MYLAN-TADALAFIL TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

TADALAFIL

Disponibil de la:

MYLAN PHARMACEUTICALS ULC

Codul ATC:

G04BE08

INN (nume internaţional):

TADALAFIL

Dozare:

20MG

Forma farmaceutică:

TABLET

Compoziție:

TADALAFIL 20MG

Calea de administrare:

ORAL

Unități în pachet:

4/30

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Rezumat produs:

Active ingredient group (AIG) number: 0149485002; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2016-07-12

Caracteristicilor produsului

_ _
_Page 1 of 52_
PRODUCT MONOGRAPH
PR MYLAN-TADALAFIL
Tadalafil Tablets, USP
2.5 mg, 5 mg Tablets (for _Once-a-day _use),
10 mg, 20 mg Tablets (for _“On-Demand” _dosing)
cGMP-Specific Phosphodiesterase Type 5 Inhibitor
TREATMENT OF ERECTILE DYSFUNCTION (ED)
TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH)
TREATMENT OF ERECTILE DYSFUNCTION AND
BENIGN PROSTATIC HYPERPLASIA (ED/BPH)
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Revision:
February 7, 2017
Submission Control No: 201793
_ _
_Page 2 of 52_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
8
DRUG INTERACTIONS
.................................................................................................
12
DOSAGE AND ADMINISTRATION
.............................................................................
15
OVERDOSAGE
...............................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 17
STORAGE AND STABILITY
.........................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 23
PART II: SCIENTIFIC INFORMATION
...............................................................................
24
PHARMACEUTICAL INFORMATION
...........................................