Veterinary medicinal products containing paromomycin to be administered parenterally to pigs - referral

Current status

European Commission final decision

Overview

On 18 July 2019, the European Medicines Agency recommended suspending the marketing authorisations for paromomycin antibiotics given to pigs by injection into a muscle. The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of these medicines do not outweigh their risks because of inadequate data supporting their use in pigs and the possibility of bacterial resistance.

What is paromomycin?

Paromomycin is an aminoglycoside antibiotic used to treat a wide range of bacterial infections and is given to pigs by injection into a muscle.

Why were veterinary medicines containing paromomycin reviewed?

On 25 September 2018, the Belgian medicines authority requested that the CVMP review all available data on paromomycin’s effectiveness and residue depletion (how long a medicine takes to fall below maximum residue limits (MRLs) in the animal’s body).

The Belgian authority noted that there were different approved uses, dose schedules and withdrawal periods across the EU. The withdrawal period is the minimum time that has to elapse before an animal treated with a medicine can be slaughtered and its meat or other animal derived products may be used for human consumption.

Which data has the CVMP reviewed?

The CVMP reviewed available data on effectiveness and residue depletion. These included data from companies and published literature.

What are the conclusions of the CVMP?

Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CVMP concluded that the benefits of veterinary medicines containing paromomycin given to pigs by injection into the muscle do not outweigh their risks. The Committee based its opinion on the lack of adequate data on how effective these medicines are and residue depletion data. The Committee also noted the possibility that inappropriate doses could lead to bacterial resistance.

Therefore, the CVMP recommended suspending the marketing authorisations for these veterinary medicines until adequate data are available.

The European Commission issued a decision on 11 October 2019.

Paromomycin Article-35 referral: Questions and answers on suspension of marketing authorisations for injectable veterinary medicines containing paromomycin given to pigs

Reference Number: EMA/487471/2019

Key facts

About this medicine

• Approved name:
  Veterinary medicinal products containing paromomycin to be administered parenterally to pigs
• International non-proprietary name (INN) or common name:
  paromycin
• Associated names:
  • Parofor
  • Gabbrovet
  • Gabbrocol

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/V/A/129
• 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.

• Authorisation model:
  Nationally authorised product(s)

Key dates and outcomes

• Opinion date:
  18/07/2019
• EC decision date:
  11/10/2019

All documents

European Commission final decision

Paromomycin Article-35 referral: Annex I, II, III

Paromomycin Article-35 referral: Questions and answers on suspension of marketing authorisations for injectable veterinary medicines containing paromomycin given to pigs

Reference Number: EMA/487471/2019

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)