ISSN 1977-091X |
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Official Journal of the European Union |
C 171 |
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English edition |
Information and Notices |
Volume 60 |
Notice No |
Contents |
page |
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IV Notices |
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NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
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European Commission |
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2017/C 171/01 |
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2017/C 171/02 |
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 |
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 |
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 |
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) |
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 |
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 |
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 |
(1) OJ L 136, 30.4.2004, p. 1.
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 |
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 |
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 |