EMEA-002181-PIP01-17 - paediatric investigation plan

Pilocarpine (hydrochloride)

Oxymetazoline hydrochloride

Key facts

• Active Substance:
  • Pilocarpine (hydrochloride)
  • Oxymetazoline hydrochloride
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/0333/2017
• PIP number:
  EMEA-002181-PIP01-17
• Pharmaceutical form(s):
  • Eye drops, solution
  • Solution
• Condition(s) / indication(s):
  Treatment of presbyopia
• Route(s) of administration:
  Ophthalmic use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  31/10/2017

Decision

P/0333/2017: EMA decision of 31 October 2017 on the granting of a product specific waiver for pilocarpine (hydrochloride) / oxymetazoline (hydrochloride) (EMEA-002181-PIP01-17)

AdoptedReference Number: EMA/661912/2017