ELREXFIO SOLUTION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

ELRANATAMAB

Dostupné s:

PFIZER CANADA ULC

ATC kód:

L01FX

INN (Mezinárodní Name):

OTHER MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES

Dávkování:

44MG

Léková forma:

SOLUTION

Složení:

ELRANATAMAB 44MG

Podání:

SUBCUTANEOUS

Jednotky v balení:

15G/50G

Druh předpisu:

Prescription

Přehled produktů:

Active ingredient group (AIG) number: 0165382001; AHFS:

Stav Autorizace:

APPROVED

Datum autorizace:

2023-12-06

Charakteristika produktu

_Pr_
_ELREXFIO_
_TM_
_ (elranatamab injection) _
_Page 1 of 34_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
ELREXFIO
TM
elranatamab injection
44 mg/1.1 mL (40 mg/mL) solution for subcutaneous injection
76 mg/1.9 mL (40 mg/mL) solution for subcutaneous injection
Professional Standard
Antineoplastic, monoclonal antibody
ATC code: L01FXXX
“Elrexfio (elranatamab solution for injection), indicated for:
- the treatment of adult patients with relapsed or refractory multiple
myeloma who have received at
least 3 prior lines of therapy, including a proteasome inhibitor, an
immunomodulatory agent, and an
anti-CD38 monoclonal antibody, and who have demonstrated disease
progression on the last
therapy
has been issued market 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 Elrexfio 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”
Pfizer Canada ULC
17,300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
Date of Initial Authorization:
DEC 6, 2023
Submission Control Number: 273519
TM
Pfizer Inc.
Pfizer Canada licensee
_ _
_Pr_
_ELREXFIO_
_TM_
_ (elranatamab injection) _
_Page 2 of 34_
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, are of high quality and possess
an acceptable safety _
_profile based on a benefit/risk assessment. In addition, they either
respond to a serious _
_unmet medical need in Canada