Altrenogest

Current status:
European Commission final decision

Overview

On 19 May 2016, the European Medicines Agency (the Agency) completed a review of the potential serious risk to the environment from the use of veterinary medicinal products containing altrenogest and administered orally to pigs and horses. The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that overall benefit-risk balance for the veterinary medicinal products containing altrenogest for pigs is positive, but recommended amendments to the product information to make the user aware that altrenogest may be hazardous for fish and other aquatic organisms.

The CVMP also concluded that the use of concerned products in mares is not considered to pose a risk to the environment, given the minimal environmental exposure associated with the use in individual animals when used as specified in the product information.

Key facts

Approved name
Altrenogest
International non-proprietary name (INN) or common name
n/a
Class
-
Reference number
EMEA/V/A/095
Type
Article 35

Community interest referral: initiated in cases involving the interests of the Community or concerns relating to the protection of human or animal health or the environment.

Status
European Commission final decision
Opinion date
19/05/2016
EC decision date
29/07/2016

All documents

Document description

  • Opinion - contains the CVMP 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 may not always be available:

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