Product information
From Health Canada
The product monograph is developed by a drug sponsor according to guidelines published by Health Canada that provide direction on the content and format. The veterinary labelling is developed by the drug sponsor according to the Food and Drug Regulations. While Health Canada reviews the product monograph or the veterinary labelling as part of the drug review process, it remains the responsibility of the drug sponsor to ensure that the product monograph or the veterinary labelling is complete and accurate.
Current status:
Cancelled Post Market
Current status date:
2018-08-15
Original market date: See footnote 1
2015-01-06
Lot number: See footnote 2
1070376
Expiry date: See footnote 2
2018-08-15
Product name:
HOLKIRA PAK
Description:
KIT INCLUDES PINK TAB. (OMBITASVIR/ PARITAPREVIR/ RITONAVIR FIXED COMBINATION), AND BEIGE TAB. (DASABUVIR)
DIN:
02436027
Product Monograph/Veterinary Labelling:
Date:
2018-02-22
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
ABBVIE CORPORATION
8401 Trans-Canada Highway
Saint-Laurent
Quebec
Canada
H4S 1Z1
Class:
Human
Dosage form(s):
Tablet , Kit
Route(s) of administration:
Oral
Number of active ingredient(s):
4
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
08:18.40.16 , 08:18.40.24 , 08:18.40.20
Anatomical Therapeutic Chemical (ATC): See footnote 4
J05AP52 DASABUVIR, OMBITASVIR, PARITAPREVIR AND RITONAVIR
Active ingredient group (AIG) number:See footnote5
0456390001
Active ingredient(s) | Strength |
---|---|
DASABUVIR (DASABUVIR SODIUM MONOHYDRATE) | 250 MG |
OMBITASVIR | 12.5 MG |
PARITAPREVIR | 75 MG |
RITONAVIR | 50 MG |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.