ABEVMY SOLUTION

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

BEVACIZUMAB

Disponibbli minn:

BIOSIMILAR COLLABORATIONS IRELAND LIMITED

Kodiċi ATC:

L01FG01

INN (Isem Internazzjonali):

BEVACIZUMAB

Dożaġġ:

100MG

Għamla farmaċewtika:

SOLUTION

Kompożizzjoni:

BEVACIZUMAB 100MG

Rotta amministrattiva:

INTRAVENOUS

Unitajiet fil-pakkett:

15G/50G

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

ANTINEOPLASTIC AGENTS

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0151381001; AHFS:

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2021-11-05

Karatteristiċi tal-prodott

ABEVMY (bevacizumab for injection)
Page
1
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
ABEVMY
®
bevacizumab for injection
100 mg and 400 mg vials (25 mg/mL solution for injection)
Antineoplastic
Manufactured by:
Biosimilar Collaborations Ireland Limited
Unit 35/36, Grange Parade Baldoyle Industrial Estate,
Dublin 13, DUBLIN Ireland D13 R20R
Distributed by:
BGP Pharma ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Initial Approval:
November 05, 2021
Date of Revision:
May 15, 2023
Submission Control No: 273572
ABEVMY (bevacizumab for injection)
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2
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
11/2022
3. SERIOUS WARNINGS AND PRECAUTIONS BOX
11/2022
4. DOSAGE AND ADMINISTRATION; 4.2 Recommended Dose and Dosage
Adjustment
11/2022
7. WARNINGS AND PRECAUTIONS; Hypertension, Proteinuria, CNS
hemorrhage,
Non-CNS hemorrhage, Thrombocytopenia, Neurologic, Wound healing; 7.1.4
Geriatrics
11/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................................
4
1
INDICATIONS
............................................................................................................
4
1.1
Pediatrics
....................................................................................................................
5
1.2
Geriatrics
....................................................................................................................
5
2
CONTRAINDICATIONS
.............................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
................................................... 5
4
DOSAGE AND ADMINISTRATION
............................................................................
6
4.1
Dosing Considerations
...........................................