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MAXALT MIGRAINE RELIEF rizatriptan 5 mg (as benzoate) wafer blister pack, ORGANON PHARMA PTY LTD, CON-1239
Product name
MAXALT MIGRAINE RELIEF rizatriptan 5 mg (as benzoate) wafer blister pack
Sponsor name
ORGANON PHARMA PTY LTD
Batches
5109201
Consent start
Consent no.
CON-1239
Duration
The consent is effective from 16 May 2024 until 31 December 2024.
Standard
paragraphs 8(1)(a), 9(1)(a) and 10(8)(a)(vi) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines
Non-compliance with standard
Batch 5109201 of the product does not comply because the medicine name on the
foil blister and the sachet labels is slightly different to the approved name
included in the Australian Register of Therapeutic Goods and the foil blister
label displays the name of the active ingredient as rizatriptan instead of
rizatriptan (as benzoate).
Therapeutic product type
Over-the-counter medicines