EMEA-002291-PIP01-17 - paediatric investigation plan

( 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

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. [phone]; E-mail: [e-mail]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  07/05/2018

Decision

P/0134/2018: EMA decision of 7 May 2018 on the granting of a product specific waiver for (2R)-2-Amino-1-[3-({2-[p-(4-{3-[(3,5-diamino-6- chloro-2-pyrazinyl)carbonyl]guanidino}butyl)phenoxy]ethyl}{3-[(2R)-2-amino-6- guanidinohexanoylamino]propyl}amino)prop

AdoptedReference Number: EMA/201423/2018