Moxidectin-containing veterinary medicines used in cattle, sheep and horses

Current status:
European Commission final decision

Overview

On 11 May 2017, the European Medicines Agency completed a review of oral, topical and injectable moxidectin-containing veterinary medicines used in cattle, sheep and horses. The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that these medicines might have a long-term impact on the environment due to their persistent, bioaccumulative and toxic (PBT) properties. Consequently, the CVMP recommended measures to mitigate against the environmental risks, as well as warnings, to be included within the product information. In addition, a condition was placed on the marketing authorisations with the purpose of obtaining field data to determine whether, under actual conditions of use and relevant environmental conditions, the hazards due to the PBT properties of these products can be prevented.

Key facts

Approved name
Moxidectin-containing veterinary medicines used in cattle, sheep and horses
International non-proprietary name (INN) or common name

moxidectin

Associated names
See annex I
Reference number
EMEA/V/A/116
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
11/05/2017
EC decision date
26/09/2017

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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