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VOXZOGO vosoritide 1.2 mg powder for injection vial and diluent pre-filled syringe (376618)

ARTG ID 376618

ARTG Name

VOXZOGO vosoritide 1.2 mg powder for injection vial and diluent pre-filled syringe

Product name

VOXZOGO vosoritide 1.2 mg powder for injection vial and diluent pre-filled syringe

ARTG Date

6 July 2022

Registration Type

Medicine

Therapeutic good type

Medicine

Ingredients

vosoritide

Licence category

RE

Licence status

A

Summary

Product Information

Consumer Medicine Information

VOXZOGO vosoritide 1.2 mg powder for injection vial and diluent pre-filled syringe, PharmaLex Pty Ltd (agent for BioMarin Pharmaceutical Australia Pty Ltd), CON-1063

16 January 2023

Section 14 consent

Consent to while noncompliant with standards. The consent is effective from 16 January 2023 until 31 July 2023.
VOXZOGO vosoritide 1.2 mg powder for injection vial and diluent pre-filled syringe, BioMarin Pharmaceutical Australia Pty Ltd, CON-1107

16 January 2023

Section 14 consent

Consent to while noncompliant with standards. The consent is effective from 16 January 2023 until 31 July 2023.
The consent is effective for all batches of the product that are labelled as per the international English/ bilingual language pack for marketing in the EU (as described in the consent letter) imported into and supplied in Australia.