PROVERA medroxyprogesterone acetate 100 mg tablet blister pack, Pfizer Australia Pty Ltd, CON-1035
Product name
PROVERA medroxyprogesterone acetate 100 mg tablet blister pack
Sponsor name
Pfizer Australia Pty Ltd
Batches
GD9405, FR3315, ER1782, ER2778, EG9425, GL0803 & DW2135
Consent start
Consent no.
CON-1035
Standard
Standard for labels of prescription and related medicines (TGO 91) Paragraph 8(1)(j) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product carton labels do not include the declaration of benzoates being
present in the medicine
Conditions imposed
1. a 'Dear Healthcare Provider' letter identical to that provided to the
Therapeutic Goods Administration on 26 October 2022 will be supplied with each
affected batch.
2. The Company must inform Therapeutic Goods Administration of the batch number
for the one referenced batch of 12331 with batch number not currently
known to which this consent is requested (letter of 14 November 2022), prior to
supplying the affected batch.
Therapeutic product type
Prescription medicines