MUPHORAN fotemustine 208mg powder for injection with diluent, Servier Laboratories Australia Pty Ltd, CON-397
Product name
MUPHORAN fotemustine 208mg powder for injection with diluent
Sponsor name
Servier Laboratories Australia Pty Ltd
ARTG
44019
Consent start
Consent no.
CON-397
Standard
Section 7, Section 8, Section 9 and Section 10 in the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
In that the product is being supplied with Spanish-labelled product originally
packaged for supply within Spain, including Spanish carton and vial labels.
Conditions imposed
The Spanish labelled product will be supplied in a clear, A4 zip lock bag with
no markings or printings on the bag. The bag will contain one unit of
non-compliant stock, a Dear Healthcare Professional letter which includes the
number (i.e. 44019) and an assurance that the Spanish labelled
product contained within is identical to the Australian approved product; a copy
of the Australian PI; and a copy of the Australian approved labelling, all
printed on A4 paper.A 'Dear Healthcare Provider' letter identical to that
provided to the TherapeuticGoodsAdministrationon 27th April 2020 will be
supplied with the affected batch, outlining the number of the product,
and providing assurance that the Spanish-labelled product contained in the bag
is identical to the equivalent product routinely supplied in Australia.
Therapeutic product type
Prescription medicines