# Official Journal C 171/30 M

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 171 |
| | |
| English edition | Information and Notices | Volume 6030 May 2017 |

ISSN 1977-091X

Official Journal

of the European Union

C 171

English edition

Information and Notices

Volume 6030 May 2017

---

| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2017/C 171/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2017 to 30 April 2017(Published pursuant to Article 13 or 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |
| 2017/C 171/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2017 to 30 April 2017(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 11 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2017/C 171/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2017 to 30 April 2017(Published pursuant to Article 13 or 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

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

1

2017/C 171/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2017 to 30 April 2017(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)

11

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

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 30.5.2017 | EN | Official Journal of the European Union | C 171/1 |
| --- | --- | --- | --- |

30.5.2017

EN

Official Journal of the European Union

C 171/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2017 to 30 April 2017

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

(2017/C 171/01)

| — | 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 (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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 10.4.2017 | Chenodeoxycholic acid sigma-tau | chenodeoxycholic acid | sigma-tau Arzeimittel GmbH
  Liebherrstr. 22, 80538 München, Deutschland | EU/1/16/1110 | Capsule, hard | A05AA01 | 12.4.2017 |
| 20.4.2017 | Roteas | edoxaban | Daiichi Sankyo Europe GmbH
  Zielstattstrasse 48, D-81379 München, Deutschland | EU/1/16/1152 | Film-coated tablet | B01AF03 | 24.4.2017 |
| 20.4.2017 | Varuby | rolapitant | TESARO UK LIMITED
  55 Baker Street, London W1U 7EU, United Kingdom | EU/1/17/1180 | Film-coated tablet | A04AD14 | 24.4.2017 |
| 24.4.2017 | Natpar | parathyroid hormone | Shire Pharmaceuticals Ireland Limited
  5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/15/1078 | Powder and solution for injection | H05AA03 | 26.4.2017 |
| 24.4.2017 | Pemetrexed Hospira UK Limited | pemetrexed | Hospira UK Limited
  Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom | EU/1/17/1183 | Powder for concentrate for solution for infusion | L01BA04 | 26.4.2017 |
| 24.4.2017 | TAGRISSO | osimertinib | AstraZeneca AB
  Gärtunavägen, SE-151 85 Södertälje, Sverige | EU/1/16/1086 | Film-coated tablet | L01XE35 | 26.4.2017 |
| 28.4.2017 | Darzalex | daratumumab | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/16/1101 | Concentrate for solution for infusion | L01XC24 | 3.5.2017 |
| 28.4.2017 | Emtricitabine/Tenofovir disoproxil Krka d.d. | emtricitabine/tenofovir disoproxil | KRKA, d.d.
  Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/17/1182 | Film-coated tablet | J05AR03 | 3.5.2017 |

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

10.4.2017

Chenodeoxycholic acid sigma-tau

chenodeoxycholic acid

sigma-tau Arzeimittel GmbH

Liebherrstr. 22, 80538 München, Deutschland

EU/1/16/1110

Capsule, hard

A05AA01

12.4.2017

20.4.2017

Roteas

edoxaban

Daiichi Sankyo Europe GmbH

Zielstattstrasse 48, D-81379 München, Deutschland

EU/1/16/1152

Film-coated tablet

B01AF03

24.4.2017

20.4.2017

Varuby

rolapitant

TESARO UK LIMITED

55 Baker Street, London W1U 7EU, United Kingdom

EU/1/17/1180

Film-coated tablet

A04AD14

24.4.2017

24.4.2017

Natpar

parathyroid hormone

Shire Pharmaceuticals Ireland Limited

5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/15/1078

Powder and solution for injection

H05AA03

26.4.2017

24.4.2017

Pemetrexed Hospira UK Limited

pemetrexed

Hospira UK Limited

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

EU/1/17/1183

Powder for concentrate for solution for infusion

L01BA04

26.4.2017

24.4.2017

TAGRISSO

osimertinib

AstraZeneca AB

Gärtunavägen, SE-151 85 Södertälje, Sverige

EU/1/16/1086

Film-coated tablet

L01XE35

26.4.2017

28.4.2017

Darzalex

daratumumab

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/16/1101

Concentrate for solution for infusion

L01XC24

3.5.2017

28.4.2017

Emtricitabine/Tenofovir disoproxil Krka d.d.

emtricitabine/tenofovir disoproxil

KRKA, d.d.

Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/17/1182

Film-coated tablet

J05AR03

3.5.2017

| — | 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 (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 |
| --- | --- | --- | --- | --- |
| 3.4.2017 | Clopidogrel Zentiva | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/08/465 | 5.4.2017 |
| 3.4.2017 | Corlentor | Les Laboratoires Servier
  50 rue Carnot, F-92284 Suresnes CEDEX, France | EU/1/05/317 | 5.4.2017 |
| 3.4.2017 | DuoPlavin | Sanofi Clir SNC
  54 rue La Boétie, F-75008 Paris, France | EU/1/10/619 | 5.4.2017 |
| 3.4.2017 | JEVTANA | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/11/676 | 5.4.2017 |
| 3.4.2017 | Procoralan | Les Laboratoires Servier
  50 rue Carnot, F-92284 Suresnes CEDEX, France | EU/1/05/316 | 5.4.2017 |
| 3.4.2017 | Vepacel | Nanotherapeutics UK Limited
  10 Chiswell Street, 2nd Floor London, EC1Y 4UQ, United Kingdom | EU/1/12/752 | 5.4.2017 |
| 3.4.2017 | Xofigo | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/13/873 | 5.4.2017 |
| 6.4.2017 | Evra | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/02/223 | 10.4.2017 |
| 6.4.2017 | Fycompa | Eisai Europe Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom | EU/1/12/776 | 10.4.2017 |
| 6.4.2017 | Irbesartan Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/576 | 10.4.2017 |
| 6.4.2017 | Levetiracetam Hospira | Hospira UK Limited
  Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom | EU/1/13/889 | 10.4.2017 |
| 6.4.2017 | Vivanza | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/03/249 | 10.4.2017 |
| 6.4.2017 | Zalviso | Grünenthal GmbH
  Zieglerstrasse 6, D-52078, Aachen, Deutschland | EU/1/15/1042 | 10.4.2017 |
| 11.4.2017 | Abasaglar | Eli Lilly Regional Operations GmbH.
  Kölblgasse 8-10, 1030 Wien, Österreich | EU/1/14/944 | 13.4.2017 |
| 11.4.2017 | Constella | Allergan Pharmaceuticals International Limited
  Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland | EU/1/12/801 | 13.4.2017 |
| 11.4.2017 | Envarsus | Chiesi Farmaceutici S.P.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/14/935 | 13.4.2017 |
| 11.4.2017 | Helixate NexGen | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/00/144 | 13.4.2017 |
| 11.4.2017 | Hexacima | Sanofi Pasteur SA
  2 avenue Pont Pasteur, F-69007 Lyon, France | EU/1/13/828 | 13.4.2017 |
| 11.4.2017 | Iblias | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/15/1077 | 13.4.2017 |
| 11.4.2017 | KOGENATE Bayer | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/00/143 | 13.4.2017 |
| 11.4.2017 | Kovaltry | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/15/1076 | 13.4.2017 |
| 11.4.2017 | Optimark | Guerbet
  15, rue des Vanesses, 93420, Villepinte, France | EU/1/07/398 | 13.4.2017 |
| 11.4.2017 | Orgalutran | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/00/130 | 13.4.2017 |
| 11.4.2017 | Sylvant | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/14/928 | 13.4.2017 |
| 12.4.2017 | Eylea | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/12/797 | 19.4.2017 |
| 12.4.2017 | Myfenax | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/07/438 | 19.4.2017 |
| 12.4.2017 | Ovaleap | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/13/871 | 19.4.2017 |
| 12.4.2017 | Tecfidera | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/13/837 | 19.4.2017 |
| 20.4.2017 | Bretaris Genuair | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/12/781 | 24.4.2017 |
| 20.4.2017 | Briviact | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/15/1073 | 24.4.2017 |
| 20.4.2017 | Cetrotide | Merck Serono Europe Limited
  56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/99/100 | 25.4.2017 |
| 20.4.2017 | Edistride | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/15/1052 | 24.4.2017 |
| 20.4.2017 | Eklira Genuair | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/12/778 | 24.4.2017 |
| 20.4.2017 | Forxiga | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/12/795 | 24.4.2017 |
| 20.4.2017 | Glybera | uniQure biopharma B.V.
  Meibergdreef 61, NL-1105 BA Amsterdam, Nederland | EU/1/12/791 | 24.4.2017 |
| 20.4.2017 | Invokana | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/13/884 | 24.4.2017 |
| 20.4.2017 | Izba | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/13/905 | 24.4.2017 |
| 20.4.2017 | Jardiance | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/14/930 | 24.4.2017 |
| 20.4.2017 | Lonquex | UAB ‘Sicor Biotech’
  Molėtų pl. 5, LT-08409 Vilnius, Lietuva | EU/1/13/856 | 24.4.2017 |
| 20.4.2017 | Mycophenolate mofetil Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/07/439 | 24.4.2017 |
| 20.4.2017 | Pandemic influenza vaccine H5N1 MedImmune | MedImmune, LLC
  Lagelandseweg 78, NL-6545 CG Nijmegen, Nederland | EU/1/16/1089 | 24.4.2017 |
| 20.4.2017 | Picato | LEO Laboratories Ltd.
  285 Cashel Road, Crumlin, Dublin 12, Ireland | EU/1/12/796 | 24.4.2017 |
| 20.4.2017 | Rotarix | GlaxoSmithKline Biologicals S.A.
  rue de l’Institut 89, 1330 Rixensart, Belgique | EU/1/05/330 | 24.4.2017 |
| 20.4.2017 | Synjardy | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/15/1003 | 24.4.2017 |
| 20.4.2017 | Tamiflu | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/02/222 | 24.4.2017 |
| 20.4.2017 | Travatan | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/01/199 | 24.4.2017 |
| 20.4.2017 | Vokanamet | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/14/918 | 24.4.2017 |
| 20.4.2017 | Xigduo | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/13/900 | 24.4.2017 |
| 24.4.2017 | CANCIDAS | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/01/196 | 26.4.2017 |
| 24.4.2017 | Darzalex | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/16/1101 | 26.4.2017 |
| 24.4.2017 | Docetaxel Winthrop | Aventis Pharma S.A.
  20 avenue Raymond Aron, F-92165 Antony CEDEX, France | EU/1/07/384 | 26.4.2017 |
| 24.4.2017 | Esbriet | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/11/667 | 26.4.2017 |
| 24.4.2017 | Flebogamma DIF | Instituto Grifols, S.A.
  Can Guasch 2, Parets del Vallès, E-08150 Barcelona, Espaňa | EU/1/07/404 | 26.4.2017 |
| 24.4.2017 | Imatinib Actavis | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland | EU/1/13/825 | 26.4.2017 |
| 24.4.2017 | Jakavi | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/12/773 | 26.4.2017 |
| 24.4.2017 | Opatanol | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/02/217 | 26.4.2017 |
| 24.4.2017 | Siklos | Addmedica
  101 rue Saint Lazare, F-75009 Paris, France | EU/1/07/397 | 26.4.2017 |
| 24.4.2017 | Zinforo | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/12/785 | 26.4.2017 |
| 28.4.2017 | Actos | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/00/150 | 3.5.2017 |
| 28.4.2017 | Cholestagel | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/03/268 | 3.5.2017 |
| 28.4.2017 | Cimzia | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/09/544 | 4.5.2017 |
| 28.4.2017 | Cinqaero | Teva Pharmaceuticals Limited
  Ridings Point, Whistler Drive, Castleford, West Yorkshire, WF10 5HX, United Kingdom | EU/1/16/1125 | 3.5.2017 |
| 28.4.2017 | CONTROLOC Control | Takeda GmbH, (HRB 701016)
  Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | EU/1/09/515 | 3.5.2017 |
| 28.4.2017 | Fertavid | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/09/510 | 3.5.2017 |
| 28.4.2017 | Glustin | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/00/151 | 3.5.2017 |
| 28.4.2017 | Imatinib Medac | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstr. 6, D-22880 Wedel, Deutschland | EU/1/13/876 | 3.5.2017 |
| 28.4.2017 | Invokana | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/13/884 | 3.5.2017 |
| 28.4.2017 | Ixiaro | Valneva Austria GmbH
  Campus Vienna Biocenter 3, A-1030 Wien, Österreich | EU/1/08/501 | 3.5.2017 |
| 28.4.2017 | Kalydeco | Vertex Pharmaceuticals (Europe) Limited
  2 Kingdom Street, London W2 6BD, United Kingdom | EU/1/12/782 | 3.5.2017 |
| 28.4.2017 | NovoNorm | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/98/076 | 3.5.2017 |
| 28.4.2017 | Opdivo | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/15/1014 | 3.5.2017 |
| 28.4.2017 | PANTOLOC Control | Takeda GmbH, (HRB 701016)
  Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | EU/1/09/519 | 3.5.2017 |
| 28.4.2017 | PANTOZOL Control | Takeda GmbH, (HRB 701016)
  Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | EU/1/09/517 | 3.5.2017 |
| 28.4.2017 | Prandin | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/00/162 | 3.5.2017 |
| 28.4.2017 | Puregon | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/96/008 | 3.5.2017 |
| 28.4.2017 | Repaglinide Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/530 | 3.5.2017 |
| 28.4.2017 | SOMAC Control | Takeda GmbH, (HRB 701016)
  Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | EU/1/09/516 | 3.5.2017 |
| 28.4.2017 | Temozolomide Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/606 | 3.5.2017 |
| 28.4.2017 | Tresiba | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/12/807 | 3.5.2017 |
| 28.4.2017 | Trobalt | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/11/681 | 3.5.2017 |
| 28.4.2017 | Vizarsin | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/09/551 | 3.5.2017 |
| 28.4.2017 | Vokanamet | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/14/918 | 3.5.2017 |
| 28.4.2017 | Xeplion | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/11/672 | 3.5.2017 |
| 28.4.2017 | Zebinix | Bial-Portela & Ca, SA
  À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado, Portugal | EU/1/09/514 | 3.5.2017 |
| 28.4.2017 | Zoledronic acid medac | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstr. 6, D-22880 Wedel, Deutschland | EU/1/12/779 | 3.5.2017 |

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

3.4.2017

Clopidogrel Zentiva

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/08/465

5.4.2017

3.4.2017

Corlentor

Les Laboratoires Servier

50 rue Carnot, F-92284 Suresnes CEDEX, France

EU/1/05/317

5.4.2017

3.4.2017

DuoPlavin

Sanofi Clir SNC

54 rue La Boétie, F-75008 Paris, France

EU/1/10/619

5.4.2017

3.4.2017

JEVTANA

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/11/676

5.4.2017

3.4.2017

Procoralan

Les Laboratoires Servier

50 rue Carnot, F-92284 Suresnes CEDEX, France

EU/1/05/316

5.4.2017

3.4.2017

Vepacel

Nanotherapeutics UK Limited

10 Chiswell Street, 2nd Floor London, EC1Y 4UQ, United Kingdom

EU/1/12/752

5.4.2017

3.4.2017

Xofigo

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/13/873

5.4.2017

6.4.2017

Evra

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/02/223

10.4.2017

6.4.2017

Fycompa

Eisai Europe Limited

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

EU/1/12/776

10.4.2017

6.4.2017

Irbesartan Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/576

10.4.2017

6.4.2017

Levetiracetam Hospira

Hospira UK Limited

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

EU/1/13/889

10.4.2017

6.4.2017

Vivanza

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/03/249

10.4.2017

6.4.2017

Zalviso

Grünenthal GmbH

Zieglerstrasse 6, D-52078, Aachen, Deutschland

EU/1/15/1042

10.4.2017

11.4.2017

Abasaglar

Eli Lilly Regional Operations GmbH.

Kölblgasse 8-10, 1030 Wien, Österreich

EU/1/14/944

13.4.2017

11.4.2017

Constella

Allergan Pharmaceuticals International Limited

Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland

EU/1/12/801

13.4.2017

11.4.2017

Envarsus

Chiesi Farmaceutici S.P.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/14/935

13.4.2017

11.4.2017

Helixate NexGen

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/00/144

13.4.2017

11.4.2017

Hexacima

Sanofi Pasteur SA

2 avenue Pont Pasteur, F-69007 Lyon, France

EU/1/13/828

13.4.2017

11.4.2017

Iblias

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/15/1077

13.4.2017

11.4.2017

KOGENATE Bayer

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/00/143

13.4.2017

11.4.2017

Kovaltry

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/15/1076

13.4.2017

11.4.2017

Optimark

Guerbet

15, rue des Vanesses, 93420, Villepinte, France

EU/1/07/398

13.4.2017

11.4.2017

Orgalutran

Merck Sharp & Dohme Limited

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

EU/1/00/130

13.4.2017

11.4.2017

Sylvant

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/14/928

13.4.2017

12.4.2017

Eylea

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/12/797

19.4.2017

12.4.2017

Myfenax

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/07/438

19.4.2017

12.4.2017

Ovaleap

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/13/871

19.4.2017

12.4.2017

Tecfidera

Biogen Idec Limited

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

EU/1/13/837

19.4.2017

20.4.2017

Bretaris Genuair

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/12/781

24.4.2017

20.4.2017

Briviact

UCB Pharma S.A.

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

EU/1/15/1073

24.4.2017

20.4.2017

Cetrotide

Merck Serono Europe Limited

56, Marsh Wall, London E14 9TP, United Kingdom

EU/1/99/100

25.4.2017

20.4.2017

Edistride

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/15/1052

24.4.2017

20.4.2017

Eklira Genuair

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/12/778

24.4.2017

20.4.2017

Forxiga

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/12/795

24.4.2017

20.4.2017

Glybera

uniQure biopharma B.V.

Meibergdreef 61, NL-1105 BA Amsterdam, Nederland

EU/1/12/791

24.4.2017

20.4.2017

Invokana

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/13/884

24.4.2017

20.4.2017

Izba

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/13/905

24.4.2017

20.4.2017

Jardiance

Boehringer Ingelheim International GmbH

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

EU/1/14/930

24.4.2017

20.4.2017

Lonquex

UAB ‘Sicor Biotech’

Molėtų pl. 5, LT-08409 Vilnius, Lietuva

EU/1/13/856

24.4.2017

20.4.2017

Mycophenolate mofetil Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/07/439

24.4.2017

20.4.2017

Pandemic influenza vaccine H5N1 MedImmune

MedImmune, LLC

Lagelandseweg 78, NL-6545 CG Nijmegen, Nederland

EU/1/16/1089

24.4.2017

20.4.2017

Picato

LEO Laboratories Ltd.

285 Cashel Road, Crumlin, Dublin 12, Ireland

EU/1/12/796

24.4.2017

20.4.2017

Rotarix

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, 1330 Rixensart, Belgique

EU/1/05/330

24.4.2017

20.4.2017

Synjardy

Boehringer Ingelheim International GmbH

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

EU/1/15/1003

24.4.2017

20.4.2017

Tamiflu

Roche Registration Limited

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

EU/1/02/222

24.4.2017

20.4.2017

Travatan

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/01/199

24.4.2017

20.4.2017

Vokanamet

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/14/918

24.4.2017

20.4.2017

Xigduo

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/13/900

24.4.2017

24.4.2017

CANCIDAS

Merck Sharp & Dohme Limited

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

EU/1/01/196

26.4.2017

24.4.2017

Darzalex

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/16/1101

26.4.2017

24.4.2017

Docetaxel Winthrop

Aventis Pharma S.A.

20 avenue Raymond Aron, F-92165 Antony CEDEX, France

EU/1/07/384

26.4.2017

24.4.2017

Esbriet

Roche Registration Limited

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

EU/1/11/667

26.4.2017

24.4.2017

Flebogamma DIF

Instituto Grifols, S.A.

Can Guasch 2, Parets del Vallès, E-08150 Barcelona, Espaňa

EU/1/07/404

26.4.2017

24.4.2017

Imatinib Actavis

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/13/825

26.4.2017

24.4.2017

Jakavi

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/12/773

26.4.2017

24.4.2017

Opatanol

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/02/217

26.4.2017

24.4.2017

Siklos

Addmedica

101 rue Saint Lazare, F-75009 Paris, France

EU/1/07/397

26.4.2017

24.4.2017

Zinforo

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/12/785

26.4.2017

28.4.2017

Actos

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/00/150

3.5.2017

28.4.2017

Cholestagel

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/03/268

3.5.2017

28.4.2017

Cimzia

UCB Pharma S.A.

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

EU/1/09/544

4.5.2017

28.4.2017

Cinqaero

Teva Pharmaceuticals Limited

Ridings Point, Whistler Drive, Castleford, West Yorkshire, WF10 5HX, United Kingdom

EU/1/16/1125

3.5.2017

28.4.2017

CONTROLOC Control

Takeda GmbH, (HRB 701016)

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

EU/1/09/515

3.5.2017

28.4.2017

Fertavid

Merck Sharp & Dohme Limited

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

EU/1/09/510

3.5.2017

28.4.2017

Glustin

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/00/151

3.5.2017

28.4.2017

Imatinib Medac

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstr. 6, D-22880 Wedel, Deutschland

EU/1/13/876

3.5.2017

28.4.2017

Invokana

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/13/884

3.5.2017

28.4.2017

Ixiaro

Valneva Austria GmbH

Campus Vienna Biocenter 3, A-1030 Wien, Österreich

EU/1/08/501

3.5.2017

28.4.2017

Kalydeco

Vertex Pharmaceuticals (Europe) Limited

2 Kingdom Street, London W2 6BD, United Kingdom

EU/1/12/782

3.5.2017

28.4.2017

NovoNorm

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/98/076

3.5.2017

28.4.2017

Opdivo

Bristol-Myers Squibb Pharma EEIG

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

EU/1/15/1014

3.5.2017

28.4.2017

PANTOLOC Control

Takeda GmbH, (HRB 701016)

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

EU/1/09/519

3.5.2017

28.4.2017

PANTOZOL Control

Takeda GmbH, (HRB 701016)

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

EU/1/09/517

3.5.2017

28.4.2017

Prandin

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/00/162

3.5.2017

28.4.2017

Puregon

Merck Sharp & Dohme Limited

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

EU/1/96/008

3.5.2017

28.4.2017

Repaglinide Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/530

3.5.2017

28.4.2017

SOMAC Control

Takeda GmbH, (HRB 701016)

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

EU/1/09/516

3.5.2017

28.4.2017

Temozolomide Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/606

3.5.2017

28.4.2017

Tresiba

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/12/807

3.5.2017

28.4.2017

Trobalt

Glaxo Group Ltd

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

EU/1/11/681

3.5.2017

28.4.2017

Vizarsin

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/551

3.5.2017

28.4.2017

Vokanamet

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/14/918

3.5.2017

28.4.2017

Xeplion

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/11/672

3.5.2017

28.4.2017

Zebinix

Bial-Portela & Ca, SA

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

EU/1/09/514

3.5.2017

28.4.2017

Zoledronic acid medac

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstr. 6, D-22880 Wedel, Deutschland

EU/1/12/779

3.5.2017

| — | 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 (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 |
| --- | --- | --- | --- | --- |
| 3.4.2017 | Imprida | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/06/373 | 5.4.2017 |
| 24.4.2017 | DUTREBIS | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/15/995 | 26.4.2017 |

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

3.4.2017

Imprida

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/06/373

5.4.2017

24.4.2017

DUTREBIS

Merck Sharp & Dohme Limited

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

EU/1/15/995

26.4.2017

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

—

Issuing 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 | 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 25.4.2017 | Credelio | lotilaner | Elanco Europe Ltd.
  Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom | EU/2/17/206 | Chewable tablet | QP53BE04 | 27.4.2017 |
| 25.4.2017 | CYTOPOINT | lokivetmab | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/17/205 | solution for injection in a vial | QD11AH91 | 27.4.2017 |
| 25.4.2017 | Zulvac BTV Ovis | Bluetongue vaccine (inactivated): serotype 1, 4, 8 | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/17/207 | Suspension for injection | QI04AA02 | 27.4.2017 |

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

25.4.2017

Credelio

lotilaner

Elanco Europe Ltd.

Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom

EU/2/17/206

Chewable tablet

QP53BE04

27.4.2017

25.4.2017

CYTOPOINT

lokivetmab

Zoetis Belgium S.A.

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

EU/2/17/205

solution for injection in a vial

QD11AH91

27.4.2017

25.4.2017

Zulvac BTV Ovis

Bluetongue vaccine (inactivated): serotype 1, 4, 8

Zoetis Belgium S.A.

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

EU/2/17/207

Suspension for injection

QI04AA02

27.4.2017

| — | 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 (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 |
| --- | --- | --- | --- | --- |
| 11.4.2017 | Procox | Bayer Animal Health GmbH
  D-51368 Leverkusen, Deutschland | EU/2/11/123 | 19.4.2017 |
| 12.4.2017 | FORTEKOR PLUS | Elanco Europe Ltd.
  Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom | EU/2/15/185 | 19.4.2017 |
| 25.4.2017 | Cerenia | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/06/062 | 27.4.2017 |
| 25.4.2017 | Quadrisol | VETCOOL B.V.
  Otto Hahnweg 24, 3542 AX Utrecht, Nederland | EU/2/97/005 | 28.4.2017 |

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

11.4.2017

Procox

Bayer Animal Health GmbH

D-51368 Leverkusen, Deutschland

EU/2/11/123

19.4.2017

12.4.2017

FORTEKOR PLUS

Elanco Europe Ltd.

Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom

EU/2/15/185

19.4.2017

25.4.2017

Cerenia

Zoetis Belgium S.A.

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

EU/2/06/062

27.4.2017

25.4.2017

Quadrisol

VETCOOL B.V.

Otto Hahnweg 24, 3542 AX Utrecht, Nederland

EU/2/97/005

28.4.2017

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.

---

| 30.5.2017 | EN | Official Journal of the European Union | C 171/11 |
| --- | --- | --- | --- |

30.5.2017

EN

Official Journal of the European Union

C 171/11

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2017 to 30 April 2017

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

(2017/C 171/02)

| — | Issuing, maintenance or modification of a national marketing authorisation |
| --- | --- |

—

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 |
| --- | --- | --- | --- | --- | --- |
| 28.4.2017 | Haldol Decanoate and associated names — Art. 30 | haloperidol decanoate | See Annex I | See Annex I | 2.5.2017 |
| 28.4.2017 | Haldol and associated names — Art. 30 | haloperidol | See Annex II | See Annex II | 2.5.2017 |

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

28.4.2017

Haldol Decanoate and associated names — Art. 30

haloperidol decanoate

See Annex I

See Annex I

2.5.2017

28.4.2017

Haldol and associated names — Art. 30

haloperidol

See Annex II

See Annex II

2.5.2017

---

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

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

---

ANNEX I

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State
  EU/EEA | Marketing authorisation holder | Name | Strength | Pharmaceutical form | Route of administration | Content
  (concentration) |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Janssen-Cilag Pharma GmbH
  Vorgartenstraße 206B
  AT-1020 Vienna
  Austria | Haldol Decanoat | 50 mg/ml | Solution for injection | Intramuscular use | 50 mg/ml |
| Austria | Janssen-Cilag Pharma GmbH
  Vorgartenstraße 206B
  AT-1020 Vienna
  Austria | Haldol Decanoat | 150 mg/3 ml | Solution for injection | Intramuscular use | 50 mg/ml |
| Belgium | Janssen-Cilag NV
  Antwerpseweg 15-17
  B-2340 Beerse
  Belgium | Haldol Decanoas | 50 mg/ml | Solution for injection | Intramuscular use | 50 mg/ml |
| Belgium | Janssen-Cilag NV
  Antwerpseweg 15-17
  B-2340 Beerse
  Belgium | Haldol Decanoas | 150 mg/3 ml | Solution for injection | Intramuscular use | 50 mg/ml |
| Belgium | Janssen-Cilag NV
  Antwerpseweg 15-17
  B-2340 Beerse
  Belgium | Haldol Decanoas | 100 mg/ml | Solution for injection | Intramuscular use | 100 mg/ml |
| Cyprus | Janssen-Cilag International NV
  Turnhoutseweg 30,
  2340 Beerse
  Belgium | Haldol Decanoate | 50 mg/ml | Solution for injection | Intramuscular use | 50 mg/ml |
| Cyprus | Janssen-Cilag International NV
  Turnhoutseweg 30,
  2340 Beerse
  Belgium | Haldol Decanoate | 100 mg/ml | Solution for injection | Intramuscular use | 100 mg/ml |
| Denmark | Janssen-Cilag A/S
  Bregnerødvej 133
  3460 Birkerød
  Denmark | Serenase Dekanoat | 50 mg/ml | Solution for injection | Intramuscular use | 50 mg/ml |
| Denmark | Janssen-Cilag A/S
  Bregnerødvej 133
  3460 Birkerød
  Denmark | Serenase Dekanoat | 100 mg/ml | Solution for injection | Intramuscular use | 100 mg/ml |
| Finland | Janssen-Cilag Oy
  Vaisalantie 2
  02130 Espoo
  Finland | Serenase Depot | 50 mg/ml | Solution for injection | Intramuscular use | 50 mg/ml |
| Finland | Janssen-Cilag Oy
  Vaisalantie 2
  02130 Espoo
  Finland | Serenase Depot | 100 mg/ml | Solution for injection | Intramuscular use | 100 mg/ml |
| France | Janssen-Cilag
  1, rue Camille Desmoulins, TSA 91003
  F-92787 Issy Les Moulineaux, Cedex 9
  France | Haldol Decanoas | 50 mg/ml | Solution for injection | Intramuscular use | 50 mg/ml |
| Germany | Janssen-Cilag GmbH
  Johnson & Johnson Platz 1
  41470 Neuss
  Germany | Haldol — Janssen Decanoat Depot | 50 mg/ml | Solution for injection | Intramuscular use | 50 mg/ml |
| Germany | Janssen-Cilag GmbH
  Johnson & Johnson Platz 1
  41470 Neuss
  Germany | Haldol — Janssen Decanoat Depot 3 ml | 150 mg/3 ml | Solution for injection | Intramuscular use | 50 mg/ml |
| Greece | Janssen-Cilag
  Pharmaceutical S.A.C.I.
  56 Eirinis Ave, Pefki
  Athens GR-151 21
  Greece | Aloperidin Decanoas | 50 mg/ml | Solution for injection | Intramuscular use | 50 mg/ml |
| Greece | Janssen-Cilag
  Pharmaceutical S.A.C.I.
  56 Eirinis Ave, Pefki
  Athens GR-151 21
  Greece | Aloperidin Decanoas | 150 mg/3 ml | Solution for injection | Intramuscular use | 50 mg/ml |
| Greece | Janssen-Cilag
  Pharmaceutical S.A.C.I.
  56 Eirinis Ave, Pefki,
  Athens GR-151 21
  Greece | Aloperidin Decanoas | 100 mg/ml | Solution for injection | Intramuscular use | 100 mg/ml |
| Iceland | Janssen-Cilag AB
  Box 4042
  16904 Solna
  Sweden | Haldol Depot | 100 mg/ml | Solution for injection | Intramuscular use | 100 mg/ml |
| Ireland | Janssen-Cilag Limited
  50-100 Holmers Farm Way
  High Wycombe
  Buckinghamshire HP12 4EG United Kingdom | Haldol Decanoate | 50 mg/ml | Solution for injection | Intramuscular use | 50 mg/ml |
| Ireland | Janssen-Cilag Limited
  50-100 Holmers Farm Way
  High Wycombe
  Buckinghamshire HP12 4EG United Kingdom | Haldol Decanoate | 100 mg/ml | Solution for injection | Intramuscular use | 100 mg/ml |
| Italy | Janssen-Cilag SpA
  Via M.Buonarroti, 23
  I-20093 Cologno Monzese MI,
  Italy | Haldol Decanoas | 50 mg/ml | Solution for injection | Intramuscular use | 50 mg/ml |
| Italy | Janssen-Cilag SpA
  Via M.Buonarroti, 23
  I-20093 Cologno Monzese MI,
  Italy | Haldol Decanoas | 150 mg/3 ml | Solution for injection | Intramuscular use | 50 mg/ml |
| Luxembourg | Janssen-Cilag NV
  Antwerpseweg 15-17
  B-2340 Beerse
  Belgium | Haldol Decanoas | 50 mg/ml | Solution for injection | Intramuscular use | 50 mg/ml |
| Luxembourg | Janssen-Cilag NV
  Antwerpseweg 15-17
  B-2340 Beerse
  Belgium | Haldol Decanoas | 150 mg/3 ml | Solution for injection | Intramuscular use | 50 mg/ml |
| Luxembourg | Janssen-Cilag NV
  Antwerpseweg 15-17
  B-2340 Beerse
  Belgium | Haldol Decanoas | 100 mg/ml | Solution for injection | Intramuscular use | 100 mg/ml |
| The Netherlands | Janssen-Cilag BV
  Dr. Paul Janssenweg 150
  5026 RH Tilburg
  The Netherlands | Haldol Decanoas oplossing voor injectie 50 mg/ml | 50 mg/ml | Solution for injection | Intramuscular use | 50 mg/ml |
| The Netherlands | Janssen-Cilag BV
  Dr. Paul Janssenweg 150
  5026 RH Tilburg
  The Netherlands | Haldol Decanoas oplossing voor injectie 100 mg/ml | 100 mg/ml | Solution for injection | Intramuscular use | 100 mg/ml |
| Norway | JANSSEN-CILAG AS
  Drammensveien 288
  0283 Oslo
  Norway | Haldol Depot | 100 mg/ml | Solution for injection | Intramuscular use | 100 mg/ml |
| Portugal | Janssen Farmacêutica Portugal, Lda
  Estrada Consiglieri Pedroso, 69 A, Queluz de Baixo2734 503 Barcarena
  Portugal | Haldol Decanoato | 50 mg/1 ml | Solution for injection | Intramuscular use | 50 mg/ml |
| Portugal | Janssen Farmacêutica Portugal, Lda
  Estrada Consiglieri Pedroso, 69 A, Queluz de Baixo
  2734 503 Barcarena
  Portugal | Haldol Decanoato | 100 mg/1 ml | Solution for injection | Intramuscular use | 100 mg/ml |
| Sweden | Janssen-Cilag AB
  Box 4042
  16904 Solna
  Sweden | Haldol Depot | 50 mg/ml | Solution for injection | Intramuscular use | 50 mg/ml |
| Sweden | Janssen-Cilag AB
  Box 4042
  16904 Solna
  Sweden | Haldol Depot | 100 mg/ml | Solution for injection | Intramuscular use | 100 mg/ml |
| United Kingdom | Janssen-Cilag Limited
  50-100 Holmers Farm Way
  High Wycombe
  Buckinghamshire
  HP12 4EG
  United Kingdom | Haldol Decanoate | 50 mg/ml | Solution for injection | Intramuscular use | 50 mg/ml |
| United Kingdom | Janssen-Cilag Limited
  50-100 Holmers Farm Way
  High Wycombe
  Buckinghamshire
  HP12 4EG,
  United Kingdom | Haldol Decanoate | 100 mg/ml | Solution for injection | Intramuscular use | 100 mg/ml |

Member State

EU/EEA

Marketing authorisation holder

Name

Strength

Pharmaceutical form

Route of administration

Content

(concentration)

Austria

Janssen-Cilag Pharma GmbH

Vorgartenstraße 206B

AT-1020 Vienna

Austria

Haldol Decanoat

50 mg/ml

Solution for injection

Intramuscular use

50 mg/ml

Austria

Janssen-Cilag Pharma GmbH

Vorgartenstraße 206B

AT-1020 Vienna

Austria

Haldol Decanoat

150 mg/3 ml

Solution for injection

Intramuscular use

50 mg/ml

Belgium

Janssen-Cilag NV

Antwerpseweg 15-17

B-2340 Beerse

Belgium

Haldol Decanoas

50 mg/ml

Solution for injection

Intramuscular use

50 mg/ml

Belgium

Janssen-Cilag NV

Antwerpseweg 15-17

B-2340 Beerse

Belgium

Haldol Decanoas

150 mg/3 ml

Solution for injection

Intramuscular use

50 mg/ml

Belgium

Janssen-Cilag NV

Antwerpseweg 15-17

B-2340 Beerse

Belgium

Haldol Decanoas

100 mg/ml

Solution for injection

Intramuscular use

100 mg/ml

Cyprus

Janssen-Cilag International NV

Turnhoutseweg 30,

2340 Beerse

Belgium

Haldol Decanoate

50 mg/ml

Solution for injection

Intramuscular use

50 mg/ml

Cyprus

Janssen-Cilag International NV

Turnhoutseweg 30,

2340 Beerse

Belgium

Haldol Decanoate

100 mg/ml

Solution for injection

Intramuscular use

100 mg/ml

Denmark

Janssen-Cilag A/S

Bregnerødvej 133

3460 Birkerød

Denmark

Serenase Dekanoat

50 mg/ml

Solution for injection

Intramuscular use

50 mg/ml

Denmark

Janssen-Cilag A/S

Bregnerødvej 133

3460 Birkerød

Denmark

Serenase Dekanoat

100 mg/ml

Solution for injection

Intramuscular use

100 mg/ml

Finland

Janssen-Cilag Oy

Vaisalantie 2

02130 Espoo

Finland

Serenase Depot

50 mg/ml

Solution for injection

Intramuscular use

50 mg/ml

Finland

Janssen-Cilag Oy

Vaisalantie 2

02130 Espoo

Finland

Serenase Depot

100 mg/ml

Solution for injection

Intramuscular use

100 mg/ml

France

Janssen-Cilag

1, rue Camille Desmoulins, TSA 91003

F-92787 Issy Les Moulineaux, Cedex 9

France

Haldol Decanoas

50 mg/ml

Solution for injection

Intramuscular use

50 mg/ml

Germany

Janssen-Cilag GmbH

Johnson & Johnson Platz 1

41470 Neuss

Germany

Haldol — Janssen Decanoat Depot

50 mg/ml

Solution for injection

Intramuscular use

50 mg/ml

Germany

Janssen-Cilag GmbH

Johnson & Johnson Platz 1

41470 Neuss

Germany

Haldol — Janssen Decanoat Depot 3 ml

150 mg/3 ml

Solution for injection

Intramuscular use

50 mg/ml

Greece

Janssen-Cilag

Pharmaceutical S.A.C.I.

56 Eirinis Ave, Pefki

Athens GR-151 21

Greece

Aloperidin Decanoas

50 mg/ml

Solution for injection

Intramuscular use

50 mg/ml

Greece

Janssen-Cilag

Pharmaceutical S.A.C.I.

56 Eirinis Ave, Pefki

Athens GR-151 21

Greece

Aloperidin Decanoas

150 mg/3 ml

Solution for injection

Intramuscular use

50 mg/ml

Greece

Janssen-Cilag

Pharmaceutical S.A.C.I.

56 Eirinis Ave, Pefki,

Athens GR-151 21

Greece

Aloperidin Decanoas

100 mg/ml

Solution for injection

Intramuscular use

100 mg/ml

Iceland

Janssen-Cilag AB

Box 4042

16904 Solna

Sweden

Haldol Depot

100 mg/ml

Solution for injection

Intramuscular use

100 mg/ml

Ireland

Janssen-Cilag Limited

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire HP12 4EG United Kingdom

Haldol Decanoate

50 mg/ml

Solution for injection

Intramuscular use

50 mg/ml

Ireland

Janssen-Cilag Limited

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire HP12 4EG United Kingdom

Haldol Decanoate

100 mg/ml

Solution for injection

Intramuscular use

100 mg/ml

Italy

Janssen-Cilag SpA

Via M.Buonarroti, 23

I-20093 Cologno Monzese MI,

Italy

Haldol Decanoas

50 mg/ml

Solution for injection

Intramuscular use

50 mg/ml

Italy

Janssen-Cilag SpA

Via M.Buonarroti, 23

I-20093 Cologno Monzese MI,

Italy

Haldol Decanoas

150 mg/3 ml

Solution for injection

Intramuscular use

50 mg/ml

Luxembourg

Janssen-Cilag NV

Antwerpseweg 15-17

B-2340 Beerse

Belgium

Haldol Decanoas

50 mg/ml

Solution for injection

Intramuscular use

50 mg/ml

Luxembourg

Janssen-Cilag NV

Antwerpseweg 15-17

B-2340 Beerse

Belgium

Haldol Decanoas

150 mg/3 ml

Solution for injection

Intramuscular use

50 mg/ml

Luxembourg

Janssen-Cilag NV

Antwerpseweg 15-17

B-2340 Beerse

Belgium

Haldol Decanoas

100 mg/ml

Solution for injection

Intramuscular use

100 mg/ml

The Netherlands

Janssen-Cilag BV

Dr. Paul Janssenweg 150

5026 RH Tilburg

The Netherlands

Haldol Decanoas oplossing voor injectie 50 mg/ml

50 mg/ml

Solution for injection

Intramuscular use

50 mg/ml

The Netherlands

Janssen-Cilag BV

Dr. Paul Janssenweg 150

5026 RH Tilburg

The Netherlands

Haldol Decanoas oplossing voor injectie 100 mg/ml

100 mg/ml

Solution for injection

Intramuscular use

100 mg/ml

Norway

JANSSEN-CILAG AS

Drammensveien 288

0283 Oslo

Norway

Haldol Depot

100 mg/ml

Solution for injection

Intramuscular use

100 mg/ml

Portugal

Janssen Farmacêutica Portugal, Lda

Estrada Consiglieri Pedroso, 69 A, Queluz de Baixo2734 503 Barcarena

Portugal

Haldol Decanoato

50 mg/1 ml

Solution for injection

Intramuscular use

50 mg/ml

Portugal

Janssen Farmacêutica Portugal, Lda

Estrada Consiglieri Pedroso, 69 A, Queluz de Baixo

2734 503 Barcarena

Portugal

Haldol Decanoato

100 mg/1 ml

Solution for injection

Intramuscular use

100 mg/ml

Sweden

Janssen-Cilag AB

Box 4042

16904 Solna

Sweden

Haldol Depot

50 mg/ml

Solution for injection

Intramuscular use

50 mg/ml

Sweden

Janssen-Cilag AB

Box 4042

16904 Solna

Sweden

Haldol Depot

100 mg/ml

Solution for injection

Intramuscular use

100 mg/ml

United Kingdom

Janssen-Cilag Limited

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

United Kingdom

Haldol Decanoate

50 mg/ml

Solution for injection

Intramuscular use

50 mg/ml

United Kingdom

Janssen-Cilag Limited

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG,

United Kingdom

Haldol Decanoate

100 mg/ml

Solution for injection

Intramuscular use

100 mg/ml

---

ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State
  EU/EEA | Marketing authorisation holder | Name | Strength | Pharmaceutical form | Route of administration | Content
  (concentration) |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Janssen-Cilag Pharma GmbH
  Vorgartenstraße 206B
  AT-1020 Vienna
  Austria | Haldol | 2 mg/ml | Oral solution | Oral use | 2 mg/ml |
| Austria | Janssen-Cilag Pharma GmbH
  Vorgartenstraße 206B
  AT-1020 Vienna
  Austria | Haldol | 150 mg/30 ml | Solution for injection | Intramuscular use | 5 mg/ml |
| Austria | Janssen-Cilag Pharma GmbH
  Vorgartenstraße 206B
  AT-1020 Vienna
  Austria | Haldol | 1 mg | Tablet | Oral use | N/A |
| Austria | Janssen-Cilag Pharma GmbH
  Vorgartenstraße 206B
  AT-1020 Vienna
  Austria | Haldol | 10 mg | Tablet | Oral use | N/A |
| Belgium | Janssen-Cilag NV
  Antwerpseweg 15-17
  B-2340 Beerse
  Belgium | Haldol | 30 mg/15 ml | Oral solution | Oral use | 2 mg/ml |
| Belgium | Janssen-Cilag NV
  Antwerpseweg 15-17
  B-2340 Beerse
  Belgium | Haldol | 60 mg/30 ml | Oral solution | Oral use | 2 mg/ml |
| Belgium | Janssen-Cilag NV
  Antwerpseweg 15-17
  B-2340 Beerse
  Belgium | Haldol | 200 mg/100 ml | Oral solution | Oral use | 2 mg/ml |
| Belgium | Janssen-Cilag NV
  Antwerpseweg 15-17
  B-2340 Beerse
  Belgium | Haldol | 300 mg/30 ml | Oral solution | Oral use | 10 mg/ml |
| Belgium | Janssen-Cilag NV
  Antwerpseweg 15-17
  B-2340 Beerse
  Belgium | Haldol | 1 000  mg/100 ml | Oral solution | Oral use | 10 mg/ml |
| Belgium | Janssen-Cilag NV
  Antwerpseweg 15-17
  B-2340 Beerse
  Belgium | Haldol | 5 mg/ml | Solution for injection | Intramuscular use; Intravenous use | 5 mg/ml |
| Belgium | Janssen-Cilag NV
  Antwerpseweg 15-17
  B-2340 Beerse
  Belgium | Haldol | 2 mg | Tablet | Oral use | N/A |
| Belgium | Janssen-Cilag NV
  Antwerpseweg 15-17
  B-2340 Beerse
  Belgium | Haldol | 5 mg | Tablet | Oral use | N/A |
| Belgium | Janssen-Cilag NV
  Antwerpseweg 15-17
  B-2340 Beerse
  Belgium | Haldol | 20 mg | Tablet | Oral use | N/A |
| Cyprus | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340
  Beerse, Belgium | Haldol | 30 mg/15 ml | Oral solution | Oral use | 2 mg/ml |
| Cyprus | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340
  Beerse, Belgium | Haldol | 5 mg/ml | Solution for injection | Intramuscular use | 5 mg/ml |
| Cyprus | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340
  Beerse, Belgium | Haldol | 5 mg | Tablet | Oral use | N/A |
| Denmark | JANSSEN-CILAG A/S
  Bregnerødvej 133
  3460 Birkerød
  Denmark | Serenase | 2 mg/ml | Oral solution | Oral use | 2 mg/ml |
| Denmark | JANSSEN-CILAG A/S
  Bregnerødvej 133
  3460 Birkerød
  Denmark | Serenase | 5 mg/ml | Solution for injection | Intramuscular use; Intravenous use | 5 mg/ml |
| Denmark | JANSSEN-CILAG A/S
  Bregnerødvej 133
  3460 Birkerød
  Denmark | Serenase | 2 mg | Tablet | Oral use | N/A |
| Denmark | JANSSEN-CILAG A/S
  Bregnerødvej 133
  3460 Birkerød
  Denmark | Serenase | 5 mg | Tablet | Oral use | N/A |
| Denmark | JANSSEN-CILAG A/S
  Bregnerødvej 133
  3460 Birkerød
  Denmark | Serenase | 20 mg | Tablet | Oral use | N/A |
| Finland | Janssen-Cilag Oy
  Vaisalantie 2
  02130 Espoo
  Finland | Serenase | 2 mg/ml | Oral solution | Oral use | 2 mg/ml |
| Finland | Janssen-Cilag Oy
  Vaisalantie 2
  02130 Espoo
  Finland | Serenase | 5 mg/ml | Solution for injection | Intramuscular use | 5 mg/ml |
| Finland | Janssen-Cilag Oy
  Vaisalantie 2
  02130 Espoo
  Finland | Serenase | 1 mg | Tablet | Oral use | N/A |
| Finland | Janssen-Cilag Oy
  Vaisalantie 2
  02130 Espoo
  Finland | Serenase | 4 mg | Tablet | Oral use | N/A |
| Finland | Janssen-Cilag Oy
  Vaisalantie 2
  02130 Espoo
  Finland | Serenase | 10 mg | Tablet | Oral use | N/A |
| France | Janssen-Cilag
  1, rue Camille Desmoulins, TSA 91003
  F-92787 Issy Les Moulineaux, Cedex 9
  France | Haldol | 2 mg/ml in bottles of 15 ml, 30 ml, 100 ml and 195 ml | Oral solution | Oral use | 2 mg/ml |
| France | Janssen-Cilag
  1, rue Camille Desmoulins, TSA 91003
  F-92787 Issy Les Moulineaux, Cedex 9
  France | Haldol | 5 mg/ml | Solution for injection | Intramuscular use | 5 mg/ml |
| France | Janssen-Cilag
  1, rue Camille Desmoulins, TSA 91003
  F-92787 Issy Les Moulineaux, Cedex 9
  France | Haldol | 1 mg | Tablet | Oral use | N/A |
| France | Janssen-Cilag
  1, rue Camille Desmoulins, TSA 91003
  F-92787 Issy Les Moulineaux, Cedex 9
  France | Haldol | 5 mg | Tablet | Oral use | N/A |
| Germany | Janssen-Cilag GmbH
  Johnson & Johnson Platz 1
  41470 Neuss
  Germany | Haldol-Janssen | 2 mg/ml in bottles of 30 ml and 100 ml) | Oral solution | Oral use | 2 mg/ml |
| Germany | Janssen-Cilag GmbH
  Johnson & Johnson Platz 1
  41470 Neuss
  Germany | Haldol-Janssen | 5 mg/ml | Solution for injection | Intramuscular use | 5 mg/ml |
| Germany | Janssen-Cilag GmbH
  Johnson & Johnson Platz 1
  41470 Neuss
  Germany | Haldol-Janssen | 1 mg | Tablet | Oral use | N/A |
| Germany | Janssen-Cilag GmbH
  Johnson & Johnson Platz 1
  41470 Neuss
  Germany | Haldol-Janssen | 2 mg | Tablet | Oral use | N/A |
| Germany | Janssen-Cilag GmbH
  Johnson & Johnson Platz 1
  41470 Neuss
  Germany | Haldol-Janssen | 5 mg | Tablet | Oral use | N/A |
| Germany | Janssen-Cilag GmbH
  Johnson & Johnson Platz 1
  41470 Neuss
  Germany | Haldol-Janssen | 10 mg | Tablet | Oral use | N/A |
| Greece | Janssen-Cilag
  Pharmaceutical S.A.C.I.
  56 Eirinis Ave, Pefki
  Athens GR-151 21
  Greece | Aloperidin | 30 mg/15 ml | Oral Drops, Solution | Oral use | 2 mg/ml |
| Greece | Janssen-Cilag
  Pharmaceutical S.A.C.I.
  56 Eirinis Ave, Pefki
  Athens GR-151 21
  Greece | Aloperidin | 150 mg/15 ml
  300 mg/30 ml | Oral Drops, Solution | Oral use | 10 mg/ml |
| Greece | Janssen-Cilag
  Pharmaceutical S.A.C.I.
  56 Eirinis Ave, Pefki
  Athens GR-151 21
  Greece | Aloperidin | 5 mg/ml
  (BTx5AMP x1ML, BTx50AMP x1ML) | Solution for injection | Intramuscular use | 5 mg/ml |
| Greece | Janssen-Cilag
  Pharmaceutical S.A.C.I.
  56 Eirinis Ave, Pefki,
  Athens GR-151 21
  Greece | Aloperidin | 1 mg | Tablet | Oral use | N/A |
| Greece | Janssen-Cilag
  Pharmaceutical S.A.C.I.
  56 Eirinis Ave, Pefki,
  Athens GR-151 21
  Greece | Aloperidin | 2 mg | Tablet | Oral use | N/A |
| Greece | Janssen-Cilag
  Pharmaceutical S.A.C.I.
  56 Eirinis Ave, Pefki,
  Athens GR-151 21
  Greece | Aloperidin | 5 mg | Tablet | Oral use | N/A |
| Greece | Janssen-Cilag
  Pharmaceutical S.A.C.I.
  56 Eirinis Ave, Pefki,
  Athens GR-151 21
  Greece | Aloperidin | 10 mg | Tablet | Oral use | N/A |
| Greece | Janssen-Cilag
  Pharmaceutical S.A.C.I.
  56 Eirinis Ave, Pefki,
  Athens GR-151 21
  Greece | Aloperidin | 20 mg | Tablet | Oral use | N/A |
| Iceland | Janssen-Cilag AB
  Box 4042
  16904 Solna
  Sweden | Haldol | 5 mg/ml | Solution for injection | Intramuscular use | 5 mg/ml |
| Iceland | Janssen-Cilag AB
  Box 4042
  16904 Solna
  Sweden | Haldol | 1 mg | Tablet | Oral use | N/A |
| Iceland | Janssen-Cilag AB
  Box 4042
  16904 Solna
  Sweden | Haldol | 4 mg | Tablet | Oral use | N/A |
| Italy | Janssen-Cilag SpA
  Via M.Buonarroti, 23
  I-20093 Cologno Monzese MI,
  Italy | Haldol | 60 mg/30 ml | Oral drops, | Oral use | 2 mg/ml |
| Italy | Janssen-Cilag SpA
  Via M.Buonarroti, 23
  I-20093 Cologno Monzese MI,
  Italy | Haldol | 300 mg/30 ml | Oral drops, solution | Oral use | 10 mg/ml |
| Italy | Janssen-Cilag SpA
  Via M.Buonarroti, 23
  I-20093 Cologno Monzese MI,
  Italy | Haldol | 5 mg/ml | Solution for injection | Intramuscular use | 5 mg/ml |
| Italy | Janssen-Cilag SpA
  Via M.Buonarroti, 23
  I-20093 Cologno Monzese MI,
  Italy | Haldol | 1 mg | Tablet | Oral use | N/A |
| Italy | Janssen-Cilag SpA
  Via M.Buonarroti, 23
  I-20093 Cologno Monzese MI,
  Italy | Haldol | 5 mg | Tablet | Oral use | N/A |
| Luxembourg | Janssen-Cilag NV
  Antwerpseweg 15-17
  B-2340 Beerse
  Belgium | Haldol | 30 mg/15 ml | Oral solution | Oral use | 2 mg/ml |
| Luxembourg | Janssen-Cilag NV
  Antwerpseweg 15-17
  B-2340 Beerse
  Belgium | Haldol | 60 mg/30 ml | Oral solution | Oral use | 2 mg/ml |
| Luxembourg | Janssen-Cilag NV
  Antwerpseweg 15-17
  B-2340 Beerse
  Belgium | Haldol | 200 mg/100 ml | Oral solution | Oral use | 2 mg/ml |
| Luxembourg | Janssen-Cilag NV
  Antwerpseweg 15-17
  B-2340 Beerse
  Belgium | Haldol | 300 mg/30 ml | Oral solution | Oral use | 10 mg/ml |
| Luxembourg | Janssen-Cilag NV
  Antwerpseweg 15-17
  B-2340 Beerse
  Belgium | Haldol | 1 000  mg/100 ml | Oral solution | Oral use | 10 mg/ml |
| Luxembourg | Janssen-Cilag NV
  Antwerpseweg 15-17
  B-2340 Beerse
  Belgium | Haldol | 5 mg/ml | Solution for injection | Intramuscular use; Intravenous use | 5 mg/ml |
| Luxembourg | Janssen-Cilag NV
  Antwerpseweg 15-17
  B-2340 Beerse
  Belgium | Haldol | 2 mg | Tablet | Oral use | N/A |
| Luxembourg | Janssen-Cilag NV
  Antwerpseweg 15-17
  B-2340 Beerse
  Belgium | Haldol | 5 mg | Tablet | Oral use | N/A |
| Luxembourg | Janssen-Cilag NV
  Antwerpseweg 15-17
  B-2340 Beerse
  Belgium | Haldol | 20 mg | Tablet | Oral use | N/A |
| Malta | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse
  Belgium | Haldol | 5 mg | Tablet | Oral use | N/A |
| The Netherlands | Janssen-Cilag BV
  Dr. Paul Janssenweg 150
  5026 RH Tilburg
  The Netherlands | Haldol druppels 2 mg/ml | 60 mg/30 ml | Oral solution | Oral use | 2 mg/ml |
| The Netherlands | Janssen-Cilag BV
  Dr. Paul Janssenweg 150
  5026 RH Tilburg
  The Netherlands | Haldol oplossing voor injectie 5 mg/ml | 5 mg/ml | Solution for injection | Intramuscular use; Intravenous use | 5 mg/ml |
| The Netherlands | Janssen-Cilag BV
  Dr. Paul Janssenweg 150
  5026 RH Tilburg
  The Netherlands | Haldol tabletten 10 mg | 10 mg | Tablet | Oral use | N/A |
| Norway | JANSSEN-CILAG AS
  Drammensveien 288
  0283 Oslo
  Norway | Haldol | 5 mg/ml | Solution for injection | Intramuscular use | 5 mg/ml |
| Norway | JANSSEN-CILAG AS
  Drammensveien 288
  0283 Oslo
  Norway | Haldol | 1 mg | Tablet | Oral use | N/A |
| Norway | JANSSEN-CILAG AS
  Drammensveien 288
  0283 Oslo
  Norway | Haldol | 4 mg | Tablet | Oral use | N/A |
| Portugal | Janssen Farmacêutica Portugal, Lda.
  Estrada Consiglieri Pedroso, 69 A, Queluz de Baixo
  2734 503 Barcarena
  Portugal | Haldol | 2 mg/ml | Oral solution | Oral use | 2 mg/ml |
| Portugal | Janssen Farmacêutica Portugal, Lda.
  Estrada Consiglieri Pedroso, 69 A, Queluz de Baixo
  2734 503 Barcarena
  Portugal | Haldol | 1 mg | Tablet | Oral use | N/A |
| Portugal | Janssen Farmacêutica Portugal, Lda.
  Estrada Consiglieri Pedroso, 69 A, Queluz de Baixo
  2734 503 Barcarena
  Portugal | Haldol | 2 mg | Tablet | Oral use | N/A |
| Portugal | Janssen Farmacêutica Portugal, Lda.
  Estrada Consiglieri Pedroso, 69 A, Queluz de Baixo
  2734 503 Barcarena
  Portugal | Haldol | 5 mg | Tablet | Oral use | N/A |
| Portugal | Janssen Farmacêutica Portugal, Lda.
  Estrada Consiglieri Pedroso, 69 A, Queluz de Baixo
  2734 503 Barcarena
  Portugal | Haldol | 10 mg | Tablet | Oral use | N/A |
| Romania | Janssen Pharmaceutica N.V.
  Turnhoutseweg 30, B-2340 Beerse
  Belgium | Haldol | 5 mg | Tablet | Oral use | N/A |
| Sweden | Janssen-Cilag AB
  Box 4042
  16904 Solna
  Sweden | Haldol | 200 mg/100 ml | Oral solution | Oral use | 2 mg/ml |
| Sweden | Janssen-Cilag AB
  Box 4042
  16904 Solna
  Sweden | Haldol | 5 mg/ml | Solution for injection | Intramuscular use | 5 mg/ml |
| Sweden | Janssen-Cilag AB
  Box 4042
  16904 Solna
  Sweden | Haldol | 1 mg | Tablet | Oral use | NA |
| Sweden | Janssen-Cilag AB
  Box 4042
  16904 Solna
  Sweden | Haldol | 4 mg | Tablet | Oral use | NA |
| United Kingdom | Janssen-Cilag Limited
  50-100 Holmers Farm Way
  High Wycombe
  Buckinghamshire
  HP12 4EG
  United Kingdom | Haldol | 2 mg/ml | Oral solution | Oral use | N/A |
| United Kingdom | Janssen-Cilag Limited
  50-100 Holmers Farm Way
  High Wycombe
  Buckinghamshire
  HP12 4EG
  United Kingdom | Haldol | 5 mg/ml | Solution for injection | Intramuscular use | 5 mg/ml |
| United Kingdom | Janssen-Cilag Limited
  50-100 Holmers Farm Way
  High Wycombe
  Buckinghamshire
  HP12 4EG
  United Kingdom | Haldol | 10 mg/2 ml | Solution for injection | Intramuscular use | 5 mg/ml |

Member State

EU/EEA

Marketing authorisation holder

Name

Strength

Pharmaceutical form

Route of administration

Content

(concentration)

Austria

Janssen-Cilag Pharma GmbH

Vorgartenstraße 206B

AT-1020 Vienna

Austria

Haldol

2 mg/ml

Oral solution

Oral use

2 mg/ml

Austria

Janssen-Cilag Pharma GmbH

Vorgartenstraße 206B

AT-1020 Vienna

Austria

Haldol

150 mg/30 ml

Solution for injection

Intramuscular use

5 mg/ml

Austria

Janssen-Cilag Pharma GmbH

Vorgartenstraße 206B

AT-1020 Vienna

Austria

Haldol

1 mg

Tablet

Oral use

N/A

Austria

Janssen-Cilag Pharma GmbH

Vorgartenstraße 206B

AT-1020 Vienna

Austria

Haldol

10 mg

Tablet

Oral use

N/A

Belgium

Janssen-Cilag NV

Antwerpseweg 15-17

B-2340 Beerse

Belgium

Haldol

30 mg/15 ml

Oral solution

Oral use

2 mg/ml

Belgium

Janssen-Cilag NV

Antwerpseweg 15-17

B-2340 Beerse

Belgium

Haldol

60 mg/30 ml

Oral solution

Oral use

2 mg/ml

Belgium

Janssen-Cilag NV

Antwerpseweg 15-17

B-2340 Beerse

Belgium

Haldol

200 mg/100 ml

Oral solution

Oral use

2 mg/ml

Belgium

Janssen-Cilag NV

Antwerpseweg 15-17

B-2340 Beerse

Belgium

Haldol

300 mg/30 ml

Oral solution

Oral use

10 mg/ml

Belgium

Janssen-Cilag NV

Antwerpseweg 15-17

B-2340 Beerse

Belgium

Haldol

1 000  mg/100 ml

Oral solution

Oral use

10 mg/ml

Belgium

Janssen-Cilag NV

Antwerpseweg 15-17

B-2340 Beerse

Belgium

Haldol

5 mg/ml

Solution for injection

Intramuscular use; Intravenous use

5 mg/ml

Belgium

Janssen-Cilag NV

Antwerpseweg 15-17

B-2340 Beerse

Belgium

Haldol

2 mg

Tablet

Oral use

N/A

Belgium

Janssen-Cilag NV

Antwerpseweg 15-17

B-2340 Beerse

Belgium

Haldol

5 mg

Tablet

Oral use

N/A

Belgium

Janssen-Cilag NV

Antwerpseweg 15-17

B-2340 Beerse

Belgium

Haldol

20 mg

Tablet

Oral use

N/A

Cyprus

Janssen-Cilag International NV

Turnhoutseweg 30, 2340

Beerse, Belgium

Haldol

30 mg/15 ml

Oral solution

Oral use

2 mg/ml

Cyprus

Janssen-Cilag International NV

Turnhoutseweg 30, 2340

Beerse, Belgium

Haldol

5 mg/ml

Solution for injection

Intramuscular use

5 mg/ml

Cyprus

Janssen-Cilag International NV

Turnhoutseweg 30, 2340

Beerse, Belgium

Haldol

5 mg

Tablet

Oral use

N/A

Denmark

JANSSEN-CILAG A/S

Bregnerødvej 133

3460 Birkerød

Denmark

Serenase

2 mg/ml

Oral solution

Oral use

2 mg/ml

Denmark

JANSSEN-CILAG A/S

Bregnerødvej 133

3460 Birkerød

Denmark

Serenase

5 mg/ml

Solution for injection

Intramuscular use; Intravenous use

5 mg/ml

Denmark

JANSSEN-CILAG A/S

Bregnerødvej 133

3460 Birkerød

Denmark

Serenase

2 mg

Tablet

Oral use

N/A

Denmark

JANSSEN-CILAG A/S

Bregnerødvej 133

3460 Birkerød

Denmark

Serenase

5 mg

Tablet

Oral use

N/A

Denmark

JANSSEN-CILAG A/S

Bregnerødvej 133

3460 Birkerød

Denmark

Serenase

20 mg

Tablet

Oral use

N/A

Finland

Janssen-Cilag Oy

Vaisalantie 2

02130 Espoo

Finland

Serenase

2 mg/ml

Oral solution

Oral use

2 mg/ml

Finland

Janssen-Cilag Oy

Vaisalantie 2

02130 Espoo

Finland

Serenase

5 mg/ml

Solution for injection

Intramuscular use

5 mg/ml

Finland

Janssen-Cilag Oy

Vaisalantie 2

02130 Espoo

Finland

Serenase

1 mg

Tablet

Oral use

N/A

Finland

Janssen-Cilag Oy

Vaisalantie 2

02130 Espoo

Finland

Serenase

4 mg

Tablet

Oral use

N/A

Finland

Janssen-Cilag Oy

Vaisalantie 2

02130 Espoo

Finland

Serenase

10 mg

Tablet

Oral use

N/A

France

Janssen-Cilag

1, rue Camille Desmoulins, TSA 91003

F-92787 Issy Les Moulineaux, Cedex 9

France

Haldol

2 mg/ml in bottles of 15 ml, 30 ml, 100 ml and 195 ml

Oral solution

Oral use

2 mg/ml

France

Janssen-Cilag

1, rue Camille Desmoulins, TSA 91003

F-92787 Issy Les Moulineaux, Cedex 9

France

Haldol

5 mg/ml

Solution for injection

Intramuscular use

5 mg/ml

France

Janssen-Cilag

1, rue Camille Desmoulins, TSA 91003

F-92787 Issy Les Moulineaux, Cedex 9

France

Haldol

1 mg

Tablet

Oral use

N/A

France

Janssen-Cilag

1, rue Camille Desmoulins, TSA 91003

F-92787 Issy Les Moulineaux, Cedex 9

France

Haldol

5 mg

Tablet

Oral use

N/A

Germany

Janssen-Cilag GmbH

Johnson & Johnson Platz 1

41470 Neuss

Germany

Haldol-Janssen

2 mg/ml in bottles of 30 ml and 100 ml)

Oral solution

Oral use

2 mg/ml

Germany

Janssen-Cilag GmbH

Johnson & Johnson Platz 1

41470 Neuss

Germany

Haldol-Janssen

5 mg/ml

Solution for injection

Intramuscular use

5 mg/ml

Germany

Janssen-Cilag GmbH

Johnson & Johnson Platz 1

41470 Neuss

Germany

Haldol-Janssen

1 mg

Tablet

Oral use

N/A

Germany

Janssen-Cilag GmbH

Johnson & Johnson Platz 1

41470 Neuss

Germany

Haldol-Janssen

2 mg

Tablet

Oral use

N/A

Germany

Janssen-Cilag GmbH

Johnson & Johnson Platz 1

41470 Neuss

Germany

Haldol-Janssen

5 mg

Tablet

Oral use

N/A

Germany

Janssen-Cilag GmbH

Johnson & Johnson Platz 1

41470 Neuss

Germany

Haldol-Janssen

10 mg

Tablet

Oral use

N/A

Greece

Janssen-Cilag

Pharmaceutical S.A.C.I.

56 Eirinis Ave, Pefki

Athens GR-151 21

Greece

Aloperidin

30 mg/15 ml

Oral Drops, Solution

Oral use

2 mg/ml

Greece

Janssen-Cilag

Pharmaceutical S.A.C.I.

56 Eirinis Ave, Pefki

Athens GR-151 21

Greece

Aloperidin

150 mg/15 ml

300 mg/30 ml

Oral Drops, Solution

Oral use

10 mg/ml

Greece

Janssen-Cilag

Pharmaceutical S.A.C.I.

56 Eirinis Ave, Pefki

Athens GR-151 21

Greece

Aloperidin

5 mg/ml

(BTx5AMP x1ML, BTx50AMP x1ML)

Solution for injection

Intramuscular use

5 mg/ml

Greece

Janssen-Cilag

Pharmaceutical S.A.C.I.

56 Eirinis Ave, Pefki,

Athens GR-151 21

Greece

Aloperidin

1 mg

Tablet

Oral use

N/A

Greece

Janssen-Cilag

Pharmaceutical S.A.C.I.

56 Eirinis Ave, Pefki,

Athens GR-151 21

Greece

Aloperidin

2 mg

Tablet

Oral use

N/A

Greece

Janssen-Cilag

Pharmaceutical S.A.C.I.

56 Eirinis Ave, Pefki,

Athens GR-151 21

Greece

Aloperidin

5 mg

Tablet

Oral use

N/A

Greece

Janssen-Cilag

Pharmaceutical S.A.C.I.

56 Eirinis Ave, Pefki,

Athens GR-151 21

Greece

Aloperidin

10 mg

Tablet

Oral use

N/A

Greece

Janssen-Cilag

Pharmaceutical S.A.C.I.

56 Eirinis Ave, Pefki,

Athens GR-151 21

Greece

Aloperidin

20 mg

Tablet

Oral use

N/A

Iceland

Janssen-Cilag AB

Box 4042

16904 Solna

Sweden

Haldol

5 mg/ml

Solution for injection

Intramuscular use

5 mg/ml

Iceland

Janssen-Cilag AB

Box 4042

16904 Solna

Sweden

Haldol

1 mg

Tablet

Oral use

N/A

Iceland

Janssen-Cilag AB

Box 4042

16904 Solna

Sweden

Haldol

4 mg

Tablet

Oral use

N/A

Italy

Janssen-Cilag SpA

Via M.Buonarroti, 23

I-20093 Cologno Monzese MI,

Italy

Haldol

60 mg/30 ml

Oral drops,

Oral use

2 mg/ml

Italy

Janssen-Cilag SpA

Via M.Buonarroti, 23

I-20093 Cologno Monzese MI,

Italy

Haldol

300 mg/30 ml

Oral drops, solution

Oral use

10 mg/ml

Italy

Janssen-Cilag SpA

Via M.Buonarroti, 23

I-20093 Cologno Monzese MI,

Italy

Haldol

5 mg/ml

Solution for injection

Intramuscular use

5 mg/ml

Italy

Janssen-Cilag SpA

Via M.Buonarroti, 23

I-20093 Cologno Monzese MI,

Italy

Haldol

1 mg

Tablet

Oral use

N/A

Italy

Janssen-Cilag SpA

Via M.Buonarroti, 23

I-20093 Cologno Monzese MI,

Italy

Haldol

5 mg

Tablet

Oral use

N/A

Luxembourg

Janssen-Cilag NV

Antwerpseweg 15-17

B-2340 Beerse

Belgium

Haldol

30 mg/15 ml

Oral solution

Oral use

2 mg/ml

Luxembourg

Janssen-Cilag NV

Antwerpseweg 15-17

B-2340 Beerse

Belgium

Haldol

60 mg/30 ml

Oral solution

Oral use

2 mg/ml

Luxembourg

Janssen-Cilag NV

Antwerpseweg 15-17

B-2340 Beerse

Belgium

Haldol

200 mg/100 ml

Oral solution

Oral use

2 mg/ml

Luxembourg

Janssen-Cilag NV

Antwerpseweg 15-17

B-2340 Beerse

Belgium

Haldol

300 mg/30 ml

Oral solution

Oral use

10 mg/ml

Luxembourg

Janssen-Cilag NV

Antwerpseweg 15-17

B-2340 Beerse

Belgium

Haldol

1 000  mg/100 ml

Oral solution

Oral use

10 mg/ml

Luxembourg

Janssen-Cilag NV

Antwerpseweg 15-17

B-2340 Beerse

Belgium

Haldol

5 mg/ml

Solution for injection

Intramuscular use; Intravenous use

5 mg/ml

Luxembourg

Janssen-Cilag NV

Antwerpseweg 15-17

B-2340 Beerse

Belgium

Haldol

2 mg

Tablet

Oral use

N/A

Luxembourg

Janssen-Cilag NV

Antwerpseweg 15-17

B-2340 Beerse

Belgium

Haldol

5 mg

Tablet

Oral use

N/A

Luxembourg

Janssen-Cilag NV

Antwerpseweg 15-17

B-2340 Beerse

Belgium

Haldol

20 mg

Tablet

Oral use

N/A

Malta

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse

Belgium

Haldol

5 mg

Tablet

Oral use

N/A

The Netherlands

Janssen-Cilag BV

Dr. Paul Janssenweg 150

5026 RH Tilburg

The Netherlands

Haldol druppels 2 mg/ml

60 mg/30 ml

Oral solution

Oral use

2 mg/ml

The Netherlands

Janssen-Cilag BV

Dr. Paul Janssenweg 150

5026 RH Tilburg

The Netherlands

Haldol oplossing voor injectie 5 mg/ml

5 mg/ml

Solution for injection

Intramuscular use; Intravenous use

5 mg/ml

The Netherlands

Janssen-Cilag BV

Dr. Paul Janssenweg 150

5026 RH Tilburg

The Netherlands

Haldol tabletten 10 mg

10 mg

Tablet

Oral use

N/A

Norway

JANSSEN-CILAG AS

Drammensveien 288

0283 Oslo

Norway

Haldol

5 mg/ml

Solution for injection

Intramuscular use

5 mg/ml

Norway

JANSSEN-CILAG AS

Drammensveien 288

0283 Oslo

Norway

Haldol

1 mg

Tablet

Oral use

N/A

Norway

JANSSEN-CILAG AS

Drammensveien 288

0283 Oslo

Norway

Haldol

4 mg

Tablet

Oral use

N/A

Portugal

Janssen Farmacêutica Portugal, Lda.

Estrada Consiglieri Pedroso, 69 A, Queluz de Baixo

2734 503 Barcarena

Portugal

Haldol

2 mg/ml

Oral solution

Oral use

2 mg/ml

Portugal

Janssen Farmacêutica Portugal, Lda.

Estrada Consiglieri Pedroso, 69 A, Queluz de Baixo

2734 503 Barcarena

Portugal

Haldol

1 mg

Tablet

Oral use

N/A

Portugal

Janssen Farmacêutica Portugal, Lda.

Estrada Consiglieri Pedroso, 69 A, Queluz de Baixo

2734 503 Barcarena

Portugal

Haldol

2 mg

Tablet

Oral use

N/A

Portugal

Janssen Farmacêutica Portugal, Lda.

Estrada Consiglieri Pedroso, 69 A, Queluz de Baixo

2734 503 Barcarena

Portugal

Haldol

5 mg

Tablet

Oral use

N/A

Portugal

Janssen Farmacêutica Portugal, Lda.

Estrada Consiglieri Pedroso, 69 A, Queluz de Baixo

2734 503 Barcarena

Portugal

Haldol

10 mg

Tablet

Oral use

N/A

Romania

Janssen Pharmaceutica N.V.

Turnhoutseweg 30, B-2340 Beerse

Belgium

Haldol

5 mg

Tablet

Oral use

N/A

Sweden

Janssen-Cilag AB

Box 4042

16904 Solna

Sweden

Haldol

200 mg/100 ml

Oral solution

Oral use

2 mg/ml

Sweden

Janssen-Cilag AB

Box 4042

16904 Solna

Sweden

Haldol

5 mg/ml

Solution for injection

Intramuscular use

5 mg/ml

Sweden

Janssen-Cilag AB

Box 4042

16904 Solna

Sweden

Haldol

1 mg

Tablet

Oral use

NA

Sweden

Janssen-Cilag AB

Box 4042

16904 Solna

Sweden

Haldol

4 mg

Tablet

Oral use

NA

United Kingdom

Janssen-Cilag Limited

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

United Kingdom

Haldol

2 mg/ml

Oral solution

Oral use

N/A

United Kingdom

Janssen-Cilag Limited

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

United Kingdom

Haldol

5 mg/ml

Solution for injection

Intramuscular use

5 mg/ml

United Kingdom

Janssen-Cilag Limited

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

United Kingdom

Haldol

10 mg/2 ml

Solution for injection

Intramuscular use

5 mg/ml

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