EMEA-000832-PIP01-10-M05

Key facts

Invented name
Tecfidera
Active substance
dimethyl fumarate
Therapeutic area
Neurology
Decision number
P/0177/2020
PIP number
EMEA-000832-PIP01-10-M05
Pharmaceutical form(s)
Capsule, hard
Condition(s) / indication(s)
Treatment of multiple sclerosis
Route(s) of administration
Oral use
Contact for public enquiries
Biogen Idec Ltd

Tel.  +01 628501000
E-mail: pip.enquiries@biogen.com

Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-000832-PIP01-10-M05
Compliance opinion date
14/06/2021
Compliance outcome
positive

Decision

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