Zynyz
retifanlimab
Carcinoma, Merkel Cell
Date of authorisation:
Last updated:
MedicineHumanAuthorised
Strimvelis
autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence
Severe Combined Immunodeficiency
Date of authorisation:
Revision: 10
Last updated:
MedicineHumanAuthorised
EMEA-002798-PIP03-22 - paediatric investigation plan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: P/0014/2023
Route(s) of administration: All routes of administration
Pharmaceutical form(s):
All pharmaceutical forms
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Zynyz
retifanlimab
Date of withdrawal:
Last updated:
MedicineHumanWithdrawn application
Strimvelis - direct healthcare professional communication (DHPC)
Active substance: autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ADA) cDNA sequence from human haematopoietic stem/progenitor (CD34+) cells
DHPC type:
Adverse event
Last updated:
DHPCHuman
EMEA-001289-PIP01-12-M01 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: P/0190/2014
Route(s) of administration: Intravenous use
Pharmaceutical form(s):
Cell suspension for infusion
Decision date:
Last updated:
Compliance check: ✔
PIPHuman