Pfizer Receives EMA’s CHMP Positive Opinion of Paxlovid for COVID-19

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Pfizer Receives EMA’s CHMP Positive Opinion of Paxlovid for COVID-19


  • The EMA’s CHMP issued a positive opinion recommending the conversion of cMA for Paxlovid (SARS-CoV-2 Mpro inhibitor) to full MA for adults with COVID-19 who do not require supplemental oxygen & are at increased risk of the disease becoming severe. The EC’s final decision is expected shortly
  • The recommendation was based on the totality of efficacy, safety & quality data. Paxlovid's advantages in assisting in lowering sev. COVID-19-related outcomes, such as hospitalization and death in high-risk patients continue to outweigh its potential risks
  • Paxlovid was approved or authorized for conditional or emergency use in 70+ countries. It is generally administered at 300mg (two 150 mg tablets) of nirmatrelvir with one 100mg of ritonavir, BID for 5 days

Ref: Pfizer~ | Image: Pfizer

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Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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