GLN-APREMILAST TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

APREMILAST

Dostępny od:

GLENMARK PHARMACEUTICALS CANADA INC.

Kod ATC:

L04AA32

INN (International Nazwa):

APREMILAST

Dawkowanie:

30MG

Forma farmaceutyczna:

TABLET

Skład:

APREMILAST 30MG

Droga podania:

ORAL

Sztuk w opakowaniu:

15G/50G

Typ recepty:

Prescription

Podsumowanie produktu:

Active ingredient group (AIG) number: 0156231002; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2022-11-14

Charakterystyka produktu

_Pr_
_GLN-APREMILAST (Apremilast Tablets 10 mg, 20 mg, 30 mg) _
_Page 1 of 37_
PRODUCT MONOGRAPH
PR
GLN-APREMILAST
apremilast tablets
10 mg, 20 mg, and 30 mg
Selective Immunosuppressant
Glenmark Pharmaceuticals Canada Inc.
1600 Steeles Ave. West,
Suite 407, Concord, ON
L4K 4M2
Date of Preparation:
August 06, 2021
Submission Control No: 243974
_Pr_
_GLN-APREMILAST (Apremilast Tablets 10 mg, 20 mg, 30 mg) _
_Page 2 of 37_
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
..................................................................................................
7
DRUG INTERACTIONS
................................................................................................
11
DOSAGE AND ADMINISTRATION
.............................................................................
14
OVERDOSAGE..............................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 15
STORAGE AND STABILITY
........................................................................................
18
DOSAGE FORMS, COMPOSITION AND
PACKAGING............................................... 18
PART II: SCIENTIFIC INFORMATION
........................................................................
20
PHARMACEUTICAL INFORMATION
.........................................................................
20
CLINICAL
TRIALS............................................................................