Study title: A Multi-centre randomised , double masked, vehicle controlled parallel group study evaluating the safety and tolerability of Ketorolac Tromethamine 0.5 % ophthalmic solution used four times daily for 6 weeks in normal paediatric subjects.
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Eye Diseases | |||||
Brands: Please see report | |||||
MAH holders: Please see report | |||||
Assessment: | |||||
Active substance: KETOROLAC | |||||
ATC code: S01BC05 | |||||
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Document date: | |||||
Study number: 1990442-004 | |||||
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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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