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Sandiummum Neoral 50 mg Capsules

NAFDAC Reg. No. 04-3626 · Drug

Registered with NAFDAC. Registration activeAs of 27 October 2026 · synced automatically from official sources.
Product
Sandiummum Neoral 50 mg Capsules
NAFDAC number
04-3626
Active ingredient
Ciclosporin
Strength
50 mg
Form
Capsule
Pack size
5 x 10's (in blisters)
Manufacturer
Not listed
Applicant (holder)
Novartis Nigeria Limited
Approved
27 May 2021
Status
Inactive View on NAFDAC ↗
Registration valid to
26 May 2026
WHO alerts
None found
Community reports
None
Times checked
0

What we found

  • Sandiummum Neoral 50 mg Capsules is on the NAFDAC register with an active registration (04-3626). A valid number alone does not prove a pack is genuine — counterfeiters copy real numbers, so also check the expiry date, seal and print quality.

Generated automatically from the NAFDAC register, WHO alerts and community data as of today. This is not medical advice. Always follow your doctor or pharmacist.

What Sandiummum Neoral 50 mg Capsules is used for

From the official U.S. FDA label for ciclosporin, the active ingredient registered with NAFDAC.

Boxed warning: Only physicians experienced in management of systemic immunosuppressive therapy for the indicated disease should prescribe cyclosporine capsules, (modified). At doses used in solid organ transplantation, only physicians experienced in immunosuppressive therapy and management of organ transplant recipients should prescribe cyclosporine capsules, (modified). Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. …
What it is used for

Kidney, Liver, and Heart Transplantation Cyclosporine capsules (modified) is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Cyclosporine capsules (modified) has been used in combination with azathioprine and corticosteroids. Rheumatoid Arthritis Cyclosporine capsules (modified) is indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate. Cyclosporine capsules (modified) can be used in combination with methotrexate in rheumatoid arthritis patients who do not respond adequately to methotrexate alone. …

Possible side effects

Kidney, Liver, and Heart Transplantation The principal adverse reactions of cyclosporine therapy are renal dysfunction, tremor, hirsutism, hypertension, and gum hyperplasia. Hypertension Hypertension, which is usually mild to moderate, may occur in approximately 50% of patients following renal transplantation and in most cardiac transplant patients. Glomerular Capillary Thrombosis Glomerular capillary thrombosis has been found in patients treated with cyclosporine and may progress to graft failure. …

Do not use if

General Cyclosporine capsules (modified) is contraindicated in patients with a hypersensitivity to cyclosporine or to any of the ingredients of the formulation. Rheumatoid Arthritis Rheumatoid arthritis patients with abnormal renal function, uncontrolled hypertension, or malignancies should not receive cyclosporine capsules, (modified). …

Warnings

(See also BOXED WARNING ) All Patients Cyclosporine, the active ingredient of cyclosporine capsules, (modified), can cause nephrotoxicity and hepatotoxicity. The risk increases with increasing doses of cyclosporine. Renal dysfunction including structural kidney damage is a potential consequence of cyclosporine capsules (modified) and therefore renal function must be monitored during therapy. Care should be taken in using cyclosporine with nephrotoxic drugs (see PRECAUTIONS). Patients receiving cyclosporine capsules (modified) require frequent monitoring of serum creatinine (see Special Monitoring under DOSAGE AND ADMINISTRATION ). …

Pregnancy & breastfeeding

Pregnancy Risk Summary Available data from published literature, including the Transplant Pregnancy Registry International, observational cohort studies, case-controlled studies, meta-analysis, case series, and case reports, over decades of use with cyclosporine in pregnancy have not identified a drug associated risk of major birth defects, or miscarriage. …

General information only, not dosing advice. Always follow the leaflet in your pack and your doctor or pharmacist.

Check your pack of Sandiummum Neoral 50 mg Capsules

Add the expiry date on your pack for a full Trust Score.

3 free checks left today Official sources: NAFDAC Green Book & recalls · WHO · U.S. FDA · NLM RxNorm

About Sandiummum Neoral 50 mg Capsules

What is in Sandiummum Neoral 50 mg Capsules?

Sandiummum Neoral 50 mg Capsules contains Ciclosporin (50 mg), as capsule, according to its NAFDAC registration record.

Is Sandiummum Neoral 50 mg Capsules registered with NAFDAC?

Yes. Sandiummum Neoral 50 mg Capsules is listed on the NAFDAC register under registration number 04-3626, and its registration is active as of 27 October 2026.

Has Sandiummum Neoral 50 mg Capsules been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Sandiummum Neoral 50 mg Capsules in our automatically synced alert list.

How can I check that my pack of Sandiummum Neoral 50 mg Capsules is genuine?

Run a free authenticity scan with the NAFDAC number 04-3626, your pack's expiry date and batch number to get a Trust Score, compare the pack with the NAFDAC record (ingredient, strength, form, manufacturer), and buy only from licensed pharmacies.

What is Sandiummum Neoral 50 mg Capsules used for?

Kidney, Liver, and Heart Transplantation Cyclosporine capsules (modified) is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Cyclosporine capsules (modified) has been used in combination with azathioprine and corticosteroids. Rheumatoid Arthritis Cyclosporine capsules (modified) is indicated for the treatment of patients with severe active, rheu (Summarised from the official U.S. FDA label for ciclosporin. Always follow your doctor or pharmacist.)

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