DOM-ATORVASTATIN TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

ATORVASTATIN (ATORVASTATIN CALCIUM)

Διαθέσιμο από:

DOMINION PHARMACAL

Φαρμακολογική κατηγορία (ATC):

C10AA05

INN (Διεθνής Όνομα):

ATORVASTATIN

Δοσολογία:

10MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

ATORVASTATIN (ATORVASTATIN CALCIUM) 10MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

500

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

HMG-COA REDUCTASE INHIBITORS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0133055001; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2019-07-31

Αρχείο Π.Χ.Π.

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PRODUCT MONOGRAPH
PR
DOM-ATORVASTATIN
(Atorvastatin calcium tablets)
10 mg, 20 mg, 40 mg and 80 mg atorvastatin
LIPID METABOLISM REGULATOR
DOMINION PHARMACAL
Date of Revision: July 26, 2016
6111 Royalmount Ave., Suite 100
Montreal, Quebec
H4P 2T4
Submission Control No: 196412
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
5
WARNINGS AND PRECAUTIONS
........................................................................................
5
ADVERSE REACTIONS
.........................................................................................................
10
DRUG INTERACTIONS
.........................................................................................................
13
DOSAGE AND ADMINISTRATION
....................................................................................
18
OVERDOSAGE
.......................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 19
STORAGE AND STABILITY
................................................................................................
22
SPECIAL HANDLING INSTRUCTIONS
..............................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 23
PART II: SCIENTIFIC INFORMATION
...............................................................................24
PHARMACEUTICAL INFORMATION
...................