European Union - English - 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.

European Union - English - EMA (European Medicines Agency)

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.

European Union - English - 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.,

European Union - English - EMA (European Medicines Agency)

pfizer europe ma eeig - pegvisomant - acromegaly - pituitary and hypothalamic hormones and analogues - treatment of adult patients with acromegaly who have had an inadequate response to surgery and/or radiation therapy and in whom an appropriate medical treatment with somatostatin analogues did not normalize igf-i concentrations or was not tolerated.treatment of adult patients with acromegaly who have had an inadequate response to surgery and/or radiation therapy and in whom an appropriate medical treatment with somatostatin analogues did not normalize igf -i concentrations or was not tolerated.

European Union - English - EMA (European Medicines Agency)

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.,

European Union - English - 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).

European Union - English - EMA (European Medicines Agency)

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.

European Union - English - EMA (European Medicines Agency)

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.

European Union - English - EMA (European Medicines Agency)

pfizer europe ma eeig - inotuzumab ozogamicin - precursor cell lymphoblastic leukemia-lymphoma - antineoplastic agents - besponsa is indicated as monotherapy for the treatment of adults with relapsed or refractory cd22-positive b cell precursor acute lymphoblastic leukaemia (all). adult patients with philadelphia chromosome positive (ph+) relapsed or refractory b cell precursor all should have failed treatment with at least 1 tyrosine kinase inhibitor (tki).

European Union - English - 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).