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BioWorld - Monday, April 6, 2026
Home » Topics » Regulatory » EMA

EMA
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EMA grants orphan drug designation to Protalix's taliglucerase alfa for Gaucher's disease

March 30, 2010

Bioalliance Pharma's antiemetic Setofilm approved in Europe

March 30, 2010

European Commission approves DuoPlavin/DuoCover dual antiplatelet combination tablet

March 26, 2010

EMA accepts Cinryze MAA for hereditary angioedema for filing

March 25, 2010

EMA completes validation of InterMune's pirfenidone MAA for IPF

March 24, 2010

FDA and EMA respond to GSK's report on rotavirus DNA in Rotarix vaccine

March 24, 2010

EMA's CHMP recommends new Kepivance label in Europe

March 24, 2010

EMA recommends amendment to warning for concomitant use of clopidogrel-containing medicines and PPIs

March 23, 2010

EMA completes arbitration procedure regarding Levact and associated names

March 23, 2010

EMA recommends harmonization of prescribing information for Atacand and associated names

March 23, 2010
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