EMEA-002015-PIP01-16 - paediatric investigation plan

terguride (hydrogenmaleate)

Key facts

• Active substance:
  terguride (hydrogenmaleate)
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0349/2016
• PIP number:
  EMEA-002015-PIP01-16
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of systemic sclerosis
• Route(s) of administration:
  Oral use
• Decision type:
  RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
• Decision date:
  02/12/2016
• Compliance check done:
  No

Decision

P/0349/2016: EMA decision of 2 December 2016 on the refusal of a product specific waiver for terguride (hydrogenmaleate) (EMEA-002015-PIP01-16)

Adopted Reference Number: EMA/757984/2016