EMEA-001277-PIP01-12 - paediatric investigation plan

[N-((2S,3R,3aS,3´R,4a´R,6S,6a´R,6b´S,7aR,12a´S,12b´S,Z)-3,6,11´,12b´-tetramethyl-2´,3a,3´,4,4´,4a´,5,5´,6,6´,6a´,6b´,7,7a,7´,8´,10´,12´,12a´,12b´-icosahydro-1´H,3Hspiro[furo[3,2-b]pyridine-2,9´-naphtho[2,1-a]azulene]-3´-yl)methanesulfonamide hydrochloride]

Key facts

• Active substance:
  [N-((2S,3R,3aS,3´R,4a´R,6S,6a´R,6b´S,7aR,12a´S,12b´S,Z)-3,6,11´,12b´-tetramethyl-2´,3a,3´,4,4´,4a´,5,5´,6,6´,6a´,6b´,7,7a,7´,8´,10´,12´,12a´,12b´-icosahydro-1´H,3Hspiro[furo[3,2-b]pyridine-2,9´-naphtho[2,1-a]azulene]-3´-yl)methanesulfonamide hydrochloride]
• Therapeutic area:
  Oncology
• Decision number:
  P/0187/2012
• PIP number:
  EMEA-001277-PIP01-12
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment of chondrosarcoma
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  21/08/2012
• Compliance check done:
  No

Decision

P/0187/2012: EMA decision of 21 August 2012 on the granting of a product specific waiver for [N- ((2S,3R,3aS,3´R,4a´R,6S,6a´R,6b´S,7aR,12a´S,12b´S,Z)-3,6,11´,12b´-tetramethyl- 2´,3a,3´,4,4´,4a´,5,5´,6,6´,6a´,6b´,7,7a,7...

Adopted Reference Number: EMA/528778/2012