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HYDROXYCARBAMIDE MEDICIANZ, HYDROXYCARBAMIDE MEDSURGE (Medicianz Healthcare Pty Ltd)
Product name
HYDROXYCARBAMIDE MEDICIANZ, HYDROXYCARBAMIDE MEDSURGE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
152 working days (255)
Active ingredients
hydroxycarbamide (hydroxyurea)
Registration type
New generic medicine
Indication
Significant tumour response to HYDROXYCARBAMIDE MEDICIANZ, HYDROXYCARBAMIDE MEDSURGE (hard capsule) has been demonstrated in chronic myelocytic leukaemia (pretreatment phase and palliative care) and recurrent, metastatic, or inoperable carcinoma of the ovary.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine