EMEA-003586-PIP01-24 - paediatric investigation plan

(5aSa,17aRa)-20-Chloro-2-[(2S,5R)-2,5-dimethyl-4-(prop-2-enoyl)piperazin-1-yl]-14,17-difluoro-6- (propan-2-yl)-11,12-dihydro-4H-1,18-(ethanediylidene)pyrido[4,3-e]pyrimido[1,6- g][1,4,7,9]benzodioxadiazacyclododecin-4-one (MK-1084)

Key facts

• Active substance:
  (5aSa,17aRa)-20-Chloro-2-[(2S,5R)-2,5-dimethyl-4-(prop-2-enoyl)piperazin-1-yl]-14,17-difluoro-6- (propan-2-yl)-11,12-dihydro-4H-1,18-(ethanediylidene)pyrido[4,3-e]pyrimido[1,6- g][1,4,7,9]benzodioxadiazacyclododecin-4-one (MK-1084)
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0202/2024
• PIP number:
  EMEA-003586-PIP01-24
• Pharmaceutical form(s):
  Tablet.
• Condition(s) / indication(s):
  Treatment of all solid and haematological malignancies
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  14/06/2024
• Compliance check done:
  No

Decision

EMA decision of 14 June 2024 on the granting of a product-specific waiver for (5aSa,17aRa)-20-Chloro-2-[(2S,5R)-2,5-dimethyl-4- (prop-2-enoyl)piperazin-1-yl]-14,17-difluoro-6-(propan-2-yl)-11,12-dihydro-4H-1,18... (EMEA-003586-PIP01-24)

Adopted