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Compassionate Use Policy - Regeneron Pharmaceuticals
In the USA, this type of compassionate use program is also known as an Expanded Access Program (EAP) and is intended for patients with serious or life-threatening conditions who do not have any viable or available treatment options and are unable to partic ipate in ongoing clinical trials. To view a list of Regeneron’s open clinical trials, visit
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HIGHLIGHTS OF PRESCRIBING INFORMATION immune …
www.regeneron.comHIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LIBTAYO safely and effectively. See full prescribing information for LIBTAYO.
FACT SHEET FOR HEALTH CARE PROVIDERS EMERGENCY USE ...
www.regeneron.comjustifying the authorization of the emergency use of REGEN-COV under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Treatment This EUA is for the use of the unapproved product, REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab)
HIGHLIGHTS OF PRESCRIBING INFORMATION Diabetic …
www.regeneron.comThese highlights do not include all the information needed to use EYLEA safely and effectively. See full prescribing information for EYLEA. EYLEA® (aflibercept) Injection, for intravitreal use Initial U.S. Approval: 2011 INDICATIONS AND USAGE EYLEA is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients ...
HIGHLIGHTS OF PRESCRIBING INFORMATION …
www.regeneron.com5% Dextrose Injection, USP to a final concentration between 1 mg/mL to 20 mg/mL. • Mix diluted solution by gentle inversion. Do not shake. • Discard any unused medicinal product or waste material. Storage of Infusion Solution • Store at room temperature up to 25°C (77°F) for no more than 8 hours from the time
INSTRUCTIONS FOR USE DUPIXENT (DU-pix-ent) (dupilumab ...
www.regeneron.comMarketed by: sanofi-aventis U.S. LLC (Bridgewater, NJ 08807) and Regeneron Pharmaceuticals, Inc. (Tarrytown, NY 10591) DUPIXENT ...
HIGHLIGHTS OF PRESCRIBING INFORMATION Dosage in …
www.regeneron.com• Injection: 300 mg/2 mL solution in a single-dose pre-filled syringe with needle shield. (3) • Injection: 200 mg/1.14 mL solution in a single-dose pre-filled pen. (3) • Injection: 200 mg/1.14 mL solution in a single-dose pre-filled syringe with needle shield. (3) • Injection: 100 mg/0.67 mL solution in a single-dose pre-filled ...
DUPIXENT (DU-pix-ent) (dupilumab) injection, Single-Dose ...
www.regeneron.comB. Choose and prepare your injection site B1. Wash your hands well with soap and water B2. Choose an injection site • Thigh • Stomach except for the 2 inches (5 cm) around your belly button (navel). • A caregiver can also inject in the outer area of the upper arm. • Chooseadif ferent site for each injection. B3. Prepare the injection ...
FACT SHEET FOR PATIENTS, PARENTS AND CAREGIVERS …
www.regeneron.comREGEN-COV to treat people with COVID-19 or to prevent COVID-19 in people who are at high risk of being exposed to someone who is infected with SARS-CoV-2. REGEN-COV is not authorized for pre-exposure prophylaxis for prevention of COVID-19. The FDA has authorized the emergency use of . REGEN-COV . for the treatment of COVID-19
HIGHLIGHTS OF PRESCRIBING INFORMATION The …
www.regeneron.comhospitalization in adults with established cardiovascular disease. (1) ... 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not ... the population were women, 90% were White, 4% were Black or African American, and 3% were Asian. Adverse reactions reported in at least 2% of PRALUENT ...
FICHA TÉCNICA PARA PACIENTES, PADRES Y CUIDADORES ...
www.regeneron.comcontacto estrecho con alguien infectado por el SARS-CoV-2 se define como estar a una distancia de 6 pies (1,82 m, aproximadamente) o menos durante un total de 15 minutos o más, brindar atención en casa a alguien enfermo, tener contacto físico directo con la persona (abrazar o besar, por ejemplo), compartir utensilios para comer o tomar, o estar
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