União Europeia - inglês - EMA (European Medicines Agency)

ratiopharm gmbh - desloratadine - rhinitis, allergic, perennial; urticaria; rhinitis, allergic, seasonal - antihistamines for systemic use, - desloratadine ratiopharm is indicated in adults for the relief of symptoms associated with:allergic rhinitischronic idiopathic urticaria as initially diagnosed by a physician

União Europeia - inglês - EMA (European Medicines Agency)

teva b.v - desloratadine - rhinitis, allergic, perennial; rhinitis, allergic, seasonal - antihistamines for systemic use, - desloratadine teva is indicated for the relief of symptoms associated with:allergic rhinitis;urticaria.

União Europeia - inglês - EMA (European Medicines Agency)

actavis group ptc ehf - oseltamivir - influenza, human - antivirals for systemic use, neuraminidase inhibitors - treatment of influenzain patients one year of age and older who present with symptoms typical of influenza, when influenza virus is circulating in the community.ebilfumin is indicated for the treatment of infants less than 1 year of age during a pandemic influenza outbreak (see section 5.2 of the smpc). the treating physician should take into account the pathogenicity of the circulating strain and the underlying condition of the patient to ensure there is a potential benefit to the child.prevention of influenzapost-exposure prevention in individuals 1 year of age or older following contact with a clinically diagnosed influenza case when influenza virus is circulating in the community.the appropriate use of ebilfumin for prevention of influenza should be determined on a case by case basis by the circumstances and the population requiring protection. in exceptional situations (e.g. in case of a mismatch between the circulating and vaccine virus strains, and a pandemic situation) seasonal prevention could be considered in individuals one year of age or older.ebilfumin is indicated for post-exposure prevention of influenza in infants less than 1 year of age during a pandemic influenza outbreak (see section 5.2 of the smpc).ebilfumin is not a substitute for influenza vaccination.

União Europeia - inglês - EMA (European Medicines Agency)

teva b.v. - efavirenz - hiv infections - antivirals for systemic use - efavirenz is indicated in antiviral combination treatment of human-immunodeficiency-virus-1 (hiv-1)-infected adults, adolescents and children 3 years of age and older.efavirenz has not been adequately studied in patients with advanced hiv disease, namely in patients with cd4 counts < 50 cells/mm3, or after failure of protease inhibitor (pi)-containing regimens. although cross-resistance of efavirenz with protease inhibitors (pis) has not been documented, there are at present insufficient data on the efficacy of subsequent use of pi-based combination therapy after failure of regimens containing efavirenz.

União Europeia - inglês - EMA (European Medicines Agency)

teva b.v. - fentanyl - pain; cancer - analgesics - effentora is indicated for the treatment of breakthrough pain (btp) in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain. btp is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain. patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer. ,

União Europeia - inglês - EMA (European Medicines Agency)

teva pharma b.v. - entacapone - parkinson disease - anti-parkinson drugs - entacapone is indicated as an adjunct to standard preparations of levodopa / benserazide or levodopa / carbidopa for use in adult patients with parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.

União Europeia - inglês - EMA (European Medicines Agency)

ratiopharm gmbh - epoetin theta - kidney failure, chronic; anemia; cancer - other antianemic preparations - treatment of symptomatic anaemia associated with chronic renal failure in adult patients.treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.

União Europeia - inglês - EMA (European Medicines Agency)

teva pharma b.v. - ibandronic acid - breast neoplasms; neoplasm metastasis; fractures, bone; osteoporosis, postmenopausal - drugs for treatment of bone diseases - ibandronic acid 50mgibandronic acid teva is indicated for the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.ibandronic acid 150mgtreatment of osteoporosis in postmenopausal women at increased risk of fracture. a reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established.

União Europeia - inglês - EMA (European Medicines Agency)

actavis group ptc ehf - imatinib - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - protein kinase inhibitors, antineoplastic agents - imatinib actavis is indicated for the treatment of: , 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;, paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis;, adult patients with ph+ cml in blast crisis;, adult 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-pdgfr rearrangement;, 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. , the effect of imatinib on the outcome of bone marrow transplantation has not been determined. imatinib actavis is indicated for: , 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 dfsp. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited. there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.

União Europeia - inglês - 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.