Unión Europea - español - EMA (European Medicines Agency)

kyowa kirin holdings b.v. - oxalato de naloxegol - constipation; opioid-related disorders - periférica de los receptores de opioides antagonistas, medicamentos para el estreñimiento - tratamiento del estreñimiento inducido por opioides (oic) en pacientes adultos que han tenido una respuesta inadecuada al laxante (s).

Unión Europea - español - EMA (European Medicines Agency)

janssen-cilag international nv - darunavir, cobicistat, emtricitabina, tenofovir alafenamide - infecciones por vih - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - symtuza está indicado para el tratamiento de la infección por el virus de inmunodeficiencia humana tipo 1 (vih-1) en adultos y adolescentes (a partir de 12 años con un peso corporal de al menos 40 kg). genotypic testing should guide the use of symtuza.

Unión Europea - español - EMA (European Medicines Agency)

janssen-cilag international nv - darunavir - infecciones por vih - antivirales para uso sistémico - prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). in deciding to initiate treatment with prezista co administered with cobicistat or low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista 75 mg, 150 mg, and 600 mg tablets may be used to provide suitable dose regimens:for the treatment of hiv 1 infection in antiretroviral treatment (art) experienced adult patients, including those that have been highly pre treated. for the treatment of hiv 1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight. in deciding to initiate treatment with prezista co administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). prezista 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of hiv 1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:antiretroviral therapy (art) naïve. art experienced with no darunavir resistance associated mutations (drv rams) and who have plasma hiv 1 rna < 100,000 copies/ml and cd4+ cell count ≥ 100 cells x 106/l. in deciding to initiate treatment with prezista in such art experienced patients, genotypic testing should guide the use of prezista.

Unión Europea - español - EMA (European Medicines Agency)

mylan pharmaceuticals limited - darunavir - infecciones por vih - antivirales para uso sistémico - darunavir, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv-1) infection (see section 4. darunavir mylan 75 mg, 150 mg, 300 mg and 600 mg tablets may be used to provide suitable dose regimens (see section 4. 2):para el tratamiento de la infección por vih-1 en tratamiento antirretroviral (art)-experiencia de los pacientes adultos, incluyendo aquellos que han sido altamente pre-tratados. para el tratamiento de la infección por vih-1 en pacientes pediátricos a partir de la edad de 3 años y en menos de 15 kg de peso corporal. en la decisión de iniciar el tratamiento con darunavir coadministrado con dosis bajas de ritonavir, se debe prestar especial consideración a la historia del tratamiento del paciente y de los patrones de mutaciones asociadas con los diferentes agentes. genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir (see sections 4. 2, 4. 4 y 5. darunavir coadministrado con dosis bajas de ritonavir está indicado en combinación con otros medicamentos antirretrovirales para el tratamiento de pacientes con virus de inmunodeficiencia humana (vih-1) .  darunavir co-administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv-1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg) (see section 4.  darunavir mylan 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of hiv-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are: antiretroviral therapy (art)-naïve (see section 4.  art-experienced with no darunavir resistance associated mutations (drv-rams) and who have plasma hiv-1 rna < 100,000 copies/ml and cd4+ cell count ≥ 100 cells x 10⁶/l. en la decisión de iniciar el tratamiento con darunavir en el arte como experiencia de los pacientes, el análisis genotípico deben guiar el uso de darunavir (ver secciones 4. 2, 4. 3, 4. 4 y 5.

Unión Europea - español - EMA (European Medicines Agency)

gilead sciences ireland uc - bulevirtide acetate - hepatitis d, chronic - antivirales para uso sistémico - hepcludex is indicated for the treatment of chronic hepatitis delta virus (hdv) infection in plasma (or serum) hdv-rna positive adult patients with compensated liver disease.

Unión Europea - español - EMA (European Medicines Agency)

seagen b.v. - tucatinib - breast neoplasms; neoplasm metastasis - agentes antineoplásicos - tukysa is indicated in combination with trastuzumab and capecitabine for the treatment of adult patients with her2‑positive locally advanced or metastatic breast cancer who have received at least 2 prior anti‑her2 treatment regimens.

Unión Europea - español - EMA (European Medicines Agency)

eli lilly nederland b.v. - selpercatinib - carcinoma, non-small-cell lung; thyroid neoplasms - agentes antineoplásicos - retsevmo as monotherapy is indicated for the treatment of adults and adolescents 12 years and older with advanced ret-mutant medullary thyroid cancer (mtc)advanced ret fusion-positive non-small cell lung cancer (nsclc) not previously treated with a ret inhibitoradvanced ret fusion-positive thyroid cancer who require systematic therapy following prior treatment.

Unión Europea - español - EMA (European Medicines Agency)

pfizer europe ma eeig - nirmatrelvir, ritonavir - covid-19 virus infection - paxlovid is indicated for the treatment of coronavirus disease 2019 (covid-19) in adults who do not require supplemental oxygen and who are at increased risk for progressing to severe covid 19.

Unión Europea - español - EMA (European Medicines Agency)

hikma farmaceutica (portugal) s.a. - voriconazol - bacterial infections and mycoses; aspergillosis; candidiasis - antimicóticos para uso sistémico - el voriconazol es un amplio espectro, triazol agente antifúngico y está indicado en adultos y niños de 2 años y por encima de la siguiente manera:el tratamiento de la aspergilosis invasiva;el tratamiento de candidaemia no neutropénicos pacientes;el tratamiento de fluconazol resistente invasiva grave las infecciones por candida (incluyendo c. krusei);el tratamiento de graves de las infecciones fúngicas causadas por scedosporium spp. y fusarium spp. voriconazol debe ser administrado principalmente a pacientes con progresiva, posiblemente infecciones peligrosas para la vida. profilaxis de las infecciones fúngicas invasivas en alto riesgo de trasplante alogénico de trasplante de células madre hematopoyéticas (hsct).

Unión Europea - español - EMA (European Medicines Agency)

accord healthcare s.l.u. - voriconazol - aspergillosis; candidiasis; mycoses - antimicóticos para uso sistémico, derivados de triazol - el voriconazol es un amplio espectro, triazol agente antifúngico y está indicado en adultos y niños mayores de dos años y por encima de la siguiente manera:el tratamiento de la aspergilosis invasiva;el tratamiento de candidaemia no neutropénicos pacientes;el tratamiento de fluconazol resistente invasiva grave las infecciones por candida (incluyendo c. krusei);el tratamiento de graves de las infecciones fúngicas causadas por scedosporium spp. y fusarium spp. voriconazol acuerdo debe ser administrado principalmente a pacientes con progresiva, posiblemente infecciones peligrosas para la vida.