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
altrenogest
Class
-
Current status
European Commission final decision
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.

Opinion date
19/05/2016
EC decision date
29/07/2016

All documents

Description of documents published

Please note that some of the listed documents apply only to certain procedures.

  • Overview - lay-language summary of the stage of the procedure
  • Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
  • List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
  • Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
  • List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
  • List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. veterinary healthcare professionals, farmers, academia) (if applicable)
  • Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
  • Scientific conclusions – scientific conclusions of CVMP
  • Divergent positions – divergent positions of the CVMP members (if applicable)
  • Changes to the summary of product characteristicslabelling and package leaflet (amended sections or fully revised version) (if applicable)
  • Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
  • Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)

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