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NOVICRIT epoetin lambda (rch) 5,000 IU/0.5 mL solution for injection syringe, Sandoz Pty Ltd, CON-364
Product name
NOVICRIT epoetin lambda (rch) 5,000 IU/0.5 mL solution for injection syringe
Sponsor name
Sandoz Pty Ltd
Consent start
Consent no.
CON-364
Standard
European Pharmacopoeia Monograph for 'Erythropoetin concentrated solution' (Ph. Eur. ).
Non-compliance with standard
The products will not have the residual DNA test included in their Drug
Substance or Drug Product specifications.
Conditions imposed
The products to which this consent applies are those specified in the request
submitted.
Therapeutic product type
Prescription medicines