EMEA-000784-PIP02-11-M01

Key facts

Invented name
Orfadin
Active substance
nitisinone
Therapeutic area
Endocrinology, -gynacology-fertility-metabolism
Decision number
P/0276/2013
PIP number
EMEA-000784-PIP02-11-M01
Pharmaceutical form(s)
Oral suspension
Condition(s) / indication(s)
Treatment of tyrosinemia type 1
Route(s) of administration
Oral use
Contact for public enquiries
Swedish Orphan Biovitrum International AB
Sweden
E-mail: maria.sahlberg@sobi.com
Tel. +46 (0)8697 2030
Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-000784-PIP02-11-M01
Compliance opinion date
17/01/2014
Compliance outcome
positive

Decision

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