Study title: TO GATHER ADDITIONAL DATA ON THE SAFETY AND EFFECTIVENESS OF FLUCONAZOLE IN PATIENTS CRYPTOCOCCAL MENINGITIS. TO MAKE FLUCONAZOLE AVAILABLE FOR USE IN PATIENTS WITH CRYPTOCOCCAL MENINGITIS WHO IN THE INVESTIGATOR JUDGEMENT WOULD BENEFIT FROM TREATMENT WITH THIS AGENT
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Bacterial Infections and Mycoses [C01] | |||||
Brands: Please see report, Please see report, Please see report, Please see report | |||||
MAH holders: Please see report, Please see report, Please see report | |||||
Assessment: | |||||
Active substance: FLUCONAZOLE | |||||
ATC code: | |||||
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Document date: | |||||
Study number: FCA-NY-89-001 | |||||
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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) |
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