EMEA-001824-PIP01-15 - paediatric investigation plan

(R)-N-({5-[3-(2,5-Difluorophenyl)-2-(2,3-dihydro-1H-benzimidazol-2-ylidene)-3- oxopropanoyl]-2-fluorophenyl}sulfonyl)-2-hydroxypropanimidamide

Key facts

• Active Substance:
  (R)-N-({5-[3-(2,5-Difluorophenyl)-2-(2,3-dihydro-1H-benzimidazol-2-ylidene)-3- oxopropanoyl]-2-fluorophenyl}sulfonyl)-2-hydroxypropanimidamide
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0292/2015
• PIP number:
  EMEA-001824-PIP01-15
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of endometriosis
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Astellas Pharma Europe B.V.

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  27/11/2015

Decision

P/0292/2015: EMA decision of 27 November 2015 on the granting of a product specific waiver for (R)-N-({5-[3-(2,5-Difluorophenyl)-2-(2,3-dihydro-1H-benzimidazol-2-ylidene)-3- oxopropanoyl]-2-fluorophenyl}sulfonyl)-2-hydro...

AdoptedReference Number: EMA/509834/2015