CELLCEPT POWDER FOR SUSPENSION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

MYCOPHENOLATE MOFETIL

Dostopno od:

HOFFMANN-LA ROCHE LIMITED

Koda artikla:

L04AA06

INN (mednarodno ime):

MYCOPHENOLIC ACID

Odmerek:

200MG

Farmacevtska oblika:

POWDER FOR SUSPENSION

Sestava:

MYCOPHENOLATE MOFETIL 200MG

Pot uporabe:

ORAL

Enote v paketu:

175 ML

Tip zastaranja:

Prescription

Terapevtsko območje:

IMMUNOSUPPRESSIVE AGENTS

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2000-05-09

Lastnosti izdelka

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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 _
_Page 2 of 85_
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...........................................................