EMEA-001485-PIP01-13-M01 - paediatric investigation plan

asunaprevir

(1aR,12bS)-8-Cyclohexyl-N-(dimethylsulfamoyl)-11-methoxy-1a-(((1R,5S)-3-methyl-3,8-diazabicyclo[3.2.1]oct-8-yl)carbonyl)-1,1a,2,12b-tetrahydrocyclopropa[d]indolo[2,1-a][2]benzazepine-5-carboxamide hydrochloride (BMS-791325)

daclatasvir dihydrochloride

Key facts

• Active Substance:
  • asunaprevir
  • (1aR,12bS)-8-Cyclohexyl-N-(dimethylsulfamoyl)-11-methoxy-1a-(((1R,5S)-3-methyl-3,8-diazabicyclo[3.2.1]oct-8-yl)carbonyl)-1,1a,2,12b-tetrahydrocyclopropa[d]indolo[2,1-a][2]benzazepine-5-carboxamide hydrochloride (BMS-791325)
  • daclatasvir dihydrochloride
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0002/2015
• PIP number:
  EMEA-001485-PIP01-13-M01
• Pharmaceutical form(s):
  • Age-appropriate oral solid dosage form
  • Film-coated tablet
• Condition(s) / indication(s):
  Treatment of chronic hepatitis C
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  15/01/2015

Decision

P/0002/2015: EMA decision of 15 January 2015 of 15 January 2015 on the acceptance of a modification of an agreed paediatric investigation plan for daclatasvir (dihydrochloride) / asunaprevir / (1aR,12bS)-8-Cyclohexyl-N-...

AdoptedReference Number: EMA/779625/2014