GLN-APREMILAST TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

APREMILAST

Dostopno od:

GLENMARK PHARMACEUTICALS CANADA INC.

Koda artikla:

L04AA32

INN (mednarodno ime):

APREMILAST

Odmerek:

30MG

Farmacevtska oblika:

TABLET

Sestava:

APREMILAST 30MG

Pot uporabe:

ORAL

Enote v paketu:

15G/50G

Tip zastaranja:

Prescription

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2022-11-14

Lastnosti izdelka

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