XALATAN SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

LATANOPROST

Dostopno od:

BGP PHARMA ULC

Koda artikla:

S01EE01

INN (mednarodno ime):

LATANOPROST

Odmerek:

50MCG

Farmacevtska oblika:

SOLUTION

Sestava:

LATANOPROST 50MCG

Pot uporabe:

OPHTHALMIC

Enote v paketu:

15G/50G

Tip zastaranja:

Prescription

Terapevtsko območje:

PROSTAGLANDIN ANALOGS

Povzetek izdelek:

Active ingredient group (AIG) number: 0132916001; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2020-05-01

Lastnosti izdelka

_XALATAN (latanoprost) _
_Page 1 of 28_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
XALATAN®
Latanoprost ophthalmic solution
Solution, 50 mcg/mL, Ophthalmic
Prostaglandin F
2α
analogue
BGP Pharma ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Date of Initial Authorization:
JUL 31, 2023
Submission Control Number: 277063
®
Viatris Specialty LLC
BGP Pharma ULC, a Viatris company, Licensee
©
BGP Pharma ULC, 2023
_ _
_XALATAN (latanoprost) _
_Page 2 of 28_
RECENT MAJOR LABEL CHANGES
None at the time of most recent authorization
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................
4
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics
................................................................................................................
4
1.2
Geriatrics
................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
4
DOSAGE AND ADMINISTRATION
.................................................................................
4
4.1
Dosing Considerations
............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
....................................................... 4
4.4
Administration
........................................................................................................
5
4.5
Missed Dose
....................................