EMEA-000694-PIP01-09-M08

Table of contents

Key facts

Invented name
Forxiga
Active substance
dapagliflozin
Therapeutic area
Endocrinology, -gynacology-fertility-metabolism
Decision number
P/0086/2020
PIP number
EMEA-000694-PIP01-09-M08
Pharmaceutical form(s)
Film-coated tablet
Condition(s) / indication(s)
Treatment of type II diabetes mellitus
Route(s) of administration
Oral use
Contact for public enquiries
AstraZeneca AB (Sweden)

E-mail: paediatrics@astrazeneca.com
Tel. +46 8553 27591

Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-000694-PIP01-09-M08
Compliance opinion date
11/12/2020
Compliance outcome
positive

Decision

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