- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Pursuant to Article 29 of Regulation (EC) No 1901/2006, as amended, and Annex II (point 2(iv)) of Regulation 1084/2003, Merck Sharp & Dohme BV submitted to the EMEA on 23 May 2008 an application for a new pharmaceutical form associated with a new strength for the above mentioned medicinal product.
The application concerns powder and solvent for oral suspension 2.5 mg/ml.
Merck Sharp & Dohme BV is the Marketing Authorisation Holder for Cozaar and associated names film-coated tablets which was included in the list of products for Product Information harmonisation, drawn up by the CMD(h), in accordance with Article 30(2) of the Directive 2001/83/EC in order to resolve divergences amongst the nationally authorised SPCs and therefore to harmonise these divergent SPCs across the European Union
Following the Art 30 Referral Procedure the European Commission has adopted a decision amending the marketing authorizations for Cozaar and associated names on 3 September 2008.
Cozaar and associated names are registered in the following EU Members States: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom as well as in Iceland and Norway.
The Rapporteur and Co-Rapporteur appointed by the CHMP were:
Rapporteur: Pieter A. de Graeff; Co-Rapporteur: Harald Enzman
Pursuant to Article 8 of Regulation (EC) No 1901/2006, the application included an EMEA Decision on a Paediatric Investigation Plan (PIP) – (Decision P/9/2008) issued on 29 February 2008. The PIP is not yet completed and the application contained only the paediatric results collected in accordance with the Measure 1 of the agreed PIP (Decision P/9/2008) which is related to age appropriate liquid formulation subject of the applied dossier. The PDCO (Paediatric Committee) has performed the compliance check with the Measure 1 of the agreed PIP and issued a Report on 8 May 2008 confirming compliance with the completion of the Measure 1.
About this medicine
|International non-proprietary name (INN) or common name||
About this procedure
European Commission final decision
Article 29 paediatrics
This type of procedure may be triggered by a marketing-authorisation holder when applying for a new indication, new pharmaceutical form or new route of administration for use in children for a product authorised under Directive 2001/83/EC.
Key dates and outcomes
|CHMP opinion date||
|EC decision date||
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.