RATIO-SILDENAFIL TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

SILDENAFIL (SILDENAFIL CITRATE)

Dostępny od:

TEVA CANADA LIMITED

Kod ATC:

G04BE03

INN (International Nazwa):

SILDENAFIL

Dawkowanie:

25MG

Forma farmaceutyczna:

TABLET

Skład:

SILDENAFIL (SILDENAFIL CITRATE) 25MG

Droga podania:

ORAL

Sztuk w opakowaniu:

4/8/30/100

Typ recepty:

Prescription

Dziedzina terapeutyczna:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Podsumowanie produktu:

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

Status autoryzacji:

CANCELLED PRE MARKET

Data autoryzacji:

2015-11-25

Charakterystyka produktu

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_ratio-SILDENAFIL Tablets 25 mg, 50 mg and 100 mg _
_Page 1 of 49_
PRODUCT MONOGRAPH
PR
RATIO-SILDENAFIL
Sildenafil Citrate
25 mg, 50 mg and 100 mg of sildenafil (as sildenafil citrate)
Film Coated Tablets
cGMP-Specific Phosphodiesterase Type 5 Inhibitor
Treatment of Erectile Dysfunction
ratiopharm inc.
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
www.tevacanada.com
DATE OF PREPARATION:
NOVEMBER 8, 2012
SUBMISSION CONTROL NO: 121353, 129879, 158416
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_ratio-SILDENAFIL Tablets 25 mg, 50 mg and 100 mg _
_Page 2 of 49_
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
..............................................................................
21
PHARMACEUTICAL INFORMATION
.............................................