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European Commission approves Ronapreve to treat non-hospitalised COVID-19 patients
ExpressPharma
November 17, 2021
Roche recently announced that the European Commission has granted a marketing authorisation for Ronapreve (casirivimab and imdevimab) for treating COVID-19 in adults and adolescents...
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European Commission buys additional doses of Moderna’s Covid-19 vaccine
pharmaceutical-business-review
June 23, 2021
The European Commission has purchased an additional 150 million Moderna’s Covid-19 vaccine doses, bringing its confirmed order commitment to 460 million doses.
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European Commission scores 200 million doses of J&J’s potential COVID-19 vaccine
pharmatimes
October 10, 2020
The European Commission, acting on behalf of the European Union member states, has approved an advanced purchase agreement for 200 million doses of J&J’s COVID-19 vaccine.
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Venclyxto gains approval in Europe
pharmatimes
March 16, 2020
The European Commission has approved Venclyxto (venetoclax) in combination with Gazyvaro (obinutuzumab) for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
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EC approves Alnylam’s Givlaari for acute hepatic porphyria
pharmaceutical-technology
March 05, 2020
The European Commission (EC) has approved Alnylam’s Givlaari (givosiran) for adults and adolescents with acute hepatic porphyria (AHP).
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Lupin gets European Commission nod for myotonia treatment drug
expressbpd
January 09, 2019
The approval makes NaMuscla (mexiletine) the first treatment to be licensed throughout the EU for the symptomatic treatment of myotonia in adults with NOM disorders
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Sun Pharma bags receipt of European Commission approval
expressbpd
September 20, 2018
The drug ILUMETRI (tildrakizumab) is indicated for the treatment of adults with moderate-to-severe chronic plaque psoriasis
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European Commission Approves Bydureon BCise Device for Patients with Type-2 Diabetes
americanpharmaceuticalreview
August 31, 2018
AstraZeneca announced the European Commission (EC) has approved Bydureon BCise (exenatide 2mg prolonged-release suspension for injection in pre-filled pen) as a new formulation within the marketing authorization for Bydureon (exenatide extended release) f
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European Commission Grants Orphan Drug Designation to Onvansertib
americanpharmaceuticalreview
August 30, 2018
Trovagene announced the European Commission (EC) has endorsed the positive opinion of the Committee for Orphan Medicinal Products (COMP) and has granted Orphan Drug Designation (ODD) for Onvansertib, a first-in-class, 3rd generation, oral and highly-selec
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European Commission Approves Expanded Indication Blincyto
americanpharmaceuticalreview
August 30, 2018
Amgen announced the European Commission (EC) has approved an expanded indication for Blincyto (blinatumomab) as monotherapy for the treatment of pediatric patients aged one year or older with Philadelphia chromosome-negative CD19 positive B-cell precursor