EMEA-001354-PIP01-12 - paediatric investigation plan

2,6-Bis-{(1-napthalenyl-3,6-disulfonic acid)-oxyacetamido}-2,6-bis-2,6-bis-2,6-bis-(2,6-diamino-hexanoylamino)-2,6-diamino-hexanoic acid (diphenylmethyl)-amide, polysodium salt

Key facts

• Active Substance:
  2,6-Bis-{(1-napthalenyl-3,6-disulfonic acid)-oxyacetamido}-2,6-bis-2,6-bis-2,6-bis-(2,6-diamino-hexanoylamino)-2,6-diamino-hexanoic acid (diphenylmethyl)-amide, polysodium salt
• Therapeutic area:
  Other
• Decision number:
  P/0033/2013
• PIP number:
  EMEA-001354-PIP01-12
• Pharmaceutical form(s):
  Vaginal gel
• Condition(s) / indication(s):
  Treatment of bacterial vaginosis
• Route(s) of administration:
  Vaginal use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  26/02/2013

Decision

P/0033/2013: EMA decision of 26 February 2013 on the agreement of a paediatric investigation plan and on the granting of a waiver for 2,6-bis-{(1-napthalenyl-3,6-disulfonic acid)-oxyacetamido}-2,6-bis-2,6-bis-2,6-bis-(2,...

AdoptedReference Number: EMA/65700/2013