EMEA-000694-PIP02-14-M03

Table of contents

Key facts

Invented name
Forxiga
Active substance
dapagliflozin
Therapeutic area
Endocrinology-Gynaecology-Fertility-Metabolism
Decision number
P/0161/2022
PIP number
EMEA-000694-PIP02-14-M03
Pharmaceutical form(s)
  • Film-coated tablet
  • Age-appropriate oral dosage form
Condition(s) / indication(s)
Treatment of type I diabetes mellitus
Route(s) of administration
Oral use
Contact for public enquiries
AstraZeneca AB

E-mail: paediatrics@astrazeneca.com
Tel. +46(8)55324400

Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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