OFEV CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

NINTEDANIB (NINTEDANIB ESILATE)

Available from:

BOEHRINGER INGELHEIM (CANADA) LTD LTEE

ATC code:

L01EX09

INN (International Name):

NINTEDANIB

Dosage:

100MG

Pharmaceutical form:

CAPSULE

Composition:

NINTEDANIB (NINTEDANIB ESILATE) 100MG

Administration route:

ORAL

Units in package:

60

Prescription type:

Prescription

Therapeutic area:

ANTIFIBROTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0157030001; AHFS:

Authorization status:

APPROVED

Authorization date:

2015-06-25

Summary of Product characteristics

_Product Monograph _
_ _
_OFEV (nintedanib) _
_Page 1 of 54_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
OFEV
®
Nintedanib
Capsules, 100 mg and 150 mg, Orally Ingested
Protein Kinase Inhibitor
Anti-fibrotic/Anti-inflammatory Agent
Boehringer Ingelheim (Canada) Ltd.
5180 South Service Road
Burlington, ON L7L 5H4
www.boehringer-ingelheim.ca
Date of Initial Authorization:
JUN 25 2015
Date of Revision:
JUL 5, 2021
Submission Control Number: 249336
BICL 0286-21
Ofev
®
is a registered trademark of Boehringer Ingelheim International GmbH,
used under
license
_Product Monograph _
_ _
_OFEV (nintedanib) _
_Page 2 of 54_
RECENT MAJOR LABEL CHANGES
1 Indication
05/2020
4 Dosing and Administration; 4.1 Dosing Considerations
11/2019
4 Dosage and Administration; 4.2 Recommended Dose and Dosage
Adjustment
11/2019
4 Dosage and Administration; 4.4 Administration
07/2021
7 Warnings and Precautions
06/2021
7 Warnings and Precautions; 7.1.1 Pregnant Women
11/2019
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
1
INDICATIONS
................................................................................................................4
1.1
Pediatrics
............................................................................................................4
1.2
Geriatrics.............................................................................................................4
2
CONTRAINDICATIONS
...................................................................................................4
4
DOSAGE AND
ADMINISTRATION...................................................................................4
4.1
Dosing Considerations
....................................................................