EMEA-002177-PIP01-17 - paediatric investigation plan

fluticasone propionate

salmeterol xinafoate

Key facts

• Active substance:
  • fluticasone propionate
  • salmeterol xinafoate
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0245/2017
• PIP number:
  EMEA-002177-PIP01-17
• Pharmaceutical form(s):
  Inhalation powder
• Condition(s) / indication(s):
  Treatment of asthma
• Route(s) of administration:
  Inhalation use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  04/09/2017
• Compliance check done:
  No

Decision

P/0245/2017: EMA decision of 4 September 2017 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of a waiver for salmeterol (xinafoate) / fluticasone (propionate) (EME...

Adopted Reference Number: EMA/497687/2017