TEVA-EFAVIRENZ TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

EFAVIRENZ

Διαθέσιμο από:

TEVA CANADA LIMITED

Φαρμακολογική κατηγορία (ATC):

J05AG03

INN (Διεθνής Όνομα):

EFAVIRENZ

Δοσολογία:

600MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

EFAVIRENZ 600MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

30

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0137031005; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2013-07-30

Αρχείο Π.Χ.Π.

_Page 1 of 54 _
PRODUCT MONOGRAPH
PR
TEVA-EFAVIRENZ
Efavirenz Tablets
600 mg
Teva Standard
Antiretroviral Agent
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Control No.: 280170
Date of Revision:
July 07, 2013
Date of Revision:
January 22, 2024
_Page 2 of 54 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
...................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
.................................................................................................
11
DRUG INTERACTIONS
.................................................................................................
17
DOSAGE AND ADMINISTRATION
.............................................................................
23
OVERDOSAGE
................................................................................................................
24
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 24
STORAGE AND STABILITY
.........................................................................................
31
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 31
PART II: SCIENTIFIC INFORMATION
.............................................................................
33
PHARMACEUTICAL INFORMATION
.........................................................................
33
CLINICAL TRIALS
.........................................................................................................
34
DETAILED PHARMACOLOGY
................................................................................