EMEA-000200-PIP01-08-M10 - paediatric investigation plan

Saxagliptin
PIPHuman

Key facts

Invented name
  • Onglyza
  • Onglyza
Active Substance
Saxagliptin
Therapeutic area
Endocrinology-Gynaecology-Fertility-Metabolism
Decision number
P/0478/2022
PIP number
EMEA-000200-PIP01-08-M10
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
Email: paediatrics@astrazeneca.com
Tel. +46 855324400

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date
Compliance procedure number
EMEA-C-000200-PIP01-08-M10
Compliance opinion date
Compliance outcome
Positive

Decision

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