EMEA-002291-PIP01-17

Key facts

Active substance
( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-guanidino-1-hexanone hexahydrochloride
Therapeutic area
Ophthalmology
Decision number
P/0134/2018
PIP number
EMEA-002291-PIP01-17
Pharmaceutical form(s)
Eye drops, solution
Condition(s) / indication(s)
Treatment of dry eye disease
Route(s) of administration
Ophthalmic use
Contact for public enquiries
Shire Pharmaceuticals Ireland Limited

Tel. +44 (0)8008 38470
E-mail: medinfoeuceemea@shire.com

Decision type
W: decision granting a waiver in all age groups for all conditions/indications

Decision

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