- 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that all Marketing Authorisations for medicinal products containing naftidrofuryl for parenteral infusion should be withdrawn.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
- Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
- Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
- List of the medicines affected by the referral (Annex I)
- Scientific conclusions of the Committee (Annex II)
The following two documents are sometimes available:
- Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes havebeen recommended by the Committee
- Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be takenfor the marketing authorisation(s) such as safety measures or extra studies