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)
Date: 2017-05-30
Institutions: European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product








C_2017171EN.01001101.xml










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