# C_2017171EN.01001101.xml

| 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))

1

2

(2017/C 171/02)

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

—

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

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

1

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

2

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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

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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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