Европейский союз - испанский - EMA (European Medicines Agency)

teva pharma b.v. - budesonide, formoterol - asma - medicamentos para la enfermedad obstructiva de las vías respiratorias enfermedades, - budesonida / formoterol teva pharma b. está indicado únicamente en adultos de 18 años de edad o mayores. asthmabudesonide/formoterol teva pharma b. is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate: orin patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists. in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.

Европейский союз - испанский - EMA (European Medicines Agency)

ipsen pharma - cabozantinib (s)-malate - carcinoma, renal cell; carcinomas, hepatocellular - agentes antineoplásicos - renal cell carcinoma (rcc)cabometyx is indicated as monotherapy for the treatment of advanced renal cell carcinoma (rcc):in treatment-naïve adults with intermediate or poor risk,in adults following prior vascular endothelial growth factor (vegf)-targeted therapy. cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults. hepatocellular carcinoma (hcc)cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (hcc) in adults who have previously been treated with sorafenib.

Европейский союз - испанский - EMA (European Medicines Agency)

viiv healthcare b.v. - maraviroc - infecciones por vih - antivirales para uso sistémico - celsentri, in combination with other antiretroviral medicinal products, is indicated for treatment experienced adults, adolescents and children of 2 years of age and older and weighing at least 10 kg infected with only ccr5-tropic hiv-1 detectable,.

Европейский союз - испанский - EMA (European Medicines Agency)

viatris limited - besilato de clopidogrel - peripheral vascular diseases; stroke; myocardial infarction - agentes antitrombóticos - secondary prevention of atherothrombotic events clopidogrel is indicated in:adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. adult patients suffering from acute coronary syndrome. non-st segment elevation acute coronary syndrome (unstable angina or non-q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (asa). elevación del segmento st infarto agudo de miocardio, en combinación con aas en los pacientes tratados médicamente elegibles para la terapia trombolítica. in patients with moderate to high-risk transient ischaemic attack (tia) or minor ischaemic stroke (is) clopidogrel in combination with asa is indicated in:adult patients with moderate to high-risk tia (abcd2 score ≥4) or minor is (nihss ≤3) within 24 hours of either the tia or is event. prevention of atherothrombotic and thromboembolic events in atrial fibrillation:in adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with vitamin k antagonists (vka) and who have a low bleeding risk, clopidogrel is indicated in combination with asa for the prevention of atherothrombotic and thromboembolic events, including stroke. para más información, por favor refiérase a la sección 5.

Европейский союз - испанский - EMA (European Medicines Agency)

taw pharma (ireland) limited - clorhidrato de clopidogrel - peripheral vascular diseases; stroke; myocardial infarction; acute coronary syndrome - agentes antitrombóticos - , , , , secondary prevention of atherothrombotic events, , clopidogrel is indicated in: , - adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. , - adult patients suffering from acute coronary syndrome:,    - non-st segment elevation acute coronary syndrome (unstable angina or non-q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (asa). ,     - st segment elevation acute myocardial infarction, in combination with asa in medically treated patients eligible for thrombolytic therapy. , , in patients with moderate to high-risk transient ischaemic attack (tia) or minor ischaemic stroke (is), clopidogrel in combination with asa is indicated in:, - adult patients with moderate to high-risk tia (abcd2  score ≥4) or minor is (nihss  ≤3) within 24 hours of either the tia or is event.  , , prevention of atherothrombotic and thromboembolic events in atrial fibrillation, in adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with vitamin k antagonists (vka) and who have a low bleeding risk, clopidogrel is indicated in combination with asa for the prevention of atherothrombotic and thromboembolic events, including stroke. , , for further information please refer to section 5. , , ,.

Европейский союз - испанский - EMA (European Medicines Agency)

teva pharma b.v. - clopidogrel (as hydrochloride) - peripheral vascular diseases; acute coronary syndrome; myocardial infarction; stroke - agentes antitrombóticos - clopidogrel está indicado en adultos para la prevención de eventos aterotrombóticos en:los pacientes que sufren de infarto de miocardio (desde pocos días hasta menos de 35 días), el accidente cerebrovascular isquémico (desde 7 días hasta menos de 6 meses) o enfermedad arterial periférica establecida. patients suffering from acute coronary syndrome:non-st segment elevation acute coronary syndrome (unstable angina or non-q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (asa). elevación del segmento st infarto agudo de miocardio, en combinación con aas en los pacientes tratados médicamente elegibles para la terapia trombolítica. para más información, por favor refiérase a la sección 5.

Европейский союз - испанский - EMA (European Medicines Agency)

viiv healthcare bv - la lamivudina, zidovudina - infecciones por vih - antivirales para uso sistémico - combivir is indicated in antiretroviral combination therapy for the treatment of human immunodeficiency virus (hiv) infection.

Европейский союз - испанский - EMA (European Medicines Agency)

novartis europharm limited - secukinumab - arthritis, psoriatic; psoriasis; spondylitis, ankylosing - inmunosupresores - plaque psoriasiscosentyx is indicated for the treatment of moderate to severe plaque psoriasis in adults and children from the age of 6 years old who are candidates for systemic therapy. hidradenitis suppurativa (hs)cosentyx is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic hs therapy. psoriásica arthritiscosentyx, solo o en combinación con metotrexato (mtx), está indicado para el tratamiento de la artritis psoriásica activa en pacientes adultos cuando la respuesta a la anterior modificadores de la enfermedad anti reumáticas de drogas (dmard), la terapia ha sido insuficiente. axial spondyloarthritis (axspa)espondilitis anquilosante (como, radiografía axial spondyloarthritis)cosentyx está indicado para el tratamiento de la espondilitis anquilosante activa en los adultos que han respondido de forma inadecuada a la terapia convencional. non-radiographic axial spondyloarthritis (nr-axspa)cosentyx is indicated for the treatment of active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or magnetic resonance imaging (mri) evidence in adults who have responded inadequately to non steroidal anti inflammatory drugs (nsaids). juvenile idiopathic arthritis (jia)enthesitis-related arthritis (era)cosentyx, alone or in combination with methotrexate (mtx), is indicated for the treatment of active enthesitis-related arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy. juvenile psoriatic arthritis (jpsa)cosentyx, alone or in combination with methotrexate (mtx), is indicated for the treatment of active juvenile psoriatic arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.

Европейский союз - испанский - 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.

Европейский союз - испанский - EMA (European Medicines Agency)

otsuka novel products gmbh - delamanid - tuberculosis, resistente a múltiples fármacos - antimicobacterianos - deltyba is indicated for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (mdr-tb) in adults, adolescents, children and infants with a body weight of at least 10 kg when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability (see sections 4. 2, 4. 4 y 5. se debe dar consideración a las directrices oficiales sobre el uso adecuado de agentes antibacterianos.