Study title: Submission of result-related information on paediatric studies submitted under Article 45 of the Paediatric Regulation No 1901/2006. Product concerned by this submission: Claritine/Clarityn Syrup and Associated Tradenames (loratadine)Merck Sharp & Dohme (Europe), Inc. Clos du Lynx 5 Lynx Binnenhof B-1200 Brussels
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Respiratory Tract Diseases [C08] | |||||
Brands: Please see report | |||||
MAH holders: Please see report | |||||
Assessment: | |||||
Active substance: LORATADINE | |||||
ATC code: R06A X13 | |||||
Document link: | |||||
Document date: 2015-01-22 | |||||
Study number: | |||||
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 | Y | Y |