AG-SILDENAFIL TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

SILDENAFIL (SILDENAFIL CITRATE)

Available from:

ANGITA PHARMA INC.

ATC code:

G04BE03

INN (International Name):

SILDENAFIL

Dosage:

25MG

Pharmaceutical form:

TABLET

Composition:

SILDENAFIL (SILDENAFIL CITRATE) 25MG

Administration route:

ORAL

Units in package:

4

Prescription type:

Prescription

Therapeutic area:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Product summary:

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

Authorization status:

CANCELLED POST MARKET

Authorization date:

2022-11-15

Summary of Product characteristics

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PRODUCT MONOGRAPH
PR
AG-SILDENAFIL
sildenafil (as sildenafil citrate) tablets
25 mg, 50 mg and 100 mg
cGMP-Specific Phosphodiesterase Type 5 Inhibitor
Treatment of Erectile Dysfunction
Date of Revision:
August 28, 2018
Angita Pharma Inc.
1310 Nobel Street
Boucherville, Quebec
J4B 5H3
SUBMISSION CONTROL NO.: 214622
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_AG-SILDENAFIL_
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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
DOSAGEAND
ADMINISTRATION...................................................................................
14
OVERDOSAGE
....................................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
................................................................
16
STORAGE AND
STABILITY..............................................................................................
19
SPECIAL HANDLING
INSTRUCTIONS...........................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................
19
PART II: SCIENTIFIC INFORMATION
............................................................................
20
PHARMACEUTICAL
INFORMATION......................................................