Procedimientos de autorización excepcional de medicamentos

1.1 Autorización Sanitaria de Uso de Emergencia (ASUE)

1.1.1 Formatos y guías

Formato de presentación de solicitud de autorización de uso de emergencia para medicamentos de síntesis y biològicos ASS-RSA-FM150.docx 24/12/2025 Formato de solicitud de modificaciones a la autorizaciòn sanitaria de uso de emergencia ASS-RSA-FM155.pdf 24/12/2025 Formato de solicitud de renovación automática de autorización sanitaria de uso de emergencia para medicamentos de síntesis química y biológicos. ASS-RSA-FM156.doc 24/12/2025

1.1.2 Resoluciones de autorización por producto

PFIZER-BIONTECH COVID-19 VACCINE 20195221_Mod 2.pdf 24/12/2025 PFIZER-BIONTECH COVID-19 VACCINE 20195221_Mod 10.pdf 24/12/2025 PFIZER-BIONTECH COVID-19 VACCINE 20195221_Mod 8.pdf 24/12/2025 PFIZER-BIONTECH COVID-19 VACCINE 20195221_Mod 5.pdf 24/12/2025 PFIZER-BIONTECH COVID-19 VACCINE 20195221_Mod 13.pdf 24/12/2025 PFIZER-BIONTECH COVID-19 VACCINE 20195221_Mod 14.pdf 24/12/2025 PFIZER-BIONTECH COVID-19 VACCINE 20195221_Mod 1.pdf 24/12/2025 PFIZER-BIONTECH COVID-19 VACCINE 20195221_Inicial.pdf 24/12/2025 PFIZER-BIONTECH COVID-19 VACCINE 20195221_Mod 7.pdf 24/12/2025 PFIZER-BIONTECH COVID-19 VACCINE 20195221_Mod 3.pdf 24/12/2025 PFIZER-BIONTECH COVID-19 VACCINE 20195221_Mod 6.pdf 24/12/2025 PFIZER-BIONTECH COVID-19 VACCINE 20195221_R2.pdf 24/12/2025 PFIZER-BIONTECH COVID-19 VACCINE 20195221_Mod 9.pdf 24/12/2025 PFIZER-BIONTECH COVID-19 VACCINE 20195221_Mod 11.pdf 24/12/2025 PFIZER-BIONTECH COVID-19 VACCINE 20195221_Mod 4.pdf 24/12/2025 PFIZER-BIONTECH COVID-19 VACCINE 20195221_Mod 12.pdf 24/12/2025 PFIZER-BIONTECH COVID-19 VACCINE 20195221_R1.pdf 24/12/2025

VACUNA COVID 19 JANSSEN 20199703_Mod 2.pdf 24/12/2025 VACUNA COVID 19 JANSSEN 20199703_Mod 8.pdf 24/12/2025 VACUNA COVID 19 JANSSEN 20199703_Mod 4.pdf 24/12/2025 VACUNA COVID 19 JANSSEN 20199703_R1.pdf 24/12/2025 VACUNA COVID 19 JANSSEN 20199703_Mod 7.pdf 24/12/2025 VACUNA COVID 19 JANSSEN 20199703_Mod 1.pdf 24/12/2025 VACUNA COVID 19 JANSSEN 20199703_Inicial.pdf 24/12/2025 VACUNA COVID 19 JANSSEN 20199703_Mod 6.pdf 24/12/2025 VACUNA COVID 19 JANSSEN 20199703_Mod 5.pdf 24/12/2025 VACUNA COVID 19 JANSSEN 20199703_Mod 3.pdf 24/12/2025

VACUNA COVID CORONAVAC (SINOVAC) 20203974_R1.pdf 24/12/2025 VACUNA COVID CORONAVAC (SINOVAC) 20203974_Mod 1.pdf 24/12/2025 VACUNA COVID CORONAVAC (SINOVAC) 20203974_R2.pdf 24/12/2025 VACUNA COVID CORONAVAC (SINOVAC) 20203974_Mod 2.pdf 24/12/2025 VACUNA COVID CORONAVAC (SINOVAC) 20203974_RS.pdf 24/12/2025 VACUNA COVID CORONAVAC (SINOVAC) 20203974_Mod 4.pdf 24/12/2025 VACUNA COVID CORONAVAC (SINOVAC) 20203974_Mod 3.pdf 24/12/2025 VACUNA COVID CORONAVAC (SINOVAC) 20203974_Mod 5.pdf 24/12/2025

SpikeVax Covid-19 Vaccine Moderna 20205136_Mod 5.pdf 24/12/2025 SpikeVax Covid-19 Vaccine Moderna 20205136_Mod 22.pdf 24/12/2025 SpikeVax Covid-19 Vaccine Moderna 20205136_Mod 17.pdf 24/12/2025 SpikeVax Covid-19 Vaccine Moderna 20205136_RS.pdf 24/12/2025 SpikeVax Covid-19 Vaccine Moderna 20205136_Mod 16.pdf 24/12/2025 SpikeVax Covid-19 Vaccine Moderna 20205136_Mod 12.pdf 24/12/2025 SpikeVax Covid-19 Vaccine Moderna 20205136_Mod 18.pdf 24/12/2025 SpikeVax Covid-19 Vaccine Moderna 20205136_Mod 1.pdf 24/12/2025 SpikeVax Covid-19 Vaccine Moderna 20205136_Mod 9.pdf 24/12/2025 SpikeVax Covid-19 Vaccine Moderna 20205136_Mod 19.pdf 24/12/2025 SpikeVax Covid-19 Vaccine Moderna 20205136_Mod 2.pdf 24/12/2025 SpikeVax Covid-19 Vaccine Moderna 20205136_R2.pdf 24/12/2025 SpikeVax Covid-19 Vaccine Moderna 20205136_Mod 20_1.pdf 24/12/2025 SpikeVax Covid-19 Vaccine Moderna 20205136_Mod 14.pdf 24/12/2025 SpikeVax Covid-19 Vaccine Moderna 20205136_Mod 6.pdf 24/12/2025 SpikeVax Covid-19 Vaccine Moderna 20205136_Mod 13.pdf 24/12/2025 SpikeVax Covid-19 Vaccine Moderna 20205136_Mod 7.pdf 24/12/2025 SpikeVax Covid-19 Vaccine Moderna 20205136_Mod 10.pdf 24/12/2025 SpikeVax Covid-19 Vaccine Moderna 20205136_Mod 21.pdf 24/12/2025 SpikeVax Covid-19 Vaccine Moderna 20205136_Mod 4.pdf 24/12/2025 SpikeVax Covid-19 Vaccine Moderna 20205136_R1.pdf 24/12/2025 SpikeVax Covid-19 Vaccine Moderna 20205136_Mod 20.pdf 24/12/2025 SpikeVax Covid-19 Vaccine Moderna 20205136_Mod 15.pdf 24/12/2025 SpikeVax Covid-19 Vaccine Moderna 20205136_Mod 11.pdf 24/12/2025 SpikeVax Covid-19 Vaccine Moderna 20205136_Mod 3.pdf 24/12/2025 SpikeVax Covid-19 Vaccine Moderna 20205136_Mod 8.pdf 24/12/2025

VACUNA RECOMBINANTE CONTRA EL CORONAVIRUS 20213380_R1.pdf 24/12/2025 VACUNA RECOMBINANTE CONTRA EL CORONAVIRUS 20213380_RS.pdf 24/12/2025 VACUNA RECOMBINANTE CONTRA EL CORONAVIRUS 20213380_R1_1.pdf 24/12/2025

LAGEVRIO® 200MG CAPSULAS 20219428_Mod 5.pdf 24/12/2025 LAGEVRIO® 200MG CAPSULAS 20219428_Mod 7.pdf 24/12/2025 LAGEVRIO® 200MG CAPSULAS 20219428_Mod 2_1.pdf 24/12/2025 LAGEVRIO® 200MG CAPSULAS 20219428_Mod 3.pdf 24/12/2025 LAGEVRIO® 200MG CAPSULAS 20219428_Mod 8.pdf 24/12/2025 LAGEVRIO® 200MG CAPSULAS 20219428_Mod 1.pdf 24/12/2025 LAGEVRIO® 200MG CAPSULAS 20219428_R1.pdf 24/12/2025 LAGEVRIO® 200MG CAPSULAS 20219428_Mod 6.pdf 24/12/2025 LAGEVRIO® 200MG CAPSULAS 20219428_RS.pdf 24/12/2025 LAGEVRIO® 200MG CAPSULAS 20219428_Mod 2.pdf 24/12/2025 LAGEVRIO® 200MG CAPSULAS 20219428_Mod 4.pdf 24/12/2025

SPIKEVAX BIVALENT ORIGINAL OMICRON 20242175_RS.pdf 24/12/2025

COMIRNATY 20245139_Mod 1.pdf 24/12/2025 COMIRNATY 20245139_RS.pdf 24/12/2025

Actemra 200mg_10ml 20221606_RS.pdf 24/12/2025

COMIRNATY OMICRON XBB.1.5 20260260_RS.pdf 24/12/2025 COMIRNATY OMICRON XBB.1.5 20260260_Mod 2.pdf 24/12/2025 COMIRNATY OMICRON XBB.1.5 20260260_Mod 1.pdf 24/12/2025

COMIRNATY OMICRON XBB.1.5 20260258_Mod 1.pdf 24/12/2025 COMIRNATY OMICRON XBB.1.5 20260258_RS.pdf 24/12/2025

SPIKEVAX XBB.1.5 20260253_RS.pdf 24/12/2025 SPIKEVAX XBB.1.5 20260253.pdf 24/12/2025

1.2 Usos no incluidos en el registro sanitario (UNIRS)

1.2.1 Formatos y guías

FORMATO DE PRESENTACION DE LA EVALUACIÓN FARMACOLÓGICA DE USOS NO INCLUIDOS EN REGISTROS SANITARIOS (UNIRS) ASS-RSA-FM130.doc 24/12/2025 GUÍA PARA LA PRESENTACIÓN DE EVALUACIÓN FARMACOLÓGICA PARA - ASS-RSA-GU68.pdf 24/12/2025

1.2.2 Informes de evaluación

INFORME DE REVISIÒN PARA LA SOLICITUD DE INDICACIONES UNIRS SIN EVIDENCIA DE AUTORIZACIÒN POR AGENCIAS DE REFERENCIA 29/12/2025