Procaine benzylpenicillin

Current status
Procedure started


Start of review concerning veterinary medicines containing procaine benzylpenicillin

EMA has started a review of veterinary medicines containing procaine benzylpenicillin as a single active substance presented as suspensions for injection.

These medicines have been used widely throughout the EU for decades. It has been noticed that the authorised durations of treatment vary between the different products and based on available data not all of them might be appropriate to treat all claimed indications effectively. This could also lead to a risk of development of antimicrobial resistance.

Having considered this issue, the national veterinary medicines regulatory authority of Germany requested EMA’s veterinary medicines committee (CVMP) to assess its impact on the benefits and risks of veterinary medicinal products containing procaine benzylpenicillin as a single active substance presented as suspensions for injection.

EMA will now review the available data to determine if any action is necessary to protect animal or public health or the environment.

Key facts

Approved name
Procaine benzylpenicillin
Current status
Procedure started
Reference number
Article 82

This type of referral is triggered when the interests of the Union are involved, following concerns relating to the quality, safety or efficacy of veterinary medicines.

Authorisation model
Nationally authorised product(s)
Opinion date

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 characteristicslabelling 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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