desmopressin (as acetate) (NOCDURNA) 50 micrograms sublingual wafers blister pack, Ferring Pharmaceuticals Pty Ltd, CON-121
Product name
desmopressin (as acetate) (NOCDURNA) 50 micrograms sublingual wafers blister pack
Sponsor name
Ferring Pharmaceuticals Pty Ltd
Consent start
Consent no.
CON-121
Standard
Section 11(b) of Therapeutic Goods Order No. 78 - Standard for Tablets and Capsules.
Non-compliance with standard
with regard to the lower assay expiry limit.
Conditions imposed
Assay limits of 90.0-110.0% at expiry are approved for the products and;
This exemption applies for one year from the date of approval of the
products.
Therapeutic product type
Prescription medicines