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SAIZEN (Merck Healthcare Pty Ltd)

Product name
SAIZEN
Date registered
Evaluation commenced
Decision date
Approval time
213 (255 working days)
Active ingredients
Somatropin
Registration type
EOI
Indication

Growth disturbance (current height standard deviation score (H SDS) <-2.5 and parental adjusted H SDS <-1) in short children born small for gestational age (SGA) with a birth weight and/or length below -2 standard deviations (SD), who failed to show catch-up growth (height velocity standard deviation score (HV SDS) <0 during the last year) by four years of age or later.

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