Study title: A 12-month, multicenter, open, single arm, pilot study to evaluate the safety, tolerability and efficacy of Myfortic® in combination with Neoral® and steroids in paediatric de novo renal transplant patients
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Pathological Conditions, Signs and Symptoms | |||||
Brands: Please see report | |||||
MAH holders: Please see report, Please see report | |||||
Assessment: | |||||
Active substance: MYCOPHENOLIC ACID | |||||
ATC code: | |||||
Document link: Myfortic_publication of Article 45 result-related information_final Aug 2011.xls | |||||
Document date: 2011-09-22 | |||||
Study number: CERL080 AFR03 | |||||
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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