Federación - Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) - (FED)
Solicitud del día 08/08/2023 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 392M2017 del medicamento Mavyret (Glecaprevir / Pibrentasvir), incluyendo modificaciones del registro a la fecha de respuestaOtros datosData from the Sanitary Registry Registry number: 392M2017 SSA Distinctive denomination: MAVYRET Issue / Expiration Date: December 21, 2017 / December 21, 2022 Registration Status: Current Pharmaceutical form: Tablet Therapeutic Indication: Treatment of chronic hepatitis C virus (HCV) infection in adults, without cirrhosis or with compensated cirrhosis (Child-Pugh A). Contraindications: Hypersensitivity to the active principles or any of the components of the formula, severe hepatic insufficiency (Child-Pugh C), concomitant use with atazanavir, atorvastatin, simvastatin, dabigatran etexilate, products containing ethinyl estradiol and strong inducers of P-gp and CYP3A (for example: rifampicin, carbamazepine, St. John's wort [Hypericum perforatum], phenobarbital, phen Useful life: Sale condition: fraction IV Generic name: GLECAPREVIR / PIBRENTASVIR Route of Administration: Oral Type of Medication: New Molecules Presentations: Cardboard box with 4 individual boxes, each with 7 blister packs with 3 tablets and attached instructions. Drug / Concentration: Glecaprevir 100,000 mg / Pibrentasvir 40,000 mg Organic System: J ANTI-INFECTIVES IN GENERAL FOR SYSTEMIC USE Pharmacological Group: J05 Antivirals for systemic use Pharmacological Subgroup: J05A Agents of direct action. Chemical Subgroup: J05AP Antivirals for the treatment of HCV infections. Chemical substance: Registration Holder: Home: Drug Manufacturer: Abbvie SRL SR 148 Pontina Km 52 SNC (loc. Campovberde Di Aprilia) – 04011 Aprilia (Lt)., Italy. Drug Manufacturer: Fournier Laboratories Ireland Limited. Anngrove, Carrigtwohill, Co. Cork, Ireland.. Conditioned By: AbbVIE FARMACEUTICOS SA DE CV Av. Boulevard Adolfo Ruiz Cortines No. 3720 Int. Int. 10-001 Col. Jardines del Pedregal CP 01900 ÁLVARO OBREGÓN MÉXICO AbbVie Inc. 1N Waukegan Rd, North Chicago, Illinois (IL) 60064, AbbVie Deutschland GmbH & Co.KG. Knollstrasse, 67061 Ludwigshafen,Respuesta del día12/09/2023Texto de respuestaVER ARCHIVOArchivo adjuntoDescargarFolioFED-IP-330007923008767