VOXZOGO vosoritide 0.56 mg powder for injection vial and diluent pre-filled syringe, PharmaLex Pty Ltd (agent for BioMarin Pharmaceutical Australia Pty Ltd), CON-1063
Product name
VOXZOGO vosoritide 0.56 mg powder for injection vial and diluent pre-filled syringe
Sponsor name
PharmaLex Pty Ltd (agent for BioMarin Pharmaceutical Australia Pty Ltd)
Consent start
Consent no.
CON-1063
Standard
section 8(1)(h), section 11(5)(iii), section 8(1)(d), section 8(1)(l), section 8(1)(l)(iii), section 9(3)(a), section 10(3)(a), section 10(3)(b), section 10(5)(d), section 10(5)(h), section 8(3)(a), section 8(3)(c), section 8(3)(f) and section 10(5)(d) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The products are labelled as per the international English / bilingual language
pack for marketing in the EU.
Conditions imposed
1. The consent only applies to affected batches (international English/
bilingual language pack for marketing in the EU) imported into and supplied in
Australia on or before 31st July 2023.
2. The Sponsor will advise pharmacies and affected healthcare providers of the
temporary use of international labels, including links to the Australian PI and
CMI, as detailed in the section14 request.
3. The Sponsor will over-sticker the carton label to include:
a. the Australian Sponsor's details on the main label prefaced by 'Supplied by:'
to make it clear to consumers it is the Australian distributor.
b. the number.
c. signal heading 'PRESCRIPTION ONLY MEDICINE' and cautionary statement 'KEEP
OUT OF REACH OF CHILDREN'.
d. the statement 'Refer to the Australian CMI available at
www.biomarin.com/en-au/voxzogoconsumer-medicine-information/' on the main label
to allow patients and their carers easy access to the Australian approved CMI
which also includes Instructions For Use.
Therapeutic product type
Prescription medicines