PAXLOVID TABLET

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

RITONAVIR; NIRMATRELVIR

Disponível em:

PFIZER CANADA ULC

Código ATC:

J05AE30

DCI (Denominação Comum Internacional):

NIRMATRELVIR AND RITONAVIR

Dosagem:

100MG; 150MG

Forma farmacêutica:

TABLET

Composição:

RITONAVIR 100MG; NIRMATRELVIR 150MG

Via de administração:

ORAL

Unidades em pacote:

15G/50G

Tipo de prescrição:

Prescription

Resumo do produto:

Active ingredient group (AIG) number: 0263338001; AHFS:

Status de autorização:

APPROVED

Data de autorização:

2022-01-17

Características técnicas

_ _
_PAXLOVID_
_TM_
_ (nirmatrelvir; ritonavir) Product Monograph _
_Page 1 of 56 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
PAXLOVID™
nirmatrelvir tablets; ritonavir tablets
Tablets, 150 mg nirmatrelvir; 100 mg ritonavir
co-packaged for oral use
Protease Inhibitor
Antiviral
Pfizer Canada ULC
17300 Trans-Canada Highway
Kirkland, Quebec H9J 2M5
Date of Initial Authorization:
January 17, 2022
Date of Revision:
January 2, 2024
Submission Control Number: 278009
_ _
_PAXLOVID_
_TM_
_ (nirmatrelvir; ritonavir) Product Monograph _
_Page 2 of 56 _
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
06/2023
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
06/2022
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations, 4.2
Recommended Dose and Dosage Adjustment
06/2022
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
06/2022
7 WARNINGS AND PRECAUTIONS
08/2023
7 WARNINGS AND PRECAUTIONS, Immune
11/2023
7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female
and Male Potential
08/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
TABLE OF CONTENTS
............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1
INDICATIONS
.............................................................................................................
4
1.1
Pediatrics
..................................................................................................................
4
1.2
Geriatrics
..................................................................................................................
4
2
CONTRAINDICATIONS
................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................... 8
4
DOSAGE AND ADMINISTRATION
..........................................................