SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|
| ACTEMRA 162 mg/0.9 ml solution for injection in pre-filled syringe | 180 mg/ml | Solution for injection · Subcutaneous use | 4 Pre-filled syringe | SAR 3613.10 | NCE · Prescription | ROCHE | Valid |
| ACTEMRA 20 MG/ML Solution for injection/infusion | 20 mg/ml | Solution for infusion · Intravenous use | 1 Vial | SAR 2936.40 | NCE · Prescription | ROCHE | Valid |
| ACTEMRA 20 MG/ML Solution for injection/infusion | 20 mg/ml | Solution for infusion · Intravenous use | 1 Vial | SAR 1468.20 | NCE · Prescription | ROCHE | Valid |
| ACTEMRA 20 MG/ML Solution for injection/infusion | 20 mg/ml | Solution for infusion · Intravenous use | 1 Vial | SAR 587.30 | NCE · Prescription | ROCHE | Valid |
| Tyenne | 162 mg | Solution for injection · Subcutaneous use | 1 Pre-filled pen | SAR 1003.70 | Biological · Prescription | Boston Oncology Arabia | Valid |
| Tyenne 162 mg per 0.9 ml | 180 mg/ml | Solution for injection · Subcutaneous use | 4 Pre-filled syringe | SAR 3345.45 | Biological · Prescription | Boston Oncology Arabia | Valid |
| Tyenne 200 mg per 10 ml | 20 mg/ml | Solution for infusion · Intravenous use | 1 Vial | SAR 1366.80 | Biological · Prescription | Boston Oncology Arabia | Valid |
| Tyenne 400 mg per 20 ml | 20 mg/ml | Solution for infusion · Intravenous use | 1 Vial | SAR 2703.60 | Biological · Prescription | Boston Oncology Arabia | Valid |
| Tyenne 80 me per 4 ml | 20 mg/ml | Solution for infusion · Intravenous use | 1 Vial | SAR 554.70 | Biological · Prescription | Boston Oncology Arabia | Valid |
Indications — CHI Daman Drug Formulary
CASTLEMAN DISEASE; JUVENILE POLYARTHRITIS; NON-INFECTIOUS UVEITIS; RHEUMATOID ARITHRITIS; SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| ACTEMRA | 80MG/4ML; 200MG/10ML; 400MG/20ML | injectable · injection | GENENTECH | Prescription | 8 Jan 2010 |
| ACTEMRA | 162MG/0.9ML | injectable · intravenous, subcutaneous | GENENTECH | Prescription | 21 Oct 2013 |
| TOFIDENCE | 80MG/4ML; 200MG/10ML; 400MG/20ML | injectable · injection | BIOGEN MA | Prescription | 29 Sep 2023 |
| TYENNE | 80MG/4ML; 200MG/10ML; 400MG/20ML | injectable · intravenous | FRESENIUS KABI USA | Prescription | 5 Mar 2024 |
| AVTOZMA | 80MG/4ML(20MG/ML); 200MG/10ML(20MG/ML); 400MG/20ML(20MG/ML) | injectable · intravenous | CELLTRION INC | Prescription | 24 Jan 2025 |
| AVTOZMA | 162MG/0.9ML | injectable · subcutaneous | CELLTRION INC | Prescription | 24 Jan 2025 |
| TYENNE | 162MG/0.9ML | injectable · subcutaneous | FRESENIUS KABI USA | Prescription | 14 Mar 2025 |
| AVTOZMA | 80MG/4ML(20MG/ML); 200MG/10ML(20MG/ML); 400MG/20ML(20MG/ML) | injectable · iv (infusion) | CELLTRION INC | Prescription | 21 Jan 2026 |
| AVTOZMA | 162MG/20ML(20MG/ML) | injectable · subcutaneous | CELLTRION INC | Prescription | 21 Jan 2026 |
EMA European Union — centrally authorised medicines
RoActemra Roche Registration GmbH · Authorised · authorised 16 Jan 2009 · ATC L04AC07
Therapeutic indication (EMA)
RoActemra, in combination with methotrexate (MTX), is indicated for the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX. the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. In these patients, RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. RoActemra has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate. RoActemra is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 1 year of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. RoActemra can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX. RoActemra in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX. RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. RoActemra is indicated for the treatment of Giant Cell Arteritis (GCA) in adult patients. RoActemra, in combination with methotrexate (MTX), is indicated for: the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX. the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. In these patients, RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. RoActemra has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate. RoActemra is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. RoActemra is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 2 years of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. RoActemra can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX. RoActemra in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX. RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. RoActemra is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 2 years of age and older. RoActemra, in combination with methotrexate (MTX), is indicated for: the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX. the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. In these patients, RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. RoActemra has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate. RoActemra is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. RoActemra is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 2 years of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. RoActemra can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX. RoActemra in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX. RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. RoActemra is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 2 years of age and older.
Tyenne Fresenius Kabi Deutschland GmbH · Authorised · authorised 15 Sep 2023 · ATC L04AC07
Therapeutic indication (EMA)
Tyenne, in combination with methotrexate (MTX), is indicated for the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX. the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. In these patients, Tyenne can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Tocilizumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate. Tyenne is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. Tyenne is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 1 year of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. Tyenne can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX. Tyenne in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX.Tyenne can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Tyenne is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 2 years of age and older. Tyenne is indicated for the treatment of Giant Cell Arteritis (GCA) in adult patients.
Therapeutic indication (EMA)
Rheumatoid arthritis (RA): - the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with methotrexate (MTX) (monotherapy or in combination with MTX). - the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumor necrosis factor (TNF) antagonists (monotherapy or in combination with MTX). Coronavirus disease 2019 (COVID-19): the treatment of coronavirus disease 2019 (COVID-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. Polyarticular juvenile idiopathic arthritis (pJIA): the treatment of juvenile idiopathic polyarthritis (PJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX (monotherapy or in combination with MTX). Systemic juvenile idiopathic arthritis (sJIA): the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 2 years of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids (monotherapy or in combination with MTX).
Avtozma Celltrion Healthcare Hungary Kft. · Authorised · authorised 14 Feb 2025 · ATC L04AC07
Therapeutic indication (EMA)
Avtozma, in combination with methotrexate (MTX), is indicated for: the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX. the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. In these patients, Avtozma can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Avtozma has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate. Avtozma is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. Avtozma is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 2 years of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. Avtozma can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX. Avtozma in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX. Avtozma can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Avtozma is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 2 years of age and older. Avtozma, in combination with methotrexate (MTX), is indicated for the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX. the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. In these patients, Avtozma can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Avtozma has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate. Avtozma is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 1 year of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. Avtozma can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX. Avtozma in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX. Avtozma can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Avtozma is indicated for the treatment of Giant Cell Arteritis (GCA) in adult patients. Avtozma, in combination with methotrexate (MTX), is indicated for the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX. the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. In these patients, Avtozma can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Avtozma has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate. Avtozma is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 12 years of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids (see Section 4.2). Avtozma can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX. Avtozma in combination with methotrexate (MTX) is indicated for thetreatment of juvenile idiopathic polyarthritis (pJIA; rheumatoidfactor positive or negative and extended oligoarthritis) in patients 12 years of age and older, who have responded inadequately to previous therapy with MTX (see Section4.2). Avtozma can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Avtozma is indicated for the treatment of Giant Cell Arteritis (GCA) in adult patients.
Tuyory Chemical Works of Gedeon Richter Plc. (Gedeon Richter Plc.) · Authorised · authorised 27 Apr 2026 · ATC L04AC07
Therapeutic indication (EMA)
Rheumatoid arthritis (RA) Tuyory, in combination with methotrexate (MTX), is indicated for:- the treatment of severe, active and progressive RA in adults not previously treated with MTX.- the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease- modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists.In these patients, Tuyory can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.Tocilizumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate. Coronavirus disease 2019 (COVID-19) Tuyory is indicated for the treatment of COVID-19 in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. Systemic juvenile idiopathic arthritis (sJIA) Tuyory is indicated for the treatment of active sJIA in patients 1 year of age and older, who have responded inadequately to previous therapy with non-steroidal anti-inflammatory drugs (NSAIDs) and systemic corticosteroids. Tuyory can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX.Polyarticular juvenile idiopathic arthritis (pJIA) Tuyory in combination with MTX is indicated for the treatment of pJIA (rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX. Tuyory can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.Cytokine release syndrome (CRS) Tuyory is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening CRS in adults and paediatric patients 2 years of age and older. Giant cell arteritis (GCA) Tuyory is indicated for the treatment of GCA in adult patients.
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|
| ACTEMRA | 02350092 | 80 MG / 4 ML | SOLUTION · INTRAVENOUS | HOFFMANN-LA ROCHE LIMITED |
| ACTEMRA | 02350106 | 200 MG / 10 ML | SOLUTION · INTRAVENOUS | HOFFMANN-LA ROCHE LIMITED |
| ACTEMRA | 02350114 | 400 MG / 20 ML | SOLUTION · INTRAVENOUS | HOFFMANN-LA ROCHE LIMITED |
| ACTEMRA | 02424770 | 162 MG / 0.9 ML | SOLUTION · SUBCUTANEOUS | HOFFMANN-LA ROCHE LIMITED |
| ACTEMRA | 02483327 | 162 MG / 0.9 ML | SOLUTION · SUBCUTANEOUS | HOFFMANN-LA ROCHE LIMITED |
| AVTOZMA | 02562022 | 80 MG / 4 ML | SOLUTION · INTRAVENOUS | CELLTRION INC. |
| AVTOZMA | 02562030 | 200 MG / 10 ML | SOLUTION · INTRAVENOUS | CELLTRION INC. |
| AVTOZMA | 02562049 | 400 MG / 20 ML | SOLUTION · INTRAVENOUS | CELLTRION INC. |
| AVTOZMA | 02562057 | 162 MG / 0.9 ML | SOLUTION · SUBCUTANEOUS | CELLTRION INC. |
| AVTOZMA | 02562065 | 162 MG / 0.9 ML | SOLUTION · SUBCUTANEOUS | CELLTRION INC. |
| TYENNE | 02552450 | 80 MG / 4 ML | SOLUTION · INTRAVENOUS | FRESENIUS KABI CANADA LTD |
| TYENNE | 02552469 | 200 MG / 10 ML | SOLUTION · INTRAVENOUS | FRESENIUS KABI CANADA LTD |
| TYENNE | 02552477 | 400 MG / 20 ML | SOLUTION · INTRAVENOUS | FRESENIUS KABI CANADA LTD |
| TYENNE | 02552485 | 162 MG / 0.9 ML | SOLUTION · SUBCUTANEOUS | FRESENIUS KABI CANADA LTD |
| TYENNE | 02552493 | 162 MG / 0.9 ML | SOLUTION · SUBCUTANEOUS | FRESENIUS KABI CANADA LTD |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|
| US NADAC | TYENNE 162 MG/0.9 ML AUTOINJCT | $820.99658 | per ML | 23 Sep 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.