- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
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
Opinion following an Article 7(5) referral for Laurina and related invented names International Non-Proprietary Name (INN): Desogestrel/ethinlestradiol: Background information and Annexes I, II (English) and Annex III (a... (PDF/335.14 KB)Adopted
First published: 02/02/2004
Last updated: 02/02/2004
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 Laurina and related invented names International Non-Proprietary Name (INN): Desogestrel/ethinlestradiol: Background information and Annexes I, II (English) and Annex III (a... (PDF/335.14 KB)
First published: 02/02/2004
Last updated: 02/02/2004
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.