EMEA-001614-PIP01-13 - paediatric investigation plan

clarithromycin

Key facts

• Active substance:
  clarithromycin
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0157/2014
• PIP number:
  EMEA-001614-PIP01-13
• Pharmaceutical form(s):
  • Orodispersible tablet
  • Film-coated tablet
  • Gastro-resistant tablet
  • 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:
  18/06/2014
• Compliance check done:
  No

Decision

P/0157/2014: EMA decision of 18 June 2014 on the granting of a product specific waiver for clarithromycin (in combination with amoxicillin + metronidazole + pantoprazole) (EMEA-001614-PIP01-13)

Adopted Reference Number: EMA/259616/2014