JAMP BRIMONIDINE/TIMOLOL SOLUTION

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

BRIMONIDINE TARTRATE; TIMOLOL (TIMOLOL MALEATE)

Saatavilla:

JAMP PHARMA CORPORATION

ATC-koodi:

S01ED51

INN (Kansainvälinen yleisnimi):

TIMOLOL, COMBINATIONS

Annos:

0.2%; 0.5%

Lääkemuoto:

SOLUTION

Koostumus:

BRIMONIDINE TARTRATE 0.2%; TIMOLOL (TIMOLOL MALEATE) 0.5%

Antoreitti:

OPHTHALMIC

Kpl paketissa:

15G/50G

Prescription tyyppi:

Prescription

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0249643001; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2023-04-11

Valmisteyhteenveto

_JAMP Brimonidine / Timolol (Brimonidine Tartrate and Timolol Maleate
Ophthalmic Solution) _
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_Page 1 of 31_
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
JAMP BRIMONIDINE / TIMOLOL
Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution
Solution, Brimonidine tartrate 0.2% / Timolol (as Timolol maleate)
0.5%, for ophthalmic use
Relatively Selective α2-adrenoceptor Agonist and β-adrenergic
Blocking Agent
(ATC Code: S01ED51)
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Date of Initial Authorization:
October 4, 2022
Submission Control Number: 259975
_JAMP Brimonidine / Timolol (Brimonidine Tartrate and Timolol Maleate
Ophthalmic Solution) _
_ _
_Page 2 of 31_
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RECENT MAJOR LABEL CHANGES
None at the time of the 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 a