# Jurnalul Oficial C 115/28 m

| | ISSN 1977-1029 |
| --- | --- |
| Jurnalul Oficial
  al Uniunii Europene | C 115 |
| | |
| Ediţia în limba română | Comunicări şi informări | Anul 6128 martie 2018 |

ISSN 1977-1029

Jurnalul Oficial

al Uniunii Europene

C 115

Ediţia în limba română

Comunicări şi informări

Anul 6128 martie 2018

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| Informarea nr. | Cuprins | Pagina |
| --- | --- | --- |
| | IV   Informări |
| | INFORMĂRI PROVENIND DE LA INSTITUŢIILE, ORGANELE ȘI ORGANISMELE UNIUNII EUROPENE |
| | Comisia Europeană |
| 2018/C 115/01 | Rezumatul deciziilor Uniunii Europene privind autorizațiile de introducere pe piață pentru medicamentele de la 1 februarie 2018 până la 28 februarie 2018[Publicat în temeiul articolului 13 sau al articolului 38 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului] | 1 |
| 2018/C 115/02 | Rezumatul deciziilor Uniunii Europene privind autorizațiile de introducere pe piață pentru medicamentele de la 1 februarie 2018 până la 28 februarie 2018[Deciziile luate în temeiul articolului 34 din Directiva 2001/83/CE sau al articolului 38 din Directiva 2001/82/CE] | 9 |

Informarea nr.

Cuprins

Pagina

IV   Informări

INFORMĂRI PROVENIND DE LA INSTITUŢIILE, ORGANELE ȘI ORGANISMELE UNIUNII EUROPENE

Comisia Europeană

2018/C 115/01

Rezumatul deciziilor Uniunii Europene privind autorizațiile de introducere pe piață pentru medicamentele de la 1 februarie 2018 până la 28 februarie 2018[Publicat în temeiul articolului 13 sau al articolului 38 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului]

[Publicat în temeiul articolului 13 sau al articolului 38 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului]

1

2018/C 115/02

Rezumatul deciziilor Uniunii Europene privind autorizațiile de introducere pe piață pentru medicamentele de la 1 februarie 2018 până la 28 februarie 2018[Deciziile luate în temeiul articolului 34 din Directiva 2001/83/CE sau al articolului 38 din Directiva 2001/82/CE]

[Deciziile luate în temeiul articolului 34 din Directiva 2001/83/CE sau al articolului 38 din Directiva 2001/82/CE]

9

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| RO | |
| --- | --- |

RO

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IV Informări

INFORMĂRI PROVENIND DE LA INSTITUŢIILE, ORGANELE ȘI ORGANISMELE UNIUNII EUROPENE

Comisia Europeană

| 28.3.2018 | RO | Jurnalul Oficial al Uniunii Europene | C 115/1 |
| --- | --- | --- | --- |

28.3.2018

RO

Jurnalul Oficial al Uniunii Europene

C 115/1

---

Rezumatul deciziilor Uniunii Europene privind autorizațiile de introducere pe piață pentru medicamentele de la 1 februarie 2018 până la 28 februarie 2018

[Publicat în temeiul articolului 13 sau al articolului 38 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului (1)]

(2018/C 115/01)

| — | Emiterea unei autorizații de introducere pe piață [articolul 13 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului]: Acceptat |
| --- | --- |

—

Emiterea unei autorizații de introducere pe piață [articolul 13 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului]: Acceptat

| Data deciziei | Denumirea medicamentului | DCI (Denumirea Comună Internațională) | Titularul autorizației de introducere pe piață | Numărul de înregistrare în Registrul comunitar | Formă farmaceutică | Codul ATC (Codul Anatomic-Terapeutic-Chimic) | Data notificării |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 8.2.2018 | Efavirenz/Emtricitabine/Tenofovir disoproxil Krka | efavirenz / emtricitabină / tenofovir disoproxil | Krka d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/17/1263 | Comprimat filmat | J05AR06 | 12.2.2018 |
| 8.2.2018 | Ozempic | semaglutidă | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/17/1251 | Soluţie injectabilă | A10BJ06 | 12.2.2018 |
| 9.2.2018 | Alkindi | hidrocortizon | Diurnal Ltd
  Cardiff Medicentre, Heath Park, Cardiff CF14 4UJ, United Kingdom | EU/1/17/1260 | Granule ambalate în capsule care trebuie deschise | H02AB09 | 13.2.2018 |
| 9.2.2018 | Herzuma | trastuzumab | Celltrion Healthcare Hungary Kft.
  Bajcsy-Zsilinszky út 12., 4. em. 410, 1051 Budapest, Magyarország | EU/1/17/1257 | Pulbere pentru concentrat pentru soluţie perfuzabilă | L01XC03 | 13.2.2018 |
| 15.2.2018 | Anagrelidă Mylan | anagrelidă | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/17/1256 | Capsule | L01XX35 | 19.2.2018 |
| 19.2.2018 | CRYSVITA | Burosumab | Kyowa Kirin Limited
  Galabank Business Park, Galashiels, TD1 1QH, United Kingdom | EU/1/17/1262 | Soluţie injectabilă | M05BX | 21.2.2018 |
| 23.2.2018 | Hemlibra | emicizumab | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/18/1271 | Soluţie injectabilă | B02BX06 | 27.2.2018 |

Data deciziei

Denumirea medicamentului

DCI (Denumirea Comună Internațională)

Titularul autorizației de introducere pe piață

Numărul de înregistrare în Registrul comunitar

Formă farmaceutică

Codul ATC (Codul Anatomic-Terapeutic-Chimic)

Data notificării

8.2.2018

Efavirenz/Emtricitabine/Tenofovir disoproxil Krka

efavirenz / emtricitabină / tenofovir disoproxil

Krka d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/17/1263

Comprimat filmat

J05AR06

12.2.2018

8.2.2018

Ozempic

semaglutidă

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/17/1251

Soluţie injectabilă

A10BJ06

12.2.2018

9.2.2018

Alkindi

hidrocortizon

Diurnal Ltd

Cardiff Medicentre, Heath Park, Cardiff CF14 4UJ, United Kingdom

EU/1/17/1260

Granule ambalate în capsule care trebuie deschise

H02AB09

13.2.2018

9.2.2018

Herzuma

trastuzumab

Celltrion Healthcare Hungary Kft.

Bajcsy-Zsilinszky út 12., 4. em. 410, 1051 Budapest, Magyarország

EU/1/17/1257

Pulbere pentru concentrat pentru soluţie perfuzabilă

L01XC03

13.2.2018

15.2.2018

Anagrelidă Mylan

anagrelidă

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/17/1256

Capsule

L01XX35

19.2.2018

19.2.2018

CRYSVITA

Burosumab

Kyowa Kirin Limited

Galabank Business Park, Galashiels, TD1 1QH, United Kingdom

EU/1/17/1262

Soluţie injectabilă

M05BX

21.2.2018

23.2.2018

Hemlibra

emicizumab

Roche Registration Limited

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

EU/1/18/1271

Soluţie injectabilă

B02BX06

27.2.2018

| — | Modificarea unei autorizații de introducere pe piață [articolul 13 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului]: Acceptat |
| --- | --- |

—

Modificarea unei autorizații de introducere pe piață [articolul 13 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului]: Acceptat

| Data deciziei | Denumirea medicamentului | Titularul autorizației de introducere pe piață | Numărul de înregistrare în Registrul comunitar | Data notificării |
| --- | --- | --- | --- | --- |
| 5.2.2018 | Ebilfumin | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland | EU/1/14/915 | 7.2.2018 |
| 5.2.2018 | Episalvan | Amryt AG
  Streiflingsweg 11, 75223 Niefern-Öschelbronn, Deutschland | EU/1/15/1069 | 8.2.2018 |
| 5.2.2018 | NULOJIX | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/11/694 | 7.2.2018 |
| 5.2.2018 | Pedea | Orphan Europe S.A.R.L.
  Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France | EU/1/04/284 | 8.2.2018 |
| 5.2.2018 | Pregabalin Sandoz | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/15/1011 | 7.2.2018 |
| 5.2.2018 | Pregabalin Sandoz GmbH | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/15/1012 | 7.2.2018 |
| 5.2.2018 | PREZISTA | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/06/380 | 7.2.2018 |
| 5.2.2018 | Truvada | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/04/305 | 7.2.2018 |
| 5.2.2018 | Vedrop | Orphan Europe S.A.R.L.
  Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France | EU/1/09/533 | 8.2.2018 |
| 8.2.2018 | Bosulif | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/13/818 | 12.2.2018 |
| 8.2.2018 | Clorură de metiltioniniu Proveblue | Provepharm S.A.S.
  22 rue Marc Donadille, 13013 Marseille, France | EU/1/11/682 | 15.2.2018 |
| 8.2.2018 | Daptomycin Hospira | Hospira UK Limited
  Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom | EU/1/17/1175 | 12.2.2018 |
| 8.2.2018 | Esbriet | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/11/667 | 12.2.2018 |
| 8.2.2018 | Exforge | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/06/370 | 12.2.2018 |
| 8.2.2018 | Iclusig | Incyte Biosciences UK Ltd
  Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom | EU/1/13/839 | 12.2.2018 |
| 8.2.2018 | OLYSIO | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/14/924 | 12.2.2018 |
| 8.2.2018 | Rezolsta | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/14/967 | 12.2.2018 |
| 8.2.2018 | Thalidomide Celgene | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | EU/1/08/443 | 12.2.2018 |
| 8.2.2018 | VELCADE | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/04/274 | 12.2.2018 |
| 8.2.2018 | Victrelis | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/11/704 | 12.2.2018 |
| 8.2.2018 | Voriconazole Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/13/835 | 12.2.2018 |
| 8.2.2018 | Xtandi | Astellas Pharma Europe B.V.
  Sylviusweg 62, 2333 BE Leiden, Nederland | EU/1/13/846 | 12.2.2018 |
| 9.2.2018 | Caprelsa | Genzyme Europe B.V.
  Gooimeer 10, 1411 DD Naarden, Nederland | EU/1/11/749 | 13.2.2018 |
| 9.2.2018 | Cymbalta | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/04/296 | 13.2.2018 |
| 9.2.2018 | Cystadane | Orphan Europe S.A.R.L.
  Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France | EU/1/06/379 | 13.2.2018 |
| 9.2.2018 | Entyvio | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/14/923 | 13.2.2018 |
| 9.2.2018 | IMBRUVICA | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/14/945 | 13.2.2018 |
| 9.2.2018 | Neuraceq | Piramal Imaging Limited
  Langstone Technology Park, Langstone Road, Havant, Hampshire, PO9 1SA, United Kingdom | EU/1/13/906 | 13.2.2018 |
| 9.2.2018 | Ventavis | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/03/255 | 13.2.2018 |
| 15.2.2018 | Emselex | Merus Labs Luxco II S.à R.L.
  26-28, rue Edward Steichen, 2540 Luxembourg | EU/1/04/294 | 19.2.2018 |
| 15.2.2018 | Fosavance | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/05/310 | 19.2.2018 |
| 15.2.2018 | Vantavo | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/09/572 | 19.2.2018 |
| 16.2.2018 | Esmya | Gedeon Richter Plc.
  Gyömrői út 19-21., 1103 Budapest, Magyarország | EU/1/12/750 | 20.2.2018 |
| 19.2.2018 | Adcirca | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/08/476 | 21.2.2018 |
| 19.2.2018 | Aerivio Spiromax | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/16/1122 | 21.2.2018 |
| 19.2.2018 | Airexar Spiromax | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/16/1123 | 21.2.2018 |
| 19.2.2018 | Anoro | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/14/898 | 21.2.2018 |
| 19.2.2018 | Gardasil 9 | MSD VACCINS
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/15/1007 | 21.2.2018 |
| 19.2.2018 | Icandra | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/08/484 | 21.2.2018 |
| 19.2.2018 | Lyrica | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/04/279 | 21.2.2018 |
| 19.2.2018 | Mycamine | Astellas Pharma Europe B.V.
  Sylviusweg 62, 2333 BE Leiden, Nederland | EU/1/08/448 | 21.2.2018 |
| 19.2.2018 | Neulasta | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/02/227 | 21.2.2018 |
| 19.2.2018 | Nucala | GlaxoSmithKline Trading Services Limited
  Currabinny, Carrigaline, County Cork, Ireland | EU/1/15/1043 | 21.2.2018 |
| 19.2.2018 | Olanzapine Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/07/427 | 21.2.2018 |
| 19.2.2018 | Ongentys | Bial – Portela & Ca, SA
  À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado, Portugal | EU/1/15/1066 | 22.2.2018 |
| 19.2.2018 | Orkambi | Vertex Pharmaceuticals (Europe) Limited
  2 Kingdom Street, London W2 6BD, United Kingdom | EU/1/15/1059 | 21.2.2018 |
| 19.2.2018 | PegIntron | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/00/131 | 21.2.2018 |
| 19.2.2018 | Rebetol | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/99/107 | 21.2.2018 |
| 19.2.2018 | Senshio | Shionogi Limited
  33 Kingsway, London WC2B 6UF, United Kingdom | EU/1/14/978 | 21.2.2018 |
| 19.2.2018 | Simulect | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/98/084 | 21.2.2018 |
| 19.2.2018 | Talmanco | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/16/1153 | 21.2.2018 |
| 19.2.2018 | Tenofovir disoproxil Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/16/1129 | 21.2.2018 |
| 19.2.2018 | Vfend | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/02/212 | 21.2.2018 |
| 19.2.2018 | ViraferonPeg | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/00/132 | 21.2.2018 |
| 19.2.2018 | Wilzin | Orphan Europe S.A.R.L.
  Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France | EU/1/04/286 | 21.2.2018 |
| 19.2.2018 | Zyprexa Velotab | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/99/125 | 21.2.2018 |
| 22.2.2018 | Dynastat | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/02/209 | 26.2.2018 |
| 22.2.2018 | Eucreas | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/07/425 | 26.2.2018 |
| 22.2.2018 | NutropinAq | Ipsen Pharma
  65 quai Georges Gorse, 92100 Boulogne-Billancourt, France | EU/1/00/164 | 26.2.2018 |
| 22.2.2018 | Trulicity | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/14/956 | 26.2.2018 |
| 22.2.2018 | Zurampic | Grünenthal GmbH
  Zieglerstraße 6, 52078, Aachen, Deutschland | EU/1/15/1080 | 26.2.2018 |
| 27.2.2018 | Abasaglar | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/14/944 | 1.3.2018 |
| 27.2.2018 | Omnitrope | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/06/332 | 1.3.2018 |

Data deciziei

Denumirea medicamentului

Titularul autorizației de introducere pe piață

Numărul de înregistrare în Registrul comunitar

Data notificării

5.2.2018

Ebilfumin

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/14/915

7.2.2018

5.2.2018

Episalvan

Amryt AG

Streiflingsweg 11, 75223 Niefern-Öschelbronn, Deutschland

EU/1/15/1069

8.2.2018

5.2.2018

NULOJIX

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/11/694

7.2.2018

5.2.2018

Pedea

Orphan Europe S.A.R.L.

Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France

EU/1/04/284

8.2.2018

5.2.2018

Pregabalin Sandoz

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/15/1011

7.2.2018

5.2.2018

Pregabalin Sandoz GmbH

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/15/1012

7.2.2018

5.2.2018

PREZISTA

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/06/380

7.2.2018

5.2.2018

Truvada

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/04/305

7.2.2018

5.2.2018

Vedrop

Orphan Europe S.A.R.L.

Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France

EU/1/09/533

8.2.2018

8.2.2018

Bosulif

Pfizer Limited

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

EU/1/13/818

12.2.2018

8.2.2018

Clorură de metiltioniniu Proveblue

Provepharm S.A.S.

22 rue Marc Donadille, 13013 Marseille, France

EU/1/11/682

15.2.2018

8.2.2018

Daptomycin Hospira

Hospira UK Limited

Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom

EU/1/17/1175

12.2.2018

8.2.2018

Esbriet

Roche Registration Limited

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

EU/1/11/667

12.2.2018

8.2.2018

Exforge

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/06/370

12.2.2018

8.2.2018

Iclusig

Incyte Biosciences UK Ltd

Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom

EU/1/13/839

12.2.2018

8.2.2018

OLYSIO

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/924

12.2.2018

8.2.2018

Rezolsta

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/967

12.2.2018

8.2.2018

Thalidomide Celgene

Celgene Europe Limited

1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom

EU/1/08/443

12.2.2018

8.2.2018

VELCADE

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/04/274

12.2.2018

8.2.2018

Victrelis

Merck Sharp & Dohme Limited

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

EU/1/11/704

12.2.2018

8.2.2018

Voriconazole Accord

Accord Healthcare Limited

Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

EU/1/13/835

12.2.2018

8.2.2018

Xtandi

Astellas Pharma Europe B.V.

Sylviusweg 62, 2333 BE Leiden, Nederland

EU/1/13/846

12.2.2018

9.2.2018

Caprelsa

Genzyme Europe B.V.

Gooimeer 10, 1411 DD Naarden, Nederland

EU/1/11/749

13.2.2018

9.2.2018

Cymbalta

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/04/296

13.2.2018

9.2.2018

Cystadane

Orphan Europe S.A.R.L.

Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France

EU/1/06/379

13.2.2018

9.2.2018

Entyvio

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/14/923

13.2.2018

9.2.2018

IMBRUVICA

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/945

13.2.2018

9.2.2018

Neuraceq

Piramal Imaging Limited

Langstone Technology Park, Langstone Road, Havant, Hampshire, PO9 1SA, United Kingdom

EU/1/13/906

13.2.2018

9.2.2018

Ventavis

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/03/255

13.2.2018

15.2.2018

Emselex

Merus Labs Luxco II S.à R.L.

26-28, rue Edward Steichen, 2540 Luxembourg

EU/1/04/294

19.2.2018

15.2.2018

Fosavance

Merck Sharp & Dohme Limited

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

EU/1/05/310

19.2.2018

15.2.2018

Vantavo

Merck Sharp & Dohme Limited

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

EU/1/09/572

19.2.2018

16.2.2018

Esmya

Gedeon Richter Plc.

Gyömrői út 19-21., 1103 Budapest, Magyarország

EU/1/12/750

20.2.2018

19.2.2018

Adcirca

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/08/476

21.2.2018

19.2.2018

Aerivio Spiromax

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/16/1122

21.2.2018

19.2.2018

Airexar Spiromax

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/16/1123

21.2.2018

19.2.2018

Anoro

Glaxo Group Ltd

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

EU/1/14/898

21.2.2018

19.2.2018

Gardasil 9

MSD VACCINS

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/15/1007

21.2.2018

19.2.2018

Icandra

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/08/484

21.2.2018

19.2.2018

Lyrica

Pfizer Limited

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

EU/1/04/279

21.2.2018

19.2.2018

Mycamine

Astellas Pharma Europe B.V.

Sylviusweg 62, 2333 BE Leiden, Nederland

EU/1/08/448

21.2.2018

19.2.2018

Neulasta

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/02/227

21.2.2018

19.2.2018

Nucala

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

EU/1/15/1043

21.2.2018

19.2.2018

Olanzapine Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/07/427

21.2.2018

19.2.2018

Ongentys

Bial – Portela & Ca, SA

À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado, Portugal

EU/1/15/1066

22.2.2018

19.2.2018

Orkambi

Vertex Pharmaceuticals (Europe) Limited

2 Kingdom Street, London W2 6BD, United Kingdom

EU/1/15/1059

21.2.2018

19.2.2018

PegIntron

Merck Sharp & Dohme Limited

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

EU/1/00/131

21.2.2018

19.2.2018

Rebetol

Merck Sharp & Dohme Limited

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

EU/1/99/107

21.2.2018

19.2.2018

Senshio

Shionogi Limited

33 Kingsway, London WC2B 6UF, United Kingdom

EU/1/14/978

21.2.2018

19.2.2018

Simulect

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/98/084

21.2.2018

19.2.2018

Talmanco

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/16/1153

21.2.2018

19.2.2018

Tenofovir disoproxil Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/16/1129

21.2.2018

19.2.2018

Vfend

Pfizer Limited

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

EU/1/02/212

21.2.2018

19.2.2018

ViraferonPeg

Merck Sharp & Dohme Limited

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

EU/1/00/132

21.2.2018

19.2.2018

Wilzin

Orphan Europe S.A.R.L.

Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France

EU/1/04/286

21.2.2018

19.2.2018

Zyprexa Velotab

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/99/125

21.2.2018

22.2.2018

Dynastat

Pfizer Limited

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

EU/1/02/209

26.2.2018

22.2.2018

Eucreas

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/07/425

26.2.2018

22.2.2018

NutropinAq

Ipsen Pharma

65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/00/164

26.2.2018

22.2.2018

Trulicity

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/14/956

26.2.2018

22.2.2018

Zurampic

Grünenthal GmbH

Zieglerstraße 6, 52078, Aachen, Deutschland

EU/1/15/1080

26.2.2018

27.2.2018

Abasaglar

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/14/944

1.3.2018

27.2.2018

Omnitrope

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/06/332

1.3.2018

| — | Emiterea unei autorizații de introducere pe piață [articolul 38 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului]: Acceptat |
| --- | --- |

—

Emiterea unei autorizații de introducere pe piață [articolul 38 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului]: Acceptat

| Data deciziei | Denumirea medicamentului | DCI (Denumirea Comună Internațională) | Titularul autorizației de introducere pe piață | Numărul de înregistrare în Registrul comunitar | Formă farmaceutică | Codul ATC (Codul Anatomic-Terapeutic-Chimic) | Data notificării |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 7.2.2018 | Suvaxyn Circo | Vaccin circovirus porcin (inactivat, recombinant) | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/17/223 | Emulsie injectabilă | QI09AA07 | 9.2.2018 |

Data deciziei

Denumirea medicamentului

DCI (Denumirea Comună Internațională)

Titularul autorizației de introducere pe piață

Numărul de înregistrare în Registrul comunitar

Formă farmaceutică

Codul ATC (Codul Anatomic-Terapeutic-Chimic)

Data notificării

7.2.2018

Suvaxyn Circo

Vaccin circovirus porcin (inactivat, recombinant)

Zoetis Belgium S.A.

rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/17/223

Emulsie injectabilă

QI09AA07

9.2.2018

| — | Modificarea unei autorizații de introducere pe piață [articolul 38 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului]: Acceptat |
| --- | --- |

—

Modificarea unei autorizații de introducere pe piață [articolul 38 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului]: Acceptat

| Data deciziei | Denumirea medicamentului | Titularul autorizației de introducere pe piață | Numărul de înregistrare în Registrul comunitar | Data notificării |
| --- | --- | --- | --- | --- |
| 20.2.2018 | Advocate | Bayer Animal Health GmbH
  D-51368 Leverkusen, Deutschland | EU/2/03/039 | 22.2.2018 |
| 20.2.2018 | Porcilis PCV | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/08/091 | 22.2.2018 |
| 20.2.2018 | Porcilis PCV M Hyo | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/14/175 | 22.2.2018 |
| 20.2.2018 | Vectormune ND | CEVA-Phylaxia Co. Ltd.
  Szállás u. 5, 1107 Budapest, Magyarország | EU/2/15/188 | 22.2.2018 |

Data deciziei

Denumirea medicamentului

Titularul autorizației de introducere pe piață

Numărul de înregistrare în Registrul comunitar

Data notificării

20.2.2018

Advocate

Bayer Animal Health GmbH

D-51368 Leverkusen, Deutschland

EU/2/03/039

22.2.2018

20.2.2018

Porcilis PCV

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/08/091

22.2.2018

20.2.2018

Porcilis PCV M Hyo

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/14/175

22.2.2018

20.2.2018

Vectormune ND

CEVA-Phylaxia Co. Ltd.

Szállás u. 5, 1107 Budapest, Magyarország

EU/2/15/188

22.2.2018

Oricine este interesat să consulte raportul public de evaluare al medicamentului în cauză și deciziile aferente este invitat să contacteze:

| European Medicines Agency |
| --- |
| 30 Churchill Place |
| Canary Wharf |
| London E14 5EU |
| UNITED KINGDOM |

European Medicines Agency

30 Churchill Place

Canary Wharf

London E14 5EU

UNITED KINGDOM

---

(1)  JO L 136, 30.4.2004, p. 1.

---

| 28.3.2018 | RO | Jurnalul Oficial al Uniunii Europene | C 115/9 |
| --- | --- | --- | --- |

28.3.2018

RO

Jurnalul Oficial al Uniunii Europene

C 115/9

---

Rezumatul deciziilor Uniunii Europene privind autorizațiile de introducere pe piață pentru medicamentele de la 1 februarie 2018 până la 28 februarie 2018

[Deciziile luate în temeiul articolului 34 din Directiva 2001/83/CE (1) sau al articolului 38 din Directiva 2001/82/CE (2)]

(2018/C 115/02)

| — | Suspendarea unei autorizații naționale de introducere pe piață |
| --- | --- |

—

Suspendarea unei autorizații naționale de introducere pe piață

| Data deciziei | Denumirea medicamentului (medicamentelor) | DCI (Denumirea Comună Internațională) | Titularul (titularii) autorizației de introducere pe piață | Statul membru în cauză | Data notificării |
| --- | --- | --- | --- | --- | --- |
| 19.2.2018 | Paracetamol, modified and prolonged release | paracetamol, modified and prolonged release | A se vedea anexa I | A se vedea anexa I | 20.2.2018 |

Data deciziei

Denumirea medicamentului (medicamentelor)

DCI (Denumirea Comună Internațională)

Titularul (titularii) autorizației de introducere pe piață

Statul membru în cauză

Data notificării

19.2.2018

Paracetamol, modified and prolonged release

paracetamol, modified and prolonged release

A se vedea anexa I

A se vedea anexa I

20.2.2018

---

(1)  JO L 311, 28.11.2001, p. 67.

(2)  JO L 311, 28.11.2001, p. 1.

---

ANEXA I

Lista medicamentelor autorizate prin procedură națională

| Statul membru al
  UE/SEE | Titularul autorizației de punere pe piață | Numele inventat | INN + Concentrația | Forma farmaceutică | Calea de administrare |
| --- | --- | --- | --- | --- | --- |
| Belgia | GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V. | PANADOL RETARD 8 HEURES, 665 MG COMPRIMÉ À LIBÉRATION MODIFIÉE | PARACETAMOL 665MG COMPRIMAT | MODIFIED-RELEASE TABLET | ORAL USE |
| Belgia | GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V. | PANADOL RETARD 8 HEURES, 665 MG COMPRIMÉ À LIBÉRATION MODIFIÉE | PARACETAMOL 665MG COMPRIMAT | MODIFIED-RELEASE TABLET | ORAL USE |
| Belgia | GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V. | PANADOL RETARD 8 STUNDEN, 665 MG TABLETTE MIT VERÄNDERTER WIRKSTOFFFREISETZUNG PARACETAMOL | PARACETAMOL 665MG COMPRIMAT | MODIFIED-RELEASE TABLET | ORAL USE |
| Belgia | GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V. | PANADOL RETARD 8 STUNDEN, 665 MG TABLETTE MIT VERÄNDERTER WIRKSTOFFFREISETZUNG PARACETAMOL | PARACETAMOL 665MG COMPRIMAT | MODIFIED-RELEASE TABLET | ORAL USE |
| Belgia | GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V. | PANADOL RETARD 8 UUR, 665 MG TABLET MET GEREGULEERDE AFGIFTE | PARACETAMOL 665MG COMPRIMAT | MODIFIED-RELEASE TABLET | ORAL USE |
| Belgia | GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V. | PANADOL RETARD 8 UUR, 665 MG TABLET MET GEREGULEERDE AFGIFTE | PARACETAMOL 665MG COMPRIMAT | MODIFIED-RELEASE TABLET | ORAL USE |
| Bulgaria | KRKA, D.D., NOVO MESTO | ДОРЕТА SR 75 MG/650 MG ТАБЛЕТКИ С УДЪЛЖЕНО ОСВОБОЖДАВАНЕ | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Republica Cehă | KRKA, D.D., NOVO MESTO | DORETA PROLONG 75 MG/650 MG TABLETY S PRODLOUŽENÝM UVOLŇOVÁNÍM | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Danemarca | GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S | PANODIL RETARD, DEPOTTABLETTER | PARACETAMOL 500MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Danemarca | GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S | PANODIL, TABLETTER MED MODIFICERET UDLØSNING | PARACETAMOL 665MG COMPRIMAT | MODIFIED-RELEASE TABLET | ORAL USE |
| Danemarca | ACTAVIS GROUP HF. | PINEX RETARD | PARACETAMOL 500MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Estonia | KRKA, D.D., NOVO MESTO | DORETA, 75 MG/650 MG TOIMEAINET PROLONGEERITULT VABASTAVAD TABLETID | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Finlanda | GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S | PANADOL EXTEND 665 MG SÄÄDELLYSTI VAPAUTTAVA TABLETTI | PARACETAMOL 665MG COMPRIMAT | MODIFIED-RELEASE TABLET | ORAL USE |
| Finlanda | GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S | PANADOL EXTEND 665 MG TABLETT MED MODIFIERAD FRISÄTTNING PARACETAMOL | PARACETAMOL 665MG COMPRIMAT | MODIFIED-RELEASE TABLET | ORAL USE |
| Grecia | GLAXOSMITHKLINE CONSUMER HEALTHCARE HELLAS SA | PANADOL EXTEND 665 MG ΔΙΣΚΙΑ ΕΛΕΓΧOΜΕΝΗΣ ΑΠΟΔEΣΜΕΥΣΗΣ | PARACETAMOL 665MG COMPRIMAT | MODIFIED-RELEASE TABLET | ORAL USE |
| Ungaria | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG RETARD TABLETTA | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Ungaria | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG RETARD TABLETTA | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Ungaria | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG RETARD TABLETTA | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Ungaria | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG RETARD TABLETTA | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Ungaria | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG RETARD TABLETTA | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Ungaria | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG RETARD TABLETTA | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Ungaria | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG RETARD TABLETTA | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Ungaria | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG RETARD TABLETTA | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Ungaria | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG RETARD TABLETTA | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Ungaria | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG RETARD TABLETTA | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Islanda | GEBRO PHARMA GMBH | DILIBAN RETARD 75 MG/650 MG FORÐATÖFLUR | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Islanda | GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S | PANODIL EXTEND | PARACETAMOL 665MG COMPRIMAT | MODIFIED-RELEASE TABLET | ORAL USE |
| Islanda | ACTAVIS HF. | PARATABS RETARD | PARACETAMOL 500MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Letonia | KRKA, D.D., NOVO MESTO | DORETA 75 MG/650 MG ILGSTOŠĀS DARBĪBAS TABLETES | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Lituania | KRKA, D.D., NOVO MESTO | DORETA 75 MG/650 MG PAILGINTO ATPALAIDAVIMO TABLETĖS | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Lituania | KRKA, D.D., NOVO MESTO | DORETA 75 MG/650 MG PAILGINTO ATPALAIDAVIMO TABLETĖS | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Lituania | KRKA, D.D., NOVO MESTO | DORETA 75 MG/650 MG PAILGINTO ATPALAIDAVIMO TABLETĖS | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Lituania | KRKA, D.D., NOVO MESTO | DORETA 75 MG/650 MG PAILGINTO ATPALAIDAVIMO TABLETĖS | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Lituania | KRKA, D.D., NOVO MESTO | DORETA 75 MG/650 MG PAILGINTO ATPALAIDAVIMO TABLETĖS | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Lituania | KRKA, D.D., NOVO MESTO | DORETA 75 MG/650 MG PAILGINTO ATPALAIDAVIMO TABLETĖS | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Lituania | KRKA, D.D., NOVO MESTO | DORETA 75 MG/650 MG PAILGINTO ATPALAIDAVIMO TABLETĖS | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Luxemburg | GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V. | PANADOL RETARD 8 HEURES, 665 MG COMPRIMÉ À LIBÉRATION MODIFIÉE | PARACETAMOL 665MG COMPRIMAT | MODIFIED-RELEASE TABLET | ORAL USE |
| Luxemburg | GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V. | PANADOL RETARD 8 STUNDEN, 665 MG TABLETTE MIT VERÄNDERTER WIRKSTOFFFREISETZUNG PARACETAMOL | PARACETAMOL 665MG COMPRIMAT | MODIFIED-RELEASE TABLET | ORAL USE |
| Olanda | GLAXOSMITHKLINE CONSUMER HEALTHCARE B.V | PANADOL EXTEND 665 MG, TABLETTEN MET GEREGULEERDE AFGIFTE | PARACETAMOL 665MG COMPRIMAT | MODIFIED-RELEASE TABLET | ORAL USE |
| Polonia | KRKA, D.D., NOVO MESTO | DORETA SR, 75 MG + 650 MG, TABLETKI O PRZEDŁUŻONYM UWALNIANIU | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Portugalia | JABA RECORDATI, S.A. | DILIBAN RETARD 75 MG + 650 MG COMPRIMIDOS DE LIBERTAÇÃO PROLONGADA | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Portugalia | JABA RECORDATI, S.A. | DILIBAN RETARD 75 MG + 650 MG COMPRIMIDOS DE LIBERTAÇÃO PROLONGADA | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Portugalia | GLAXOSMITHKLINE CONSUMER HEALTHCARE, PRODUTOS PARA A SAÚDE E HIGIENE, LDA | PANADOL PROLONG, 665 MG, COMPRIMIDOS DE LIBERTAÇÃO PROLONGADA | PARACETAMOL 665MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Portugalia | KRKA, D.D., NOVO MESTO | TRAMADOL + PARACETAMOL KRKA 75 MG + 650 MG COMPRIMIDOS DE LIBERTAÇÃO PROLONGADA | PARACETAMOL 650MG COMPRIMAT, TRAMADOL 75MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Portugalia | KRKA, D.D., NOVO MESTO | TRAMADOL + PARACETAMOL KRKA 75 MG + 650 MG COMPRIMIDOS DE LIBERTAÇÃO PROLONGADA | PARACETAMOL 650MG COMPRIMAT, TRAMADOL 75MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Portugalia | KRKA, D.D., NOVO MESTO | TRAMADOL + PARACETAMOL KRKA 75 MG + 650 MG COMPRIMIDOS DE LIBERTAÇÃO PROLONGADA | PARACETAMOL 650MG COMPRIMAT, TRAMADOL 75MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Portugalia | KRKA, D.D., NOVO MESTO | TRAMADOL + PARACETAMOL KRKA 75 MG + 650 MG COMPRIMIDOS DE LIBERTAÇÃO PROLONGADA | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| România | KRKA, D.D., NOVO MESTO | DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| România | KRKA, D.D., NOVO MESTO | DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| România | KRKA, D.D., NOVO MESTO | DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| România | KRKA, D.D., NOVO MESTO | DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| România | KRKA, D.D., NOVO MESTO | DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| România | KRKA, D.D., NOVO MESTO | DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| România | KRKA, D.D., NOVO MESTO | DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| România | KRKA, D.D., NOVO MESTO | DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| România | KRKA, D.D., NOVO MESTO | DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| România | KRKA, D.D., NOVO MESTO | DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| România | KRKA, D.D., NOVO MESTO | DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| România | KRKA, D.D., NOVO MESTO | DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| România | KRKA, D.D., NOVO MESTO | DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| România | KRKA, D.D., NOVO MESTO | DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| România | GLAXOSMITHKLINE CONSUMER HEALTHCARE, GLAXOSMITHKLINE EXPORT LTD | PANADOL ARTRO 665 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ | PARACETAMOL 665MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| România | GLAXOSMITHKLINE CONSUMER HEALTHCARE, GLAXOSMITHKLINE EXPORT LTD | PANADOL ARTRO 665 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ | PARACETAMOL 665MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| România | GLAXOSMITHKLINE CONSUMER HEALTHCARE, GLAXOSMITHKLINE EXPORT LTD | PANADOL ARTRO 665 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ | PARACETAMOL 665MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| România | GLAXOSMITHKLINE CONSUMER HEALTHCARE, GLAXOSMITHKLINE EXPORT LTD | PANADOL ARTRO 665 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ | PARACETAMOL 665MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Republica Slovacă | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG TABLETY S PREDLŽENÝM UVOLNOVANÍM | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Slovenia | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Slovenia | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Slovenia | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Slovenia | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Slovenia | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Slovenia | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Slovenia | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Slovenia | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Slovenia | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Slovenia | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Slovenia | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Slovenia | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Slovenia | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Slovenia | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Spania | LABORATORIOS GEBRO PHARMA, S.A. | DILIBAN RETARD 75 MG/650 MG COMPRIMIDOS DE LIBERACIÓN PROLONGADA | CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT | PROLONGED-RELEASE TABLET | ORAL USE |
| Suedia | GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S | ALVEDON 665 MG TABLETT MED MODIFIERAD FRISÄTTNING | PARACETAMOL 665MG COMPRIMAT | COMPRIMAT CU ELIBERARE MODIFICATĂ | ADMINISTRARE ORALĂ |

Statul membru al

UE/SEE

Titularul autorizației de punere pe piață

Numele inventat

INN + Concentrația

Forma farmaceutică

Calea de administrare

Belgia

GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.

PANADOL RETARD 8 HEURES, 665 MG COMPRIMÉ À LIBÉRATION MODIFIÉE

PARACETAMOL 665MG COMPRIMAT

MODIFIED-RELEASE TABLET

ORAL USE

Belgia

GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.

PANADOL RETARD 8 HEURES, 665 MG COMPRIMÉ À LIBÉRATION MODIFIÉE

PARACETAMOL 665MG COMPRIMAT

MODIFIED-RELEASE TABLET

ORAL USE

Belgia

GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.

PANADOL RETARD 8 STUNDEN, 665 MG TABLETTE MIT VERÄNDERTER WIRKSTOFFFREISETZUNG PARACETAMOL

PARACETAMOL 665MG COMPRIMAT

MODIFIED-RELEASE TABLET

ORAL USE

Belgia

GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.

PANADOL RETARD 8 STUNDEN, 665 MG TABLETTE MIT VERÄNDERTER WIRKSTOFFFREISETZUNG PARACETAMOL

PARACETAMOL 665MG COMPRIMAT

MODIFIED-RELEASE TABLET

ORAL USE

Belgia

GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.

PANADOL RETARD 8 UUR, 665 MG TABLET MET GEREGULEERDE AFGIFTE

PARACETAMOL 665MG COMPRIMAT

MODIFIED-RELEASE TABLET

ORAL USE

Belgia

GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.

PANADOL RETARD 8 UUR, 665 MG TABLET MET GEREGULEERDE AFGIFTE

PARACETAMOL 665MG COMPRIMAT

MODIFIED-RELEASE TABLET

ORAL USE

Bulgaria

KRKA, D.D., NOVO MESTO

ДОРЕТА SR 75 MG/650 MG ТАБЛЕТКИ С УДЪЛЖЕНО ОСВОБОЖДАВАНЕ

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Republica Cehă

KRKA, D.D., NOVO MESTO

DORETA PROLONG 75 MG/650 MG TABLETY S PRODLOUŽENÝM UVOLŇOVÁNÍM

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Danemarca

GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S

PANODIL RETARD, DEPOTTABLETTER

PARACETAMOL 500MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Danemarca

GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S

PANODIL, TABLETTER MED MODIFICERET UDLØSNING

PARACETAMOL 665MG COMPRIMAT

MODIFIED-RELEASE TABLET

ORAL USE

Danemarca

ACTAVIS GROUP HF.

PINEX RETARD

PARACETAMOL 500MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Estonia

KRKA, D.D., NOVO MESTO

DORETA, 75 MG/650 MG TOIMEAINET PROLONGEERITULT VABASTAVAD TABLETID

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Finlanda

GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S

PANADOL EXTEND 665 MG SÄÄDELLYSTI VAPAUTTAVA TABLETTI

PARACETAMOL 665MG COMPRIMAT

MODIFIED-RELEASE TABLET

ORAL USE

Finlanda

GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S

PANADOL EXTEND 665 MG TABLETT MED MODIFIERAD FRISÄTTNING PARACETAMOL

PARACETAMOL 665MG COMPRIMAT

MODIFIED-RELEASE TABLET

ORAL USE

Grecia

GLAXOSMITHKLINE CONSUMER HEALTHCARE HELLAS SA

PANADOL EXTEND 665 MG ΔΙΣΚΙΑ ΕΛΕΓΧOΜΕΝΗΣ ΑΠΟΔEΣΜΕΥΣΗΣ

PARACETAMOL 665MG COMPRIMAT

MODIFIED-RELEASE TABLET

ORAL USE

Ungaria

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG RETARD TABLETTA

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Ungaria

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG RETARD TABLETTA

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Ungaria

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG RETARD TABLETTA

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Ungaria

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG RETARD TABLETTA

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Ungaria

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG RETARD TABLETTA

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Ungaria

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG RETARD TABLETTA

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Ungaria

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG RETARD TABLETTA

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Ungaria

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG RETARD TABLETTA

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Ungaria

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG RETARD TABLETTA

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Ungaria

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG RETARD TABLETTA

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Islanda

GEBRO PHARMA GMBH

DILIBAN RETARD 75 MG/650 MG FORÐATÖFLUR

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Islanda

GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S

PANODIL EXTEND

PARACETAMOL 665MG COMPRIMAT

MODIFIED-RELEASE TABLET

ORAL USE

Islanda

ACTAVIS HF.

PARATABS RETARD

PARACETAMOL 500MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Letonia

KRKA, D.D., NOVO MESTO

DORETA 75 MG/650 MG ILGSTOŠĀS DARBĪBAS TABLETES

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Lituania

KRKA, D.D., NOVO MESTO

DORETA 75 MG/650 MG PAILGINTO ATPALAIDAVIMO TABLETĖS

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Lituania

KRKA, D.D., NOVO MESTO

DORETA 75 MG/650 MG PAILGINTO ATPALAIDAVIMO TABLETĖS

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Lituania

KRKA, D.D., NOVO MESTO

DORETA 75 MG/650 MG PAILGINTO ATPALAIDAVIMO TABLETĖS

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Lituania

KRKA, D.D., NOVO MESTO

DORETA 75 MG/650 MG PAILGINTO ATPALAIDAVIMO TABLETĖS

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Lituania

KRKA, D.D., NOVO MESTO

DORETA 75 MG/650 MG PAILGINTO ATPALAIDAVIMO TABLETĖS

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Lituania

KRKA, D.D., NOVO MESTO

DORETA 75 MG/650 MG PAILGINTO ATPALAIDAVIMO TABLETĖS

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Lituania

KRKA, D.D., NOVO MESTO

DORETA 75 MG/650 MG PAILGINTO ATPALAIDAVIMO TABLETĖS

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Luxemburg

GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.

PANADOL RETARD 8 HEURES, 665 MG COMPRIMÉ À LIBÉRATION MODIFIÉE

PARACETAMOL 665MG COMPRIMAT

MODIFIED-RELEASE TABLET

ORAL USE

Luxemburg

GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.

PANADOL RETARD 8 STUNDEN, 665 MG TABLETTE MIT VERÄNDERTER WIRKSTOFFFREISETZUNG PARACETAMOL

PARACETAMOL 665MG COMPRIMAT

MODIFIED-RELEASE TABLET

ORAL USE

Olanda

GLAXOSMITHKLINE CONSUMER HEALTHCARE B.V

PANADOL EXTEND 665 MG, TABLETTEN MET GEREGULEERDE AFGIFTE

PARACETAMOL 665MG COMPRIMAT

MODIFIED-RELEASE TABLET

ORAL USE

Polonia

KRKA, D.D., NOVO MESTO

DORETA SR, 75 MG + 650 MG, TABLETKI O PRZEDŁUŻONYM UWALNIANIU

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Portugalia

JABA RECORDATI, S.A.

DILIBAN RETARD 75 MG + 650 MG COMPRIMIDOS DE LIBERTAÇÃO PROLONGADA

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Portugalia

JABA RECORDATI, S.A.

DILIBAN RETARD 75 MG + 650 MG COMPRIMIDOS DE LIBERTAÇÃO PROLONGADA

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Portugalia

GLAXOSMITHKLINE CONSUMER HEALTHCARE, PRODUTOS PARA A SAÚDE E HIGIENE, LDA

PANADOL PROLONG, 665 MG, COMPRIMIDOS DE LIBERTAÇÃO PROLONGADA

PARACETAMOL 665MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Portugalia

KRKA, D.D., NOVO MESTO

TRAMADOL + PARACETAMOL KRKA 75 MG + 650 MG COMPRIMIDOS DE LIBERTAÇÃO PROLONGADA

PARACETAMOL 650MG COMPRIMAT, TRAMADOL 75MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Portugalia

KRKA, D.D., NOVO MESTO

TRAMADOL + PARACETAMOL KRKA 75 MG + 650 MG COMPRIMIDOS DE LIBERTAÇÃO PROLONGADA

PARACETAMOL 650MG COMPRIMAT, TRAMADOL 75MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Portugalia

KRKA, D.D., NOVO MESTO

TRAMADOL + PARACETAMOL KRKA 75 MG + 650 MG COMPRIMIDOS DE LIBERTAÇÃO PROLONGADA

PARACETAMOL 650MG COMPRIMAT, TRAMADOL 75MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Portugalia

KRKA, D.D., NOVO MESTO

TRAMADOL + PARACETAMOL KRKA 75 MG + 650 MG COMPRIMIDOS DE LIBERTAÇÃO PROLONGADA

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

România

KRKA, D.D., NOVO MESTO

DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

România

KRKA, D.D., NOVO MESTO

DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

România

KRKA, D.D., NOVO MESTO

DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

România

KRKA, D.D., NOVO MESTO

DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

România

KRKA, D.D., NOVO MESTO

DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

România

KRKA, D.D., NOVO MESTO

DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

România

KRKA, D.D., NOVO MESTO

DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

România

KRKA, D.D., NOVO MESTO

DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

România

KRKA, D.D., NOVO MESTO

DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

România

KRKA, D.D., NOVO MESTO

DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

România

KRKA, D.D., NOVO MESTO

DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

România

KRKA, D.D., NOVO MESTO

DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

România

KRKA, D.D., NOVO MESTO

DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

România

KRKA, D.D., NOVO MESTO

DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

România

GLAXOSMITHKLINE CONSUMER HEALTHCARE, GLAXOSMITHKLINE EXPORT LTD

PANADOL ARTRO 665 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ

PARACETAMOL 665MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

România

GLAXOSMITHKLINE CONSUMER HEALTHCARE, GLAXOSMITHKLINE EXPORT LTD

PANADOL ARTRO 665 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ

PARACETAMOL 665MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

România

GLAXOSMITHKLINE CONSUMER HEALTHCARE, GLAXOSMITHKLINE EXPORT LTD

PANADOL ARTRO 665 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ

PARACETAMOL 665MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

România

GLAXOSMITHKLINE CONSUMER HEALTHCARE, GLAXOSMITHKLINE EXPORT LTD

PANADOL ARTRO 665 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ

PARACETAMOL 665MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Republica Slovacă

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG TABLETY S PREDLŽENÝM UVOLNOVANÍM

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Slovenia

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Slovenia

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Slovenia

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Slovenia

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Slovenia

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Slovenia

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Slovenia

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Slovenia

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Slovenia

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Slovenia

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Slovenia

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Slovenia

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Slovenia

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Slovenia

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Spania

LABORATORIOS GEBRO PHARMA, S.A.

DILIBAN RETARD 75 MG/650 MG COMPRIMIDOS DE LIBERACIÓN PROLONGADA

CLORHIDRAT DE TRAMADOL 75MG COMPRIMAT, PARACETAMOL 650MG COMPRIMAT

PROLONGED-RELEASE TABLET

ORAL USE

Suedia

GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S

ALVEDON 665 MG TABLETT MED MODIFIERAD FRISÄTTNING

PARACETAMOL 665MG COMPRIMAT

COMPRIMAT CU ELIBERARE MODIFICATĂ

ADMINISTRARE ORALĂ

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