IMVAMUNE SUSPENSION

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

MODIFIED VACCINIA VIRUS (ANKARA-BAVARIAN NORDIC)

Pieejams no:

BAVARIAN NORDIC AS

ATĶ kods:

J07BX01

SNN (starptautisko nepatentēto nosaukumu):

SMALLPOX AND MONKEYPOX VACCINES

Deva:

50000000CCID50

Zāļu forma:

SUSPENSION

Kompozīcija:

MODIFIED VACCINIA VIRUS (ANKARA-BAVARIAN NORDIC) 50000000CCID50

Ievadīšanas:

SUBCUTANEOUS

Vienības iepakojumā:

20X0.5ML

Receptes veids:

Schedule D

Ārstniecības joma:

VACCINES

Produktu pārskats:

Active ingredient group (AIG) number: 0155011001; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2013-11-21

Produkta apraksts

_Product Monograph Master Template _
_Template Date: September 2020 _
_IMVAMUNE Smallpox and mpox Vaccine _
_Page 1 of 32_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
IMVAMUNE
®
Smallpox and mpox Vaccine
Modified Vaccinia Ankara-Bavarian Nordic
®
(live-attenuated, non-replicating)
Suspension for Injection
at least 0.5 x 10
8
Inf.U/ per 0.5 mL single dose
Pharmacotherapeutic group: Other viral vaccines
ATC code: J07BX
Bavarian Nordic A/S
Philip Heymans Alle 3
DK-2900 Hellerup
Denmark
Distributor:
Progress Therapeutics Inc.
320 Harry Walker Pky. N., Suite #14
Newmarket, Ontario L3Y 7B4
Date of Initial Approval:
November 21, 2013
Date of Revision:
August 3, 2023
Submission Control No: 272722
_Product Monograph Master Template _
_Template Date: September 2020 _
_IMVAMUNE Smallpox and mpox Vaccine _
_Page 2 of 32_
RECENT MAJOR LABEL CHANGES
Since September 2019, major label changes related to safety and
efficacy have been made
under the following sections:
1 Indications
11/2020
3 Serious Warnings and Precautions Box
11/2020
4 Dosage and Administration_4.5 Missed Dose
11/2020
7 Warnings and Precautions_7.1 Special Populations
11/2020
TABLE OF CONTENTS
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
3
S