EMEA-001525-PIP01-13 - paediatric investigation plan

Alpha-1 antitrypsin

Key facts

• Active Substance:
  Alpha-1 antitrypsin
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0318/2013
• PIP number:
  EMEA-001525-PIP01-13
• Pharmaceutical form(s):
  Nebuliser solution
• Condition(s) / indication(s):
  Treatment of emphysema secondary to congenital deficiency of alpha-1 antitrypsin
• Route(s) of administration:
  Inhalation use
• Contact for public enquiries:

  Triskel EU Services Ltd

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  19/12/2013

Decision

P/0318/2013: EMA decision of 19 December 2013 on the granting of a product specific waiver for alpha-1 antitrypsin (EMEA-001525-PIP01-13)

AdoptedReference Number: EMA/693820/2013