Tylosin injection for mastitis

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
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.

Status
European Commission final decision
Opinion date
16/03/2017
EC decision date
10/07/2017

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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