EMEA-000184-PIP03-16 - paediatric investigation plan

Tobramycin

Key facts

• Invented name:
  • Tobi Podhaler
  • Tobi Podhaler
• Active Substance:
  Tobramycin
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0114/2017
• PIP number:
  EMEA-000184-PIP03-16
• Pharmaceutical form(s):
  • Inhalation powder
  • Capsule (hard)
• Condition(s) / indication(s):
  Treatment of Pseudomonas aeruginosa pulmonary colonisation in patients with bronchiectasis
• Route(s) of administration:
  Inhalation use
• Contact for public enquiries:

  Mylan IRE Healthcare Limited

  E-mail: [e-mail]; Tel. + 44 (0)1707853000

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  11/04/2017

Decision

P/0114/2017: EMA decision of 11 April 2017 on the granting of a product specific waiver for tobramycin (TOBI Podhaler) (EMEA-000184-PIP03-16)

AdoptedReference Number: EMA/199884/2017