NERLYNX (neratinib) tablets
NERLYNX is a prescription medicine used to treat osteoporosis. It is not commercially registered or marketed in India, but eligible patients can legally access it through the Named Patient Program (NPP). This pathway allows individuals to import the medication for personal use by obtaining specific regulatory clearance from the CDSCO.
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NERLYNX (neratinib) tablets
Crinecerfont is indicated as adjunctive treatment to glucocorticoid replacement to control androgens in people four years of age and older with classic congenital adrenal hyperplasia.
NERLYNX is a kinase inhibitor indicated for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy
In the European Union and the United States, neratinib is indicated for the extended adjuvant treatment of adults with early stage (human epidermal growth factor receptor 2) HER2-overexpressed/amplified breast cancer and who are less than one year from the completion of prior adjuvant trastuzumab based therapy.
In the United States, it is also indicated, in combination with capecitabine, for the treatment of adults with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting.
NERLYNX (neratinib) tablets, for oral use Initial U.S. Approval: 2017
Drug Name: NERLYNX
Active Ingredient: neratinib
Approval Date: 12/13/2017
FDA-approved use on approval date: To treat t treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer.
Company: Puma Biotechnology, Inc.
Dosage Forms And Strengths: Capsules: 25 mg, 50 mg, 100 mg. Oral Solution: 50 mg/mL
Active ingredient: neratinib
Inactive ingredients: Tablet Core: colloidal silicon dioxide, mannitol, microcrystalline cellulose, crospovidone, povidone,
magnesium stearate & purified water. Coating: red film coat: polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc,
iron oxide red.
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Alleviare Life Sciences
About Us
Alleviare Life Sciences Pvt. Ltd. (India) serves as a facilitator for medical and pharmaceutical products, commencing its operations in 2005. Headquartered in Delhi, India, Alleviare operates nationwide, providing a range of comprehensive services to patients, doctors, hospitals, and government healthcare facilities.
Our specialization lies in facilitating access to medicines, leveraging our expertise in sourcing and providing documentation assistance for programs such as Named Patient Program, Managed Access Program, and Early Access Program. We take pride in ensuring smooth and efficient access to medications for those who require them.
