Omacetaxine mepesuccinate - paediatric investigation plan
omacetaxine mepesuccinate
PIPHuman
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
- Contact for public enquiries
ChemGenex Europe S.A.S.
E-mail: abenichou@chemgenex.com
Country: France
Phone: +33 478429526
Fax: +33 478425571- Decision type
- W: decision granting a waiver in all age groups for all conditions or indications
- Decision date