EMA requests UEMO to disseminate safety information on Paxlovid

31/01/2022 71 Views

UEMO, a member of EMA’s Healthcare Professionals Working Party and of EMA’s Covid-19 Task Force, has been asked by EMA to disseminate the safety information of the first antiviral for ambulatory use in Covid-19 patients, Paxlovid, approved on 27 January for use in the European Union.

We have been asked in particular to highlight the  warnings and advice included in the product information, in particular:

• the medicines (and also the herbal product St. John’s wort (Hypericum perforatum), that are contraindicated to be used concomitantly with Paxlovid

• the need to review concomitant medicines before and during treatment with Paxlovid

• the need to monitor patients for the adverse reactions associated with any concomitant medicines.

Read the product information in detail here.

EMA’s human medicines committee s recommended granting a conditional marketing authorisation for the oral antiviral medicine Paxlovid for the treatment of COVID-19. Paxlovid’s  applicant is Pfizer Europe MA EEIG.

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