- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Lisinopril Biochemie, which contains the active ingredient lisinopril is a highly specific, competitive inhibitor of angiotensin-I converting enzyme and therefore belongs to the group of drugs known as ACE inhibitors. Lisinopril is indicated for the treatment of hypertension, heart failure, acute myocardial infarction and, in some EU Member States, incipient nephropathy.
The Marketing Authorisation Holder (MAH) for Lisinopril Biochemie applied to the Reference Member State (Denmark) for a variation through the Mutual Recognition Procedure to add an indication: “treatment of incipient nephropathy.” This was refused by the RMS because they would not accept an indication that was not approved for the reference product Zestril (and associated names) unless the MAH could submit sufficient clinical data of its own.
In the Netherlands, Zestril does have the incipient nephropathy indication and since Lisinopril Biochemie is claimed to be essentially similar to Zestril and will be used as a substitute, the Dutch Medicines Evaluation Board was of the opinion that refusal of the variation could cause a safety issue and a risk to public health because of differences in indications in the Summary of Product Characteristics and in the patient information leaflets. On 25th July 2002, the Netherlands referred the matter to the CPMP. The referral procedure started on 20 September 2002. The Rapporteur and Co-Rapporteur appointed were Dr. P. Nilsson and Prof R. Bass, respectively. Written explanations were provided by the Marketing Authorisation Holders on 9 January 2003, 27 June 2003 and 11 July 2003.
Based on evaluation of the currently available data and the Rapporteurs' assessment reports, the CPMP considered that the data did not support an indication in normotensive insulin dependent diabetes mellitus patients but that a revised indication: “Treatment of renal disease in hypertensive patients with type 2 diabetes melitus and incipient nephropathy” could be granted. The CPMP therefore adopted an opinion on 24 July 2003 recommending the above variation to the Marketing Authorisations together with an amended Summary of Product Characteristics.
The competent authorites of the Member States will continue to keep the product under regular review. A list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amended Summary of Product Characteristics in Annex III.
The final opinion was converted into a Decision by the European Commission on 23 February 2004
Opinion following an Article 7(5) referral for Lisinopril Biochemie International Non-Proprietary Name (INN): Lisinopril: Background information and Annexes I, II (English) and Annex III (all languages) (PDF/259.35 KB)Adopted
First published: 01/09/2003
Last updated: 01/09/2003
About this medicine
|International non-proprietary name (INN) or common name||
About this procedure
European Commission final decision
Article 6(12) referrals (prior to January 2010)
This type of referral was triggered for a medicine that had been authorised by mutual recognition or via the decentralised procedure when there was disagreement between Member States on a variation (type II). This referral has been replaced by Article 13 referrals.
Key dates and outcomes
|CHMP opinion date||
|EC decision date||
Opinion following an Article 7(5) referral for Lisinopril Biochemie International Non-Proprietary Name (INN): Lisinopril: Background information and Annexes I, II (English) and Annex III (all languages) (PDF/259.35 KB)
First published: 01/09/2003
Last updated: 01/09/2003
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.