Ikervis Santen Oy · Authorised · authorised 19 Mar 2015 · ATC S01XA18
Therapeutic indication (EMA)
Treatment of severe keratitis in adult patients with dry eye disease, which has not improved despite treatment with tear substitutes.
Active substance
Ciclosporin
- SFDA 14
- US FDA 41
- EMA 5
- Health Canada 14
- US price lines 16
- NHS prices 7
- WHO EML 1
- Safety 6
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| CLASGEN | 0.5 mg/ml | Eye drops · Ophthalmic use | 30 Single Dose Container | SAR 91.10 | Generic · Prescription | Amman Pharmaceutical Industries (API) | Valid |
| Effyren | 25 mg | Capsule, hard · Oral use | 30 Blister | SAR 72.95 | Generic · Prescription | Panacea Biotec Pharma Ltd | Valid |
| RESTASIS 0.05% Eye Drop Emulsion | 0.05 % | Eye drops, emulsion · Ophthalmic use | 30 Vial | SAR 101.20 | NCE · Prescription | AbbVie Inc | Valid |
| SANDIMMUN 50MG-ML AMPULE | 50 mg/ml | Concentrate for solution for infusion · Intravenous use | 1 Ampoule | SAR 124.70 | NCE · Prescription | NOVARTIS PHARMA AG | Valid |
| SANDIMMUN CONC.FOR INFUSIN 250MG-5ML | 50 mg/ml | Concentrate for solution for infusion · Intravenous use | 10 Vial | SAR 531.35 | NCE · Prescription | NOVARTIS PHARMA AG | Valid |
| SANDIMMUN NEORAL 100MG CAPS | 100 mg | Capsule · Oral use | 50 Blister | SAR 646.20 | NCE · Prescription | NOVARTIS PHARMA AG | Valid |
| SANDIMMUN NEORAL 25MG CAPS | 25 mg | Capsule · Oral use | 50 Blister | SAR 161.60 | NCE · Prescription | NOVARTIS PHARMA AG | Valid |
| SANDIMMUN NEORAL 50MG CAP | 50 mg | Capsule · Oral use | 50 Blister | SAR 290.90 | NCE · Prescription | NOVARTIS PHARMA AG | Valid |
| SANDIMMUN NEORAL DRINK 100MG-ML | 100 mg/ml | Oral solution · Oral use | 1 Bottle | SAR 706.85 | NCE · Prescription | NOVARTIS PHARMA AG | Valid |
| VERKAZIA | 1 mg/ml | Eye drops, emulsion · Ocular use | 120 Single Dose Container | SAR 1324.95 | NCE · Prescription | Santen Oy | Valid |
| GENGRAF 100 MG MODIFIED CAPSULE | 100 mg | Modified-release capsule, soft · Oral use | 30 Blister | SAR 374.70 | NCE · Prescription | Abbott Laboratories | Withdrawn by MAH · Not Marketed |
| GENGRAF 25MG MODIFIED CAPSULE | 25 mg | Modified-release capsule, soft · Oral use | 30 Blister | SAR 97.95 | NCE · Prescription | Abbott Laboratories | Withdrawn by MAH · Not Marketed |
| SANDIMMUN 50MG-ML AMPULE | 50 mg/ml | Concentrate for solution for infusion · Intravenous use | 1 Ampoule | SAR 161.95 | NCE · Prescription | NOVARTIS | Withdrawn by MAH · Not Marketed |
| SANDIMMUN CONC.FOR INFUSIN 250MG-5ML | 50 mg/ml | Concentrate for solution for infusion · Intravenous use | 10 Vial | SAR 591.55 | NCE · Prescription | NOVARTIS | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
ALLERGIC CONJUCTIVITIS (AC); KERATITIS, ADENOVIRAL CONJUNCTIVITIS; SJOGREN'S SYNDROME
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| SANDIMMUNE | 50MG/ML | injectable · injection | NOVARTIS | Prescription | 14 Nov 1983 |
| SANDIMMUNE | 100MG/ML | solution · oral | NOVARTIS | Prescription | 14 Nov 1983 |
| SANDIMMUNE | 25MG; 100MG; 50MG | capsule · oral | NOVARTIS | Prescription | 2 Mar 1990 |
| NEORAL | 25MG; 100MG | capsule · oral | NOVARTIS | Prescription | 14 Jul 1995 |
| NEORAL | 100MG/ML | solution · oral | NOVARTIS | Prescription | 14 Jul 1995 |
| NEORAL | 25MG; 100MG | capsule · oral | NOVARTIS | Prescription | 22 May 1997 |
| NEORAL | 25MG; 100MG | capsule · oral | NOVARTIS | Prescription | 22 May 1997 |
| NEORAL | 25MG; 100MG | capsule · oral | NOVARTIS | Prescription | 19 Jun 1997 |
| NEORAL | 25MG; 100MG | capsule · oral | NOVARTIS | Prescription | 19 Jun 1997 |
| CYCLOSPORINE | 50MG/ML | injectable · injection | HIKMA PHARMS | Prescription | 29 Oct 1999 |
| CYCLOSPORINE | 100MG; 25MG | capsule · oral | SANDOZ | Prescription | 13 Jan 2000 |
| GENGRAF | 25MG; 100MG | capsule · oral | ABBVIE | Prescription | 12 May 2000 |
| CYCLOSPORINE | 100MG; 25MG | capsule · oral | DR REDDYS LABS SA | Prescription | 20 Dec 2000 |
| CYCLOSPORINE | 25MG; 100MG | capsule · oral | APOTEX | Prescription | 9 May 2002 |
| RESTASIS | 0.05% | emulsion · ophthalmic | ABBVIE | Prescription | 23 Dec 2002 |
| RESTASIS MULTIDOSE | 0.05% | emulsion · ophthalmic | ABBVIE | Prescription | 23 Dec 2002 |
| RESTASIS | 0.05% | emulsion · ophthalmic | ALLERGAN | Prescription | 10 Oct 2003 |
| CYCLOSPORINE | 100MG/ML | solution · oral | IVAX SUB TEVA PHARMS | Prescription | 25 Mar 2005 |
| CYCLOSPORINE | 50MG; 100MG; 25MG | capsule · oral | IVAX SUB TEVA PHARMS | Prescription | 29 Mar 2005 |
| CEQUA | 0.09% | solution · ophthalmic | SUN PHARM | Prescription | 14 Aug 2018 |
| CYCLOSPORINE | 25MG; 50MG; 100MG | capsule · oral | APOTEX | Prescription | 10 Jul 2019 |
| VERKAZIA | 0.1% | emulsion · ophthalmic | HARROW EYE | Prescription | 23 Jun 2021 |
| CYCLOSPORINE | 0.05% | emulsion · ophthalmic | MYLAN | Prescription | 2 Feb 2022 |
| CYCLOSPORINE | 25MG; 50MG; 100MG | capsule · oral | ONESOURCE | Prescription | 2 Aug 2022 |
| VEVYE | 0.1% | solution · ophthalmic | HARROW EYE | Prescription | 30 May 2023 |
16 more — full table
EMA European Union — centrally authorised medicines
Verkazia Santen Oy · Authorised · authorised 6 Jul 2018 · ATC S01XA18
Therapeutic indication (EMA)
Treatment of severe vernal keratoconjunctivitis (VKC) in children from 4 years of age and adolescents.
Vevizye Laboratoires Théa · Authorised · authorised 19 Sep 2024 · ATC S01XA18
Therapeutic indication (EMA)
Treatment of moderate to severe dry eye disease (keratoconjunctivitis sicca) in adult patients, which has not improved despite treatment with tear substitutes.
Vekacia Novagali Pharma S.A. · Application withdrawn
Restaysis Allergan Pharmaceuticals International Limited · Application withdrawn · ATC S01XA18
Therapeutic indication (EMA)
For the treatment of moderate dry eye disease in adults.
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| CEQUA | 02512629 | 0.09 % / W/V | SOLUTION · OPHTHALMIC | SUN PHARMACEUTICAL INDUSTRIES LIMITED |
| NEORAL | 02150662 | 50 MG | CAPSULE · ORAL | NOVARTIS PHARMACEUTICALS CANADA INC |
| NEORAL | 02150670 | 100 MG | CAPSULE · ORAL | NOVARTIS PHARMACEUTICALS CANADA INC |
| NEORAL | 02150689 | 25 MG | CAPSULE · ORAL | NOVARTIS PHARMACEUTICALS CANADA INC |
| NEORAL | 02150697 | 100 MG / ML | SOLUTION · ORAL | NOVARTIS PHARMACEUTICALS CANADA INC |
| NEORAL | 02237671 | 10 MG | CAPSULE · ORAL | NOVARTIS PHARMACEUTICALS CANADA INC |
| RESTASIS | 02355655 | 0.05 % / W/V | EMULSION · OPHTHALMIC | ABBVIE CORPORATION |
| RESTASIS MULTIDOSE | 02476835 | 0.05 % / W/V | EMULSION · OPHTHALMIC | ABBVIE CORPORATION |
| SANDIMMUNE I.V. | 00593257 | 50 MG / ML | SOLUTION · INTRAVENOUS | NOVARTIS PHARMACEUTICALS CANADA INC |
| SANDOZ CYCLOSPORINE | 02242821 | 100 MG | CAPSULE · ORAL | SANDOZ CANADA INCORPORATED |
| SANDOZ CYCLOSPORINE | 02247073 | 25 MG | CAPSULE · ORAL | SANDOZ CANADA INCORPORATED |
| SANDOZ CYCLOSPORINE | 02247074 | 50 MG | CAPSULE · ORAL | SANDOZ CANADA INCORPORATED |
| TEVA-CYCLOSPORINE | 02462486 | 0.05 % / W/V | EMULSION · OPHTHALMIC | TEVA CANADA LIMITED |
| VERKAZIA | 02484137 | 0.1 % / W/V | EMULSION · OPHTHALMIC | APOTEX INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | CEQUA 0.09% SOLUTION | $10.38279 | per EA | 23 Sep 2026 |
| US NADAC | CYCLOSPORINE 0.05% EYE EMULSION | $1.18033 | per EA | 23 Sep 2026 |
| US NADAC | CYCLOSPORINE 0.05% EYE EMULSION | $0.90945 | per EA | 23 Sep 2026 |
| US NADAC | CYCLOSPORINE 100 MG CAPSULE | $7.50676 | per EA | 23 Sep 2026 |
| US NADAC | CYCLOSPORINE 25 MG CAPSULE | $2.5957 | per EA | 23 Sep 2026 |
| US NADAC | CYCLOSPORINE MODIFIED 100 MG | $1.23348 | per EA | 23 Sep 2026 |
| US NADAC | CYCLOSPORINE MODIFIED 100 MG/ML | $2.03685 | per ML | 23 Sep 2026 |
| US NADAC | CYCLOSPORINE MODIFIED 25 MG | $0.31377 | per EA | 23 Sep 2026 |
| US NADAC | CYCLOSPORINE MODIFIED 50 MG | $0.76459 | per EA | 23 Sep 2026 |
| US NADAC | GENGRAF 25 MG CAPSULE | $1.86549 | per EA | 2 Jan 2026 |
| US NADAC | NEORAL 100 MG GELATIN CAPSULE | $11.7731 | per EA | 8 Jul 2026 |
| US NADAC | NEORAL 25 MG GELATIN CAPSULE | $2.94566 | per EA | 8 Jul 2026 |
| NHS Drug Tariff | Ciclosporin 100mg capsules | £68.28 | 30 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Ciclosporin 100mg/ml oral solution sugar free | £102.30 | 50 ml | 1 Oct 2026 |
| NHS Drug Tariff | Ciclosporin 10mg capsules | £18.25 | 60 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Ciclosporin 1mg/ml eye drops 0.3ml unit dose | £72.00 | 30 unit dose | 1 Oct 2026 |
| NHS Drug Tariff | Ciclosporin 25mg capsules | £18.37 | 30 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Ciclosporin 50mg capsules | £35.97 | 30 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Ciclosporin 900micrograms/ml eye drops 0.25ml unit dose preservative free | £64.80 | 60 unit dose | 1 Oct 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.
WHO WHO Model List of Essential Medicines (2025)
- 8.1. Immunomodulators for non-malignant disease · complementary
Failure or rejection of transplanted organs or tissues
Parenteral > General injections > IV: 50 mg per mL in 1 mL ampoule concentrate for injection | Oral > Liquid: 100 mg per mL (EMLc) | Oral > Solid > capsule: 25 mg
Safety signals and safety-related labeling changes
- US FDA 6 Mar 2026 SANDIMMUNE — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations - US FDA 6 Mar 2026 SANDIMMUNE — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations - US FDA 6 Mar 2026 SANDIMMUNE — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations - US FDA 26 Sep 2023 NEORAL — safety-related labeling change
Labeling sections changed: Warnings and Precautions - US FDA 26 Sep 2023 NEORAL — safety-related labeling change
Labeling sections changed: Warnings and Precautions - US FDA 18 Jul 2017 RESTASIS — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
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.