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ORGARAN danaparoid sodium 750 anti-Xa units per 0.6mL injection ampoule, Aspen Pharmacare Australia Pty Ltd, CON-295
Product name
ORGARAN danaparoid sodium 750 anti-Xa units per 0.6mL injection ampoule
Sponsor name
Aspen Pharmacare Australia Pty Ltd
Consent start
Consent no.
CON-295
Duration
The consent is effective from 9 October 2018 until the anti-Xa potency limit in the European Pharmacopoeia monograph for Danaparoid Sodium is updated.
Standard
European Pharmacopoeia monograph for Danaparoid Sodium
Non-compliance with standard
The limit for anti-Xa potency has been widened from 11.0 - 17.0 U/mg to 11.0 - 19.0 U/mg for both ORGARAN drug substance and drug product.
Conditions imposed
Only the product indicated is covered by this consent.
Import, Supply, &/or Export
Import and supply
Therapeutic product type
Prescription medicines