Closamectin Pour-on Solution and associated names

Current status:
European Commission final decision

Overview

On 8 October 2015, the European Medicines Agency (the Agency) completed a review of the animal safety of Closamectin Pour-On Solution and associated names. The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Closamectin Pour-On Solution and associated names continue to outweigh their risks subject to variation of the marketing authorisations to include new adverse reactions and precautionary measures and conditions concerning risk mitigation and surveillance measures.

Key facts

Approved name
Closamectin Pour-on Solution and associated names
International non-proprietary name (INN) or common name
Ivermectin, closantel
Reference number
EMEA/V/A/113
Type
Article 78

Pharmacovigilance urgent measures: initiated when, as a result of the evaluation of veterinary pharmacovigilance data, a Member State considers that a marketing authorisation should be suspended, withdrawn or varied to restrict the indications or availability, amend the posology, add a contraindication or add a new precautionary measure.

Status
European Commission final decision
Opinion date
08/10/2015
EC decision date
22/03/2016

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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