EMEA-002072-PIP01-16-M01 - paediatric investigation plan

(Z)-N-(3-bromo-4- fluorophenyl)-N-hydroxy-4-(2-(sulfamoylamino)ethylamino)-1,2,5-oxadiazole-3-carboximidamide

Key facts

• Active substance:
  (Z)-N-(3-bromo-4- fluorophenyl)-N-hydroxy-4-(2-(sulfamoylamino)ethylamino)-1,2,5-oxadiazole-3-carboximidamide
• Therapeutic area:
  Oncology
• Decision number:
  P/0246/2018
• PIP number:
  EMEA-002072-PIP01-16-M01
• Pharmaceutical form(s):
  • Tablet
  • Age appropriate oral formulation
• Condition(s) / indication(s):
  Treatment of all conditions included in the category of malignant neoplasms including Hodgkin lymphoma (except nervous system, haematopoietic and lymphoid tissue other than Hodgkin lymphoma)
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  15/08/2018
• Compliance check done:
  No

Decision

P/0246/2018: EMA decision of 15 Aug 2018 on the acceptance of a modification of an agreed PIP for (Z)-N-(3-bromo-4- fluorophenyl)-N-hydroxy-4-(2-(sulfamoylamino)ethylamino)-1,2,5-oxadiazole-3-carboximidamide (EMEA-002072-PIP01-16-M01)

Adopted Reference Number: EMA/469681/2018