JAMP PIRFENIDONE TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

PIRFENIDONE

Pieejams no:

JAMP PHARMA CORPORATION

ATĶ kods:

L04AX05

SNN (starptautisko nepatentēto nosaukumu):

PIRFENIDONE

Deva:

801MG

Zāļu forma:

TABLET

Kompozīcija:

PIRFENIDONE 801MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

15G/50G

Receptes veids:

Prescription

Ārstniecības joma:

ANTIFIBROTIC AGENTS

Produktu pārskats:

Active ingredient group (AIG) number: 0153328003; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2021-05-18

Produkta apraksts

_JAMP Pirfenidone (Pirfenidone Tablets) Page 1 of 45 _
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
JAMP PIRFENIDONE
Pirfenidone Tablets
Film coated tablets, 267 mg and 801 mg
Anti-fibrotic / Anti-inflammatory Agent
JAMP Pharma Corporation
1310, rue Nobel
Boucherville, Quebec
Canada, J4B 5H3
Submission Control No: 260317
Date of Initial Authorization:
May 18, 2021
Date of Revision:
June 14, 2022
_JAMP Pirfenidone (Pirfenidone Tablets) Page 2 of 45 _
_ _
RECENT MAJOR LABEL CHANGES
4 Dosage and Administration, 4.2 Recommended Dose and
Dosage Adjustment
[06/2022]
7 Warnings and Precautions
[06/2022]
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
PART I: HEALTH PROFESSIONAL INFORMATION .......................................................... 4
1 INDICATIONS
...............................................................................................................
4
1.1 Pediatrics
............................................................................................................
4
1.2 Geriatrics
...........................................................................................................
4
2 CONTRAINDICATIONS .............................................................................................
4
3 SERIOUS WARNINGS AND PRECAUTIONS BOX ................................................... 4
4 DOSAGE AND ADMINISTRATION ................................................................................
5
4.1 Dosing Considerations
....................................................................................
5
4.2 Recommended Dose and Dosage Adjustment
................................................. 5
4.3.
Reconstitution
..............................................