Israel - engelsk - Ministry of Health

naomi shaco-ezra ltd - buprenorphine as hydrochloride; naloxone as hydrochloride dihydrate - sublingual film - buprenorphine as hydrochloride 12 mg; naloxone as hydrochloride dihydrate 3 mg - buprenorphine - suboxone sublingual film is indicated for treatment of opioid dependence in adults and adolescents over 15 years of age. suboxone sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support

Israel - engelsk - Ministry of Health

naomi shaco-ezra ltd - buprenorphine as hydrochloride; naloxone as hydrochloride dihydrate - sublingual film - buprenorphine as hydrochloride 2 mg; naloxone as hydrochloride dihydrate 0.5 mg - buprenorphine - suboxone sublingual film is indicated for treatment of opioid dependence in adults and adolescents over 15 years of age. suboxone sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support.

Israel - engelsk - Ministry of Health

naomi shaco-ezra ltd - buprenorphine as hydrochloride; naloxone as hydrochloride dihydrate - sublingual film - buprenorphine as hydrochloride 8 mg; naloxone as hydrochloride dihydrate 2 mg - buprenorphine - suboxone sublingual film is indicated for treatment of opioid dependence in adults and adolescents over 15 years of age. suboxone sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support

Singapore - engelsk - HSA (Health Sciences Authority)

accord healthcare private limited - sorafenib tosylate eqv to sorafenib - tablet, film coated - sorafenib tosylate eqv to sorafenib 200 mg

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

pharmacor pty ltd - imatinib mesilate, quantity: 478 mg (equivalent: imatinib, qty 400 mg) - tablet, film coated - excipient ingredients: magnesium stearate; titanium dioxide; macrogol 8000; hypromellose; purified talc - gilmat is indicated for the:,? treatment of patients with chronic myeloid leukaemia (cml) ? treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy ? treatment of adult patients with relapsed or refractory ph+ all as monotherapy ? treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements, where conventional therapies have failed ? treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) ?treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) ?adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of kit (cd117)-positive primary gist (see dosage and administration and clinical trials) ? treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

fit-bioceuticals pty ltd - ubidecarenone, quantity: 150 mg - tablet, orally disintegrating - excipient ingredients: magnesium stearate; citric acid; povidone; sorbitol; mannitol; flavour - antioxidant/reduce free radicals formed in the body ; maintain/support energy levels ; maintain/support energy production ; maintain/support physical endurance/capacity/stamina ; maintain/support general health and wellbeing ; maintain/support cardiovascular system health ; maintain/support muscle function ; maintain/support sperm health ; maintain/support sperm motility

Den Europæiske Union - engelsk - EMA (European Medicines Agency)

roche registration gmbh - faricimab - wet macular degeneration; macular edema; diabetes complications - ophthalmologicals - vabysmo is indicated for the treatment of adult patients with:neovascular (wet) age-related macular degeneration (namd),visual impairment due to diabetic macular oedema (dme).

Den Europæiske Union - engelsk - EMA (European Medicines Agency)

amgen europe b.v. - talimogene laherparepvec - melanoma - antineoplastic agents - imlygic is indicated for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (stage iiib, iiic and ivm1a) with no bone, brain, lung or other visceral disease.

Den Europæiske Union - engelsk - EMA (European Medicines Agency)

novartis europharm limited  - brolucizumab - wet macular degeneration - ophthalmologicals - beovu is indicated in adults for the treatment of neovascular (wet) age-related macular degeneration (amd).

Irland - engelsk - HPRA (Health Products Regulatory Authority)

clonmel healthcare ltd - cimetidine - film-coated tablet - 400 milligram(s) - h2-receptor antagonists; cimetidine