Study title: In Vitro Evaluation of Allergic Reactions in hemophilia B Subjects who have Exhibited a Systemic Allergic Response after Exposure to BeneFIX (Nonacog Alfa; recombinant Factor IX)
Type of medicine: Centrally authorised medicines | |||||
Therapeutic area: Hemic and Lymphatic Diseases [C15] | |||||
Brands: Please see report | |||||
MAH holders: Please see report | |||||
Assessment: | |||||
Active substance: NONACOG ALFA | |||||
ATC code: B02BD04 | |||||
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Document date: | |||||
Study number: 3090A-101795 | |||||
EudraCT number: | |||||
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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