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Further post marketing surveillance data on selected serious adverse drug reactions

The CHMP gave a positive opinion on 24 April 2008 recommending the harmonisation of the SPC, labelling and package leaflet for Cozaar Comp. and associated names.

Supplementary information was provided by the Marketing Authorisation Holder on 23 May 2006.

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During its July 2008 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package Leaflet was acceptable and that they should be amended.

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Supplementary information was provided by the Marketing Authorisation Holders on 15 March 1999 and on 22 April 1999.

During its February 2007 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package leaflet was acceptable and that they should be amended.

During its May 2008 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package Leaflet was acceptable and that they should be amended.

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