Study title: A Multicenter, Open‑Label Study to Compare On‑Demand Treatment With 2 Prophylaxis Regimens of Recombinant Coagulation Factor IX (BeneFIX) Reformulated Drug Product (rFIX‑R) in Subjects With Severe Hemophilia B
Type of medicine: Centrally authorised medicines | |||||
Therapeutic area: Hemic and Lymphatic Diseases [C15] | |||||
Brands: Please see report | |||||
MAH holders: Please see report | |||||
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Active substance: NONACOG ALFA | |||||
ATC code: B02BD04 | |||||
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Study number: 3090A1-400-WW | |||||
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Scope of study: CLINICAL | |||||
Population of study subjects: | Preterm newborn Infants | Newborn infants (1 to 27 days) | Infants and toddlers (28 days to 24 months) | Children (2 to 11 years) | Adolescents (12 to 18 years) |
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