VEKLURY POWDER FOR SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

REMDESIVIR

Dostopno od:

GILEAD SCIENCES CANADA INC

Koda artikla:

J05AB16

INN (mednarodno ime):

REMDESIVIR

Odmerek:

100MG

Farmacevtska oblika:

POWDER FOR SOLUTION

Sestava:

REMDESIVIR 100MG

Pot uporabe:

INTRAVENOUS

Enote v paketu:

15G/50G

Tip zastaranja:

Prescription

Terapevtsko območje:

NUCLEOSIDES AND NUCLEOTIDES

Povzetek izdelek:

Active ingredient group (AIG) number: 0162395002; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2020-07-27

Lastnosti izdelka

_Product Monograph _
_VEKLURY_
_ ®_
_ (remdesivir) powder for solution for infusion _
_Page 1 of 41_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
VEKLURY
®
Remdesivir for injection,
Powder for solution for infusion, 100 mg/vial (5 mg/mL when
reconstituted)
Nucleotide Prodrug
Gilead Sciences Canada, Inc.
6711 Mississauga Rd, Suite 600
Mississauga, ON
L5N 2W3
www.gilead.ca
Date of Initial Authorization:
July 27, 2020
Date of Revision:
November 17, 2023
Submission Control No: 270659
_VEKLURY (remdesivir), indicated for: _
_- the treatment of coronavirus disease 2019 (COVID-19) in; _
•
hospitalized adults and pediatric patients (at least 4 weeks of age
and weighing at
least 3 kg) with pneumonia requiring supplemental oxygen;
•
non-hospitalized adults and pediatric patients (weighing at least 40
kg) with positive
results of direct severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2) viral
testing, and who are at high risk for progression to severe COVID-19,
including
hospitalization and death.
_has been issued marketing authorization with conditions, pending the
results of trials to _
_verify its clinical benefit. Patients should be advised of the nature
of the authorization. For _
_further information for VEKLURY please refer to Health Canada’s
Notice of Compliance _
_with conditions - drug products web site:_
_https://www.canada.ca/en/health-_
_canada/services/drugs-health-products/drug-products/notice-compliance/conditions.html_
_ _
_ _
_ _
_Product Monograph _
_VEKLURY_
_ ®_
_ (remdesivir) powder for solution for infusion _
_Page 2 of 41_
WHAT IS A NOTICE OF COMPLIANCE WITH CONDITIONS (NOC/C)?
An NOC/c is a form of market approval granted to a product on the
basis of PROMISING
evidence of clinical effectiveness following review of the submission
by Health Canada.
Products authorized under Health Canada’s NOC/c policy are intended
for the treatment,
prevention or diagnosis of a serious, life-threatening or severely
debilitating illness. They have
demonstrated promising benefit, a