Elocalcitol - paediatric investigation plan

Elocalcitol

Key facts

• Active Substance:
  Elocalcitol
• Therapeutic area:
  Uro-nephrology
• Decision number:
  P/41/2008
• PIP number:
  Elocalcitol
• Pharmaceutical form(s):
  Capsule
• Condition(s) / indication(s):
  Treatment of benign prostatic hyperplasia
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  BioXell SpA

  E-mail: [e-mail]; Country: Italy; Phone: [phone]; Fax: [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  24/06/2008

Decision

P/41/2008: European medicines agency decision of 24 June 2008 on the application for product specific waiver for elocalcitol (EMEA-000182-PIP01-08) in accordance with Regulation (EC) No 1901/2006 of the European Parliam...

AdoptedReference Number: EMEA/313552/2008