ERVEBO SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

EBOLA ZAÏRE VACCINE (rVSV [DELTA] G-ZEBOV-GP, LIVE)

Available from:

MERCK CANADA INC

ATC code:

J07BX02

INN (International Name):

EBOLA VACCINES

Dosage:

72000000PFU

Pharmaceutical form:

SOLUTION

Composition:

EBOLA ZAÏRE VACCINE (rVSV [DELTA] G-ZEBOV-GP, LIVE) 72000000PFU

Administration route:

INTRAMUSCULAR

Units in package:

100

Prescription type:

Schedule D

Product summary:

Active ingredient group (AIG) number: 0164261001; AHFS:

Authorization status:

APPROVED

Authorization date:

2022-11-09

Summary of Product characteristics

_ERVEBO® (Ebola Zaire Vaccine (rVSVΔG -ZEBOV-GP, live)) _
_Page 1 of 26 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
ERVEBO®
Ebola Zaire Vaccine (rVSVΔG-ZEBOV-GP, live)
Solution for intramuscular injection
72 million plaque forming units (pfu) per 1 mL single-dose vial of
rVSVΔG-ZEBOV-GP, live
Active immunizing agent
Merck Canada Inc.
16750 route Transcanadienne
Kirkland QC Canada H9H 4M7
www.merck.ca
Date of Initial Authorization:
November 9, 2022
Submission Control Number: 256568
_ERVEBO® (Ebola Zaire Vaccine (rVSVΔG -ZEBOV-GP, live)) _
_Page 2 of 26 _
RECENT MAJOR LABEL CHANGES
Not applicable
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 (< 18 years of
age)..............................................................................
4
1.2
Geriatrics (≥ 65 years of age)
..............................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
4
DOSAGE AND
ADMINISTRATION.................................................................................
4
4.2
Recommended Dose and Dosage
Adjustment..................................................... 4
4.4
Administration...................................................................................................
4
5
OVERDOSAGE
.............................................................................................................
5
6
DOSAGE FOR