MYLAN-NIFEDIPINE EXTENDED RELEASE TABLET (EXTENDED-RELEASE)

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

NIFEDIPINE

Disponível em:

MYLAN PHARMACEUTICALS ULC

Código ATC:

C08CA05

DCI (Denominação Comum Internacional):

NIFEDIPINE

Dosagem:

60MG

Forma farmacêutica:

TABLET (EXTENDED-RELEASE)

Composição:

NIFEDIPINE 60MG

Via de administração:

ORAL

Unidades em pacote:

100

Tipo de prescrição:

Prescription

Área terapêutica:

DIHYDROPYRIDINES

Resumo do produto:

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

Status de autorização:

APPROVED

Data de autorização:

2009-03-04

Características técnicas

_MYLAN-NEFIDIPINE EXTENDED RELEASE _
_Page 1 of 51_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
MYLAN-NIFEDIPINE EXTENDED RELEASE
Nifedipine Extended-Release Tablets
Extended-Release Tablets, 30 mg and 60 mg, Oral
USP
Antianginal / Antihypertensive Agent
Mylan Pharmaceuticals ULC
Date of Initial Authorization:
85 Advance Road
December 30, 2008
Etobicoke, ON
M8Z 2S6
Date of Revision:
January 24, 2024
Submission Control Number: 278098
_ _
_MYLAN-NEFIDIPINE EXTENDED RELEASE _
_Page 2 of 51_
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
01/2024
2 CONTRAINDICATIONS
01/2024
4.2 Recommended Dose and Dosage Adjustment
01/2024
4.5 Missed Dose
01/2024
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................
4
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics
................................................................................................................
4
1.2
Geriatrics
................................................................................................................
5
2
CONTRAINDICATIONS
.................................................................................................
5
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1
Dosing Considerations
............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
....................................................... 5
4.4
Administration
...............................................