Key facts

Invented name
  • Pegasys
  • Pegasys
Active Substance
peginterferon alfa-2a
Therapeutic area
Infectious diseases
Decision number
P/0143/2018
PIP number
EMEA-000298-PIP01-08-M06
Pharmaceutical form(s)
Solution for injection
Condition(s) / indication(s)
  • Treatment of chronic hepatitis B
  • Treatment of chronic hepatitis C
Route(s) of administration
Subcutaneous use
Contact for public enquiries

Roche Registration GmbH

Tel. +41 6169 79411
E-mail: global.paediatrics@roche.com

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date
Compliance procedure number
EMEA-C-000298-PIP01-08-M06
Compliance opinion date
Compliance outcome
Positive

Decision

P/0143/2018: EMA decision of 7 May 2018 on the acceptance of a modification of an agreed paediatric investigation plan for peginterferon alfa-2a (Pegasys), (EMEA-000298-PIP01-08-M06)

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