EMEA-000315-PIP02-15-M04 - paediatric investigation plan
osilodrostat
PIPHuman
Dutch is available via eTranslation, the European Commission's machine translation service.
Translate to Dutch | Important information about machine translation
Key facts
- Invented name
- Isturisa
- Active substance
- osilodrostat
- Therapeutic area
- Endocrine disorders
- Decision number
- P/0325/2024
- PIP number
- EMEA-000315-PIP02-15-M04
- Pharmaceutical form(s)
- Film-coated tablet
- Condition(s) / indication(s)
- Treatment of adrenal cortical hyperfunction
- Route(s) of administration
- Oral use
- Contact for public enquiries
Recordati Rare Diseases
roquelaure.c@recordati.com
+33 170824420- Decision type
- PM: decision on the application for modification of an agreed PIP
- Decision date
- Compliance check done
- Nee