EMEA-000470-PIP01-08-M11
Key facts
Invented name |
Januvia
|
Active substance |
sitagliptin
|
Therapeutic area |
Endocrinology, -gynacology-fertility-metabolism
|
Decision number |
P/0358/2019
|
PIP number |
EMEA-000470-PIP01-08-M11
|
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 |
Merck Sharp and Dohme (Europe), Inc.
Tel. +44 (0)1992 452396 |
Decision type |
PM: decision on the application for modification of an agreed PIP
|
Compliance procedure number |
EMEA-C-000470-PIP01-08-M11
|
Compliance opinion date |
28/02/2020
|
Compliance outcome |
positive
|