EMEA-001779-PIP01-15 - paediatric investigation plan

enclomifene citrate

Key facts

• Active Substance:
  enclomifene citrate
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0204/2015
• PIP number:
  EMEA-001779-PIP01-15
• Pharmaceutical form(s):
  Capsule (hard)
• Condition(s) / indication(s):
  Treatment of hypogonadotrophic hypogonadism
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Renable Pharma Limited

  United Kingdom; E-mail: [e-mail]; Tel. [phone]; Fax [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  07/09/2015

Decision

P/0204/2015: EMA decision of 4 September 2015 on the granting of a product-specific waiver for enclomifene (citrate) (EMEA-001779-PIP01-15)

AdoptedReference Number: EMA/505398/2015