VOXZOGO vosoritide 0.56 mg powder for injection vial and diluent pre-filled syringe, BioMarin Pharmaceutical Australia Pty Ltd, CON-1107
Product name
VOXZOGO vosoritide 0.56 mg powder for injection vial and diluent pre-filled syringe
Sponsor name
BioMarin Pharmaceutical Australia Pty Ltd
Consent start
Consent no.
CON-1107
Standard
Carton
section 8(1)(h), 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)
Vial label
section 10(5)(d), section 10(5)(h)
Intermediate packaging label (diluent syringe tray)
section 8(3)(a), section 8(3)(c), section 8(3)(f)
Diluent syringe label
section 10(5)(d) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
section 8(1)(h), 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)
Vial label
section 10(5)(d), section 10(5)(h)
Intermediate packaging label (diluent syringe tray)
section 8(3)(a), section 8(3)(c), section 8(3)(f)
Diluent syringe label
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 Product
Information (PI) and Consumer Medicine Information (CMI).
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