EMEA-000582-PIP01-09-M03

Key facts

Invented name
Rupafin and associated names
Active substance
Rupatadine fumarate
Therapeutic area
Pneumology-allergology
Decision number
P/0043/2014
PIP number
EMEA-000582-PIP01-09-M03
Pharmaceutical form(s)
  • Tablets
  • Granules
  • Oral liquid
Condition(s) / indication(s)
  • Treatment of chronic idiopathic urticaria
  • Treatment of allergic rhinitis
Route(s) of administration
Oral use
Contact for public enquiries
J. Uriach y Compañía, S.A
Spain
E-mail: clin-izquierdo@uriach.com
Tel. +34 938630272
Fax:  +34 938646606
Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Compliance procedure number
EMEA-C-000582-PIP01-09-M03
Compliance opinion date
21/03/2014
Compliance outcome
positive

Decision

How useful was this page?

Add your rating
Average
1 rating