Study title: A MULTICENTER, DOUBLE-BLIND, FOLLOW-UP TRIAL EVALUATING THE LONG-TERM SAFETY OF LEVETIRACETAM (1000 TO 3000 MG/DAY B.I.D.) AND CARBAMAZEPINE (400 TO 1200 MG/DAY ORAL B.I.D.), USED AS MONOTHERAPY IN SUBJECTS ( 16 YEARS) COMING FROM THE N01061 TRIAL.
Type of medicine: Centrally authorised medicines | |||||
Therapeutic area: Nervous System Diseases | |||||
Brands: Please see report, Please see report | |||||
MAH holders: Please see report, Please see report | |||||
Assessment: | |||||
Active substance: levetiracetam | |||||
ATC code: N03AX14 | |||||
Document link: N01093 - Levetiracetam - RRCE05L2109.pdf | |||||
Document date: 2011-11-28 | |||||
Study number: RRCE05L2109 | |||||
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) |
- | - | - | - | Y |