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Actemra 80 mg

NAFDAC Reg. No. A6-100068 · Drug

Registered with NAFDAC. Registration activeAs of 27 October 2026 · synced automatically from official sources.
Product
Actemra 80 mg
NAFDAC number
A6-100068
Active ingredient
Tocilizumab
Strength
80 mg/4 mL
Form
Concentrate for solution for infusion
Pack size
4 mL x 1’s; 4 mL x 4’s (in vials)
Manufacturer
Not listed
Applicant (holder)
Roche Products Limited
Approved
18 Dec 2022
Status
Active View on NAFDAC ↗
Registration valid to
17 Dec 2027
WHO alerts
None found
Community reports
None
Times checked
0

What we found

  • Actemra 80 mg is on the NAFDAC register with an active registration (A6-100068). 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 Actemra 80 mg is used for

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

Boxed warning: RISK OF SERIOUS INFECTIONS Patients treated with tocilizumab products including TOFIDENCE are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) , Adverse Reactions (6.1) ]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt TOFIDENCE until the infection is controlled. …
What it is used for

TOFIDENCE™ (tocilizumab-bavi) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: Rheumatoid Arthritis (RA) ( 1.1 ) Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs). Giant Cell Arteritis (GCA) ( 1.2 ) Adult patients with giant cell arteritis. Polyarticular Juvenile Idiopathic Arthritis (PJIA) ( 1.3 ) Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis. Systemic Juvenile Idiopathic Arthritis (SJIA) ( 1.4 ) Patients 2 years of age and older with active systemic juvenile idiopathic arthritis. …

Possible side effects

The following serious adverse reactions are described elsewhere in labeling: Serious Infections [see Warnings and Precautions (5.1) ] Gastrointestinal Perforations [see Warnings and Precautions (5.2) ] Laboratory Parameters [see Warnings and Precautions (5.4) ] Immunosuppression [see Warnings and Precautions (5.5) ] Hypersensitivity Reactions, Including Anaphylaxis [see Warnings and Precautions (5.6) ] Demyelinating Disorders [see Warnings and Precautions (5.7) ] Active Hepatic Disease and Hepatic Impairment [see Warnings and Precautions (5.8) ] Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be …

Do not use if

TOFIDENCE is contraindicated in patients with known hypersensitivity to tocilizumab products [see Warnings and Precautions (5.6) ]. Known hypersensitivity to tocilizumab products. ( 4 )

Warnings

Serious Infections – do not administer TOFIDENCE during an active infection, including localized infections. If a serious infection develops, interrupt TOFIDENCE until the infection is controlled. ( 5.1 ) Gastrointestinal (GI) perforation—use with caution in patients who may be at increased risk. ( 5.2 ) Hepatotoxicity- Monitor patients for signs and symptoms of hepatic injury. Modify or discontinue TOFIDENCE if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop. ( 2.8 , 5.3 ) Laboratory monitoring—recommended due to potential consequences of treatment-related changes in neutrophils, platelets, lipids, and liver function tests. …

Pregnancy & breastfeeding

8.1 Pregnancy Risk Summary The available data with tocilizumab products from a pregnancy exposure registry, retrospective cohort study, pharmacovigilance, and published literature are insufficient to draw conclusion about a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. …

Storage

Do not use beyond expiration date on the container or package. TOFIDENCE must be refrigerated at 36°F to 46°F (2°C to 8°C). Do not freeze. Protect the vials from light by storage in the original package until time of use.

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

Check your pack of Actemra 80 mg

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 Actemra 80 mg

What is in Actemra 80 mg?

Actemra 80 mg contains Tocilizumab (80 mg/4 mL), as concentrate for solution for infusion, according to its NAFDAC registration record.

Is Actemra 80 mg registered with NAFDAC?

Yes. Actemra 80 mg is listed on the NAFDAC register under registration number A6-100068, and its registration is active as of 27 October 2026.

Has Actemra 80 mg been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Actemra 80 mg in our automatically synced alert list.

How can I check that my pack of Actemra 80 mg is genuine?

Run a free authenticity scan with the NAFDAC number A6-100068, 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 Actemra 80 mg used for?

TOFIDENCE™ (tocilizumab-bavi) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: Rheumatoid Arthritis (RA) ( 1.1 ) Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs). Giant Cell Arteritis (GCA) ( 1.2 ) Adult patients with giant cell arteritis. Polyarticular (Summarised from the official U.S. FDA label for tocilizumab. Always follow your doctor or pharmacist.)

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