EMEA-001809-PIP01-15-M03 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: P/0090/2023
Route(s) of administration: Parenteral use
Pharmaceutical form(s):
Powder for solution for infusion
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Vokanamet
canagliflozin
metformin
Diabetes Mellitus, Type 2
Date of authorisation:
Revision: 22
Last updated:
MedicineHumanAuthorised
Invokana
canagliflozin
Diabetes Mellitus, Type 2
Date of authorisation:
Revision: 23
Last updated:
MedicineHumanAuthorised
EMEA-001030-PIP01-10-M10 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: P/0208/2022
Route(s) of administration: Oral use
Pharmaceutical form(s):
Film-coated tablet
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
SGLT2 inhibitors (previously canagliflozin) - referral
canagliflozin
empagliflozin
dapagliflozin
metformin
Article 20 procedures
Associated names:
Invokana
Vokanamet
Jardiance
Synjardy
Forxiga
Edistride
Xigduo
Ebymect
Status: European Commission final decision
Opinion/position date:
EC decision date:
Last updated:
ReferralHuman
SGLT2 inhibitors - referral
canagliflozin
dapagliflozin
empagliflozin
Article 20 procedures
Status: European Commission final decision
Opinion/position date:
EC decision date:
Last updated:
ReferralHuman
EMEA-001111-PIP01-10 - paediatric investigation plan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: P/138/2011
Route(s) of administration: Oral use
Pharmaceutical form(s):
Tablet
Decision date:
Last updated:
Compliance check: ✖
PIPHuman