Tiamulin hydrogen fumarate presented as premix for medicated feeding stuff and oral powder for in-feed use to be administered to pigs

Table of contents

Current status
European Commission final decision

Overview

On 9 September 2020, the European Medicines Agency (the Agency) completed a review of the safety and effectiveness of veterinary medicines containing tiamulin hydrogen fumarate presented as premix for medicated feeding stuff and oral powder for in-feed use given to pigs. The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of these medicines continue to outweigh their risks but that their use should be restricted to prevent the development of resistance.

Key facts

Approved name
Tiamulin hydrogen fumarate presented as premix for medicated feeding stuff and oral powder for in-feed use to be administered to pigs
International non-proprietary name (INN) or common name
tiamulin hydrogen fumarate
Current status
European Commission final decision
Reference number
EMEA/V/A/137
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
09/09/2020
EC decision date
09/12/2020

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 characteristics, labelling 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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