SAPHRIS asenapine (as maleate) 5mg sublingual wafer blister pack, Organon Pharma Pty Ltd, CON-882
Product name
SAPHRIS asenapine (as maleate) 5mg sublingual wafer blister pack
Sponsor name
Organon Pharma Pty Ltd
Consent start
Consent no.
CON-882
Standard
Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 '“ Standard for labels of prescription and related medicines (TGO 91)
Non-compliance with standard
The products do not conform with the requirement of Paragraph 8(1)(i) of
Therapeutic Goods Order No. 91 '“ Standard for labels of prescription and related
medicines in that the labels do not include the current sponsor details (Organon
Pharma Pty Ltd).
Therapeutic product type
Prescription medicines