CLADRITAB cladribine 10mg tablet blister pack, Merck Healthcare Pty Ltd , CON-1466
Product name
CLADRITAB cladribine 10mg tablet blister pack
Sponsor name
Merck Healthcare Pty Ltd
ARTG details
5014226
Consent start
Consent no.
CON-1466
Duration
The consent is effective from 9 February 2026 until 31 December 2026.
Standard
Subparagraph 19(14)(a)(iv) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The name of the medicine is incorrectly presented as MAVENCLAB in place of
CLADRITAB on the blister pack of the medicine.
Conditions imposed
A ‘Dear Healthcare Provider’ letter will be supplied with each affected batch.
It will include details on where to access the PI and CMI documents, along with
contact details. The carton will contain over-stickers.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines