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Mabthera 500 mg Concentrate for Solution for Infusion

NAFDAC Reg. No. A6-0104 · Drug

Registered with NAFDAC. Registration activeAs of 27 October 2026 · synced automatically from official sources.
Product
Mabthera 500 mg Concentrate for Solution for Infusion
NAFDAC number
A6-0104
Active ingredient
Rituximab
Strength
500 mg/50 mL
Form
Concentrate for solution for infusion
Pack size
50 mL x 1's (in vial)
Manufacturer
Not listed
Applicant (holder)
Roche Products Limited
Approved
27 Jun 2024
Status
Active View on NAFDAC ↗
Registration valid to
26 Jun 2029
WHO alerts
None found
Community reports
None
Times checked
0

What we found

  • Mabthera 500 mg Concentrate for Solution for Infusion is on the NAFDAC register with an active registration (A6-0104). 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 Mabthera 500 mg Concentrate for Solution for Infusion is used for

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

Boxed warning: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY See full prescribing information for complete boxed warning. Fatal infusion-related reactions within 24 hours of RITUXAN infusion; approximately 80% of fatal reactions occurred with first infusion. …
What it is used for

RITUXAN is a CD20-directed cytolytic antibody indicated for the treatment of: Adult patients with Non-Hodgkin's Lymphoma (NHL) ( 1.1 ). Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent. Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy. Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy. …

Possible side effects

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Infusion-related reactions [see Warnings and Precautions (5.1) ] Severe mucocutaneous reactions [see Warnings and Precautions (5.2) ] Hepatitis B reactivation with fulminant hepatitis [see Warnings and Precautions (5.3) ] Progressive multifocal leukoencephalopathy [see Warnings and Precautions (5.4) ] Tumor lysis syndrome [see Warnings and Precautions (5.5) ] Infections [see Warnings and Precautions (5.6) ] Cardiovascular adverse reactions [see Warnings and Precautions (5.7) ] Renal toxicity [see Warnings and Precautions (5.8) ] Bowel obstruction and perforation [see Warn …

Do not use if

None. None ( 4 )

Warnings

Tumor lysis syndrome: Administer aggressive intravenous hydration, anti-hyperuricemic agents, monitor renal function ( 5.5 ). Infections: Withhold RITUXAN and institute appropriate anti-infective therapy ( 5.6 ). Cardiac adverse reactions: Discontinue infusions in case of serious or life-threatening events ( 5.7 ). Renal toxicity: Discontinue in patients with rising serum creatinine or oliguria ( 5.8 ). Bowel obstruction and perforation: Consider and evaluate for abdominal pain, vomiting, or related symptoms ( 5.9 ). Immunizations: Live virus vaccinations prior to or during RITUXAN treatment not recommended ( 5.10 ). Embryo-Fetal toxicity: Can cause fetal harm. …

Pregnancy & breastfeeding

8.1 Pregnancy Risk Summary Based on human data, RITUXAN can cause adverse developmental outcomes including B-cell lymphocytopenia in infants exposed to RITUXAN in-utero ( see Clinical Considerations ). In animal reproduction studies, intravenous administration of rituximab to pregnant cynomolgus monkeys during the period of organogenesis caused lymphoid B-cell depletion in the newborn offspring at doses resulting in 80% of the exposure (based on …

Storage

Store RITUXAN vials refrigerated at 2°C to 8°C (36°F to 46°F). RITUXAN vials should be protected from direct sunlight. Do not freeze or shake.

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

Check your pack of Mabthera 500 mg Concentrate for Solution for Infusion

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 Mabthera 500 mg Concentrate for Solution for Infusion

What is in Mabthera 500 mg Concentrate for Solution for Infusion?

Mabthera 500 mg Concentrate for Solution for Infusion contains Rituximab (500 mg/50 mL), as concentrate for solution for infusion, according to its NAFDAC registration record.

Is Mabthera 500 mg Concentrate for Solution for Infusion registered with NAFDAC?

Yes. Mabthera 500 mg Concentrate for Solution for Infusion is listed on the NAFDAC register under registration number A6-0104, and its registration is active as of 27 October 2026.

Has Mabthera 500 mg Concentrate for Solution for Infusion been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Mabthera 500 mg Concentrate for Solution for Infusion in our automatically synced alert list.

How can I check that my pack of Mabthera 500 mg Concentrate for Solution for Infusion is genuine?

Run a free authenticity scan with the NAFDAC number A6-0104, 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 Mabthera 500 mg Concentrate for Solution for Infusion used for?

RITUXAN is a CD20-directed cytolytic antibody indicated for the treatment of: Adult patients with Non-Hodgkin's Lymphoma (NHL) ( 1.1 ). Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent. Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a ritux (Summarised from the official U.S. FDA label for rituximab. Always follow your doctor or pharmacist.)

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