Haldol Decanoate and associated names

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
Current status:
European Commission final decision

Overview

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

Key facts

Approved name
Haldol Decanoate and associated names
International non-proprietary name (INN) or common name
haloperidol decanoate
Associated names
  • Haldol Decanoat
  • Haldol Decanoas
  • Serenase Dekanoat
  • Serenase Depot
  • Haldol - Janssen Decanoat Depot
  • Haldol Decanoato
  • Haldol Depot
Reference number
EMEA/H/A-30/1405
Type
Article 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 EU.

Status
European Commission final decision
Opinion date
23/02/2017
EC decision date
28/04/2017

All documents

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:

News

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