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FERRIC CARBOXYMALTOSE SANDOZ (Sandoz Pty Ltd)
Product name
FERRIC CARBOXYMALTOSE SANDOZ
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
187 (255 working days)
Active ingredients
ferric carboxymaltose
Registration type
New generic medicine
Indication
FERRIC CARBOXYMALTOSE SANDOZ is indicated for the treatment of iron deficiency in adults and adolescents aged 14 years and older when:
- oral iron preparations are ineffective
- oral iron preparations cannot be used
- there is a clinical need to deliver iron rapidly
The diagnosis of iron deficiency must be based on laboratory tests.
FERRIC CARBOXYMALTOSE SANDOZ is indicated for the treatment of iron deficiency anaemia in children aged 1 to 13 years when:
- oral iron preparations are ineffective
- oral iron preparations cannot be used