EMEA-001475-PIP01-13 - paediatric investigation plan

(4R,5R)-1-[[4-[[4-[3,3-dibutyl-7-(dimethylamino)-2,3,4,5-tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabicyclo[2.2.2]octane chloride

Key facts

• Active Substance:
  (4R,5R)-1-[[4-[[4-[3,3-dibutyl-7-(dimethylamino)-2,3,4,5-tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabicyclo[2.2.2]octane chloride
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0272/2013
• PIP number:
  EMEA-001475-PIP01-13
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of primary biliary cirrhosis
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Mirum Pharmaceuticals

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  30/10/2013

Decision

P/0272/2013: EMA decision of 30 October 2013 on the granting of a product specific waiver for (4R,5R)-1-[[4-[[4-[3,3-dibutyl-7-(dimethylamino)-2,3,4,5-tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]p...

Reference Number: EMA/587446/2013