TEVA-NEVIRAPINE TABLET

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

NEVIRAPINE

Disponibbli minn:

TEVA CANADA LIMITED

Kodiċi ATC:

J05AG01

INN (Isem Internazzjonali):

NEVIRAPINE

Dożaġġ:

200MG

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

NEVIRAPINE 200MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

60/100

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

CANCELLED POST MARKET

Data ta 'l-awtorizzazzjoni:

2018-06-19

Karatteristiċi tal-prodott

1
PRODUCT MONOGRAPH
PR
TEVA-NEVIRAPINE
(NEVIRAPINE)
TABLETS, 200 MG TEVA STANDARD
ANTIRETROVIRAL AGENT
NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR
WITH ACTIVITY AGAINST
HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1)
TEVA CANADA LIMITED
30 NOVOPHARM COURT
TORONTO, ONTARIO
M1B 2K9
Date of Revision: September 11, 2015
CONTROL NUMBER: 187340
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
.................................................................................................
12
DRUG INTERACTIONS
.................................................................................................
18
DOSAGE AND ADMINISTRATION
.............................................................................
29
OVERDOSAGE
...............................................................................................................
31
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 31
STORAGE AND STABILITY
.........................................................................................
34
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 34
PART II: SCIENTIFIC INFORMATION
...............................................................................
35
PHARMACEUTICAL INFORMATION
.........................................................................
35
CLINICAL TRIALS
.........................................................................................................
35
DETAILED PHARMACOLOGY
.............