EMEA-000630-PIP02-09-M05 - paediatric investigation plan

Betula alba

aluminium hydroxide adsorbed

depigmented glutaraldehyde polymerised

Key facts

• Active Substance:
  • Betula alba
  • aluminium hydroxide adsorbed
  • depigmented glutaraldehyde polymerised
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0013/2014
• PIP number:
  EMEA-000630-PIP02-09-M05
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Treatment of allergic rhinitis / rhino-conjunctivitis
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Leti Pharma GmbH

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

• Decision type:
  RPM: decision refers to a refusal on the application for modification of an agreed PIP
• Decision date:
  30/12/2022

Decision

P/0013/2014: European Medicines Agency decision of 22 January 2014 on the acceptance of a modification of an agreed paediatric investigation plan for aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerised, ...

AdoptedReference Number: EMA/10910/2014

P/0549/2022: EMA decision of 30 December 2022 on the refusal of a modification of an agreed paediatric investigation plan for aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerised...(EMEA-000630-PIP02-09-M05)

AdoptedReference Number: EMA/934749/2022