AG-SILDENAFIL TABLET

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

SILDENAFIL (SILDENAFIL CITRATE)

Доступна з:

ANGITA PHARMA INC.

Код атс:

G04BE03

ІПН (Міжнародна Ім'я):

SILDENAFIL

Дозування:

25MG

Фармацевтична форма:

TABLET

Склад:

SILDENAFIL (SILDENAFIL CITRATE) 25MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

4

Тип рецепту:

Prescription

Терапевтична области:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Огляд продуктів:

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

Статус Авторизація:

CANCELLED POST MARKET

Дата Авторизація:

2022-11-15

Характеристики продукта

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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
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_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......................................................