CELLCEPT POWDER FOR SUSPENSION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

MYCOPHENOLATE MOFETIL

Tersedia dari:

HOFFMANN-LA ROCHE LIMITED

Kode ATC:

L04AA06

INN (Nama Internasional):

MYCOPHENOLIC ACID

Dosis:

200MG

Bentuk farmasi:

POWDER FOR SUSPENSION

Komposisi:

MYCOPHENOLATE MOFETIL 200MG

Rute administrasi :

ORAL

Unit dalam paket:

175 ML

Jenis Resep:

Prescription

Area terapi:

IMMUNOSUPPRESSIVE AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0128158003; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2000-05-09

Karakteristik produk

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_CELLCEPT® mycophenolate mofetil _
_Page 1 of 85_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
CELLCEPT
®
mycophenolate mofetil
Capsules – 250 mg
Film-Coated Tablets – 500 mg
Powder for Oral Suspension – 200 mg/mL (when reconstituted)
PR
CELLCEPT
®
I.V.
mycophenolate mofetil for injection (as hydrochloride) – 500 mg/vial
Manufacturer’s Standard
Immunosuppressive Agent
Hoffmann-La Roche Ltd.
7070 Mississauga Road
Mississauga, Ontario
L5N 5M8
Date of Initial Authorization:
December 31, 1995
Date of Revision:
July 8, 2021
Submission Control Number: 248429
www.rochecanada.com
CellCept
®
is a registered trade-mark of Syntex Pharm AG, used under license
©
Copyright 1995-2021, Hoffmann-La Roche Limited.
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_CELLCEPT® mycophenolate mofetil _
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RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Immune
06-2021
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
.....................................................................
5
1
INDICATIONS
..............................................................................................................
5
1.1
Pediatrics
..........................................................................................................
5
1.2
Geriatrics...........................................................................................................
5
2
CONTRAINDICATIONS
.................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND
ADMINISTRATION...........................................................