Haldol and associated names

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On 23 February 2017, the European Medicines Agency completed a review of Haldol. The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Haldol in the European Union (EU).

What is Haldol?

Haldol is an antipsychotic medicine used in adults and children for a number of mental and other brain disorders including schizophrenia, mania (feeling elated or over-excited), aggression, Tourette's syndrome and tics (repeated and uncontrollable movements) and choreatic movements (jerky and uncontrolled movements mainly of the face and hands). It is also used for the treatment of vomiting.

Haldol and associated names (such as Aloperidin and Serenase) is marketed in Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Italy, Luxembourg, Malta, the Netherlands, Portugal, Romania, Sweden and United Kingdom, and also in Iceland and Norway. It contains the active substance haloperidol and is available as tablets, oral solutions, and injection. It is also available in the EU as generic haloperidol.

The companies that market these medicines include Janssen-Cilag Ltd and associated companies.

Why was Haldol reviewed?

Haldol is authorised in the EU via national procedures. This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.

Haldol was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh).

On 18 June 2014, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Haldol and associated names in the EU.

What are the conclusions of the CHMP?

The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.

The areas harmonised include:

4.1 Therapeutic indications

The CHMP agreed that Haldol tablets and oral solutions can be used as follows.

In adults, for:

  • treatment of schizophrenia and schizoaffective disorder;
  • acute treatment of delirium when non-pharmacological treatments (treatments that do not involve medicines) have not worked;
  • treatment of moderate to severe manic episodes associated with bipolar I disorder;
  • treatment of acute psychomotor agitation associated with psychotic disorder or manic episodes of bipolar I disorder;
  • treatment of persistent aggression and psychotic symptoms in patients with moderate to severe Alzheimer’s dementia and vascular dementia when non-pharmacological treatments have not worked and when there is a risk of harm to the patient or to others;
  • treatment of tic disorders, including Tourette’s syndrome, in patients with severe impairment after educational and psychological treatments and other medicines have not worked;
  • treatment of mild to moderate chorea in Huntington’s disease, when other medicines do not work or have unacceptable side effects.

In children and adolescents, for:

  • schizophrenia in adolescents aged 13 to 17 years when other medicines have not worked or cause unacceptable side effects;
  • persistent, severe aggression in children and adolescents aged 6 to 17 years with autism or pervasive developmental disorders, when other treatments have not worked or cause unacceptable side effects;
  • tic disorders, including Tourette’s syndrome, in children and adolescents aged 10 to 17 years with severe impairment after educational and psychological treatments and other medicines have not worked.

The CHMP agreed that Haldol injection can be used in adults as follows:

  • for rapid control of severe acute psychomotor agitation linked to psychotic disorder or manic episodes of bipolar I disorder when medicines cannot be given by mouth;
  • for short-term treatment of delirium when non-pharmacological treatments have not worked;
  • for treatment of mild to moderate chorea in Huntington’s disease, when other medicines are ineffective or have unacceptable side effects and when medicines cannot be given by mouth;
  • alone or with other medicines, for prevention of nausea and vomiting after surgery in those who are at moderate to high risk, when other medicines do not work or have unacceptable side effects;
  • with other medicines, for treatment of nausea and vomiting after surgery when other medicines do not work or have unacceptable side effects.

The CHMP agreed that Haldol should no longer be used for the treatment of delirium, delusions or hallucinations which follow alcohol withdrawal because the medicine has not proven effective for treating the underlying condition and there is inadequate evidence that it is of benefit when used with a benzodiazepine.

4.2 Posology and method of administration

The CHMP harmonised the starting, maintenance and maximum doses for each of the different uses of Haldol in adults, elderly patients and in children and adolescents. The CHMP agreed that starting dose in the elderly should be as low as possible and harmonised advice on the starting doses of Haldol in those with liver or kidney disorders.

4.3 Contra-indications

The CHMP agreed to harmonisation of Haldol’s contra-indications. In particular, Haldol must not be used in patients with heart disorders such as certain heart-rhythm problems, heart failure and recent heart attack, and with central nervous depression (reduced brain activity that slows down breathing and heart rate and reduces alertness).

4.4 Special warnings and precautions

The CHMP harmonised the SmPC to include a warning that patients with bipolar disorders may suffer sudden depression, calling for close supervision of such patients. The section was also harmonised with information on when Haldol’s side effects on movement might appear, details on mortality in the elderly, and effects on the heart and the brain. The SmPC recommends caution in patients who have a high level of the hormone prolactin and in those who have tumours that are worsened by prolactin.

Other changes

The CHMP harmonised other sections of the SmPC including interactions between Haldol and other medicines (section 4.5), information on pregnancy, lactation and fertility (section 4.6) and added angioedema as a side effect (section 4.8).

Name Language First published Last updated
Questions and answers on Haldol and associated names (haloperidol tablets, oral solutions and injectable solution) BG = bălgarski 2017-02-24 2017-05-05
Questions and answers on Haldol and associated names (haloperidol tablets, oral solutions and injectable solution) ES = español 2017-02-24 2017-05-05
Questions and answers on Haldol and associated names (haloperidol tablets, oral solutions and injectable solution) CS = čeština 2017-02-24 2017-05-05
Questions and answers on Haldol and associated names (haloperidol tablets, oral solutions and injectable solution) DA = dansk 2017-02-24 2017-05-05
Questions and answers on Haldol and associated names (haloperidol tablets, oral solutions and injectable solution) DE = Deutsch 2017-02-24 2017-05-05
Questions and answers on Haldol and associated names (haloperidol tablets, oral solutions and injectable solution) ET = eesti keel 2017-02-24 2017-05-05
Questions and answers on Haldol and associated names (haloperidol tablets, oral solutions and injectable solution) EL = elliniká 2017-02-24 2017-05-05
Questions and answers on Haldol and associated names (haloperidol tablets, oral solutions and injectable solution) EN = English 2017-02-24 2017-05-05
Questions and answers on Haldol and associated names (haloperidol tablets, oral solutions and injectable solution) FR = français 2017-02-24 2017-05-05
Questions and answers on Haldol and associated names (haloperidol tablets, oral solutions and injectable solution) IT = italiano 2017-02-24 2017-05-05
Questions and answers on Haldol and associated names (haloperidol tablets, oral solutions and injectable solution) LV = latviešu valoda 2017-02-24 2017-05-05
Questions and answers on Haldol and associated names (haloperidol tablets, oral solutions and injectable solution) LT = lietuvių kalba 2017-02-24 2017-05-05
Questions and answers on Haldol and associated names (haloperidol tablets, oral solutions and injectable solution) HU = magyar 2017-02-24 2017-05-05
Questions and answers on Haldol and associated names (haloperidol tablets, oral solutions and injectable solution) MT = Malti 2017-02-24 2017-05-05
Questions and answers on Haldol and associated names (haloperidol tablets, oral solutions and injectable solution) NL = Nederlands 2017-02-24 2017-05-05
Questions and answers on Haldol and associated names (haloperidol tablets, oral solutions and injectable solution) PL = polski 2017-02-24 2017-05-05
Questions and answers on Haldol and associated names (haloperidol tablets, oral solutions and injectable solution) PT = português 2017-02-24 2017-05-05
Questions and answers on Haldol and associated names (haloperidol tablets, oral solutions and injectable solution) RO = română 2017-02-24 2017-05-05
Questions and answers on Haldol and associated names (haloperidol tablets, oral solutions and injectable solution) SK = slovenčina 2017-02-24 2017-05-05
Questions and answers on Haldol and associated names (haloperidol tablets, oral solutions and injectable solution) SL = slovenščina 2017-02-24 2017-05-05
Questions and answers on Haldol and associated names (haloperidol tablets, oral solutions and injectable solution) FI = suomi 2017-02-24 2017-05-05
Questions and answers on Haldol and associated names (haloperidol tablets, oral solutions and injectable solution) SV = svenska 2017-02-24 2017-05-05
Questions and answers on Haldol and associated names (haloperidol tablets, oral solutions and injectable solution) HR = Hrvatski 2017-02-24 2017-05-05

Key facts

Approved nameHaldol and associated names
International non-proprietary name (INN) or common name

haloperidol

Associated namesAloperidin, Haldol-Janssen, Serenase
Class
Reference numberEMEA/H/A-30/1393
TypeArticle 30 referrals

This type of referral is triggered when Member States have adopted different decisions over the years for some medicines (e.g. different indications, contraindications or posology) and there is a need to harmonise across the European Union.

StatusEuropean Commission final decision
Opinion date23/02/2017

All documents

Name Language First published Last updated
Questions and answers on Haldol and associated names (haloperidol tablets, oral solutions and injectable solution) BG = bălgarski 2017-02-24 2017-05-05
Questions and answers on Haldol and associated names (haloperidol tablets, oral solutions and injectable solution) ES = español 2017-02-24 2017-05-05
Questions and answers on Haldol and associated names (haloperidol tablets, oral solutions and injectable solution) CS = čeština 2017-02-24 2017-05-05
Questions and answers on Haldol and associated names (haloperidol tablets, oral solutions and injectable solution) DA = dansk 2017-02-24 2017-05-05
Questions and answers on Haldol and associated names (haloperidol tablets, oral solutions and injectable solution) DE = Deutsch 2017-02-24 2017-05-05
Questions and answers on Haldol and associated names (haloperidol tablets, oral solutions and injectable solution) ET = eesti keel 2017-02-24 2017-05-05
Questions and answers on Haldol and associated names (haloperidol tablets, oral solutions and injectable solution) EL = elliniká 2017-02-24 2017-05-05
Questions and answers on Haldol and associated names (haloperidol tablets, oral solutions and injectable solution) EN = English 2017-02-24 2017-05-05
Questions and answers on Haldol and associated names (haloperidol tablets, oral solutions and injectable solution) FR = français 2017-02-24 2017-05-05
Questions and answers on Haldol and associated names (haloperidol tablets, oral solutions and injectable solution) IT = italiano 2017-02-24 2017-05-05
Questions and answers on Haldol and associated names (haloperidol tablets, oral solutions and injectable solution) LV = latviešu valoda 2017-02-24 2017-05-05
Questions and answers on Haldol and associated names (haloperidol tablets, oral solutions and injectable solution) LT = lietuvių kalba 2017-02-24 2017-05-05
Questions and answers on Haldol and associated names (haloperidol tablets, oral solutions and injectable solution) HU = magyar 2017-02-24 2017-05-05
Questions and answers on Haldol and associated names (haloperidol tablets, oral solutions and injectable solution) MT = Malti 2017-02-24 2017-05-05
Questions and answers on Haldol and associated names (haloperidol tablets, oral solutions and injectable solution) NL = Nederlands 2017-02-24 2017-05-05
Questions and answers on Haldol and associated names (haloperidol tablets, oral solutions and injectable solution) PL = polski 2017-02-24 2017-05-05
Questions and answers on Haldol and associated names (haloperidol tablets, oral solutions and injectable solution) PT = português 2017-02-24 2017-05-05
Questions and answers on Haldol and associated names (haloperidol tablets, oral solutions and injectable solution) RO = română 2017-02-24 2017-05-05
Questions and answers on Haldol and associated names (haloperidol tablets, oral solutions and injectable solution) SK = slovenčina 2017-02-24 2017-05-05
Questions and answers on Haldol and associated names (haloperidol tablets, oral solutions and injectable solution) SL = slovenščina 2017-02-24 2017-05-05
Questions and answers on Haldol and associated names (haloperidol tablets, oral solutions and injectable solution) FI = suomi 2017-02-24 2017-05-05
Questions and answers on Haldol and associated names (haloperidol tablets, oral solutions and injectable solution) SV = svenska 2017-02-24 2017-05-05
Questions and answers on Haldol and associated names (haloperidol tablets, oral solutions and injectable solution) HR = Hrvatski 2017-02-24 2017-05-05
Haldol Article-30 referral - Assessment report (English only) 2017-05-05  
Haldol Article-30 referral - Annex I BG = bălgarski 2017-05-05  
Haldol Article-30 referral - Annex I ES = español 2017-05-05  
Haldol Article-30 referral - Annex I CS = čeština 2017-05-05  
Haldol Article-30 referral - Annex I DA = dansk 2017-05-05  
Haldol Article-30 referral - Annex I DE = Deutsch 2017-05-05  
Haldol Article-30 referral - Annex I ET = eesti keel 2017-05-05  
Haldol Article-30 referral - Annex I EL = elliniká 2017-05-05  
Haldol Article-30 referral - Annex I EN = English 2017-05-05  
Haldol Article-30 referral - Annex I FR = français 2017-05-05  
Haldol Article-30 referral - Annex I IT = italiano 2017-05-05  
Haldol Article-30 referral - Annex I LV = latviešu valoda 2017-05-05  
Haldol Article-30 referral - Annex I LT = lietuvių kalba 2017-05-05  
Haldol Article-30 referral - Annex I HU = magyar 2017-05-05  
Haldol Article-30 referral - Annex I MT = Malti 2017-05-05  
Haldol Article-30 referral - Annex I NL = Nederlands 2017-05-05  
Haldol Article-30 referral - Annex I PL = polski 2017-05-05  
Haldol Article-30 referral - Annex I PT = português 2017-05-05  
Haldol Article-30 referral - Annex I RO = română 2017-05-05  
Haldol Article-30 referral - Annex I SK = slovenčina 2017-05-05  
Haldol Article-30 referral - Annex I SL = slovenščina 2017-05-05  
Haldol Article-30 referral - Annex I FI = suomi 2017-05-05  
Haldol Article-30 referral - Annex I SV = svenska 2017-05-05  
Haldol Article-30 referral - Annex I HR = Hrvatski 2017-05-05  
Haldol Article-30 referral - Annex I IS = Islenska 2017-05-05  
Haldol Article-30 referral - Annex I NO = Norsk 2017-05-05  
Haldol Article-30 referral - Annex II BG = bălgarski 2017-05-05  
Haldol Article-30 referral - Annex II ES = español 2017-05-05  
Haldol Article-30 referral - Annex II CS = čeština 2017-05-05  
Haldol Article-30 referral - Annex II DA = dansk 2017-05-05  
Haldol Article-30 referral - Annex II DE = Deutsch 2017-05-05  
Haldol Article-30 referral - Annex II ET = eesti keel 2017-05-05  
Haldol Article-30 referral - Annex II EL = elliniká 2017-05-05  
Haldol Article-30 referral - Annex II EN = English 2017-05-05  
Haldol Article-30 referral - Annex II FR = français 2017-05-05  
Haldol Article-30 referral - Annex II IT = italiano 2017-05-05  
Haldol Article-30 referral - Annex II LV = latviešu valoda 2017-05-05  
Haldol Article-30 referral - Annex II LT = lietuvių kalba 2017-05-05  
Haldol Article-30 referral - Annex II HU = magyar 2017-05-05  
Haldol Article-30 referral - Annex II MT = Malti 2017-05-05  
Haldol Article-30 referral - Annex II NL = Nederlands 2017-05-05  
Haldol Article-30 referral - Annex II PL = polski 2017-05-05  
Haldol Article-30 referral - Annex II PT = português 2017-05-05  
Haldol Article-30 referral - Annex II RO = română 2017-05-05  
Haldol Article-30 referral - Annex II SK = slovenčina 2017-05-05  
Haldol Article-30 referral - Annex II SL = slovenščina 2017-05-05  
Haldol Article-30 referral - Annex II FI = suomi 2017-05-05  
Haldol Article-30 referral - Annex II SV = svenska 2017-05-05  
Haldol Article-30 referral - Annex II HR = Hrvatski 2017-05-05  
Haldol Article-30 referral - Annex III BG = bălgarski 2017-02-24 2017-05-05
Haldol Article-30 referral - Annex III ES = español 2017-02-24 2017-05-05
Haldol Article-30 referral - Annex III CS = čeština 2017-02-24 2017-05-05
Haldol Article-30 referral - Annex III DA = dansk 2017-02-24 2017-05-05
Haldol Article-30 referral - Annex III DE = Deutsch 2017-02-24 2017-05-05
Haldol Article-30 referral - Annex III ET = eesti keel 2017-02-24 2017-05-05
Haldol Article-30 referral - Annex III EL = elliniká 2017-02-24 2017-05-05
Haldol Article-30 referral - Annex III EN = English 2017-02-24 2017-05-05
Haldol Article-30 referral - Annex III FR = français 2017-02-24 2017-05-05
Haldol Article-30 referral - Annex III IT = italiano 2017-02-24 2017-05-05
Haldol Article-30 referral - Annex III LV = latviešu valoda 2017-02-24 2017-05-05
Haldol Article-30 referral - Annex III LT = lietuvių kalba 2017-02-24 2017-05-05
Haldol Article-30 referral - Annex III HU = magyar 2017-02-24 2017-05-05
Haldol Article-30 referral - Annex III MT = Malti 2017-02-24 2017-05-05
Haldol Article-30 referral - Annex III NL = Nederlands 2017-02-24 2017-05-05
Haldol Article-30 referral - Annex III PL = polski 2017-02-24 2017-05-05
Haldol Article-30 referral - Annex III PT = português 2017-02-24 2017-05-05
Haldol Article-30 referral - Annex III RO = română 2017-02-24 2017-05-05
Haldol Article-30 referral - Annex III SK = slovenčina 2017-02-24 2017-05-05
Haldol Article-30 referral - Annex III SL = slovenščina 2017-02-24 2017-05-05
Haldol Article-30 referral - Annex III FI = suomi 2017-02-24 2017-05-05
Haldol Article-30 referral - Annex III SV = svenska 2017-02-24 2017-05-05
Haldol Article-30 referral - Annex III HR = Hrvatski 2017-02-24 2017-05-05
Haldol Article-30 referral - Annex III IS = Islenska 2017-02-24 2017-05-05
Haldol Article-30 referral - Annex III NO = Norsk 2017-02-24 2017-05-05

Document description

  • Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
  • Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents are sometimes available:

  • Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes have been recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be taken for the marketing authorisation(s) such as safety measures or extra studies

Current status:
European Commission final decision

Related information on Haldol and associated names