AG-NIFEDIPINE ER TABLET (EXTENDED-RELEASE)

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

NIFEDIPINE

Saatavilla:

ANGITA PHARMA INC.

ATC-koodi:

C08CA05

INN (Kansainvälinen yleisnimi):

NIFEDIPINE

Annos:

60MG

Lääkemuoto:

TABLET (EXTENDED-RELEASE)

Koostumus:

NIFEDIPINE 60MG

Antoreitti:

ORAL

Kpl paketissa:

15G/50G

Prescription tyyppi:

Prescription

Terapeuttinen alue:

DIHYDROPYRIDINES

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0115253005; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2021-01-27

Valmisteyhteenveto

AG-Nifedipine ER
1
PRODUCT MONOGRAPH
PR
AG-NIFEDIPINE ER
Nifedipine Extended Release Tablets USP
60 mg
Antianginal/Antihypertensive Agent
Angita Pharma Inc.
1310 rue Nobel
Boucherville, Québec
J4B 5H3
Date of Revision:
January 21, 2021
Submission Control No.: 247279
AG-Nifedipine ER
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSION-AL 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
...........................................................................................
17
OVERDOSAGE
..............................................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................
18
STORAGE AND STABILITY
.......................................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................................ 21
PART II: SCIENTIFIC INFORMATION
.......................................................................................
23
PHARMACEUTICAL INFORMATION
.....................................................................................
23
CLINICAL TRIALS
......................