JAMP NEVIRAPINE TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

NEVIRAPINE

Commercializzato da:

JAMP PHARMA CORPORATION

Codice ATC:

J05AG01

INN (Nome Internazionale):

NEVIRAPINE

Dosaggio:

200MG

Forma farmaceutica:

TABLET

Composizione:

NEVIRAPINE 200MG

Via di somministrazione:

ORAL

Confezione:

60

Tipo di ricetta:

Prescription

Area terapeutica:

NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2013-04-25

Scheda tecnica

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
..................................................................................................