Basiron AC and associated names

Current status:
Opinion provided by Committee for Medicinal Products for Human Use

Overview

Change not granted to the marketing authorisation for Basiron AC (benzoyl peroxide 5% and 10% gel) in the EU

On 28 March 2019, the European Medicines Agency completed a review of Basiron AC (benzoyl peroxide) following a disagreement among EU Member States regarding a change in the marketing authorisation of this medicine. In particular, the Agency was requested to make a recommendation on a change in the medicine’s formulation that would allow for greater stability in warmer countries. As the Agency could not conclude whether the change would impact on the effectiveness and safety of the medicinal product, the change in formulation cannot be granted.

Key facts

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

benzoyl peroxide

Reference number
EMA/H/A-13/1475
Type
Article 13 referrals

This type of referral is triggered for a medicine that has been authorised by mutual recognition or via the decentralised procedure when there is disagreement between Member States on a variation (type II), on the grounds of a potential serious risk to public health.

Status
Opinion provided by Committee for Medicinal Products for Human Use
Opinion date
28/03/2019

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:

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