Study title: Post-marketing surveillance study on the treatment of restlessness and nervous sleep disorder in children under 14 years of age (Euvegal® forte)
Type of medicine: Herbal and homoeopathic medicines | |||||
Therapeutic area: Mental Disorders [F03] | |||||
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Active substance: HERB: dry extract from Valerian root (3 - 6 : 1), extraction agent: ethanol 62 % (w/w); dry extract from Balm leaves (4 - 6 : 1), extraction agent: ethanol 30 % (w/w)./ HERB: dry extract from Valerian root (4 - 5 : 1), dry extract from Balm leaves (4 - 6 : 1)./ HERB: Extract of Valerian root, corresp. to 640-800 mg drug; + Extract of Melissa leaf, corresp. 60 320-480 mg drug./ HERB: dry extract... | |||||
ATC code: N05CM | |||||
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Study number: E05/1999 | |||||
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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 |