HANZEMA CAPSULE

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

ALITRETINOIN

Disponible des:

DR. REDDY'S LABORATORIES INC

Codi ATC:

D11AH04

Designació comuna internacional (DCI):

ALITRETINOIN

Dosis:

30MG

formulario farmacéutico:

CAPSULE

Composición:

ALITRETINOIN 30MG

Vía de administración:

ORAL

Unidades en paquete:

30

tipo de receta:

Prescription

Área terapéutica:

MISC. SKIN AND MUCOUS MEMBRANE AGENTS

Resumen del producto:

Active ingredient group (AIG) number: 0137581003; AHFS:

Estat d'Autorització:

APPROVED

Data d'autorització:

2018-08-20

Fitxa tècnica

_Page 1 of 40_
_HANZEMA _
PRODUCT MONOGRAPH
HANZEMA
Alitretinoin
Capsules
10 mg and 30 mg
Immunomodulator
/ Anti-inflammatory agent
DIN OWNER:
DR. REDDY’S LABORATORIES, INC.
Princeton, NJ – 08540 USA
IMPORTED BY:
DR. REDDY’S LABORATORIES CANADA INC.
Mississauga, ON L4W 4Y1 CANADA
Date of Preparation:
June 18, 2018
Date of Revision:
October 20, 2022
SUBMISSION CONTROL NO.: 264229
™
_Page 2 of 40_
_HANZEMA _
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
........................................................................................
12
DRUG INTERACTIONS
........................................................................................
15
DOSAGE AND ADMINISTRATION
.......................................................................
18
OVERDOSAGE
....................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
........................................................ 19
STORAGE AND STABILITY
.................................................................................
22
SPECIAL HANDLING INSTRUCTIONS
................................................................. 22
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 22
PART II: SCIENTIFIC INFORMATION
.......................................................................
23
PHARMACEUTICAL INFORMATION
................................................................... 23
CLINICAL TRIALS
..............................................................