Laurina

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

Overview

Laurina (and related invented names), which contains the active ingredients desogestrel and ethinylestradiol is a triphasic combined oral contraceptive.

Combined oral contraceptives have been subject to major scrutiny because of concerns regarding the adverse effects of these products and their use in essentially healthy women. In September 2001, the CPMP issued a public assessment report on the relative risks of VTE and made recommendations on the wording of warnings about VTE which should be included in the Summaries of Product Characteristics (SPCs) of all combined oral contraceptives. This public assessment report, although it specifically reviewed the risk of VTE in “3rd generation” COCs compared with “2nd generation” COCs, included a section on acute myocardial infarction as at one time it had been thought that the 3rd generation COCs might be less prone to cause this than earlier COCs. The Public Assessment Report concluded that there was no evidence that 3rd generation COCs significantly altered the risk of acute myocardial infarction compared with earlier COCs.

The Marketing Authorisation Holder (MAH) of Laurina applied for a renewal of the Marketing Authorisation in September 2001 before the release of the CPMP Public Assessment Report. During this renewal procedure, the MAH made the commitment to add, in a separate Type II variation, the VTE warnings according to the recommendations of the CPMP. The resulting Type II variation, which was the subject of this referral, requested a wording on VTE risk which was not strictly in accordance with that proposed by the CPMP. In addition, the MAH requested the inclusion of the results of recent epidemiological findings on arterial thrombosis, and in particular acute myocardial infarction (AMI) which they thought suggested that there was not a significantly increased risk of AMI in users of “third generation” combined oral contraceptives compared with non-users. During the procedure, the MAH revised the wording to suggest that the risk of AMI with 3rd generation COCs may be lower than in users of 2nd or 1st generation COCs. The Reference Member State (Finland) was prepared to accept the modified wordings agreed with the MAH at the end of the variation procedure, however Germany had strong objections and referred the issue to the CPMP. The referral procedure started on 21 November 2002. The Rapporteur and Co-Rapporteur appointed were Dr. F. Lekkerkerker and Dr P. Arlett, respectively. Written explanations were provided by the Marketing Authorisation Holders on 13th February and 18th July 2003 with an addendum on 24th July 2003.

Based on evaluation of the currently available data and the Rapporteurs' assessment reports, the CPMP considered that the variation with respect to a differential risk of acute myocardial infarction could not be granted. However, changes to the information in the SPC on the risk of venous thromboembolism and arterial thrombosis were accepted. The CPMP therefore adopted an opinion on 25 September 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 5th February 2004

Key facts

Approved name
Laurina
International non-proprietary name (INN) or common name
Desogestrel/ethinlestradiol
Reference number
CPMP/1390/04
Type
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.

Status
European Commission final decision
Opinion date
25/09/2003
EC decision date
05/02/2004

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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