NAT-VALGANCICLOVIR TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

VALGANCICLOVIR (VALGANCICLOVIR HYDROCHLORIDE)

Saatavilla:

NATCO PHARMA (CANADA) INC

ATC-koodi:

J05AB14

INN (Kansainvälinen yleisnimi):

VALGANCICLOVIR

Annos:

450MG

Lääkemuoto:

TABLET

Koostumus:

VALGANCICLOVIR (VALGANCICLOVIR HYDROCHLORIDE) 450MG

Antoreitti:

ORAL

Kpl paketissa:

60

Prescription tyyppi:

Prescription

Terapeuttinen alue:

NUCLEOSIDES AND NUCLEOTIDES

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0147203001; AHFS:

Valtuutuksen tilan:

CANCELLED PRE MARKET

Valtuutus päivämäärä:

2021-05-14

Valmisteyhteenveto

_NAT-VALGANCICLOVIR_ Page 1 of 58_ _
PRODUCT MONOGRAPH
Pr
NAT-VALGANCICLOVIR
Valganciclovir Film Coated Tablets
450 mg (as valganciclovir hydrochloride)
Manufacturer’s Standard
Antiviral Agent
Natco Pharma (Canada) Inc.
2550 Argentia Rd, Suite 116
Mississauga, Ontario
L5N 5R1
Date of Preparation:
June 30, 2017
Submission Control No: 184251
_NAT-VALGANCICLOVIR_ Page 2 of 58_ _
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
........................................................................................................
8
DRUG INTERACTIONS
......................................................................................................
19
DOSAGE AND ADMINISTRATION
..................................................................................
23
OVERDOSAGE
....................................................................................................................
25
ACTION AND CLINICAL PHARMACOLOGY
................................................................ 26
STORAGE AND STABILITY
..............................................................................................
29
SPECIAL HANDLING INSTRUCTIONS
...........................................................................
29
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................. 29
PART II: SCIENTIFIC INFORMATION
....................................................................................
30
PHARMACEUTICAL INFORMATION
.......................