Sprycel
dasatinib (anhydrous)
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation:
Revision: 43
Last updated:
MedicineHumanAuthorised
Dasatinib Accord
dasatinib (anhydrous)
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation:
Revision: 1
Last updated:
MedicineHumanWithdrawn
Dasatinib Accordpharma
dasatinib (anhydrous)
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation:
Revision: 1
Last updated:
MedicineHumanWithdrawn
EMEA-001024-PIP01-10-M02 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: P/0014/2020
Route(s) of administration: Intravenous use
Pharmaceutical form(s):
Powder and solvent for solution for injection
Decision date:
Last updated:
Compliance check: ✔
PIPHuman
Daruph and Anafezyn - referral
dasatinib (anhydrous)
Article 29(4) referrals
Status: European Commission final decision
Opinion/position date:
EC decision date:
Last updated:
ReferralHuman
EMEA-000567-PIP01-09-M05 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: P/0042/2018
Route(s) of administration: Oral use
Pharmaceutical form(s):
Film-coated tablet
Age-appropriate oral formulation
Decision date:
Last updated:
Compliance check: ✔
PIPHuman