MYLAN-IRBESARTAN HCTZ TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

IRBESARTAN; HYDROCHLOROTHIAZIDE

Disponibil de la:

MYLAN PHARMACEUTICALS ULC

Codul ATC:

C09DA04

INN (nume internaţional):

IRBESARTAN AND DIURETICS

Dozare:

300MG; 25MG

Forma farmaceutică:

TABLET

Compoziție:

IRBESARTAN 300MG; HYDROCHLOROTHIAZIDE 25MG

Calea de administrare:

ORAL

Unități în pachet:

90

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Rezumat produs:

Active ingredient group (AIG) number: 0240086003; AHFS:

Statutul autorizaţiei:

CANCELLED PRE MARKET

Data de autorizare:

2016-11-02

Caracteristicilor produsului

1
PRODUCT MONOGRAPH
PR MYLAN-IRBESARTAN HCTZ
Irbesartan and Hydrochlorothiazide Tablets
150/12.5 mg, 300/12.5 mg and 300/25 mg
Manufacturer’s Standard
Angiotensin II AT
1
Receptor Blocker / Diuretic
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Submission Control No.: 189365
Date of Revision: November 24, 2015
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
5
ADVERSE REACTIONS
...........................................................................................................
9
DRUG INTERACTIONS
.........................................................................................................
14
DOSAGE AND ADMINISTRATION
.....................................................................................
20
OVERDOSAGE
.......................................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 22
STORAGE AND STABILITY
.................................................................................................
26
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 26
PART II: SCIENTIFIC INFORMATION
...............................................................................
27
PHARMACEUTICAL INFORMATION
.................................................................................
27
CLINICAL TRIALS
.......................................................