Highlights of the February 2022 meeting of EMA’s human medicines committee (CHMP) include the recommendation of 13 medicines for approval, along with updates to other drugs and COVID-19 vaccines.
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Committee for Medicinal Products for Human Use (CHMP)
The European Medicines Agency (EMA)’s human medicines committee (CHMP) recommends extending RoActemra's indication to include COVID-19 patients receiving systemic treatment.
The European Medicines Agency (EMA)'s human medicines agency (CHMP) begins a rolling review of Valneva's COVID-19 vaccine VLA2001 following positive preliminary results.
The human medicines committee issue a positive opinion on the COVID-19 vaccine Comirnaty® in children aged five to under 12 years.
The Europe Medicines Agency (EMA)'s human medicine committee advise (CHMP) that Lagevrio can be used for COVID-19 patients who do not require oxygen and are at increased risk.
The European Medicines Agency (EMA)'s human medicines committee (CHMP) concludes that a booster dose of Spikevax can be administered in adults aged 18 or over.
The European Medicines Agency's human medicines committee (CHMP) begins its rolling review of the investigational oral antiviral molnupiravir.
Phase II/III trial shows Ronapreve significantly reduced viral load in seronegative patients hospitalised with COVID-19, complimenting previous findings.
In its most recent meeting, the CHMP recommended nine new medicines and concluded its review of Vaxzevria’s thrombosis risk.
The European Commission (EC) approved Ultomiris for children and adolescents with paroxysmal nocturnal haemoglobinuria (PNH).
The CHMP has adopted recommendations to increase manufacturing capacity and supply of COVID-19 Vaccines Comirnaty and Moderna in Europe.
The Committee for Medicinal Products for Human Use (CHMP) recommended two medicines for approval and provided a negative opinion on Nouryant.
The European Medicines Agency has released recommendations about which patients could benefit from remdesivir and the possible criteria for compassionate use of the drug.
A summary of the CHMP meeting conclusions, including medicines recommended for approval and indication extension and several safety review findings.
The EMA’s human medicines committee (CHMP) recommended fifteen medicines for various approvals at its January 2020 meeting; with ten drugs receiving marketing authorisation recommendations and five receiving positive opinions for specific treatments.