EMEA-000216-PIP01-08 - paediatric investigation plan

dutasteride

tamsulosin hydrochloride

Key facts

• Active substance:
  • dutasteride
  • tamsulosin hydrochloride
• Therapeutic area:
  Uro-nephrology
• Decision number:
  P/42/2008
• PIP number:
  EMEA-000216-PIP01-08
• Pharmaceutical form(s):
  Capsule
• Condition(s) / indication(s):
  Treatment of benign prostatic hyperplasia
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  24/06/2008
• Compliance check done:
  No

Decision

P/42/2008: European medicines agency decision of 24 June 2008 on the application for product specific waiver for dutasteride, tamsulosin hydrochloride (EMEA-000216-PIP01-08) in accordance with Regulation (EC) No 1901/20...

Adopted Reference Number: EMEA/313699/2008