RoActemra
tocilizumab
Arthritis, Rheumatoid
Arthritis, Juvenile Rheumatoid
Cytokine Release Syndrome
Giant Cell Arteritis
COVID-19 virus infection
Date of authorisation:
Revision: 43
Last updated:
MedicineHumanAuthorised
EMEA-000309-PIP09-21 - paediatric investigation plan
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: P/0354/2022
Route(s) of administration: Subcutaneous use
Pharmaceutical form(s):
Solution for injection
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-000309-PIP06-21 - paediatric investigation plan
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: P/0466/2021
Route(s) of administration: Subcutaneous use
Pharmaceutical form(s):
Solution for injection
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-000309-PIP04-17-M03 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: P/0303/2021
Route(s) of administration: Subcutaneous useIntravenous use
Pharmaceutical form(s):
Solution for injection
Concentrate for solution for infusion
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
RenuTend
tenogenic primed equine allogeneic peripheral blood-derived mesenchymal stem cells
Last updated:
MedicineVeterinaryAuthorised
EMEA-000309-PIP07-21 - paediatric investigation plan
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Infectious diseases
PIP number: P/0333/2021
Route(s) of administration: Intravenous use
Pharmaceutical form(s):
Concentrate for solution for infusion
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-000309-PIP01-08-M07 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: P/0266/2015
Route(s) of administration: Intravenous useSubcutaneous use
Pharmaceutical form(s):
Concentrate for solution for infusion
Decision date:
Last updated:
Compliance check: ✔
PIPHuman