Ireland - English - HPRA (Health Products Regulatory Authority)

teva pharmaceuticals limited - glatiramer acetate - solution for injection - 40 mg/ml - other immunostimulants - antineoplastic and immunomodulating agents, immunostimulants - it is indicated for the treatment of relapsing forms of multiple sclerosis (ms) (see section 5.1 for important information on the population for which efficacy has been established). copaxone is not indicated in primary or secondary progressive ms.

European Union - English - EMA (European Medicines Agency)

teva gmbh - filgrastim - neutropenia; hematopoietic stem cell transplantation; cancer - immunostimulants, - tevagrastim 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.tevagrastim is indicated for the mobilisation of peripheral blood progenitor cells (pbpc).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 tevagrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.tevagrastim is indicated for the treatment of persistent neutropenia (anc less than or equal to 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.

Israel - English - Ministry of Health

teva israel ltd - filgrastim - solution for injection / infusion - filgrastim 0.6 mg/ml - filgrastim - filgrastim - tevagrastim 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 tevagrastim are similar in adults and children receiving cytotoxic chemotherapy. tevagrastim is indicated for the mobilisation of peripheral blood progenitor cells in normal donors (allogeneic pbpc). in patients children or adults with severe congenital neutropenia cyclic or idiopathic neutropenia with an absolute nuetrophil count (anc) less than or equal to 0.5 x 1000000000 /l and a history of severe or recurrent infections long term administration of tevagrastim is indicated to increase neutophil count and to reduce the incidence and duration of infection-related events. tevagrastim in indicated for the treatment of persistent neutopenia (anc less than or equal to 1.0 x 1000000000/l ) in patients with advanced hiv infection in order to reduce the risk of bacterial infections when other options to manage neutopenia are inappropriate.

European Union - English - EMA (European Medicines Agency)

teva pharma b.v. - capecitabine - colonic neoplasms; breast neoplasms; colorectal neoplasms; stomach neoplasms - antineoplastic agents - capecitabine teva is indicated for the adjuvant treatment of patients following surgery of stage iii (dukes’ stage c) colon cancer.capecitabine teva is indicated for the treatment of metastatic colorectal cancer.capecitabine teva is indicated for first‑line treatment of advanced gastric cancer in combination with a platinum‑based regimen.capecitabine teva in combination with docetaxel 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. capecitabine teva is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.

European Union - English - EMA (European Medicines Agency)

teva b.v. - imatinib - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - antineoplastic agents, protein kinase inhibitors - imatinib teva is indicated for the treatment ofadult and paediatric patients with newly diagnosed philadelphia chromosome (bcr‑abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment.adult and paediatric patients with ph+ cml in chronic phase after failure of interferon‑alpha therapy, or in accelerated phase or blast crisis.adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy.adult patients with relapsed or refractory ph+ all as monotherapy.adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements.adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfrα rearrangement.the effect of imatinib on the outcome of bone marrow transplantation has not been determined.imatinib teva is indicated forthe treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist).the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. patients who have a low or very low risk of recurrence should not receive adjuvant treatment.the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery.in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic gist and dfsp and on recurrence-free survival in adjuvant gist. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5.1). except in newly diagnosed chronic phase cml, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases. 

European Union - English - EMA (European Medicines Agency)

teva pharma b.v.  - lamivudine, zidovudine - hiv infections - antivirals for systemic use - lamivudine/zidovudine teva is indicated in antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (hiv) infection.

European Union - English - EMA (European Medicines Agency)

teva b.v. - levetiracetam - epilepsy - nervous system - levetiracetam teva 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 teva is indicated as adjunctive therapy:in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents, children and infants from 1 month 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.

European Union - English - EMA (European Medicines Agency)

teva pharma b.v. - mycophenolate mofetil - graft rejection - immunosuppressants - mycophenolate mofetil teva is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.

European Union - English - EMA (European Medicines Agency)

teva b.v.  - sildenafil - erectile dysfunction - drugs used in erectile dysfunction - treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. in order for sildenafil teva to be effective, sexual stimulation is required.,

European Union - English - EMA (European Medicines Agency)

teva pharma b.v. - pramipexole dihydrochloride monohydrate - parkinson disease - anti-parkinson drugs - pramipexole teva is indicated for treatment of the signs and symptoms of idiopathic parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end-of-dose or 'on-off' fluctuations).pramipexole teva is indicated in adults for symptomatic treatment of moderate to severe idiopathic restless legs syndrome in doses up to 0.54 mg of base (0.75 mg of salt) (see section 4.2).