ULTIVA Remifentanil (as hydrochloride) 5 mg powder for injection vial, Aspen Pharmacare Pty Ltd, CON-228
Product name
ULTIVA Remifentanil (as hydrochloride) 5 mg powder for injection vial
Sponsor name
Aspen Pharmacare Pty Ltd
Consent start
Consent no.
CON-228
Standard
Subsection 3(2)(l) of the Therapeutic Goods Order No.69 '“ General requirements for the labels for medicines
Non-compliance with standard
The labels do not bear the current sponsor's name and address.
Conditions imposed
Arrangements are in place with the former sponsor GSK for the prompt
referral of any queries or complaints concerning the products to Aspen
Pharmacare Pty Ltd
Therapeutic product type
Prescription medicines