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

ratiopharm uk ltd - terbinafine hydrochloride - cutaneous cream - 10mg/1gram

European Union - English - EMA (European Medicines Agency)

gedeon richter - cariprazine hydrochloride - schizophrenia - psycholeptics - reagila is indicated for the treatment of schizophrenia in adult patients.

Australia - English - Department of Health (Therapeutic Goods Administration)

gedeon richter australia pty ltd - 44127 - needle, injector, medication/vaccine - a slender, sharply pointed needle used to penetrate the skin to deliver medicine to a patient. the device is only for single use

Australia - English - Department of Health (Therapeutic Goods Administration)

gedeon richter australia pty ltd - 45771 - cartridge-accepting autoinjector, mechanical - a portable, hand-held, mechanical device in the form of a large pen, designed to accept a pharmaceutical-containing cartridge and intended to be used by a patient to subcutaneously inject a dose of the pharmaceutical agent via a replaceable needle. the cartridge is inserted into the device and a dial on the device is operated for dosing. the cartridge is replaced once the pharmaceutical is exhausted. this is a reusable device.

Australia - English - Department of Health (Therapeutic Goods Administration)

gedeon richter australia pty ltd - teriparatide, quantity: 250 microgram/ml - injection, solution - excipient ingredients: metacresol; water for injections; sodium hydroxide; hydrochloric acid; glacial acetic acid; mannitol; sodium acetate trihydrate - terrosa is indicated for the treatment of osteoporosis in postmenopausal women and the treatment of primary osteoporosis in men when other agents are considered unsuitable and when there is a high risk of fractures.,terrosa is indicated for the treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at high risk for fracture.

Ireland - English - HPRA (Health Products Regulatory Authority)

gedeon richter plc - levonorgestrel; ethinylestradiol - film-coated tablet - progestogens and estrogens, fixed combinations; levonorgestrel and ethinylestradiol

Singapore - English - HSA (Health Sciences Authority)

pharmline marketing pte. ltd. - chlormadinone acetate; ethinylestradiol - tablet, film coated - chlormadinone acetate 2.000 mg; ethinylestradiol 0.030 mg

Israel - English - Ministry of Health

trima israel pharmaceutical products maabarot ltd - prasugrel - film coated tablets - prasugrel 10 mg - prasugrel - prasugrel - trima 10 mg, co-administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in patients with acute coronary syndrome ( i.e. unstable angina, non-st segment elevation myocardial infarction [ua/nstemi] or st segment elevation myocardial infarction [stemi] undergoing primary or delayed percutaneous coronary intervention (pci). the increased efficacy should be balanced with the increased risk in patients with bleeding tendencyin those who had tia/cva in the past and in those above the age of 75 or weight below 60 kg.

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

gedeon richter plc - ethinylestradiol, levonorgestrel - tablets film-coated - i-0,03mg+ 0,05mg, ii-0,04mg+ 0,075mg, iii-0,03mg+ 0,125mg

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - follitropin alfa 150 [iu] (11 mcg) - solution for injection - 600 iu/ml - active: follitropin alfa 150 [iu] (11 mcg) excipient: dibasic sodium phosphate dihydrate methionine monobasic sodium phosphate dihydrate phosphoric acid poloxamer sucrose water for injection - in adult men: bemfola is indicated with concomitant human chorionic gonadotrophin (hcg) therapy for the stimulation of spermatogenesis in gonadotrophin-deficient men in whom hcg alone is ineffective.