# Official Journal C 154/29 A

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 154 |
| | |
| English edition | Information and Notices | Volume 5929 April 2016 |

ISSN 1977-091X

Official Journal

of the European Union

C 154

English edition

Information and Notices

Volume 5929 April 2016

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| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2016/C 154/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2016 to 31 March 2016(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |
| 2016/C 154/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2016 to 31 March 2016(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 8 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2016/C 154/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2016 to 31 March 2016(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

2016/C 154/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2016 to 31 March 2016(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)

8

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

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 29.4.2016 | EN | Official Journal of the European Union | C 154/1 |
| --- | --- | --- | --- |

29.4.2016

EN

Official Journal of the European Union

C 154/1

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2016 to 31 March 2016

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

(2016/C 154/01)

—   Issuing of a marketing authorisation (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 authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 16.3.2016 | Coagadex | human coagulation factor X | Bio Products Laboratory Ltd
  Dagger Lane, Elstree, Hertfordshire WD6 3BX, United Kingdom | EU/1/16/1087 | Powder and solvent for solution for injection | B02BD13 | 18.3.2016 |
| 16.3.2016 | Neofordex | dexamethasone | Laboratoires CTRS
  63 rue de l’Est, F-92100 Boulogne-Billancourt, France | EU/1/15/1053 | Tablet | H02AB02 | 18.3.2016 |
| 22.3.2016 | Amlodipine/Valsartan Mylan | amlodipine/valsartan | Mylan S.A.S
  117 allée des Parcs, F-69800 Saint Priest, France | EU/1/16/1092 | Film-coated tablet | C09DB01 | 29.3.2016 |
| 31.3.2016 | Wakix | Pitolisant hydrochloride | Bioprojet Pharma
  9 rue Rameau, F-75002 Paris, France | EU/1/15/1068 | Film-coated tablet | N07XX11 | 4.4.2016 |
| 31.3.2016 | Zonisamide Mylan | zonisamide | Mylan S.A.S
  117 allée des Parcs, F-69800 Saint Priest, France | EU/1/16/1093 | Capsule, hard | N03AX15 | 4.4.2016 |

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

16.3.2016

Coagadex

human coagulation factor X

Bio Products Laboratory Ltd

Dagger Lane, Elstree, Hertfordshire WD6 3BX, United Kingdom

EU/1/16/1087

Powder and solvent for solution for injection

B02BD13

18.3.2016

16.3.2016

Neofordex

dexamethasone

Laboratoires CTRS

63 rue de l’Est, F-92100 Boulogne-Billancourt, France

EU/1/15/1053

Tablet

H02AB02

18.3.2016

22.3.2016

Amlodipine/Valsartan Mylan

amlodipine/valsartan

Mylan S.A.S

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

EU/1/16/1092

Film-coated tablet

C09DB01

29.3.2016

31.3.2016

Wakix

Pitolisant hydrochloride

Bioprojet Pharma

9 rue Rameau, F-75002 Paris, France

EU/1/15/1068

Film-coated tablet

N07XX11

4.4.2016

31.3.2016

Zonisamide Mylan

zonisamide

Mylan S.A.S

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

EU/1/16/1093

Capsule, hard

N03AX15

4.4.2016

—   Modification of a marketing authorisation (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 authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 2.3.2016 | Copalia | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/06/372 | 4.3.2016 |
| 2.3.2016 | Dafiro | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/06/371 | 4.3.2016 |
| 2.3.2016 | DuoPlavin | Sanofi Clir SNC
  54 rue La Boétie, F-75008 Paris, France | EU/1/10/619 | 7.3.2016 |
| 2.3.2016 | Efavirenz Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/11/742 | 4.3.2016 |
| 2.3.2016 | Exforge HCT | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/09/569 | 4.3.2016 |
| 2.3.2016 | Faslodex | AstraZeneca UK Limited
  Alderley Park, Macclesfield, Cheshire, SK10 4TG United Kingdom | EU/1/03/269 | 4.3.2016 |
| 2.3.2016 | Jentadueto | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/12/780 | 7.3.2016 |
| 2.3.2016 | Menveo | GSK Vaccines S.r.l.
  Via Fiorentina, 1, IT-53100 Siena, Italia | EU/1/10/614 | 4.3.2016 |
| 2.3.2016 | Mozobil | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/09/537 | 4.3.2016 |
| 2.3.2016 | Xydalba | Durata Therapeutics International B.V.
  Spaces Zuidas II, Barbara Strozzilaan 101, 1083 HN Amsterdam, Nederland | EU/1/14/986 | 4.3.2016 |
| 7.3.2016 | Avamys | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/07/434 | 9.3.2016 |
| 7.3.2016 | Dacogen | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/12/792 | 9.3.2016 |
| 7.3.2016 | Signifor | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/12/753 | 9.3.2016 |
| 7.3.2016 | Triumeq | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/14/940 | 9.3.2016 |
| 10.3.2016 | Celsentri | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/07/418 | 14.3.2016 |
| 10.3.2016 | Onglyza | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/09/545 | 14.3.2016 |
| 11.3.2016 | Deltyba | Otsuka Novel Products GmbH
  Erika-Mann-Straße 21, D-80636 München, Deutschland | EU/1/13/875 | 16.3.2016 |
| 11.3.2016 | Savene | Clinigen Healthcare Limited
  Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom | EU/1/06/350 | 16.3.2016 |
| 11.3.2016 | Topotecan Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/552 | 16.3.2016 |
| 16.3.2016 | Cuprymina | SPARKLE S.r.l.
  Località Cavallino, 62010 Montecosaro (MC), Italia | EU/1/12/784 | 21.3.2016 |
| 22.3.2016 | Copalia HCT | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/09/575 | 29.3.2016 |
| 22.3.2016 | Exforge | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/06/370 | 29.3.2016 |
| 22.3.2016 | Exjade | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/06/356 | 29.3.2016 |
| 22.3.2016 | Iclusig | ARIAD Pharma Ltd
  Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom | EU/1/13/839 | 29.3.2016 |
| 22.3.2016 | Kepivance | Swedish Orphan Biovitrum AB (publ)
  SE-112 76 Stockholm, Sverige | EU/1/05/314 | 29.3.2016 |
| 22.3.2016 | Laventair | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/14/899 | 29.3.2016 |
| 22.3.2016 | Mekinist | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/14/931 | 29.3.2016 |
| 22.3.2016 | Pixuvri | CTI Life Sciences Ltd
  Highlands House, Basingstoke Road, Spencers Wood, Reading, Berkshire RG7 1NT, United Kingdom | EU/1/12/764 | 29.3.2016 |
| 22.3.2016 | Trajenta | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/11/707 | 29.3.2016 |
| 22.3.2016 | Zykadia | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/15/999 | 29.3.2016 |
| 23.3.2016 | Elocta | Swedish Orphan Biovitrum AB (publ)
  SE-112 76 Stockholm, Sverige | EU/1/15/1046 | 30.3.2016 |
| 30.3.2016 | Abseamed | Medice Arzneimittel Pütter GmbH & Co KG
  Kuhloweg 37, D-58638 Iserlohn, Deutschland | EU/1/07/412 | 1.4.2016 |
| 30.3.2016 | Anoro | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/14/898 | 1.4.2016 |
| 30.3.2016 | Evra | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/02/223 | 1.4.2016 |
| 30.3.2016 | TachoSil | Takeda Austria GmbH
  St.-Peter-Strasse 25, A-4020 Linz, Österreich | EU/1/04/277 | 1.4.2016 |
| 30.3.2016 | Vidaza | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge UB11 1DB, United Kingdom | EU/1/08/488 | 1.4.2016 |
| 31.3.2016 | Betmiga | Astellas Pharma Europe B.V.
  Sylviusweg 62, NL-2333 BE Leiden, Nederland | EU/1/12/809 | 4.4.2016 |
| 31.3.2016 | Binocrit | Sandoz GmbH
  Biochemiestrasse 10, A-6250 Kundl, Österreich | EU/1/07/410 | 4.4.2016 |
| 31.3.2016 | Caelyx | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/96/011 | 4.4.2016 |
| 31.3.2016 | Capecitabine Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/12/761 | 4.4.2016 |
| 31.3.2016 | Ecansya | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/12/763 | 4.4.2016 |
| 31.3.2016 | Epoetin alfa Hexal | Hexal AG
  Industriestrasse 25, D-83607 Holzkirchen, Deutschland | EU/1/07/411 | 4.4.2016 |
| 31.3.2016 | Eviplera | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/11/737 | 4.4.2016 |
| 31.3.2016 | Giotrif | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/13/879 | 4.4.2016 |
| 31.3.2016 | Lynparza | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/14/959 | 4.4.2016 |
| 31.3.2016 | Revatio | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/05/318 | 4.4.2016 |
| 31.3.2016 | Ruconest | Pharming Group N.V.
  Darwinweg 24, NL-2333 CR Leiden, Nederland | EU/1/10/641 | 4.4.2016 |
| 31.3.2016 | Vargatef | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/14/954 | 4.4.2016 |

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

2.3.2016

Copalia

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/06/372

4.3.2016

2.3.2016

Dafiro

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/06/371

4.3.2016

2.3.2016

DuoPlavin

Sanofi Clir SNC

54 rue La Boétie, F-75008 Paris, France

EU/1/10/619

7.3.2016

2.3.2016

Efavirenz Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/742

4.3.2016

2.3.2016

Exforge HCT

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/09/569

4.3.2016

2.3.2016

Faslodex

AstraZeneca UK Limited

Alderley Park, Macclesfield, Cheshire, SK10 4TG United Kingdom

EU/1/03/269

4.3.2016

2.3.2016

Jentadueto

Boehringer Ingelheim International GmbH

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

EU/1/12/780

7.3.2016

2.3.2016

Menveo

GSK Vaccines S.r.l.

Via Fiorentina, 1, IT-53100 Siena, Italia

EU/1/10/614

4.3.2016

2.3.2016

Mozobil

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/09/537

4.3.2016

2.3.2016

Xydalba

Durata Therapeutics International B.V.

Spaces Zuidas II, Barbara Strozzilaan 101, 1083 HN Amsterdam, Nederland

EU/1/14/986

4.3.2016

7.3.2016

Avamys

Glaxo Group Ltd

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

EU/1/07/434

9.3.2016

7.3.2016

Dacogen

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/12/792

9.3.2016

7.3.2016

Signifor

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/12/753

9.3.2016

7.3.2016

Triumeq

ViiV Healthcare UK Limited

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

EU/1/14/940

9.3.2016

10.3.2016

Celsentri

ViiV Healthcare UK Limited

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

EU/1/07/418

14.3.2016

10.3.2016

Onglyza

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/09/545

14.3.2016

11.3.2016

Deltyba

Otsuka Novel Products GmbH

Erika-Mann-Straße 21, D-80636 München, Deutschland

EU/1/13/875

16.3.2016

11.3.2016

Savene

Clinigen Healthcare Limited

Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom

EU/1/06/350

16.3.2016

11.3.2016

Topotecan Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/552

16.3.2016

16.3.2016

Cuprymina

SPARKLE S.r.l.

Località Cavallino, 62010 Montecosaro (MC), Italia

EU/1/12/784

21.3.2016

22.3.2016

Copalia HCT

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/09/575

29.3.2016

22.3.2016

Exforge

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/06/370

29.3.2016

22.3.2016

Exjade

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/06/356

29.3.2016

22.3.2016

Iclusig

ARIAD Pharma Ltd

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

EU/1/13/839

29.3.2016

22.3.2016

Kepivance

Swedish Orphan Biovitrum AB (publ)

SE-112 76 Stockholm, Sverige

EU/1/05/314

29.3.2016

22.3.2016

Laventair

Glaxo Group Ltd

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

EU/1/14/899

29.3.2016

22.3.2016

Mekinist

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/14/931

29.3.2016

22.3.2016

Pixuvri

CTI Life Sciences Ltd

Highlands House, Basingstoke Road, Spencers Wood, Reading, Berkshire RG7 1NT, United Kingdom

EU/1/12/764

29.3.2016

22.3.2016

Trajenta

Boehringer Ingelheim International GmbH

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

EU/1/11/707

29.3.2016

22.3.2016

Zykadia

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/15/999

29.3.2016

23.3.2016

Elocta

Swedish Orphan Biovitrum AB (publ)

SE-112 76 Stockholm, Sverige

EU/1/15/1046

30.3.2016

30.3.2016

Abseamed

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37, D-58638 Iserlohn, Deutschland

EU/1/07/412

1.4.2016

30.3.2016

Anoro

Glaxo Group Ltd

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

EU/1/14/898

1.4.2016

30.3.2016

Evra

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/02/223

1.4.2016

30.3.2016

TachoSil

Takeda Austria GmbH

St.-Peter-Strasse 25, A-4020 Linz, Österreich

EU/1/04/277

1.4.2016

30.3.2016

Vidaza

Celgene Europe Limited

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

EU/1/08/488

1.4.2016

31.3.2016

Betmiga

Astellas Pharma Europe B.V.

Sylviusweg 62, NL-2333 BE Leiden, Nederland

EU/1/12/809

4.4.2016

31.3.2016

Binocrit

Sandoz GmbH

Biochemiestrasse 10, A-6250 Kundl, Österreich

EU/1/07/410

4.4.2016

31.3.2016

Caelyx

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/96/011

4.4.2016

31.3.2016

Capecitabine Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/761

4.4.2016

31.3.2016

Ecansya

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/12/763

4.4.2016

31.3.2016

Epoetin alfa Hexal

Hexal AG

Industriestrasse 25, D-83607 Holzkirchen, Deutschland

EU/1/07/411

4.4.2016

31.3.2016

Eviplera

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/11/737

4.4.2016

31.3.2016

Giotrif

Boehringer Ingelheim International GmbH

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

EU/1/13/879

4.4.2016

31.3.2016

Lynparza

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/14/959

4.4.2016

31.3.2016

Revatio

Pfizer Limited

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

EU/1/05/318

4.4.2016

31.3.2016

Ruconest

Pharming Group N.V.

Darwinweg 24, NL-2333 CR Leiden, Nederland

EU/1/10/641

4.4.2016

31.3.2016

Vargatef

Boehringer Ingelheim International GmbH

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

EU/1/14/954

4.4.2016

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

| 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 |
| --- | --- | --- | --- | --- |
| 2.3.2016 | Nuedexta | Jenson Pharmaceutical Services Ltd
  Carradine House 237 Regents Park Road, London N3 3LF, United Kingdom | EU/1/13/833 | 4.3.2016 |

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

2.3.2016

Nuedexta

Jenson Pharmaceutical Services Ltd

Carradine House 237 Regents Park Road, London N3 3LF, United Kingdom

EU/1/13/833

4.3.2016

—   Suspension of a marketing authorisation (Article 20 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

| 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 |
| --- | --- | --- | --- | --- |
| 23.3.2016 | Zydelig | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/14/938 | 30.3.2016 |

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

23.3.2016

Zydelig

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/14/938

30.3.2016

—   Modification of a marketing authorisation (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 authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 8.3.2016 | Palladia | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/09/100 | 10.3.2016 |
| 15.3.2016 | BLUEVAC BTV8 | CZ Veterinaria, S.A.
  La Relva s/n, 36400 Porriño, España | EU/2/11/122 | 17.3.2016 |
| 15.3.2016 | Versican Plus DHPPi | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/14/169 | 17.3.2016 |
| 15.3.2016 | Versican Plus DHPPi/L4 | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/14/164 | 17.3.2016 |
| 15.3.2016 | Versican Plus DHPPi/L4R | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/14/163 | 17.3.2016 |

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

8.3.2016

Palladia

Zoetis Belgium S.A.

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

EU/2/09/100

10.3.2016

15.3.2016

BLUEVAC BTV8

CZ Veterinaria, S.A.

La Relva s/n, 36400 Porriño, España

EU/2/11/122

17.3.2016

15.3.2016

Versican Plus DHPPi

Zoetis Belgium S.A.

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

EU/2/14/169

17.3.2016

15.3.2016

Versican Plus DHPPi/L4

Zoetis Belgium S.A.

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

EU/2/14/164

17.3.2016

15.3.2016

Versican Plus DHPPi/L4R

Zoetis Belgium S.A.

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

EU/2/14/163

17.3.2016

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.

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| 29.4.2016 | EN | Official Journal of the European Union | C 154/8 |
| --- | --- | --- | --- |

29.4.2016

EN

Official Journal of the European Union

C 154/8

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2016 to 31 March 2016

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

(2016/C 154/02)

—   Issuing, maintenance or modification of a national marketing authorisation

| Date of the decision | Name(s) of the medicinal product | INN (International Non-Proprietary Name) | Holder(s) of the marketing authorisation | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- | --- |
| 22.3.2016 | Closamectin Pour-On Solution and associated names — Art. 78 | Closantel and ivermectin | See Annex | See Annex | 29.3.2016 |
| 7.3.2016 | Rivastigmine Rectificative Decision PSUSA 2654 201501 | Rivastigmine | Not applicable | Not applicable | 8.3.2016 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorisation

Member State concerned

Date of notification

22.3.2016

Closamectin Pour-On Solution and associated names — Art. 78

Closantel and ivermectin

See Annex

See Annex

29.3.2016

7.3.2016

Rivastigmine Rectificative Decision PSUSA 2654 201501

Rivastigmine

Not applicable

Not applicable

8.3.2016

---

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

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

---

ANNEX

List of the names, pharmaceutical form, strength of the veterinary medicinal products, animal species, route of administration, marketing authorisation holder in the Member States

| Member State (EU/EEA) | Marketing authorisation holder | Product name | INN | Strength | Pharmaceutical form | Animal species | Route of administration |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland | Closamectin 5 mg/ml + 200 mg/ml Pour-On Lösung für Rinder | Ivermectin Closantel | 5 mg/ml 200 mg/ml | Pour-On solution | Cattle | Topical use |
| Belgium | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland | Closamectin 5 mg/ml + 200 mg/ml pour-on oplossing voor rundvee | Ivermectin Closantel | 5 mg/ml 200 mg/ml | Pour-On solution | Cattle | Topical use |
| Czech Republic | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland | Closamectin 5 mg/ml + 200 mg/ml roztok pro nalévání na hřbet — pour-on | Ivermectin Closantel | 5 mg/ml 200 mg/ml | Pour-On solution | Cattle | Topical use |
| Denmark | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland | Closamectin Pour-On | Ivermectin Closantel | 5 mg/ml 200 mg/ml | Pour-On solution | Cattle | Topical use |
| France | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland | CLOSAMECTIN POUR-ON SOLUTION POUR BOVINS | Ivermectin Closantel | 5 mg/ml 200 mg/ml | Pour-On solution | Cattle | Topical use |
| Germany | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland | Closamectin 5 mg/ml + 200 mg/ml Pour-On Lösung zum Übergießen für Rinder | Ivermectin Closantel | 5 mg/ml 200 mg/ml | Pour-On solution | Cattle | Topical use |
| Greece | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland | Closamectin 5 mg/ml + 200 mg/ml διάλυμα επίχυσης για Βοοειδή | Ivermectin Closantel | 5 mg/ml 200 mg/ml | Pour-On solution | Cattle | Topical use |
| Ireland | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland | Closamectin 5 mg/ml + 200 mg/ml Pour-On Solution for Cattle | Ivermectin Closantel | 5 mg/ml 200 mg/ml | Pour-On solution | Cattle | Topical use |
| Ireland | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland | Closivet Pour-On Solution for Cattle | Ivermectin Closantel | 5 mg/ml 200 mg/ml | Pour-On solution | Cattle | Topical use |
| Italy | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland | Closamectin 5 mg/ml + 200 mg/ml Soluzione Pour-On per bovini | Ivermectin Closantel | 5 mg/ml 200 mg/ml | Pour-On solution | Cattle | Topical use |
| Italy | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland | Vermax Pour-On 5 mg/ml + 200 mg/ml Soluzione Pour-On per bovini | Ivermectin Closantel | 5 mg/ml 200 mg/ml | Pour-On solution | Cattle | Topical use |
| Poland | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland | Closamectin Pour-On 5 mg/ml + 200 mg/ml, roztwór do polewania dla bydła | Ivermectin Closantel | 5 mg/ml 200 mg/ml | Pour-On solution | Cattle | Topical use |
| Portugal | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland | Closamectin FF 5 mg/ml + 200 mg/ml solução para unção contínua para bovinos | Ivermectin Closantel | 5 mg/ml 200 mg/ml | Pour-On solution | Cattle | Topical use |
| Romania | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland | Closamectin 5 mg/ml + 200 mg/ml Soluţie Pour-On pentru bovine | Ivermectin Closantel | 5 mg/ml 200 mg/ml | Pour-On solution | Cattle | Topical use |
| Spain | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland | CLOSAMECTIN 5 mg/ml + 200 mg/ml SOLUCION POUR-ON PARA BOVINO | Ivermectin Closantel | 5 mg/ml 200 mg/ml | Pour-On solution | Cattle | Topical use |
| Spain | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland | Closivet Solución Pour-On | Ivermectin Closantel | 5 mg/ml 200 mg/ml | Pour-On solution | Cattle | Topical use |
| Sweden | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland | Closamectin vet 5 mg/ml+200 mg/ml Pour-on lösning till nöt | Ivermectin Closantel | 5 mg/ml 200 mg/ml | Pour-On solution | Cattle | Topical use |
| Slovenia | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland | Closamectin 5 mg/ml + 200 mg/ml Pour-On kožni poliv, raztopina za govedo | Ivermectin Closantel | 5 mg/ml 200 mg/ml | Pour-On solution | Cattle | Topical use |
| Slovakia | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland | Closamectin 5 mg/ml + 200 mg/ml pour-on roztok pre hovädzí dobytok | Ivermectin Closantel | 5 mg/ml 200 mg/ml | Pour-On solution | Cattle | Topical use |
| United Kingdom | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland | Closamectin 5 mg/ml + 200 mg/ml Pour-on Solution for Cattle | Ivermectin Closantel | 5 mg/ml 200 mg/ml | Pour-On solution | Cattle | Topical use |
| United Kingdom | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland | Closiver 5 mg/ml + 200 mg/ml Pour-On Solution for Cattle | Ivermectin Closantel | 5 mg/ml 200 mg/ml | Pour-On solution | Cattle | Topical use |
| United Kingdom | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland | Norofas Pour-On Solution for Cattle | Ivermectin Closantel | 5 mg/ml 200 mg/ml | Pour-On solution | Cattle | Topical use |

Member State (EU/EEA)

Marketing authorisation holder

Product name

INN

Strength

Pharmaceutical form

Animal species

Route of administration

Austria

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland

Closamectin 5 mg/ml + 200 mg/ml Pour-On Lösung für Rinder

Ivermectin Closantel

5 mg/ml 200 mg/ml

Pour-On solution

Cattle

Topical use

Belgium

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland

Closamectin 5 mg/ml + 200 mg/ml pour-on oplossing voor rundvee

Ivermectin Closantel

5 mg/ml 200 mg/ml

Pour-On solution

Cattle

Topical use

Czech Republic

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland

Closamectin 5 mg/ml + 200 mg/ml roztok pro nalévání na hřbet — pour-on

Ivermectin Closantel

5 mg/ml 200 mg/ml

Pour-On solution

Cattle

Topical use

Denmark

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland

Closamectin Pour-On

Ivermectin Closantel

5 mg/ml 200 mg/ml

Pour-On solution

Cattle

Topical use

France

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland

CLOSAMECTIN POUR-ON SOLUTION POUR BOVINS

Ivermectin Closantel

5 mg/ml 200 mg/ml

Pour-On solution

Cattle

Topical use

Germany

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland

Closamectin 5 mg/ml + 200 mg/ml Pour-On Lösung zum Übergießen für Rinder

Ivermectin Closantel

5 mg/ml 200 mg/ml

Pour-On solution

Cattle

Topical use

Greece

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland

Closamectin 5 mg/ml + 200 mg/ml διάλυμα επίχυσης για Βοοειδή

Ivermectin Closantel

5 mg/ml 200 mg/ml

Pour-On solution

Cattle

Topical use

Ireland

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland

Closamectin 5 mg/ml + 200 mg/ml Pour-On Solution for Cattle

Ivermectin Closantel

5 mg/ml 200 mg/ml

Pour-On solution

Cattle

Topical use

Ireland

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland

Closivet Pour-On Solution for Cattle

Ivermectin Closantel

5 mg/ml 200 mg/ml

Pour-On solution

Cattle

Topical use

Italy

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland

Closamectin 5 mg/ml + 200 mg/ml Soluzione Pour-On per bovini

Ivermectin Closantel

5 mg/ml 200 mg/ml

Pour-On solution

Cattle

Topical use

Italy

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland

Vermax Pour-On 5 mg/ml + 200 mg/ml Soluzione Pour-On per bovini

Ivermectin Closantel

5 mg/ml 200 mg/ml

Pour-On solution

Cattle

Topical use

Poland

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland

Closamectin Pour-On 5 mg/ml + 200 mg/ml, roztwór do polewania dla bydła

Ivermectin Closantel

5 mg/ml 200 mg/ml

Pour-On solution

Cattle

Topical use

Portugal

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland

Closamectin FF 5 mg/ml + 200 mg/ml solução para unção contínua para bovinos

Ivermectin Closantel

5 mg/ml 200 mg/ml

Pour-On solution

Cattle

Topical use

Romania

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland

Closamectin 5 mg/ml + 200 mg/ml Soluţie Pour-On pentru bovine

Ivermectin Closantel

5 mg/ml 200 mg/ml

Pour-On solution

Cattle

Topical use

Spain

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland

CLOSAMECTIN 5 mg/ml + 200 mg/ml SOLUCION POUR-ON PARA BOVINO

Ivermectin Closantel

5 mg/ml 200 mg/ml

Pour-On solution

Cattle

Topical use

Spain

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland

Closivet Solución Pour-On

Ivermectin Closantel

5 mg/ml 200 mg/ml

Pour-On solution

Cattle

Topical use

Sweden

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland

Closamectin vet 5 mg/ml+200 mg/ml Pour-on lösning till nöt

Ivermectin Closantel

5 mg/ml 200 mg/ml

Pour-On solution

Cattle

Topical use

Slovenia

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland

Closamectin 5 mg/ml + 200 mg/ml Pour-On kožni poliv, raztopina za govedo

Ivermectin Closantel

5 mg/ml 200 mg/ml

Pour-On solution

Cattle

Topical use

Slovakia

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland

Closamectin 5 mg/ml + 200 mg/ml pour-on roztok pre hovädzí dobytok

Ivermectin Closantel

5 mg/ml 200 mg/ml

Pour-On solution

Cattle

Topical use

United Kingdom

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland

Closamectin 5 mg/ml + 200 mg/ml Pour-on Solution for Cattle

Ivermectin Closantel

5 mg/ml 200 mg/ml

Pour-On solution

Cattle

Topical use

United Kingdom

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland

Closiver 5 mg/ml + 200 mg/ml Pour-On Solution for Cattle

Ivermectin Closantel

5 mg/ml 200 mg/ml

Pour-On solution

Cattle

Topical use

United Kingdom

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland

Norofas Pour-On Solution for Cattle

Ivermectin Closantel

5 mg/ml 200 mg/ml

Pour-On solution

Cattle

Topical use

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