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
Dificlir
fidaxomicin
Clostridium Infections
Date of authorisation:
Revision: 17
Last updated:
MedicineHumanAuthorised
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-000636-PIP01-09-M07 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: P/0062/2018
Route(s) of administration: Oral use
Pharmaceutical form(s):
Film-coated tablet
Granules for oral suspension
Decision date:
Last updated:
Compliance check: ✔
PIPHuman
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