Diamorphine hydrochloride - paediatric investigation plan

diamorphine hydrochloride

Key facts

• Active Substance:
  diamorphine hydrochloride
• Therapeutic area:
  Other
• Decision number:
  P/70/2010
• PIP number:
  Diamorphine hydrochloride
• Pharmaceutical form(s):
  Powder for solution for injection
• Condition(s) / indication(s):
  Dependence to intravenous heroin use
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Genus Pharmaceuticals Limited

  E-mail: [e-mail]; Country: United Kingdom; Phone: [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  04/05/2010

Decision

P/70/2010: European Medicines Agency decision on the granting of a product specific waiver for diamorphine hydrochloride (EMEA-000799-PIP01-09)

AdoptedReference Number: EMA/236650/2010