MYCOPHENOLIC ACID TABLET (ENTERIC-COATED)

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

MYCOPHENOLIC ACID (MYCOPHENOLATE SODIUM)

Tillgänglig från:

JAMP PHARMA CORPORATION

ATC-kod:

L04AA06

INN (International namn):

MYCOPHENOLIC ACID

Dos:

360MG

Läkemedelsform:

TABLET (ENTERIC-COATED)

Sammansättning:

MYCOPHENOLIC ACID (MYCOPHENOLATE SODIUM) 360MG

Administreringssätt:

ORAL

Enheter i paketet:

15G/50G

Receptbelagda typ:

Prescription

Terapiområde:

IMMUNOSUPPRESSIVE AGENTS

Produktsammanfattning:

Active ingredient group (AIG) number: 0150521002; AHFS:

Bemyndigande status:

APPROVED

Tillstånd datum:

2021-08-06

Produktens egenskaper

_JAMP Mycophenolic Acid (Mycophenolic Acid Enteric-Coated Tablets)
Product Monograph Page 1 of 39 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
JAMP MYCOPHENOLIC ACID
Mycophenolic Acid Enteric-Coated Tablets
Enteric-Coated Tablets, 180 mg and 360 mg mycophenolic acid (as
mycophenolate sodium), Oral
Manufacturer’s Standard
Immunosuppressant
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Quebec
Canada, J4B 5H3
Date of Initial Authorization:
MAR 14, 2024
Submission Control Number: 261977
_JAMP Mycophenolic Acid (Mycophenolic Acid Enteric-Coated Tablets)
Product Monograph Page 2 of 39 _
RECENT MAJOR LABEL CHANGES
None at the time of authorisation
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
........