Tylosin injection for mastitis

Table of contents

Current status
European Commission final decision

Overview

Questions and answers on veterinary medicinal products containing tylosin that are administered parenterally and intended for the treatment of bovine mastitis caused by Mycoplasma spp.

Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/121)

On 16 March 2017, the European Medicines Agency (the Agency) completed a review of the effectiveness of veterinary medicinal products containing tylosin that are administered parenterally and intended for the treatment of bovine mastitis caused by Mycoplasma spp. The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that, in the absence of pre-clinical or clinical data, treatment of bovine mastitis caused by Mycoplasma spp. with the aforementioned veterinary medicinal products is not effective. The CVMP recommended deletion of the indications related to 'bovine mastitis caused by Mycoplasma spp.' or 'bovine mastitis caused byMycoplasma bovis' from the product information for the products concerned.

Key facts

Approved name
Tylosin injection for mastitis
International non-proprietary name (INN) or common name
tylosin
Current status
European Commission final decision
Reference number
EMEA-V-A-121
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
16/03/2017
EC decision date
10/07/2017

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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