MYLAN-LATANOPROST/TIMOLOL SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

TIMOLOL (TIMOLOL MALEATE); LATANOPROST

Dostopno od:

MYLAN PHARMACEUTICALS ULC

Koda artikla:

S01ED51

INN (mednarodno ime):

TIMOLOL, COMBINATIONS

Odmerek:

5MG; 50MCG

Farmacevtska oblika:

SOLUTION

Sestava:

TIMOLOL (TIMOLOL MALEATE) 5MG; LATANOPROST 50MCG

Pot uporabe:

OPHTHALMIC

Enote v paketu:

15G/50G

Tip zastaranja:

Prescription

Terapevtsko območje:

BETA-ADRENERGIC AGENTS

Povzetek izdelek:

Active ingredient group (AIG) number: 0248501001; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2020-05-11

Lastnosti izdelka

_MYLAN-LATANOPROST/TIMOLOL (latanoprost and timolol) _
_Page 1 of 36_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MYLAN-LATANOPROST/TIMOLOL
Latanoprost and timolol ophthalmic solution
Solution, latanoprost 50 mcg/mL and timolol 5 mg/mL as timolol
maleate, Ophthalmic
Prostaglandin F
2α
Analogue and Beta-adrenergic Receptor Blocker
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Date of Initial Authorization:
NOV 16, 2023
Submission Control Number: 279765
© 2023 Mylan Pharmaceuticals ULC, a Viatris company.
_ _
_MYLAN-LATANOPROST/TIMOLOL (latanoprost and timolol) _
_Page 2 of 36_
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
........................................................ 5
4.4
Administration
...............