RETROVIR (AZT) CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ZIDOVUDINE

Available from:

VIIV HEALTHCARE ULC

ATC code:

J05AF01

INN (International Name):

ZIDOVUDINE

Dosage:

100MG

Pharmaceutical form:

CAPSULE

Composition:

ZIDOVUDINE 100MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

NUCLEOSIDE AND NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0122716002; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2021-06-28

Summary of Product characteristics

_RETROVIR (AZT) (Zidovudine Capsules, Syrup and Solution for Infusion)
_
_Page 1 of 58_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
RETROVIR (AZT)
Zidovudine Capsules USP, 100 mg
Zidovudine Syrup, 50 mg/5mL
Zidovudine Solution for Infusion, 10 mg/mL
Antiretroviral Agent
ViiV Healthcare ULC
245, boulevard Armand-Frappier
Laval, Quebec
H7V 4A7
Date of Initial Authorization:
January 12, 1995
Date of Revision:
June 9, 2021
Submission Control Number: 249459
_©_
_2021 ViiV Healthcare group of companies or its licensor _
_Trademarks are owned by or licensed to the ViiV Healthcare group of
companies _
_RETROVIR (AZT) (Zidovudine Capsules, Syrup and Solution for Infusion)
_
_Page 2 of 58_
RECENT MAJOR LABEL CHANGES
1 INDICATIONS, 1.1 PEDIATRICS
06/2021
1 INDICATIONS, 1.2 GERIATRICS
06/2021
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
06/2021
4 DOSAGE AND ADMINISTRATION, 4.1 DOSING CONSIDERATIONS
06/2021
4 DOSAGE AND ADMINISTRATION, 4.2 RECOMMENDED DOSE AND
DOSAGE ADJUSTMENT
06/2021
7 WARNINGS AND PRECAUTIONS, GENERAL
06/2021
7 WARNINGS AND PRECAUTIONS, HEPATIC/BILIARY/PANCREATIC
06/2021
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL
CHANGES..............................................................................................2
TABLE OF CONTENTS
................................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................4
1
INDICATIONS
................................................................................................................4
1.1
Pediatrics
............................................................................................................5
1.2
Geriatrics.............................................................................................................5
2
CONTRAINDICATIONS
...............................................................