EMEA-000339-PIP02-09-M03
Key facts
Invented name |
Baraclude
|
Active substance |
Entecavir
|
Therapeutic area |
Infectious diseases
|
Decision number |
P/0125/2014
|
PIP number |
EMEA-000339-PIP02-09-M03
|
Pharmaceutical form(s) |
|
Condition(s) / indication(s) |
Treatment of chronic hepatitis B
|
Route(s) of administration |
Oral use
|
Contact for public enquiries |
Bristol-Myers Squibb Pharma EEIG
|
Decision type |
PM: decision on the application for modification of an agreed PIP
|
Compliance procedure number |
EMEA-C-000339-PIP02-09-M03
|
Compliance opinion date |
20/06/2014
|
Compliance outcome |
positive
|