The Therapeutic Goods Administration (TGA) is advising that we have assessed that nirmatrelvir + ritonavir (PAXLOVID) tablet blister packs for the batch numbers below, can be used up to the revised (‘new’) expiry date, provided that approved storage conditions of storage below 25 °C have been maintained.
| Batch number (LOT) | Label printed expiry date (EXP) | New expiry date |
|---|---|---|
FT4565 FT4889 | 08/2022 | 02/2023 |
| FT5412 | 11/2022 | 05/2023 |
| FT9972 | 12/2022 | 06/2023 |
FX7183 FX7184 | 01/2023 | 07/2023 |
GA8046 GA8765 GA8771 GC2916 GC2932 FY1866 FY1868 FY1869 FY1870 FY1871 FY1872 FY1874 | 02/2023 | 08/2023 |
GC0803 GC0805 GC0806 GC5722 GC5724 GC5725 GC8173 GD1179 GD1180 GD1182 GD1184 GD3145 GD4572 GD4586 GD4587 | 03/2023 | 09/2023 |
GC5729 GD1189 | 04/2023 | 10/2023 |
At the time of the initial provisional registration for nirmatrelvir + ritonavir (PAXLOVID), the shelf-life was 12 months when stored below 25 °C. The TGA subsequently approved an application from the sponsor, Pfizer Australia Pty Ltd, for an extension of shelf-life to 18 months when stored below 25 °C. This is the current shelf-life.
Pfizer supplied some batches of nirmatrelvir + ritonavir (PAXLOVID) to the Australian government before applying to the TGA for an extension of shelf-life. This means that the previously approved expiry date (of 12 months) appears on some batches of nirmatrelvir + ritonavir (PAXLOVID) product labels. The labels associated with the specified batches above have not been amended to reflect the extended expiry date (of 18 months), however these batches can be used up to the revised expiry date.
