# Official Journal C 115/28 M

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 115 |
| | |
| English edition | Information and Notices | Volume 6128 March 2018 |

ISSN 1977-091X

Official Journal

of the European Union

C 115

English edition

Information and Notices

Volume 6128 March 2018

---

| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2018/C 115/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2018 to 28 February 2018(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |
| 2018/C 115/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2018 to 28 February 2018(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 9 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2018/C 115/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2018 to 28 February 2018(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

1

2018/C 115/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2018 to 28 February 2018(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

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

9

---

| EN | |
| --- | --- |

EN

---

IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 28.3.2018 | EN | Official Journal of the European Union | C 115/1 |
| --- | --- | --- | --- |

28.3.2018

EN

Official Journal of the European Union

C 115/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2018 to 28 February 2018

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))

(2018/C 115/01)

| — | Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted |
| --- | --- |

—

Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 8.2.2018 | Efavirenz/Emtricitabine/Tenofovir disoproxil Krka | efavirenz/emtricitabine/tenofovir disoproxil | Krka d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/17/1263 | Film-coated tablet | J05AR06 | 12.2.2018 |
| 8.2.2018 | Ozempic | semaglutide | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/17/1251 | Solution for injection | A10BJ06 | 12.2.2018 |
| 9.2.2018 | Alkindi | hydrocortisone | Diurnal Ltd
  Cardiff Medicentre, Heath Park, Cardiff CF14 4UJ, United Kingdom | EU/1/17/1260 | Granules in capsules for opening | 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 | Powder for concentrate for solution for infusion | L01XC03 | 13.2.2018 |
| 15.2.2018 | Anagrelide Mylan | anagrelide | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/17/1256 | Capsule, hard | L01XX35 | 19.2.2018 |
| 19.2.2018 | CRYSVITA | Burosumab | Kyowa Kirin Limited
  Galabank Business Park, Galashiels, TD1 1QH, United Kingdom | EU/1/17/1262 | Solution for injection | 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 | Solution for injection | B02BX06 | 27.2.2018 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

8.2.2018

Efavirenz/Emtricitabine/Tenofovir disoproxil Krka

efavirenz/emtricitabine/tenofovir disoproxil

Krka d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/17/1263

Film-coated tablet

J05AR06

12.2.2018

8.2.2018

Ozempic

semaglutide

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/17/1251

Solution for injection

A10BJ06

12.2.2018

9.2.2018

Alkindi

hydrocortisone

Diurnal Ltd

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

EU/1/17/1260

Granules in capsules for opening

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

Powder for concentrate for solution for infusion

L01XC03

13.2.2018

15.2.2018

Anagrelide Mylan

anagrelide

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/17/1256

Capsule, hard

L01XX35

19.2.2018

19.2.2018

CRYSVITA

Burosumab

Kyowa Kirin Limited

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

EU/1/17/1262

Solution for injection

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

Solution for injection

B02BX06

27.2.2018

| — | Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted |
| --- | --- |

—

Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 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 | 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 | Methylthioninium chloride Proveblue | Provepharm S.A.S.
  22 rue Marc Donadille, 13013 Marseille, France | EU/1/11/682 | 15.2.2018 |
| 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 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

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

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

Methylthioninium chloride Proveblue

Provepharm S.A.S.

22 rue Marc Donadille, 13013 Marseille, France

EU/1/11/682

15.2.2018

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

| — | Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted |
| --- | --- |

—

Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 7.2.2018 | Suvaxyn Circo | Porcine circovirus vaccine (inactivated, recombinant) | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/17/223 | Emulsion for injection | QI09AA07 | 9.2.2018 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

7.2.2018

Suvaxyn Circo

Porcine circovirus vaccine (inactivated, recombinant)

Zoetis Belgium S.A.

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

EU/2/17/223

Emulsion for injection

QI09AA07

9.2.2018

| — | Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted |
| --- | --- |

—

Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 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 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

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

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

| 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)  OJ L 136, 30.4.2004, p. 1.

---

| 28.3.2018 | EN | Official Journal of the European Union | C 115/9 |
| --- | --- | --- | --- |

28.3.2018

EN

Official Journal of the European Union

C 115/9

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2018 to 28 February 2018

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

(2018/C 115/02)

| — | Suspension of a national marketing authorization |
| --- | --- |

—

Suspension of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | INN (International Non-Proprietary Name) | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- | --- |
| 19.2.2018 | Paracetamol, modified and prolonged release | paracetamol, modified and prolonged release | See Annex I | See Annex I | 20.2.2018 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorization

Member State concerned

Date of notification

19.2.2018

Paracetamol, modified and prolonged release

paracetamol, modified and prolonged release

See Annex I

See Annex I

20.2.2018

---

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

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

---

ANNEX I

List of nationally authorised medicinal products

| Member State
  EU/EEA | Marketing authorisation holder | Invented name | INN + Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Belgium | GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V. | PANADOL RETARD 8 HEURES, 665 MG COMPRIMÉ À LIBÉRATION MODIFIÉE | PARACETAMOL 665MG TABLET | MODIFIED-RELEASE TABLET | ORAL USE |
| Belgium | GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V. | PANADOL RETARD 8 HEURES, 665 MG COMPRIMÉ À LIBÉRATION MODIFIÉE | PARACETAMOL 665MG TABLET | MODIFIED-RELEASE TABLET | ORAL USE |
| Belgium | GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V. | PANADOL RETARD 8 STUNDEN, 665 MG TABLETTE MIT VERÄNDERTER WIRKSTOFFFREISETZUNG PARACETAMOL | PARACETAMOL 665MG TABLET | MODIFIED-RELEASE TABLET | ORAL USE |
| Belgium | GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V. | PANADOL RETARD 8 STUNDEN, 665 MG TABLETTE MIT VERÄNDERTER WIRKSTOFFFREISETZUNG PARACETAMOL | PARACETAMOL 665MG TABLET | MODIFIED-RELEASE TABLET | ORAL USE |
| Belgium | GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V. | PANADOL RETARD 8 UUR, 665 MG TABLET MET GEREGULEERDE AFGIFTE | PARACETAMOL 665MG TABLET | MODIFIED-RELEASE TABLET | ORAL USE |
| Belgium | GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V. | PANADOL RETARD 8 UUR, 665 MG TABLET MET GEREGULEERDE AFGIFTE | PARACETAMOL 665MG TABLET | MODIFIED-RELEASE TABLET | ORAL USE |
| Bulgaria | KRKA, D.D., NOVO MESTO | ДОРЕТА SR 75 MG/650 MG ТАБЛЕТКИ С УДЪЛЖЕНО ОСВОБОЖДАВАНЕ | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Czech Republic | KRKA, D.D., NOVO MESTO | DORETA PROLONG 75 MG/650 MG TABLETY S PRODLOUŽENÝM UVOLŇOVÁNÍM | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Denmark | GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S | PANODIL RETARD, DEPOTTABLETTER | PARACETAMOL 500MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Denmark | GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S | PANODIL, TABLETTER MED MODIFICERET UDLØSNING | PARACETAMOL 665MG TABLET | MODIFIED-RELEASE TABLET | ORAL USE |
| Denmark | ACTAVIS GROUP HF. | PINEX RETARD | PARACETAMOL 500MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Estonia | KRKA, D.D., NOVO MESTO | DORETA, 75 MG/650 MG TOIMEAINET PROLONGEERITULT VABASTAVAD TABLETID | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Finland | GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S | PANADOL EXTEND 665 MG SÄÄDELLYSTI VAPAUTTAVA TABLETTI | PARACETAMOL 665MG TABLET | MODIFIED-RELEASE TABLET | ORAL USE |
| Finland | GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S | PANADOL EXTEND 665 MG TABLETT MED MODIFIERAD FRISÄTTNING PARACETAMOL | PARACETAMOL 665MG TABLET | MODIFIED-RELEASE TABLET | ORAL USE |
| Greece | GLAXOSMITHKLINE CONSUMER HEALTHCARE HELLAS SA | PANADOL EXTEND 665 MG ΔΙΣΚΙΑ ΕΛΕΓΧOΜΕΝΗΣ ΑΠΟΔEΣΜΕΥΣΗΣ | PARACETAMOL 665MG TABLET | MODIFIED-RELEASE TABLET | ORAL USE |
| Hungary | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG RETARD TABLETTA | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Hungary | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG RETARD TABLETTA | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Hungary | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG RETARD TABLETTA | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Hungary | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG RETARD TABLETTA | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Hungary | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG RETARD TABLETTA | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Hungary | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG RETARD TABLETTA | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Hungary | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG RETARD TABLETTA | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Hungary | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG RETARD TABLETTA | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Hungary | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG RETARD TABLETTA | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Hungary | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG RETARD TABLETTA | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Iceland | GEBRO PHARMA GMBH | DILIBAN RETARD 75 MG/650 MG FORÐATÖFLUR | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Iceland | GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S | PANODIL EXTEND | PARACETAMOL 665MG TABLET | MODIFIED-RELEASE TABLET | ORAL USE |
| Iceland | ACTAVIS HF. | PARATABS RETARD | PARACETAMOL 500MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Latvia | KRKA, D.D., NOVO MESTO | DORETA 75 MG/650 MG ILGSTOŠĀS DARBĪBAS TABLETES | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Lithuania | KRKA, D.D., NOVO MESTO | DORETA 75 MG/650 MG PAILGINTO ATPALAIDAVIMO TABLETĖS | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Lithuania | KRKA, D.D., NOVO MESTO | DORETA 75 MG/650 MG PAILGINTO ATPALAIDAVIMO TABLETĖS | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Lithuania | KRKA, D.D., NOVO MESTO | DORETA 75 MG/650 MG PAILGINTO ATPALAIDAVIMO TABLETĖS | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Lithuania | KRKA, D.D., NOVO MESTO | DORETA 75 MG/650 MG PAILGINTO ATPALAIDAVIMO TABLETĖS | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Lithuania | KRKA, D.D., NOVO MESTO | DORETA 75 MG/650 MG PAILGINTO ATPALAIDAVIMO TABLETĖS | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Lithuania | KRKA, D.D., NOVO MESTO | DORETA 75 MG/650 MG PAILGINTO ATPALAIDAVIMO TABLETĖS | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Lithuania | KRKA, D.D., NOVO MESTO | DORETA 75 MG/650 MG PAILGINTO ATPALAIDAVIMO TABLETĖS | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Luxembourg | GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V. | PANADOL RETARD 8 HEURES, 665 MG COMPRIMÉ À LIBÉRATION MODIFIÉE | PARACETAMOL 665MG TABLET | MODIFIED-RELEASE TABLET | ORAL USE |
| Luxembourg | GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V. | PANADOL RETARD 8 STUNDEN, 665 MG TABLETTE MIT VERÄNDERTER WIRKSTOFFFREISETZUNG PARACETAMOL | PARACETAMOL 665MG TABLET | MODIFIED-RELEASE TABLET | ORAL USE |
| Netherlands | GLAXOSMITHKLINE CONSUMER HEALTHCARE B.V | PANADOL EXTEND 665 MG, TABLETTEN MET GEREGULEERDE AFGIFTE | PARACETAMOL 665MG TABLET | MODIFIED-RELEASE TABLET | ORAL USE |
| Poland | KRKA, D.D., NOVO MESTO | DORETA SR, 75 MG + 650 MG, TABLETKI O PRZEDŁUŻONYM UWALNIANIU | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Portugal | JABA RECORDATI, S.A. | DILIBAN RETARD 75 MG + 650 MG COMPRIMIDOS DE LIBERTAÇÃO PROLONGADA | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Portugal | JABA RECORDATI, S.A. | DILIBAN RETARD 75 MG + 650 MG COMPRIMIDOS DE LIBERTAÇÃO PROLONGADA | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Portugal | GLAXOSMITHKLINE CONSUMER HEALTHCARE, PRODUTOS PARA A SAÚDE E HIGIENE, LDA | PANADOL PROLONG, 665 MG, COMPRIMIDOS DE LIBERTAÇÃO PROLONGADA | PARACETAMOL 665MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Portugal | KRKA, D.D., NOVO MESTO | TRAMADOL + PARACETAMOL KRKA 75 MG + 650 MG COMPRIMIDOS DE LIBERTAÇÃO PROLONGADA | PARACETAMOL 650MG TABLET, TRAMADOL 75MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Portugal | KRKA, D.D., NOVO MESTO | TRAMADOL + PARACETAMOL KRKA 75 MG + 650 MG COMPRIMIDOS DE LIBERTAÇÃO PROLONGADA | PARACETAMOL 650MG TABLET, TRAMADOL 75MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Portugal | KRKA, D.D., NOVO MESTO | TRAMADOL + PARACETAMOL KRKA 75 MG + 650 MG COMPRIMIDOS DE LIBERTAÇÃO PROLONGADA | PARACETAMOL 650MG TABLET, TRAMADOL 75MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Portugal | KRKA, D.D., NOVO MESTO | TRAMADOL + PARACETAMOL KRKA 75 MG + 650 MG COMPRIMIDOS DE LIBERTAÇÃO PROLONGADA | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Romania | KRKA, D.D., NOVO MESTO | DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Romania | KRKA, D.D., NOVO MESTO | DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Romania | KRKA, D.D., NOVO MESTO | DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Romania | KRKA, D.D., NOVO MESTO | DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Romania | KRKA, D.D., NOVO MESTO | DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Romania | KRKA, D.D., NOVO MESTO | DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Romania | KRKA, D.D., NOVO MESTO | DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Romania | KRKA, D.D., NOVO MESTO | DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Romania | KRKA, D.D., NOVO MESTO | DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Romania | KRKA, D.D., NOVO MESTO | DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Romania | KRKA, D.D., NOVO MESTO | DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Romania | KRKA, D.D., NOVO MESTO | DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Romania | KRKA, D.D., NOVO MESTO | DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Romania | KRKA, D.D., NOVO MESTO | DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Romania | GLAXOSMITHKLINE CONSUMER HEALTHCARE, GLAXOSMITHKLINE EXPORT LTD | PANADOL ARTRO 665 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ | PARACETAMOL 665MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Romania | GLAXOSMITHKLINE CONSUMER HEALTHCARE, GLAXOSMITHKLINE EXPORT LTD | PANADOL ARTRO 665 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ | PARACETAMOL 665MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Romania | GLAXOSMITHKLINE CONSUMER HEALTHCARE, GLAXOSMITHKLINE EXPORT LTD | PANADOL ARTRO 665 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ | PARACETAMOL 665MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Romania | GLAXOSMITHKLINE CONSUMER HEALTHCARE, GLAXOSMITHKLINE EXPORT LTD | PANADOL ARTRO 665 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ | PARACETAMOL 665MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Slovakia | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG TABLETY S PREDLŽENÝM UVOLNOVANÍM | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Slovenia | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Slovenia | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Slovenia | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Slovenia | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Slovenia | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Slovenia | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Slovenia | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Slovenia | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Slovenia | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Slovenia | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Slovenia | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Slovenia | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Slovenia | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Slovenia | KRKA, D.D., NOVO MESTO | DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Spain | LABORATORIOS GEBRO PHARMA, S.A. | DILIBAN RETARD 75 MG/650 MG COMPRIMIDOS DE LIBERACIÓN PROLONGADA | TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET | PROLONGED-RELEASE TABLET | ORAL USE |
| Sweden | GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S | ALVEDON 665 MG TABLETT MED MODIFIERAD FRISÄTTNING | PARACETAMOL 665MG TABLET | MODIFIED-RELEASE TABLET | ORAL USE |

Member State

EU/EEA

Marketing authorisation holder

Invented name

INN + Strength

Pharmaceutical form

Route of administration

Belgium

GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.

PANADOL RETARD 8 HEURES, 665 MG COMPRIMÉ À LIBÉRATION MODIFIÉE

PARACETAMOL 665MG TABLET

MODIFIED-RELEASE TABLET

ORAL USE

Belgium

GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.

PANADOL RETARD 8 HEURES, 665 MG COMPRIMÉ À LIBÉRATION MODIFIÉE

PARACETAMOL 665MG TABLET

MODIFIED-RELEASE TABLET

ORAL USE

Belgium

GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.

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

PARACETAMOL 665MG TABLET

MODIFIED-RELEASE TABLET

ORAL USE

Belgium

GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.

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

PARACETAMOL 665MG TABLET

MODIFIED-RELEASE TABLET

ORAL USE

Belgium

GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.

PANADOL RETARD 8 UUR, 665 MG TABLET MET GEREGULEERDE AFGIFTE

PARACETAMOL 665MG TABLET

MODIFIED-RELEASE TABLET

ORAL USE

Belgium

GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.

PANADOL RETARD 8 UUR, 665 MG TABLET MET GEREGULEERDE AFGIFTE

PARACETAMOL 665MG TABLET

MODIFIED-RELEASE TABLET

ORAL USE

Bulgaria

KRKA, D.D., NOVO MESTO

ДОРЕТА SR 75 MG/650 MG ТАБЛЕТКИ С УДЪЛЖЕНО ОСВОБОЖДАВАНЕ

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Czech Republic

KRKA, D.D., NOVO MESTO

DORETA PROLONG 75 MG/650 MG TABLETY S PRODLOUŽENÝM UVOLŇOVÁNÍM

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Denmark

GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S

PANODIL RETARD, DEPOTTABLETTER

PARACETAMOL 500MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Denmark

GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S

PANODIL, TABLETTER MED MODIFICERET UDLØSNING

PARACETAMOL 665MG TABLET

MODIFIED-RELEASE TABLET

ORAL USE

Denmark

ACTAVIS GROUP HF.

PINEX RETARD

PARACETAMOL 500MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Estonia

KRKA, D.D., NOVO MESTO

DORETA, 75 MG/650 MG TOIMEAINET PROLONGEERITULT VABASTAVAD TABLETID

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Finland

GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S

PANADOL EXTEND 665 MG SÄÄDELLYSTI VAPAUTTAVA TABLETTI

PARACETAMOL 665MG TABLET

MODIFIED-RELEASE TABLET

ORAL USE

Finland

GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S

PANADOL EXTEND 665 MG TABLETT MED MODIFIERAD FRISÄTTNING PARACETAMOL

PARACETAMOL 665MG TABLET

MODIFIED-RELEASE TABLET

ORAL USE

Greece

GLAXOSMITHKLINE CONSUMER HEALTHCARE HELLAS SA

PANADOL EXTEND 665 MG ΔΙΣΚΙΑ ΕΛΕΓΧOΜΕΝΗΣ ΑΠΟΔEΣΜΕΥΣΗΣ

PARACETAMOL 665MG TABLET

MODIFIED-RELEASE TABLET

ORAL USE

Hungary

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG RETARD TABLETTA

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Hungary

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG RETARD TABLETTA

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Hungary

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG RETARD TABLETTA

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Hungary

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG RETARD TABLETTA

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Hungary

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG RETARD TABLETTA

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Hungary

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG RETARD TABLETTA

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Hungary

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG RETARD TABLETTA

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Hungary

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG RETARD TABLETTA

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Hungary

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG RETARD TABLETTA

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Hungary

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG RETARD TABLETTA

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Iceland

GEBRO PHARMA GMBH

DILIBAN RETARD 75 MG/650 MG FORÐATÖFLUR

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Iceland

GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S

PANODIL EXTEND

PARACETAMOL 665MG TABLET

MODIFIED-RELEASE TABLET

ORAL USE

Iceland

ACTAVIS HF.

PARATABS RETARD

PARACETAMOL 500MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Latvia

KRKA, D.D., NOVO MESTO

DORETA 75 MG/650 MG ILGSTOŠĀS DARBĪBAS TABLETES

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Lithuania

KRKA, D.D., NOVO MESTO

DORETA 75 MG/650 MG PAILGINTO ATPALAIDAVIMO TABLETĖS

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Lithuania

KRKA, D.D., NOVO MESTO

DORETA 75 MG/650 MG PAILGINTO ATPALAIDAVIMO TABLETĖS

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Lithuania

KRKA, D.D., NOVO MESTO

DORETA 75 MG/650 MG PAILGINTO ATPALAIDAVIMO TABLETĖS

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Lithuania

KRKA, D.D., NOVO MESTO

DORETA 75 MG/650 MG PAILGINTO ATPALAIDAVIMO TABLETĖS

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Lithuania

KRKA, D.D., NOVO MESTO

DORETA 75 MG/650 MG PAILGINTO ATPALAIDAVIMO TABLETĖS

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Lithuania

KRKA, D.D., NOVO MESTO

DORETA 75 MG/650 MG PAILGINTO ATPALAIDAVIMO TABLETĖS

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Lithuania

KRKA, D.D., NOVO MESTO

DORETA 75 MG/650 MG PAILGINTO ATPALAIDAVIMO TABLETĖS

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Luxembourg

GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.

PANADOL RETARD 8 HEURES, 665 MG COMPRIMÉ À LIBÉRATION MODIFIÉE

PARACETAMOL 665MG TABLET

MODIFIED-RELEASE TABLET

ORAL USE

Luxembourg

GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.

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

PARACETAMOL 665MG TABLET

MODIFIED-RELEASE TABLET

ORAL USE

Netherlands

GLAXOSMITHKLINE CONSUMER HEALTHCARE B.V

PANADOL EXTEND 665 MG, TABLETTEN MET GEREGULEERDE AFGIFTE

PARACETAMOL 665MG TABLET

MODIFIED-RELEASE TABLET

ORAL USE

Poland

KRKA, D.D., NOVO MESTO

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

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Portugal

JABA RECORDATI, S.A.

DILIBAN RETARD 75 MG + 650 MG COMPRIMIDOS DE LIBERTAÇÃO PROLONGADA

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Portugal

JABA RECORDATI, S.A.

DILIBAN RETARD 75 MG + 650 MG COMPRIMIDOS DE LIBERTAÇÃO PROLONGADA

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Portugal

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

PANADOL PROLONG, 665 MG, COMPRIMIDOS DE LIBERTAÇÃO PROLONGADA

PARACETAMOL 665MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Portugal

KRKA, D.D., NOVO MESTO

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

PARACETAMOL 650MG TABLET, TRAMADOL 75MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Portugal

KRKA, D.D., NOVO MESTO

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

PARACETAMOL 650MG TABLET, TRAMADOL 75MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Portugal

KRKA, D.D., NOVO MESTO

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

PARACETAMOL 650MG TABLET, TRAMADOL 75MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Portugal

KRKA, D.D., NOVO MESTO

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

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Romania

KRKA, D.D., NOVO MESTO

DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Romania

KRKA, D.D., NOVO MESTO

DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Romania

KRKA, D.D., NOVO MESTO

DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Romania

KRKA, D.D., NOVO MESTO

DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Romania

KRKA, D.D., NOVO MESTO

DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Romania

KRKA, D.D., NOVO MESTO

DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Romania

KRKA, D.D., NOVO MESTO

DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Romania

KRKA, D.D., NOVO MESTO

DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Romania

KRKA, D.D., NOVO MESTO

DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Romania

KRKA, D.D., NOVO MESTO

DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Romania

KRKA, D.D., NOVO MESTO

DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Romania

KRKA, D.D., NOVO MESTO

DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Romania

KRKA, D.D., NOVO MESTO

DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Romania

KRKA, D.D., NOVO MESTO

DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Romania

GLAXOSMITHKLINE CONSUMER HEALTHCARE, GLAXOSMITHKLINE EXPORT LTD

PANADOL ARTRO 665 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ

PARACETAMOL 665MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Romania

GLAXOSMITHKLINE CONSUMER HEALTHCARE, GLAXOSMITHKLINE EXPORT LTD

PANADOL ARTRO 665 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ

PARACETAMOL 665MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Romania

GLAXOSMITHKLINE CONSUMER HEALTHCARE, GLAXOSMITHKLINE EXPORT LTD

PANADOL ARTRO 665 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ

PARACETAMOL 665MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Romania

GLAXOSMITHKLINE CONSUMER HEALTHCARE, GLAXOSMITHKLINE EXPORT LTD

PANADOL ARTRO 665 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ

PARACETAMOL 665MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Slovakia

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG TABLETY S PREDLŽENÝM UVOLNOVANÍM

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Slovenia

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Slovenia

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Slovenia

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Slovenia

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Slovenia

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Slovenia

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Slovenia

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Slovenia

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Slovenia

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Slovenia

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Slovenia

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Slovenia

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Slovenia

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Slovenia

KRKA, D.D., NOVO MESTO

DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Spain

LABORATORIOS GEBRO PHARMA, S.A.

DILIBAN RETARD 75 MG/650 MG COMPRIMIDOS DE LIBERACIÓN PROLONGADA

TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET

PROLONGED-RELEASE TABLET

ORAL USE

Sweden

GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S

ALVEDON 665 MG TABLETT MED MODIFIERAD FRISÄTTNING

PARACETAMOL 665MG TABLET

MODIFIED-RELEASE TABLET

ORAL USE

---