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
Duration
The consent is effective for all relevant batches released from 13 October 2022 until 29 September 2023.
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 AUST R number.
Conditions imposed
A Dear Healthcare Professional letter identical to that provided to the Therapeutic Goods Administration on 22 August 2022 will be supplied with each affected batchThe Australian PI and CMI documents will be supplied with each affected batch.
Import, Supply, &/or Export
Import and supply
Therapeutic product type
Prescription medicines