European Union - English - EMA (European Medicines Agency)

mylan s.a.s - ribavirin - hepatitis c, chronic - antivirals for systemic use - ribavirin mylan is indicated for the treatment of chronic hepatitis c and must only be used as part of a combination regimen with interferon alfa-2b (adults, children (three years of age and older) and adolescents). ribavirin monotherapy must not be used.there is no safety or efficacy information on the use of ribavirin with other forms of interferon (i.e. not alfa-2b).please refer also to the interferon alfa-2b summary of product characteristics (smpc) for prescribing information particular to that product.naïve patientsadult patientsribavirin mylan is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with all types of chronic hepatitis c except genotype 1, not previously treated, without liver decompensation, with elevated alanine aminotransferase (alt), who are positive for serum hepatitis-c-virus (hcv) rna.children and adolescentsribavirin mylan is indicated, in a combination regimen with interferon alfa-2b, for the treatment of children and adolescents three years of age and older, who have all types of chronic hepatitis c except genotype 1, not previously treated, without liver decompensation, and who are positive for serum hcv rna. when deciding to not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition. the reversibility of growth inhibition is uncertain. the decision to treat should be made on a case-by-case basis (see section 4.4).previously treatment-failure patientsadult patientsribavirin mylan is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with chronic hepatitis c who have previously responded (with normalisation of alt at the end of treatment) to interferon alpha monotherapy but who have subsequently relapsed.

European Union - English - EMA (European Medicines Agency)

upjohn eesv - sildenafil - erectile dysfunction - urologicals - 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 viagra to be effective, sexual stimulation is required.

European Union - English - EMA (European Medicines Agency)

upjohn eesv - sildenafil - hypertension, pulmonary - urologicals - treatment of adult patients with pulmonary arterial hypertension classified as world health organization (who) functional class ii and iii, to improve exercise capacity. efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease.paediatric populationtreatment of paediatric patients aged one year to 17 years old with pulmonary arterial hypertension. efficacy in terms of improvement of exercise capacity or pulmonary haemodynamics has been shown in primary pulmonary hypertension and pulmonary hypertension associated with congenital heart disease.revatio solution for injection is for the treatment of adult patients with pulmonary arterial hypertension who are currently prescribed oral revatio and who are temporarily unable to take oral therapy, but are otherwise clinically and haemodynamically stable.revatio (oral) is indicated for treatment of adult patients with pulmonary arterial hypertension classified as who functional class ii and iii, to improve exercise capacity. efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease.

European Union - English - EMA (European Medicines Agency)

viatris limited - tadalafil - hypertension, pulmonary - urologicals - talmanco is indicated in adults for the treatment of pulmonary arterial hypertension (pah) classified as who functional class ii and iii, to improve exercise capacity. efficacy has been shown in idiopathic pah (ipah) and in pah related to collagen vascular disease.

European Union - English - EMA (European Medicines Agency)

mylan pharmaceuticals limited - tadalafil - erectile dysfunction - urologicals - treatment of erectile dysfunction in adult males.in order for tadalafil to be effective, sexual stimulation is required.tadalafil mylan is not indicated for use by women.

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)

mylan pharmaceuticals limited - zoledronic acid - fractures, bone - drugs for treatment of bone diseases - 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).

European Union - English - EMA (European Medicines Agency)

mylan pharmaceuticals limited - zonisamide - epilepsy - antiepileptics, - monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy;adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults, adolescents, and children aged 6 years and above.

Canada - English - Health Canada

bgp pharma ulc - phenytoin - suspension - 125mg - phenytoin 125mg - hydantoins

Canada - English - Health Canada

bgp pharma ulc - phenytoin - suspension - 30mg - phenytoin 30mg - hydantoins