AG-OLMESARTAN TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

OLMESARTAN MEDOXOMIL

Dostupno od:

ANGITA PHARMA INC.

ATC koda:

C09CA08

INN (International ime):

OLMESARTAN MEDOXOMIL

Doziranje:

20MG

Farmaceutski oblik:

TABLET

Sastav:

OLMESARTAN MEDOXOMIL 20MG

Administracija rute:

ORAL

Jedinice u paketu:

100

Tip recepta:

Prescription

Područje terapije:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Proizvod sažetak:

Active ingredient group (AIG) number: 0152496002; AHFS:

Status autorizacije:

APPROVED

Datum autorizacije:

2018-05-22

Svojstava lijeka

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PRODUCT MONOGRAPH
PR
AG-OLMESARTAN
Olmesartan Medoxomil Tablets
20 mg, and 40 mg
Angiotensin II AT
1
Receptor Blocker
Angita Pharma Inc.
Date of Preparation:
1310 rue Nobel,
May 18, 2018
Boucherville, Quebec
J4B 5H3
Submission Control No.: 214735
_Pr_
_AG-OLMESARTAN_
Page 2 of 24
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.................................................................................................
10
DOSAGE AND
ADMINISTRATION.............................................................................
11
OVERDOSAGE................................................................................................................
13
ACTION AND CLINICAL
PHARMACOLOGY............................................................
13
STORAGE AND
STABILITY.........................................................................................
15
DOSAGE FORMS, COMPOSITION AND
PACKAGING............................................
15
PART II: SCIENTIFIC
INFORMATION...............................................................................
16
PHARMACEUTICAL
INFORMATION.........................................................................
16
CLINICAL
TRIALS.........................................................................................................
16
DETAILED
PHARMACOLOGY.................................................................