Import ZELBORAF (Vemurafenib) in India

This medication requires a valid prescription. Please refer to the ‘Prescription Guide’ for details.

Note: We can assist only if the medicine is unavailable in your country.”

MitoGENE helps Indian patients import Zelboraf (vemurafenib) legally and safely under their doctor’s supervision.

Available Dosage Form& Package

56 Film-coated Tablets of 240 mg

Medicine Approved by:

U.S. Food and Drug Administration (FDA) – United States
European Medicines Agency (EMA) – European Union
Swissmedic – Switzerland
Australian Therapeutic Goods Administration (TGA) – Australia
Health Canada – Canada
Pharmaceuticals and Medical Devices Agency (PMDA) – Japan
MedSafe – New Zealand
Other national regulatory authorities in multiple countries across Asia, Latin America, and the Middle East

ZELBORAF (Vemurafenib)

Access ZELBORAF (Vemurafenib) in India

Zelboraf (vemurafenib) has been approved in countries like the U.S. and Europe but is not yet available for commercial sale in India. However, it is accessible through the Named Patient Program (NPP) for eligible patients.

MitoGENE helps Indian patients access Zelboraf (vemurafenib) legally and safely under their doctor’s supervision. We handle the documentation, regulatory approvals, and logistics to ensure compliance with Indian regulations.

If you or your loved one may benefit from Zelboraf (vemurafenib), MitoGENE is here to support your journey to access this treatment.

Product Description:

Zelboraf (vemurafenib) is an oral targeted cancer therapy used for treating advanced or unresectable melanoma in patients carrying the BRAF V600 mutation. This small‑molecule kinase inhibitor works by blocking abnormal BRAF proteins that drive cancer cell growth and tumor progression.

Disease Indications: Melanoma

Manufacturer: Genentech, Inc.,

Shipping: Room Temperature Shipping. This medication is shipped using standard delivery methods, ensuring it remains within a controlled room temperature range of 15°C to 25°C throughout transit.

What is ZELBORAF (vemurafenib)?

ZELBORAF (vemurafenib) is a prescription medicine used to treat adults with:

Unresectable (inoperable) or metastatic melanoma that is BRAF V600 mutation-positive
Erdheim‑Chester disease (ECD) with a confirmed BRAF V600 mutation

Before starting treatment, your healthcare provider will perform a BRAF gene mutation test, as ZELBORAF is effective only for patients with this specific biomarker.

ZELBORAF is not approved for use in children. Its initial U.S. FDA approval was granted in August 2011 based on clinical trial data showing improved overall survival and progression-free survival compared to standard therapy. In 2017, its use was expanded to include patients with Erdheim‑Chester disease.

In India, ZELBORAF (vemurafenib) is not yet commercially available. However, eligible patients may be able to access it through the Named Patient Program, a legal pathway for importing global cancer medicines under the supervision of their treating oncologist.

Important Safety Information

Possible Serious Side Effects Include:

Skin-related problems: rash, photosensitivity (sensitivity to sunlight), and risk of developing secondary skin cancers.
Heart rhythm problems (QT prolongation): may cause changes in heart rhythm requiring monitoring.
Liver and kidney function changes: may require regular blood tests.

Common Side Effects May Include:

Joint pain, muscle pain
Tiredness or weakness
Rash or redness of skin
Hair loss
Nausea, diarrhea, or loss of appetite
Headache
Photosensitivity reactions (skin sensitivity to sunlight)

This is not a complete list. Speak to your doctor or pharmacist for full safety information. Side effects may also be reported to the U.S. FDA at 1‑800‑FDA‑1088.

ZELBORAF Access in India

Although ZELBORAF (vemurafenib) is approved in the United States, European Union, Switzerland, and other regions, it is not available commercially in India.

Patients with BRAF V600 mutation-positive advanced or metastatic melanoma or Erdheim‑Chester disease can potentially access ZELBORAF through the Named Patient Program, which allows for legal, personal import of medicines not yet registered in India.

MitoGENE supports patients and their doctors by:

Preparing medical and regulatory documentation
Coordinating import permits and logistics
Ensuring secure delivery of global cancer therapies directly to the treating hospital

References

FDA Drug Approval: Zelboraf (vemurafenib)
Genentech Press Release: Zelboraf for Erdheim‑Chester Disease
NCBI Bookshelf: Vemurafenib Pharmacology & Clinical Data
ASCO Post: Zelboraf FDA Approval Summary

Disclaimer: ZELBORAF (vemurafenib) is not approved for commercial sale in India. Access is provided strictly for personal use under physician supervision in accordance with Indian regulatory guidelines through the Named Patient Program (NPP). MitoGENE does not market, advertise, or sell unapproved drugs. All content is for informational purposes and not a substitute for professional medical advice.

How to Access Zelboraf (vemurafenib) in India in 4 Simple Steps with MitoGENE via the Named Patient Program (NPP)?

If Zelboraf (vemurafenib) is not yet approved or commercially available in India, MitoGENE can assist you in accessing it legally through the Named Patient Program (NPP). Here’s how the process works: