Zolpidem Vitabalans

10 mg

filmom obložena tableta

kroz usta

Litva

Zentiva, k.s.

U kabelovny 130

Prague 10, Dolni Mecholupy

10237

Czech Republic

HYPNOGEN

10 mg

filmom obložena tableta

kroz usta

Luksemburg

MYLAN BVBA/SPRL

Terhulpsesteenweg 6A

1560 Hoeilaart

Belgium

Dodorest

10 mg

obložena tableta

kroz usta

Luksemburg

SANOFI BELGIUM

Airport Plaza, Montreal Building, Leonardo Da Vincilaan 19

1831 Diegem

Belgium

Stilnoct

10 mg

obložena tableta

kroz usta

Luksemburg

Eurogenerics S.A.

Esplanade Heysel, b22

1020 Bruxelles

Belgium

Zolpidem EG cpr.eff.

10 mg

šumeća tableta

kroz usta

Luksemburg

Eurogenerics S.A.

Esplanade Heysel, b22

1020 Bruxelles

Belgium

Zolpidem EG cpr.pellic.

10 mg

obložena tableta

kroz usta

Luksemburg

Genthon BV

Microweg, 22

6545 Nijmegen

The Netherlands

Zolpidem Genthion

10 mg

obložena tableta

kroz usta

Luksemburg

Genthon BV

Microweg, 22

6545 Nijmegen

The Netherlands

Zolpidem Genthion

5 mg

obložena tableta

kroz usta

Luksemburg

Apotex Europe B.V.

Darwinweg 20

NL 2333 CR Leiden

The Netherlands

Zolpitop

10 mg

obložena tableta

kroz usta

Luksemburg

Apotex Europe B.V.

Darwinweg 20

NL 2333 CR Leiden

The Netherlands

Zolpitop

5 mg

obložena tableta

kroz usta

Luksemburg

MEDA PHARMA

Chaussee de la Hulpe 166

1170 Watermael-Boitsfort

Belgium

Zolpeduar

10 mg

sublingvalna tableta

pod jezik

Luksemburg

MEDA PHARMA

Chaussee de la Hulpe 166

1170 Watermael-Boitsfort

Belgium

Zolpeduar

5 mg

sublingvalna tableta

pod jezik

Malta

Sanofi Malta Ltd.

St. Julian’s Rd.

San Gwann SGN 2805

Malta

Stilnox

10 mg

filmom obložena tableta

kroz usta

Malta

Pharma MT

103, Stuart Street,

Gzira,

Malta

Nytamel

10 mg

filmom obložena tableta

kroz usta

Norveška

Sanofi Aventis Norge

Strandveien 15,

1366 Lysaker, Norway

Stilnoct

5 mg

filmom obložena tableta

kroz usta

Norveška

Sanofi Aventis Norge

Strandveien 15,

1366 Lysaker, Norway

Stilnoct

10 mg

filmom obložena tableta

kroz usta

Norveška

Actavis Norway AS, P.O.BOX 409, 0213 Skoyen, OSLO, Norway

Zolpidem Actavis

5 mg

filmom obložena tableta

kroz usta

Norveška

Actavis Norway AS, P.O.BOX 409, 0213 Skoyen, OSLO, Norway

Zolpidem Actavis

10 mg

filmom obložena tableta

kroz usta

Norveška

Meda Norge, P.O.BOX 194, 1371 ASKER, Norway

Edluar

5 mg

sublingvalna tableta

kroz usta

Norveška

Meda Norge, P.O.BOX 194, 1371 ASKER, Norway

Edluar

10 mg

sublingvalna tableta

kroz usta

Norveška

Vitabalans Oy

Varastokatu 8

13500 Hämeenlinna

Finland

Zolpidem Vitabalans

10 mg

filmom obložena tableta

kroz usta

Poljska

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

IS-220 Hafnarfjördur

Iceland

Noxizol

10 mg

filmom obložena tableta

kroz usta

Poljska

Apotex Europe B.V.

Darwinweg 20

NL 2333 CR Leiden

The Netherlands

Apo-Zolpin

10 mg

filmom obložena tableta

kroz usta

Poljska

Farma-Projekt Sp. z o.o.

ul. Józefińska 2

30-529 Kraków

Poland

Xentic

10 mg

filmom obložena tableta

kroz usta

Poljska

Generics [UK] Ltd.

Station Close

EN6 1TL Hertfordshire – Potters Bar

United Kingdom

ZolpiGen

10 mg

filmom obložena tableta

kroz usta

Poljska

Ipca, Produtos Farmaceuticos, Unipessoal Lda

Rua Chanceler-Mor 11 R/c Frt.

Cacem

2735-615

Portugal

Zolpidem IPCA

5 mg

filmom obložena tableta

kroz usta

Poljska

Ipca, Produtos Farmaceuticos, Unipessoal Lda

Rua Chanceler-Mor 11 R/c Frt.

Cacem

2735-615

Portugal

Zolpidem IPCA

10 mg

filmom obložena tableta

kroz usta

Poljska

Italfarmaco S.p.A.

Viale Fulvio 330

20126 Milano

Italy

Sonirem

10 mg/ml

oralne kapi, otopina

kroz usta

Poljska

Krka, d.d., Novo mesto

Šmarješka cesta 6

8000 Novo mesto

Slovenia

Zolsana

10 mg

filmom obložena tableta

kroz usta

Poljska

Meda Pharma GmbH & Co. KG

Benzstrasse 1

Bad Homburg v.d.H

61352

Germany

Edluar

5 mg

sublingvalna tableta

kroz usta

Poljska

Meda Pharma GmbH & Co. KG

Benzstrasse 1

Bad Homburg v.d.H

61352

Germany

Edluar

10 mg

sublingvalna tableta

kroz usta

Poljska

Orion Corporation

Orionintie 1/A

FI-02200 Espoo

Finland

Onirex

10 mg

filmom obložena tableta

kroz usta

Poljska

Pabianickie Zakłady Farmaceutyczne Polfa S.A.

ul. Marszałka J. Piłsudskiego 5

95-200 Pabianice

Poland

Polsen

10 mg

filmom obložena tableta

kroz usta

Poljska

Pfizer Europe MA EEIG

Ramsgate Road

Kent, Sandwich

CT13 9 NJ

United Kingdom

Zolpidem Pfizer

10 mg

filmom obložena tableta

kroz usta

Poljska

Polfarmex S.A.

Józefów 9

99-300 Kutno

Poland

Nasen

10 mg

filmom obložena tableta

kroz usta

Poljska

Sandoz GmbH

ul. Biochemiestrasse 10

Kundli

6250

Austria

Sanval

10 mg

filmom obložena tableta

kroz usta

Poljska

Sanofi-Aventis France

1-13 boulevard Romain Rolland

75014 Paris

France

Stilnox

10 mg

filmom obložena tableta

kroz usta

Poljska

Vitabalans Oy

Varastokatu 8

13500 Hämeenlinna

Finland

Zolpidem Vitabalans

10 mg

filmom obložena tableta

kroz usta

Poljska

VULM CZ, a.s.

Olivova 1888

Ricany

251 01

Czech Republic

Insom

10 mg

šumeća tableta

kroz usta

Poljska

Zakłady Farmaceutyczne POLPHARMA S.A.

Pelplińska 19

83-200 Starogard Gdański

Poland

Zolpic

10 mg

filmom obložena tableta

kroz usta

Poljska

Zentiva, k.s.

U kabelovny 130

Prague 10, Dolni Mecholupy

10237

Czech Republic

Hypnogen

10 mg

filmom obložena tableta

kroz usta

Portugal

Actavis A/S Sucursal

Rua Virgílio Correia, 11 – A

1600-219 Lisboa

Portugal

Zolpidem Actavis

10 mg

filmom obložena tableta

kroz usta

Portugal

Aurobindo Pharma (Portugal), Unipessoal Lda.

Av. do Forte, no 3 – Parque Suécia, Edifício. IV, 2o

2794-038 Carnaxide

Portugal

Zolpidem Aurobindo

5 mg

filmom obložena tableta

kroz usta

Portugal

Aurobindo Pharma (Portugal), Unipessoal Lda.

Av. do Forte, no 3 – Parque Suécia, Edifício. IV, 2o

2794-038 Carnaxide

Portugal

Zolpidem Aurobindo

10 mg

filmom obložena tableta

kroz usta

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

filmom obložena tableta

kroz usta

Portugal

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Zolpidem Generis 5 mg Comprimidos Revestidos

5 mg

filmom obložena tableta

kroz usta

Portugal

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Zolpidem Generis 10 mg Comprimidos Revestidos

10 mg

filmom obložena tableta

kroz usta

Portugal

Genthon GmbH

Groesbeeker Weg, 1

D-47559 Kranenburg

Germany

Zolpidem 5 mg Comprimidos Revestidos

5 mg

filmom obložena tableta

kroz usta

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

filmom obložena tableta

kroz usta

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

filmom obložena tableta

kroz usta

Portugal

Labesfal Genéricos, S.A

Avenida Dr. Afonso Costa, 1370

3465-051 Campo de Besteiros

Portugal

Zolpidem Labesfal

10 mg

filmom obložena tableta

kroz usta

Portugal

Laboratórios Azevedos – Indústria Farmacêutica, S.A.

Edifícios Azevedos – Estrada Nacional 117-2, Alfragide

2614-504 Amadora

Portugal

Cymerion

10 mg

filmom obložena tableta

kroz usta

Portugal

Meda Pharma – Produtos Farmacêuticos, S.A.

Rua do Centro Cultural, 13

1749-066 Lisboa

Portugal

Edluar

5 mg

sublingvalna tableta

pod jezik

Portugal

Meda Pharma – Produtos Farmacêuticos, S.A.

Rua do Centro Cultural, 13

1749-066 Lisboa

Portugal

Edluar

10 mg

sublingvalna tableta

pod jezik

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

filmom obložena tableta

kroz usta

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

filmom obložena tableta

kroz usta

Portugal

Sandoz Farmacêutica, Lda.

Alameda da Beloura, Edifício 1, 2o – Escritório 15

2710-693 Sintra

Portugal

Zolpidem Sandoz

10 mg

filmom obložena tableta

kroz usta

Portugal

Sanofi – Produtos Farmacêuticos, Lda.

Empreendimento Lagoas Park Edifício 7, 3o Piso

2740-244 Porto Salvo

Portugal

Stilnox

10 mg

filmom obložena tableta

kroz usta

Portugal

Wynn Industrial Pharma, S.A.

Rua Tierno Galvan, Torre 3, 16o Piso, Amoreiras

1070-274 Lisboa

Portugal

Zolpidem Wynn

10 mg

filmom obložena tableta

kroz usta

Rumunjska

ALKALOID-INT d.o.o.

Šlandrova ulica 4

1231 Ljubljana-Črnuče Slovenia

ZADOBRA 5 mg

5 mg

filmom obložena tableta

kroz usta

Rumunjska

ALKALOID-INT d.o.o.

Šlandrova ulica 4

1231 Ljubljana-Črnuče Slovenia

ZADOBRA 10 mg

10 mg

filmom obložena tableta

kroz usta

Rumunjska

ITALFARMACO S.p.A.

Viale Fulvio Testi 330, 20126 Milano, Italia

ONIRIA 10 mg/ml

10 mg/ml

oralne kapi, otopina

kroz usta

Rumunjska

Krka, d.d., Novo mesto

Šmarješka cesta 6

8000 Novo mesto

Slovenia

ZOLSANA 5 mg

5 mg

filmom obložena tableta

kroz usta

Rumunjska

Krka, d.d., Novo mesto

Šmarješka cesta 6

8000 Novo mesto

Slovenia

ZOLSANA 10 mg

10 mg

filmom obložena tableta

kroz usta

Rumunjska

LABORMED PHARMA S.A.

B-dul Theodor Pallady nr. 44B

Sector 3, Bucureşti, România

ZOLPIDEM 10 mg

10 mg

filmom obložena tableta

kroz usta

Rumunjska

LEK farmacevtska družba d.d. Verovškova 57

1526 Ljubljana

Slovenia

SANVAL 10 mg

10 mg

filmom obložena tableta

kroz usta

Rumunjska

Meda Pharma GmbH & Co. KG

Benzstrasse 1

Bad Homburg v.d.H

61352

Germany

EDLUAR 5 mg

5 mg

sublingvalna tableta

kroz usta

Rumunjska

Meda Pharma GmbH & Co. KG

Benzstrasse 1

Bad Homburg v.d.H

61352

Germany

EDLUAR 10 mg

10 mg

sublingvalna tableta

kroz usta

Rumunjska

S.C. ANTIBIOTICE S.A.,

Str. Valea Lupului nr.1, Iaşi, România

ZOLPIDEM ATB 10 mg

10 mg

filmom obložena tableta

kroz usta

Rumunjska

SANOFI-AVENTIS ROMÂNIA S.R.L.

Str. Izvor, Nr. 80, Et. 6-11

Sector 5, Bucureşti, România

STILNOX 10 mg

10 mg

filmom obložena tableta

kroz usta

Slovačka Republika

ALKALOID-INT d.o.o.

Šlandrova ulica 4

1231 Ljubljana-Črnuče Slovenia

ADORMA 5 mg filmom obalené tablety

5 mg

filmom obložena tableta

kroz usta

Slovačka Republika

ALKALOID-INT d.o.o.

Šlandrova ulica 4

1231 Ljubljana-Črnuče Slovenia

ADORMA 10 mg filmom obalené tablety

10 mg

filmom obložena tableta

kroz usta

Slovačka Republika

Generics [UK] Ltd.

Station Close

EN6 1TL Hertfordshire – Potters Bar

United Kingdom

Zolpidem Mylan 10 mg

10 mg

filmom obložena tableta

kroz usta

Slovačka Republika

Orion Corporation

Orionintie 1/A

FI-02200 Espoo

Finland

Zolpidem Orion 10 mg

10 mg

filmom obložena tableta

kroz usta

Slovačka Republika

Sandoz d.d.

Verovškova 57,

1000 Ljubljana,

Slovenia

SANVAL 5 mg

5 mg

filmom obložena tableta

kroz usta

Slovačka Republika

Sandoz d.d.

Verovškova 57,

1000 Ljubljana,

Slovenia

SANVAL 10 mg

10 mg

filmom obložena tableta

kroz usta

Slovačka Republika

sanofi-aventis Slovakia s.r.o. Einsteinova 24

85101 Bratislava

Slovak Republic

STILNOX

10 mg

filmom obložena tableta

kroz usta

Slovačka Republika

SVUS Pharma a.s., Smetanovo nábřeží 1238/20a

500 02 Hradec Králové Czech Republic

ZOLPINOX

10 mg

filmom obložena tableta

kroz usta

Slovačka Republika

Takeda GmbH 2 Byk-Gulden Strasse

78467 Konstanz Germany

HYPNOGEN

10 mg

filmom obložena tableta

kroz usta

Slovačka Republika

Vitabalans Oy

Varastokatu 8

13500 Hämeenlinna

Finland

Zolpidem Vitabalans 10 mg filmom obalené tablety

10 mg

filmom obložena tableta

kroz usta

Slovenija

ALKALOID-INT d.o.o.

Šlandrova ulica 4

1231 Ljubljana-Črnuče Slovenia

Perluna 10 mg filmsko obožene tablete

10 mg

filmom obložena tableta

kroz usta

Slovenija

ALKALOID-INT d.o.o.

Šlandrova ulica 4

1231 Ljubljana-Črnuče Slovenia

Perluna 5 mg filmsko obožene tablete

5 mg

filmom obložena tableta

kroz usta

Slovenija

Krka, d.d., Novo mesto

Šmarješka cesta 6

8000 Novo mesto

Slovenia

Zolsana 10 mg filmsko obložene tablete

10 mg

filmom obložena tableta

kroz usta

Slovenija

Krka, d.d., Novo mesto

Šmarješka cesta 6

8000 Novo mesto

Slovenia

Zolsana 5 mg filmsko obložene tablete

5 mg

filmom obložena tableta

kroz usta

Slovenija

LEK farmacevtska družba d.d. Verovškova 57

1526 Ljubljana

Slovenia

Sanval 10 mg filmsko obožene tablete

10 mg

filmom obložena tableta

kroz usta

Slovenija

LEK farmacevtska družba d.d. Verovškova 57

1526 Ljubljana

Slovenia

Sanval 5 mg filmsko obložene tablete

5 mg

filmom obložena tableta

kroz usta

Slovenija

Meda Pharma GmbH & Co. KG

Benzstrasse 1

Bad Homburg v.d.H

61352

Germany

Edluar 10 mg podjezične tablete

10 mg

sublingvalna tableta

pod jezik

Slovenija

Meda Pharma GmbH & Co. KG

Benzstrasse 1

Bad Homburg v.d.H

61352

Germany

Edluar 5 mg podjezične tablete

5 mg

sublingvalna tableta

pod jezik

Slovenija

Vitabalans Oy

Varastokatu 8

13500 Hämeenlinna

Finland

Zolpidem Vitabalans 10 mg filmsko obložene tablete

10 mg

filmom obložena tableta

kroz usta

Španjolska

ANGELINI FARMACEUTICA, S.A. Osi, 7-9 Barcelona. 08034. SPAIN

DALPARAN 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA

10 mg

filmom obložena tableta

kroz usta

Španjolska

Apotex Europe B.V.

Darwinweg 20

NL 2333 CR Leiden

The Netherlands

ZOLPIDEM APOTEX 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG

10 mg

filmom obložena tableta

kroz usta

Španjolska

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

filmom obložena tableta

kroz usta

Španjolska

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

filmom obložena tableta

kroz usta

Španjolska

FARMALIDER, S.A. Aragoneses, 2, Alcobendas (Madrid). 28108.SPAIN

ZOLPIDEM FARMALIDER 10 mg COMPRIMIDOS RECUBIERTOS EFG

10 mg

filmom obložena tableta

kroz usta

Španjolska

GENERFARMA, S.L. Ronda Isaac Peral, 6 Parque Tecnológico 46980 Paterna (Valencia) SPAIN

ZOLPIDEM DESGEN 5 mg COMPRIMIDOS EFG

5 mg

tableta

kroz usta

Španjolska

GENERFARMA, S.L. Ronda Isaac Peral, 6 Parque Tecnológico 46980 Paterna (Valencia) SPAIN

ZOLPIDEM DESGEN 10 mg COMPRIMIDOS EFG

10 mg

tableta

kroz usta

Španjolska

GERMED FARMACEUTICA S.L. Chile, 8 – 2a planta. Oficina 203, Las Matas (Madrid). 28290. SPAIN

ZOLPIDEM EDIGEN 10 mg COMPRIMIDOS RECUBIERTOS EFG

10 mg

filmom obložena tableta

kroz usta

Španjolska

LABORATORIO STADA, S.L. Frederic Mompou, 5 , Sant Just Desvern (Barcelona). 08960

SPAIN

ZOLPIDEM STADA 10 mg COMPRIMIDOS RECUBIERTOS EFG

10 mg

filmom obložena tableta

kroz usta

Španjolska

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

filmom obložena tableta

kroz usta

Španjolska

LABORATORIOS NORMON, S.A. Ronda de Valdecarrizo, 6, Tres Cantos (Madrid). 28760. SPAIN

ZOLPIDEM NORMON 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG

10 mg

filmom obložena tableta

kroz usta

Španjolska

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

sublingvalna tableta

kroz usta

Španjolska

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

sublingvalna tableta

kroz usta

Španjolska

MYLAN PHARMACEUTICALS, S.L. Plom 2-4, 5o Planta, Barcelona. 08038. SPAIN

ZOLPIDEM MYLAN 10 mg COMPRIMIDOS RECUBIERTOS EFG

10 mg

filmom obložena tableta

kroz usta

Španjolska

PHARMAGENUS, S.A. Avda. Camí Real, 51-57 Palau-solita i Plegamans (Barcelona). 08184. SPAIN

ZOLPIDEM PHARMAGENUS 5 mg COMPRIMIDOS

5 mg

tableta

kroz usta

Španjolska

PHARMAGENUS, S.A. Avda. Camí Real, 51-57 Palau-solita i Plegamans (Barcelona). 08184. SPAIN

ZOLPIDEM PHARMAGENUS 10 mg COMPRIMIDOS EFG

10 mg

tableta

kroz usta

Španjolska

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

filmom obložena tableta

kroz usta

Španjolska

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

filmom obložena tableta

kroz usta

Španjolska

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

filmom obložena tableta

kroz usta

Španjolska

SANDOZ FARMACÉUTICA, S.A.

Avda. Osa Mayor, 4

28023 Aravaca (Madrid)

Spain

ZOLPIDEM SANDOZ 10 mg COMPRIMIDOS EFG

10 mg

tableta

kroz usta

Španjolska

SANOFI AVENTIS, S.A.

Josep Plá, 2,

Barcelona. 08019

SPAIN

STILNOX 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA

10 mg

filmom obložena tableta

kroz usta

Španjolska

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

filmom obložena tableta

kroz usta

Španjolska

Zentiva, k.s.

U kabelovny 130

Prague 10, Dolni Mecholupy

10237

Czech Republic

ZOLPIDEM ZENTIVA 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG

10 mg

filmom obložena tableta

kroz usta

Švedska

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

IS-220 Hafnarfjördur

Iceland

Zolpidem Actavis

5 mg

filmom obložena tableta

kroz usta

Švedska

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

IS-220 Hafnarfjördur

Iceland

Zolpidem Actavis

10 mg

filmom obložena tableta

kroz usta

Švedska

Hexal A/S

Edvard Thomsens Vej 14

DK-2300 Köpenhamn S

Denmark

Zolpidem HEXAL

10 mg

filmom obložena tableta

kroz usta

Švedska

Ranbaxy (UK) Ltd,

Building 4

Chiswick Park

London W4 5YE

United Kingdom

Zolpidem Ranbaxy

5 mg

filmom obložena tableta

kroz usta

Švedska

Ranbaxy (UK) Ltd,

Building 4

Chiswick Park

London W4 5YE

United Kingdom

Zolpidem Ranbaxy

10 mg

filmom obložena tableta

kroz usta

Švedska

Meda AB, Pipers väg 2A, Box 906, SE-170 09, Sweden

Edluar

5 mg

sublingvalna tableta

kroz usta

Švedska

Meda AB, Pipers väg 2A, Box 906, SE-170 09, Sweden

Edluar

10 mg

sublingvalna tableta

kroz usta

Švedska

Mylan AB

Box 23033

104 35 Stockholm

Sweden

Zolpidem Mylan

10 mg

filmom obložena tableta

kroz usta

Švedska

Orifarm Generics A/S

Energivej 15 POB 69

DK-5260 Odense S

Denmark

Zolpidem Orifarm

5 mg

filmom obložena tableta

kroz usta

Švedska

Orifarm Generics A/S

Energivej 15 POB 69

DK-5260 Odense S

Denmark

Zolpidem Orifarm

10 mg

filmom obložena tableta

kroz usta

Švedska

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Zolpidem ratiopharm

5 mg

filmom obložena tableta

kroz usta

Švedska

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Zolpidem ratiopharm

10 mg

filmom obložena tableta

kroz usta

Švedska

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 Köpenhamn S

Denmark

Zolpidem Sandoz

5 mg

filmom obložena tableta

kroz usta

Švedska

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 Köpenhamn S

Denmark

Zolpidem Sandoz

10 mg

filmom obložena tableta

kroz usta

Švedska

sanofi-aventis AB

Box 14142

167 14 Bromma

Sweden

Stilnoct

5 mg

filmom obložena tableta

kroz usta

Švedska

sanofi-aventis AB

Box 14142

167 14 Bromma

Sweden

Stilnoct

10 mg

filmom obložena tableta

kroz usta

Švedska

STADA Arzneimittel AG

Stadastrasse 2-18

DE-61118 Bad Vilbel

Germany

Zolpidem STADA

5 mg

filmom obložena tableta

kroz usta

Švedska

STADA Arzneimittel AG

Stadastrasse 2-18

DE-61118 Bad Vilbel

Germany

Zolpidem STADA

10 mg

filmom obložena tableta

kroz usta

Švedska

Synthon BV, Microweg 22, NL-6545 CM Nijmegen, The Netherlands

Zolpidem Genthon

5 mg

filmom obložena tableta

kroz usta

Švedska

Synthon BV, Microweg 22, NL-6545 CM Nijmegen, The Netherlands

Zolpidem Genthon

10 mg

filmom obložena tableta

kroz usta

Švedska

Vitabalans Oy

Varastokatu 8

13500 Hämeenlinna

Finland

Zolpidem Vitabalans

10 mg

filmom obložena tableta

kroz usta

Nizozemska

Actavis B.V.

Baarnsche Dijk 1

3741 LN BAARN

The Netherlands

Zolpidemtartaat Actavis 5 mg, tabletten

5 mg

tableta

kroz usta

Nizozemska

Actavis B.V.

Baarnsche Dijk 1

3741 LN BAARN

The Netherlands

Zolpidemtartraat Actavis 10 mg, tabletten

10 mg

tableta

kroz usta

Nizozemska

ADOH B.V.

Godfried Bomansstraat 31

6543 JA NIJMEGEN

The Netherlands

Zolpidemtartraat ADOH bruistabletten 10 mg, bruistabletten

10 mg

šumeća tableta

kroz usta

Nizozemska

Pharmachemie B.V.

Swensweg 5

2031 GA HAARLEM

The Netherlands

Zolpidemtartraat 5 mg PCH, filmomhulde tabletten

5 mg

filmom obložena tableta

kroz usta

Nizozemska

Pharmachemie B.V.

Swensweg 5

2031 GA HAARLEM

The Netherlands

Zolpidemtartraat 10 mg PCH, filmomhulde tabletten

10 mg

filmom obložena tableta

kroz usta

Nizozemska

ratiopharm Nederland B.V.

Swensweg 5

2031 GA HAARLEM

The Netherlands

Zolpidemtartraat ratiopharm 5 mg, tabletten

5 mg

tableta

kroz usta

Nizozemska

ratiopharm Nederland B.V.

Swensweg 5

2031 GA HAARLEM

The Netherlands

Zolpidemtartraat ratiopharm 10 mg, tabletten

10 mg

tableta

kroz usta

Nizozemska

ratiopharm Nederland B.V.

Swensweg 5

2031 GA HAARLEM

The Netherlands

Zolpidemtartraat ratiopharm 5 mg, filmomhulde tabletten

5 mg

filmom obložena tableta

kroz usta

Nizozemska

ratiopharm Nederland B.V.

Swensweg 5

2031 GA HAARLEM

The Netherlands

Zolpidemtartraat ratiopharm 10 mg, filmomhulde tabletten

10 mg

filmom obložena tableta

kroz usta

Nizozemska

ratiopharm Nederland B.V.

Swensweg 5

2031 GA HAARLEM

The Netherlands

Zolpidemtartraat ratiopharm 10 mg, filmomhulde tabletten

10 mg

filmom obložena tableta

kroz usta

Nizozemska

Sandoz B.V.

Veluwezoom 22

1327 AH ALMERE

The Netherlands

Zolpidemtartraat Sandoz 10 mg, filmomhulde tabletten

10 mg

filmom obložena tableta

kroz usta

Nizozemska

Sandoz B.V.

Veluwezoom 22

1327 AH ALMERE

The Netherlands

Zolpidemtartraat Sandoz 5, filmomhulde tabletten 5 mg

5 mg

filmom obložena tableta

kroz usta

Nizozemska

Sandoz B.V.

Veluwezoom 22

1327 AH ALMERE

The Netherlands

Zolpidemtartraat Sandoz 10,filmomhulde tabletten 10 mg

10 mg

filmom obložena tableta

kroz usta

Nizozemska

Synthon B.V.

Microweg 22

6545 CM NIJMEGEN

The Netherlands

Zolpidemtartraat 5 mg, filmomhulde tabletten

5 mg

filmom obložena tableta

kroz usta

Nizozemska

Synthon B.V.

Microweg 22

6545 CM NIJMEGEN

The Netherlands

Zolpidemtartraat 10 mg, filmomhulde tabletten

10 mg

filmom obložena tableta

kroz usta

Nizozemska

Synthon B.V.

Microweg 22

6545 CM NIJMEGEN

The Netherlands

Zolpidemtartraat 5 mg, filmomhulde tabletten

5 mg

filmom obložena tableta

kroz usta

Nizozemska

Synthon B.V.

Microweg 22

6545 CM NIJMEGEN

The Netherlands

Zolpidemtartraat 10 mg, filmomhulde tabletten

10 mg

filmom obložena tableta

kroz usta

Nizozemska

Synthon B.V.

Microweg 22

6545 CM NIJMEGEN

The Netherlands

Zolpidemtartraat 5 mg, filmomhulde tabletten

5 mg

filmom obložena tableta

kroz usta

Nizozemska

Synthon B.V.

Microweg 22

6545 CM NIJMEGEN

The Netherlands

Zolpidemtartraat 10 mg, filmomhulde tabletten

10 mg

filmom obložena tableta

kroz usta

Nizozemska

ADOH B.V.

Godfried Bomansstraat 31

6543 JA NIJMEGEN

The Netherlands

Zolpidemtartraat ADOH 10 mg, bruistabletten

10 mg

šumeća tableta

kroz usta

Nizozemska

Apotex Europe B.V.

Darwinweg 20

NL 2333 CR Leiden

The Netherlands

Zolpidemtartraat Apotex 5 mg, filmomhulde tabletten

5 mg

filmom obložena tableta

kroz usta

Nizozemska

Apotex Europe B.V.

Darwinweg 20

NL 2333 CR Leiden

The Netherlands

Zolpidemtartraat Apotex 10 mg, filmomhulde tabletten

10 mg

filmom obložena tableta

kroz usta

Nizozemska

Centrafarm B.V.

Nieuwe Donk 3

4879 AC ETTEN LEUR

The Netherlands

Zolpidemtartraat CF 5 mg, film-omhulde tabletten

5 mg

filmom obložena tableta

kroz usta

Nizozemska

Centrafarm B.V.

Nieuwe Donk 3

4879 AC ETTEN LEUR

The Netherlands

Zolpidemtartraat CF 10 mg, film-omhulde tabletten

10 mg

filmom obložena tableta

kroz usta

Nizozemska

Eurogenerics S.A.

Esplanade Heysel, b22

1020 Bruxelles

Belgium

Zolpidem Eurogenerics bruis 10 mg bruistabletten, bruistabletten

10 mg

šumeća tableta

kroz usta

Nizozemska

FIDIA Farmaceutici S.p.a.

Via Ponte della Fabbrica, 3/a, Abano Terme, Padova – 35031 Italy

Zolpidemtartraat 10 mg, filmomhulde tabletten

10 mg

filmom obložena tableta

kroz usta

Nizozemska

Genthon BV

Microweg, 22

6545 Nijmegen

The Netherlands

Zolpidemtartraat 5 mg, filmomhulde tabletten

5 mg

filmom obložena tableta

kroz usta

Nizozemska

Genthon BV

Microweg, 22

6545 Nijmegen

The Netherlands

Zolpidemtartraat 10 mg, filmomhulde tabletten

10 mg

filmom obložena tableta

kroz usta

Nizozemska

Meda Pharma B.V.

Krijgsman 20

1186 DM AMSTELVEEN

The Netherlands

Edluar 5 mg, tablet voor sublinguaal gebruik

5 mg

sublingvalna tableta

pod jezik

Nizozemska

Meda Pharma B.V.

Krijgsman 20

1186 DM AMSTELVEEN

The Netherlands

Edluar 10 mg, tablet voor sublinguaal gebruik

10 mg

sublingvalna tableta

pod jezik

Nizozemska

Mylan B.V.

Dieselweg 25

3752 LB BUNSCHOTEN

The Netherlands

Zolpidemtartraat Mylan 10 mg, filmomhulde tabletten

10 mg

filmom obložena tableta

kroz usta

Nizozemska

Pharmachemie B.V.

Swensweg 5

2031 GA HAARLEM

The Netherlands

Zolpidemtartraat 5 PCH, filmomhulde tabletten 5 mg

5 mg

filmom obložena tableta

kroz usta

Nizozemska

Pharmachemie B.V.

Swensweg 5

2031 GA HAARLEM

The Netherlands

Zolpidemtartraat 10 PCH, filmomhulde tabletten 10 mg

10 mg

filmom obložena tableta

kroz usta

Nizozemska

Sanofi-Aventis Netherlands B.V.

Kampenringweg 45 D-E

2803 PE GOUDA

The Netherlands

Stilnoct, tabletten 10 mg

10 mg

tableta

kroz usta

Nizozemska

STADA Arzneimittel AG

Stadastrasse 2-18

DE-61118 Bad Vilbel

Germany

Zolpidemtartraat Stada 5 mg, filmomhulde tabletten

5 mg

filmom obložena tableta

kroz usta

Nizozemska

STADA Arzneimittel AG

Stadastrasse 2-18

DE-61118 Bad Vilbel

Germany

Zolpidemtartraat Stada 10 mg, filmomhulde tabletten

10 mg

filmom obložena tableta

kroz usta

Nizozemska

Synthon B.V.

Microweg 22

6545 CM NIJMEGEN

The Netherlands

Zolpidemtartraat 10 mg, filmomhulde tabletten

10 mg

filmom obložena tableta

kroz usta

Velika Britanija

Actavis UK Limited, Whiddon Valley, Barnstaple, North Devon EX32 8NS

United Kingdom

Zolpidem Tartrate 5 mg tablets

5 mg

filmom obložena tableta

kroz usta

Velika Britanija

Actavis UK Limited, Whiddon Valley, Barnstaple, North Devon EX32 8NS

United Kingdom

Zolpidem Tartrate 10 mg tablets

10 mg

filmom obložena tableta

kroz usta

Velika Britanija

ALKALOID-INT d.o.o.

Šlandrova ulica 4

1231 Ljubljana-Črnuče Slovenia

Zolpidem Tartrate 5 mg film-coated tablets

5 mg

filmom obložena tableta

kroz usta

Velika Britanija

ALKALOID-INT d.o.o.

Šlandrova ulica 4

1231 Ljubljana-Črnuče Slovenia

Zolpidem Tartrate 10 mg film-coated tablets

10 mg

filmom obložena tableta

kroz usta

Velika Britanija

Aventis Pharma Limited, One Onslow Street, Guildford, Surrey GU1 4SY

United Kingdom

Stilnoct 5 mg fiilm-coated tablets

5 mg

obložena tableta

kroz usta

Velika Britanija

Aventis Pharma Limited, One Onslow Street, Guildford, Surrey GU1 4SY

United Kingdom

Stilnoct 10 mg film-coated tablets

10 mg

obložena tableta

kroz usta

Velika Britanija

Bristol Laboratories Limited, Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire HP4 1EG

United Kingdom

Zolpidem Tartrate 5 mg film-coated tablets

5 mg

filmom obložena tableta

kroz usta

Velika Britanija

Bristol Laboratories Limited, Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire HP4 1EG

United Kingdom

Zolpidem Tartrate 10 mg film-coated tablets

10 mg

filmom obložena tableta

kroz usta

Velika Britanija

Generics [UK] Ltd.

Station Close

EN6 1TL Hertfordshire – Potters Bar

United Kingdom

Zolpidem 10 mg film-coated tablets

10 mg

filmom obložena tableta

kroz usta

Velika Britanija

Meda Pharmaceuticals Limited, Skyway House, Parsonage Road, Takeley, Bishops Stortford CM22 6PU

United Kingdom

Edluar 5 mg sublingual tablets

5 mg

sublingvalna tableta

kroz usta

Velika Britanija

Meda Pharmaceuticals Limited, Skyway House, Parsonage Road, Takeley, Bishops Stortford CM22 6PU

United Kingdom

Edluar 10 mg sublingual tablets

10 mg

sublingvalna tableta

kroz usta

Velika Britanija

Amneal Pharma Europe Limited, 70 Sir John Rogerson's Quay, Dublin 2, Ireland

Zolpidem Tartrate 5 mg film-coated tablets

5 mg

filmom obložena tableta

kroz usta

Velika Britanija

Amneal Pharma Europe Limited, 70 Sir John Rogerson's Quay, Dublin 2, Ireland

Zolpidem Tartrate 10 mg film-coated tablets

10 mg

filmom obložena tableta

kroz usta

Velika Britanija

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Zolpidem Tartrate 5 mg film-coated tablets

5 mg

filmom obložena tableta

kroz usta

Velika Britanija

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Zolpidem Tartrate 10 mg film-coated tablets

10 mg

filmom obložena tableta

kroz usta

Velika Britanija

Sandoz Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR

United Kingdom

Zolpidem Tartrate 10 mg tablets

10 mg

filmom obložena tableta

kroz usta

Velika Britanija

Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex BN22 9AG

United Kingdom

Zolpidem Tartrate 5 mg, film-coated tablets

5 mg

filmom obložena tableta

kroz usta

Velika Britanija

Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex BN22 9AG

United Kingdom

Zolpidem Tartrate 10 mg, film-coated tablets

10 mg

filmom obložena tableta

kroz usta

Velika Britanija

Tillomed Laboratories Limited, 3 Howard Road, Eaton Socon, St Neots, Cambridgeshire PE19 8ET

United Kingdom

Zolpidem 10 mg film-coated tablets

10 mg

filmom obložena tableta

kroz usta

Velika Britanija

Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS

United Kingdom

Zolpidem Tartrate 5 mg tablets

5 mg

filmom obložena tableta

kroz usta

Velika Britanija

Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS

United Kingdom

Zolpidem Tartrate 10 mg tablets

10 mg

filmom obložena tableta

kroz usta

---

Dodatak II

Popis naziva, farmaceutskih oblika, jačina lijekova, putova primjene i nositelja odobrenja u državama članicama

| Država članica EU/EGP | Nositelj odobrenja
  Naziv tvrtke, adresa | Zaštićeno ime | Jačina | Farmaceutski oblik | Put primjene |
| --- | --- | --- | --- | --- | --- |
| Austrija | AstraZeneca Österreich GmbH, |
| Schwarzenbergplatz 7, |
| A-1037 Wien, |
| Austria |

Država članica EU/EGP

Nositelj odobrenja

Naziv tvrtke, adresa

Zaštićeno ime

Jačina

Farmaceutski oblik

Put primjene

Austrija

AstraZeneca Österreich GmbH,

Schwarzenbergplatz 7,

A-1037 Wien,

Austria

Crestor 5 mg – Filmtabletten

5 mg

filmom obložene tablete

kroz usta

Austrija

| AstraZeneca Österreich GmbH, |
| --- |
| Schwarzenbergplatz 7, |
| A-1037 Wien, |
| Austria |

AstraZeneca Österreich GmbH,

Schwarzenbergplatz 7,

A-1037 Wien,

Austria

Crestor 10 mg – Filmtabletten

10 mg

filmom obložene tablete

kroz usta

Austrija

| AstraZeneca Österreich GmbH, |
| --- |
| Schwarzenbergplatz 7, |
| A-1037 Wien, |
| Austria |

AstraZeneca Österreich GmbH,

Schwarzenbergplatz 7,

A-1037 Wien,

Austria

Crestor 20 mg – Filmtabletten

20 mg

filmom obložene tablete

kroz usta

Austrija

| AstraZeneca Österreich GmbH, |
| --- |
| Schwarzenbergplatz 7, |
| A-1037 Wien, |
| Austria |

AstraZeneca Österreich GmbH,

Schwarzenbergplatz 7,

A-1037 Wien,

Austria

Crestor 40 mg – Filmtabletten

40 mg

filmom obložene tablete

kroz usta

Belgija

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussels, |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels,

Belgium

Crestor

5 mg

filmom obložene tablete

kroz usta

Belgija

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussels, |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels,

Belgium

Crestor

10 mg

filmom obložene tablete

kroz usta

Belgija

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussels, |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels,

Belgium

Crestor

20 mg

filmom obložene tablete

kroz usta

Belgija

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussels, |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels,

Belgium

Crestor

40 mg

filmom obložene tablete

kroz usta

Bugarska

| AstraZeneca |
| --- |
| Pharmaceuticals AB, |
| S-151 85 Södertälje, |
| Sweden |

AstraZeneca

Pharmaceuticals AB,

S-151 85 Södertälje,

Sweden

Crestor

5 mg

filmom obložene tablete

kroz usta

Bugarska

| AstraZeneca |
| --- |
| Pharmaceuticals AB, |
| S-151 85 Södertälje, |
| Sweden |

AstraZeneca

Pharmaceuticals AB,

S-151 85 Södertälje,

Sweden

Crestor

10 mg

filmom obložene tablete

kroz usta

Bugarska

| AstraZeneca |
| --- |
| Pharmaceuticals AB, |
| S-151 85 Södertälje, |
| Sweden |

AstraZeneca

Pharmaceuticals AB,

S-151 85 Södertälje,

Sweden

Crestor

20 mg

filmom obložene tablete

kroz usta

Hrvatska

| AstraZeneca d.o.o. |
| --- |
| Radnička cesta 80 |
| 10000 Zagreb |
| Croatia |

AstraZeneca d.o.o.

Radnička cesta 80

10000 Zagreb

Croatia

Crestor 5 mg filmom obložene tablete

5 mg

filmom obložene tablete

kroz usta

Hrvatska

| AstraZeneca d.o.o. |
| --- |
| Radnička cesta 80 |
| 10000 Zagreb |
| Croatia |

AstraZeneca d.o.o.

Radnička cesta 80

10000 Zagreb

Croatia

Crestor 10 mg filmom obložene tablete

10 mg

filmom obložene tablete

kroz usta

Hrvatska

| AstraZeneca d.o.o. |
| --- |
| Radnička cesta 80 |
| 10000 Zagreb |
| Croatia |

AstraZeneca d.o.o.

Radnička cesta 80

10000 Zagreb

Croatia

Crestor 20 mg filmom obložene tablete

20 mg

filmom obložene tablete

kroz usta

Hrvatska

| AstraZeneca d.o.o. |
| --- |
| Radnička cesta 80 |
| 10000 Zagreb |
| Croatia |

AstraZeneca d.o.o.

Radnička cesta 80

10000 Zagreb

Croatia

Crestor 40 mg filmom obložene tablete

40 mg

filmom obložene tablete

kroz usta

Cipar

| AstraZeneca UK Limited, |
| --- |
| 2 Kingdom Street, |
| London W2 6BD, |
| United Kingdom |

AstraZeneca UK Limited,

2 Kingdom Street,

London W2 6BD,

United Kingdom

Crestor

5 mg

filmom obložene tablete

kroz usta

Cipar

| AstraZeneca UK Limited, |
| --- |
| 2 Kingdom Street, |
| London W2 6BD, |
| United Kingdom |

AstraZeneca UK Limited,

2 Kingdom Street,

London W2 6BD,

United Kingdom

Crestor

10 mg

filmom obložene tablete

kroz usta

Cipar

| AstraZeneca UK Limited, |
| --- |
| 2 Kingdom Street, |
| London W2 6BD, |
| United Kingdom |

AstraZeneca UK Limited,

2 Kingdom Street,

London W2 6BD,

United Kingdom

Crestor

20 mg

filmom obložene tablete

kroz usta

Cipar

| AstraZeneca UK Limited, |
| --- |
| 2 Kingdom Street, |
| London W2 6BD, |
| United Kingdom |

AstraZeneca UK Limited,

2 Kingdom Street,

London W2 6BD,

United Kingdom

Crestor

40 mg

filmom obložene tablete

kroz usta

Češka Republika

| AstraZeneca UK Limited, |
| --- |
| 2 Kingdom Street |
| London W2 6BD |
| United Kingdom |

AstraZeneca UK Limited,

2 Kingdom Street

London W2 6BD

United Kingdom

Crestor 5 mg

5 mg

filmom obložene tablete

kroz usta

Češka Republika

| AstraZeneca UK Limited, |
| --- |
| 2 Kingdom Street |
| London W2 6BD |
| United Kingdom |

AstraZeneca UK Limited,

2 Kingdom Street

London W2 6BD

United Kingdom

Crestor 10 mg

10 mg

filmom obložene tablete

kroz usta

Češka Republika

| AstraZeneca UK Limited, |
| --- |
| 2 Kingdom Street |
| London W2 6BD |
| United Kingdom |

AstraZeneca UK Limited,

2 Kingdom Street

London W2 6BD

United Kingdom

Crestor 20 mg

20 mg

filmom obložene tablete

kroz usta

Češka Republika

| AstraZeneca UK Limited, |
| --- |
| 2 Kingdom Street |
| London W2 6BD |
| United Kingdom |

AstraZeneca UK Limited,

2 Kingdom Street

London W2 6BD

United Kingdom

Crestor 40 mg

40 mg

filmom obložene tablete

kroz usta

Danska

| AstraZeneca A/S |
| --- |
| Arne Jacobsens Allé 13 |
| 2300 København S |
| Denmark |

AstraZeneca A/S

Arne Jacobsens Allé 13

2300 København S

Denmark

Crestor

5 mg

filmom obložene tablete

kroz usta

Danska

| AstraZeneca A/S |
| --- |
| Arne Jacobsens Allé 13 |
| 2300 København S |
| Denmark |

AstraZeneca A/S

Arne Jacobsens Allé 13

2300 København S

Denmark

Crestor

10 mg

filmom obložene tablete

kroz usta

Danska

| AstraZeneca A/S |
| --- |
| Arne Jacobsens Allé 13 |
| 2300 København S |
| Denmark |

AstraZeneca A/S

Arne Jacobsens Allé 13

2300 København S

Denmark

Crestor

20 mg

filmom obložene tablete

kroz usta

Danska

| AstraZeneca A/S |
| --- |
| Arne Jacobsens Allé 13 |
| 2300 København S |
| Denmark |

AstraZeneca A/S

Arne Jacobsens Allé 13

2300 København S

Denmark

Crestor

40 mg

filmom obložene tablete

kroz usta

Estonija

| AstraZeneca UK Ltd. |
| --- |
| 2 Kingdom Street, |
| London W2 6BD, |
| United Kingdom |

AstraZeneca UK Ltd.

2 Kingdom Street,

London W2 6BD,

United Kingdom

Crestor

5 mg

filmom obložene tablete

kroz usta

Estonija

| AstraZeneca UK Ltd. |
| --- |
| 2 Kingdom Street, |
| London W2 6BD, |
| United Kingdom |

AstraZeneca UK Ltd.

2 Kingdom Street,

London W2 6BD,

United Kingdom

Crestor

10 mg

filmom obložene tablete

kroz usta

Estonija

| AstraZeneca UK Ltd. |
| --- |
| 2 Kingdom Street, |
| London W2 6BD, |
| United Kingdom |

AstraZeneca UK Ltd.

2 Kingdom Street,

London W2 6BD,

United Kingdom

Crestor

20 mg

filmom obložene tablete

kroz usta

Finska

| AstraZeneca Oy |
| --- |
| Itsehallintokuja 4 |
| 02600 Espoo |
| Finland |

AstraZeneca Oy

Itsehallintokuja 4

02600 Espoo

Finland

Crestor

5 mg

filmom obložene tablete

kroz usta

Finska

| AstraZeneca Oy |
| --- |
| Itsehallintokuja 4 |
| 02600 Espoo |
| Finland |

AstraZeneca Oy

Itsehallintokuja 4

02600 Espoo

Finland

Crestor

10 mg

filmom obložene tablete

kroz usta

Finska

| AstraZeneca Oy |
| --- |
| Itsehallintokuja 4 |
| 02600 Espoo |
| Finland |

AstraZeneca Oy

Itsehallintokuja 4

02600 Espoo

Finland

Crestor

20 mg

filmom obložene tablete

kroz usta

Finska

| AstraZeneca Oy |
| --- |
| Itsehallintokuja 4 |
| 02600 Espoo |
| Finland |

AstraZeneca Oy

Itsehallintokuja 4

02600 Espoo

Finland

Crestor

40 mg

filmom obložene tablete

kroz usta

Francuska

| AstraZeneca |
| --- |
| 1, Place Renault |
| 92844 Rueil-Malmaison Cedex, |
| France |

AstraZeneca

1, Place Renault

92844 Rueil-Malmaison Cedex,

France

Crestor

5 mg

filmom obložene tablete

kroz usta

Francuska

| AstraZeneca |
| --- |
| 1, Place Renault |
| 92844 Rueil-Malmaison Cedex, |
| France |

AstraZeneca

1, Place Renault

92844 Rueil-Malmaison Cedex,

France

Crestor

10 mg

filmom obložene tablete

kroz usta

Francuska

| AstraZeneca |
| --- |
| 1, Place Renault |
| 92844 Rueil-Malmaison Cedex, |
| France |

AstraZeneca

1, Place Renault

92844 Rueil-Malmaison Cedex,

France

Crestor

20 mg

filmom obložene tablete

kroz usta

Njemačka

| AstraZeneca GmbH, |
| --- |
| 22876 Wedel, |
| Germany |

AstraZeneca GmbH,

22876 Wedel,

Germany

CRESTOR 5 mg Filmtabletten

5 mg

filmom obložene tablete

kroz usta

Njemačka

| AstraZeneca GmbH, |
| --- |
| 22876 Wedel, |
| Germany |

AstraZeneca GmbH,

22876 Wedel,

Germany

CRESTOR 10 mg Filmtabletten

10 mg

filmom obložene tablete

kroz usta

Njemačka

| AstraZeneca GmbH, |
| --- |
| 22876 Wedel, |
| Germany |

AstraZeneca GmbH,

22876 Wedel,

Germany

CRESTOR 20 mg Filmtabletten

20 mg

filmom obložene tablete

kroz usta

Njemačka

| AstraZeneca GmbH, |
| --- |
| 22876 Wedel, |
| Germany |

AstraZeneca GmbH,

22876 Wedel,

Germany

CRESTOR 40 mg Filmtabletten

40 mg

filmom obložene tablete

kroz usta

Grčka

| AstraZeneca SA |
| --- |
| 4 Theotokopoulou & Astronafton str |
| 151 25 Maroussi, Athens |
| Greece |

AstraZeneca SA

4 Theotokopoulou & Astronafton str

151 25 Maroussi, Athens

Greece

Crestor

5 mg

filmom obložene tablete

kroz usta

Grčka

| AstraZeneca SA |
| --- |
| 4 Theotokopoulou & Astronafton str |
| 151 25 Maroussi, Athens |
| Greece |

AstraZeneca SA

4 Theotokopoulou & Astronafton str

151 25 Maroussi, Athens

Greece

Crestor

10 mg

filmom obložene tablete

kroz usta

Grčka

| AstraZeneca SA |
| --- |
| 4 Theotokopoulou & Astronafton str |
| 151 25 Maroussi, Athens |
| Greece |

AstraZeneca SA

4 Theotokopoulou & Astronafton str

151 25 Maroussi, Athens

Greece

Crestor

20 mg

filmom obložene tablete

kroz usta

Grčka

| AstraZeneca SA |
| --- |
| 4 Theotokopoulou & Astronafton str |
| 151 25 Maroussi, Athens |
| Greece |

AstraZeneca SA

4 Theotokopoulou & Astronafton str

151 25 Maroussi, Athens

Greece

Crestor

40 mg

filmom obložene tablete

kroz usta

Mađarska

| AstraZeneca Kft., |
| --- |
| 1113 Budapest, |
| Bocskai út 134-146., |
| Hungary |

AstraZeneca Kft.,

1113 Budapest,

Bocskai út 134-146.,

Hungary

Crestor 5 mg filmtabletta

5 mg

filmom obložene tablete

kroz usta

Mađarska

| AstraZeneca Kft., |
| --- |
| 1113 Budapest, |
| Bocskai út 134-146., |
| Hungary |

AstraZeneca Kft.,

1113 Budapest,

Bocskai út 134-146.,

Hungary

Crestor 10 mg filmtabletta

10 mg

filmom obložene tablete

kroz usta

Mađarska

| AstraZeneca Kft., |
| --- |
| 1113 Budapest, |
| Bocskai út 134-146., |
| Hungary |

AstraZeneca Kft.,

1113 Budapest,

Bocskai út 134-146.,

Hungary

Crestor 20 mg filmtabletta

20 mg

filmom obložene tablete

kroz usta

Island

| AstraZeneca A/S |
| --- |
| Arne Jacobsens Allé 13 |
| 2300 København S |
| Denmark |

AstraZeneca A/S

Arne Jacobsens Allé 13

2300 København S

Denmark

Crestor

5 mg

filmom obložene tablete

kroz usta

Island

| AstraZeneca A/S |
| --- |
| Arne Jacobsens Allé 13 |
| 2300 København S |
| Denmark |

AstraZeneca A/S

Arne Jacobsens Allé 13

2300 København S

Denmark

Crestor

10 mg

filmom obložene tablete

kroz usta

Island

| AstraZeneca A/S |
| --- |
| Arne Jacobsens Allé 13 |
| 2300 København S |
| Denmark |

AstraZeneca A/S

Arne Jacobsens Allé 13

2300 København S

Denmark

Crestor

20 mg

filmom obložene tablete

kroz usta

Island

| AstraZeneca A/S |
| --- |
| Arne Jacobsens Allé 13 |
| 2300 København S |
| Denmark |

AstraZeneca A/S

Arne Jacobsens Allé 13

2300 København S

Denmark

Crestor

40 mg

filmom obložene tablete

kroz usta

Irska

| AstraZeneca UK Limited, |
| --- |
| 600 Capability Green, |
| Luton, LU1 3LU, |
| United Kingdom |

AstraZeneca UK Limited,

600 Capability Green,

Luton, LU1 3LU,

United Kingdom

Crestor

5 mg

filmom obložene tablete

kroz usta

Irska

| AstraZeneca UK Limited, |
| --- |
| 600 Capability Green, |
| Luton, LU1 3LU, |
| United Kingdom |

AstraZeneca UK Limited,

600 Capability Green,

Luton, LU1 3LU,

United Kingdom

Crestor

10 mg

filmom obložene tablete

kroz usta

Irska

| AstraZeneca UK Limited, |
| --- |
| 600 Capability Green, |
| Luton, LU1 3LU, |
| United Kingdom |

AstraZeneca UK Limited,

600 Capability Green,

Luton, LU1 3LU,

United Kingdom

Crestor

20 mg

filmom obložene tablete

kroz usta

Irska

| AstraZeneca UK Limited, |
| --- |
| 600 Capability Green, |
| Luton, LU1 3LU, |
| United Kingdom |

AstraZeneca UK Limited,

600 Capability Green,

Luton, LU1 3LU,

United Kingdom

Crestor

40 mg

filmom obložene tablete

kroz usta

Italija

| AstraZeneca S.p.A. |
| --- |
| Palazzo Volta, Via F. Sforza |
| 20080 Basiglio (MI), |
| Italy |

AstraZeneca S.p.A.

Palazzo Volta, Via F. Sforza

20080 Basiglio (MI),

Italy

Crestor

5 mg

filmom obložene tablete

kroz usta

Italija

| AstraZeneca S.p.A. |
| --- |
| Palazzo Volta, Via F. Sforza |
| 20080 Basiglio (MI), |
| Italy |

AstraZeneca S.p.A.

Palazzo Volta, Via F. Sforza

20080 Basiglio (MI),

Italy

Crestor

10 mg

filmom obložene tablete

kroz usta

Italija

| AstraZeneca S.p.A. |
| --- |
| Palazzo Volta, Via F. Sforza |
| 20080 Basiglio (MI), |
| Italy |

AstraZeneca S.p.A.

Palazzo Volta, Via F. Sforza

20080 Basiglio (MI),

Italy

Crestor

20 mg

filmom obložene tablete

kroz usta

Italija

| AstraZeneca S.p.A. |
| --- |
| Palazzo Volta, Via F. Sforza |
| 20080 Basiglio (MI), |
| Italy |

AstraZeneca S.p.A.

Palazzo Volta, Via F. Sforza

20080 Basiglio (MI),

Italy

Crestor

40 mg

filmom obložene tablete

kroz usta

Italija

| AstraZeneca S.p.A. |
| --- |
| Palazzo Volta, Via F. Sforza |
| 20080 Basiglio (MI), |
| Italy |

AstraZeneca S.p.A.

Palazzo Volta, Via F. Sforza

20080 Basiglio (MI),

Italy

Cirantan

5 mg

filmom obložene tablete

kroz usta

Italija

| AstraZeneca S.p.A. |
| --- |
| Palazzo Volta, Via F. Sforza |
| 20080 Basiglio (MI), |
| Italy |

AstraZeneca S.p.A.

Palazzo Volta, Via F. Sforza

20080 Basiglio (MI),

Italy

Cirantan

10 mg

filmom obložene tablete

kroz usta

Italija

| AstraZeneca S.p.A. |
| --- |
| Palazzo Volta, Via F. Sforza |
| 20080 Basiglio (MI), |
| Italy |

AstraZeneca S.p.A.

Palazzo Volta, Via F. Sforza

20080 Basiglio (MI),

Italy

Cirantan

20 mg

filmom obložene tablete

kroz usta

Italija

| AstraZeneca S.p.A. |
| --- |
| Palazzo Volta, Via F. Sforza |
| 20080 Basiglio (MI), |
| Italy |

AstraZeneca S.p.A.

Palazzo Volta, Via F. Sforza

20080 Basiglio (MI),

Italy

Cirantan

40 mg

filmom obložene tablete

kroz usta

Italija

| AstraZeneca S.p.A. |
| --- |
| Palazzo Volta, Via F. Sforza |
| 20080 Basiglio (MI), |
| Italy |

AstraZeneca S.p.A.

Palazzo Volta, Via F. Sforza

20080 Basiglio (MI),

Italy

Provisacor

5 mg

filmom obložene tablete

kroz usta

Italija

| AstraZeneca S.p.A. |
| --- |
| Palazzo Volta, Via F. Sforza |
| 20080 Basiglio (MI), |
| Italy |

AstraZeneca S.p.A.

Palazzo Volta, Via F. Sforza

20080 Basiglio (MI),

Italy

Provisacor

10 mg

filmom obložene tablete

kroz usta

Italija

| AstraZeneca S.p.A. |
| --- |
| Palazzo Volta, Via F. Sforza |
| 20080 Basiglio (MI), |
| Italy |

AstraZeneca S.p.A.

Palazzo Volta, Via F. Sforza

20080 Basiglio (MI),

Italy

Provisacor

20 mg

filmom obložene tablete

kroz usta

Italija

| AstraZeneca S.p.A. |
| --- |
| Palazzo Volta, Via F. Sforza |
| 20080 Basiglio (MI), |
| Italy |

AstraZeneca S.p.A.

Palazzo Volta, Via F. Sforza

20080 Basiglio (MI),

Italy

Provisacor

40 mg

filmom obložene tablete

kroz usta

Italija

| Simesa S.P.A. |
| --- |
| Palazzo Galileo, Via F. Sforza, |
| 20080 Basiglio (MI), |
| Italy |

Simesa S.P.A.

Palazzo Galileo, Via F. Sforza,

20080 Basiglio (MI),

Italy

Simestat

5 mg

filmom obložene tablete

kroz usta

Italija

| Simesa S.P.A. |
| --- |
| Palazzo Galileo, Via F. Sforza, |
| 20080 Basiglio (MI), |
| Italy |

Simesa S.P.A.

Palazzo Galileo, Via F. Sforza,

20080 Basiglio (MI),

Italy

Simestat

10 mg

filmom obložene tablete

kroz usta

Italija

| Simesa S.P.A. |
| --- |
| Palazzo Galileo, Via F. Sforza, |
| 20080 Basiglio (MI), |
| Italy |

Simesa S.P.A.

Palazzo Galileo, Via F. Sforza,

20080 Basiglio (MI),

Italy

Simestat

20 mg

filmom obložene tablete

kroz usta

Italija

| Simesa S.P.A. |
| --- |
| Palazzo Galileo, Via F. Sforza, |
| 20080 Basiglio (MI), |
| Italy |

Simesa S.P.A.

Palazzo Galileo, Via F. Sforza,

20080 Basiglio (MI),

Italy

Simestat

40 mg

filmom obložene tablete

kroz usta

Latvija

| AstraZeneca UK Limited |
| --- |
| 2 Kingdom Street |
| London W2 6BD |
| United Kingdom |

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

Crestor 5 mg apvalkotās tabletes

5 mg

filmom obložene tablete

kroz usta

Latvija

| AstraZeneca UK Limited |
| --- |
| 2 Kingdom Street |
| London W2 6BD |
| United Kingdom |

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

Crestor 10 mg apvalkotās tabletes

10 mg

filmom obložene tablete

kroz usta

Latvija

| AstraZeneca UK Limited |
| --- |
| 2 Kingdom Street |
| London W2 6BD |
| United Kingdom |

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

Crestor 20 mg apvalkotās tabletes

20 mg

filmom obložene tablete

kroz usta

Latvija

| AstraZeneca UK Limited |
| --- |
| 2 Kingdom Street |
| London W2 6BD |
| United Kingdom |

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

Crestor 40 mg apvalkotās tabletes

40 mg

filmom obložene tablete

kroz usta

Litva

| AstraZeneca UK Limited |
| --- |
| 2 Kingdom Street |
| London W2 6BD |
| United Kingdom |

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

Crestor

5 mg

filmom obložene tablete

kroz usta

Litva

| AstraZeneca UK Limited |
| --- |
| 2 Kingdom Street |
| London W2 6BD |
| United Kingdom |

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

Crestor

10 mg

filmom obložene tablete

kroz usta

Litva

| AstraZeneca UK Limited |
| --- |
| 2 Kingdom Street |
| London W2 6BD |
| United Kingdom |

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

Crestor

20 mg

filmom obložene tablete

kroz usta

Litva

| AstraZeneca UK Limited |
| --- |
| 2 Kingdom Street |
| London W2 6BD |
| United Kingdom |

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

Crestor

40 mg

filmom obložene tablete

kroz usta

Luksemburg

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussels, |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels,

Belgium

Crestor

5 mg

filmom obložene tablete

kroz usta

Luksemburg

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussels, |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels,

Belgium

Crestor

10 mg

filmom obložene tablete

kroz usta

Luksemburg

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussels, |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels,

Belgium

Crestor

20 mg

filmom obložene tablete

kroz usta

Luksemburg

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussels, |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels,

Belgium

Crestor

40 mg

filmom obložene tablete

kroz usta

Malta

| AstraZeneca UK Limited |
| --- |
| 2 Kingdom Street |
| London W2 6BD |
| United Kingdom |

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

Crestor

5 mg

filmom obložene tablete

kroz usta

Malta

| AstraZeneca UK Limited |
| --- |
| 2 Kingdom Street |
| London W2 6BD |
| United Kingdom |

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

Crestor

10 mg

filmom obložene tablete

kroz usta

Malta

| AstraZeneca UK Limited |
| --- |
| 2 Kingdom Street |
| London W2 6BD |
| United Kingdom |

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

Crestor

20 mg

filmom obložene tablete

kroz usta

Malta

| AstraZeneca UK Limited |
| --- |
| 2 Kingdom Street |
| London W2 6BD |
| United Kingdom |

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

Crestor

40 mg

filmom obložene tablete

kroz usta

Nizozemska

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE Zoetermeer |
| The Netherlands |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Crestor

5 mg

filmom obložene tablete

kroz usta

Nizozemska

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE Zoetermeer |
| The Netherlands |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Crestor

10 mg

filmom obložene tablete

kroz usta

Nizozemska

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE Zoetermeer |
| The Netherlands |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Crestor

20 mg

filmom obložene tablete

kroz usta

Nizozemska

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE Zoetermeer |
| The Netherlands |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Crestor

40 mg

filmom obložene tablete

kroz usta

Nizozemska

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE Zoetermeer |
| The Netherlands |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Cirantan

5 mg

filmom obložene tablete

kroz usta

Nizozemska

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE Zoetermeer |
| The Netherlands |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Cirantan

10 mg

filmom obložene tablete

kroz usta

Nizozemska

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE Zoetermeer |
| The Netherlands |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Cirantan

20 mg

filmom obložene tablete

kroz usta

Nizozemska

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE Zoetermeer |
| The Netherlands |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Cirantan

40 mg

filmom obložene tablete

kroz usta

Nizozemska

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE Zoetermeer |
| The Netherlands |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Provisacor

5 mg

filmom obložene tablete

kroz usta

Nizozemska

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE Zoetermeer |
| The Netherlands |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Provisacor

10 mg

filmom obložene tablete

kroz usta

Nizozemska

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE Zoetermeer |
| The Netherlands |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Provisacor

20 mg

filmom obložene tablete

kroz usta

Nizozemska

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE Zoetermeer |
| The Netherlands |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Provisacor

40 mg

filmom obložene tablete

kroz usta

Nizozemska

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE Zoetermeer |
| The Netherlands |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Rosuvastatin AstraZeneca

5 mg

filmom obložene tablete

kroz usta

Nizozemska

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE Zoetermeer |
| The Netherlands |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Rosuvastatin AstraZeneca

10 mg

filmom obložene tablete

kroz usta

Nizozemska

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE Zoetermeer |
| The Netherlands |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Rosuvastatin AstraZeneca

20 mg

filmom obložene tablete

kroz usta

Nizozemska

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE Zoetermeer |
| The Netherlands |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Rosuvastatin AstraZeneca

40 mg

filmom obložene tablete

kroz usta

Norveška

| AstraZeneca AS |
| --- |
| Postboks 6050, |
| Etterstad |
| 0601 Oslo |
| Norway |

AstraZeneca AS

Postboks 6050,

Etterstad

0601 Oslo

Norway

Crestor

5 mg

filmom obložene tablete

kroz usta

Norveška

| AstraZeneca AS |
| --- |
| Postboks 6050, |
| Etterstad |
| 0601 Oslo |
| Norway |

AstraZeneca AS

Postboks 6050,

Etterstad

0601 Oslo

Norway

Crestor

10 mg

filmom obložene tablete

kroz usta

Norveška

| AstraZeneca AS |
| --- |
| Postboks 6050, |
| Etterstad |
| 0601 Oslo |
| Norway |

AstraZeneca AS

Postboks 6050,

Etterstad

0601 Oslo

Norway

Crestor

20 mg

filmom obložene tablete

kroz usta

Norveška

| AstraZeneca AS |
| --- |
| Postboks 6050, |
| Etterstad |
| 0601 Oslo |
| Norway |

AstraZeneca AS

Postboks 6050,

Etterstad

0601 Oslo

Norway

Crestor

40 mg

filmom obložene tablete

kroz usta

Poljska

| AstraZeneca AB, |
| --- |
| S-151 85 Södertälje, |
| Sweden |

AstraZeneca AB,

S-151 85 Södertälje,

Sweden

Crestor

5 mg

filmom obložene tablete

kroz usta

Poljska

| AstraZeneca AB, |
| --- |
| S-151 85 Södertälje, |
| Sweden |

AstraZeneca AB,

S-151 85 Södertälje,

Sweden

Crestor

10 mg

filmom obložene tablete

kroz usta

Poljska

| AstraZeneca AB, |
| --- |
| S-151 85 Södertälje, |
| Sweden |

AstraZeneca AB,

S-151 85 Södertälje,

Sweden

Crestor

20 mg

filmom obložene tablete

kroz usta

Poljska

| AstraZeneca AB, |
| --- |
| S-151 85 Södertälje, |
| Sweden |

AstraZeneca AB,

S-151 85 Södertälje,

Sweden

Crestor

40 mg

filmom obložene tablete

kroz usta

Portugal

| AstraZeneca Produtos Farmacêuticos, Lda. |
| --- |
| Rua Humberto Madeira, 7 |
| Queluz de Baixo |
| 2730-097 Barcarena |
| Portugal |

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, 7

Queluz de Baixo

2730-097 Barcarena

Portugal

Crestor 5 mg

5 mg

filmom obložene tablete

kroz usta

Portugal

| AstraZeneca Produtos Farmacêuticos, Lda. |
| --- |
| Rua Humberto Madeira, 7 |
| Queluz de Baixo |
| 2730-097 Barcarena |
| Portugal |

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, 7

Queluz de Baixo

2730-097 Barcarena

Portugal

Crestor 10 mg

10 mg

filmom obložene tablete

kroz usta

Portugal

| AstraZeneca Produtos Farmacêuticos, Lda. |
| --- |
| Rua Humberto Madeira, 7 |
| Queluz de Baixo |
| 2730-097 Barcarena |
| Portugal |

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, 7

Queluz de Baixo

2730-097 Barcarena

Portugal

Crestor 20 mg

20 mg

filmom obložene tablete

kroz usta

Portugal

| AstraZeneca Produtos Farmacêuticos, Lda. |
| --- |
| Rua Humberto Madeira, 7 |
| Queluz de Baixo |
| 2730-097 Barcarena |
| Portugal |

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, 7

Queluz de Baixo

2730-097 Barcarena

Portugal

Crestor 40 mg

40 mg

filmom obložene tablete

kroz usta

Portugal

| AstraZeneca Produtos Farmacêuticos, Lda. |
| --- |
| Rua Humberto Madeira, 7, |
| Queluz de Baixo |
| 2730-097 Barcarena |
| Portugal |

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, 7,

Queluz de Baixo

2730-097 Barcarena

Portugal

Visacor 5 mg

5 mg

filmom obložene tablete

kroz usta

Portugal

| AstraZeneca Produtos Farmacêuticos, Lda. |
| --- |
| Rua Humberto Madeira, 7, |
| Queluz de Baixo |
| 2730-097 Barcarena |
| Portugal |

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, 7,

Queluz de Baixo

2730-097 Barcarena

Portugal

Visacor 10 mg

10 mg

filmom obložene tablete

kroz usta

Portugal

| AstraZeneca Produtos Farmacêuticos, Lda. |
| --- |
| Rua Humberto Madeira, 7, |
| Queluz de Baixo |
| 2730-097 Barcarena |
| Portugal |

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, 7,

Queluz de Baixo

2730-097 Barcarena

Portugal

Visacor 20 mg

20 mg

filmom obložene tablete

kroz usta

Portugal

| AstraZeneca Produtos Farmacêuticos, Lda. |
| --- |
| Rua Humberto Madeira, 7, |
| Queluz de Baixo |
| 2730-097 Barcarena |
| Portugal |

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, 7,

Queluz de Baixo

2730-097 Barcarena

Portugal

Visacor 40 mg

40 mg

filmom obložene tablete

kroz usta

Rumunjska

| AstraZeneca UK Limited |
| --- |
| 2 Kingdom Street, |
| London W2 6BD, |
| United Kingdom |

AstraZeneca UK Limited

2 Kingdom Street,

London W2 6BD,

United Kingdom

Crestor 5 mg comprimate filmate

5 mg

filmom obložene tablete

kroz usta

Rumunjska

| AstraZeneca UK Limited |
| --- |
| 2 Kingdom Street, |
| London W2 6BD, |
| United Kingdom |

AstraZeneca UK Limited

2 Kingdom Street,

London W2 6BD,

United Kingdom

Crestor 10 mg comprimate filmate

10 mg

filmom obložene tablete

kroz usta

Rumunjska

| AstraZeneca UK Limited |
| --- |
| 2 Kingdom Street, |
| London W2 6BD, |
| United Kingdom |

AstraZeneca UK Limited

2 Kingdom Street,

London W2 6BD,

United Kingdom

Crestor 20 mg comprimate filmate

20 mg

filmom obložene tablete

kroz usta

Rumunjska

| AstraZeneca UK Limited |
| --- |
| 2 Kingdom Street, |
| London W2 6BD, |
| United Kingdom |

AstraZeneca UK Limited

2 Kingdom Street,

London W2 6BD,

United Kingdom

Crestor 40 mg comprimate filmate

40 mg

filmom obložene tablete

kroz usta

Slovačka Republika

| AstraZeneca UK Ltd |
| --- |
| 2 Kingdom Street |
| London, W2 6BD, |
| United Kingdom |

AstraZeneca UK Ltd

2 Kingdom Street

London, W2 6BD,

United Kingdom

CRESTOR 5 mg

5 mg

filmom obložene tablete

kroz usta

Slovačka Republika

| AstraZeneca UK Ltd |
| --- |
| 2 Kingdom Street |
| London, W2 6BD, |
| United Kingdom |

AstraZeneca UK Ltd

2 Kingdom Street

London, W2 6BD,

United Kingdom

CRESTOR 10 mg

10 mg

filmom obložene tablete

kroz usta

Slovačka Republika

| AstraZeneca UK Ltd |
| --- |
| 2 Kingdom Street |
| London, W2 6BD, |
| United Kingdom |

AstraZeneca UK Ltd

2 Kingdom Street

London, W2 6BD,

United Kingdom

CRESTOR 20 mg

20 mg

filmom obložene tablete

kroz usta

Slovačka Republika

| AstraZeneca UK Ltd |
| --- |
| 2 Kingdom Street |
| London, W2 6BD, |
| United Kingdom |

AstraZeneca UK Ltd

2 Kingdom Street

London, W2 6BD,

United Kingdom

CRESTOR 40 mg

40mg

filmom obložene tablete

kroz usta

Slovenija

| AstraZeneca UK Limited |
| --- |
| 2 Kingdom Street |
| London, W2 6BD, |
| United Kingdom |

AstraZeneca UK Limited

2 Kingdom Street

London, W2 6BD,

United Kingdom

Crestor 5 mg filmsko obložene tablete

5 mg

filmom obložene tablete

kroz usta

Slovenija

| AstraZeneca UK Limited |
| --- |
| 2 Kingdom Street |
| London, W2 6BD, |
| United Kingdom |

AstraZeneca UK Limited

2 Kingdom Street

London, W2 6BD,

United Kingdom

Crestor 10 mg filmsko obložene tablete

10 mg

filmom obložene tablete

kroz usta

Slovenija

| AstraZeneca UK Limited |
| --- |
| 2 Kingdom Street |
| London, W2 6BD, |
| United Kingdom |

AstraZeneca UK Limited

2 Kingdom Street

London, W2 6BD,

United Kingdom

Crestor 20 mg filmsko obložene tablete

20 mg

filmom obložene tablete

kroz usta

Slovenija

| AstraZeneca UK Limited |
| --- |
| 2 Kingdom Street |
| London, W2 6BD, |
| United Kingdom |

AstraZeneca UK Limited

2 Kingdom Street

London, W2 6BD,

United Kingdom

Crestor 40 mg filmsko obložene tablete

40 mg

filmom obložene tablete

kroz usta

Španjolska

| AstraZeneca Farmacéutica Spain, S.A. |
| --- |
| Parque Norte.Edificio Roble. |
| C/Serrano Galvache 56, |
| 28033 Madrid, |
| Spain. |

AstraZeneca Farmacéutica Spain, S.A.

Parque Norte.Edificio Roble.

C/Serrano Galvache 56,

28033 Madrid,

Spain.

Crestor 5 mg comprimidos recubiertos con película

5 mg

filmom obložene tablete

kroz usta

Španjolska

| AstraZeneca Farmacéutica Spain, S.A. |
| --- |
| Parque Norte.Edificio Roble. |
| C/Serrano Galvache 56, |
| 28033 Madrid, |
| Spain. |

AstraZeneca Farmacéutica Spain, S.A.

Parque Norte.Edificio Roble.

C/Serrano Galvache 56,

28033 Madrid,

Spain.

Crestor 10 mg comprimidos recubiertos con película

10 mg

filmom obložene tablete

kroz usta

Španjolska

| AstraZeneca Farmacéutica Spain, S.A. |
| --- |
| Parque Norte.Edificio Roble. |
| C/Serrano Galvache 56, |
| 28033 Madrid, |
| Spain. |

AstraZeneca Farmacéutica Spain, S.A.

Parque Norte.Edificio Roble.

C/Serrano Galvache 56,

28033 Madrid,

Spain.

Crestor 20 mg comprimidos recubiertos con película

20 mg

filmom obložene tablete

kroz usta

Španjolska

| AstraZeneca Farmacéutica Spain, S.A. |
| --- |
| Parque Norte.Edificio Roble. |
| C/Serrano Galvache 56, |
| 28033 Madrid, |
| Spain. |

AstraZeneca Farmacéutica Spain, S.A.

Parque Norte.Edificio Roble.

C/Serrano Galvache 56,

28033 Madrid,

Spain.

Crestor 40 mg comprimidos recubiertos con película

40 mg

filmom obložene tablete

kroz usta

Španjolska

| AstraZeneca Farmacéutica Spain, S.A. |
| --- |
| Parque Norte.Edificio Roble. |
| C/Serrano Galvache 56, |
| 28033 Madrid, |
| Spain. |

AstraZeneca Farmacéutica Spain, S.A.

Parque Norte.Edificio Roble.

C/Serrano Galvache 56,

28033 Madrid,

Spain.

Provisacor 5 mg comprimidos recubiertos con película

5 mg

filmom obložene tablete

kroz usta

Španjolska

| AstraZeneca Farmacéutica Spain, S.A. |
| --- |
| Parque Norte.Edificio Roble. |
| C/Serrano Galvache 56, |
| 28033 Madrid, |
| Spain. |

AstraZeneca Farmacéutica Spain, S.A.

Parque Norte.Edificio Roble.

C/Serrano Galvache 56,

28033 Madrid,

Spain.

Provisacor 10 mg comprimidos recubiertos con película

10 mg

filmom obložene tablete

kroz usta

Španjolska

| AstraZeneca Farmacéutica Spain, S.A. |
| --- |
| Parque Norte.Edificio Roble. |
| C/Serrano Galvache 56, |
| 28033 Madrid, |
| Spain. |

AstraZeneca Farmacéutica Spain, S.A.

Parque Norte.Edificio Roble.

C/Serrano Galvache 56,

28033 Madrid,

Spain.

Provisacor 20 mg comprimidos recubiertos con película

20 mg

filmom obložene tablete

kroz usta

Španjolska

| AstraZeneca Farmacéutica Spain, S.A. |
| --- |
| Parque Norte.Edificio Roble. |
| C/Serrano Galvache 56, |
| 28033 Madrid, |
| Spain. |

AstraZeneca Farmacéutica Spain, S.A.

Parque Norte.Edificio Roble.

C/Serrano Galvache 56,

28033 Madrid,

Spain.

Provisacor 40 mg comprimidos recubiertos con película

40 mg

filmom obložene tablete

kroz usta

Švedska

| AstraZeneca AB, |
| --- |
| S-151 85 Södertälje |
| Sweden |

AstraZeneca AB,

S-151 85 Södertälje

Sweden

Crestor

5 mg

filmom obložene tablete

kroz usta

Švedska

| AstraZeneca AB, |
| --- |
| S-151 85 Södertälje |
| Sweden |

AstraZeneca AB,

S-151 85 Södertälje

Sweden

Crestor

10 mg

filmom obložene tablete

kroz usta

Švedska

| AstraZeneca AB, |
| --- |
| S-151 85 Södertälje |
| Sweden |

AstraZeneca AB,

S-151 85 Södertälje

Sweden

Crestor

20 mg

filmom obložene tablete

kroz usta

Švedska

| AstraZeneca AB, |
| --- |
| S-151 85 Södertälje |
| Sweden |

AstraZeneca AB,

S-151 85 Södertälje

Sweden

Crestor

40 mg

filmom obložene tablete

kroz usta

Velika Britanija

| AstraZeneca UK Limited, |
| --- |
| 600 Capability Green, |
| Luton, LU1 3LU, |
| United Kingdom |

AstraZeneca UK Limited,

600 Capability Green,

Luton, LU1 3LU,

United Kingdom

Crestor

5 mg

filmom obložene tablete

kroz usta

Velika Britanija

| AstraZeneca UK Limited, |
| --- |
| 600 Capability Green, |
| Luton, LU1 3LU, |
| United Kingdom |

AstraZeneca UK Limited,

600 Capability Green,

Luton, LU1 3LU,

United Kingdom

Crestor

10 mg

filmom obložene tablete

kroz usta

Velika Britanija

| AstraZeneca UK Limited, |
| --- |
| 600 Capability Green, |
| Luton, LU1 3LU, |
| United Kingdom |

AstraZeneca UK Limited,

600 Capability Green,

Luton, LU1 3LU,

United Kingdom

Crestor

20 mg

filmom obložene tablete

kroz usta

Velika Britanija

| AstraZeneca UK Limited, |
| --- |
| 600 Capability Green, |
| Luton, LU1 3LU, |
| United Kingdom |

AstraZeneca UK Limited,

600 Capability Green,

Luton, LU1 3LU,

United Kingdom

Crestor

40 mg

filmom obložene tablete

kroz usta

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