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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
Duration
The consent is effective for all batches of the products released from the 9 November 2021 until 30 June 2022.
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).
Import, Supply, &/or Export
Import and supply
Therapeutic product type
Prescription medicines