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


Captopril is a highly specific, competitive inhibitor of angiotensin-I converting enzyme, belonging to the category of ACE inhibitors. Hydrochlorothiazide is a thiazide diuretic. Hydrochlorothiazide has been widely used as an antihypertensive agent and captopril has also been indicated in the treatment of hypertension, among others. The addition of a thiazide diuretic to an ACE inhibitor produces at least an additive antihypertensive effect. The combination product captopril/ hydrochlorothiazide got the first national authorisation in 1984 and has since been registered in all EU countries in the second line treatment of hypertension, i.e. in patients who did not respond sufficiently to monotherapy.

From the registrations in Member States, different Summaries of Product Characteristics have been issued, based on national, divergent decisions. On 24 August 2000, France presented to the EMEA a referral under Article 30 of Directive 2001/83/EC1.

The referral procedure started on 1 March 2001 in order to harmonise the Summaries of Product Characteristics (SPC) within the Member States and Norway and Iceland. The CPMP having considered the Rapporteur and the Co-Rapporteur assessment reports, scientific discussion within the Committee and comments from the Marketing Authorisation Holders, was of the opinion that the benefit/risk ratio of captopril/hydrochlorothiazide is considered to be favourable for the agreed indications. The CPMP issued a positive opinion, on 25 April 2002, recommending the harmonisation of the SPC for Ecazide and associated names. The grounds for referral are appended to this report.

An overall summary of the scientific evaluation is provided together with the amended summary of product characteristics.

A Decision was issued by the European Commission on 22 August 2002.

1 Corresponding to Article 11 of Directive 75/319/EEC, for referrals presented before 18 December 2001

Key facts

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


Reference number
Article 30 referrals

This type of referral is triggered when Member States have adopted different decisions over the years for some medicines (e.g. different indications, contraindications or posology) and there is a need to harmonise across the EU.

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

How useful was this page?

Add your rating