Study title: A multicentre, open, prospective study investigating clinical efficacy, safety, and pharmacokinetic properties of the human normal immunoglobulin for intravenous administration BT681 with intraindividual comparisons to previous standard treatment in patients with primary immunodeficiency disease (PID).
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Immune System Diseases | |||||
Brands: Please see report | |||||
MAH holders: Please see report | |||||
Assessment: | |||||
Active substance: IMMUNOGLOBULINS | |||||
ATC code: | |||||
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Study number: 941 | |||||
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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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