SHINGRIX SUSPENSION

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

VARICELLA-ZOSTER VIRUS GLYCOPROTEIN E ANTIGEN

Inapatikana kutoka:

GLAXOSMITHKLINE INC

ATC kanuni:

J07BK

INN (Jina la Kimataifa):

VARICELLA ZOSTER VACCINES

Kipimo:

50MCG

Dawa fomu:

SUSPENSION

Tungo:

VARICELLA-ZOSTER VIRUS GLYCOPROTEIN E ANTIGEN 50MCG

Njia ya uendeshaji:

INTRAMUSCULAR

Vitengo katika mfuko:

15G/50G

Dawa ya aina:

Schedule D

Eneo la matibabu:

VACCINES

Bidhaa muhtasari:

Active ingredient group (AIG) number: 0159510001; AHFS:

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2017-10-13

Tabia za bidhaa

_ _
_October 25, 2022 _
_Shingrix, Herpes Zoster vaccine _
_Page 1 of 36_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
SHINGRIX
Herpes Zoster vaccine (non-live recombinant, AS01
B
adjuvanted)
Suspension for injection, 50 mcg Varicella Zoster Virus (VZV)
glycoprotein E (gE), Intramuscular Injection
Active Immunizing Agent
ATC Code: J07BK03
GlaxoSmithKline Inc.
100 Milverton Drive, Suite 800
Mississauga, Ontario
L5R 4H1
Date of Initial Authorization:
October 13, 2017
Date of Revision:
November 15, 2022
Submission Control Number: 265524
_©_
_2022 GSK group of companies or its licensor _
_Trademarks are owned by or licensed to the GSK group of companies _
_ _
_October 25, 2022 _
_Shingrix, Herpes Zoster vaccine _
_Page 2 of 36_
RECENT MAJOR LABEL CHANGES
SECTION
DATE
1 INDICATIONS
11/2021
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and
Dose Adjustment
11/2021
7 WARNINGS AND PRECAUTIONS
11/2021
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
............................................................................................................4
1.2
Geriatrics.............................................................................................................4
2
CONTRAINDICATIONS
...................................................................................................4
4
DOSAGE AND
ADMINISTRATION...................................................................................4
4.1
Dosing Considerations
........