PAXLOVID®▼ (nirmatrelvir; ritonavir) is authorised in Ireland, nirmatrelvir is also known as PF-07321332

Marketing Authorisation 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.

▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.

Shelf-life Extension

On 24^th January 2023 a new shelf-life for PAXLOVID has been approved in the European Union (EU). The Product Information for PAXLOVID film-coated tablets has been updated with the new shelf-life, which has been extended from 18 to 24 months.
This extension applies to product manufactured after this approval date.
In addition, this extension of the shelf-life may be applied retrospectively to all PAXLOVID batches manufactured prior to this approval, including those batches temporarily authorised for distribution at national level before the granting of marketing authorisation. This medicinal product does not require any special storage conditions.
Cartons with an expiry date of 11/2022 through to 12/2023 printed on the carton or blisters may remain in use for a longer period beyond the printed date.
Paxlovid is a co-packaged product consisting of nirmatrelvir and ritonavir tablets, which could have different production dates. For this reason, the updated expiry date cannot be calculated by adding 6 months or 12 months to the printed expiry date (that was determined based on the shelf life approved at the time of manufacturing) and must be determined identifying the specific batch number in the list below.

Batch Codes	Printed Date	Updated Expiry Date
GC0763	February 2023	October 2023
GC0765	February 2023	October 2023
GJ5809	April 2023	January 2024
GN6222	October 2023	February 2024

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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. Nirmatrelvir 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.