Omacetaxine mepesuccinate - paediatric investigation plan

omacetaxine mepesuccinate

Key facts

• Active substance:
  omacetaxine mepesuccinate
• Therapeutic area:
  Oncology
• Decision number:
  P/138/2009
• PIP number:
  Omacetaxine mepesuccinate
• Pharmaceutical form(s):
  Powder for solution for injection
• Condition(s) / indication(s):
  Philadelphia chromosome positive chronic myeloid leukaemia in patients who have the T315I Bcr-Abl kinase domain mutation and who are resistant to prior imatinib therapy.
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  15/07/2009
• Compliance check done:
  No

Decision

P/138/2009: European Medicines Agency decision of 15 July 2009 on the granting of a product specific waiver for omacetaxine mepesuccinate (EMEA-000484-PIP01-08) in accordance with Regulation (EC) No 1901/2006 of the Euro...

Adopted Reference Number: EMEA/416511/2009