EMEA-000184-PIP01-08-M02 - paediatric investigation plan

Tobramycin

Key facts

• Invented name:
  • Tobi Podhaler
  • Tobi Podhaler
• Active Substance:
  Tobramycin
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0177/2014
• PIP number:
  EMEA-000184-PIP01-08-M02
• Pharmaceutical form(s):
  • Inhalation powder
  • Capsule (hard)
• Condition(s) / indication(s):
  Treatment of Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
• Route(s) of administration:
  Inhalation use
• Contact for public enquiries:

  Mylan IRE Healthcare Limited

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  08/07/2014
• Compliance procedure number:
  EMEA-C-000184-PIP01-08-M02
• Compliance opinion date:
  12/09/2014
• Compliance outcome:
  Positive

Decision

P/0177/2014: EMA decision of 7 July 2014 on the acceptance of a modification of an agreed paediatric investigation plan for tobramycin (Tobi Podhaler), (EMEA-000184-PIP01-08-M02)

AdoptedReference Number: EMA/391612/2014