EMEA-001400-PIP01-12 - paediatric investigation plan

sialic acid

Key facts

• Active Substance:
  sialic acid
• Therapeutic area:
  Other
• Decision number:
  P/0080/2013
• PIP number:
  EMEA-001400-PIP01-12
• Pharmaceutical form(s):
  Modified-release film-coated tablet
• Condition(s) / indication(s):
  Treatment of distal myopathy, Nonaka type (hereditary inclusion-body myopathy)
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Ultragenyx UK Limited c/o Regus

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  27/03/2013

Decision

P/0080/2013: EMA decision of 27 March 2013 on the granting of a product-specific waiver for sialic acid (EMEA-001400-PIP01-12)

AdoptedReference Number: EMA/115012/2013