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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.

Licensing status:
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.

Key facts

Approved name
International non-proprietary name (INN) or common name
Associated names
  • Loortan
  • Loortan Cardio Start
  • Cozaar Startpakkle
  • Cardopal Start
  • Lorzaar
  • Lorzaar start
  • Lorzaar Protect
  • Pinzaar
  • Lorzaar Varipharmstart
  • Lortaan
  • Neo-Lotan
  • Losaprex
  • Cozaar IC
  • Lortaar IC
Reference number
EMEA/H/A-29 PAD/1022
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.

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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