AURO-NEVIRAPINE TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

NEVIRAPINE

Tersedia dari:

AURO PHARMA INC

Kode ATC:

J05AG01

INN (Nama Internasional):

NEVIRAPINE

Dosis:

200MG

Bentuk farmasi:

TABLET

Komposisi:

NEVIRAPINE 200MG

Rute administrasi :

ORAL

Unit dalam paket:

15G/50G

Jenis Resep:

Prescription

Area terapi:

NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

Ringkasan produk:

Active ingredient group (AIG) number: 0134602001; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2010-11-16

Karakteristik produk

_Page 1 of 55_
PRODUCT MONOGRAPH
PR
AURO-NEVIRAPINE
Nevirapine Tablets USP
200 MG
ANTIRETROVIRAL AGENT
NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR
WITH ACTIVITY AGAINST
HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1)
AURO PHARMA INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8, CANADA
www.auropharma.ca
SUBMISSION CONTROL NO.: 242225 DATE OF PREPARATION:
November 16, 2020
_Page 2 of 55_
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
...........................................................................................14
DRUG INTERACTIONS
...........................................................................................20
DOSAGE AND ADMINISTRATION
.......................................................................32
OVERDOSAGE
.........................................................................................................33
ACTION AND CLINICAL PHARMACOLOGY
.....................................................34
STORAGE AND STABILITY
...................................................................................36
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................36
PART II: SCIENTIFIC INFORMATION
...............................................................................38
PHARMACEUTICAL INFORMATION
....................................................................38
CLINICAL TRIALS
....................................................................................................39
DETAILED PHARMACOLOGY
.................................