Lisinopril Biochemie

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
Current status:
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

Key facts

Approved name
Lisinopril Biochemie
International non-proprietary name (INN) or common name


Reference number
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.

European Commission final decision
Opinion date
EC decision date

All documents

Document description

  • 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

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