- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
On 22 February 1995, Luxembourg requested the CPMP, under Article 12 of Council Directive 75/319/EEC, to provide an Opinion "on the risks and benefit of parenteral Naftidrofuryl Infusion" due to concerns about safety, particularly cardiac and neurological toxicity, and efficacy.
According to the CPMP Opinion given on 8 June 1995, the balance of benefits and risks for parenteral naftidrofuryl was unfavourable, and the Committee recommended that all Marketing Authorisations for medicinal products containing naftidrofuryl for parenteral infusion should be withdrawn.
Some of the Marketing Authorisation Holders of Naftidrofuryl appealed against the Opinion and grounds for appeal were submitted on 11 August 1995.
On the 19 October 1995, the CPMP having considered the grounds for appeal adopted a final Opinion maintaining the conclusions of the Opinion dated 8 June 1995.
A copy of the final Opinion for Naftidrofuryl Infusion is provided on the internet, together with its Annex. Translations of the Opinion and its Annex, are also provided on the internet in French, German, and Spanish.
The final Opinion was converted into a Decision by the European Commission on 26 June 1996.
|International non-proprietary name (INN) or common name||
Article 31 referrals
This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.
European Commission final decision
|EC decision date||
Opinion following an Article 12 referral for Naftidrofuryl 200mg/10ml infusion International Non-Proprietary Name (INN): Naftidrofuryl: Background information (PDF/7.06 KB)Adopted
First published: 03/04/1997
Last updated: 03/04/1997
Final opinion of the Committee for proprietary medicinal products in accordance with Article 12 of Directive 75/319/EEC as amended for Naftidrofuryl International Non-Proprietary Name (INN): Naftidrofuryl (PDF/11.66 KB)Adopted
First published: 26/06/1996
Last updated: 26/06/1996
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
- Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
- 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. healthcare professionals, patient organisations, individual patients) (if applicable)
- Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
- Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
- Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
- Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (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)
- Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)
Note that older documents may have different titles.