# C_2016490EN.01000101.xml

| 30.12.2016 | EN | Official Journal of the European Union | C 490/1 |
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30.12.2016

EN

Official Journal of the European Union

C 490/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2016 to 30 November 2016

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

1

(2016/C 490/01)

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

Issuing of a marketing authorisation

Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 9.11.2016 | Emtricitabine/Tenofovir disoproxil Zentiva | emtricitabine/tenofovir disoproxil | Zentiva, k.s.
  U Kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/16/1148 | Film-coated tablet | J05AR03 | 11.11.2016 |
| 9.11.2016 | IBRANCE | palbociclib | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/16/1147 | Capsule, hard | L01XE33 | 11.11.2016 |
| 9.11.2016 | Lartruvo | olaratumab | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/16/1143 | Concentrate for solution for infusion | L01XC27 | 11.11.2016 |
| 11.11.2016 | Glyxambi | empagliflozin/linagliptin | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/16/1146 | Film-coated tablet | A10BD19 | 15.11.2016 |
| 11.11.2016 | Ivabradine JensonR | ivabradine | JensonR+ Limited
  Fishleigh Court, Fishleigh Road, Barnstaple, Devon, EX31 UD, United Kingdom | EU/1/16/1145 | Film-coated tablet | C01EB17 | 15.11.2016 |
| 11.11.2016 | Ivabradine Zentiva | ivabradine | Zentiva, k.s.
  U Kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/16/1144 | Film-coated tablet | C01EB17 | 15.11.2016 |
| 11.11.2016 | Parsabiv | etelcalcetide | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/16/1142 | Solution for injection | H05BX04 | 15.11.2016 |
| 11.11.2016 | XALKORI | crizotinib | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/12/793 | Capsule, hard | L01XE16 | 15.11.2016 |
| 14.11.2016 | Erivedge | vismodegib | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/13/848 | Capsule, hard | L01XX43 | 16.11.2016 |
| 14.11.2016 | Granpidam | sildenafil | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/16/1137 | Film-coated tablet | G04BE03 | 16.11.2016 |
| 21.11.2016 | Ninlaro | ixazomib | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/16/1094 | Capsule, hard | L01XX50 | 23.11.2016 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

9.11.2016

Emtricitabine/Tenofovir disoproxil Zentiva

emtricitabine/tenofovir disoproxil

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/16/1148

Film-coated tablet

J05AR03

11.11.2016

9.11.2016

IBRANCE

palbociclib

Pfizer Limited

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

EU/1/16/1147

Capsule, hard

L01XE33

11.11.2016

9.11.2016

Lartruvo

olaratumab

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/16/1143

Concentrate for solution for infusion

L01XC27

11.11.2016

11.11.2016

Glyxambi

empagliflozin/linagliptin

Boehringer Ingelheim International GmbH

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

EU/1/16/1146

Film-coated tablet

A10BD19

15.11.2016

11.11.2016

Ivabradine JensonR

ivabradine

JensonR+ Limited

Fishleigh Court, Fishleigh Road, Barnstaple, Devon, EX31 UD, United Kingdom

EU/1/16/1145

Film-coated tablet

C01EB17

15.11.2016

11.11.2016

Ivabradine Zentiva

ivabradine

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/16/1144

Film-coated tablet

C01EB17

15.11.2016

11.11.2016

Parsabiv

etelcalcetide

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/16/1142

Solution for injection

H05BX04

15.11.2016

11.11.2016

XALKORI

crizotinib

Pfizer Limited

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

EU/1/12/793

Capsule, hard

L01XE16

15.11.2016

14.11.2016

Erivedge

vismodegib

Roche Registration Limited

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

EU/1/13/848

Capsule, hard

L01XX43

16.11.2016

14.11.2016

Granpidam

sildenafil

Accord Healthcare Limited

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

EU/1/16/1137

Film-coated tablet

G04BE03

16.11.2016

21.11.2016

Ninlaro

ixazomib

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/16/1094

Capsule, hard

L01XX50

23.11.2016

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

Modification of a marketing authorisation

Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 3.11.2016 | Daliresp | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/11/668 | 7.11.2016 |
| 3.11.2016 | Emtriva | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/03/261 | 7.11.2016 |
| 3.11.2016 | Intanza | Sanofi Pasteur Europe
  2 Avenue Pont Pasteur, 69007 Lyon, France | EU/1/08/505 | 7.11.2016 |
| 3.11.2016 | Libertek | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/11/666 | 7.11.2016 |
| 3.11.2016 | Vibativ | Theravance Biopharma Ireland Limited
  Fitzwilliam Hall, Fitzwilliam Place, Dublin 2, Ireland | EU/1/11/705 | 7.11.2016 |
| 9.11.2016 | Iclusig | Incyte Biosciences UK Ltd
  Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom | EU/1/13/839 | 11.11.2016 |
| 9.11.2016 | Lyrica | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/04/279 | 11.11.2016 |
| 9.11.2016 | Sutent | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/06/347 | 11.11.2016 |
| 9.11.2016 | Zytiga | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/11/714 | 14.11.2016 |
| 11.11.2016 | Abraxane | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge UB11 1DB, United Kingdom | EU/1/07/428 | 15.11.2016 |
| 11.11.2016 | Desloratadine Actavis | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland | EU/1/11/745 | 15.11.2016 |
| 11.11.2016 | Erivedge | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/13/848 | 15.11.2016 |
| 11.11.2016 | Foscan | biolitec Pharma Ltd.
  Otto-Schott-Str. 15, 07745 Jena, Deutschland | EU/1/01/197 | 15.11.2016 |
| 11.11.2016 | Glidipion | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland | EU/1/12/756 | 15.11.2016 |
| 11.11.2016 | Hexyon | Sanofi Pasteur Europe
  2 Avenue Pont Pasteur, 69007 Lyon, France | EU/1/13/829 | 15.11.2016 |
| 11.11.2016 | Incruse | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/14/922 | 15.11.2016 |
| 11.11.2016 | Keppra | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/00/146 | 15.11.2016 |
| 11.11.2016 | Lojuxta | Aegerion Pharmaceuticals Limited
  Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge UB11 1BD, United Kingdom | EU/1/13/851 | 15.11.2016 |
| 11.11.2016 | Lucentis | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/06/374 | 15.11.2016 |
| 11.11.2016 | Mirvaso | Galderma International
  Tour Europlaza, 20 avenue André Prothin, La Défense 4, La Défense Cedex 92927, France | EU/1/13/904 | 15.11.2016 |
| 11.11.2016 | Neuraceq | Piramal Imaging Limited
  Langstone Technology Park, Langstone Road, Havant, Hampshire, PO9 1SA, United Kingdom | EU/1/13/906 | 15.11.2016 |
| 11.11.2016 | Picato | Leo Pharma A/S
  Industriparken 55, DK-2750 Ballerup, Danmark | EU/1/12/796 | 15.11.2016 |
| 11.11.2016 | Pioglitazone Actavis | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland | EU/1/12/755 | 15.11.2016 |
| 11.11.2016 | Pregabalin Pfizer | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/14/916 | 15.11.2016 |
| 11.11.2016 | Stelara | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/08/494 | 15.11.2016 |
| 11.11.2016 | Strensiq | Alexion Europe SAS
  1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France | EU/1/15/1015 | 15.11.2016 |
| 11.11.2016 | Taxespira | Hospira UK Limited
  Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom | EU/1/15/1017 | 15.11.2016 |
| 11.11.2016 | Teysuno | Nordic Group B.V.
  Siriusdreef 22, NL-2132 WT Hoofddorp, Nederland | EU/1/11/669 | 15.11.2016 |
| 11.11.2016 | Translarna | PTC Therapeutics International Limited
  77 Sir John Rogerson’s Quay, Dublin 2, Ireland | EU/1/13/902 | 15.11.2016 |
| 14.11.2016 | Bretaris Genuair | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/12/781 | 16.11.2016 |
| 14.11.2016 | Clopidogrel ratiopharm | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/14/975 | 16.11.2016 |
| 14.11.2016 | Duloxetine Zentiva | Zentiva, k.s.
  U Kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/15/1028 | 16.11.2016 |
| 14.11.2016 | Edarbi | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/11/734 | 16.11.2016 |
| 14.11.2016 | Eklira Genuair | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/12/778 | 16.11.2016 |
| 14.11.2016 | Esmya | Gedeon Richter Plc.
  Gyömrői út 19-21., H-1103 Budapest, Magyarország | EU/1/12/750 | 16.11.2016 |
| 14.11.2016 | Giotrif | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/13/879 | 16.11.2016 |
| 14.11.2016 | Iasibon | Pharmathen S.A.
  6 Dervenakion, 15351 Pallini Attiki, Ελλάδα | EU/1/10/659 | 16.11.2016 |
| 14.11.2016 | Isentress | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/436 | 16.11.2016 |
| 14.11.2016 | Levetiracetam SUN | Sun Pharmaceutical Industries Europe BV
  Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland | EU/1/11/741 | 16.11.2016 |
| 14.11.2016 | Lucentis | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/06/374 | 16.11.2016 |
| 14.11.2016 | Numient | Impax Laboratories Ireland Limited, 56 Fitzwilliam Square, Dublin 2, Ireland | EU/1/15/1044 | 16.11.2016 |
| 14.11.2016 | Pioglitazone Actavis | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland | EU/1/12/755 | 17.11.2016 |
| 14.11.2016 | Pioglitazone Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/12/757 | 16.11.2016 |
| 14.11.2016 | Praluent | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/15/1031 | 16.11.2016 |
| 14.11.2016 | Ribavirin Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/509 | 16.11.2016 |
| 14.11.2016 | Ribavirin Teva Pharma BV | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/527 | 16.11.2016 |
| 14.11.2016 | Topotecan Hospira | Hospira UK Limited
  Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom | EU/1/10/633 | 16.11.2016 |
| 14.11.2016 | Trisenox | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/02/204 | 16.11.2016 |
| 14.11.2016 | Triumeq | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/14/940 | 16.11.2016 |
| 18.11.2016 | Daxas | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/10/636 | 22.11.2016 |
| 18.11.2016 | Jakavi | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/12/773 | 22.11.2016 |
| 18.11.2016 | Pioglitazone Teva Pharma | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/12/758 | 22.11.2016 |
| 18.11.2016 | Procysbi | Raptor Pharmaceuticals Europe BV
  Naritaweg 165, NL-1043 BW Amsterdam, Nederland | EU/1/13/861 | 22.12.2016 |
| 18.11.2016 | Selincro | H. Lundbeck A/S
  Ottiliavej 9, DK-2500 Valby, Danmark | EU/1/12/815 | 22.11.2016 |
| 18.11.2016 | Signifor | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/12/753 | 22.11.2016 |
| 18.11.2016 | Thymanax | Servier (Ireland) Industries Limited
  Gorey Road, Arklow, Co. Wicklow, Ireland | EU/1/08/498 | 22.11.2016 |
| 18.11.2016 | Valdoxan | Les Laboratoires Servier
  50 rue Carnot, F-92284 Suresnes Cedex, France | EU/1/08/499 | 22.11.2016 |
| 18.11.2016 | Xaluprine | Nova Laboratories Limited
  Martin House, Gloucester Crescent, Wigston Leicester, LE18 4YL, United Kingdom | EU/1/11/727 | 22.11.2016 |
| 21.11.2016 | Ameluz | Biofrontera Bioscience GmbH
  Hemmelrather Weg 201, D-51377 Leverkusen, Deutschland | EU/1/11/740 | 23.11.2016 |
| 21.11.2016 | Bemfola | Gedeon Richter Plc.
  Gyömrői út 19-21., H-1103 Budapest, Magyarország | EU/1/13/909 | 23.11.2016 |
| 21.11.2016 | Cystadane | Orphan Europe S.A.R.L.
  Immeuble Le Wilson, 70 avenue du Général de Gaulle, F- 92 800 Puteaux, France | EU/1/06/379 | 23.11.2016 |
| 21.11.2016 | Elonva | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/09/609 | 23.11.2016 |
| 21.11.2016 | Opdivo | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/15/1014 | 23.11.2016 |
| 29.11.2016 | Ammonaps | Swedish Orphan Biovitrum International AB
  SE-112 76 Stockholm, Sverige | EU/1/99/120 | 1.12.2016 |
| 29.11.2016 | PANTOLOC Control | Takeda GmbH, (HRB 701016)
  Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | EU/1/09/519 | 1.12.2016 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

3.11.2016

Daliresp

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/11/668

7.11.2016

3.11.2016

Emtriva

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/03/261

7.11.2016

3.11.2016

Intanza

Sanofi Pasteur Europe

2 Avenue Pont Pasteur, 69007 Lyon, France

EU/1/08/505

7.11.2016

3.11.2016

Libertek

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/11/666

7.11.2016

3.11.2016

Vibativ

Theravance Biopharma Ireland Limited

Fitzwilliam Hall, Fitzwilliam Place, Dublin 2, Ireland

EU/1/11/705

7.11.2016

9.11.2016

Iclusig

Incyte Biosciences UK Ltd

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

EU/1/13/839

11.11.2016

9.11.2016

Lyrica

Pfizer Limited

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

EU/1/04/279

11.11.2016

9.11.2016

Sutent

Pfizer Limited

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

EU/1/06/347

11.11.2016

9.11.2016

Zytiga

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/11/714

14.11.2016

11.11.2016

Abraxane

Celgene Europe Limited

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

EU/1/07/428

15.11.2016

11.11.2016

Desloratadine Actavis

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/11/745

15.11.2016

11.11.2016

Erivedge

Roche Registration Limited

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

EU/1/13/848

15.11.2016

11.11.2016

Foscan

biolitec Pharma Ltd.

Otto-Schott-Str. 15, 07745 Jena, Deutschland

EU/1/01/197

15.11.2016

11.11.2016

Glidipion

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/12/756

15.11.2016

11.11.2016

Hexyon

Sanofi Pasteur Europe

2 Avenue Pont Pasteur, 69007 Lyon, France

EU/1/13/829

15.11.2016

11.11.2016

Incruse

Glaxo Group Ltd

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

EU/1/14/922

15.11.2016

11.11.2016

Keppra

UCB Pharma S.A.

Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België

EU/1/00/146

15.11.2016

11.11.2016

Lojuxta

Aegerion Pharmaceuticals Limited

Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge UB11 1BD, United Kingdom

EU/1/13/851

15.11.2016

11.11.2016

Lucentis

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/06/374

15.11.2016

11.11.2016

Mirvaso

Galderma International

Tour Europlaza, 20 avenue André Prothin, La Défense 4, La Défense Cedex 92927, France

EU/1/13/904

15.11.2016

11.11.2016

Neuraceq

Piramal Imaging Limited

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

EU/1/13/906

15.11.2016

11.11.2016

Picato

Leo Pharma A/S

Industriparken 55, DK-2750 Ballerup, Danmark

EU/1/12/796

15.11.2016

11.11.2016

Pioglitazone Actavis

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/12/755

15.11.2016

11.11.2016

Pregabalin Pfizer

Pfizer Limited

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

EU/1/14/916

15.11.2016

11.11.2016

Stelara

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/08/494

15.11.2016

11.11.2016

Strensiq

Alexion Europe SAS

1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France

EU/1/15/1015

15.11.2016

11.11.2016

Taxespira

Hospira UK Limited

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

EU/1/15/1017

15.11.2016

11.11.2016

Teysuno

Nordic Group B.V.

Siriusdreef 22, NL-2132 WT Hoofddorp, Nederland

EU/1/11/669

15.11.2016

11.11.2016

Translarna

PTC Therapeutics International Limited

77 Sir John Rogerson’s Quay, Dublin 2, Ireland

EU/1/13/902

15.11.2016

14.11.2016

Bretaris Genuair

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/12/781

16.11.2016

14.11.2016

Clopidogrel ratiopharm

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/14/975

16.11.2016

14.11.2016

Duloxetine Zentiva

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/15/1028

16.11.2016

14.11.2016

Edarbi

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/11/734

16.11.2016

14.11.2016

Eklira Genuair

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/12/778

16.11.2016

14.11.2016

Esmya

Gedeon Richter Plc.

Gyömrői út 19-21., H-1103 Budapest, Magyarország

EU/1/12/750

16.11.2016

14.11.2016

Giotrif

Boehringer Ingelheim International GmbH

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

EU/1/13/879

16.11.2016

14.11.2016

Iasibon

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/10/659

16.11.2016

14.11.2016

Isentress

Merck Sharp & Dohme Limited

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

EU/1/07/436

16.11.2016

14.11.2016

Levetiracetam SUN

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland

EU/1/11/741

16.11.2016

14.11.2016

Lucentis

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/06/374

16.11.2016

14.11.2016

Numient

Impax Laboratories Ireland Limited, 56 Fitzwilliam Square, Dublin 2, Ireland

EU/1/15/1044

16.11.2016

14.11.2016

Pioglitazone Actavis

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/12/755

17.11.2016

14.11.2016

Pioglitazone Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/757

16.11.2016

14.11.2016

Praluent

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/15/1031

16.11.2016

14.11.2016

Ribavirin Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/509

16.11.2016

14.11.2016

Ribavirin Teva Pharma BV

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/527

16.11.2016

14.11.2016

Topotecan Hospira

Hospira UK Limited

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

EU/1/10/633

16.11.2016

14.11.2016

Trisenox

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/02/204

16.11.2016

14.11.2016

Triumeq

ViiV Healthcare UK Limited

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

EU/1/14/940

16.11.2016

18.11.2016

Daxas

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/10/636

22.11.2016

18.11.2016

Jakavi

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/12/773

22.11.2016

18.11.2016

Pioglitazone Teva Pharma

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/758

22.11.2016

18.11.2016

Procysbi

Raptor Pharmaceuticals Europe BV

Naritaweg 165, NL-1043 BW Amsterdam, Nederland

EU/1/13/861

22.12.2016

18.11.2016

Selincro

H. Lundbeck A/S

Ottiliavej 9, DK-2500 Valby, Danmark

EU/1/12/815

22.11.2016

18.11.2016

Signifor

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/12/753

22.11.2016

18.11.2016

Thymanax

Servier (Ireland) Industries Limited

Gorey Road, Arklow, Co. Wicklow, Ireland

EU/1/08/498

22.11.2016

18.11.2016

Valdoxan

Les Laboratoires Servier

50 rue Carnot, F-92284 Suresnes Cedex, France

EU/1/08/499

22.11.2016

18.11.2016

Xaluprine

Nova Laboratories Limited

Martin House, Gloucester Crescent, Wigston Leicester, LE18 4YL, United Kingdom

EU/1/11/727

22.11.2016

21.11.2016

Ameluz

Biofrontera Bioscience GmbH

Hemmelrather Weg 201, D-51377 Leverkusen, Deutschland

EU/1/11/740

23.11.2016

21.11.2016

Bemfola

Gedeon Richter Plc.

Gyömrői út 19-21., H-1103 Budapest, Magyarország

EU/1/13/909

23.11.2016

21.11.2016

Cystadane

Orphan Europe S.A.R.L.

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

EU/1/06/379

23.11.2016

21.11.2016

Elonva

Merck Sharp & Dohme Limited

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

EU/1/09/609

23.11.2016

21.11.2016

Opdivo

Bristol-Myers Squibb Pharma EEIG

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

EU/1/15/1014

23.11.2016

29.11.2016

Ammonaps

Swedish Orphan Biovitrum International AB

SE-112 76 Stockholm, Sverige

EU/1/99/120

1.12.2016

29.11.2016

PANTOLOC Control

Takeda GmbH, (HRB 701016)

Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland

EU/1/09/519

1.12.2016

—   Withdrawal of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

Withdrawal of a marketing authorisation

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 3.11.2016 | Vitekta | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/13/883 | 7.11.2016 |
| 21.11.2016 | Celvapan | Nanotherapeutics Bohumil, s.r.o.
  Bohumil 138, 28163 Jevany, Česká republika | EU/1/08/506 | 23.11.2016 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

3.11.2016

Vitekta

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/13/883

7.11.2016

21.11.2016

Celvapan

Nanotherapeutics Bohumil, s.r.o.

Bohumil 138, 28163 Jevany, Česká republika

EU/1/08/506

23.11.2016

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

Modification of a marketing authorisation

Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 3.11.2016 | Fungitraxx | Avimedical B.V.
  Abbinkdijk 1, 7255 LX Hengelo (Gld), Nederland | EU/2/13/160 | 7.11.2016 |
| 9.11.2016 | Draxxin | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/03/041 | 14.11.2016 |
| 9.11.2016 | Inflacam | Chanelle Pharmaceuticals Manufacturing Limited
  Loughrea, Co. Galway, Ireland | EU/2/11/134 | 11.11.2016 |
| 9.11.2016 | Semintra | Boehringer Ingelheim Vetmedica GmbH
  D-55216 Ingelheim am Rhein, Deutschland | EU/2/12/146 | 11.11.2016 |
| 11.11.2016 | Sileo | Orion Corporation
  Orionintie 1, FI-02200 Espoo, Suomi | EU/2/15/181 | 15.11.2016 |
| 29.11.2016 | BROADLINE | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/13/157 | 1.12.2016 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

3.11.2016

Fungitraxx

Avimedical B.V.

Abbinkdijk 1, 7255 LX Hengelo (Gld), Nederland

EU/2/13/160

7.11.2016

9.11.2016

Draxxin

Zoetis Belgium S.A.

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

EU/2/03/041

14.11.2016

9.11.2016

Inflacam

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, Ireland

EU/2/11/134

11.11.2016

9.11.2016

Semintra

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/12/146

11.11.2016

11.11.2016

Sileo

Orion Corporation

Orionintie 1, FI-02200 Espoo, Suomi

EU/2/15/181

15.11.2016

29.11.2016

BROADLINE

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/13/157

1.12.2016

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.

1

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