JAMP NEVIRAPINE TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

NEVIRAPINE

Disponible des:

JAMP PHARMA CORPORATION

Codi ATC:

J05AG01

Designació comuna internacional (DCI):

NEVIRAPINE

Dosis:

200MG

formulario farmacéutico:

TABLET

Composición:

NEVIRAPINE 200MG

Vía de administración:

ORAL

Unidades en paquete:

60

tipo de receta:

Prescription

Área terapéutica:

NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

Resumen del producto:

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

Estat d'Autorització:

APPROVED

Data d'autorització:

2013-04-25

Fitxa tècnica

PRODUCT MONOGRAPH
PR
JAMP NEVIRAPINE
Nevirapine Tablets, USP
200 mg
ANTIRETROVIRAL AGENT
NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR
WITH ACTIVITY AGAINST
HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1)
JAMP PHARMA CORPORATION
1310 rue Nobel
Boucherville, Québec
J4B 5H3 DATE OF REVISION:
February 27, 2019
SUBMISSION CONTROL NO.: 224516
_JAMP NEVIRAPINE Product Monograph _
_Page 2 of 53_
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
..................................................................................................19
DOSAGE AND ADMINISTRATION
..............................................................................31
OVERDOSAGE
................................................................................................................33
ACTION AND CLINICAL PHARMACOLOGY
............................................................34
STORAGE AND STABILITY
..........................................................................................36
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................36
PART II: SCIENTIFIC INFORMATION
...............................................................................37
PHARMACEUTICAL INFORMATION
..........................................................................37
CLINICAL TRIALS
..................................................................................................