Ireland - English - HPRA (Health Products Regulatory Authority)

pharma nord aps - melatonin - film-coated tablet - 3 milligram(s) - melatonin

Israel - English - Ministry of Health

mbi pharma ltd., israel - dexamethasone phosphate ( as sodium phosphate ) - solution for injection / infusion - dexamethasone phosphate ( as sodium phosphate ) 4 mg/ml - dexamethasone - dexamethasone kern pharma is indicated in the treatment of:• endocrine diseases such as nonsuppurative thyroiditis, hypercalcaemia associated with cancer and congenital adrenal hyperplasia.• allergy: severe or disabling allergic conditions resistant to conventional treatments, as in: bronchial asthma, contact or atopical dermatitis, seasonal or perennial allergic rhinitis, hypersensitivity reactions to drugs.• ophtalmic: serious inflammatory and allergic processes, acute and chronic, affecting the eyes, such as: iritis and iridocyclitis, chorioretinitis, choroiditis and diffuse posterior uveitis, optical neuritis, allergic conjunctivitis, allergic marginal corneal ulcers.• inflammatory bowel dis.: systemic treatment in exacerbations of ulcerative colitis and regional enteritis.• dermatological diseases (pemphigus, stevens johnson syndrome, exfoliative dermatitis, severe psoriasis and mycosis fungoides) • respiratory diseases (symptomatic sarcoidosis, berylliosis, loeffler's syndrome)• haematological: acquired )autoimmune( haemolytic anaemia, idiopathic thrombocytopenic purpura in adult, pure red cell aplasia• nephrotic syndrome of the idioplathic type or that due to lupus erythematosus• cerebral edema caused by brain tumor, neurosurgery, brain abscess, bacterial meningitis• collagen diseases: active rheumatoid arthritis with severe progressive course, fast destructive remitting forms and / or extra-articular manifestations, juvenile idiopathic arthritis with severe systemic-onset form (still's disease) or locally with no control, rheumatic fever with carditis, dermatomyositis, polymyositis, sle, temporal arteritis.• infectious diseases: bacterial meningitis – adjunct to antibiotics in suspected pneumococcal meningitis and tb meningitis. severe infectious diseases with toxic states (eg tuberculosis, typhoid, brucellosis;. only with simultaneous anti-infective therapy)• fetal lung maturation• chemotherapy – associated nausea and vomiting• multiple myeloma – part of chemotherapy protocols (eg vad)• prevention and treatment of acute mountain sickness/hace

European Union - English - EMA (European Medicines Agency)

teva pharma b.v.  - budesonide, formoterol fumarate dihydrate - asthma; pulmonary disease, chronic obstructive - drugs for obstructive airway diseases, - budesonide/formoterol teva pharma b.v. is indicated in adults 18 years of age and older only.asthmabudesonide/formoterol teva pharma b.v. is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate:-in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.or-in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.copdsymptomatic treatment of patients with copd with forced expiratory volume in 1 second (fev1) 

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - terlipressin acetate 0.2 mg/ml equivalent to terlipressin 0.17mg/ml;   - solution for injection - 1 mg/5ml - active: terlipressin acetate 0.2 mg/ml equivalent to terlipressin 0.17mg/ml   excipient: glacial acetic acid hydrochloric acid sodium chloride sodium hydroxide water for injection - indicated for: - the treatment of bleeding oesophageal varices (bov); and - type 1 hepatorenal syndrome, characterised by spontaneous acute renal insufficiency, in patients suffering from severe cirrhosis with ascites.

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - terlipressin acetate 0.2 mg/ml equivalent to terlipressin 0.17mg/ml;   - solution for injection - 2 mg/10ml - active: terlipressin acetate 0.2 mg/ml equivalent to terlipressin 0.17mg/ml   excipient: glacial acetic acid hydrochloric acid sodium chloride sodium hydroxide water for injection - indicated for: - the treatment of bleeding oesophageal varices (bov); and - type 1 hepatorenal syndrome, characterised by spontaneous acute renal insufficiency, in patients suffering from severe cirrhosis with ascites.

Malta - English - Medicines Authority

laboratorios q pharma, s.l c/ moratín, 15 entlo. oficinas 6-7, alicante 03008, spain - dutasteride, tamsulosin hydrochloride - hard capsule - dutasteride 0.5 mg tamsulosin hydrochloride 0.4 mg - urologicals

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - dexmedetomidine hydrochloride 0.1182 mg/ml equivalent to dexmedetomidine 0.1mg/ml - concentrate for injection - active: dexmedetomidine hydrochloride 0.1182 mg/ml equivalent to dexmedetomidine 0.1mg/ml excipient: sodium chloride water for injection - for sedation of initially intubated patients during treatment in an intensive care setting. the use of dexmedetomidine hydrochloride ever pharma by continuous intubation in these patents should not exceed 24 hours. for sedation of non-intubated patients prior to and/or during surgical and other procedures.

Malta - English - Medicines Authority

kern pharma, s.l. polígono industrial colón ii calle venus 72 08228, terrassa, barcelona , spain - film-coated tablet - sitagliptin 50 mg metformin hydrochloride 850 mg - drugs used in diabetes

Malta - English - Medicines Authority

kern pharma, s.l. polígono industrial colón ii calle venus 72 08228, terrassa, barcelona , spain - film-coated tablet - sitagliptin 50 mg metformin hydrochloride 1000 mg - drugs used in diabetes

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

idaman pharma manufacturing sdn bhd - chlorpromazine hydrochloride -