AG-SILDENAFIL TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

SILDENAFIL (SILDENAFIL CITRATE)

Διαθέσιμο από:

ANGITA PHARMA INC.

Φαρμακολογική κατηγορία (ATC):

G04BE03

INN (Διεθνής Όνομα):

SILDENAFIL

Δοσολογία:

25MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

SILDENAFIL (SILDENAFIL CITRATE) 25MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

4

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2022-11-15

Αρχείο Π.Χ.Π.

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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......................................................