Advice on use of nirmatrelvir + ritonavir post labelled expiry date

TGA

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

08/202202/2023
FT541211/202205/2023
FT997212/202206/2023

FX7183

FX7184

01/202307/2023

GA8046

GA8765

GA8771

GC2916

GC2932

FY1866

FY1868

FY1869

FY1870

FY1871

FY1872

FY1874

02/202308/2023

GC0803

GC0805

GC0806

GC5722

GC5724

GC5725

GC8173

GD1179

GD1180

GD1182

GD1184

GD3145

GD4572

GD4586

GD4587

03/202309/2023

GC5729

GD1189

04/202310/2023

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.

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