Soluble yeast beta-1,3/1,6-glucan - paediatric investigation plan

Soluble yeast beta-1,3/1,6-glucan

Key facts

• Active Substance:
  Soluble yeast beta-1,3/1,6-glucan
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/221/2009
• PIP number:
  Soluble yeast beta-1,3/1,6-glucan
• Pharmaceutical form(s):
  Cutaneous solution
• Condition(s) / indication(s):
  Treatment of diabetic foot ulcer
• Route(s) of administration:
  Cutaneous use
• Contact for public enquiries:

  Biotec Pharmacon ASA

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  03/11/2009

Decision

P/221/2009: European Medicines Agency Decision of 3 November 2009 on the granting of a product specific waiver for soluble yeast beta-1,3/1,6-glucan EMEA-000633-PIP01-09) in accordance with Regulation (EC) No 1901/2006 o...

AdoptedReference Number: EMEA/687790/2009