EMEA-002549-PIP01-19 - paediatric investigation plan

clarithromycin

Key facts

• Active Substance:
  clarithromycin
• Therapeutic area:
  Other
• Decision number:
  P/0183/2019
• PIP number:
  EMEA-002549-PIP01-19
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of Helicobacter spp. infections
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  15/05/2019

Decision

P/0183/2019: EMA decision of 15 May 2019 on the granting of a product specific waiver for clarithromycin (in combination with pantoprazole + amoxicillin) (EMEA-002549-PIP01-19)

AdoptedReference Number: EMA/256070/2019