EMEA-001746-PIP01-15 - paediatric investigation plan

Clonidine

Key facts

• Active Substance:
  Clonidine
• Therapeutic area:
  Pain
• Decision number:
  P/0158/2015
• PIP number:
  EMEA-001746-PIP01-15
• Pharmaceutical form(s):
  Gel
• Condition(s) / indication(s):
  Treatment of painful diabetic neuropathy
• Route(s) of administration:
  Cutaneous use
• Contact for public enquiries:

  BioDelivery Sciences International, Inc.

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  10/07/2015

Decision

P/0158/2015: EMA decision of 10 July 2015 on the granting of a product specific waiver for clonidine (EMEA-001746-PIP01-15)

AdoptedReference Number: EMA/366856/2015