MDK-NITISINONE CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
29-11-2017
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Active ingredient:
NITISINONE
Available from:
MENDELIKABS INC
ATC code:
A16AX04
INN (International Name):
NITISINONE
Dosage:
5MG
Pharmaceutical form:
CAPSULE
Composition:
NITISINONE 5MG
Administration route:
ORAL
Units in package:
60
Prescription type:
Prescription
Therapeutic area:
OTHER MISCELLANEOUS THERAPEUTIC AGENTS
Product summary:
Active ingredient group (AIG) number: 0158450002; AHFS:
Authorization status:
APPROVED
Authorization date:
2016-09-20
Summary of Product characteristics
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_Page 1 of 21_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MDK-NITISINONE
Nitisinone capsules
Capsules, 2 mg, 5 mg, 10 mg and 20 mg
ATC CODE: A16AX04
Various alimentary tract and metabolism products
MendeliKABS Inc
4601, rue de Tonnancour
Saint-Hubert (Quebec)
Canada, J3Y 9J3
Date of Revision:
November 29, 2017
Submission Control No: 202740
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_Page 2 of 21_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................3
ADVERSE REACTIONS
....................................................................................................6
DRUG INTERACTIONS
....................................................................................................8
DOSAGE AND ADMINISTRATION
................................................................................9
OVERDOSAGE
................................................................................................................10
ACTION AND CLINICAL PHARMACOLOGY
............................................................10
STORAGE AND STABILITY
..........................................................................................13
SPECIAL HANDLING INSTRUCTIONS
.......................................................................13
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................13
PART II: SCIENTIFIC INFORMATION
...............................................................................15
PHARMACEUTICAL INFORMATION
..........................................................................15
CLINICAL
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