COVISHIELD SOLUTION

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

CHADOX1-S [RECOMBINANT]

Pieejams no:

VERITY PHARMACEUTICALS INC.

ATĶ kods:

J07BN02

SNN (starptautisko nepatentēto nosaukumu):

COVID-19, VIRAL VECTOR, NON-REPLICATING

Deva:

50000000000VP

Zāļu forma:

SOLUTION

Kompozīcija:

CHADOX1-S [RECOMBINANT] 50000000000VP

Ievadīšanas:

INTRAMUSCULAR

Vienības iepakojumā:

100

Receptes veids:

COVID-19 - IO - Authorization

Produktu pārskats:

Active ingredient group (AIG) number: 0162722001; AHFS:

Autorizācija statuss:

AUTHORIZATION BY INTERIM ORDER EXPIRED

Autorizācija datums:

2021-09-16

Produkta apraksts

_ _
_COVISHIELD Product Monograph. COPYRIGHT 2021, Verity Pharmaceuticals
INC._
_Page 1 of 29_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
COVISHIELD
COVID-19 VACCINE (CHADOX1-S [RECOMBINANT]
),
COVISHIELD (MANUFACTURED BY SERUM INSTITUTE OF INDIA) AND ASTRAZENECA
COVID-19 VACCINE
(MANUFACTURED BY ASTRAZENECA) ARE CHADOX1-S RECOMBINANT VACCINES
DEVELOPED BY
ASTRAZENECA AND THE UNIVERSITY OF OXFORD. HEALTH CANADA HAS REVIEWED
THE MANUFACTURING
INFORMATION FOR THESE VACCINES AND FOUND THEM TO BE COMPARABLE.
SOLUTION FOR INTRAMUSCULAR INJECTION
Multiple Dose Vial
(each vial contains 10 doses of 0.5 mL)
Active Immunizing Agent
HEALTH CANADA HAS AUTHORIZED THE SALE OF THIS COVID-19 Vaccine
UNDER AN INTERIM ORDER
COVISHIELD is indicated for:
Active immunization of individuals 18 years of age and older for the
prevention of
coronavirus disease 2019 (COVID-19).
The use of COVISHIELD is permitted under an interim authorization
delivered in
accordance with section 5 of the COVID-19 Interim order (IO)*.
Patients should be
advised of the nature of the authorization. The interim authorization
is associated
with Terms and Conditions that need to be met by the Market
Authorization Holder to
ascertain the continued quality, safety and efficacy of the product.
For further
information on authorization under this pathway, please refer to
Health Canada’s IO
Respecting the Importation, Sale and Advertising of Drugs for Use in
Relation to
COVID-19.
*
https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-
industry/drugsvaccines-treatments/interim-order-import-sale-advertising-
drugs.html#a2.8
Verity Pharmaceuticals Inc
2560 Matheson Blvd E, Suite 220
Mississauga, ON
L4W 4Y9
www.veritypharma.com
Date of Initial Authorization:
FEB 26, 2021
Date of Revision:
August 13, 2021
Submission Control Number: 254910
_ _
_COVISHIELD Product Monograph. COPYRIGHT 2021, Verity Pharmaceuticals
INC._
_Page 2 of 29_
RECENT MAJOR LABEL CHANGES
CONTRAINDICATIONS (2)
04/2021
CONTRAINDICATIONS (2)
06/2021
SERIOUS WARN