(AGENPARL) - Roma, 17 Marzo 2023(AGENPARL) – SILVER SPRING ven 17 marzo 2023
Healthcare Providers (656KB)
Patients and Caregivers (413KB)
Frequently Asked Questions on the Emergency Use Authorization of Kineret (175KB)
Bebtelovimab (460KB) (reissued August 5 and October 27, 2022)
Letter Granting EUA Amendment (March 30, 2022) (216KB)
Letter Granting EUA Amendment (September 16, 2022) (194KB)
Letter Granting EUA Amendment (November 4, 2022) (310KB)
FDA Announces Bebtelovimab is Not Currently Authorized in Any US Region (November 30, 2022)
ASPR and FDA Statement on Shelf-Life Extension of Bebtelovimab (October 28, 2022)
Bebtelovimab is not currently authorized in any U.S. region due to the high frequency of circulating SARS-CoV-2 variants that are non-susceptible to bebtelovimab. Therefore, bebtelovimab may not be administered for treatment of COVID-19 under the Emergency Use Authorization until further notice by the Agency.
Bebtelovimab is authorized for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing who are at high risk for progressing to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate.
Healthcare Providers (763KB) (updated November 4, 2022)
Patients, Parents, and Caregivers (245KB)(updated November 4, 2022)
Frequently Asked Questions on the Emergency Use Authorization of Bebtelovimab (1.01MB)
Lagevrio (molnupiravir) (286KB) (reissued August 5, October 27, 2022, and February 1, 2023)
ASPR and FDA Statement on Shelf-Life Extension Evaluation of Lagevrio (October 21, 2022)
Healthcare Providers (574KB) (updated February 1, 2023)
Patients, Parents, and Caregivers (142KB) (updated February 1, 2023)
COVID-19 Test to Treat locator (Find a treatment location near you, from ASPR)
Dear Healthcare Provider Letter (162KB) (February 1, 2023)
Dear Healthcare Provider Letter (268KB)
Frequently Asked Questions on the Emergency Use Authorization of Lagevrio (308KB) (updated February 7, 2023)
Prescriber Checklist for Lagevrio (181KB) (updated February 1, 2023)
Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) (696KB) (reissued March 17, 2022, April 14, 2022, July 6, 2022, August 5, 2022, October 27, 2022, and February 1, 2023)
Letter Granting EUA Amendment (March 18, 2022) (161KB)
Letter Granting EUA Amendment (September 26, 2022) (255KB)
FDA Authorizes Pharmacists to Prescribe Paxlovid with Certain Limitations (July 6, 2022)
ASPR and FDA Statement on Shelf-Life Extension of Paxlovid (January 18, 2023)
Healthcare Providers (671KB) (updated February 1, 2023)
Paxlovid Patient Eligibility Screening Checklist and Drug Interaction Tool (321KB) (updated February 1, 2023)
Patients, Parents, and Caregivers (425KB) (updated February 1, 2023)
COVID-19 Test to Treat locator (Find a treatment location near you, from ASPR)
Dear Healthcare Provider Letter (593KB) (updated August 5, 2022)
Important Dispensing Information for Patients with Moderate Renal Impairment (476KB)
Frequently Asked Questions on the Emergency Use Authorization for Paxlovid (248KB) (updated February 7, 2023)
Evusheld (tixagevimab co-packaged with cilgavimab) (286KB) (reissued December 20, 2021, February 24, 2022, May 17, 2022, October 27, December 8, 2022, and January 26, 2023)
FDA announces Evusheld is not currently authorized for emergency use in the U.S. (updated January 26, 2023)
ASPR and FDA Statement on Shelf-Life Extension of Evusheld (December 5, 2022)
Letter Granting EUA Amendment (June 29, 2022) (168KB)
Letter Granting EUA Amendment (November 18, 2022) (197KB)
Letter Granting EUA Amendment (December 21, 2022) (188KB)
Evusheld is not currently authorized in any U.S. region due to the high frequency of circulating SARS-CoV-2 variants that are non-susceptible to Evusheld. Therefore, Evusheld may not be administered for pre-exposure prophylaxis for prevention of COVID-19 under the Emergency Use Authorization until further notice by the Agency.
For emergency use as pre-exposure prophylaxis for prevention of COVID-19 in adults and pediatric individuals (12 years of age and older weighing at least 40 kg):
Who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to an individual infected with SARS-CoV-2 and
- Who have moderate to severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments and may not mount an adequate immune response to COVID-19 vaccination or
- For whom vaccination with any available COVID-19 vaccine, according to the approved or authorized schedule, is not recommended due to a history of severe adverse reaction to a COVID-19 vaccine(s) and/or COVID-19 vaccine component(s).
Healthcare Providers (769KB) (updated January 26, 2023)
- Spanish (1.11MB) (updated December 21, 2022)
Patients, Parents, and Caregivers (178KB) (updated January 26, 2023)
- Spanish (342KB) (updated October 3, 2022)
Dear Healthcare Provider Letter (135KB) (January 26, 2023)
Dear Healthcare Provider Letter (439KB) (June 29, 2022)
New Repeat Dosage Recommendations
Dear Healthcare Provider Letter (196KB) (October 3, 2022) Updated EVUSHELD EUA Warnings and Precautions
Dear Healthcare Provider Letter (226KB) (May 17, 2022)
Addition of EVUSHELD EUA Warning and Precaution for Risk of Cross-Hypersensitivity with COVID-19 Vaccines
Dear Healthcare Provider Letter (144KB) (March 22, 2022)
Updated EVUSHELD EUA Dosage Recommendations for Patients Who Received an Initial Dose of 150 mg tixagevimab and 150 mg cilgavimab
Frequently Asked Questions on the Emergency Use Authorization for Evusheld (942KB) (updated October 20, 2022)
For the treatment of COVID-19 in hospitalized pediatric patients (2 years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
On December 21, 2022, Actemra was approved for the treatment of COVID-19 in hospitalized adults who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.
Healthcare Providers (428KB) (updated December 21, 2022)
Patients, Parents, and Caregivers (136KB) (updated December 21, 2022)
Frequently Asked Questions on the Emergency Use Authorization of Actemra (Tocilizumab) (173KB) (updated December 21, 2022)
Sotrovimab (375KB) (reissued October 8, 2021, December 16, 2021 and February 23, 2022)
Letter Granting EUA Amendment (December 22, 2021) (161KB)
FDA updates Sotrovimab emergency use authorization (April 5, 2022)
ASPR and FDA Statement of additional Shelf-Life Extension of Strovimab (February 15, 2023)
ASPR and FDA Statement on Shelf-Life Extension of Sotrovimab (August 3, 2022)
Important updates about sotrovimab (ASPR)
Sotrovimab is not currently authorized in any U.S. region due to the high frequency of circulating SARS-CoV-2 variants that are non-susceptible to sotrovimab. Therefore, sotrovimab may not be administered for treatment of COVID-19 under the Emergency Use Authorization until further notice by the Agency.
For the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
Healthcare Providers (579KB) (updated March 17, 2023)
Patients, Parents, and Caregivers (199KB) (updated March 17, 2023)
requently Asked Questions on the Emergency Use Authorization of Sotrovimab (257KB) (updated March 25, 2022)
Propofol‐Lipuro 1% (344KB)
Letter Granting EUA Amendment (December 16, 2021) (188KB)
Healthcare Providers (446KB)
Bamlanivimab and Etesevimab (900KB) (Reissued February 25, 2021, August 27, 2021, September 16, 2021, December 3, 2021, December 22, 2021 and January 24, 2022)
ASPR and FDA Statement on Shelf-Life Extension of Bamlanivimab and Etesevimab (May 4, 2022)
Important updates about bamlanivimab/etesevimab (ASPR)
Bamlanivimab and etesevimab are not currently authorized in any U.S. region due to the high frequency of circulating SARS-CoV-2 variants that are non-susceptible to bamlanivimab and etesevimab. Therefore, these drugs may not be administered for treatment or post-exposure prevention of COVID-19 under the Emergency Use Authorization until further notice by the Agency.
Bamlanivimab and etesevimab administered together for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
Healthcare Providers (1.75MB) (updated January 24, 2022)
Patients, Parents, and Caregivers (157KB) (updated December 3, 2021)
- Spanish (158KB) (updated September 16, 2021)
Frequently Asked Questions on the Emergency Use Authorization for Bamlanivimab and Etesevimab (312KB) (updated January 31, 2022)
REGEN-COV (Casirivimab and Imdevimab) (1.03MB) (Reissued February 3, 2021, February 25, 2021, June 3, 2021, July 30, 2021, September 9, 2021, November 17, 2021 and January 24, 2022)
ASPR and FDA Statement on Shelf-Life Extension of REGEN-COV (June 27, 2022)
REGEN-COV (casirivimab and imdevimab) is not currently authorized in any U.S. region due to the high frequency of circulating SARS-CoV-2 variants that are non-susceptible to REGEN-COV. Therefore, REGEN-COV may not be administered for treatment of COVID-19 under the Emergency Use Authorization until further notice by the Agency.
Casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
Healthcare Providers (1.74MB) (updated January 24, 2022)
Patients, Parents, and Caregivers (147KB) (updated July 30, 2021)
Dear Healthcare Provider Letter (435KB) (updated September 16, 2021)
Statement on Post-Exposure Prophylaxis (July 30, 2021)
Frequently Asked Questions on the Emergency Use Authorization of REGEN-COV (Casirivimab and Imdevimab) (311KB) (updated January 31, 2022)
CDER Scientific Review Documents Supporting EUA
Quick Reference Guide for Co-Packaged REGEN-COV (38KB) (September 16, 2021)
For emergency use by healthcare providers for the treatment COVID-19 in hospitalized pediatric patients 2 to less than 18 years of age requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
On May 10, 2022, Olumiant was approved for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.
Healthcare Providers (Updated May 10, 2022) (272KB)
Patients, Parents, and Caregivers (Updated May 10, 2022) (128KB)
Frequently Asked Questions on the Emergency Use Authorization for Olumiant (baricitinib) for Treatment COVID-19 (270KB) (Updated May 10, 2022)
Patients and Caregivers (52KB)
REGIOCIT package insert for EUA (140KB)
[also listed under Medical Device EUAs]
Healthcare Providers (135KB)
Patients (125KB)
Instructions for Use, Bloodline/ Tubing (83KB)
Instructions for Use, UltraFlux (147KB)
Instructions for Use, multiFiltratePRO (15.07MB)
Summary of Product Characteristics (SmPC) (308KB)
Instructions for Use, MultiPlus (110KB)
Atropine Auto-Injector (Rafa Laboratories Ltd.)
Letter of Authorization (514 KB)
Letter granting EUA amendment(s) (28 KB)
2nd letter granting EUA amendment(s) (33 KB)
May 10, 2017 Nerve Agents and Certain Insecticides (Organophosphorus and/or Carbamate) Countermeasures
Fonte/Source: http://www.fda.gov/drugs/emergency-preparedness-drugs/emergency-use-authorizations-drugs-and-non-vaccine-biological-products
