EMEA-001586-PIP01-13 - paediatric investigation plan

Atropine (sulfate)

dimethanesulfonate

avizafone (hydrochloride)

Key facts

• Active Substance:
  • Atropine (sulfate)
  • dimethanesulfonate
  • avizafone (hydrochloride)
• Therapeutic area:
  Other
• Decision number:
  P/0089/2014
• PIP number:
  EMEA-001586-PIP01-13
• Pharmaceutical form(s):
  Powder and solvent for solution for injection
• Condition(s) / indication(s):
  Treatment of organophosphorus poisoning
• Route(s) of administration:
  Intramuscular use
• Contact for public enquiries:

  Service de Santé des Armées

  France; E-mail: [e-mail]; Tel. [phone];

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  04/04/2014

Decision

P/0089/2014: EMA decision of 4 April 2014 on the granting of a product specific waiver for atropine (sulphate) / dimethanesulfonate / avizafone (hydrochloride) (EMEA-001586-PIP01-13)

AdoptedReference Number: EMA/122781/2014