EMEA-000071-PIP01-07
Key facts
Invented name |
PegIntron
|
Active substance |
peginterferon alfa-2b
|
Therapeutic area |
Gastroentology-Hepatology
|
Decision number |
P/64/2008
|
PIP number |
EMEA-000071-PIP01-07
|
Pharmaceutical form(s) |
Powder and solvent for solution for injection in vial and in pre-filled pen
|
Condition(s) / indication(s) |
Treatment of chronic viral hepatitis C
|
Route(s) of administration |
Subcutaneous use
|
Contact for public enquiries |
Merck Sharp & Dohme (Europe), Inc.
|
Decision type |
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
|
Compliance procedure number |
EMEA-C-000071-PIP01-07
|
Compliance opinion date |
17/10/2008
|
Compliance outcome |
positive
|