SmPC UPDATE

Inclusion of ATC group and code in section 5.1. Section 4.8 updated to add the ADRs malaise, abdominal pain and nausea.

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PAXLOVID ™ (PF-07321332; ritonavir) is now authorised in Ireland

A Conditional Marketing Authorisation (CMA) has been granted in the EU for PAXLOVID™ for the treatment of coronavirus disease 2019 (COVID-19) in adults who do not require supplemental oxygen and who are at increased risk for progressing to severe COVID-19.

Summary of Product Characteristics (SmPC)  Package Leaflet: Information for the Patient Ensuring the Authenticity  Interactions Finder Report an Adverse Event
PAXLOVID™ Summary of Product Characteristics (SmPC) 

View the full Summary of Product Characteristics, which includes dosing, clinical data, and safety information. 

Click here
Shelf-life Extension

On 19th September 2022 a new shelf-life for PAXLOVID has been approved in the European Union (EU).The Product Information for PAXLOVIDTM film coated tablets has been updated with the new shelf-life, which has been extended from 1 year to 18 months. The storage conditions of ‘Do not store above 25 °C. Do not refrigerate or freeze’ remain unchanged.This 6-month extension applies to product manufactured after this approval date, including those batches temporarily authorised for distribution at national level before the granting of marketing authorisation.In addition, this 6-month extension of the shelf-life may be applied retrospectively to PAXLOVID manufactured prior to this approval.Cartons with an expiry date of 11/2022 through to 05/2023 printed on the carton or blisters may remain in use for 6 months beyond the printed date, as long as the approved storage conditions of ‘Do not store above 25 °C. Do not refrigerate or freeze’ have been maintained.Updated expiry dates are shown below.  

Printed Date

Updated Expiry Date

February 2023

August 2023

April 2023

October 2023

PAXLOVID™ Package Leaflet: Information for the Patient

View the Package Leaflet, which contains important information for the patient about how to take PAXLOVID™ and what to expect from treatment.

Click here
Ensuring the Authenticity of PAXLOVID™

Authentic PAXLOVID™ from Pfizer will include the Pfizer name on the outer carton and will be packaged in 5 aluminium push-through blister cards. To ensure that the tablets are legitimate, look for specific text debossed on each side of the tablets. PF-07321332 tablets are pink, oval-shaped and debossed with ‘PFE’ on one side and ‘3CL’ on the other side.​Ritonavir tablets are white to off white, capsule shaped, and debossed with ‘H’ on one side and ‘R9’ on the other side.  

The outer carton has a colourless, glossy coating that contains a repeated pattern of the Pfizer name and logo all over. The Pfizer name and logo appear in a contrasting matte finish. 

The flaps at each end of the carton are glued as a tamper evident feature of the packaging.

If you suspect the PAXLOVID™ you have received may be counterfeit, please report it to your local representative via 1800 633 363.

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This site is intended only for Irish healthcare professionals. The products discussed in this site may have different product labeling in different countries. The information provided is for educational purposes only.
Copyright © 2022 Pfizer Inc.
Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland. Registered in the Republic of Ireland No. 127002.

This medicinal product is subject to additional monitoring
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All rights reserved. Nov 2022. PP-PAX-IRL-0101
For Irish Healthcare Professionals

These pages are not intended for patients or for members of the general public.

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