Key facts

Active Substance
Bivalent anti-human myostatin adnectin recombinant human IgG1-Fc fusion protein (RO7239361)
Therapeutic area
Neurology
Decision number
P/0043/2019
PIP number
EMEA-001793-PIP01-15-M03
Pharmaceutical form(s)
  • Solution for injection
  • Solution for injection in pre-filled syringe
Condition(s) / indication(s)
Treatment of Duchenne muscular dystrophy
Route(s) of administration
Subcutaneous use
Contact for public enquiries

Roche Registration GmbH

Tel.  +41 616879411
E-mail: global.paediatrics@roche.com

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date

Decision

P/0043/2019: EMA decision of 29 January 2019 on the acceptance of a modification of an agreed paediatric investigation plan for bivalent anti-human myostatin adnectin recombinant human IgG1-Fc fusion protein (RO7239361) (EMEA-001793-PIP01-15- M03 )

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