The SPC has been updated as follows: Sections 4.4 and 4.8 to add a warning on the risk of hypertension and to recommend a monitoring of blood pressure and to add ‘hypertension’ to the list of ADRs.
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.
View the full Summary of Product Characteristics, which includes dosing, clinical data, and safety information.
On 24th 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 |
|
| ||
View the Package Leaflet, which contains important information for the patient about how to take PAXLOVID™ and what to expect from treatment.
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.
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 © 2023 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
All rights reserved. December 2023. PP-C1D-IRL-0020
These pages are not intended for patients or for members of the general public.
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