Key facts

Active Substance
Emicizumab
Therapeutic area
Haematology-Hemostaseology
Decision number
P/0196/2016
PIP number
EMEA-001839-PIP01-15
Pharmaceutical form(s)
Solution for injection
Condition(s) / indication(s)
Treatment of hereditary factor VIII deficiency
Route(s) of administration
Subcutaneous use
Contact for public enquiries

Roche Registration Limited

Switzerland
Tel.+41 6 6879411
Fax +41 616881560
E-mail: info.paediatrics@roche.com

Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Decision date
Compliance procedure number
EMEA-C-001839-PIP01-15
Compliance opinion date
Compliance outcome
Positive

Decision

P/0196/2016: EMA decision of 15 July 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for emicizumab (EMEA-001839-PIP01-15)

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