Tylosin injection for mastitis - referral

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.

What is tylosin?

Tylosin is a macrolide antibiotic and is active mostly against Gram-positive bacteria and mycoplasmas. Tylosin and its phosphate and tartrate salts are used in veterinary medicines for treatment of conditions caused by sensitive organisms.

Why were veterinary medicinal products containing tylosin that are administered parenterally and intended for the treatment of bovine mastitis caused by Mycoplasma spp. reviewed?

Finland considered that ineffective treatment of mycoplasma mastitis with tylosin presents a serious concern to animal and public health as it delays the correct diagnosis, enables spread of the pathogen to other cows, impedes efficient/prudent control measures and increases risk for the development of antimicrobial resistance due to unnecessary use of antimicrobials.

On 22 June 2016, Finland initiated a referral procedure under Article 35 of Directive 2001/82/EC for the aforementioned veterinary medicinal products. The CVMP was requested to review all available data and to provide its opinion on whether the indication related to 'bovine mastitis caused by Mycoplasma spp.' is justified.

Which data has the CVMP reviewed?

In the absence of submitted proprietary pre-clinical or clinical data for the products in the scope of this referral in support of the respective indication, the CVMP considered scientific references on efficacy.

What are the conclusions of the CVMP?

Based on the evaluation of the currently-available data, the CVMP concluded that, in the absence of specific pre-clinical or clinical data, and in light of the current scientific knowledge, the indication for treatment of bovine mastitis caused by Mycoplasma spp. with veterinary medicinal products containing tylosin which are administered parenterally is not supported. The Committee recommended variations to the terms of the marketing authorisations for the aforementioned veterinary medicinal products in order to remove the indications 'bovine mastitis caused by Mycoplasma spp.' or 'bovine mastitis caused by Mycoplasma bovis' from the product information.

The European Commission issued a decision on 10 July 2017.

Tylosin Article-35 referral - 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.

Reference Number: EMA/399858/2017

Key facts

About this medicine

• Approved name:
  Tylosin injection for mastitis
• International non-proprietary name (INN) or common name:
  tylosin

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA-V-A-121
• Type:
  Article 35 referrals (prior to January 2022)

  This type of referral is initiated in cases involving the interests of the Community or concerns relating to the protection of human or animal health or the environment.

Key dates and outcomes

• Opinion date:
  16/03/2017
• EC decision date:
  10/07/2017

All documents

European Commission final decision

Tylosin Article-35 referral - Annex I, II, III

Tylosin Article-35 referral - 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.

Reference Number: EMA/399858/2017

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)