EMEA-000458-PIP01-08 - paediatric investigation plan

(1R,2R,4S)-4-{(2R)-2-[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy- 10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,- 14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetracosahydro-3H-23,27-epoxypyrido[2,1-c][1,4]- oxazacyclohentriacontin-3-yl]propyl}-2-methoxycyclohexyldimethyl-phosphinate (MK-8669, or AP23573)

Key facts

• Active Substance:
  (1R,2R,4S)-4-{(2R)-2-[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy- 10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,- 14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetracosahydro-3H-23,27-epoxypyrido[2,1-c][1,4]- oxazacyclohentriacontin-3-yl]propyl}-2-methoxycyclohexyldimethyl-phosphinate (MK-8669, or AP23573)
• Therapeutic area:
  Oncology
• Decision number:
  P/2/2010
• PIP number:
  EMEA-000458-PIP01-08
• Pharmaceutical form(s):
  • Gastro-resistant tablet
  • Age-appropriate dosage form, other
  • Age-appropriate dosage form for parenteral use
• Condition(s) / indication(s):
  Treatment of solid malignant tumours
• Route(s) of administration:
  • Oral use
  • Intravenous use
• Contact for public enquiries:

  Merck Sharp and Dohme (Europe), Inc.

  Belgium; E-mail: [e-mail]; Tel. [phone]; Fax [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  25/01/2010

Decision

P/2/2010: EMA decision on the agreement of a Paediatric Investigation Plan and on the granting of a deferral and on the refusal of a waiver for (1R,2R,4S)-4-{(2R)-2- [(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy-10,21-(...)

AdoptedReference Number: EMA/27223/2010