EMEA-001485-PIP01-13-M01

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
Contact for public enquiries
Bristol-Myers Squibb International Corporation

Tel. +44 (0)1895 523740
E-mail: medical.information@bms.com
Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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