European Union - English - EMA (European Medicines Agency)

bayer animal health gmbh  - pradofloxacin - antibacterials for systemic use, fluoroquinolones - dogs; cats - dogstreatment of:wound infections caused by susceptible strains of the staphylococcus intermedius group (including s. pseudintermedius);superficial and deep pyoderma caused by susceptible strains of the staphylococcus intermedius group (including s. pseudintermedius);acute urinary-tract infections caused by susceptible strains of escherichia coli and the staphylococcus intermedius group (including s. pseudintermedius);as adjunctive treatment to mechanical or surgical periodontal therapy in the treatment of severe infections of the gingiva and periodontal tissues caused by susceptible strains of anaerobic organisms, for example porphyromonas spp. and prevotella spp.catstreatment of acute infections of the upper respiratory tract caused by susceptible strains of pasteurella multocida, escherichia coli and the staphylococcus intermedius group (including s. pseudintermedius).

European Union - English - EMA (European Medicines Agency)

immunomedics gmbh - sulesomab - osteomyelitis; radionuclide imaging - diagnostic agents - this medicinal product is for diagnostic use only.leukoscan is indicated for diagnostic imaging for determining the location and extent of infection/inflammation in bone in patients with suspected osteomyelitis, including patients with diabetic foot ulcers.leukoscan has not been employed to diagnose osteomyelitis in patients with sickle cell anaemia.

European Union - English - EMA (European Medicines Agency)

lipomed gmbh - cladribine - leukemia, hairy cell - antineoplastic agents - litak is indicated for the treatment of hairy-cell leukaemia.

European Union - English - EMA (European Medicines Agency)

warner chilcott  deutschland gmbh - testosterone - sexual dysfunctions, psychological - sex hormones and modulators of the genital system, - livensa is indicated for the treatment of hypoactive sexual desire disorder (hsdd) in bilaterally oophorectomised and hysterectomised (surgically induced menopause) women receiving concomitant estrogen therapy.

European Union - English - EMA (European Medicines Agency)

sanofi-aventis deutschland gmbh - insulin human - diabetes mellitus - drugs used in diabetes - diabetes mellitus where treatment with insulin is required. insulin human winthrop rapid is also suitable for the treatment of hyperglycaemic coma and ketoacidosis, as well as for achieving pre-, intra- and postoperative stabilisation in patients with diabetes mellitus.

European Union - English - EMA (European Medicines Agency)

astellas pharma gmbh - tacrolimus - dermatitis, atopic - other dermatological preparations - treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids. treatment of moderate to severe atopic dermatitis in children (2 years of age and above) who failed to respond adequately to conventional therapies such as topical corticosteroids.maintenance treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i.e. occurring 4 or more times per year) who have had an initial response to a maximum of 6 weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected).

European Union - English - EMA (European Medicines Agency)

neovii biotech gmbh - catumaxomab - ascites; cancer - other antineoplastic agents - removab is indicated for the intraperitoneal treatment of malignant ascites in patients with epcam-positive carcinomas where standard therapy is not available or no longer feasible.,

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 - 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.

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

hennig arzneimittel gmbh & co. kg - cinnarizine; dimenhydrinate - oral tablet - 20mg ; 40mg