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EMA starts rolling review of the Sputnik V COVID-19 vaccine

4 Březen 2021

News Human COVID-19 Vaccines

EMA review of regdanvimab for COVID-19 to support national decisions on early use

2 Březen 2021

News Human COVID-19 Medicines

EMA and Health Canada publish clinical data used to support their authorisations of the Moderna COVID-19 vaccine

2 Březen 2021

News Human COVID-19 Vaccines

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 February 2021

26 Únor 2021

News Human COVID-19 Biosimilars Generic and hybrid medicines Medicines Referrals

First oral treatment for spinal muscular atrophy (SMA) recommended for approval

26 Únor 2021

News Human Medicines

EMA issues advice on use of REGN-COV2 antibody combination (casirivimab / imdevimab)

26 Únor 2021

News Human COVID-19 Medicines

Adapting COVID-19 vaccines to SARS-CoV-2 variants: guidance for vaccine manufacturers

25 Únor 2021

News Human COVID-19 Regulatory and procedural guidance Vaccines

International cooperation to align approaches for regulation of COVID-19 vaccines and medicines

25 Únor 2021

News Human COVID-19 Medicines Vaccines

EMA starts rolling review of Celltrion antibody regdanvimab for COVID-19

24 Únor 2021

News Human COVID-19 Medicines

EMA starts evaluating use of Veklury in COVID-19 patients not requiring supplemental oxygen

23 Únor 2021

News Human COVID-19