PREVYMIS SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

LETERMOVIR

Available from:

MERCK CANADA INC

ATC code:

J05AX18

INN (International Name):

LETERMOVIR

Dosage:

20MG

Pharmaceutical form:

SOLUTION

Composition:

LETERMOVIR 20MG

Administration route:

INTRAVENOUS

Units in package:

12ML

Prescription type:

Prescription

Therapeutic area:

HIV PROTEASE INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0159630001; AHFS:

Authorization status:

APPROVED

Authorization date:

2017-11-01

Summary of Product characteristics

_PREVYMIS® (letermovir) _
_Page 1 of 49_
Confidential
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PREVYMIS®
letermovir tablets
Tablets, 240 mg and 480 mg, oral
letermovir for injection
Solution for injection, 20 mg/mL, 240 mg/vial and 480 mg/vial,
intravenous
Antiviral Agent
Merck Canada Inc.
16750 route Transcanadienne
Kirkland QC Canada H9H 4M7
www.merck.ca
Date of Initial Authorization:
November 1, 2017
Date of Revision:
MAR 13, 2024
Submission Control Number: 273906
_ _
_PREVYMIS® (letermovir) _
_Page 2 of 49_
Confidential
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
09/2023
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and
Dosage Adjustment
03/2024
7 WARNINGS AND PRECAUTIONS
09/2023
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
................................................................................................................
4
1.2
Geriatrics
................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1
Dosing Considerations
............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
....................................................... 5
4.3
Reconstit