Study title: Efficacy and safety of Factor IX (FIX) contained in FIX-GRIFOLS in patients with severe hereditary haemophilia B.
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Hemic and Lymphatic Diseases | |||||
Brands: Please see report | |||||
MAH holders: Please see report | |||||
Assessment: | |||||
Active substance: HUMAN COAGULATION FACTOR IX | |||||
ATC code: | |||||
Document link: 03 IG104 (synopsis).pdf | |||||
Document date: 2011-09-23 | |||||
Study number: IG104 | |||||
EudraCT number: | |||||
Scope of study: | |||||
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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