ZINFORO ceftaroline fosamil 600 mg powder for injection vial, Pfizer Australia Pty Ltd, CON-197
Product name
ZINFORO ceftaroline fosamil 600 mg powder for injection vial
Sponsor name
Pfizer Australia Pty Ltd
Consent start
Consent no.
CON-197
Standard
Subclause 3(2)(l) of the Therapeutic Goods Order No.69.
Non-compliance with standard
The product labelling does not bear the current sponsor's name and address.
Conditions imposed
1. The labels (carton and vial labels) to which this consent applies are those
approved for the former sponsor AstraZeneca Pty Ltd and arrangements are in
place with the former sponsor (AstraZeneca Pty Ltd) that any correspondence
concerning this product will be redirected to the current sponsor, Pfizer
Australia Pty Ltd.2. A 'Dear Healthcare Professional' letter, as assured inthe
letter of application, will be sent to relevant stakeholders explaining the
sponsorship change and new contact for this product.
Therapeutic product type
Prescription medicines