Liên Minh Châu Âu - Tiếng Anh - EMA (European Medicines Agency)

pfizer europe ma eeig - gemtuzumab ozogamicin - leukemia, myeloid, acute - antineoplastic agents - mylotarg is indicated for combination therapy with daunorubicin (dnr) and cytarabine (arac) for the treatment of patients age 15 years and above with previously untreated, de novo cd33-positive acute myeloid leukaemia (aml), except acute promyelocytic leukaemia (apl).

Liên Minh Châu Âu - Tiếng Anh - EMA (European Medicines Agency)

pfizer europe ma eeig - trastuzumab - stomach neoplasms; breast neoplasms - antineoplastic agents - breast cancermetastatic breast cancertrazimera is indicated for the treatment of adult patients with her2 positive metastatic breast cancer: (mbc):as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments.in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable.in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease.in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive mbc, not previously treated with trastuzumab.early breast cancertrazimera is indicated for the treatment of adult patients with her2 positive early breast cancer. (ebc).following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable).following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel.in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.in combination with neoadjuvant chemotherapy followed by adjuvant trazimera therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter.trazimera should only be used in patients with metastatic or early breast cancer whose tumours have either her2 overexpression or her2 gene amplification as determined by an accurate and validated assay.metastatic gastric cancertrazimera in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with her2 positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.trazimera should only be used in patients with metastatic gastric cancer (mgc) whose tumours have her2 overexpression as defined by ihc2+ and a confirmatory sish or fish result, or by an ihc 3+ result. accurate and validated assay methods should be used.

Liên Minh Châu Âu - Tiếng Anh - EMA (European Medicines Agency)

pfizer europe ma eeig - sirolimus - graft rejection; kidney transplantation - immunosuppressants - rapamune is indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving a renal transplant. it is recommended that rapamune be used initially in combination with ciclosporin microemulsion and corticosteroids for 2 to 3 months. rapamune may be continued as maintenance therapy with corticosteroids only if ciclosporin microemulsion can be progressively discontinued. rapamune is indicated for the treatment of patients with sporadic lymphangioleiomyomatosis with moderate lung disease or declining lung function.,

Liên Minh Châu Âu - Tiếng Anh - EMA (European Medicines Agency)

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).

Liên Minh Châu Âu - Tiếng Anh - EMA (European Medicines Agency)

pfizer europe ma eeig - oestrogens conjugated, bazedoxifene - postmenopause - conjugated estrogens and bazedoxifene - duavive is indicated for:treatment of oestrogen deficiency symptoms in postmenopausal women with a uterus (with at least 12 months since the last menses) for whom treatment with progestin-containing therapy is not appropriate.the experience treating women older than 65 years is limited.

Liên Minh Châu Âu - Tiếng Anh - EMA (European Medicines Agency)

pfizer europe ma eeig - parecoxib sodium - pain, postoperative - coxibs, antiinflammatory and antirheumatic products - for the short-term treatment of postoperative pain in adults.,

Liên Minh Châu Âu - Tiếng Anh - EMA (European Medicines Agency)

pfizer europe ma eeig - levetiracetam - epilepsy - antiepileptics, - levetiracetam hospira is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy.levetiracetam hospira is indicated as adjunctive therapyin the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy.in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.levetiracetam hospira concentrate is an alternative for patients when oral administration is temporarily not feasible.

Liên Minh Châu Âu - Tiếng Anh - EMA (European Medicines Agency)

pfizer europe ma eeig - neisseria meningitidis group a polysaccharide conjugated to tetanus toxoid, neisseria meningitidis group c polysaccharide conjugated to tetanus toxoid, neisseria meningitidis group w-135 polysaccharide conjugated to tetanus toxoid, neisseria meningitidis group y polysaccharide conjugated to tetanus toxoid - meningitis, meningococcal - vaccines - nimenrix is indicated for active immunisation of individuals from the age of 6 weeks against invasive meningococcal diseases caused by neisseria meningitidis group a, c, w-135, and y.

Liên Minh Châu Âu - Tiếng Anh - EMA (European Medicines Agency)

pfizer europe ma eeig  - filgrastim - neutropenia; hematopoietic stem cell transplantation; cancer - immunostimulants, - filgrastim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia.the safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy.filgrastim is indicated for the mobilisation of peripheral blood progenitor cells (pbpcs).in patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (anc) of ≤0.5 x 109/l and a history of severe or recurrent infections, long-term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.filgrastim is indicated for the treatment of persistent neutropenia (anc ≤1.0 x 109/l) in patients with advanced hiv infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.

Liên Minh Châu Âu - Tiếng Anh - EMA (European Medicines Agency)

pfizer europe ma eeig - daptomycin - soft tissue infections; skin diseases, bacterial - antibacterials for systemic use, - daptomycin is indicated for the treatment of the following infections.adult and paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections (cssti).adult patients with right-sided infective endocarditis (rie) due to staphylococcus aureus. it isrecommended that the decision to use daptomycin should take into account the antibacterial susceptibility of the organism and should be based on expert advice.adult and paediatric (1 to 17 years of age) patients with staphylococcus aureus bacteraemia (sab).in adults, use in bacteraemia should be associated with rie or with cssti, while in paediatric patients, use in bacteraemia should be associated with cssti.daptomycin is active against gram positive bacteria only. in mixed infections where gram negative and/or certain types of anaerobic bacteria are suspected, daptomycin should be co-administered with appropriate antibacterial agent(s).consideration should be given to official guidance on the appropriate use of antibacterial agents.