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BioWorld - Monday, February 23, 2026
Home » Topics » Regulatory » EMA

EMA
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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

OSI receives positive opinion on Tarceva for NSCLC from European health authorities

March 22, 2010

Pharming submits response to CHMP for Rhucin MAA for hereditary angioedema

March 19, 2010

Cangene receives European approval for ImmunoGam hepatitis B product

March 18, 2010

Novartis receives E.U. approval for meningococcal Menveo vaccine

March 18, 2010

FDA and EMA grant orphan drug status to ImmunoGen's IMGN-901 in MCC

March 9, 2010
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