Federación - Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) - (FED)
Solicitud del día 09/08/2023 a la dependencia Federación - Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) - (FED) del órgano Federación
DescripciónAtentamente se solicita copia digital de la versión pública del oficio de otorgamiento del registro sanitario 096M2019 del medicamento Ozempic (Semaglutide), incluyendo modificaciones del registro a la fecha de respuestaOtros datosData from the Sanitary Registry Registry number: 096M2019 SSA Distinctive denomination: OZEMPIC Issue / Expiration Date: June 13, 2019 / June 13, 2024 Registration Status: Current Pharmaceutical form: Solution Therapeutic Indication: Ozempic is indicated as an adjunct to diet and exercise in adults with type 2 diabetes mellitus as: • Monotherapy • Combination therapy with other medicinal products for the treatment of diabetes To reduce the risk of serious cardiovascular events (cardiovascular death, heart attack, nonfatal heart attack or nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease. Contraindications: Hypersensitivity to the active principle or some of the excipients of the formula. Pregnancy and lactation. In children and adolescents under 18 years of age. Multiple endocrine neoplasia type 2 syndrome. Patients with a personal or family history of medullary thyroid carcinoma. Useful life: Sale condition: fraction IV Generic name: Semaglutide Route of Administration: subcutaneous Type of Medication: Innovative Presentations: Cardboard box with a pen pre-filled with 3 mL (1.34 mg/mL) of solution, includes 4 Novo Fine Plus disposable needles (Reg. 625C94 SSA). Drug / Concentration: Semaglutide 1,340 mg Organic System: DIGESTIVE SYSTEM AND METABOLISM Pharmacological Group: A10 Drugs used in diabetes. Pharmacological Subgroup: A10B Oral hypoglycemic drugs. Chemical Subgroup: A10BJ Glucagon as peptide-1 (GLP-1) analogs. Chemical substance: A10BJ06 Semaglutide Registration Holder: Home: Drug Manufacturer: NOVO NORDISK A/S Novo Allé, Bagsvaerd, 2880, Denmark, DENMARK. Drug Manufacturer: Novo Nordisk Pharmaceutical Industries, LP 3612 Powhatan Road Clayton, NC 27520, USA. Conditioned By: Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd Novo Nordisk A/S Brennum Park, DK-3400 Hillerod, Denmark. Novo Nordisk Pharmaceutical Industries, LP 3612 Powhatan Road, Clayton, NC 27520,Respuesta del día23/08/2023Texto de respuestaVER ARCHIVOArchivo adjuntoDescargarFolioFED-IP-330007923008777