INVIRASE - CAP 200MG CAPSULE

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

SAQUINAVIR (SAQUINAVIR MESYLATE)

Commercializzato da:

HOFFMANN-LA ROCHE LIMITED

Codice ATC:

J05AE01

INN (Nome Internazionale):

SAQUINAVIR

Dosaggio:

200MG

Forma farmaceutica:

CAPSULE

Composizione:

SAQUINAVIR (SAQUINAVIR MESYLATE) 200MG

Via di somministrazione:

ORAL

Confezione:

270

Tipo di ricetta:

Prescription

Area terapeutica:

HIV PROTEASE INHIBITORS

Dettagli prodotto:

Active ingredient group (AIG) number: 0128571001; AHFS:

Stato dell'autorizzazione:

CANCELLED POST MARKET

Data dell'autorizzazione:

2018-12-31

Scheda tecnica

PRODUCT MONOGRAPH
Pr
INVIRASE
®
Saquinavir capsules 200 mg
(as saquinavir mesylate)
Saquinavir film-coated tablets 500mg
(as saquinavir mesylate)
Pharmaceutical standard professed
HIV Protease Inhibitor / Antiretroviral Agent
Hoffmann-La Roche Limited
7070 Mississauga Road
Mississauga, Ontario
L5N 5M8
www.rochecanada.com
Date of Revision:
March 25, 2020
Submission Control No: 235283
®
INVIRASE is a registered trade-mark of Hoffmann-La Roche Limited
©
Copyright 1996–2020 Hoffmann-La Roche Limited
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................6
ADVERSE REACTIONS
..................................................................................................11
DRUG INTERACTIONS
..................................................................................................16
DOSAGE AND ADMINISTRATION
..............................................................................31
OVERDOSAGE
................................................................................................................32
ACTION AND CLINICAL PHARMACOLOGY
............................................................32
STORAGE AND STABILITY
..........................................................................................39
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................39
PART II: SCIENTIFIC INFORMATION
...............................................................................41
PHARMACEUTICAL INFORMATION
....................................................