Unjoni Ewropea - Ingliż - EMA (European Medicines Agency)

hospira uk limited - docetaxel trihydrate - stomach neoplasms; prostatic neoplasms; breast neoplasms; head and neck neoplasms; carcinoma, non-small-cell lung - antineoplastic agents - breast cancertaxespira in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:operable node-positive breast cancer;operable node-negative breast cancer.for patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer.taxespira in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.taxespira monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. previous chemotherapy should have included an anthracycline or an alkylating agent.taxespira combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours over express her2 and who previously have not received chemotherapy for metastatic disease.taxespira in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. previous therapy should have included an anthracycline.non-small cell lung cancer taxespira indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.taxespira in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer, in patients who have not previously received chemotherapy for this condition.prostate cancer taxespira in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.gastric adenocarcinoma taxespira in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.head and neck cancer taxespira in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

Unjoni Ewropea - Ingliż - EMA (European Medicines Agency)

pfizer europe ma eeig - crizotinib - carcinoma, non-small-cell lung - antineoplastic agents - xalkori as monotherapy is indicated for:the first‑line treatment of adults with anaplastic lymphoma kinase (alk)‑positive advanced non‑small cell lung cancer (nsclc)the treatment of adults with previously treated anaplastic lymphoma kinase (alk)‑positive advanced non‑small cell lung cancer (nsclc)the treatment of adults with ros1‑positive advanced non‑small cell lung cancer (nsclc)the treatment of paediatric patients (age ≥6 to

Unjoni Ewropea - Ingliż - EMA (European Medicines Agency)

pfizer limited - sunitinib - gastrointestinal stromal tumors; carcinoma, renal cell; neuroendocrine tumors - antineoplastic agents - gastrointestinal stromal tumour (gist)sutent is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (gist) in adults after failure of imatinib mesilate treatment due to resistance or intolerance.metastatic renal cell carcinoma (mrcc)sutent is indicated for the treatment of advanced/metastatic renal cell carcinoma (mrcc) in adults.pancreatic neuroendocrine tumours (pnet)sutent is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours with disease progression in adults.experience with sutent as first-line treatment is limited (see section 5.1).

Unjoni Ewropea - Ingliż - EMA (European Medicines Agency)

pfizer europe ma eeig - pemetrexed disodium, pemetrexed disodium hemipentahydrate - carcinoma, non-small-cell lung; mesothelioma - antineoplastic agents - malignant pleural mesotheliomapemetrexed pfizer in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.non-small cell lung cancerpemetrexed pfizer in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.pemetrexed pfizer is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.pemetrexed pfizer is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.

Unjoni Ewropea - Ingliż - EMA (European Medicines Agency)

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.

Unjoni Ewropea - Ingliż - 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.

Unjoni Ewropea - Ingliż - 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.

Unjoni Ewropea - Ingliż - EMA (European Medicines Agency)

pfizer europe ma eeig - pemetrexed ditromethamine - carcinoma, non-small-cell lung; mesothelioma - folic acid analogues, antimetabolites - malignant pleural mesotheliomapemetrexed hospira uk limited in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.non-small cell lung cancerpemetrexed hospira uk limited in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see smpc section 5.1).pemetrexed hospira uk limited is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy (see smpc section 5.1).pemetrexed hospira uk limited is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see smpc section 5.1).

Unjoni Ewropea - Ingliż - 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.,

Unjoni Ewropea - Ingliż - 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.