AG-SILDENAFIL TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

SILDENAFIL (SILDENAFIL CITRATE)

Tersedia dari:

ANGITA PHARMA INC.

Kode ATC:

G04BE03

INN (Nama Internasional):

SILDENAFIL

Dosis:

50MG

Bentuk farmasi:

TABLET

Komposisi:

SILDENAFIL (SILDENAFIL CITRATE) 50MG

Rute administrasi :

ORAL

Unit dalam paket:

4

Jenis Resep:

Prescription

Area terapi:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Ringkasan produk:

Active ingredient group (AIG) number: 0136261002; AHFS:

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2022-11-15

Karakteristik produk

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_AG-SILDENAFIL_
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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
_Pr_
_AG-SILDENAFIL_
_Page 2 of 43_
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......................................................