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
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.
Therapeutic product type
Prescription medicines