AURO-APREMILAST TABLET
Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
Tabia za bidhaa
(SPC)
06-01-2022
Hati zingine za bidhaa hii hazipatikani kwa sasa, unaweza kutuma ombi kwa huduma ya wateja wetu na tutakuarifu mara tu tutakapopata.
Tuma ombi.
Tuma ombi.
Viambatanisho vya kazi:
APREMILAST; APREMILAST; APREMILAST
Inapatikana kutoka:
AURO PHARMA INC
ATC kanuni:
L04AA32
INN (Jina la Kimataifa):
APREMILAST
Kipimo:
10MG; 20MG; 30MG
Dawa fomu:
TABLET
Tungo:
APREMILAST 10MG; APREMILAST 20MG; APREMILAST 30MG
Njia ya uendeshaji:
ORAL
Vitengo katika mfuko:
15G/50G
Dawa ya aina:
Prescription
Bidhaa muhtasari:
Active ingredient group (AIG) number: 0356230001; AHFS:
Idhini hali ya:
APPROVED
Idhini ya tarehe:
2022-11-14
Tabia za bidhaa
Page 1 of 34
PRODUCT MONOGRAPH
PR
AURO-APREMILAST
Apremilast Tablets
10 mg, 20 mg, and 30 mg
Selective Immunosuppressant
AURO PHARMA INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada
Date of Preparation:
January 6, 2022
Submission Control No: 245218
Page 2 of 34
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
..........................................................................................................6
DRUG INTERACTIONS
........................................................................................................
10
DOSAGE AND
ADMINISTRATION......................................................................................
12
OVERDOSAGE
.....................................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
.....................................................................
13
STORAGE AND
STABILITY.................................................................................................
16
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................................ 16
PART II: SCIENTIFIC INFORMATION
................................................................................
18
PHARMACEUTICAL
INFORMATION..................................................................................
18
CLINICAL TRIALS
...............................................................................................
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