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.
The Netherlands
E-mail: pip.information@merck.com
Tel. +31 4126 63179
Fax +31 4126 62571
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

Decision

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