Novantrone and associated names

Current status:
European Commission final decision

Overview

On 28 April 2016, the European Medicines Agency completed a review of Novantrone. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Novantrone in the European Union (EU).

Key facts

Approved name
Novantrone and associated names
International non-proprietary name (INN) or common name
mitoxantrone
Associated names
  • Elsep
  • Ralenova
Class
Antineoplastic agent
Reference number
EMEA/H/A-30/1399
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
28/04/2016
EC decision date
24/06/2016

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:

How useful was this page?

Add your rating