European Union - English - EMA (European Medicines Agency)

biopartners gmbh - ribavirin - hepatitis c, chronic - antivirals for systemic use - ribavirin biopartners is indicated for the treatment of chronic hepatitis-c-virus (hcv) infection in adults, children three years of age and older and adolescents and must only be used as part of a combination regimen with interferon alfa-2b. 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).naïve patientsadult patientsribavirin biopartners 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 hepatitis c viral ribonucleic acid (hcv-rna) (see section 4.4)children three years of age and older and adolescentsribavirin biopartners is intended for use, in a combination regimen with interferon alfa-2b, for the treatment of children three years of age and older and adolescents, who have all types of chronic hepatitis c except genotype 1, not previously treated, without liver decompensation, and who are positive for 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).previous-treatment-failure patientsadult patientsribavirin biopartners 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 alfa monotherapy but who have subsequently relapsed (see section 5.1).

European Union - English - EMA (European Medicines Agency)

biopartners gmbh - somatropin - growth - pituitary and hypothalamic hormones and analogues, somatropin and somatropin agonists - somatropin biopartners is indicated for the replacement therapy of endogenous growth hormone in adults with childhood- or adult-onset growth-hormone deficiency (ghd).adult-onset: patients with ghd in adulthood are defined as patients with known hypothalamic-pituitary pathology and at least one additional known deficiency of a pituitary hormone excluding prolactin. these patients should undergo a single dynamic test in order to diagnose or exclude a ghd.childhood-onset: in patients with childhood-onset isolated ghd (no evidence of hypothalamic-pituitary disease or cranial irradiation), two dynamic tests should be performed after completion of growth, except for those having low insulin-like-growth-factor-i (igf-i) concentrations (< -2 standard-deviation score (sds)), who may be considered for one test. the cut-off point of the dynamic test should be strict.

European Union - English - EMA (European Medicines Agency)

biopartners gmbh - somatropin - turner syndrome; dwarfism, pituitary - pituitary and hypothalamic hormones and analogues - paediatric poulationlong-term treatment of children (2 to 11 years old) and adolescents (12 to 18 years old) with growth failure due to an inadequate secretion of normal endogenous growth hormone.treatment of short stature in children with turner syndrome, confirmed by chromosome analysis.treatment of growth retardation in pre-pubertal children with chronic renal insufficiency.adult patientsreplacement therapy in adults with pronounced growth hormone deficiency of either childhood- or adult-onset aetiology.patients with severe growth hormone deficiency in adulthood are defined as patients with known hypothalamic-pituitary pathology and at least one additional known deficiency of a pituitary hormone not being prolactin. these patients should undergo a single dynamic test in order to diagnose or exclude a growth hormone deficiency. in patients with childhood-onset isolated growth hormone deficiency (no evidence of hypothalamic-pituitary disease or cranial irradiation), two dynamic tests should be recommended, except for those having low insulin-like growth factor-1 (igf-1) concentrations (< 2 standard deviation score (sds)), who may be considered for one test. the cut-off point of the dynamic test should be strict.

European Union - English - EMA (European Medicines Agency)

biopartners gmbh - recombinant human interferon alfa-2a - hepatitis c, chronic - immunostimulants, - adult patients with histologically proven chronic hepatitis c who are positive for hepatitis c virus (hcv) antibodies or hcv rna and have elevated serum alanine aminotransferase (alt) without liver decompensation.the efficacy of interferon alfa-2a in the treatment of hepatitis c is enhanced when combined with ribavirin. alpheon should be given alone mainly in case of intolerance or contra-indication to ribavirin.

European Union - English - EMA (European Medicines Agency)

archie samiel s.r.o. - clopidogrel - peripheral vascular diseases; acute coronary syndrome; myocardial infarction; stroke - antithrombotic agents - clopidogrel is indicated in adults for the prevention of atherothrombotic events in:patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease;patients suffering from acute coronary syndrome:non-st-segment-elevation acute coronary syndrome (unstable angina or non-q wave-myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (asa);st-segment-elevation acute myocardial infarction, in combination with asa in medically treated patients eligible for thrombolytic therapy.

Malta - English - Medicines Authority

denk pharma gmbh & co. kg prinzregentenstrasse 79 81675 münchen , germany - rivaroxaban - film-coated tablet - rivaroxaban 2.5 mg - antithrombotic agents

European Union - English - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - spesolimab - psoriasis - immunosuppressants - spevigo is indicated for the treatment of flares in adult patients with generalised pustular psoriasis (gpp) as monotherapy.

European Union - English - EMA (European Medicines Agency)

abbvie deutschland gmbh & co. kg - risankizumab - psoriasis; arthritis, psoriatic - immunosuppressants - plaque psoriasisskyrizi is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.psoriatic arthritisskyrizi, alone or in combination with methotrexate (mtx), is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (dmards).crohn's diseaseskyrizi is indicated for the treatment of adult patients with moderately to severely active crohn's disease who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy.

Ireland - English - HPRA (Health Products Regulatory Authority)

aristo pharma gmbh - abiraterone acetate - tablet - 250 milligram(s) - abiraterone

Ireland - English - HPRA (Health Products Regulatory Authority)

aristo pharma gmbh - abiraterone acetate - film-coated tablet - 500 milligram(s) - abiraterone