AURO-NEVIRAPINE TABLET

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

NEVIRAPINE

Saadav alates:

AURO PHARMA INC

ATC kood:

J05AG01

INN (Rahvusvaheline Nimetus):

NEVIRAPINE

Annus:

200MG

Ravimvorm:

TABLET

Koostis:

NEVIRAPINE 200MG

Manustamisviis:

ORAL

Ühikuid pakis:

15G/50G

Retsepti tüüp:

Prescription

Terapeutiline ala:

NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

Toote kokkuvõte:

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

Volitamisolek:

APPROVED

Loa andmise kuupäev:

2010-11-16

Toote omadused

_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
.................................