BOSENTAN TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

BOSENTAN (BOSENTAN MONOHYDRATE)

Saatavilla:

ACTELION PHARMACEUTICALS LTD

ATC-koodi:

C02KX01

INN (Kansainvälinen yleisnimi):

BOSENTAN

Annos:

125MG

Lääkemuoto:

TABLET

Koostumus:

BOSENTAN (BOSENTAN MONOHYDRATE) 125MG

Antoreitti:

ORAL

Kpl paketissa:

56

Prescription tyyppi:

Prescription

Terapeuttinen alue:

VASODILATING AGENTS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0145922002; AHFS:

Valtuutuksen tilan:

CANCELLED PRE MARKET

Valtuutus päivämäärä:

2018-09-28

Valmisteyhteenveto

_ _
PRODUCT MONOGRAPH
Pr
BOSENTAN
BOSENTAN monohydrate (film coated) tablet
BOSENTAN 62.5, 125 mg
Professed standard
Endothelin Receptor Antagonist
Actelion Pharmaceuticals Ltd.
Allschwil, Switzerland
www.actelion.com
Actelion Pharmaceuticals Canada Inc.
2550 Daniel-Johnson Blvd., Suite 701
Laval, Quebec
H7T 2L1
Date of Revision:
May 9, 2017
Submission Control No.: 203871
2_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................8
DRUG INTERACTIONS
..................................................................................................15
DOSAGE AND ADMINISTRATION
..............................................................................18
OVERDOSAGE
................................................................................................................19
ACTION AND CLINICAL PHARMACOLOGY
............................................................19
STORAGE AND STABILITY
..........................................................................................21
SPECIAL HANDLING INSTRUCTIONS
.......................................................................21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................21
PART II: SCIENTIFIC INFORMATION
...............................................................................23
PHARMACEUTICAL INFORMATION
..........................................................................23
CLINICAL TRIALS
...