PRIVA-SILDENAFIL TABLET

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

SILDENAFIL (SILDENAFIL CITRATE)

Beschikbaar vanaf:

NORA PHARMA INC

ATC-code:

G04BE03

INN (Algemene Internationale Benaming):

SILDENAFIL

Dosering:

25MG

farmaceutische vorm:

TABLET

Samenstelling:

SILDENAFIL (SILDENAFIL CITRATE) 25MG

Toedieningsweg:

ORAL

Eenheden in pakket:

4/8

Prescription-type:

Prescription

Therapeutisch gebied:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Product samenvatting:

Active ingredient group (AIG) number: 0136261001; AHFS:

Autorisatie-status:

CANCELLED PRE MARKET

Autorisatie datum:

2022-07-29

Productkenmerken

PRODUCT MONOGRAPH
PR
PRIVA-SILDENAFIL
Sildenafil Citrate Tablets
25 mg, 50 mg, and 100 mg
,
cGMP-Specific Phosphodiesterase Type 5 Inhibitor
Treatment of Erectile Dysfunction
NORA PHARMA INC.
1565, Lionel-Boulet Boul.
Varennes, Quebec
J3X 1P7
Control #: 264224
Date
of
Preparation:
June 10, 2022
_Priva-SILDENAFIL_
Page 2 of 55
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...................................................................................................
7
DRUG
INTERACTIONS....................................................................................................
11
DOSAGE AND
ADMINISTRATION................................................................................
14
OVERDOSAGE..................................................................................................................
15
ACTION AND CLINICAL
PHARMACOLOGY..............................................................
16
STORAGE AND
STABILITY...........................................................................................
19
DOSAGE FORMS, COMPOSITION AND
PACKAGING...............................................
19
PART II: SCIENTIFIC
INFORMATION.........................................................................
20
PHARMACEUTICAL
INFORMATION...........................................................................
20
CLINICAL
TRIALS...........................................................................................................
21
DETAILED
PHARMACOLOGY.................................