Skip to main content

TEPMETKO tepotinib 225 mg (as hydrochloride monohydrate) tablet blister pack, Merck Healthcare Pty Ltd, CON-915

Product name
TEPMETKO tepotinib 225 mg (as hydrochloride monohydrate) tablet blister pack
Sponsor name
Merck Healthcare Pty Ltd
Consent start
Consent no.
CON-915
Duration
The consent is effective for all relevant batches released from 21 February 2022 until 31 December 2022.
Standard
Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91)
Non-compliance with standard
The product does not conform to the requirements of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91), in that 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 11 February 2022 will be supplied with each affected batch.The Australian PI and CMI documents will be supplied with each affected batch.      
Import, Supply, &/or Export
Import and supply
Therapeutic product type
Prescription medicines

Help us improve the Therapeutic Goods Administration site