Xeljanz Unión Europea - inglés - EMA (European Medicines Agency)

xeljanz

pfizer europe ma eeig - tofacitinib - arthritis, rheumatoid - immunosuppressants - rheumatoid arthritistofacitinib in combination with methotrexate (mtx) is indicated for the treatment of moderate to severe active rheumatoid arthritis (ra) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs (dmards) (see section 5.1). tofacitinib can be given as monotherapy in case of intolerance to mtx or when treatment with mtx is inappropriate (see sections 4.4 and 4.5).psoriatic arthritistofacitinib in combination with mtx is indicated for the treatment of active psoriatic arthritis (psa) in adult patients who have had an inadequate response or who have been intolerant to a prior disease modifying antirheumatic drug (dmard) therapy (see section 5.1).ulcerative colitistofacitinib is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (uc) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent (see section 5.1).tofacitinib is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (rheumatoid factor positive [rf+] or negative [rf-] polyarthritis and extended oligoarthritis), and juvenile psoriatic arthritis (psa) in patients 2 years of age and older, who have responded inadequately to previous therapy with disease modifying antirheumatic drugs (dmards).tofacitinib can be given in combination with methotrexate (mtx) or as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate.ankylosing spondylitistofacitinib is indicated for the treatment of adult patients with active ankylosing spondylitis (as) who have responded inadequately to conventional therapy.

Prevenar 13 Unión Europea - inglés - EMA (European Medicines Agency)

prevenar 13

pfizer europe ma eeig - pneumococcal polysaccharide serotype 1, pneumococcal polysaccharide serotype 3, pneumococcal polysaccharide serotype 4, pneumococcal polysaccharide serotype 5, pneumococcal polysaccharide serotype 6a, pneumococcal polysaccharide serotype 6b, pneumococcal polysaccharide serotype 7f, pneumococcal polysaccharide serotype 9v, pneumococcal polysaccharide serotype 14, pneumococcal polysaccharide serotype 18c, pneumococcal polysaccharide serotype 19a, pneumococcal polysaccharide serotype 19f, pneumococcal polysaccharide serotype 23f - pneumococcal infections; immunization - vaccines - active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by streptococcus pneumoniae in infants, children and adolescents from 6 weeks to 17 years of age.active immunisation for the prevention of invasive disease caused by streptococcus pneumoniae in adults ≥18 years of age and the elderly.see sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes.the use of prevenar 13 should be determined on the basis of official recommendations taking into consideration the risk of invasive disease in different age groups, underlying comorbidities as well as the variability of serotype epidemiology in different geographical areas.

Conbriza Unión Europea - inglés - EMA (European Medicines Agency)

conbriza

pfizer europe ma eeig - bazedoxifene - osteoporosis, postmenopausal - sex hormones and modulators of the genital system, - conbriza is indicated for the treatment of postmenopausal osteoporosis in women at increased risk of fracture. a significant reduction in the incidence of vertebral fractures has been demonstrated; efficacy on hip fractures has not been established.when determining the choice of conbriza or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits.

Enbrel Unión Europea - inglés - EMA (European Medicines Agency)

enbrel

pfizer europe ma eeig - etanercept - spondylitis, ankylosing; arthritis, juvenile rheumatoid; arthritis, psoriatic; psoriasis; arthritis, rheumatoid - immunosuppressants - rheumatoid arthritis enbrel in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate. enbrel can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. enbrel is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. enbrel, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function. juvenile idiopathic arthritis treatment of polyarthritis (rheumatoid-factor-positive or -negative) and extended oligoarthritis in children and adolescents from the age of two years who have had an inadequate response to, or who have proved intolerant of, methotrexate. treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. treatment of enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy. enbrel has not been studied in children aged less than two years. psoriatic arthritis treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. enbrel has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease. axial spondyloarthritis ankylosing spondylitis (as) treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. non-radiographic axial spondyloarthritis treatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or magnetic resonance imaging (mri) evidence, who have had an inadequate response to nonsteroidal anti-inflammatory drugs (nsaids). plaque psoriasis treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy, including ciclosporin, methotrexate or psoralen and ultraviolet-a light (puva). paediatric plaque psoriasis treatment of chronic severe plaque psoriasis in children and adolescents from the age of six years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.,

Lifmior Unión Europea - inglés - EMA (European Medicines Agency)

lifmior

pfizer europe ma eeig - etanercept - arthritis, psoriatic; spondylitis, ankylosing; psoriasis - immunosuppressants - rheumatoid arthritis;juvenile idiopathic arthritispsoriatic arthritis;axial spondyloarthritis;plaque psoriasis;paediatric plaque psoriasis.

Palonosetron Hospira Unión Europea - inglés - EMA (European Medicines Agency)

palonosetron hospira

pfizer europe ma eeig - palonosetron hydrochloride - nausea; vomiting; cancer - antiemetics and antinauseants, - palonosetron hospira is indicated in adults for:the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy;the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.palonosetron hospira is indicated in paediatric patients 1 month of age and older for:the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.

Topotecan Hospira Unión Europea - inglés - EMA (European Medicines Agency)

topotecan hospira

pfizer europe ma eeig - topotecan - uterine cervical neoplasms; small cell lung carcinoma - other antineoplastic agents - topotecan monotherapy is indicated for the treatment of patients with relapsed small-cell lung cancer (sclc) for whom re-treatment with the first-line regimen is not considered appropriate. topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with stage ivb disease. patients with prior exposure to cisplatin require a sustained treatment-free interval to justify treatment with the combination.,

Torisel Unión Europea - inglés - EMA (European Medicines Agency)

torisel

pfizer europe ma eeig - temsirolimus - carcinoma, renal cell; lymphoma, mantle-cell - antineoplastic agents - renal-cell carcinomatorisel is indicated for the first-line treatment of adult patients with advanced renal-cell carcinoma (rcc) who have at least three of six prognostic risk factors.mantle-cell lymphomatorisel is indicated for the treatment of adult patients with relapsed and / or refractory mantle-cell lymphoma (mcl).

Toviaz Unión Europea - inglés - EMA (European Medicines Agency)

toviaz

pfizer europe ma eeig - fesoterodine fumarate - urinary bladder, overactive - urologicals - treatment of the symptoms (increased urinary frequency and / or urgency and / or urgency incontinence) that may occur in patients with overactive-bladder syndrome.

Zoledronic Acid Hospira Unión Europea - inglés - EMA (European Medicines Agency)

zoledronic acid hospira

pfizer europe ma eeig - zoledronic acid monohydrate - hypercalcemia - drugs for treatment of bone diseases - 4 mg / 5 ml and 4 mg / 100 ml:prevention of skeletal-related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone.treatment of adult patients with tumour-induced hypercalcaemia (tih).5 mg / 100 ml:treatment of osteoporosis:in post-menopausal women;in men;at increased risk of fracture, including those with a recent low-trauma hip fracture.treatment of osteoporosis associated with long-term systemic glucocorticoid therapy:in post-menopausal women;in men;at increased risk of fracture.treatment of paget's disease of the bone in adults.