HANZEMA CAPSULE

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

ALITRETINOIN

Dostopno od:

DR. REDDY'S LABORATORIES INC

Koda artikla:

D11AH04

INN (mednarodno ime):

ALITRETINOIN

Odmerek:

10MG

Farmacevtska oblika:

CAPSULE

Sestava:

ALITRETINOIN 10MG

Pot uporabe:

ORAL

Enote v paketu:

15G/50G

Tip zastaranja:

Prescription

Terapevtsko območje:

MISC. SKIN AND MUCOUS MEMBRANE AGENTS

Povzetek izdelek:

Active ingredient group (AIG) number: 0137581002; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2018-08-20

Lastnosti izdelka

_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
..............................................................