TREMFYA #N/A

Riik: Lõuna-Aafrika Vabariik

keel: inglise

Allikas: South African Health Products Regulatory Authority (SAHPRA)

Saadav alates:

Janssen Pharmaceutica (Pty) Ltd

Annus:

See ingredients

Ravimvorm:

#N/A

Koostis:

EACH 1,0 ml SOLUTION CONTAINS GUSELKUMAB 100,0 mg

Volitamisolek:

Registered

Infovoldik

Applicant: JANSSEN PHARMACEUTICA (PTY) LTD
Product Proprietary Name: TREMFYA
® (52/30.1/0400)
Dosage form and strength: Solution for injection; 100 mg Guselkumab
per 1 mL
Approved : 29 February 2024
Reference number: RA/2020/05/305cp
Submission type:
:
ECTD SEQ0005: EXTENSION OF INDICATION TO INCLUDE PSORIATIC ARTHRITIS
(PSA) IN ADULT PATIENTS; AND 5-
YEAR PSORIASIS LONG-TERM DATA
___________________________________________________________________________________
CCDS versions: 9; 12, 13 & 14 (EU SmPC, Jan 2022)
Page 1 of 31
PATIENT INFORMATION LEAFLET (PIL)
.
TREMFYA
® 100 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE AND/OR PRE-FILLED
PEN
Guselkumab
Contains sugar (sucrose).
Each 1 mL of Tremfya 100 mg dose contains 79 mg sucrose.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING TREMFYA
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other
health care provider.
•
TREMFYA has been prescribed for you personally and you should not
share your
medicine with other people. It may harm them, even if their symptoms
are the same
as yours.
WHAT IS IN THIS LEAFLET
1.
What TREMFYA is and what it is used for
2.
What you need to know before you use TREMFYA
3.
How to use TREMFYA
4.
Possible side effects
5.
How to store TREMFYA
6.
Contents of the pack and other information
SCHEDULING STATUS
Schedule 4
29 February 2024
Applicant: JANSSEN PHARMACEUTICA (PTY) LTD
Product Proprietary Name: TREMFYA
® (52/30.1/0400)
Dosage form and strength: Solution for injection; 100 mg Guselkumab
per 1 mL
Approved : 29 February 2024
Reference number: RA/2020/05/305cp
Submission type:
:
ECTD SEQ0005: EXTENSION OF INDICATION TO INCLUDE PSORIATIC ARTHRITIS
(PSA) IN ADULT PATIENTS; AND 5-
YEAR PSORIASIS LONG-TERM DATA
___________________________________________________________________________________
CCDS versions: 9; 12, 13 & 14 (EU SmPC, Jan 2022)
Page 2 of 31
1.
WHAT TREMFYA IS AND WHAT IT IS USED FOR
TREMFYA contains the active substance guselkuma

Toote omadused

Applicant: JANSSEN PHARMACEUTICA (PTY) LTD
Product Proprietary Name: TREMFYA
® (52/30.1/0400)
Dosage form and strength: Solution for subcutaneous injection; 100 mg
Guselkumab in 1 mL
Approved February 2024
Reference number: RA/2022/05/305cp
Submission type: ECTD SEQ0005: EXTENSION OF INDICATION TO INCLUDE
PSORIATIC ARTHRITIS (PSA) IN ADULT
PATIENTS; AND 5-YEAR PSORIASIS LONG-TERM DATA
______________________________________________________________________________
CCDS versions 9; 12, 13 & 14 (EU SmPC, Jan 2022)
Page 1 of 20
PROFESSIONAL INFORMATION (PI)
1.
NAME OF THE MEDICINE
TREMFYA
®
100 mg solution for injection in pre-filled syringe.
TREMFYA
®
100 mg solution for injection in pre-filled pen.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
TREMFYA 100 mg solution for injection in pre-filled syringe.
Each pre-filled syringe contains 100 mg of guselkumab in 1 mL
solution.
TREMFYA 100 mg solution for injection in pre-filled pen
Each pre-filled pen contains 100 mg of guselkumab in 1 mL solution.
For the full list of excipients, see section 6.1.
Contains sugar (sucrose).
Each 1 mL of TREMFYA 100 mg dose contains 79 mg sucrose.
Guselkumab is a fully human immunoglobulin G1 lamda (IgG1λ)
monoclonal antibody
(mAb) to the interleukin (IL)-23 protein, produced in Chinese Hamster
Ovary (CHO) cells
by recombinant DNA technology.
SCHEDULING STATUS
Schedule 4
29 February 2024
Applicant: JANSSEN PHARMACEUTICA (PTY) LTD
Product Proprietary Name: TREMFYA
® (52/30.1/0400)
Dosage form and strength: Solution for subcutaneous injection; 100 mg
Guselkumab in 1 mL
Approved : February 2024
Reference number RA/2022/05/305cp
Submission type: ECTD SEQ0005: EXTENSION OF INDICATION TO INCLUDE
PSORIATIC ARTHRITIS (PSA) IN ADULT
PATIENTS; AND 5-YEAR PSORIASIS LONG-TERM DATA
______________________________________________________________________________
CCDS versions 9, 12,13 & 14 (EU SmPC, Jan 2022)
Page 2 of 20
3.
PHARMACEUTICAL FORM
TREMFYA is a clear, colourless to light yellow solution for
subcutaneous injection.
TREMFYA is essentially