Forxiga
dapagliflozin
Diabetes Mellitus, Type 2
Heart Failure, Systolic
Heart Failure
Renal Insufficiency, Chronic
Date of authorisation:
Revision: 30
Last updated:
MedicineHumanAuthorised
EMEA-000694-PIP02-14-M03 - 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/0161/2022
Route(s) of administration: Oral use
Pharmaceutical form(s):
Film-coated tablet
Age-appropriate oral dosage form
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-000694-PIP06-20 - paediatric investigation plan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: P/0515/2020
Route(s) of administration: Oral use
Pharmaceutical form(s):
Film-coated tablet
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-000694-PIP01-09-M08 - 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/0086/2020
Route(s) of administration: Oral use
Pharmaceutical form(s):
Film-coated tablet
Decision date:
Last updated:
Compliance check: ✔
PIPHuman
EMEA-000694-PIP05-20 - paediatric investigation plan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases
PIP number: P/0444/2020
Route(s) of administration: Oral use
Pharmaceutical form(s):
Film-coated tablet
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-000694-PIP04-18 - paediatric investigation plan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Uro-nephrology
PIP number: P/0373/2018
Route(s) of administration: Oral use
Pharmaceutical form(s):
Film-coated tablet
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-000694-PIP03-17 - paediatric investigation plan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: P/0202/2018
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
Kyndrisa
Date of withdrawal:
Last updated:
MedicineHumanWithdrawn application