Veterinary medicinal products containing N-methyl pyrrolidone as an excipient

Table of contents

Current status
Under evaluation

Overview

Start of review concerning veterinary medicines containing the excipient N-methyl pyrrolidone

EMA has started a review of veterinary medicines containing the excipient N-methyl pyrrolidone (NMP).

These medicines have been used widely throughout the EU for decades. It has been noticed that some of the authorised medicines containing the above-mentioned excipient do not have specific safety warnings in the product information to inform about potential risks to the users and target animals. NMP should be considered as a substance which has the potential to cause developmental toxicity and has been legally classified as ‘Repr. 1B (may damage the unborn child)’ according to the harmonised classification and labelling (ATP09) approved by the European Union.

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 N-methyl pyrrolidone.

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
Veterinary medicinal products containing N-methyl pyrrolidone as an excipient
Current status
Under evaluation
Reference number
EMEA/V/A/146
Type
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
Centrally and nationally authorised products (mixed)
Opinion date
11/05/2022

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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