TEPMETKO tepotinib 225 mg (as hydrochloride monohydrate) tablet blister pack, Merck Healthcare Pty Ltd, CON-1016
Product name
TEPMETKO tepotinib 225 mg (as hydrochloride monohydrate) tablet blister pack
Sponsor name
Merck Healthcare Pty Ltd
Consent start
Consent no.
CON-1016
Standard
Therapeutic Goods Order No.91 - Standard for labels of prescription and related medicines (TGO 91)
Non-compliance with standard
The product is packed in US labelled blister foils. The blisters are packed in
US labelled cartons which are overstickered with Australian labels, including
the number.
Conditions imposed
1. A Dear Healthcare Professional letter identical to that provided to the
Therapeutic Goods Administration on 22 August 2022 will be supplied with
each affected batch
2. The Australian PI and CMI documents will be supplied with each affected
batch.
Therapeutic product type
Prescription medicines