Dinolytic 12.5 mg/ml and 5 mg/ml solutions for injection and associated names, and generic products thereof

Current status:
European Commission final decision

Overview

On 18 June 2020, the European Medicines Agency (the Agency) completed a review of the withdrawal periods (meat and offal) for cattle for Dinolytic 12.5 mg/ml and 5 mg/ml solutions for injection and associated names, and generic products thereof. The withdrawal period is the minimum time that has to elapse before an animal treated with a medicine can be slaughtered so that its meat or other animal derived products may be used for human consumption.

The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of these medicines continue to outweigh the risks but that the withdrawal periods for cattle meat and offal should be changed.

Key facts

Approved name
Dinolytic 12.5 mg/ml and 5 mg/ml solutions for injection and associated names, and generic products thereof
International non-proprietary name (INN) or common name

Dinoprost

Reference number
EMEA-V-A-136
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
18/06/2020
EC decision date
16/09/2020

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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