SANDOZ AMBRISENTAN TABLETS

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

AMBRISENTAN

Tillgänglig från:

SANDOZ CANADA INCORPORATED

ATC-kod:

C02KX02

INN (International namn):

AMBRISENTAN

Dos:

5MG

Läkemedelsform:

TABLET

Sammansättning:

AMBRISENTAN 5MG

Administreringssätt:

ORAL

Enheter i paketet:

15G/50G

Receptbelagda typ:

Prescription

Produktsammanfattning:

Active ingredient group (AIG) number: 0152452001; AHFS:

Bemyndigande status:

APPROVED

Tillstånd datum:

2022-04-26

Produktens egenskaper

_Sandoz Ambrisentan Tablets_
_ _
_April 20, 2022 _
_ _
_Page 1 of 47_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR SANDOZ AMBRISENTAN TABLETS
Ambrisentan Tablets
Tablets, 5 mg and 10 mg, Oral
Endothelin Receptor Antagonist
Sandoz Canada Inc.
110 rue de Lauzon
Boucherville, Québec
J4B 1E6
Date of Initial Authorization:
April 22, 2022
Submission Control Number: 256552
_ _
_Sandoz Ambrisentan Tablets_
_ _
_April 20, 2022 _
_ _
_Page 2 of 47_
RECENT MAJOR LABEL CHANGES
None at the time of authorization.
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
.....................................................................................
2
TABLE OF CONTENTS
..........................................................................................................
2
PART I: HEALTH PROFESSIONAL
INFORMATION...............................................................
4
1
INDICATIONS..............................................................................................................
4
1.1
Pediatrics (< 18 years of age)
.............................................................................
4
1.2
Geriatrics (≥ 65 years of age)
..............................................................................
4
2
CONTRAINDICATIONS
...............................................................................................
4
4
DOSAGE AND ADMINISTRATION
..............................................................................
4
4.1
Dosing Considerations
........................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
.................................................... 5
4.5
Missed
Dose.......................................................................................................
5
5
OVERDOSAGE
...........................................................................................................
6
6
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
........................ 6
7
WARNINGS AND PRECAUTIONS
........