Pandemic Influenza Vaccine H5N1 BAXTER (whole virion, vero cell derived, inactivated) suspension for injection 0.5 ml dose syringe, AU Pharma Pty Ltd, CON-246
Product name
Pandemic Influenza Vaccine H5N1 BAXTER (whole virion, vero cell derived, inactivated) suspension for injection 0.5 ml dose syringe
Sponsor name
AU Pharma Pty Ltd
ARTG
204051
Consent start
Consent no.
CON-246
Standard
Subsections 8(1)(h), 8(1)(i), 8(1)(n), 9(1)(c), 9(1)(e), 9(1)(f)(i), 9(3)(a), 9(3)(b), 9(5), 10(3)(a), 10(4)(c), 10(4), 10(4)(e) and 10(4)(j) of the Therapeutic Goods Order No. 91 (TGO 91) - Standard for labels of prescription and related medicines.
Non-compliance with standard
The products are proposed to be supplied with the European product labels, in a
pandemic situation.
Conditions imposed
1. This consent applies only to batches supplied in case of a pandemic
situation.
2. A 'Dear Healthcare Provider' letter will be supplied with each affected
batch and a copy of this letter will be provided to the Therpeutic Goods
Administation (TGA) for review and approval, prior to release.
3. Australian patients and healthcare professionals will be advised of the
appropriate contact details and use of the product, as outlined in the
application form.4. Non-compliance with TGO 91 is limited to specifications
detailed in the application form submitted to the TGA on 10 January 2018.
Therapeutic product type
Prescription medicines