AG-SIMVASTATIN TABLET

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

SIMVASTATIN

Disponibbli minn:

ANGITA PHARMA INC.

Kodiċi ATC:

C10AA01

INN (Isem Internazzjonali):

SIMVASTATIN

Dożaġġ:

80MG

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

SIMVASTATIN 80MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

100

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

HMG-COA REDUCTASE INHIBITORS

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0122415005; AHFS:

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2018-08-15

Karatteristiċi tal-prodott

_Page 1 of 47 _
_AG-Simvastatin (simvastatin) tablets _
PR
AG-
SIMVASTATIN
Simvastatin Tablets, USP
5 mg, 10 mg, 20 mg, 40 mg and 80 mg
Lipid Metabolism Regulator
Angita Pharma Inc
1310 rue Nobel
Boucherville, Québec,
Canada J4B 5H3
PRODUCT MONOGRAPH
Submission
Control
No: 265942
Date
of
Revision:
August 04,
2022
_Page 2 of 47 _
_AG-Simvastatin (simvastatin) tablets _
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
..................................................................................................
12
DRUG INTERACTIONS
...................................................................................................
15
DOSAGE AND ADMINISTRATION
...............................................................................
19
OVERDOSAGE
.................................................................................................................
21
ACTION AND CLINICAL
PHARMACOLOGY..............................................................
21
STORAGE AND
STABILITY
............................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................. 22
PART II: SCIENTIFIC INFORMATION
.................................................................................
23
PHARMACEUTICAL INFORMATION
...........................................................................
23
CLINICAL
TRIALS.......................................................................................