Study title: Evaluation of the Pharmacokinetic, Clinical Efficacyand Safety of the Concentrate of Factor VIII, Emoclot D.I., in patients affected by Haemophilia A
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Hemic and Lymphatic Diseases [C15] | |||||
Brands: Please see report | |||||
MAH holders: Please see report | |||||
Assessment: | |||||
Active substance: HUMAN COAGULATION FACTOR VIII | |||||
ATC code: | |||||
Document link: 06 IG95-01B (full).pdf | |||||
Document date: 2011-09-23 | |||||
Study number: IG 95-01B | |||||
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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