TPOXX CAPSULE

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

TECOVIRIMAT (TECOVIRIMAT MONOHYDRATE)

Commercializzato da:

SIGA TECHNOLOGIES, INC.

Codice ATC:

J05AX24

INN (Nome Internazionale):

TECOVIRIMAT

Dosaggio:

200MG

Forma farmaceutica:

CAPSULE

Composizione:

TECOVIRIMAT (TECOVIRIMAT MONOHYDRATE) 200MG

Via di somministrazione:

ORAL

Confezione:

15G/50G

Tipo di ricetta:

Prescription

Area terapeutica:

MISCELLANEOUS ANTIVIRALS

Dettagli prodotto:

Active ingredient group (AIG) number: 0163279001; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2021-11-29

Scheda tecnica

_ _
_TPOXX_
_®_
_ Tecovirimat capsules _
_Page 1 of 29_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
TPOXX
®
Tecovirimat Capsules
Capsules, 200 mg tecovirimat (as tecovirimat monohydrate), Oral
Antiviral Agent (ATC: J05AX24)
“HEALTH CANADA HAS AUTHORIZED THE SALE OF THIS EXTRAORDINARY
USE NEW DRUG FOR TREATMENT OF HUMAN SMALLPOX DISEASE IN
ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 13KG BASED ON
LIMITED CLINICAL TESTING IN HUMANS”
Sponsor:
SIGA Technologies, Inc.
Date of Initial Authorization:
4575 Research Way, Ste. 110 NOV 29, 2021
Corvallis, OR 97333
USA
Distributor: Date of Revision:
Innomar Strategies, Inc OCT 18, 2023
Oakville, ON L6L 0C4
Submission Control No: 269158
_ _
_TPOXX_
_®_
_ Tecovirimat capsules _
_Page 2 of 29_
RECENT MAJOR LABEL CHANGES
Dosage and Administration, Recommended Dose and Dosage Adjustment
(4.2)
10/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
_ _
_TPOXX_
_®_
_ Tecovirimat capsules _
_Page 3 of 29_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................5
1.
INDICATIONS
.............................................................................................................5
1.1.
Pediatrics
.....................................................................................................................5
1.2.
Geriatrics
.....................................................................................................................5
2.
CONTRAINDICATIONS
............................................................................................5
4
DOSAGE AND ADMINISTRATION
........................................................................6
4.1
Dosing Considerations
..............................................................................................6
4.2
Recommended Dose and Dosage Adjustment
.....................................................6
4.4
Administration
................................