EMEA-000458-PIP01-08

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: axel_breitstadt@merck.com
Tel. +32 2776 6045
Fax +32 2776 6288
Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)

Decision

Topics

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