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
|