Study title: Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IGIV3I 10% Grifols [Immune Globulin Intravenous (Human)] for Replacement Therapy in Primary Immunodeficiency Diseases (PID)
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Immune System Diseases | |||||
Brands: | |||||
MAH holders: | |||||
Assessment: | |||||
Active substance: Human normal immunoglobulin | |||||
ATC code: J06BA02 | |||||
Document link: IG304 (synopsis).pdf | |||||
Document date: 2011-09-23 | |||||
Study number: IG304 | |||||
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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