Search For "european medicines agency"
Accord Healthcare receives positive CHMP opinion for IMULDOSA®, ustek
Updated : 1 year, 4 months ago IST
Ahmedabad (Gujarat) [India], October 19: Accord Healthcare Limited (Accord) announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorisation for Imuldosa® (development cod
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Intas and Henlius receive positive CHMP opinion for HETRONIFLY® (HANS
Updated : 1 year, 5 months ago IST
Ahmedabad (Gujarat) [India], September 25: Intas Pharmaceuticals Limited ("Intas") has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of HETRONIFLY® (serplulimab, approve
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Prestige Biopharma's Herceptin Biosimilar Tuznue® Receives Positive C
Updated : 1 year, 7 months ago IST
Singapore, August 1: Prestige Biopharma, a pioneer in biopharmaceuticals, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for Tuznue®, a Herceptin (trastuzumab) biosimilar. This miles
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EMA approves Biocon Biologics' new monoclonal antibodies facility, renews
Updated : 1 year, 8 months ago IST
According to a press release, this facility, designed to produce multiple drug substances, will now commence the production of biosimilar Bevacizumab, enhancing the company's capacity to meet the growing demand for biologics across European markets.
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Sun Pharma launches novel drug Palbociclib for treatment of advanced breas
Updated : 3 years, 1 month ago IST
According to Sun Pharma, Palbociclib is approved by the US Food and Drugs Administration (FDA), European Medicines Agency (EMA) and Central Drugs Standard Control Organisation (CDSCO) in combination with hormonal therapies for patients with hormone receptor-positive, human epidermal growth f
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Monkeypox outbreak in Europe not yet public health emergency, says EMA
Updated : 3 years, 9 months ago IST
The Hague [Netherlands], June 2 (ANI): The European Medicines Agency (EMA) said on Thursday said the current monkeypox outbreak in Europe is "not a public health emergency" presently.
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EU experiences new surge in COVID-19 cases after lifting restrictions: Rep
Updated : 3 years, 12 months ago IST
Brussels [Belgium], March 17 (ANI/Sputnik): The European Union is experiencing another surge in COVID-19 cases as member countries continue to lift restrictions and return to pre-pandemic life, Marco Cavaleri, the head of the Biological Health Threats and Vaccines Strategy of the European Me
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Omicron BA.2 sub-lineage insufficiently studied to measure difference from
Updated : 4 years, 1 month ago IST
Brussels [Belgium], February 3 (ANI/Sputnik): The subvariant of the Omicron strain of the coronavirus dubbed BA.2 requires further study to understand to what extent it is distinct from its original - the Omicron - regarding contagiousness and other factors, Marco Cavaleri, the head of Biolo
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EU drug agency clears COVID-19 therapeutics Ronapreve, Regkiron
Updated : 4 years, 4 months ago IST
Brussels [Belgium], November 11 (ANI/Sputnik): The European Medicines Agency recommended on Thursday authorizing two antibody medicines, Ronapreve and Regkirona, for COVID-19 treatment in patients who are at risk of their disease becoming severe.
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EMA starts analyzing use of Moderna's COVID-19 vaccine in children aged 6
Updated : 4 years, 4 months ago IST
Amsterdam [Netherlands], November 10 (ANI/Sputnik): The European Medicines Agency (EMA) said on Wednesday that it had begun analyzing the use of Moderna's COVID-19 vaccine in children aged 6 to 11 years old.
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Italy starts offering COVID-19 booster shots to people over 60
Updated : 4 years, 5 months ago IST
Rome [Italy], October 9 (ANI/Xinhua): Italy on Saturday began administering booster shots of COVID-19 vaccines to people over the age of 60, a day after the procedure was authorized by the Health Ministry.
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No application received for EU authorisation of Covishield, says European
Updated : 4 years, 8 months ago IST
New Delhi [India], July 16 (ANI): The European Medicines Agency (EMA) said it has not received any application from the COVID-19 vaccine Covishield maker Serum Institute of India (SII) for authorisation.
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