# Il-Ġurnal Uffiċjali C 243/25 t

| | ISSN 1977-0987 |
| --- | --- |
| Il-Ġurnal Uffiċjali
  tal-Unjoni Ewropea | C 243 |
| | |
| Edizzjoni bil-Malti | Informazzjoni u Avviżi | Volum 5725 ta' Lulju 2014 |

ISSN 1977-0987

Il-Ġurnal Uffiċjali

tal-Unjoni Ewropea

C 243

Edizzjoni bil-Malti

Informazzjoni u Avviżi

Volum 5725 ta' Lulju 2014

---

| Avviż Nru | Werrej | Paġna |
| --- | --- | --- |
| | IV   Informazzjoni |
| | INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA |
| | Il-Kummissjoni Ewropea |
| 2014/C 243/01 | Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Ġunju 2014 sat-30 ta’ Ġunju 2014(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill) | 1 |
| 2014/C 243/02 | Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Ġunju 2014 sat-30 Ġunju 2014(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE jew l-Artikolu 38 tad-Direttiva 2001/82/KE) | 11 |

Avviż Nru

Werrej

Paġna

IV   Informazzjoni

INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA

Il-Kummissjoni Ewropea

2014/C 243/01

Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Ġunju 2014 sat-30 ta’ Ġunju 2014(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill)

(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill)

1

2014/C 243/02

Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Ġunju 2014 sat-30 Ġunju 2014(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE jew l-Artikolu 38 tad-Direttiva 2001/82/KE)

(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE jew l-Artikolu 38 tad-Direttiva 2001/82/KE)

11

| MT | |
| --- | --- |

MT

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IV Informazzjoni

INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA

Il-Kummissjoni Ewropea

| 25.7.2014 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 243/1 |
| --- | --- | --- | --- |

25.7.2014

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 243/1

---

Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Ġunju 2014 sat-30 ta’ Ġunju 2014

(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill (1))

2014/C 243/01

—   Ħruġ ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | INN (Denominazzjoni Internazzjonali Komuni) | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Forma farmaċewtika | Kodiċi ATC (Kodiċi Anatomiku Terapewtiku Kimiku) | Data ta' notifika |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 30.6.2014 | Mekinist | trametinib | Glaxo Group Ltd |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

INN (Denominazzjoni Internazzjonali Komuni)

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Forma farmaċewtika

Kodiċi ATC (Kodiċi Anatomiku Terapewtiku Kimiku)

Data ta' notifika

30.6.2014

Mekinist

trametinib

Glaxo Group Ltd

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

EU/1/14/931

Pillola miksija b’rita

L01XE25

2.7.2014

—   Modifika ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Data ta' notifika |
| --- | --- | --- | --- | --- |
| 3.6.2014 | Adasuve | Alexza UK Ltd. |
| 10 Station Road, Henley-on-Thames, Oxfordshire RG9 1AY, United Kingdom |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta' notifika

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

—   Ħruġ ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill (2)): Aċċettat

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | INN (Denominazzjoni Internazzjonali Komuni) | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Forma farmaċewtika | Kodiċi ATC (Kodiċi Anatomiku Terapewtiku Kimiku) | Data ta' notifika |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 6.6.2014 | Vectra Felis | dinotefuran, pyriproxyfen | CEVA SANTE ANIMALE |
| 10 avenue de la Ballastière, F-33500 Libourne, France |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

INN (Denominazzjoni Internazzjonali Komuni)

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Forma farmaċewtika

Kodiċi ATC (Kodiċi Anatomiku Terapewtiku Kimiku)

Data ta' notifika

6.6.2014

Vectra Felis

dinotefuran, pyriproxyfen

CEVA SANTE ANIMALE

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

EU/2/14/165

Taħlita likwida għall-użu lokalizzat

QP53AX73

11.6.2014

—   Modifika ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Data ta' notifika |
| --- | --- | --- | --- | --- |
| 3.6.2014 | Activyl | Intervet International B.V. |
| Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta' notifika

3.6.2014

Activyl

Intervet International B.V.

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

EU/2/10/118

5.6.2014

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

Kull min jixtieq jikkonsulta r-rapport ta' evalwazzjoni pubblika dwar il-prodotti mediċinali kkonċernati u d-deċiżjonijiet marbuta magħhom għandu jikkuntattja lil:

| 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)  ĠU L 136, 30.4.04, p. 1.

(2)  ĠU L 136, 30.4.04, p. 1.

---

| 25.7.2014 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 243/11 |
| --- | --- | --- | --- |

25.7.2014

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 243/11

---

Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Ġunju 2014 sat-30 Ġunju 2014

(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE (1) jew l-Artikolu 38 tad-Direttiva 2001/82/KE (2))

2014/C 243/02

—   Ħruġ, manteniment jew modifika ta' awtorizzazzjoni għat-tqegħid fis-suq

| Data tad-deċiżjoni | Isem/Ismijiet tal-prodott mediċinali | INN (Denominazzjoni Internazzjonali Komuni) | Detentur(i) tal-awtorizzazzjoni għat-tqegħid fis-suq | Stat Membru kkonċernat | Data ta' notifika |
| --- | --- | --- | --- | --- | --- |
| 23.6.2014 | Zolpidem | Ara l-Anness I | Ara l-Anness I | Ara l-Anness I | 24.6.2014 |
| 30.6.2014 | Crestor | Ara l-Anness II | Ara l-Anness II | Ara l-Anness II | 1.7.2014 |

Data tad-deċiżjoni

Isem/Ismijiet tal-prodott mediċinali

INN (Denominazzjoni Internazzjonali Komuni)

Detentur(i) tal-awtorizzazzjoni għat-tqegħid fis-suq

Stat Membru kkonċernat

Data ta' notifika

23.6.2014

Zolpidem

Ara l-Anness I

Ara l-Anness I

Ara l-Anness I

24.6.2014

30.6.2014

Crestor

Ara l-Anness II

Ara l-Anness II

Ara l-Anness II

1.7.2014

---

(1)  ĠU L 311, 28.11.01, p. 67.

(2)  ĠU L 311, 28.11.01, p. 1.

---

ANNESS I

Lista tal-ismijiet, għamliet farmaċewtiċi, qawwiet tal-prodotti mediċinali, mnejn jingħata, id-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq fl-istati membri

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

  2794-038 Carnaxide
  Portugal | Zolpidem Aurobindo | 5 mg | pillola miksija b’rita | għall-użu orali |
| Il-Portugall | Aurobindo Pharma (Portugal), Unipessoal Lda.
  Av. do Forte, no 3 – Parque Suécia, Edifício. IV, 2o

  2794-038 Carnaxide
  Portugal | Zolpidem Aurobindo | 10 mg | pillola miksija b’rita | għall-użu orali |
| Il-Portugall | Cinfa Portugal, Lda.
  Av. Tomás Ribeiro, 43 – Bloco 2, 3o F – Edifício Neopark
  2790-221 Carnaxide
  Portugal | Zolpidem Cinfa 10 mg Comprimidos | 10 mg | pillola miksija b’rita | għall-użu orali |
| Il-Portugall | Generis Farmacêutica, S.A.
  Rua João de Deus, 19
  2700-487 Amadora
  Portugal | Zolpidem Generis 5 mg Comprimidos Revestidos | 5 mg | pillola miksija b’rita | għall-użu orali |
| Il-Portugall | Generis Farmacêutica, S.A.
  Rua João de Deus, 19
  2700-487 Amadora
  Portugal | Zolpidem Generis 10 mg Comprimidos Revestidos | 10 mg | pillola miksija b’rita | għall-użu orali |
| Il-Portugall | Genthon GmbH
  Groesbeeker Weg, 1
  D-47559 Kranenburg
  Germany | Zolpidem 5 mg Comprimidos Revestidos | 5 mg | pillola miksija b’rita | għall-użu orali |
| Il-Portugall | IPCA – Produtos Farmacêuticos Unipessoal, Lda.
  Rua José Nogueira Vaz, Lote 104 – Lj Esq
  2625-099 Povoa de Santa Iria
  Portugal | Zolpidem IPCA | 5 mg | pillola miksija b’rita | għall-użu orali |
| Il-Portugall | IPCA – Produtos Farmacêuticos Unipessoal, Lda.
  Rua José Nogueira Vaz, Lote 104 – Lj Esq
  2625-099 Povoa de Santa Iria
  Portugal | Zolpidem IPCA | 10 mg | pillola miksija b’rita | għall-użu orali |
| Il-Portugall | Labesfal Genéricos, S.A
  Avenida Dr. Afonso Costa, 1370
  3465-051 Campo de Besteiros
  Portugal | Zolpidem Labesfal | 10 mg | pillola miksija b’rita | għall-użu orali |
| Il-Portugall | Laboratórios Azevedos – Indústria Farmacêutica, S.A.
  Edifícios Azevedos – Estrada Nacional 117-2, Alfragide
  2614-504 Amadora
  Portugal | Cymerion | 10 mg | pillola miksija b’rita | għall-użu orali |
| Il-Portugall | Meda Pharma – Produtos Farmacêuticos, S.A.
  Rua do Centro Cultural, 13
  1749-066 Lisboa
  Portugal | Edluar | 5 mg | pillola għal taħt l-ilsien | għall-użu minn taħt l-ilsien |
| Il-Portugall | Meda Pharma – Produtos Farmacêuticos, S.A.
  Rua do Centro Cultural, 13
  1749-066 Lisboa
  Portugal | Edluar | 10 mg | pillola għal taħt l-ilsien | għall-użu minn taħt l-ilsien |
| Il-Portugall | 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 | pillola miksija b’rita | għall-użu orali |
| Il-Portugall | 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 | pillola miksija b’rita | għall-użu orali |
| Il-Portugall | Sandoz Farmacêutica, Lda.
  Alameda da Beloura, Edifício 1, 2o – Escritório 15
  2710-693 Sintra
  Portugal | Zolpidem Sandoz | 10 mg | pillola miksija b’rita | għall-użu orali |
| Il-Portugall | Sanofi – Produtos Farmacêuticos, Lda.
  Empreendimento Lagoas Park Edifício 7, 3o Piso
  2740-244 Porto Salvo
  Portugal | Stilnox | 10 mg | pillola miksija b’rita | għall-użu orali |
| Il-Portugall | Wynn Industrial Pharma, S.A.
  Rua Tierno Galvan, Torre 3, 16o Piso, Amoreiras
  1070-274 Lisboa
  Portugal | Zolpidem Wynn | 10 mg | pillola miksija b’rita | għall-użu orali |
| Ir-Rumanija | ALKALOID-INT d.o.o.
  Šlandrova ulica 4
  1231 Ljubljana-Črnuče Slovenia | ZADOBRA 5 mg | 5 mg | pillola miksija b’rita | għall-użu orali |
| Ir-Rumanija | ALKALOID-INT d.o.o.
  Šlandrova ulica 4
  1231 Ljubljana-Črnuče Slovenia | ZADOBRA 10 mg | 10 mg | pillola miksija b’rita | għall-użu orali |
| Ir-Rumanija | ITALFARMACO S.p.A.
  Viale Fulvio Testi 330, 20126 Milano, Italia | ONIRIA 10 mg/ml | 10 mg/ml | qtar orali, soluzzjoni | għall-użu orali |
| Ir-Rumanija | Krka, d.d., Novo mesto
  Šmarješka cesta 6
  8000 Novo mesto
  Slovenia | ZOLSANA 5 mg | 5 mg | pillola miksija b’rita | għall-użu orali |
| Ir-Rumanija | Krka, d.d., Novo mesto
  Šmarješka cesta 6
  8000 Novo mesto
  Slovenia | ZOLSANA 10 mg | 10 mg | pillola miksija b’rita | għall-użu orali |
| Ir-Rumanija | LABORMED PHARMA S.A.
  B-dul Theodor Pallady nr. 44B
  Sector 3, Bucureşti, România | ZOLPIDEM 10 mg | 10 mg | pillola miksija b’rita | għall-użu orali |
| Ir-Rumanija | LEK farmacevtska družba d.d. Verovškova 57
  1526 Ljubljana
  Slovenia | SANVAL 10 mg | 10 mg | pillola miksija b’rita | għall-użu orali |
| Ir-Rumanija | Meda Pharma GmbH & Co. KG
  Benzstrasse 1
  Bad Homburg v.d.H
  61352
  Germany | EDLUAR 5 mg | 5 mg | pillola għal taħt l-ilsien | għall-użu orali |
| Ir-Rumanija | Meda Pharma GmbH & Co. KG
  Benzstrasse 1
  Bad Homburg v.d.H
  61352
  Germany | EDLUAR 10 mg | 10 mg | pillola għal taħt l-ilsien | għall-użu orali |
| Ir-Rumanija | S.C. ANTIBIOTICE S.A.,
  Str. Valea Lupului nr.1, Iaşi, România | ZOLPIDEM ATB 10 mg | 10 mg | pillola miksija b’rita | għall-użu orali |
| Ir-Rumanija | SANOFI-AVENTIS ROMÂNIA S.R.L.
  Str. Izvor, Nr. 80, Et. 6-11
  Sector 5, Bucureşti, România | STILNOX 10 mg | 10 mg | pillola miksija b’rita | għall-użu orali |
| Ir-Repubblika Slovakka | ALKALOID-INT d.o.o.
  Šlandrova ulica 4
  1231 Ljubljana-Črnuče Slovenia | ADORMA 5 mg filmom obalené tablety | 5 mg | pillola miksija b’rita | għall-użu orali |
| Ir-Repubblika Slovakka | ALKALOID-INT d.o.o.
  Šlandrova ulica 4
  1231 Ljubljana-Črnuče Slovenia | ADORMA 10 mg filmom obalené tablety | 10 mg | pillola miksija b’rita | għall-użu orali |
| Ir-Repubblika Slovakka | Generics [UK] Ltd.
  Station Close
  EN6 1TL Hertfordshire – Potters Bar
  United Kingdom | Zolpidem Mylan 10 mg | 10 mg | pillola miksija b’rita | għall-użu orali |
| Ir-Repubblika Slovakka | Orion Corporation
  Orionintie 1/A
  FI-02200 Espoo
  Finland | Zolpidem Orion 10 mg | 10 mg | pillola miksija b’rita | għall-użu orali |
| Ir-Repubblika Slovakka | Sandoz d.d.
  Verovškova 57,
  1000 Ljubljana,
  Slovenia | SANVAL 5 mg | 5 mg | pillola miksija b’rita | għall-użu orali |
| Ir-Repubblika Slovakka | Sandoz d.d.
  Verovškova 57,
  1000 Ljubljana,
  Slovenia | SANVAL 10 mg | 10 mg | pillola miksija b’rita | għall-użu orali |
| Ir-Repubblika Slovakka | sanofi-aventis Slovakia s.r.o. Einsteinova 24
  85101 Bratislava
  Slovak Republic | STILNOX | 10 mg | pillola miksija b’rita | għall-użu orali |
| Ir-Repubblika Slovakka | SVUS Pharma a.s., Smetanovo nábřeží 1238/20a
  500 02 Hradec Králové Czech Republic | ZOLPINOX | 10 mg | pillola miksija b’rita | għall-użu orali |
| Ir-Repubblika Slovakka | Takeda GmbH 2 Byk-Gulden Strasse
  78467 Konstanz Germany | HYPNOGEN | 10 mg | pillola miksija b’rita | għall-użu orali |
| Ir-Repubblika Slovakka | Vitabalans Oy
  Varastokatu 8
  13500 Hämeenlinna
  Finland | Zolpidem Vitabalans 10 mg filmom obalené tablety | 10 mg | pillola miksija b’rita | għall-użu orali |
| L-Islovenja | ALKALOID-INT d.o.o.
  Šlandrova ulica 4
  1231 Ljubljana-Črnuče Slovenia | Perluna 10 mg filmsko obožene tablete | 10 mg | pillola miksija b’rita | għall-użu orali |
| L-Islovenja | ALKALOID-INT d.o.o.
  Šlandrova ulica 4
  1231 Ljubljana-Črnuče Slovenia | Perluna 5 mg filmsko obožene tablete | 5 mg | pillola miksija b’rita | għall-użu orali |
| L-Islovenja | Krka, d.d., Novo mesto
  Šmarješka cesta 6
  8000 Novo mesto
  Slovenia | Zolsana 10 mg filmsko obložene tablete | 10 mg | pillola miksija b’rita | għall-użu orali |
| L-Islovenja | Krka, d.d., Novo mesto
  Šmarješka cesta 6
  8000 Novo mesto
  Slovenia | Zolsana 5 mg filmsko obložene tablete | 5 mg | pillola miksija b’rita | għall-użu orali |
| L-Islovenja | LEK farmacevtska družba d.d. Verovškova 57
  1526 Ljubljana
  Slovenia | Sanval 10 mg filmsko obožene tablete | 10 mg | pillola miksija b’rita | għall-użu orali |
| L-Islovenja | LEK farmacevtska družba d.d. Verovškova 57
  1526 Ljubljana
  Slovenia | Sanval 5 mg filmsko obložene tablete | 5 mg | pillola miksija b’rita | għall-użu orali |
| L-Islovenja | Meda Pharma GmbH & Co. KG
  Benzstrasse 1
  Bad Homburg v.d.H
  61352
  Germany | Edluar 10 mg podjezične tablete | 10 mg | pillola għal taħt l-ilsien | għall-użu minn taħt l-ilsien |
| L-Islovenja | Meda Pharma GmbH & Co. KG
  Benzstrasse 1
  Bad Homburg v.d.H
  61352
  Germany | Edluar 5 mg podjezične tablete | 5 mg | pillola għal taħt l-ilsien | għall-użu minn taħt l-ilsien |
| L-Islovenja | Vitabalans Oy
  Varastokatu 8
  13500 Hämeenlinna
  Finland | Zolpidem Vitabalans 10 mg filmsko obložene tablete | 10 mg | pillola miksija b’rita | għall-użu orali |
| Spanja | ANGELINI FARMACEUTICA, S.A. Osi, 7-9 Barcelona. 08034. SPAIN | DALPARAN 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | 10 mg | pillola miksija b’rita | għall-użu orali |
| Spanja | Apotex Europe B.V.
  Darwinweg 20
  NL 2333 CR Leiden
  The Netherlands | ZOLPIDEM APOTEX 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | 10 mg | pillola miksija b’rita | għall-użu orali |
| Spanja | 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 | pillola miksija b’rita | għall-użu orali |
| Spanja | 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 | pillola miksija b’rita | għall-użu orali |
| Spanja | FARMALIDER, S.A. Aragoneses, 2, Alcobendas (Madrid). 28108.SPAIN | ZOLPIDEM FARMALIDER 10 mg COMPRIMIDOS RECUBIERTOS EFG | 10 mg | pillola miksija b’rita | għall-użu orali |
| Spanja | GENERFARMA, S.L. Ronda Isaac Peral, 6 Parque Tecnológico 46980 Paterna (Valencia) SPAIN | ZOLPIDEM DESGEN 5 mg COMPRIMIDOS EFG | 5 mg | pillola | għall-użu orali |
| Spanja | GENERFARMA, S.L. Ronda Isaac Peral, 6 Parque Tecnológico 46980 Paterna (Valencia) SPAIN | ZOLPIDEM DESGEN 10 mg COMPRIMIDOS EFG | 10 mg | pillola | għall-użu orali |
| Spanja | GERMED FARMACEUTICA S.L. Chile, 8 – 2a planta. Oficina 203, Las Matas (Madrid). 28290. SPAIN | ZOLPIDEM EDIGEN 10 mg COMPRIMIDOS RECUBIERTOS EFG | 10 mg | pillola miksija b’rita | għall-użu orali |
| Spanja | LABORATORIO STADA, S.L. Frederic Mompou, 5 , Sant Just Desvern (Barcelona). 08960
  SPAIN | ZOLPIDEM STADA 10 mg COMPRIMIDOS RECUBIERTOS EFG | 10 mg | pillola miksija b’rita | għall-użu orali |
| Spanja | 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 | pillola miksija b’rita | għall-użu orali |
| Spanja | LABORATORIOS NORMON, S.A. Ronda de Valdecarrizo, 6, Tres Cantos (Madrid). 28760. SPAIN | ZOLPIDEM NORMON 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | 10 mg | pillola miksija b’rita | għall-użu orali |
| Spanja | 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 | pillola għal taħt l-ilsien | għall-użu orali |
| Spanja | 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 | pillola għal taħt l-ilsien | għall-użu orali |
| Spanja | MYLAN PHARMACEUTICALS, S.L. Plom 2-4, 5o Planta, Barcelona. 08038. SPAIN | ZOLPIDEM MYLAN 10 mg COMPRIMIDOS RECUBIERTOS EFG | 10 mg | pillola miksija b’rita | għall-użu orali |
| Spanja | PHARMAGENUS, S.A. Avda. Camí Real, 51-57 Palau-solita i Plegamans (Barcelona). 08184. SPAIN | ZOLPIDEM PHARMAGENUS 5 mg COMPRIMIDOS | 5 mg | pillola | għall-użu orali |
| Spanja | PHARMAGENUS, S.A. Avda. Camí Real, 51-57 Palau-solita i Plegamans (Barcelona). 08184. SPAIN | ZOLPIDEM PHARMAGENUS 10 mg COMPRIMIDOS EFG | 10 mg | pillola | għall-użu orali |
| Spanja | 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 | pillola miksija b’rita | għall-użu orali |
| Spanja | 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 | pillola miksija b’rita | għall-użu orali |
| Spanja | 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 | pillola miksija b’rita | għall-użu orali |
| Spanja | SANDOZ FARMACÉUTICA, S.A.
  Avda. Osa Mayor, 4
  28023 Aravaca (Madrid)
  Spain | ZOLPIDEM SANDOZ 10 mg COMPRIMIDOS EFG | 10 mg | pillola | għall-użu orali |
| Spanja | SANOFI AVENTIS, S.A.
  Josep Plá, 2,
  Barcelona. 08019
  SPAIN | STILNOX 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | 10 mg | pillola miksija b’rita | għall-użu orali |
| Spanja | 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 | pillola miksija b’rita | għall-użu orali |
| Spanja | Zentiva, k.s.
  U kabelovny 130
  Prague 10, Dolni Mecholupy
  10237
  Czech Republic | ZOLPIDEM ZENTIVA 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | 10 mg | pillola miksija b’rita | għall-użu orali |
| L-Isvezja | Actavis Group PTC ehf.
  Reykjavikurvegur 76-78
  IS-220 Hafnarfjördur
  Iceland | Zolpidem Actavis | 5 mg | pillola miksija b’rita | għall-użu orali |
| L-Isvezja | Actavis Group PTC ehf.
  Reykjavikurvegur 76-78
  IS-220 Hafnarfjördur
  Iceland | Zolpidem Actavis | 10 mg | pillola miksija b’rita | għall-użu orali |
| L-Isvezja | Hexal A/S
  Edvard Thomsens Vej 14
  DK-2300 Köpenhamn S
  Denmark | Zolpidem HEXAL | 10 mg | pillola miksija b’rita | għall-użu orali |
| L-Isvezja | Ranbaxy (UK) Ltd,
  Building 4
  Chiswick Park
  London W4 5YE
  United Kingdom | Zolpidem Ranbaxy | 5 mg | pillola miksija b’rita | għall-użu orali |
| L-Isvezja | Ranbaxy (UK) Ltd,
  Building 4
  Chiswick Park
  London W4 5YE
  United Kingdom | Zolpidem Ranbaxy | 10 mg | pillola miksija b’rita | għall-użu orali |
| L-Isvezja | Meda AB, Pipers väg 2A, Box 906, SE-170 09, Sweden | Edluar | 5 mg | pillola għal taħt l-ilsien | għall-użu orali |
| L-Isvezja | Meda AB, Pipers väg 2A, Box 906, SE-170 09, Sweden | Edluar | 10 mg | pillola għal taħt l-ilsien | għall-użu orali |
| L-Isvezja | Mylan AB
  Box 23033
  104 35 Stockholm
  Sweden | Zolpidem Mylan | 10 mg | pillola miksija b’rita | għall-użu orali |
| L-Isvezja | Orifarm Generics A/S
  Energivej 15 POB 69
  DK-5260 Odense S
  Denmark | Zolpidem Orifarm | 5 mg | pillola miksija b’rita | għall-użu orali |
| L-Isvezja | Orifarm Generics A/S
  Energivej 15 POB 69
  DK-5260 Odense S
  Denmark | Zolpidem Orifarm | 10 mg | pillola miksija b’rita | għall-użu orali |
| L-Isvezja | ratiopharm GmbH
  Graf Arco Strasse 3
  D-89079 Ulm
  Germany | Zolpidem ratiopharm | 5 mg | pillola miksija b’rita | għall-użu orali |
| L-Isvezja | ratiopharm GmbH
  Graf Arco Strasse 3
  D-89079 Ulm
  Germany | Zolpidem ratiopharm | 10 mg | pillola miksija b’rita | għall-użu orali |
| L-Isvezja | Sandoz A/S
  Edvard Thomsens Vej 14
  DK-2300 Köpenhamn S
  Denmark | Zolpidem Sandoz | 5 mg | pillola miksija b’rita | għall-użu orali |
| L-Isvezja | Sandoz A/S
  Edvard Thomsens Vej 14
  DK-2300 Köpenhamn S
  Denmark | Zolpidem Sandoz | 10 mg | pillola miksija b’rita | għall-użu orali |
| L-Isvezja | sanofi-aventis AB
  Box 14142
  167 14 Bromma
  Sweden | Stilnoct | 5 mg | pillola miksija b’rita | għall-użu orali |
| L-Isvezja | sanofi-aventis AB
  Box 14142
  167 14 Bromma
  Sweden | Stilnoct | 10 mg | pillola miksija b’rita | għall-użu orali |
| L-Isvezja | STADA Arzneimittel AG
  Stadastrasse 2-18
  DE-61118 Bad Vilbel
  Germany | Zolpidem STADA | 5 mg | pillola miksija b’rita | għall-użu orali |
| L-Isvezja | STADA Arzneimittel AG
  Stadastrasse 2-18
  DE-61118 Bad Vilbel
  Germany | Zolpidem STADA | 10 mg | pillola miksija b’rita | għall-użu orali |
| L-Isvezja | Synthon BV, Microweg 22, NL-6545 CM Nijmegen, The Netherlands | Zolpidem Genthon | 5 mg | pillola miksija b’rita | għall-użu orali |
| L-Isvezja | Synthon BV, Microweg 22, NL-6545 CM Nijmegen, The Netherlands | Zolpidem Genthon | 10 mg | pillola miksija b’rita | għall-użu orali |
| L-Isvezja | Vitabalans Oy
  Varastokatu 8
  13500 Hämeenlinna
  Finland | Zolpidem Vitabalans | 10 mg | pillola miksija b’rita | għall-użu orali |
| L-Olanda | Actavis B.V.
  Baarnsche Dijk 1
  3741 LN BAARN
  The Netherlands | Zolpidemtartaat Actavis 5 mg, tabletten | 5 mg | pillola | għall-użu orali |
| L-Olanda | Actavis B.V.
  Baarnsche Dijk 1
  3741 LN BAARN
  The Netherlands | Zolpidemtartraat Actavis 10 mg, tabletten | 10 mg | pillola | għall-użu orali |
| L-Olanda | ADOH B.V.
  Godfried Bomansstraat 31
  6543 JA NIJMEGEN
  The Netherlands | Zolpidemtartraat ADOH bruistabletten 10 mg, bruistabletten | 10 mg | pillola li tfexfex | għall-użu orali |
| L-Olanda | Pharmachemie B.V.
  Swensweg 5
  2031 GA HAARLEM
  The Netherlands | Zolpidemtartraat 5 mg PCH, filmomhulde tabletten | 5 mg | pillola miksija b’rita | għall-użu orali |
| L-Olanda | Pharmachemie B.V.
  Swensweg 5
  2031 GA HAARLEM
  The Netherlands | Zolpidemtartraat 10 mg PCH, filmomhulde tabletten | 10 mg | pillola miksija b’rita | għall-użu orali |
| L-Olanda | ratiopharm Nederland B.V.
  Swensweg 5
  2031 GA HAARLEM
  The Netherlands | Zolpidemtartraat ratiopharm 5 mg, tabletten | 5 mg | pillola | għall-użu orali |
| L-Olanda | ratiopharm Nederland B.V.
  Swensweg 5
  2031 GA HAARLEM
  The Netherlands | Zolpidemtartraat ratiopharm 10 mg, tabletten | 10 mg | pillola | għall-użu orali |
| L-Olanda | ratiopharm Nederland B.V.
  Swensweg 5
  2031 GA HAARLEM
  The Netherlands | Zolpidemtartraat ratiopharm 5 mg, filmomhulde tabletten | 5 mg | pillola miksija b’rita | għall-użu orali |
| L-Olanda | ratiopharm Nederland B.V.
  Swensweg 5
  2031 GA HAARLEM
  The Netherlands | Zolpidemtartraat ratiopharm 10 mg, filmomhulde tabletten | 10 mg | pillola miksija b’rita | għall-użu orali |
| L-Olanda | ratiopharm Nederland B.V.
  Swensweg 5
  2031 GA HAARLEM
  The Netherlands | Zolpidemtartraat ratiopharm 10 mg, filmomhulde tabletten | 10 mg | pillola miksija b’rita | għall-użu orali |
| L-Olanda | Sandoz B.V.
  Veluwezoom 22
  1327 AH ALMERE
  The Netherlands | Zolpidemtartraat Sandoz 10 mg, filmomhulde tabletten | 10 mg | pillola miksija b’rita | għall-użu orali |
| L-Olanda | Sandoz B.V.
  Veluwezoom 22
  1327 AH ALMERE
  The Netherlands | Zolpidemtartraat Sandoz 5, filmomhulde tabletten 5 mg | 5 mg | pillola miksija b’rita | għall-użu orali |
| L-Olanda | Sandoz B.V.
  Veluwezoom 22
  1327 AH ALMERE
  The Netherlands | Zolpidemtartraat Sandoz 10,filmomhulde tabletten 10 mg | 10 mg | pillola miksija b’rita | għall-użu orali |
| L-Olanda | Synthon B.V.
  Microweg 22
  6545 CM NIJMEGEN
  The Netherlands | Zolpidemtartraat 5 mg, filmomhulde tabletten | 5 mg | pillola miksija b’rita | għall-użu orali |
| L-Olanda | Synthon B.V.
  Microweg 22
  6545 CM NIJMEGEN
  The Netherlands | Zolpidemtartraat 10 mg, filmomhulde tabletten | 10 mg | pillola miksija b’rita | għall-użu orali |
| L-Olanda | Synthon B.V.
  Microweg 22
  6545 CM NIJMEGEN
  The Netherlands | Zolpidemtartraat 5 mg, filmomhulde tabletten | 5 mg | pillola miksija b’rita | għall-użu orali |
| L-Olanda | Synthon B.V.
  Microweg 22
  6545 CM NIJMEGEN
  The Netherlands | Zolpidemtartraat 10 mg, filmomhulde tabletten | 10 mg | pillola miksija b’rita | għall-użu orali |
| L-Olanda | Synthon B.V.
  Microweg 22
  6545 CM NIJMEGEN
  The Netherlands | Zolpidemtartraat 5 mg, filmomhulde tabletten | 5 mg | pillola miksija b’rita | għall-użu orali |
| L-Olanda | Synthon B.V.
  Microweg 22
  6545 CM NIJMEGEN
  The Netherlands | Zolpidemtartraat 10 mg, filmomhulde tabletten | 10 mg | pillola miksija b’rita | għall-użu orali |
| L-Olanda | ADOH B.V.
  Godfried Bomansstraat 31
  6543 JA NIJMEGEN
  The Netherlands | Zolpidemtartraat ADOH 10 mg, bruistabletten | 10 mg | pillola li tfexfex | għall-użu orali |
| L-Olanda | Apotex Europe B.V.
  Darwinweg 20
  NL 2333 CR Leiden
  The Netherlands | Zolpidemtartraat Apotex 5 mg, filmomhulde tabletten | 5 mg | pillola miksija b’rita | għall-użu orali |
| L-Olanda | Apotex Europe B.V.
  Darwinweg 20
  NL 2333 CR Leiden
  The Netherlands | Zolpidemtartraat Apotex 10 mg, filmomhulde tabletten | 10 mg | pillola miksija b’rita | għall-użu orali |
| L-Olanda | Centrafarm B.V.
  Nieuwe Donk 3
  4879 AC ETTEN LEUR
  The Netherlands | Zolpidemtartraat CF 5 mg, film-omhulde tabletten | 5 mg | pillola miksija b’rita | għall-użu orali |
| L-Olanda | Centrafarm B.V.
  Nieuwe Donk 3
  4879 AC ETTEN LEUR
  The Netherlands | Zolpidemtartraat CF 10 mg, film-omhulde tabletten | 10 mg | pillola miksija b’rita | għall-użu orali |
| L-Olanda | Eurogenerics S.A.
  Esplanade Heysel, b22
  1020 Bruxelles
  Belgium | Zolpidem Eurogenerics bruis 10 mg bruistabletten, bruistabletten | 10 mg | pillola li tfexfex | għall-użu orali |
| L-Olanda | FIDIA Farmaceutici S.p.a.
  Via Ponte della Fabbrica, 3/a, Abano Terme, Padova – 35031 Italy | Zolpidemtartraat 10 mg, filmomhulde tabletten | 10 mg | pillola miksija b’rita | għall-użu orali |
| L-Olanda | Genthon BV
  Microweg, 22
  6545 Nijmegen
  The Netherlands | Zolpidemtartraat 5 mg, filmomhulde tabletten | 5 mg | pillola miksija b’rita | għall-użu orali |
| L-Olanda | Genthon BV
  Microweg, 22
  6545 Nijmegen
  The Netherlands | Zolpidemtartraat 10 mg, filmomhulde tabletten | 10 mg | pillola miksija b’rita | għall-użu orali |
| L-Olanda | Meda Pharma B.V.
  Krijgsman 20
  1186 DM AMSTELVEEN
  The Netherlands | Edluar 5 mg, tablet voor sublinguaal gebruik | 5 mg | pillola għal taħt l-ilsien | għall-użu minn taħt l-ilsien |
| L-Olanda | Meda Pharma B.V.
  Krijgsman 20
  1186 DM AMSTELVEEN
  The Netherlands | Edluar 10 mg, tablet voor sublinguaal gebruik | 10 mg | pillola għal taħt l-ilsien | għall-użu minn taħt l-ilsien |
| L-Olanda | Mylan B.V.
  Dieselweg 25
  3752 LB BUNSCHOTEN
  The Netherlands | Zolpidemtartraat Mylan 10 mg, filmomhulde tabletten | 10 mg | pillola miksija b’rita | għall-użu orali |
| L-Olanda | Pharmachemie B.V.
  Swensweg 5
  2031 GA HAARLEM
  The Netherlands | Zolpidemtartraat 5 PCH, filmomhulde tabletten 5 mg | 5 mg | pillola miksija b’rita | għall-użu orali |
| L-Olanda | Pharmachemie B.V.
  Swensweg 5
  2031 GA HAARLEM
  The Netherlands | Zolpidemtartraat 10 PCH, filmomhulde tabletten 10 mg | 10 mg | pillola miksija b’rita | għall-użu orali |
| L-Olanda | Sanofi-Aventis Netherlands B.V.
  Kampenringweg 45 D-E
  2803 PE GOUDA
  The Netherlands | Stilnoct, tabletten 10 mg | 10 mg | pillola | għall-użu orali |
| L-Olanda | STADA Arzneimittel AG
  Stadastrasse 2-18
  DE-61118 Bad Vilbel
  Germany | Zolpidemtartraat Stada 5 mg, filmomhulde tabletten | 5 mg | pillola miksija b’rita | għall-użu orali |
| L-Olanda | STADA Arzneimittel AG
  Stadastrasse 2-18
  DE-61118 Bad Vilbel
  Germany | Zolpidemtartraat Stada 10 mg, filmomhulde tabletten | 10 mg | pillola miksija b’rita | għall-użu orali |
| L-Olanda | Synthon B.V.
  Microweg 22
  6545 CM NIJMEGEN
  The Netherlands | Zolpidemtartraat 10 mg, filmomhulde tabletten | 10 mg | pillola miksija b’rita | għall-użu orali |
| Ir-Renju Unit | Actavis UK Limited, Whiddon Valley, Barnstaple, North Devon EX32 8NS
  United Kingdom | Zolpidem Tartrate 5 mg tablets | 5 mg | pillola miksija b’rita | għall-użu orali |
| Ir-Renju Unit | Actavis UK Limited, Whiddon Valley, Barnstaple, North Devon EX32 8NS
  United Kingdom | Zolpidem Tartrate 10 mg tablets | 10 mg | pillola miksija b’rita | għall-użu orali |
| Ir-Renju Unit | ALKALOID-INT d.o.o.
  Šlandrova ulica 4
  1231 Ljubljana-Črnuče Slovenia | Zolpidem Tartrate 5 mg film-coated tablets | 5 mg | pillola miksija b’rita | għall-użu orali |
| Ir-Renju Unit | ALKALOID-INT d.o.o.
  Šlandrova ulica 4
  1231 Ljubljana-Črnuče Slovenia | Zolpidem Tartrate 10 mg film-coated tablets | 10 mg | pillola miksija b’rita | għall-użu orali |
| Ir-Renju Unit | Aventis Pharma Limited, One Onslow Street, Guildford, Surrey GU1 4SY
  United Kingdom | Stilnoct 5 mg fiilm-coated tablets | 5 mg | pillola miksija | għall-użu orali |
| Ir-Renju Unit | Aventis Pharma Limited, One Onslow Street, Guildford, Surrey GU1 4SY
  United Kingdom | Stilnoct 10 mg film-coated tablets | 10 mg | pillola miksija | għall-użu orali |
| Ir-Renju Unit | Bristol Laboratories Limited, Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire HP4 1EG
  United Kingdom | Zolpidem Tartrate 5 mg film-coated tablets | 5 mg | pillola miksija b’rita | għall-użu orali |
| Ir-Renju Unit | Bristol Laboratories Limited, Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire HP4 1EG
  United Kingdom | Zolpidem Tartrate 10 mg film-coated tablets | 10 mg | pillola miksija b’rita | għall-użu orali |
| Ir-Renju Unit | Generics [UK] Ltd.
  Station Close
  EN6 1TL Hertfordshire – Potters Bar
  United Kingdom | Zolpidem 10 mg film-coated tablets | 10 mg | pillola miksija b’rita | għall-użu orali |
| Ir-Renju Unit | Meda Pharmaceuticals Limited, Skyway House, Parsonage Road, Takeley, Bishops Stortford CM22 6PU
  United Kingdom | Edluar 5 mg sublingual tablets | 5 mg | pillola għal taħt l-ilsien | għall-użu orali |
| Ir-Renju Unit | Meda Pharmaceuticals Limited, Skyway House, Parsonage Road, Takeley, Bishops Stortford CM22 6PU
  United Kingdom | Edluar 10 mg sublingual tablets | 10 mg | pillola għal taħt l-ilsien | għall-użu orali |
| Ir-Renju Unit | Amneal Pharma Europe Limited, 70 Sir John Rogerson's Quay, Dublin 2, Ireland | Zolpidem Tartrate 5 mg film-coated tablets | 5 mg | pillola miksija b’rita | għall-użu orali |
| Ir-Renju Unit | Amneal Pharma Europe Limited, 70 Sir John Rogerson's Quay, Dublin 2, Ireland | Zolpidem Tartrate 10 mg film-coated tablets | 10 mg | pillola miksija b’rita | għall-użu orali |
| Ir-Renju Unit | ratiopharm GmbH
  Graf Arco Strasse 3
  D-89079 Ulm
  Germany | Zolpidem Tartrate 5 mg film-coated tablets | 5 mg | pillola miksija b’rita | għall-użu orali |
| Ir-Renju Unit | ratiopharm GmbH
  Graf Arco Strasse 3
  D-89079 Ulm
  Germany | Zolpidem Tartrate 10 mg film-coated tablets | 10 mg | pillola miksija b’rita | għall-użu orali |
| Ir-Renju Unit | Sandoz Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR
  United Kingdom | Zolpidem Tartrate 10 mg tablets | 10 mg | pillola miksija b’rita | għall-użu orali |
| Ir-Renju Unit | Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex BN22 9AG
  United Kingdom | Zolpidem Tartrate 5 mg, film-coated tablets | 5 mg | pillola miksija b’rita | għall-użu orali |
| Ir-Renju Unit | Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex BN22 9AG
  United Kingdom | Zolpidem Tartrate 10 mg, film-coated tablets | 10 mg | pillola miksija b’rita | għall-użu orali |
| Ir-Renju Unit | Tillomed Laboratories Limited, 3 Howard Road, Eaton Socon, St Neots, Cambridgeshire PE19 8ET
  United Kingdom | Zolpidem 10 mg film-coated tablets | 10 mg | pillola miksija b’rita | għall-użu orali |
| Ir-Renju Unit | Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS
  United Kingdom | Zolpidem Tartrate 5 mg tablets | 5 mg | pillola miksija b’rita | għall-użu orali |
| Ir-Renju Unit | Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS
  United Kingdom | Zolpidem Tartrate 10 mg tablets | 10 mg | pillola miksija b’rita | għall-użu orali |

Stat Membru EU/EEA

Id-Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Isem tal-prodott

Qawwa

Għamla farmaċewtika

Mnejn jingħata

L-Awstrija

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

Zoldem 5 mg – Filmtabletten

5 mg

pillola miksija b’rita

għall-użu orali

L-Awstrija

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

Zoldem 10 mg – Filmtabletten

10 mg

pillola miksija b’rita

għall-użu orali

L-Awstrija

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

Zolpidem G.L. 10 mg – Filmtabletten

10 mg

pillola miksija b’rita

għall-użu orali

L-Awstrija

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

Zolpidem “Hexal” – Filmtabletten

10 mg

pillola miksija b’rita

għall-użu orali

L-Awstrija

Meda Pharma GmbH, Guglgasse 15, 1110 Wien, Austria

Edluar 5 mg Sublingualtabletten

5 mg

pillola għal taħt l-ilsien

għall-użu minn taħt l-ilsien

L-Awstrija

Meda Pharma GmbH, Guglgasse 15, 1110 Wien, Austria

Edluar 10 mg Sublingualtabletten

10 mg

pillola għal taħt l-ilsien

għall-użu minn taħt l-ilsien

L-Awstrija

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

Zolpidem “ratiopharm” 10 mg Filmtabletten

10 mg

pillola miksija b’rita

għall-użu orali

L-Awstrija

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

Ivadal – Filmtabletten

10 mg

pillola miksija b’rita

għall-użu orali

L-Awstrija

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

Mondeal 10 mg – Filmtabletten

10 mg

pillola miksija b’rita

għall-użu orali

Il-Belġju

APOTEX NV

Av. du Bourg. Etienne Demunter 5 box 8

1090 Jette

Belgium

Zolpitop

10 mg

pillola miksija b’rita

għall-użu orali

Il-Belġju

APOTEX NV

Av. du Bourg. Etienne Demunter 5 box 8

1090 Jette

Belgium

Zolpitop

5 mg

pillola miksija b’rita

għall-użu orali

Il-Belġju

Eurogenerics S.A.

Esplanade Heysel, b22

1020 Bruxelles

Belgium

Zolpidem EG

10 mg

pillola miksija b’rita

għall-użu orali

Il-Belġju

Eurogenerics S.A.

Esplanade Heysel, b22

1020 Bruxelles

Belgium

Zolpidem EG

10 mg

pillola li tfexfex

għall-użu orali

Il-Belġju

Ipca, Produtos Farmaceuticos, Unipessoal Lda

Rua Chanceler-Mor 11 R/c Frt.

Cacem

2735-615

Portugal

Zolpidem IPCA

5 mg

pillola miksija b’rita

għall-użu orali

Il-Belġju

Ipca, Produtos Farmaceuticos, Unipessoal Lda

Rua Chanceler-Mor 11 R/c Frt.

Cacem

2735-615

Portugal

Zolpidem IPCA

10 mg

pillola miksija b’rita

għall-użu orali

Il-Belġju

MEDA PHARMA

Chaussee de la Hulpe 166

1170 Watermael-Boitsfort

Belgium

Zolpeduar

5 mg

pillola għal taħt l-ilsien

għall-użu orali

Il-Belġju

MEDA PHARMA

Chaussee de la Hulpe 166

1170 Watermael-Boitsfort

Belgium

Zolpeduar

10 mg

pillola għal taħt l-ilsien

għall-użu orali

Il-Belġju

MYLAN BVBA/SPRL

Terhulpsesteenweg 6A

1560 Hoeilaart

Belgium

Zolpidem Mylan

10 mg

pillola miksija b’rita

għall-użu orali

Il-Belġju

SANDOZ N.V.

Telecom Gardens

Medialaan 40

1800 1800ilvoorde

Belgium

Zolpidem Sandoz

10 mg

pillola miksija b’rita

għall-użu orali

Il-Belġju

SANOFI BELGIUM

Airport Plaza, Montreal Building, Leonardo Da Vincilaan 19

1831 Diegem

Belgium

Stilnoct

10 mg

pillola

għall-użu orali

Il-Belġju

SANOFI BELGIUM

Airport Plaza, Montreal Building, Leonardo Da Vincilaan 19

1831 Diegem

Belgium

Zolpidem Sanofi-Aventis Belgium

10 mg

pillola miksija b’rita

għall-użu orali

Il-Belġju

TEVA PHARMA BELGIUM NV

Laarstraat 16

2610 Wilrijk

Belgium

Zolpidem Teva

10 mg

pillola miksija b’rita

għall-użu orali

Il-Belġju

TEVA PHARMA BELGIUM NV

Laarstraat 16

2610 Wilrijk

Belgium

Zolpidem Ratiopharm

10 mg

pillola miksija b’rita

għall-użu orali

Il-Bulgarija

ALKALOID-INT d.o.o.

Šlandrova ulica 4

1231 Ljubljana-Črnuče Slovenia

Adorma

5 mg

pillola miksija b’rita

għall-użu orali

Il-Bulgarija

ALKALOID-INT d.o.o.

Šlandrova ulica 4

1231 Ljubljana-Črnuče Slovenia

Adorma

10 mg

pillola miksija b’rita

għall-użu orali

Il-Bulgarija

Krka, d.d., Novo mesto

Šmarješka cesta 6

8000 Novo mesto

Slovenia

Zolsana

5 mg

pillola miksija b’rita

għall-użu orali

Il-Bulgarija

Krka, d.d., Novo mesto

Šmarješka cesta 6

8000 Novo mesto

Slovenia

Zolsana

10 mg

pillola miksija b’rita

għall-użu orali

Il-Bulgarija

Meda Pharma GmbH & Co. KG

Benzstrasse 1

Bad Homburg v.d.H

61352

Germany

Edluar

5 mg

pillola għal taħt l-ilsien

għall-użu minn taħt l-ilsien

Il-Bulgarija

Meda Pharma GmbH & Co. KG

Benzstrasse 1

Bad Homburg v.d.H

61352

Germany

Edluar

10 mg

pillola għal taħt l-ilsien

għall-użu minn taħt l-ilsien

Il-Bulgarija

Sanofi-Aventis Bulgaria EOOD,

103 Alexander Stamboliiski Blvd. Building Sofia Tower

Sofia 1303

Bulgaria

Stilnox

10 mg

pillola miksija b’rita

għall-użu orali

Il-Kroazja

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

Lunata 5 mg filmom obložene tablete

5 mg

pillola miksija b’rita

għall-użu orali

Il-Kroazja

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

Lunata 10 mg filmom obložene tablete

10 mg

pillola miksija b’rita

għall-użu orali

Il-Kroazja

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

Zolsana 5 mg filmom obložene tablete

5 mg

pillola miksija b’rita

għall-użu orali

Il-Kroazja

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

Zolsana 10 mg filmom obložene tablete

10 mg

pillola miksija b’rita

għall-użu orali

Il-Kroazja

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

Zonadin 5 mg tablete

5 mg

pillola miksija b’rita

għall-użu orali

Il-Kroazja

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

Zonadin 10 mg tablete

10 mg

pillola miksija b’rita

għall-użu orali

Il-Kroazja

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

Sanval 5 mg filmom obložene tablete

5 mg

pillola miksija b’rita

għall-użu orali

Il-Kroazja

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

Sanval 10 mg filmom obložene tablete

10 mg

pillola miksija b’rita

għall-użu orali

Ċipru

Sanofi-Aventis Cyprus Ltd

Charalambou Mouskou 14

Lefkosia 2015 Cyprus

Stilnox

10 mg

pillola miksija b’rita

għall-użu orali

Ir-Repubblika Ċeka

ALKALOID-INT d.o.o.

Šlandrova ulica 4

1231 Ljubljana-Črnuče Slovenia

ADORMA 5 MG

5 mg

pillola miksija b’rita

għall-użu orali

Ir-Repubblika Ċeka

ALKALOID-INT d.o.o.

Šlandrova ulica 4

1231 Ljubljana-Črnuče Slovenia

ADORMA 10 MG

10 mg

pillola miksija b’rita

għall-użu orali

Ir-Repubblika Ċeka

Apotex Europe B.V.

Darwinweg 20

NL 2333 CR Leiden

Netherlands

APO-ZOLPIDEM 10 MG

10 mg

pillola miksija b’rita

għall-użu orali

Ir-Repubblika Ċeka

Generics [UK] Ltd.

Station Close

EN6 1TL Hertfordshire – Potters Bar

United Kingdom

ZOLPIDEM MYLAN

10 mg

pillola miksija b’rita

għall-użu orali

Ir-Repubblika Ċeka

Krka, d.d., Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

ZOLSANA 10 MG

10 mg

pillola miksija b’rita

għall-użu orali

Ir-Repubblika Ċeka

MEDA Pharma s.r.o.

Kodaňská 1441/46

110 00 Prague 10

Czech Republic

EDLUAR 5 MG SUBLINGVÁLNÍ TABLETY

5 mg

pillola għal taħt l-ilsien

għall-użu minn taħt l-ilsien

Ir-Repubblika Ċeka

MEDA Pharma s.r.o.

Kodaňská 1441/46

110 00 Prague 10

Czech Republic

EDLUAR 10 MG SUBLINGVÁLNÍ TABLETY

10 mg

pillola għal taħt l-ilsien

għall-użu minn taħt l-ilsien

Ir-Repubblika Ċeka

Orion Corporation

Orionintie 1/A

FI-02200 Espoo

Finland

ZOLPIDEM ORION 10 MG

10 mg

pillola miksija b’rita

għall-użu orali

Ir-Repubblika Ċeka

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

ZOLPIDEM-RATIOPHARM 10 MG

10 mg

pillola miksija b’rita

għall-użu orali

Ir-Repubblika Ċeka

SANDOZ s.r.o.

U nákladového nádraží 3265/10

130 00 Prague 3

Czech Republic

SANVAL 10 MG

10 mg

pillola miksija b’rita

għall-użu orali

Ir-Repubblika Ċeka

sanofi-aventis, s.r.o.

Evropská 846/176a

160 00 Prague 6 – Vokovice

Czech Republic

STILNOX

10 mg

pillola miksija b’rita

għall-użu orali

Ir-Repubblika Ċeka

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

500 02 Hradec Králové Czech Republic

ZOLPINOX

10 mg

pillola miksija b’rita

għall-użu orali

Ir-Repubblika Ċeka

Takeda GmbH

Byk-Gulden-Str. 2

78467 Konstanz

Germany

HYPNOGEN

10 mg

pillola miksija b’rita

għall-użu orali

Ir-Repubblika Ċeka

Vitabalans Oy

Varastokatu 8

13500 Hämeenlinna

Finland

ZOLPIDEM VITABALANS 10 MG POTAHOVANÉ TABLETY

10 mg

pillola miksija b’rita

għall-użu orali

Id-Danimarka

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

IS-220 Hafnarfjördur

Iceland

Zolpidem “Actavis”

10 mg

pillola miksija b’rita

għall-użu orali

Id-Danimarka

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

IS-220 Hafnarfjördur

Iceland

Zolpidem “Actavis”

5 mg

pillola miksija b’rita

għall-użu orali

Id-Danimarka

Generics [UK] Ltd.

Station Close

EN6 1TL Hertfordshire – Potters Bar

United Kingdom

Zolpidem “Generics”

10 mg

pillola miksija b’rita

għall-użu orali

Id-Danimarka

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

Zolpidem “Hexal”

10 mg

pillola miksija b’rita

għall-użu orali

Id-Danimarka

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

Edluar

5 mg

pillola għal taħt l-ilsien

għall-użu minn taħt l-ilsien

Id-Danimarka

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

Edluar

10 mg

pillola għal taħt l-ilsien

għall-użu minn taħt l-ilsien

Id-Danimarka

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

Zonoct

10 mg

pillola miksija b’rita

għall-użu orali

Id-Danimarka

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

Stilnoct

10 mg

pillola miksija b’rita

għall-użu orali

Id-Danimarka

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

Zolpidem “Genthon”

5 mg

pillola miksija b’rita

għall-użu orali

Id-Danimarka

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

Zolpidem “Genthon”

10 mg

pillola miksija b’rita

għall-użu orali

Id-Danimarka

Vitabalans Oy

Varastokatu 8

13500 Hämeenlinna

Finland

Zolpidem “Vitabalans”

10 mg

pillola miksija b’rita

għall-użu orali

L-Estonja

Krka, d.d., Novo mesto

Šmarješka cesta 6

8000 Novo mesto

Slovenia

ZOLSANA

5 mg

pillola

għall-użu orali

L-Estonja

Krka, d.d., Novo mesto

Šmarješka cesta 6

8000 Novo mesto

Slovenia

ZOLSANA

10 mg

pillola

għall-użu orali

L-Estonja

Meda Pharma GmbH & Co. KG

Benzstrasse 1

Bad Homburg v.d.H

61352

Germany

EDLUAR

5 mg

pillola għal taħt l-ilsien

għall-użu orali

L-Estonja

Meda Pharma GmbH & Co. KG

Benzstrasse 1

Bad Homburg v.d.H

61352

Germany

EDLUAR

10 mg

pillola għal taħt l-ilsien

għall-użu orali

L-Estonja

Sandoz d.d.

Verovškova 57,

1000 Ljubljana,

Slovenia

ZOLPIDEM SANDOZ 10 MG

10 mg

pillola

għall-użu orali

L-Estonja

Sanofi-Aventis Estonia OÜ Pärnu mnt 139E/2

11317 Tallinn

Estonia

STILNOX

10 mg

pillola

għall-użu orali

L-Estonja

Takeda GmbH 2 Byk-Gulden Strasse

78467 Konstanz Germany

HYPNOGEN

10 mg

pillola

għall-użu orali

L-Estonja

Vitabalans Oy

Varastokatu 8

13500 Hämeenlinna

Finland

ZOLPIDEM VITABALANS 10 MG

10 mg

pillola

għall-użu orali

Il-Finlandja

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

IS-220 Hafnarfjördur

Iceland

Stella

5 mg

pillola miksija b’rita

għall-użu orali

Il-Finlandja

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

IS-220 Hafnarfjördur

Iceland

Stella

10 mg

pillola miksija b’rita

għall-użu orali

Il-Finlandja

Hexal A/S

Edvard Thomsens Vej 14

DK-2300 Köpenhamn S

Denmark

Zolpidem Hexal

10 mg

pillola miksija b’rita

għall-użu orali

Il-Finlandja

Meda Oy

Vaisalantie 4

02130 Espoo

Finland

Edluar

5 mg

pillola għal taħt l-ilsien

għall-użu minn taħt l-ilsien

Il-Finlandja

Meda Oy

Vaisalantie 4

02130 Espoo

Finland

Edluar

10 mg

pillola għal taħt l-ilsien

għall-użu minn taħt l-ilsien

Il-Finlandja

Orion Corporation

Orionintie 1/A

FI-02200 Espoo

Finland

Somnor

10 mg

pillola miksija b’rita

għall-użu orali

Il-Finlandja

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Zolpidem-Ratiopharm

10 mg

pillola miksija b’rita

għall-użu orali

Il-Finlandja

Sanofi Oy

Huopalahdentie 24

P.O.Box 22

00350 Helsinki

Finland

Stilnoct

10 mg

pillola miksija b’rita

għall-użu orali

Il-Finlandja

Vitabalans Oy

Varastokatu 8

13500 Hämeenlinna

Finland

Zolpidem Vitabalans

10 mg

pillola miksija b’rita

għall-użu orali

Franza

LABORATOIRES ALTER

3, avenue de la Baltique

ZI de Courtaboeuf

91140 Villebon Sur Yvette France

ZOLPIDEM ALTER

10 mg

pillola miksija b’rita

għall-użu orali

Franza

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

IS-220 Hafnarfjördur

Iceland

ZOLPIDEM ACTAVIS

10 MG

pillola miksija b’rita

għall-użu orali

Franza

ARROW GENERIQUES

26, avenue Tony Garnier

69007 Lyon France

ZOLPIDEM ARROW

10 mg

pillola miksija b’rita

għall-użu orali

Franza

BIOGARAN

15, boulevard Charles de Gaulle

92700 Colombes FRANCE

ZOLPIDEM ALMUS

10 mg

pillola miksija b’rita

għall-użu orali

Franza

BIOGARAN

15, boulevard Charles de Gaulle

92700 Colombes FRANCE

ZOLPIDEM BIOGARAN

10 mg

pillola miksija b’rita

għall-użu orali

Franza

CRISTERS

22 quai Gallieni

92150 Suresnes France

ZOLPIDEM CRISTERS

10 mg

pillola miksija b’rita

għall-użu orali

Franza

CTRS

Route de la Ganne

36170 Saint Benoit du Sault France

ZOLPIDEM CTRS

10 mg

pillola miksija b’rita

għall-użu orali

Franza

EG LABO – LABORATOIRES EUROGENERICS

“Le Quintet” – bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex France

ZOLPIDEM EG

10 mg

pillola miksija b’rita

għall-użu orali

Franza

EG LABO – LABORATOIRES EUROGENERICS

“Le Quintet” – bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex France

ZOLPIDEM EG

10 mg

pillola miksija

għall-użu orali

Franza

Genfarma B.V.

Postbus 2062

1500 GB Zaandam

The Netherlands

ZOLPIDEM RATIOPHARM

10 mg

pillola miksija

għall-użu orali

Franza

Kiron Pharmaceutica BV

Groesbeekseweg 11 Nijmegen, 6524 CK

The Netherlands

ZOLPIDEM KIRION

5 mg

pillola miksija b’rita

għall-użu orali

Franza

MEDA PHARMA

25, boulevard de l'Amiral Bruix

75016 Paris

FRANCE

EDLUAR

5 mg

pillola għal taħt l-ilsien

għall-użu orali

Franza

MEDA PHARMA

25, boulevard de l'Amiral Bruix

75016 Paris

FRANCE

EDLUAR

10 mg

pillola għal taħt l-ilsien

għall-użu orali

Franza

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

France

ZOLPIDEM MYLAN

10 mg

pillola miksija b’rita

għall-użu orali

Franza

PHARMACHEMIE BV

Swensweg 5 – Haarlem

PO Box 552

2003 RN Haarlem PAYS-BAS

The Netherlands

ZOLPIDEM TEVA

10 mg

pillola miksija

għall-użu orali

Franza

RANBAXY PHARMACIE GENERIQUES

11-15 Quai Dion Bouton

92800 Puteaux FRANCE

ZOLPIDEM RPG

10 mg

pillola miksija b’rita

għall-użu orali

Franza

RATIOPHARM GMBH

Graf Arco Strasse 3

89079 Ulm ALLEMAGNE

ZOLPIDEM RATIOPHARM

10 mg

pillola miksija b’rita

għall-użu orali

Franza

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret France

ZOLPIDEM GNR

10 mg

pillola miksija b’rita

għall-użu orali

Franza

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret France

ZOLPIDEM GENERES

10 mg

pillola miksija b’rita

għall-użu orali

Franza

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret France

ZOLPIDEM SANDOZ

10 mg

pillola miksija b’rita

għall-użu orali

Franza

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

France

STILNOX

10 mg

pillola miksija b’rita

għall-użu orali

Franza

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris France

ZOLPIDEM ZENTIVA

10 mg

pillola miksija b’rita

għall-użu orali

Franza

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

ZOLPIDEM BAYER

10 mg

pillola miksija b’rita

għall-użu orali

Franza

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

ZOLPIDEM BAYER

5 mg

pillola miksija b’rita

għall-użu orali

Franza

TEVA SANTE

110, Esplanade du Général de Gaulle

92931 Paris La Défense Cedex FRANCE

ZOLPIDEM TEVA

10 mg

pillola miksija b’rita

għall-użu orali

Franza

ZYDUS FRANCE

25, rue des Peupliers

ZAC Les Hautes Pâtures – Parc d’Activités des Peupliers

92000 Nanterre FRANCE

ZOLPIDEM ZYDUS

10 mg

pillola miksija b’rita

għall-użu orali

Il-Ġermanja

1 A Pharma

Keltenring 1 + 3

82041 Oberhaching

Germany

Zolpidem 10 – 1A-Pharma

10 mg

pillola miksija b’rita

għall-użu orali

Il-Ġermanja

AbZ-Pharma GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Zolpidem AbZ 10 mg Filmtabletten

10 mg

pillola miksija b’rita

għall-użu orali

Il-Ġermanja

Actavis Deutschland GmbH & Co.KG

Willy-Brandt-Allee 2

81829 München

Germany

Zolpidem-Actavis 10 mg Filmtabletten

10 mg

pillola miksija b’rita

għall-użu orali

Il-Ġermanja

Aliud Pharma GmbH

Gottlieb-Daimler-Str. 19

89150 Laichingen

Germany

Zolpidem AL 10 mg Filmtabletten

10 mg

pillola miksija b’rita

għall-użu orali

Il-Ġermanja

Aliud Pharma GmbH

Gottlieb-Daimler-Str. 19

89150 Laichingen

Germany

Zolpidem AL 5 mg Filmtabletten

5 mg

pillola miksija b’rita

għall-użu orali

Il-Ġermanja

Aristo Pharma GmbH

Wallenroder Str. 8-10

13435 Berlin

Germany

Zolpidem Aristo 10 mg Filmtabletten

10 mg

pillola miksija b’rita

għall-użu orali

Il-Ġermanja

AbZ-Pharma GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Zolpidem-CT 10 mg Filmtabletten

10 mg

pillola miksija b’rita

għall-użu orali

Il-Ġermanja

AbZ-Pharma GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Zolpidem-CT 5 mg Filmtabletten

5 mg

pillola miksija b’rita

għall-użu orali

Il-Ġermanja

Dolorgiet GmbH & Co.KG

Otto-von-Guericke-Str. 1

53757 Sankt Augustin

Germany

Zolpidem real 10 mg Filmtabletten

10 mg

pillola miksija b’rita

għall-użu orali

Il-Ġermanja

Heumann Pharma GmbH & Co. Generica KG

Südwestpark 50

90449 Nürnberg

Germany

Zolpidem Heumann 10 mg Filmtabletten

10 mg

pillola miksija b’rita

għall-użu orali

Il-Ġermanja

Heumann Pharma GmbH & Co. Generica KG

Südwestpark 50

90449 Nürnberg

Germany

Zolpidem Heumann 5 mg Filmtabletten

5 mg

pillola miksija b’rita

għall-użu orali

Il-Ġermanja

Hexal Aktiengesellschaft

Industriestr. 25

83607 Holzkirchen

Germany

Zolpidem Hexal 10 mg Filmtabletten

10 mg

pillola miksija b’rita

għall-użu orali

Il-Ġermanja

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

pillola miksija b’rita

għall-użu orali

Il-Ġermanja

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

pillola miksija b’rita

għall-użu orali

Il-Ġermanja

Juta Pharma GmbH

Gutenbergstr. 13

24941 Flensburg

Germany

Zolpi-Q 10 mg Filmtabletten

10 mg

pillola miksija b’rita

għall-użu orali

Il-Ġermanja

Krewel Meuselbach GmbH

Krewelstr. 2

53783 Eitorf

Germany

Zolpinox 10 mg

10 mg

pillola miksija b’rita

għall-użu orali

Il-Ġermanja

Meda Pharma GmbH & Co. KG

Benzstrasse 1

Bad Homburg v.d.H

61352

Germany

Edluar 10 mg Sublingualtabletten

10 mg

pillola għal taħt l-ilsien

għall-użu orali

Il-Ġermanja

Meda Pharma GmbH & Co. KG

Benzstrasse 1

Bad Homburg v.d.H

61352

Germany

Edluar 5 mg Sublingualtabletten

5 mg

pillola għal taħt l-ilsien

għall-użu orali

Il-Ġermanja

Mylan dura GmbH

Wittichstr. 6

64295 Darmstadt

Germany

Zolpidem dura 10 mg Filmtabletten

10 mg

pillola miksija b’rita

għall-użu orali

Il-Ġermanja

neuraxpharm Arzneimittel GmbH

Elisabeth-Selbert-Str. 23

40764 Langenfeld

Germany

Zolpidem-neuraxpharm 10 mg Filmtabletten

10 mg

pillola miksija b’rita

għall-użu orali

Il-Ġermanja

neuraxpharm Arzneimittel GmbH

Elisabeth-Selbert-Str. 23

40764 Langenfeld

Germany

Zolpidem-neuraxpharm 5 mg Filmtabletten

5 mg

pillola miksija b’rita

għall-użu orali

Il-Ġermanja

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Zolpidem-ratiopharm 10 mg Filmtabletten

10 mg

pillola miksija b’rita

għall-użu orali

Il-Ġermanja

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Zolpidem-ratiopharm 5 mg Filmtabletten

5 mg

pillola miksija b’rita

għall-użu orali

Il-Ġermanja

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

83607 Holzkirchen

Germany

Zolpidem Sandoz 10 mg Filmtabletten

10 mg

pillola miksija b’rita

għall-użu orali

Il-Ġermanja

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst, Gebäude K703

65926 Frankfurt am Main

Germany

Bikalm

10 mg

pillola miksija b’rita

għall-użu orali

Il-Ġermanja

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst, Gebäude K703

65926 Frankfurt am Main

Germany

Stilnox

10 mg

pillola miksija b’rita

għall-użu orali

Il-Ġermanja

Stadapharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

Zolpidem STADA 10 mg Filmtabletten

10 mg

pillola miksija b’rita

għall-użu orali

Il-Ġermanja

Stadapharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

Zolpidem STADA 5 mg Filmtabletten

5 mg

pillola miksija b’rita

għall-użu orali

Il-Ġermanja

TAD Pharma GmbH

Heinz-Lohmann-Str. 5

27472 Cuxhaven

Germany

Zolpidem TAD 10 mg

10 mg

pillola miksija b’rita

għall-użu orali

Il-Ġermanja

Vitabalans Oy

Varastokatu 8

13500 Hämeenlinna

Finland

Zolpidem Vitabalans 10 mg Filmtabletten

10 mg

pillola miksija b’rita

għall-użu orali

Il-Ġermanja

Winthrop Arzneimittel GmbH

Brüningstr. 50

65926 Frankfurt am Main

Germany

Zolpi-Lich 10 mg Filmtabletten

10 mg

pillola miksija b’rita

għall-użu orali

Il-Greċja

IOULIA AND IRENE TSETI PHARMACEUTICAL LABORATORIES ABEE, INTERMED ABEE,

Kalyftaki 27, Kifissia 14564

Greece

HYPNONORM

10 mg

pillola miksija b’rita

għall-użu orali

Il-Greċja

ITF HELLAS S.A.

Areos 103 and Ag. Triados 36, Palaio Faliro 17562

Greece

ONIRIA

10 mg/ml

qtar orali, soluzzjoni

għall-użu orali

Il-Greċja

ITF PHARMA KERESKEDELMI ES SZOLGALTATO KFT, BUDAPEST, HUNGAR

H-1056, Budapest

Duna u.1

Hungary

KALINICTA

10 mg/ml

qtar orali, soluzzjoni

għall-użu orali

Il-Greċja

SANOFI-AVENTIS AEBE

348 SYNGROU AVENUE, BUILDING A, KALLITHEA 17674

Greece

STILNOX

10 mg

pillola miksija b’rita

għall-użu orali

L-Ungerija

EGIS Gyógyszergyár Nyrt. Keresztúri út 30-38.

Budapest

1106

Hungary

PIDEZOL 10 mg filmtabletta

10 mg

pillola miksija b’rita

għall-użu orali

L-Ungerija

ExtractumPharma zRt.

Megyeri út 64.

Budapest

1044

Hungary

ZOLEP 10 mg filmtabletta

10 mg

pillola miksija b’rita

għall-użu orali

L-Ungerija

Generics (UK) Ltd.

Albany Gate, Darkes Lane, Potters bar Herts EN61AG

United Kingdom

SOMNOGEN 10 mg filmtabletta

10 mg

pillola miksija b’rita

għall-użu orali

L-Ungerija

ITF Pharma Kft Duna u. 1. Budapest 1056 Hungary

ONIRIA 10 mg/ml belsőleges oldatos cseppek

10 mg/ml

qtar orali, soluzzjoni

għall-użu orali

L-Ungerija

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

ZOLSANA 5 mg filmtabletta

5 mg

pillola miksija b’rita

għall-użu orali

L-Ungerija

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

ZOLSANA 10 mg filmtabletta

10 mg

pillola miksija b’rita

għall-użu orali

L-Ungerija

LEK Pharmaceuticals d.d. Verovskova 57

Ljubljana

Slovenia

SANVAL 5 mg filmtabletta

5 mg

pillola miksija b’rita

għall-użu orali

L-Ungerija

LEK Pharmaceuticals d.d. Verovskova 57

Ljubljana

Slovenia

SANVAL 10 mg filmtabletta

10 mg

pillola miksija b’rita

għall-użu orali

L-Ungerija

Meda Pharma Hungary Kft Váci út 91. Budapest 1139 Hungary

EDLUAR 5 mg nyelvalatti tabletta

5 mg

pillola għal taħt l-ilsien

għall-użu minn taħt l-ilsien

L-Ungerija

Meda Pharma Hungary Kft Váci út 91. Budapest 1139 Hungary

EDLUAR 10 mg nyelvalatti tabletta

10 mg

pillola għal taħt l-ilsien

għall-użu minn taħt l-ilsien

L-Ungerija

Sanofi-Aventis Magyarország Zrt

Tó u. 1-5

Budapest

1045

Hungary

STILNOX 10 mg filmtabletta

10 mg

pillola miksija b’rita

għall-użu orali

L-Ungerija

Teva Magyarország Zrt

Repülőtéri út 5.

Gödöllő 2100

Hungary

ZOLPIDEM-RATIOPHARM 10 mg filmtabletta

10 mg

pillola miksija b’rita

għall-użu orali

L-Ungerija

Vitabalans Oy Varastokatu 8. Hämeenlinna 13500

Finland

ZOLPIDEM VITABALANS 10 mg filmtabletta

10 mg

pillola miksija b’rita

għall-użu orali

L-Ungerija

Vulm CZ a.s.

Olivova 1888

Ricany 25101 Czech Republic

INSOM 10 mg pezsgőtabletta

10 mg

pillola li tfexfex

għall-użu orali

L-Ungerija

Zentiva k.s.

Dolny Mecholupy,

U kabelovny 130

Prague 10. 10237

Czech Republic

HYPNOGEN 10 mg filmtabletta

10 mg

pillola miksija b’rita

għall-użu orali

L-Islanda

LYFIS ehf., Grensásvegur 22, 108 Reykjavík, Iceland

Zolpidem LYFIS

10 mg

pillola miksija b’rita

għall-użu orali

L-Islanda

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

Edluar

5 mg

pillola għal taħt l-ilsien

għall-użu orali

L-Islanda

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

Edluar

10 mg

pillola għal taħt l-ilsien

għall-użu orali

L-Islanda

Mylan AB, Ynglingagatan 14, 10435 Stockholm, Sweden.

Zolpidem Mylan

10 mg

pillola miksija b’rita

għall-użu orali

L-Islanda

Sanofi Aventis Norge

Strandveien 15,

1366 Lysaker, Norway

Stilnoct

5 mg

pillola miksija b’rita

għall-użu orali

L-Islanda

Sanofi Aventis Norge

Strandveien 15,

1366 Lysaker, Norway

Stilnoct

10 mg

pillola miksija b’rita

għall-użu orali

L-Irlanda

Clonmel Healthcare Ltd

Waterford Road

Clonmel

Co. Tipperary

Ireland

Nytamel 5 mg Film-coated Tablets

5 mg

pillola miksija b’rita

għall-użu orali

L-Irlanda

Clonmel Healthcare Ltd

Waterford Road

Clonmel

Co. Tipperary

Ireland

Nytamel 10 mg Film-coated Tablets.

10 mg

pillola miksija b’rita

għall-użu orali

L-Irlanda

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

pillola miksija b’rita

għall-użu orali

L-Irlanda

Meda Health Sales Ireland Limited

Unit 34/35 Block A

Dunboyne Business Park

Dunboyne

Co Meath

Ireland

Edluar 5 mg sublingual tablets

5 mg

pillola għal taħt l-ilsien

għall-użu orali

L-Irlanda

Meda Health Sales Ireland Limited

Unit 34/35 Block A

Dunboyne Business Park

Dunboyne

Co Meath

Ireland

Edluar 10 mg sublingual tablets

10 mg

pillola għal taħt l-ilsien

għall-użu orali

L-Irlanda

Rowex Ltd,

Bantry,

Co. Cork,

Ireland

Zolnod 10 mg film-coated tablets

10 mg

pillola miksija b’rita

għall-użu orali

L-Irlanda

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

Stilnoct 5 mg Film-coated Tablets

5 mg

pillola miksija b’rita

għall-użu orali

L-Irlanda

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

Stilnoct 10 mg Film-coated Tablets

10 mg

pillola miksija b’rita

għall-użu orali

L-Irlanda

Teva Pharma B. V.

Computerweg 10

3542 DR Utrecht

The Netherlands

Zolpidem Tartrate Teva 5 mg Film-coated Tablets

5 mg

pillola miksija b’rita

għall-użu orali

L-Irlanda

Teva Pharma B. V.

Computerweg 10

3542 DR Utrecht

The Netherlands

Zolpidem Tartrate Teva 10 mg Film-coated Tablets

10 mg

pillola miksija b’rita

għall-użu orali

L-Italja

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

IS-220 Hafnarfjördur

Iceland

ZOLPIDEM ACTAVIS

10 mg

pillola miksija b’rita

għall-użu orali

L-Italja

Doc Generici S.r.l.

Turati 40, Milano – 20121 Italy

ZOLPIDEM DOC GENERICI

5 mg

pillola miksija b’rita

għall-użu orali

L-Italja

Doc Generici S.r.l.

Turati 40, Milano – 20121 Italy

ZOLPIDEM DOC GENERICI

10 mg

pillola miksija b’rita

għall-użu orali

L-Italja

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

ZOLPIDEM EG

10 mg

pillola miksija b’rita

għall-użu orali

L-Italja

FIDIA Farmaceutici S.p.a.

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

OPSYCON

10 mg

pillola miksija b’rita

għall-użu orali

L-Italja

HEXAL S.p.a.

Largo Umberto Boccioni 1

21040 Origgio

Varese

Italy

ZOLPIDEM HEXAL

10 mg

pillola miksija b’rita

għall-użu orali

L-Italja

IPCA – Produtos Farmacêuticos Unipessoal, Lda.

Rua José Nogueira Vaz, Lote 104 – Lj Esq

2625-099 Povoa de Santa Iria

Portugal

ZOLPIDEM IPCA

5 mg

pillola miksija b’rita

għall-użu orali

L-Italja

IPCA – Produtos Farmacêuticos Unipessoal, Lda.

Rua José Nogueira Vaz, Lote 104 – Lj Esq

2625-099 Povoa de Santa Iria

Portugal

ZOLPIDEM IPCA

10 mg

pillola miksija b’rita

għall-użu orali

L-Italja

ITALFARMACO S.p.A.

Viale Fulvio Testi 330,

20126 Milano, Italy

SONIREM

10 mg/ml

qtar orali, soluzzjoni

għall-użu orali

L-Italja

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

ZOLPREM

10 mg/ml

qtar orali, soluzzjoni

għall-użu orali

L-Italja

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

ZOLPEDUAR

5 mg

pillola għal taħt l-ilsien

għall-użu orali

L-Italja

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

ZOLPEDUAR

10 mg

pillola għal taħt l-ilsien

għall-użu orali

L-Italja

Ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

ZOLPIDEM RATIOPHARM

10 mg

pillola miksija b’rita

għall-użu orali

L-Italja

Sandoz S.p.a.

Largo Umberto Boccioni, 1,

Origgio, Varese – 21040

Italy

ZOLPIDEM SANDOZ

10 mg

pillola miksija b’rita

għall-użu orali

L-Italja

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

STILNOX

10 mg

pillola miksija b’rita

għall-użu orali

L-Italja

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

NOTTEM

10 mg

pillola miksija b’rita

għall-użu orali

L-Italja

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

ZOLPIDEM TEVA

10 mg

pillola miksija b’rita

għall-użu orali

L-Italja

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

ZOLPIDEM ZENTIVA

10 mg

pillola miksija b’rita

għall-użu orali

Il-Latvja

Krka, d.d., Novo mesto

Šmarješka cesta 6

8000 Novo mesto

Slovenia

Zolsana 5 mg coated tablets

5 mg

pillola miksija

għall-użu orali

Il-Latvja

Krka, d.d., Novo mesto

Šmarješka cesta 6

8000 Novo mesto

Slovenia

Zolsana 10 mg coated tablets

10 mg

pillola miksija

għall-użu orali

Il-Latvja

Meda Pharma GmbH & Co. KG

Benzstrasse 1

Bad Homburg v.d.H

61352

Germany

Edluar 5 mg sublingual tablets

5 mg

pillola għal taħt l-ilsienl

għall-użu minn taħt l-ilsien

Il-Latvja

Meda Pharma GmbH & Co. KG

Benzstrasse 1

Bad Homburg v.d.H

61352

Germany

Edluar 10 mg sublingual tablets

10 mg

pillola għal taħt l-ilsienl

għall-użu minn taħt l-ilsien

Il-Latvja

Sandoz d.d.

Verovškova 57,

1000 Ljubljana,

Slovenia

Zolpidem Sandoz 10 mg film-coated tablets

10 mg

pillola miksija b’rita

għall-użu orali

Il-Latvja

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

Stilnox 10 mg film-coated tablets

10 mg

pillola miksija b’rita

għall-użu orali

Il-Latvja

Vitabalans Oy

Varastokatu 8

13500 Hämeenlinna

Finland

Zolpidem Vitabalans 10 mg film-coated tablets

10 mg

pillola miksija b’rita

għall-użu orali

Il-Latvja

Zentiva, k.s.

U kabelovny 130

Prague 10, Dolni Mecholupy

10237

Czech Republic

Hypnogen 10 mg film-coated tablets

10 mg

pillola miksija b’rita

għall-użu orali

Il-Litwanja

Krka, d.d., Novo mesto

Šmarješka cesta 6

8000 Novo mesto

Slovenia

Zolsana

10 mg

pillola miksija b’rita

għall-użu orali

Il-Litwanja

Krka, d.d., Novo mesto

Šmarješka cesta 6

8000 Novo mesto

Slovenia

Zolsana

5 mg

pillola miksija b’rita

għall-użu orali

Il-Litwanja

Sandoz d.d.

Verovškova 57,

1000 Ljubljana,

Slovenia

Zolpidem Sandoz

10 mg

pillola miksija b’rita

għall-użu orali

Il-Litwanja

UAB “SANOFI-AVENTIS LIETUVA”

A. Juozapavičiaus 6/2 g.

LT-09310 Vilnius

Lithuania

Stilnox

10 mg

pillola miksija b’rita

għall-użu orali

Il-Litwanja

Vitabalans Oy

Varastokatu 8

13500 Hämeenlinna

Finland

Zolpidem Vitabalans

10 mg

pillola miksija b’rita

għall-użu orali

Il-Litwanja

Zentiva, k.s.

U kabelovny 130

Prague 10, Dolni Mecholupy

10237

Czech Republic

HYPNOGEN

10 mg

pillola miksija b’rita

għall-użu orali

Il-Lussumburgu

MYLAN BVBA/SPRL

Terhulpsesteenweg 6A

1560 Hoeilaart

Belgium

Dodorest

10 mg

pillola miksija

għall-użu orali

Il-Lussumburgu

SANOFI BELGIUM

Airport Plaza, Montreal Building, Leonardo Da Vincilaan 19

1831 Diegem

Belgium

Stilnoct

10 mg

pillola miksija

għall-użu orali

Il-Lussumburgu

Eurogenerics S.A.

Esplanade Heysel, b22

1020 Bruxelles

Belgium

Zolpidem EG cpr.eff.

10 mg

pillola li tfexfex

għall-użu orali

Il-Lussumburgu

Eurogenerics S.A.

Esplanade Heysel, b22

1020 Bruxelles

Belgium

Zolpidem EG cpr.pellic.

10 mg

pillola miksija

għall-użu orali

Il-Lussumburgu

Genthon BV

Microweg, 22

6545 Nijmegen

The Netherlands

Zolpidem Genthion

10 mg

pillola miksija

għall-użu orali

Il-Lussumburgu

Genthon BV

Microweg, 22

6545 Nijmegen

The Netherlands

Zolpidem Genthion

5 mg

pillola miksija

għall-użu orali

Il-Lussumburgu

Apotex Europe B.V.

Darwinweg 20

NL 2333 CR Leiden

The Netherlands

Zolpitop

10 mg

pillola miksija

għall-użu orali

Il-Lussumburgu

Apotex Europe B.V.

Darwinweg 20

NL 2333 CR Leiden

The Netherlands

Zolpitop

5 mg

pillola miksija

għall-użu orali

Il-Lussumburgu

MEDA PHARMA

Chaussee de la Hulpe 166

1170 Watermael-Boitsfort

Belgium

Zolpeduar

10 mg

pillola għal taħt l-ilsien

għall-użu minn taħt l-ilsien

Il-Lussumburgu

MEDA PHARMA

Chaussee de la Hulpe 166

1170 Watermael-Boitsfort

Belgium

Zolpeduar

5 mg

pillola għal taħt l-ilsien

għall-użu minn taħt l-ilsien

Malta

Sanofi Malta Ltd.

St. Julian’s Rd.

San Gwann SGN 2805

Malta

Stilnox

10 mg

pillola miksija b’rita

għall-użu orali

Malta

Pharma MT

103, Stuart Street,

Gzira,

Malta

Nytamel

10 mg

pillola miksija b’rita

għall-użu orali

In-Norveġja

Sanofi Aventis Norge

Strandveien 15,

1366 Lysaker, Norway

Stilnoct

5 mg

pillola miksija b’rita

għall-użu orali

In-Norveġja

Sanofi Aventis Norge

Strandveien 15,

1366 Lysaker, Norway

Stilnoct

10 mg

pillola miksija b’rita

għall-użu orali

In-Norveġja

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

Zolpidem Actavis

5 mg

pillola miksija b’rita

għall-użu orali

In-Norveġja

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

Zolpidem Actavis

10 mg

pillola miksija b’rita

għall-użu orali

In-Norveġja

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

Edluar

5 mg

pillola għal taħt l-ilsien

għall-użu orali

In-Norveġja

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

Edluar

10 mg

pillola għal taħt l-ilsien

għall-użu orali

In-Norveġja

Vitabalans Oy

Varastokatu 8

13500 Hämeenlinna

Finland

Zolpidem Vitabalans

10 mg

pillola miksija b’rita

għall-użu orali

Il-Polonja

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

IS-220 Hafnarfjördur

Iceland

Noxizol

10 mg

pillola miksija b’rita

għall-użu orali

Il-Polonja

Apotex Europe B.V.

Darwinweg 20

NL 2333 CR Leiden

The Netherlands

Apo-Zolpin

10 mg

pillola miksija b’rita

għall-użu orali

Il-Polonja

Farma-Projekt Sp. z o.o.

ul. Józefińska 2

30-529 Kraków

Poland

Xentic

10 mg

pillola miksija b’rita

għall-użu orali

Il-Polonja

Generics [UK] Ltd.

Station Close

EN6 1TL Hertfordshire – Potters Bar

United Kingdom

ZolpiGen

10 mg

pillola miksija b’rita

għall-użu orali

Il-Polonja

Ipca, Produtos Farmaceuticos, Unipessoal Lda

Rua Chanceler-Mor 11 R/c Frt.

Cacem

2735-615

Portugal

Zolpidem IPCA

5 mg

pillola miksija b’rita

għall-użu orali

Il-Polonja

Ipca, Produtos Farmaceuticos, Unipessoal Lda

Rua Chanceler-Mor 11 R/c Frt.

Cacem

2735-615

Portugal

Zolpidem IPCA

10 mg

pillola miksija b’rita

għall-użu orali

Il-Polonja

Italfarmaco S.p.A.

Viale Fulvio 330

20126 Milano

Italy

Sonirem

10 mg/ml

qtar orali, soluzzjoni

għall-użu orali

Il-Polonja

Krka, d.d., Novo mesto

Šmarješka cesta 6

8000 Novo mesto

Slovenia

Zolsana

10 mg

pillola miksija b’rita

għall-użu orali

Il-Polonja

Meda Pharma GmbH & Co. KG

Benzstrasse 1

Bad Homburg v.d.H

61352

Germany

Edluar

5 mg

pillola għal taħt l-ilsien

għall-użu orali

Il-Polonja

Meda Pharma GmbH & Co. KG

Benzstrasse 1

Bad Homburg v.d.H

61352

Germany

Edluar

10 mg

pillola għal taħt l-ilsien

għall-użu orali

Il-Polonja

Orion Corporation

Orionintie 1/A

FI-02200 Espoo

Finland

Onirex

10 mg

pillola miksija b’rita

għall-użu orali

Il-Polonja

Pabianickie Zakłady Farmaceutyczne Polfa S.A.

ul. Marszałka J. Piłsudskiego 5

95-200 Pabianice

Poland

Polsen

10 mg

pillola miksija b’rita

għall-użu orali

Il-Polonja

Pfizer Europe MA EEIG

Ramsgate Road

Kent, Sandwich

CT13 9 NJ

United Kingdom

Zolpidem Pfizer

10 mg

pillola miksija b’rita

għall-użu orali

Il-Polonja

Polfarmex S.A.

Józefów 9

99-300 Kutno

Poland

Nasen

10 mg

pillola miksija b’rita

għall-użu orali

Il-Polonja

Sandoz GmbH

ul. Biochemiestrasse 10

Kundli

6250

Austria

Sanval

10 mg

pillola miksija b’rita

għall-użu orali

Il-Polonja

Sanofi-Aventis France

1-13 boulevard Romain Rolland

75014 Paris

France

Stilnox

10 mg

pillola miksija b’rita

għall-użu orali

Il-Polonja

Vitabalans Oy

Varastokatu 8

13500 Hämeenlinna

Finland

Zolpidem Vitabalans

10 mg

pillola miksija b’rita

għall-użu orali

Il-Polonja

VULM CZ, a.s.

Olivova 1888

Ricany

251 01

Czech Republic

Insom

10 mg

pillola li tfexfex

għall-użu orali

Il-Polonja

Zakłady Farmaceutyczne POLPHARMA S.A.

Pelplińska 19

83-200 Starogard Gdański

Poland

Zolpic

10 mg

pillola miksija b’rita

għall-użu orali

Il-Polonja

Zentiva, k.s.

U kabelovny 130

Prague 10, Dolni Mecholupy

10237

Czech Republic

Hypnogen

10 mg

pillola miksija b’rita

għall-użu orali

Il-Portugall

Actavis A/S Sucursal

Rua Virgílio Correia, 11 – A

1600-219 Lisboa

Portugal

Zolpidem Actavis

10 mg

pillola miksija b’rita

għall-użu orali

Il-Portugall

Aurobindo Pharma (Portugal), Unipessoal Lda.

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

2794-038 Carnaxide

Portugal

Zolpidem Aurobindo

5 mg

pillola miksija b’rita

għall-użu orali

Il-Portugall

Aurobindo Pharma (Portugal), Unipessoal Lda.

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

2794-038 Carnaxide

Portugal

Zolpidem Aurobindo

10 mg

pillola miksija b’rita

għall-użu orali

Il-Portugall

Cinfa Portugal, Lda.

Av. Tomás Ribeiro, 43 – Bloco 2, 3o F – Edifício Neopark

2790-221 Carnaxide

Portugal

Zolpidem Cinfa 10 mg Comprimidos

10 mg

pillola miksija b’rita

għall-użu orali

Il-Portugall

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Zolpidem Generis 5 mg Comprimidos Revestidos

5 mg

pillola miksija b’rita

għall-użu orali

Il-Portugall

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Zolpidem Generis 10 mg Comprimidos Revestidos

10 mg

pillola miksija b’rita

għall-użu orali

Il-Portugall

Genthon GmbH

Groesbeeker Weg, 1

D-47559 Kranenburg

Germany

Zolpidem 5 mg Comprimidos Revestidos

5 mg

pillola miksija b’rita

għall-użu orali

Il-Portugall

IPCA – Produtos Farmacêuticos Unipessoal, Lda.

Rua José Nogueira Vaz, Lote 104 – Lj Esq

2625-099 Povoa de Santa Iria

Portugal

Zolpidem IPCA

5 mg

pillola miksija b’rita

għall-użu orali

Il-Portugall

IPCA – Produtos Farmacêuticos Unipessoal, Lda.

Rua José Nogueira Vaz, Lote 104 – Lj Esq

2625-099 Povoa de Santa Iria

Portugal

Zolpidem IPCA

10 mg

pillola miksija b’rita

għall-użu orali

Il-Portugall

Labesfal Genéricos, S.A

Avenida Dr. Afonso Costa, 1370

3465-051 Campo de Besteiros

Portugal

Zolpidem Labesfal

10 mg

pillola miksija b’rita

għall-użu orali

Il-Portugall

Laboratórios Azevedos – Indústria Farmacêutica, S.A.

Edifícios Azevedos – Estrada Nacional 117-2, Alfragide

2614-504 Amadora

Portugal

Cymerion

10 mg

pillola miksija b’rita

għall-użu orali

Il-Portugall

Meda Pharma – Produtos Farmacêuticos, S.A.

Rua do Centro Cultural, 13

1749-066 Lisboa

Portugal

Edluar

5 mg

pillola għal taħt l-ilsien

għall-użu minn taħt l-ilsien

Il-Portugall

Meda Pharma – Produtos Farmacêuticos, S.A.

Rua do Centro Cultural, 13

1749-066 Lisboa

Portugal

Edluar

10 mg

pillola għal taħt l-ilsien

għall-użu minn taħt l-ilsien

Il-Portugall

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

pillola miksija b’rita

għall-użu orali

Il-Portugall

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

pillola miksija b’rita

għall-użu orali

Il-Portugall

Sandoz Farmacêutica, Lda.

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

2710-693 Sintra

Portugal

Zolpidem Sandoz

10 mg

pillola miksija b’rita

għall-użu orali

Il-Portugall

Sanofi – Produtos Farmacêuticos, Lda.

Empreendimento Lagoas Park Edifício 7, 3o Piso

2740-244 Porto Salvo

Portugal

Stilnox

10 mg

pillola miksija b’rita

għall-użu orali

Il-Portugall

Wynn Industrial Pharma, S.A.

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

1070-274 Lisboa

Portugal

Zolpidem Wynn

10 mg

pillola miksija b’rita

għall-użu orali

Ir-Rumanija

ALKALOID-INT d.o.o.

Šlandrova ulica 4

1231 Ljubljana-Črnuče Slovenia

ZADOBRA 5 mg

5 mg

pillola miksija b’rita

għall-użu orali

Ir-Rumanija

ALKALOID-INT d.o.o.

Šlandrova ulica 4

1231 Ljubljana-Črnuče Slovenia

ZADOBRA 10 mg

10 mg

pillola miksija b’rita

għall-użu orali

Ir-Rumanija

ITALFARMACO S.p.A.

Viale Fulvio Testi 330, 20126 Milano, Italia

ONIRIA 10 mg/ml

10 mg/ml

qtar orali, soluzzjoni

għall-użu orali

Ir-Rumanija

Krka, d.d., Novo mesto

Šmarješka cesta 6

8000 Novo mesto

Slovenia

ZOLSANA 5 mg

5 mg

pillola miksija b’rita

għall-użu orali

Ir-Rumanija

Krka, d.d., Novo mesto

Šmarješka cesta 6

8000 Novo mesto

Slovenia

ZOLSANA 10 mg

10 mg

pillola miksija b’rita

għall-użu orali

Ir-Rumanija

LABORMED PHARMA S.A.

B-dul Theodor Pallady nr. 44B

Sector 3, Bucureşti, România

ZOLPIDEM 10 mg

10 mg

pillola miksija b’rita

għall-użu orali

Ir-Rumanija

LEK farmacevtska družba d.d. Verovškova 57

1526 Ljubljana

Slovenia

SANVAL 10 mg

10 mg

pillola miksija b’rita

għall-użu orali

Ir-Rumanija

Meda Pharma GmbH & Co. KG

Benzstrasse 1

Bad Homburg v.d.H

61352

Germany

EDLUAR 5 mg

5 mg

pillola għal taħt l-ilsien

għall-użu orali

Ir-Rumanija

Meda Pharma GmbH & Co. KG

Benzstrasse 1

Bad Homburg v.d.H

61352

Germany

EDLUAR 10 mg

10 mg

pillola għal taħt l-ilsien

għall-użu orali

Ir-Rumanija

S.C. ANTIBIOTICE S.A.,

Str. Valea Lupului nr.1, Iaşi, România

ZOLPIDEM ATB 10 mg

10 mg

pillola miksija b’rita

għall-użu orali

Ir-Rumanija

SANOFI-AVENTIS ROMÂNIA S.R.L.

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

Sector 5, Bucureşti, România

STILNOX 10 mg

10 mg

pillola miksija b’rita

għall-użu orali

Ir-Repubblika Slovakka

ALKALOID-INT d.o.o.

Šlandrova ulica 4

1231 Ljubljana-Črnuče Slovenia

ADORMA 5 mg filmom obalené tablety

5 mg

pillola miksija b’rita

għall-użu orali

Ir-Repubblika Slovakka

ALKALOID-INT d.o.o.

Šlandrova ulica 4

1231 Ljubljana-Črnuče Slovenia

ADORMA 10 mg filmom obalené tablety

10 mg

pillola miksija b’rita

għall-użu orali

Ir-Repubblika Slovakka

Generics [UK] Ltd.

Station Close

EN6 1TL Hertfordshire – Potters Bar

United Kingdom

Zolpidem Mylan 10 mg

10 mg

pillola miksija b’rita

għall-użu orali

Ir-Repubblika Slovakka

Orion Corporation

Orionintie 1/A

FI-02200 Espoo

Finland

Zolpidem Orion 10 mg

10 mg

pillola miksija b’rita

għall-użu orali

Ir-Repubblika Slovakka

Sandoz d.d.

Verovškova 57,

1000 Ljubljana,

Slovenia

SANVAL 5 mg

5 mg

pillola miksija b’rita

għall-użu orali

Ir-Repubblika Slovakka

Sandoz d.d.

Verovškova 57,

1000 Ljubljana,

Slovenia

SANVAL 10 mg

10 mg

pillola miksija b’rita

għall-użu orali

Ir-Repubblika Slovakka

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

85101 Bratislava

Slovak Republic

STILNOX

10 mg

pillola miksija b’rita

għall-użu orali

Ir-Repubblika Slovakka

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

500 02 Hradec Králové Czech Republic

ZOLPINOX

10 mg

pillola miksija b’rita

għall-użu orali

Ir-Repubblika Slovakka

Takeda GmbH 2 Byk-Gulden Strasse

78467 Konstanz Germany

HYPNOGEN

10 mg

pillola miksija b’rita

għall-użu orali

Ir-Repubblika Slovakka

Vitabalans Oy

Varastokatu 8

13500 Hämeenlinna

Finland

Zolpidem Vitabalans 10 mg filmom obalené tablety

10 mg

pillola miksija b’rita

għall-użu orali

L-Islovenja

ALKALOID-INT d.o.o.

Šlandrova ulica 4

1231 Ljubljana-Črnuče Slovenia

Perluna 10 mg filmsko obožene tablete

10 mg

pillola miksija b’rita

għall-użu orali

L-Islovenja

ALKALOID-INT d.o.o.

Šlandrova ulica 4

1231 Ljubljana-Črnuče Slovenia

Perluna 5 mg filmsko obožene tablete

5 mg

pillola miksija b’rita

għall-użu orali

L-Islovenja

Krka, d.d., Novo mesto

Šmarješka cesta 6

8000 Novo mesto

Slovenia

Zolsana 10 mg filmsko obložene tablete

10 mg

pillola miksija b’rita

għall-użu orali

L-Islovenja

Krka, d.d., Novo mesto

Šmarješka cesta 6

8000 Novo mesto

Slovenia

Zolsana 5 mg filmsko obložene tablete

5 mg

pillola miksija b’rita

għall-użu orali

L-Islovenja

LEK farmacevtska družba d.d. Verovškova 57

1526 Ljubljana

Slovenia

Sanval 10 mg filmsko obožene tablete

10 mg

pillola miksija b’rita

għall-użu orali

L-Islovenja

LEK farmacevtska družba d.d. Verovškova 57

1526 Ljubljana

Slovenia

Sanval 5 mg filmsko obložene tablete

5 mg

pillola miksija b’rita

għall-użu orali

L-Islovenja

Meda Pharma GmbH & Co. KG

Benzstrasse 1

Bad Homburg v.d.H

61352

Germany

Edluar 10 mg podjezične tablete

10 mg

pillola għal taħt l-ilsien

għall-użu minn taħt l-ilsien

L-Islovenja

Meda Pharma GmbH & Co. KG

Benzstrasse 1

Bad Homburg v.d.H

61352

Germany

Edluar 5 mg podjezične tablete

5 mg

pillola għal taħt l-ilsien

għall-użu minn taħt l-ilsien

L-Islovenja

Vitabalans Oy

Varastokatu 8

13500 Hämeenlinna

Finland

Zolpidem Vitabalans 10 mg filmsko obložene tablete

10 mg

pillola miksija b’rita

għall-użu orali

Spanja

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

DALPARAN 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA

10 mg

pillola miksija b’rita

għall-użu orali

Spanja

Apotex Europe B.V.

Darwinweg 20

NL 2333 CR Leiden

The Netherlands

ZOLPIDEM APOTEX 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG

10 mg

pillola miksija b’rita

għall-użu orali

Spanja

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

pillola miksija b’rita

għall-użu orali

Spanja

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

pillola miksija b’rita

għall-użu orali

Spanja

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

ZOLPIDEM FARMALIDER 10 mg COMPRIMIDOS RECUBIERTOS EFG

10 mg

pillola miksija b’rita

għall-użu orali

Spanja

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

ZOLPIDEM DESGEN 5 mg COMPRIMIDOS EFG

5 mg

pillola

għall-użu orali

Spanja

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

ZOLPIDEM DESGEN 10 mg COMPRIMIDOS EFG

10 mg

pillola

għall-użu orali

Spanja

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

ZOLPIDEM EDIGEN 10 mg COMPRIMIDOS RECUBIERTOS EFG

10 mg

pillola miksija b’rita

għall-użu orali

Spanja

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

SPAIN

ZOLPIDEM STADA 10 mg COMPRIMIDOS RECUBIERTOS EFG

10 mg

pillola miksija b’rita

għall-użu orali

Spanja

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

pillola miksija b’rita

għall-użu orali

Spanja

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

ZOLPIDEM NORMON 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG

10 mg

pillola miksija b’rita

għall-użu orali

Spanja

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

pillola għal taħt l-ilsien

għall-użu orali

Spanja

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

pillola għal taħt l-ilsien

għall-użu orali

Spanja

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

ZOLPIDEM MYLAN 10 mg COMPRIMIDOS RECUBIERTOS EFG

10 mg

pillola miksija b’rita

għall-użu orali

Spanja

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

ZOLPIDEM PHARMAGENUS 5 mg COMPRIMIDOS

5 mg

pillola

għall-użu orali

Spanja

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

ZOLPIDEM PHARMAGENUS 10 mg COMPRIMIDOS EFG

10 mg

pillola

għall-użu orali

Spanja

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

pillola miksija b’rita

għall-użu orali

Spanja

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

pillola miksija b’rita

għall-użu orali

Spanja

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

pillola miksija b’rita

għall-użu orali

Spanja

SANDOZ FARMACÉUTICA, S.A.

Avda. Osa Mayor, 4

28023 Aravaca (Madrid)

Spain

ZOLPIDEM SANDOZ 10 mg COMPRIMIDOS EFG

10 mg

pillola

għall-użu orali

Spanja

SANOFI AVENTIS, S.A.

Josep Plá, 2,

Barcelona. 08019

SPAIN

STILNOX 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA

10 mg

pillola miksija b’rita

għall-użu orali

Spanja

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

pillola miksija b’rita

għall-użu orali

Spanja

Zentiva, k.s.

U kabelovny 130

Prague 10, Dolni Mecholupy

10237

Czech Republic

ZOLPIDEM ZENTIVA 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG

10 mg

pillola miksija b’rita

għall-użu orali

L-Isvezja

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

IS-220 Hafnarfjördur

Iceland

Zolpidem Actavis

5 mg

pillola miksija b’rita

għall-użu orali

L-Isvezja

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

IS-220 Hafnarfjördur

Iceland

Zolpidem Actavis

10 mg

pillola miksija b’rita

għall-użu orali

L-Isvezja

Hexal A/S

Edvard Thomsens Vej 14

DK-2300 Köpenhamn S

Denmark

Zolpidem HEXAL

10 mg

pillola miksija b’rita

għall-użu orali

L-Isvezja

Ranbaxy (UK) Ltd,

Building 4

Chiswick Park

London W4 5YE

United Kingdom

Zolpidem Ranbaxy

5 mg

pillola miksija b’rita

għall-użu orali

L-Isvezja

Ranbaxy (UK) Ltd,

Building 4

Chiswick Park

London W4 5YE

United Kingdom

Zolpidem Ranbaxy

10 mg

pillola miksija b’rita

għall-użu orali

L-Isvezja

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

Edluar

5 mg

pillola għal taħt l-ilsien

għall-użu orali

L-Isvezja

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

Edluar

10 mg

pillola għal taħt l-ilsien

għall-użu orali

L-Isvezja

Mylan AB

Box 23033

104 35 Stockholm

Sweden

Zolpidem Mylan

10 mg

pillola miksija b’rita

għall-użu orali

L-Isvezja

Orifarm Generics A/S

Energivej 15 POB 69

DK-5260 Odense S

Denmark

Zolpidem Orifarm

5 mg

pillola miksija b’rita

għall-użu orali

L-Isvezja

Orifarm Generics A/S

Energivej 15 POB 69

DK-5260 Odense S

Denmark

Zolpidem Orifarm

10 mg

pillola miksija b’rita

għall-użu orali

L-Isvezja

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Zolpidem ratiopharm

5 mg

pillola miksija b’rita

għall-użu orali

L-Isvezja

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Zolpidem ratiopharm

10 mg

pillola miksija b’rita

għall-użu orali

L-Isvezja

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 Köpenhamn S

Denmark

Zolpidem Sandoz

5 mg

pillola miksija b’rita

għall-użu orali

L-Isvezja

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 Köpenhamn S

Denmark

Zolpidem Sandoz

10 mg

pillola miksija b’rita

għall-użu orali

L-Isvezja

sanofi-aventis AB

Box 14142

167 14 Bromma

Sweden

Stilnoct

5 mg

pillola miksija b’rita

għall-użu orali

L-Isvezja

sanofi-aventis AB

Box 14142

167 14 Bromma

Sweden

Stilnoct

10 mg

pillola miksija b’rita

għall-użu orali

L-Isvezja

STADA Arzneimittel AG

Stadastrasse 2-18

DE-61118 Bad Vilbel

Germany

Zolpidem STADA

5 mg

pillola miksija b’rita

għall-użu orali

L-Isvezja

STADA Arzneimittel AG

Stadastrasse 2-18

DE-61118 Bad Vilbel

Germany

Zolpidem STADA

10 mg

pillola miksija b’rita

għall-użu orali

L-Isvezja

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

Zolpidem Genthon

5 mg

pillola miksija b’rita

għall-użu orali

L-Isvezja

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

Zolpidem Genthon

10 mg

pillola miksija b’rita

għall-użu orali

L-Isvezja

Vitabalans Oy

Varastokatu 8

13500 Hämeenlinna

Finland

Zolpidem Vitabalans

10 mg

pillola miksija b’rita

għall-użu orali

L-Olanda

Actavis B.V.

Baarnsche Dijk 1

3741 LN BAARN

The Netherlands

Zolpidemtartaat Actavis 5 mg, tabletten

5 mg

pillola

għall-użu orali

L-Olanda

Actavis B.V.

Baarnsche Dijk 1

3741 LN BAARN

The Netherlands

Zolpidemtartraat Actavis 10 mg, tabletten

10 mg

pillola

għall-użu orali

L-Olanda

ADOH B.V.

Godfried Bomansstraat 31

6543 JA NIJMEGEN

The Netherlands

Zolpidemtartraat ADOH bruistabletten 10 mg, bruistabletten

10 mg

pillola li tfexfex

għall-użu orali

L-Olanda

Pharmachemie B.V.

Swensweg 5

2031 GA HAARLEM

The Netherlands

Zolpidemtartraat 5 mg PCH, filmomhulde tabletten

5 mg

pillola miksija b’rita

għall-użu orali

L-Olanda

Pharmachemie B.V.

Swensweg 5

2031 GA HAARLEM

The Netherlands

Zolpidemtartraat 10 mg PCH, filmomhulde tabletten

10 mg

pillola miksija b’rita

għall-użu orali

L-Olanda

ratiopharm Nederland B.V.

Swensweg 5

2031 GA HAARLEM

The Netherlands

Zolpidemtartraat ratiopharm 5 mg, tabletten

5 mg

pillola

għall-użu orali

L-Olanda

ratiopharm Nederland B.V.

Swensweg 5

2031 GA HAARLEM

The Netherlands

Zolpidemtartraat ratiopharm 10 mg, tabletten

10 mg

pillola

għall-użu orali

L-Olanda

ratiopharm Nederland B.V.

Swensweg 5

2031 GA HAARLEM

The Netherlands

Zolpidemtartraat ratiopharm 5 mg, filmomhulde tabletten

5 mg

pillola miksija b’rita

għall-użu orali

L-Olanda

ratiopharm Nederland B.V.

Swensweg 5

2031 GA HAARLEM

The Netherlands

Zolpidemtartraat ratiopharm 10 mg, filmomhulde tabletten

10 mg

pillola miksija b’rita

għall-użu orali

L-Olanda

ratiopharm Nederland B.V.

Swensweg 5

2031 GA HAARLEM

The Netherlands

Zolpidemtartraat ratiopharm 10 mg, filmomhulde tabletten

10 mg

pillola miksija b’rita

għall-użu orali

L-Olanda

Sandoz B.V.

Veluwezoom 22

1327 AH ALMERE

The Netherlands

Zolpidemtartraat Sandoz 10 mg, filmomhulde tabletten

10 mg

pillola miksija b’rita

għall-użu orali

L-Olanda

Sandoz B.V.

Veluwezoom 22

1327 AH ALMERE

The Netherlands

Zolpidemtartraat Sandoz 5, filmomhulde tabletten 5 mg

5 mg

pillola miksija b’rita

għall-użu orali

L-Olanda

Sandoz B.V.

Veluwezoom 22

1327 AH ALMERE

The Netherlands

Zolpidemtartraat Sandoz 10,filmomhulde tabletten 10 mg

10 mg

pillola miksija b’rita

għall-użu orali

L-Olanda

Synthon B.V.

Microweg 22

6545 CM NIJMEGEN

The Netherlands

Zolpidemtartraat 5 mg, filmomhulde tabletten

5 mg

pillola miksija b’rita

għall-użu orali

L-Olanda

Synthon B.V.

Microweg 22

6545 CM NIJMEGEN

The Netherlands

Zolpidemtartraat 10 mg, filmomhulde tabletten

10 mg

pillola miksija b’rita

għall-użu orali

L-Olanda

Synthon B.V.

Microweg 22

6545 CM NIJMEGEN

The Netherlands

Zolpidemtartraat 5 mg, filmomhulde tabletten

5 mg

pillola miksija b’rita

għall-użu orali

L-Olanda

Synthon B.V.

Microweg 22

6545 CM NIJMEGEN

The Netherlands

Zolpidemtartraat 10 mg, filmomhulde tabletten

10 mg

pillola miksija b’rita

għall-użu orali

L-Olanda

Synthon B.V.

Microweg 22

6545 CM NIJMEGEN

The Netherlands

Zolpidemtartraat 5 mg, filmomhulde tabletten

5 mg

pillola miksija b’rita

għall-użu orali

L-Olanda

Synthon B.V.

Microweg 22

6545 CM NIJMEGEN

The Netherlands

Zolpidemtartraat 10 mg, filmomhulde tabletten

10 mg

pillola miksija b’rita

għall-użu orali

L-Olanda

ADOH B.V.

Godfried Bomansstraat 31

6543 JA NIJMEGEN

The Netherlands

Zolpidemtartraat ADOH 10 mg, bruistabletten

10 mg

pillola li tfexfex

għall-użu orali

L-Olanda

Apotex Europe B.V.

Darwinweg 20

NL 2333 CR Leiden

The Netherlands

Zolpidemtartraat Apotex 5 mg, filmomhulde tabletten

5 mg

pillola miksija b’rita

għall-użu orali

L-Olanda

Apotex Europe B.V.

Darwinweg 20

NL 2333 CR Leiden

The Netherlands

Zolpidemtartraat Apotex 10 mg, filmomhulde tabletten

10 mg

pillola miksija b’rita

għall-użu orali

L-Olanda

Centrafarm B.V.

Nieuwe Donk 3

4879 AC ETTEN LEUR

The Netherlands

Zolpidemtartraat CF 5 mg, film-omhulde tabletten

5 mg

pillola miksija b’rita

għall-użu orali

L-Olanda

Centrafarm B.V.

Nieuwe Donk 3

4879 AC ETTEN LEUR

The Netherlands

Zolpidemtartraat CF 10 mg, film-omhulde tabletten

10 mg

pillola miksija b’rita

għall-użu orali

L-Olanda

Eurogenerics S.A.

Esplanade Heysel, b22

1020 Bruxelles

Belgium

Zolpidem Eurogenerics bruis 10 mg bruistabletten, bruistabletten

10 mg

pillola li tfexfex

għall-użu orali

L-Olanda

FIDIA Farmaceutici S.p.a.

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

Zolpidemtartraat 10 mg, filmomhulde tabletten

10 mg

pillola miksija b’rita

għall-użu orali

L-Olanda

Genthon BV

Microweg, 22

6545 Nijmegen

The Netherlands

Zolpidemtartraat 5 mg, filmomhulde tabletten

5 mg

pillola miksija b’rita

għall-użu orali

L-Olanda

Genthon BV

Microweg, 22

6545 Nijmegen

The Netherlands

Zolpidemtartraat 10 mg, filmomhulde tabletten

10 mg

pillola miksija b’rita

għall-użu orali

L-Olanda

Meda Pharma B.V.

Krijgsman 20

1186 DM AMSTELVEEN

The Netherlands

Edluar 5 mg, tablet voor sublinguaal gebruik

5 mg

pillola għal taħt l-ilsien

għall-użu minn taħt l-ilsien

L-Olanda

Meda Pharma B.V.

Krijgsman 20

1186 DM AMSTELVEEN

The Netherlands

Edluar 10 mg, tablet voor sublinguaal gebruik

10 mg

pillola għal taħt l-ilsien

għall-użu minn taħt l-ilsien

L-Olanda

Mylan B.V.

Dieselweg 25

3752 LB BUNSCHOTEN

The Netherlands

Zolpidemtartraat Mylan 10 mg, filmomhulde tabletten

10 mg

pillola miksija b’rita

għall-użu orali

L-Olanda

Pharmachemie B.V.

Swensweg 5

2031 GA HAARLEM

The Netherlands

Zolpidemtartraat 5 PCH, filmomhulde tabletten 5 mg

5 mg

pillola miksija b’rita

għall-użu orali

L-Olanda

Pharmachemie B.V.

Swensweg 5

2031 GA HAARLEM

The Netherlands

Zolpidemtartraat 10 PCH, filmomhulde tabletten 10 mg

10 mg

pillola miksija b’rita

għall-użu orali

L-Olanda

Sanofi-Aventis Netherlands B.V.

Kampenringweg 45 D-E

2803 PE GOUDA

The Netherlands

Stilnoct, tabletten 10 mg

10 mg

pillola

għall-użu orali

L-Olanda

STADA Arzneimittel AG

Stadastrasse 2-18

DE-61118 Bad Vilbel

Germany

Zolpidemtartraat Stada 5 mg, filmomhulde tabletten

5 mg

pillola miksija b’rita

għall-użu orali

L-Olanda

STADA Arzneimittel AG

Stadastrasse 2-18

DE-61118 Bad Vilbel

Germany

Zolpidemtartraat Stada 10 mg, filmomhulde tabletten

10 mg

pillola miksija b’rita

għall-użu orali

L-Olanda

Synthon B.V.

Microweg 22

6545 CM NIJMEGEN

The Netherlands

Zolpidemtartraat 10 mg, filmomhulde tabletten

10 mg

pillola miksija b’rita

għall-użu orali

Ir-Renju Unit

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

United Kingdom

Zolpidem Tartrate 5 mg tablets

5 mg

pillola miksija b’rita

għall-użu orali

Ir-Renju Unit

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

United Kingdom

Zolpidem Tartrate 10 mg tablets

10 mg

pillola miksija b’rita

għall-użu orali

Ir-Renju Unit

ALKALOID-INT d.o.o.

Šlandrova ulica 4

1231 Ljubljana-Črnuče Slovenia

Zolpidem Tartrate 5 mg film-coated tablets

5 mg

pillola miksija b’rita

għall-użu orali

Ir-Renju Unit

ALKALOID-INT d.o.o.

Šlandrova ulica 4

1231 Ljubljana-Črnuče Slovenia

Zolpidem Tartrate 10 mg film-coated tablets

10 mg

pillola miksija b’rita

għall-użu orali

Ir-Renju Unit

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

United Kingdom

Stilnoct 5 mg fiilm-coated tablets

5 mg

pillola miksija

għall-użu orali

Ir-Renju Unit

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

United Kingdom

Stilnoct 10 mg film-coated tablets

10 mg

pillola miksija

għall-użu orali

Ir-Renju Unit

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

United Kingdom

Zolpidem Tartrate 5 mg film-coated tablets

5 mg

pillola miksija b’rita

għall-użu orali

Ir-Renju Unit

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

United Kingdom

Zolpidem Tartrate 10 mg film-coated tablets

10 mg

pillola miksija b’rita

għall-użu orali

Ir-Renju Unit

Generics [UK] Ltd.

Station Close

EN6 1TL Hertfordshire – Potters Bar

United Kingdom

Zolpidem 10 mg film-coated tablets

10 mg

pillola miksija b’rita

għall-użu orali

Ir-Renju Unit

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

United Kingdom

Edluar 5 mg sublingual tablets

5 mg

pillola għal taħt l-ilsien

għall-użu orali

Ir-Renju Unit

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

United Kingdom

Edluar 10 mg sublingual tablets

10 mg

pillola għal taħt l-ilsien

għall-użu orali

Ir-Renju Unit

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

Zolpidem Tartrate 5 mg film-coated tablets

5 mg

pillola miksija b’rita

għall-użu orali

Ir-Renju Unit

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

Zolpidem Tartrate 10 mg film-coated tablets

10 mg

pillola miksija b’rita

għall-użu orali

Ir-Renju Unit

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Zolpidem Tartrate 5 mg film-coated tablets

5 mg

pillola miksija b’rita

għall-użu orali

Ir-Renju Unit

ratiopharm GmbH

Graf Arco Strasse 3

D-89079 Ulm

Germany

Zolpidem Tartrate 10 mg film-coated tablets

10 mg

pillola miksija b’rita

għall-użu orali

Ir-Renju Unit

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

United Kingdom

Zolpidem Tartrate 10 mg tablets

10 mg

pillola miksija b’rita

għall-użu orali

Ir-Renju Unit

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

United Kingdom

Zolpidem Tartrate 5 mg, film-coated tablets

5 mg

pillola miksija b’rita

għall-użu orali

Ir-Renju Unit

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

United Kingdom

Zolpidem Tartrate 10 mg, film-coated tablets

10 mg

pillola miksija b’rita

għall-użu orali

Ir-Renju Unit

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

United Kingdom

Zolpidem 10 mg film-coated tablets

10 mg

pillola miksija b’rita

għall-użu orali

Ir-Renju Unit

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

United Kingdom

Zolpidem Tartrate 5 mg tablets

5 mg

pillola miksija b’rita

għall-użu orali

Ir-Renju Unit

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

United Kingdom

Zolpidem Tartrate 10 mg tablets

10 mg

pillola miksija b’rita

għall-użu orali

---

ANNESS II

Lista tal-ismijiet, għamla farmaċewtika, qawwiet tal-prodotti mediċinali, mnejn jingħata, detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq fl-Istat Membri

| Stat Membru tal-UE/ŻEE | Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq
  l-isem u l-indirizz tal-kumpanija | Isem (Ivvintat) | Qawwa | Għamla farmaċewtika | Mnejn jingħata |
| --- | --- | --- | --- | --- | --- |
| L-Awstrija | AstraZeneca Österreich GmbH, |
| Schwarzenbergplatz 7, |
| A-1037 Wien, |
| Austria |

Stat Membru tal-UE/ŻEE

Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq

l-isem u l-indirizz tal-kumpanija

Isem (Ivvintat)

Qawwa

Għamla farmaċewtika

Mnejn jingħata

L-Awstrija

AstraZeneca Österreich GmbH,

Schwarzenbergplatz 7,

A-1037 Wien,

Austria

Crestor 5 mg – Filmtabletten

5 mg

Pilloli miksijin b’rita

Użu orali

L-Awstrija

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

AstraZeneca Österreich GmbH,

Schwarzenbergplatz 7,

A-1037 Wien,

Austria

Crestor 10 mg – Filmtabletten

10 mg

Pilloli miksijin b’rita

Użu orali

L-Awstrija

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

AstraZeneca Österreich GmbH,

Schwarzenbergplatz 7,

A-1037 Wien,

Austria

Crestor 20 mg – Filmtabletten

20 mg

Pilloli miksijin b’rita

Użu orali

L-Awstrija

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

AstraZeneca Österreich GmbH,

Schwarzenbergplatz 7,

A-1037 Wien,

Austria

Crestor 40 mg – Filmtabletten

40 mg

Pilloli miksijin b’rita

Użu orali

Il-Belġju

| 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

Pilloli miksijin b’rita

Użu orali

Il-Belġju

| 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

Pilloli miksijin b’rita

Użu orali

Il-Belġju

| 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

Pilloli miksijin b’rita

Użu orali

Il-Belġju

| 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

Pilloli miksijin b’rita

Użu orali

Il-Bulgarija

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

AstraZeneca

Pharmaceuticals AB,

S-151 85 Södertälje,

Sweden

Crestor

5 mg

Pilloli miksijin b’rita

Użu orali

Il-Bulgarija

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

AstraZeneca

Pharmaceuticals AB,

S-151 85 Södertälje,

Sweden

Crestor

10 mg

Pilloli miksijin b’rita

Użu orali

Il-Bulgarija

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

AstraZeneca

Pharmaceuticals AB,

S-151 85 Södertälje,

Sweden

Crestor

20 mg

Pilloli miksijin b’rita

Użu orali

Il-Kroazja

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

AstraZeneca d.o.o.

Radnička cesta 80

10000 Zagreb

Croatia

Crestor

Crestor 5 mg filmom obložene tablete

Pilloli miksijin b’rita

Użu orali

Il-Kroazja

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

AstraZeneca d.o.o.

Radnička cesta 80

10000 Zagreb

Croatia

Crestor

Crestor 10 mg filmom obložene tablete

Pilloli miksijin b’rita

Użu orali

Il-Kroazja

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

AstraZeneca d.o.o.

Radnička cesta 80

10000 Zagreb

Croatia

Crestor

Crestor 20 mg filmom obložene tablete

Pilloli miksijin b’rita

Użu orali

Il-Kroazja

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

AstraZeneca d.o.o.

Radnička cesta 80

10000 Zagreb

Croatia

Crestor

Crestor 40 mg filmom obložene tablete

Pilloli miksijin b’rita

Użu orali

Ċipru

| 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

Pilloli miksijin b’rita

Użu orali

Ċipru

| 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

Pilloli miksijin b’rita

Użu orali

Ċipru

| 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

Pilloli miksijin b’rita

Użu orali

Ċipru

| 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

Pilloli miksijin b’rita

Użu orali

Ir-Repubblika Ċeka

| 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

Pilloli miksijin b’rita

Użu orali

Ir-Repubblika Ċeka

| 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

Pilloli miksijin b’rita

Użu orali

Ir-Repubblika Ċeka

| 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

Pilloli miksijin b’rita

Użu orali

Ir-Repubblika Ċeka

| 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

Pilloli miksijin b’rita

Użu orali

Id-Danimarka

| 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

Pilloli miksijin b’rita

Użu orali

Id-Danimarka

| 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

Pilloli miksijin b’rita

Użu orali

Id-Danimarka

| 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

Pilloli miksijin b’rita

Użu orali

Id-Danimarka

| 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

Pilloli miksijin b’rita

Użu orali

L-Estonja

| 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

Pilloli miksijin b’rita

Użu orali

L-Estonja

| 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

Pilloli miksijin b’rita

Użu orali

L-Estonja

| 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

Pilloli miksijin b’rita

Użu orali

Il-Finlandja

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

AstraZeneca Oy

Itsehallintokuja 4

02600 Espoo

Finland

Crestor

5 mg

Pilloli miksijin b’rita

Użu orali

Il-Finlandja

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

AstraZeneca Oy

Itsehallintokuja 4

02600 Espoo

Finland

Crestor

10 mg

Pilloli miksijin b’rita

Użu orali

Il-Finlandja

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

AstraZeneca Oy

Itsehallintokuja 4

02600 Espoo

Finland

Crestor

20 mg

Pilloli miksijin b’rita

Użu orali

Il-Finlandja

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

AstraZeneca Oy

Itsehallintokuja 4

02600 Espoo

Finland

Crestor

40 mg

Pilloli miksijin b’rita

Użu orali

Franza

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

AstraZeneca

1, Place Renault

92844 Rueil-Malmaison Cedex,

France

Crestor

5 mg

Pilloli miksijin b’rita

Użu orali

Franza

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

AstraZeneca

1, Place Renault

92844 Rueil-Malmaison Cedex,

France

Crestor

10 mg

Pilloli miksijin b’rita

Użu orali

Franza

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

AstraZeneca

1, Place Renault

92844 Rueil-Malmaison Cedex,

France

Crestor

20 mg

Pilloli miksijin b’rita

Użu orali

Il-Ġermanja

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

AstraZeneca GmbH,

22876 Wedel,

Germany

CRESTOR 5 mg Filmtabletten

5 mg

Pilloli miksijin b’rita

Użu orali

Il-Ġermanja

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

AstraZeneca GmbH,

22876 Wedel,

Germany

CRESTOR 10 mg Filmtabletten

10 mg

Pilloli miksijin b’rita

Użu orali

Il-Ġermanja

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

AstraZeneca GmbH,

22876 Wedel,

Germany

CRESTOR 20 mg Filmtabletten

20 mg

Pilloli miksijin b’rita

Użu orali

Il-Ġermanja

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

AstraZeneca GmbH,

22876 Wedel,

Germany

CRESTOR 40 mg Filmtabletten

40 mg

Pilloli miksijin b’rita

Użu orali

Il-Greċja

| 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

Pilloli miksijin b’rita

Użu orali

Il-Greċja

| 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

Pilloli miksijin b’rita

Użu orali

Il-Greċja

| 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

Pilloli miksijin b’rita

Użu orali

Il-Greċja

| 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

Pilloli miksijin b’rita

Użu orali

L-Ungerija

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

AstraZeneca Kft.,

1113 Budapest,

Bocskai út 134-146.,

Hungary

Crestor 5 mg filmtabletta

5 mg

Pilloli miksijin b’rita

Użu orali

L-Ungerija

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

AstraZeneca Kft.,

1113 Budapest,

Bocskai út 134-146.,

Hungary

Crestor 10 mg filmtabletta

10 mg

Pilloli miksijin b’rita

Użu orali

L-Ungerija

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

AstraZeneca Kft.,

1113 Budapest,

Bocskai út 134-146.,

Hungary

Crestor 20 mg filmtabletta

20 mg

Pilloli miksijin b’rita

Użu orali

L-Islanda

| 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

Pilloli miksijin b’rita

Użu orali

L-Islanda

| 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

Pilloli miksijin b’rita

Użu orali

L-Islanda

| 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

Pilloli miksijin b’rita

Użu orali

L-Islanda

| 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

Pilloli miksijin b’rita

Użu orali

L-Irlanda

| 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

Pilloli miksijin b’rita

Użu orali

L-Irlanda

| 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

Pilloli miksijin b’rita

Użu orali

L-Irlanda

| 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

Pilloli miksijin b’rita

Użu orali

L-Irlanda

| 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

Pilloli miksijin b’rita

Użu orali

L-Italja

| 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

Pilloli miksijin b’rita

Użu orali

L-Italja

| 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

Pilloli miksijin b’rita

Użu orali

L-Italja

| 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

Pilloli miksijin b’rita

Użu orali

L-Italja

| 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

Pilloli miksijin b’rita

Użu orali

L-Italja

| 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

Pilloli miksijin b’rita

Użu orali

L-Italja

| 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

Pilloli miksijin b’rita

Użu orali

L-Italja

| 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

Pilloli miksijin b’rita

Użu orali

L-Italja

| 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

Pilloli miksijin b’rita

Użu orali

L-Italja

| 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

Pilloli miksijin b’rita

Użu orali

L-Italja

| 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

Pilloli miksijin b’rita

Użu orali

L-Italja

| 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

Pilloli miksijin b’rita

Użu orali

L-Italja

| 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

Pilloli miksijin b’rita

Użu orali

L-Italja

| 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

Pilloli miksijin b’rita

Użu orali

L-Italja

| 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

Pilloli miksijin b’rita

Użu orali

L-Italja

| 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

Pilloli miksijin b’rita

Użu orali

L-Italja

| 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

Pilloli miksijin b’rita

Użu orali

Il-Latvja

| 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

Pilloli miksijin b’rita

Użu orali

Il-Latvja

| 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

Pilloli miksijin b’rita

Użu orali

Il-Latvja

| 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

Pilloli miksijin b’rita

Użu orali

Il-Latvja

| 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

Pilloli miksijin b’rita

Użu orali

Il-Litwanja

| 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

Pilloli miksijin b’rita

Użu orali

Il-Litwanja

| 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

Pilloli miksijin b’rita

Użu orali

Il-Litwanja

| 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

Pilloli miksijin b’rita

Użu orali

Il-Litwanja

| 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

Pilloli miksijin b’rita

Użu orali

Il-Lussemburgu

| 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

Pilloli miksijin b’rita

Użu orali

Il-Lussemburgu

| 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

Pilloli miksijin b’rita

Użu orali

Il-Lussemburgu

| 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

Pilloli miksijin b’rita

Użu orali

Il-Lussemburgu

| 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

Pilloli miksijin b’rita

Użu orali

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

Pilloli miksijin b’rita

Użu orali

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

Pilloli miksijin b’rita

Użu orali

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

Pilloli miksijin b’rita

Użu orali

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

Pilloli miksijin b’rita

Użu orali

Il-Pajjiżi l-Baxxi

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

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Crestor

5 mg

Pilloli miksijin b’rita

Użu orali

Il-Pajjiżi l-Baxxi

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

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Crestor

10 mg

Pilloli miksijin b’rita

Użu orali

Il-Pajjiżi l-Baxxi

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

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Crestor

20 mg

Pilloli miksijin b’rita

Użu orali

Il-Pajjiżi l-Baxxi

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

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Crestor

40 mg

Pilloli miksijin b’rita

Użu orali

Il-Pajjiżi l-Baxxi

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

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Cirantan

5 mg

Pilloli miksijin b’rita

Użu orali

Il-Pajjiżi l-Baxxi

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

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Cirantan

10 mg

Pilloli miksijin b’rita

Użu orali

Il-Pajjiżi l-Baxxi

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

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Cirantan

20 mg

Pilloli miksijin b’rita

Użu orali

Il-Pajjiżi l-Baxxi

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

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Cirantan

40 mg

Pilloli miksijin b’rita

Użu orali

Il-Pajjiżi l-Baxxi

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

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Provisacor

5 mg

Pilloli miksijin b’rita

Użu orali

Il-Pajjiżi l-Baxxi

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

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Provisacor

10 mg

Pilloli miksijin b’rita

Użu orali

Il-Pajjiżi l-Baxxi

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

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Provisacor

20 mg

Pilloli miksijin b’rita

Użu orali

Il-Pajjiżi l-Baxxi

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

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Provisacor

40 mg

Pilloli miksijin b’rita

Użu orali

Il-Pajjiżi l-Baxxi

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

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Rosuvastatin AstraZeneca

5 mg

Pilloli miksijin b’rita

Użu orali

Il-Pajjiżi l-Baxxi

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

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Rosuvastatin AstraZeneca

10 mg

Pilloli miksijin b’rita

Użu orali

Il-Pajjiżi l-Baxxi

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

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Rosuvastatin AstraZeneca

20 mg

Pilloli miksijin b’rita

Użu orali

Il-Pajjiżi l-Baxxi

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

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Rosuvastatin AstraZeneca

40 mg

Pilloli miksijin b’rita

Użu orali

In-Norveġja

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

AstraZeneca AS

Postboks 6050,

Etterstad

0601 Oslo

Norway

Crestor

5 mg

Pilloli miksijin b’rita

Użu orali

In-Norveġja

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

AstraZeneca AS

Postboks 6050,

Etterstad

0601 Oslo

Norway

Crestor

10 mg

Pilloli miksijin b’rita

Użu orali

In-Norveġja

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

AstraZeneca AS

Postboks 6050,

Etterstad

0601 Oslo

Norway

Crestor

20 mg

Pilloli miksijin b’rita

Użu orali

In-Norveġja

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

AstraZeneca AS

Postboks 6050,

Etterstad

0601 Oslo

Norway

Crestor

40 mg

Pilloli miksijin b’rita

Użu orali

Il-Polonja

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

AstraZeneca AB,

S-151 85 Södertälje,

Sweden

Crestor

5 mg

Pilloli miksijin b’rita

Użu orali

Il-Polonja

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

AstraZeneca AB,

S-151 85 Södertälje,

Sweden

Crestor

10 mg

Pilloli miksijin b’rita

Użu orali

Il-Polonja

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

AstraZeneca AB,

S-151 85 Södertälje,

Sweden

Crestor

20 mg

Pilloli miksijin b’rita

Użu orali

Il-Polonja

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

AstraZeneca AB,

S-151 85 Södertälje,

Sweden

Crestor

40 mg

Pilloli miksijin b’rita

Użu orali

Il-Portugall

| 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

Pilloli miksijin b’rita

Użu orali

Il-Portugall

| 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

Pilloli miksijin b’rita

Użu orali

Il-Portugall

| 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

Pilloli miksijin b’rita

Użu orali

Il-Portugall

| 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

Pilloli miksijin b’rita

Użu orali

Il-Portugall

| 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

Pilloli miksijin b’rita

Użu orali

Il-Portugall

| 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

Pilloli miksijin b’rita

Użu orali

Il-Portugall

| 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

Pilloli miksijin b’rita

Użu orali

Il-Portugall

| 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

Pilloli miksijin b’rita

Użu orali

Ir-Rumanija

| 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

Pilloli miksijin b’rita

Użu orali

Ir-Rumanija

| 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

Pilloli miksijin b’rita

Użu orali

Ir-Rumanija

| 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

Pilloli miksijin b’rita

Użu orali

Ir-Rumanija

| 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

Pilloli miksijin b’rita

Użu orali

Ir-Repubblika Slovakka

| 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

Pilloli miksijin b’rita

Użu orali

Ir-Repubblika Slovakka

| 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

Pilloli miksijin b’rita

Użu orali

Ir-Repubblika Slovakka

| 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

Pilloli miksijin b’rita

Użu orali

Ir-Repubblika Slovakka

| 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

Pilloli miksijin b’rita

Użu orali

Is-Slovenja

| 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

Pilloli miksijin b’rita

Użu orali

Is-Slovenja

| 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

Pilloli miksijin b’rita

Użu orali

Is-Slovenja

| 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

Pilloli miksijin b’rita

Użu orali

Is-Slovenja

| 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

Pilloli miksijin b’rita

Użu orali

Spanja

| 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

Pilloli miksijin b’rita

Użu orali

Spanja

| 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

Pilloli miksijin b’rita

Użu orali

Spanja

| 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

Pilloli miksijin b’rita

Użu orali

Spanja

| 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

Pilloli miksijin b’rita

Użu orali

Spanja

| 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

Pilloli miksijin b’rita

Użu orali

Spanja

| 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

Pilloli miksijin b’rita

Użu orali

Spanja

| 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

Pilloli miksijin b’rita

Użu orali

Spanja

| 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

Pilloli miksijin b’rita

Użu orali

L-Isvezja

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

AstraZeneca AB,

S-151 85 Södertälje

Sweden

Crestor

5 mg

Pilloli miksijin b’rita

Użu orali

L-Isvezja

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

AstraZeneca AB,

S-151 85 Södertälje

Sweden

Crestor

10 mg

Pilloli miksijin b’rita

Użu orali

L-Isvezja

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

AstraZeneca AB,

S-151 85 Södertälje

Sweden

Crestor

20 mg

Pilloli miksijin b’rita

Użu orali

L-Isvezja

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

AstraZeneca AB,

S-151 85 Södertälje

Sweden

Crestor

40 mg

Pilloli miksijin b’rita

Użu orali

Ir-Renju Unit

| 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

Pilloli miksijin b’rita

Użu orali

Ir-Renju Unit

| 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

Pilloli miksijin b’rita

Użu orali

Ir-Renju Unit

| 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

Pilloli miksijin b’rita

Użu orali

Ir-Renju Unit

| 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

Pilloli miksijin b’rita

Użu orali

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