RIVA-TADALAFIL TABLET

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

TADALAFIL

Verfügbar ab:

LABORATOIRE RIVA INC.

ATC-Code:

G04BE08

INN (Internationale Bezeichnung):

TADALAFIL

Dosierung:

2.5MG

Darreichungsform:

TABLET

Zusammensetzung:

TADALAFIL 2.5MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

100

Verschreibungstyp:

Prescription

Therapiebereich:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Produktbesonderheiten:

Active ingredient group (AIG) number: 0149485003; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2022-11-25

Fachinformation

_RIVA-TADALAFIL - Product Monograph _
_Page 1 of 48_
PRODUCT MONOGRAPH
PR
RIVA-TADALAFIL
Tadalafil Tablets, USP
2.5 mg, 5 mg tablets (for _Once-a-Day_ use)
10 mg, 20 mg tablets (for _“On-Demand”_ dosing)
cGMP-Specific Phosphodiesterase Type 5 Inhibitor
TREATMENT OF ERECTILE DYSFUNCTION (ED)
LABORATOIRE RIVA INC.
660 Boul. Industriel
Blainville, Quebec
J7C 3V4
www.labriva.com
Submission Control No.: 269361
DATE OF INITIAL APPROVAL:
JUL 12, 2016
DATE
OF REVISION:
NOV
23, 2022
_RIVA-TADALAFIL - Product Monograph _
_Page 2 of 48_
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
.................................................................................................
10
DOSAGE AND ADMINISTRATION
.............................................................................
13
OVERDOSAGE
...............................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 15
STORAGE AND STABILITY
.........................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 20
PART II: SCIENTIFIC INFORMATION
...............................................................................
22
PHARMACEUTICAL INFORMATION
..........................................