MYLAN-CLOPIDOGREL TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

CLOPIDOGREL (CLOPIDOGREL BISULFATE)

Commercializzato da:

MYLAN PHARMACEUTICALS ULC

Codice ATC:

B01AC04

INN (Nome Internazionale):

CLOPIDOGREL

Dosaggio:

75MG

Forma farmaceutica:

TABLET

Composizione:

CLOPIDOGREL (CLOPIDOGREL BISULFATE) 75MG

Via di somministrazione:

ORAL

Confezione:

100/500

Tipo di ricetta:

Prescription

Area terapeutica:

PLATELET AGGREGATION INHIBITORS

Dettagli prodotto:

Active ingredient group (AIG) number: 0134440001; AHFS:

Stato dell'autorizzazione:

CANCELLED POST MARKET

Data dell'autorizzazione:

2018-03-09

Scheda tecnica

1
PRODUCT MONOGRAPH
Pr
MYLAN-CLOPIDOGREL
Clopidogrel Tablets
75 mg and 300 mg clopidogrel, as clopidogrel bisulfate
USP
Platelet Aggregation Inhibitor
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Submission Control No.: 202677
Date of Revision: February 28, 2017
2
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
.........................................................................................................8
DRUG INTERACTIONS
.......................................................................................................17
DOSAGE AND ADMINISTRATION
...................................................................................21
OVERDOSAGE
......................................................................................................................22
ACTION AND CLINICAL PHARMACOLOGY
.................................................................22
STORAGE AND STABILITY
...............................................................................................26
SPECIAL HANDLING INSTRUCTIONS
............................................................................27
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................27
PART II: SCIENTIFIC INFORMATION
.............................................................................28
PHARMACEUTICAL INFORMATION
...............................................................................28
CLINICAL TRIALS
.....................................