# C_2016399EN.01000101.xml

| 28.10.2016 | EN | Official Journal of the European Union | C 399/1 |
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28.10.2016

EN

Official Journal of the European Union

C 399/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2016 to 30 September 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 399/01)

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

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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

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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 9.9.2016 | CABOMETYX | cabozantinib | Ipsen Pharma
  65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France | EU/1/16/1136 | Film-coated tablet | L01XE26 | 13.9.2016 |
| 15.9.2016 | Inhixa | enoxaparin sodium | Techdow Europe AB
  Banérgatan 36, 75237 Uppsala, Sverige | EU/1/16/1132 | Solution for injection | B01AB05 | 19.9.2016 |
| 15.9.2016 | Mysildecard | sildenafil | Mylan S.A.S
  117 allée des Parcs, F-69800 Saint Priest, France | EU/1/16/1134 | Film-coated tablet | G04BE03 | 19.9.2016 |
| 15.9.2016 | Sialanar | glycopyrronium bromide | Proveca Limited
  Daresbury Innovation Centre, Keckwick Lane, Daresbury, Halton, Cheshire, WA4 4FS, United Kingdom | EU/1/16/1135 | Oral solution | A03AB02 | 19.9.2016 |
| 15.9.2016 | Tenofovir disoproxil Zentiva | tenofovir disoproxil | Zentiva, k.s.
  U Kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/16/1127 | Film-coated tablet | J05AF07 | 19.9.2016 |
| 15.9.2016 | Thorinane | enoxaparin sodium | Pharmathen S.A.
  6 Dervenakion, 15351 Pallini Attiki, Ελλάδα | EU/1/16/1131 | Solution for injection | B01AB05 | 19.9.2016 |
| 19.9.2016 | Truberzi | eluxadoline | Aptalis Pharma SAS
  5/6 Place de l’Iris — La Défense 5 92400 Courbevoie France | EU/1/16/1126 | Film-coated tablet | Pending | 21.9.2016 |

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

9.9.2016

CABOMETYX

cabozantinib

Ipsen Pharma

65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France

EU/1/16/1136

Film-coated tablet

L01XE26

13.9.2016

15.9.2016

Inhixa

enoxaparin sodium

Techdow Europe AB

Banérgatan 36, 75237 Uppsala, Sverige

EU/1/16/1132

Solution for injection

B01AB05

19.9.2016

15.9.2016

Mysildecard

sildenafil

Mylan S.A.S

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

EU/1/16/1134

Film-coated tablet

G04BE03

19.9.2016

15.9.2016

Sialanar

glycopyrronium bromide

Proveca Limited

Daresbury Innovation Centre, Keckwick Lane, Daresbury, Halton, Cheshire, WA4 4FS, United Kingdom

EU/1/16/1135

Oral solution

A03AB02

19.9.2016

15.9.2016

Tenofovir disoproxil Zentiva

tenofovir disoproxil

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/16/1127

Film-coated tablet

J05AF07

19.9.2016

15.9.2016

Thorinane

enoxaparin sodium

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/16/1131

Solution for injection

B01AB05

19.9.2016

19.9.2016

Truberzi

eluxadoline

Aptalis Pharma SAS

5/6 Place de l’Iris — La Défense 5 92400 Courbevoie France

EU/1/16/1126

Film-coated tablet

Pending

21.9.2016

| — | 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

Modification of a marketing authorization

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 |
| --- | --- | --- | --- | --- |
| 2.9.2016 | Enzepi | Allergan Pharmaceuticals International Limited,
  Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland | EU/1/16/1113 | 6.9.2016 |
| 2.9.2016 | Extavia | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/08/454 | 6.9.2016 |
| 2.9.2016 | Kengrexal | Chiesi Farmaceutici S.P.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/15/994 | 6.9.2016 |
| 2.9.2016 | Ofev | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/14/979 | 6.9.2016 |
| 5.9.2016 | Nimvastid | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/09/525 | 7.9.2016 |
| 8.9.2016 | Betaferon | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/95/003 | 12.9.2016 |
| 8.9.2016 | Budesonide/Formoterol Teva Pharma B.V. | Teva Pharma B.V.
  Swensweg 5, 2031GA Haarlem, Nederland | EU/1/14/950 | 12.9.2016 |
| 8.9.2016 | Caprelsa | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/11/749 | 12.9.2016 |
| 8.9.2016 | DUAVIVE | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/14/960 | 12.9.2016 |
| 8.9.2016 | Insulatard | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/02/233 | 12.9.2016 |
| 8.9.2016 | Levetiracetam Actavis | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Ísland | EU/1/11/713 | 12.9.2016 |
| 8.9.2016 | Lucentis | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/06/374 | 12.9.2016 |
| 8.9.2016 | Panretin | Eisai Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | EU/1/00/149 | 12.9.2016 |
| 8.9.2016 | Plegridy | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/14/934 | 12.9.2016 |
| 8.9.2016 | Protaphane | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/02/234 | 12.9.2016 |
| 9.9.2016 | Ameluz | Biofrontera Bioscience GmbH
  Hemmelrather Weg 201, D-51377 Leverkusen, Deutschland | EU/1/11/740 | 13.9.2016 |
| 9.9.2016 | Efavirenz Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/11/742 | 13.9.2016 |
| 9.9.2016 | Elaprase | Shire Human Genetic Therapies AB
  Vasagatan 7, 111 20 Stockholm, Sverige | EU/1/06/365 | 13.9.2016 |
| 9.9.2016 | Eurartesim | Sigma-Tau Industrie Farmaceutiche Riunite S.p.A
  Viale Shakespeare 47, 00144 Roma, Italia | EU/1/11/716 | 13.9.2016 |
| 9.9.2016 | Laventair | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/14/899 | 16.9.2016 |
| 9.9.2016 | Revlimid | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | EU/1/07/391 | 13.9.2016 |
| 9.9.2016 | Tandemact | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/06/366 | 13.9.2016 |
| 9.9.2016 | Tracleer | Actelion Registration Ltd
  Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | EU/1/02/220 | 13.9.2016 |
| 9.9.2016 | Velphoro | Vifor Fresenius Medical Care Renal Pharma France
  7-13 boulevard Paul-Emile Victor, 92521 Neuilly-sur-Seine, France | EU/1/14/943 | 15.9.2016 |
| 9.9.2016 | Xolair | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/05/319 | 13.9.2016 |
| 15.9.2016 | Arava | Sanofi-Aventis Deutschland GmbH
  D-65926 Frankfurt am Main, Deutschland | EU/1/99/118 | 19.9.2016 |
| 15.9.2016 | Arixtra | Aspen Pharma Trading Limited
  3016 Lake Drive Citywest Business Campus Dublin 24 Ireland | EU/1/02/206 | 19.9.2016 |
| 15.9.2016 | Evoltra | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/06/334 | 19.9.2016 |
| 15.9.2016 | Fosavance | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/05/310 | 19.9.2016 |
| 15.9.2016 | Ganfort | Allergan Pharmaceuticals Ireland, (514125)
  Castlebar Road, Westport, County Mayo, Ireland | EU/1/06/340 | 19.9.2016 |
| 15.9.2016 | Ibandronic Acid Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/10/642 | 19.9.2016 |
| 15.9.2016 | Intelence | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/08/468 | 19.9.2016 |
| 15.9.2016 | PANTECTA Control | Takeda GmbH, (HRB 701016)
  Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | EU/1/09/518 | 19.9.2016 |
| 15.9.2016 | Trulicity | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/14/956 | 19.9.2016 |
| 15.9.2016 | Zydelig | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/14/938 | 19.9.2016 |
| 16.9.2016 | Lamivudine Teva Pharma B.V. | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/596 | 20.9.2016 |
| 19.9.2016 | Adrovance | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/06/364 | 21.9.2016 |
| 19.9.2016 | Enbrel | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/99/126 | 21.9.2016 |
| 19.9.2016 | Fycompa | Eisai Europe Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom | EU/1/12/776 | 21.9.2016 |
| 19.9.2016 | Repaglinide Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, Harrow, HA1 4HF, United Kingdom | EU/1/11/743 | 21.9.2016 |
| 19.9.2016 | Soliris | Alexion Europe SAS
  1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France | EU/1/07/393 | 21.9.2016 |
| 19.9.2016 | Sovaldi | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/13/894 | 21.9.2016 |
| 19.9.2016 | Vantavo | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/09/572 | 21.9.2016 |
| 19.9.2016 | Zydelig | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/14/938 | 21.9.2016 |
| 22.9.2016 | Anoro | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/14/898 | 26.9.2016 |
| 22.9.2016 | Blincyto | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/15/1047 | 26.9.2016 |
| 22.9.2016 | EVARREST | Omrix Biopharmaceuticals N.V.
  Leonardo Da Vincilaan 15, B-1831 Diegem, België | EU/1/13/868 | 26.9.2016 |
| 22.9.2016 | Instanyl | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/09/531 | 26.9.2016 |
| 22.9.2016 | Leflunomide ratiopharm | ratiopharm GmbH
  Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/10/654 | 26.9.2016 |
| 22.9.2016 | Pregabalin Sandoz GmbH | Sandoz GmbH
  Biochemiestrasse 10, A-6250 Kundl, Österreich | EU/1/15/1012 | 26.9.2016 |
| 22.9.2016 | Saxenda | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/15/992 | 26.9.2016 |
| 22.9.2016 | Stayveer | Marklas Nederland B.V.
  Beneluxlaan 2b, NL-3446 GR Woerden, Nederland | EU/1/13/832 | 26.9.2016 |
| 22.9.2016 | Victoza | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/09/529 | 26.9.2016 |
| 22.9.2016 | Zelboraf | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/12/751 | 26.9.2016 |
| 26.9.2016 | Colobreathe | Forest Laboratories UK Ltd.
  Whiddon Valley Barnstaple, North Devon, EX32 8NS, United Kingdom | EU/1/11/747 | 28.9.2016 |
| 26.9.2016 | Tivicay | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/13/892 | 28.9.2016 |
| 30.9.2016 | Cometriq | Ipsen Pharma
  65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France | EU/1/13/890 | 4.10.2016 |
| 30.9.2016 | Moventig | Kyowa Kirin Limited
  Galabank Business Park, Galashiels, TD1 1QH, United Kingdom | EU/1/14/962 | 4.10.2016 |
| 30.9.2016 | Vantobra | PARI Pharma GmbH
  Moosstrasse 3, D-82319 Starnberg, Deutschland | EU/1/14/932 | 4.10.2016 |

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

2.9.2016

Enzepi

Allergan Pharmaceuticals International Limited,

Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland

EU/1/16/1113

6.9.2016

2.9.2016

Extavia

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/08/454

6.9.2016

2.9.2016

Kengrexal

Chiesi Farmaceutici S.P.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/15/994

6.9.2016

2.9.2016

Ofev

Boehringer Ingelheim International GmbH

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

EU/1/14/979

6.9.2016

5.9.2016

Nimvastid

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/525

7.9.2016

8.9.2016

Betaferon

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/95/003

12.9.2016

8.9.2016

Budesonide/Formoterol Teva Pharma B.V.

Teva Pharma B.V.

Swensweg 5, 2031GA Haarlem, Nederland

EU/1/14/950

12.9.2016

8.9.2016

Caprelsa

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/11/749

12.9.2016

8.9.2016

DUAVIVE

Pfizer Limited

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

EU/1/14/960

12.9.2016

8.9.2016

Insulatard

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/02/233

12.9.2016

8.9.2016

Levetiracetam Actavis

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Ísland

EU/1/11/713

12.9.2016

8.9.2016

Lucentis

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/06/374

12.9.2016

8.9.2016

Panretin

Eisai Limited

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

EU/1/00/149

12.9.2016

8.9.2016

Plegridy

Biogen Idec Limited

Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom

EU/1/14/934

12.9.2016

8.9.2016

Protaphane

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/02/234

12.9.2016

9.9.2016

Ameluz

Biofrontera Bioscience GmbH

Hemmelrather Weg 201, D-51377 Leverkusen, Deutschland

EU/1/11/740

13.9.2016

9.9.2016

Efavirenz Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/742

13.9.2016

9.9.2016

Elaprase

Shire Human Genetic Therapies AB

Vasagatan 7, 111 20 Stockholm, Sverige

EU/1/06/365

13.9.2016

9.9.2016

Eurartesim

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A

Viale Shakespeare 47, 00144 Roma, Italia

EU/1/11/716

13.9.2016

9.9.2016

Laventair

Glaxo Group Ltd

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

EU/1/14/899

16.9.2016

9.9.2016

Revlimid

Celgene Europe Limited

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

EU/1/07/391

13.9.2016

9.9.2016

Tandemact

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/06/366

13.9.2016

9.9.2016

Tracleer

Actelion Registration Ltd

Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom

EU/1/02/220

13.9.2016

9.9.2016

Velphoro

Vifor Fresenius Medical Care Renal Pharma France

7-13 boulevard Paul-Emile Victor, 92521 Neuilly-sur-Seine, France

EU/1/14/943

15.9.2016

9.9.2016

Xolair

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/05/319

13.9.2016

15.9.2016

Arava

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/99/118

19.9.2016

15.9.2016

Arixtra

Aspen Pharma Trading Limited

3016 Lake Drive Citywest Business Campus Dublin 24 Ireland

EU/1/02/206

19.9.2016

15.9.2016

Evoltra

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/06/334

19.9.2016

15.9.2016

Fosavance

Merck Sharp & Dohme Limited

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

EU/1/05/310

19.9.2016

15.9.2016

Ganfort

Allergan Pharmaceuticals Ireland, (514125)

Castlebar Road, Westport, County Mayo, Ireland

EU/1/06/340

19.9.2016

15.9.2016

Ibandronic Acid Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/10/642

19.9.2016

15.9.2016

Intelence

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/08/468

19.9.2016

15.9.2016

PANTECTA Control

Takeda GmbH, (HRB 701016)

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

EU/1/09/518

19.9.2016

15.9.2016

Trulicity

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/14/956

19.9.2016

15.9.2016

Zydelig

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/14/938

19.9.2016

16.9.2016

Lamivudine Teva Pharma B.V.

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/596

20.9.2016

19.9.2016

Adrovance

Merck Sharp & Dohme Limited

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

EU/1/06/364

21.9.2016

19.9.2016

Enbrel

Pfizer Limited

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

EU/1/99/126

21.9.2016

19.9.2016

Fycompa

Eisai Europe Limited

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

EU/1/12/776

21.9.2016

19.9.2016

Repaglinide Accord

Accord Healthcare Limited

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

EU/1/11/743

21.9.2016

19.9.2016

Soliris

Alexion Europe SAS

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

EU/1/07/393

21.9.2016

19.9.2016

Sovaldi

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/13/894

21.9.2016

19.9.2016

Vantavo

Merck Sharp & Dohme Limited

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

EU/1/09/572

21.9.2016

19.9.2016

Zydelig

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/14/938

21.9.2016

22.9.2016

Anoro

Glaxo Group Ltd

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

EU/1/14/898

26.9.2016

22.9.2016

Blincyto

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/15/1047

26.9.2016

22.9.2016

EVARREST

Omrix Biopharmaceuticals N.V.

Leonardo Da Vincilaan 15, B-1831 Diegem, België

EU/1/13/868

26.9.2016

22.9.2016

Instanyl

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/09/531

26.9.2016

22.9.2016

Leflunomide ratiopharm

ratiopharm GmbH

Graf-Arco-Straße 3, D-89079 Ulm, Deutschland

EU/1/10/654

26.9.2016

22.9.2016

Pregabalin Sandoz GmbH

Sandoz GmbH

Biochemiestrasse 10, A-6250 Kundl, Österreich

EU/1/15/1012

26.9.2016

22.9.2016

Saxenda

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/15/992

26.9.2016

22.9.2016

Stayveer

Marklas Nederland B.V.

Beneluxlaan 2b, NL-3446 GR Woerden, Nederland

EU/1/13/832

26.9.2016

22.9.2016

Victoza

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/09/529

26.9.2016

22.9.2016

Zelboraf

Roche Registration Limited

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

EU/1/12/751

26.9.2016

26.9.2016

Colobreathe

Forest Laboratories UK Ltd.

Whiddon Valley Barnstaple, North Devon, EX32 8NS, United Kingdom

EU/1/11/747

28.9.2016

26.9.2016

Tivicay

ViiV Healthcare UK Limited

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

EU/1/13/892

28.9.2016

30.9.2016

Cometriq

Ipsen Pharma

65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France

EU/1/13/890

4.10.2016

30.9.2016

Moventig

Kyowa Kirin Limited

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

EU/1/14/962

4.10.2016

30.9.2016

Vantobra

PARI Pharma GmbH

Moosstrasse 3, D-82319 Starnberg, Deutschland

EU/1/14/932

4.10.2016

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

—

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

Withdrawal of a marketing authorization

| 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 |
| --- | --- | --- | --- | --- |
| 19.9.2016 | PANTECTA Control | Takeda GmbH, (HRB 701016)
  Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | EU/1/09/518 | 21.9.2016 |

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

19.9.2016

PANTECTA Control

Takeda GmbH, (HRB 701016)

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

EU/1/09/518

21.9.2016

| — | 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

Issuing of a marketing authorization

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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 22.9.2016 | ERAVAC | rabbit haemorrhagic disease vaccine (inactivated) | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, E-17170 Amer (Girona), España | EU/2/16/199 | Emulsion for injection | QI08AA | 26.9.2016 |

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

22.9.2016

ERAVAC

rabbit haemorrhagic disease vaccine (inactivated)

Laboratorios Hipra, S.A.

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

EU/2/16/199

Emulsion for injection

QI08AA

26.9.2016

| — | 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

Modification of a marketing authorization

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 |
| --- | --- | --- | --- | --- |
| 19.9.2016 | Reconcile | Nexcyon Pharmaceuticals Ltd
  First Floor Denmark House, 143 High Street, Chalfont St Peter SL9 9QL, United Kingdom | EU/2/08/080 | 29.9.2016 |
| 28.9.2016 | Coliprotec F4 | Prevtec Microbia GmbH
  Geyerspergerstr 27, 80689 München, Deutschland | EU/2/14/180 | 30.9.2016 |

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

19.9.2016

Reconcile

Nexcyon Pharmaceuticals Ltd

First Floor Denmark House, 143 High Street, Chalfont St Peter SL9 9QL, United Kingdom

EU/2/08/080

29.9.2016

28.9.2016

Coliprotec F4

Prevtec Microbia GmbH

Geyerspergerstr 27, 80689 München, Deutschland

EU/2/14/180

30.9.2016

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

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

1

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