Study title: A multinational, multicentre, prospective, Zaldiar post marketing surveillance observation to assess the safety of Zaldiar (tramadol/paracetamol 37.5 mg/325 mg) and patient satisfaction in the routine Latin American clinical setting
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Anesthesia and Analgesia [E03] | |||||
Brands: Please see report | |||||
MAH holders: Please see report | |||||
Assessment: | |||||
Active substance: PARACETAMOL AND TRAMADOL | |||||
ATC code: N02AX52 | |||||
Document link: | |||||
Document date: | |||||
Study number: Z-LA-PMS | |||||
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) |
- | - | - | - | - |