European Union - English - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - follitropin beta - infertility; hypogonadism - sex hormones and modulators of the genital system, - in the female:fertavid is indicated for the treatment of female infertility in the following clinical situations:anovulation (including polycystic ovarian disease, pcod) in women who have been unresponsive to treatment with clomifene citratecontrolled ovarian hyperstimulation to induce the development of multiple follicles in medically assisted reproduction programs [e.g. in vitro fertilisation/embryo transfer (ivf/et), gamete intra-fallopian transfer (gift) and intracytoplasmic sperm injection (icsi).in the male:deficient spermatogenesis due to hypogonadotrophic hypogonadism.

European Union - English - EMA (European Medicines Agency)

schering-plough europe - interferon alfa-2b - hepatitis c, chronic; hepatitis b, chronic - immunostimulants, - chronic hepatitis b: treatment of adult patients with chronic hepatitis b associated with evidence of hepatitis b viral replication (presence of hbv-dna and hbeag), elevated alanine aminotransferase (alt) and histologically proven active liver inflammation and/or fibrosis.chronic hepatitis c:adult patients:introna is indicated for the treatment of adult patients with chronic hepatitis c who have elevated transaminases without liver decompensation and who are positive for serum hcv-rna or anti-hcv (see section 4.4).the best way to use introna in this indication is in combination with ribavirin.chidren and adolescents:introna is intended for use, in a combination regimen with ribavirin, for the treatment of children and adolescents 3 years of age and older, who have chronic hepatitis c, not previously treated, without liver decompensation, and who are positive for serum hcv-rna. the decision to treat should be made on a case by case basis, taking into account any evidence of disease progression such as hepatic inflammation and fibrosis, as well as prognostic factors for response, hcv genotype and viral load. the expected benefit of treatment should be weighed against the safety findings observed for paediatric subjects in the clinical trials (see sections 4.4, 4.8 and 5.1).

European Union - English - EMA (European Medicines Agency)

sandoz gmbh - pemetrexed disodium hemipentahydrate - carcinoma, non-small-cell lung; mesothelioma - antineoplastic agents - malignant pleural mesothelioma pemetrexed sandoz in combination with cisplatin is indicated for the treatment of chemotherapy naive patients with unresectable malignant pleural mesothelioma. non-small cell lung cancer pemetrexed sandoz 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 sandoz 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 sandoz 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.,

European Union - English - EMA (European Medicines Agency)

schering-plough europe - posaconazole - candidiasis; mycoses; coccidioidomycosis; aspergillosis - antimycotics for systemic use - posaconazole sp is indicated for use in the treatment of the following fungal infections in adults (see section 5.1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products;- oropharyngeal candidiasis: as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor.refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.posaconazole sp is also indicated for prophylaxis of invasive fungal infections in the following patients:- patients receiving remission-induction chemotherapy for acute myelogenous leukemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who areat high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.

European Union - English - EMA (European Medicines Agency)

sandoz gmbh - pregabalin - anxiety disorders; neuralgia; epilepsy - antiepileptics, - neuropathic painpregabalin sandoz is indicated for the treatment of peripheral and central neuropathic pain in adults.epilepsypregabalin sandoz is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.generalised anxiety disorderpregabalin sandoz is indicated for the treatment of generalised anxiety disorder (gad) in adults.

European Union - English - EMA (European Medicines Agency)

sandoz gmbh - pregabalin - anxiety disorders; epilepsy - antiepileptics, - epilepsypregabalin sandoz gmbh is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.generalised anxiety disorderpregabalin sandoz gmbh is indicated for the treatment of generalised anxiety disorder (gad) in adults.

European Union - English - EMA (European Medicines Agency)

meda ab - zaleplon - sleep initiation and maintenance disorders - psycholeptics - sonata is indicated for the treatment of patients with insomnia who have difficulty falling asleep. it is indicated only when the disorder is severe, disabling or subjecting the individual to extreme distress.

European Union - English - EMA (European Medicines Agency)

viatris healthcare limited - tolcapone - parkinson disease - anti-parkinson drugs, other dopaminergic agents - tasmar is indicated in combination with levodopa / benserazide or levodopa / carbidopa for use in patients with levodopa-responsive idiopathic parkinson’s disease and motor fluctuations, who failed to respond to or are intolerant of other catechol-o-methyltransferase (comt) inhibitors.because of the risk of potentially fatal, acute liver injury, tasmar should not be considered as a first-line adjunct therapy to levodopa / benserazide or levodopa / carbidopa.since tasmar should be used only in combination with levodopa / benserazide and levodopa / carbidopa, the prescribing information for these levodopa preparations is also applicable to their concomitant use with tasmar.

European Union - English - EMA (European Medicines Agency)

hexal ag - temozolomide - glioma; glioblastoma - antineoplastic agents - for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (rt) and subsequently as monotherapy treatment.for the treatment of children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

meda pharmaceuticals ltd - tolcapone - tablet - 100mg