European Union - English - EMA (European Medicines Agency)

nova laboratories ireland limited - azathioprine - graft rejection - immunosuppressants - jayempi is indicated in combination with other immunosuppressive agents for the prophylaxis of transplant rejection in patients receiving allogenic kidney, liver, heart, lung or pancreas transplants. azathioprine is indicated in immunosuppressive regimens as an adjunct to immunosuppressive agents that form the mainstay of treatment (basis immunosuppression).jayempi is used as an immunosuppressant antimetabolite either alone or, more commonly, in combination with other agents (usually corticosteroids) and/ or procedures which influence the immune response.jayempi is indicated in patients who are intolerant to glucocorticosteroids or if the therapeutic response is inadequate despite treatment with high doses of glucocorticosteroids, in the following diseases:severe active rheumatoid arthritis (chronic polyarthritis) that cannot be kept under control by less toxic agents (disease-modifying anti-rheumatic -medicinal products – dmards)auto-immune hepatitis systemic lupus erythematosusdermatomyositispolyarteritis nodosapemphigus vulgaris and bullous pemphigoidbehçet’s diseaserefractory auto-immune haemolytic anaemia, caused by warm igg antibodieschronic refractory idiopathic thrombocytopenic purpurajayempi is used for the treatment of moderately severe to severe forms of chronic inflammatory bowel disease (ibd) (crohn’s disease or ulcerative colitis) in patients in whom glucocorticosteroid therapy is necessary, but where glucocorticosteroids are not tolerated, or in whom the disease is untreatable with other common means of first choice.it is also indicated in adult patients in relapsing multiple sclerosis, if an immunomodulatory therapy is indicated but beta interferon therapy is not possible, or a stable course has been achieved with previous treatment with azathioprine. 3jayempi is indicated for the treatment of generalised myasthenia gravis. depending on the severity of the disease, jayempi should be given in combination with glucocorticosteroids because of slow onset of action at the beginning of treatment and the glucocorticosteroid dose should be gradually reduced after several months of treatment.

Israel - English - Ministry of Health

astrazeneca (israel) ltd - anifrolumab - concentrate for solution for infusion - anifrolumab 150 mg/ml - anifrolumab - saphnelo is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (sle), who are receiving standard therapy.limitations of usethe efficacy of saphnelo has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. use of saphnelo is not recommended in these situations.

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

astrazeneca pty ltd - anifrolumab, quantity: 300 mg - injection, concentrated - excipient ingredients: polysorbate 80; water for injections; trehalose dihydrate; histidine hydrochloride monohydrate; histidine; lysine hydrochloride - saphnelo (anifrolumab) is indicated as add on treatment of adult patients with moderate to severe, active systemic lupus erythematosus (sle), despite standard therapy.,the safety and efficacy of saphnelo have not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus.

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

sandoz pty ltd - azathioprine, quantity: 25 mg - tablet, film coated - excipient ingredients: purified talc; lactose monohydrate; magnesium stearate; maize starch; povidone; colloidal anhydrous silica; titanium dioxide; hypromellose; microcrystalline cellulose; peg-8 stearate - immunosuppressant antimetabolite: either alone, or more commonly, in combination with other agents (usually corticosteroids) and procedures which influence the immune response. therapeutic effect may be evident only after weeks or months and can include a steroid-sparing effect, thereby reducing the toxicity associated with higher dosage and prolonged usage of corticosteroids. azathioprine, in combination with cortocosteroids and/or other immunosuppressive agents and procedures, is indicated in the management of patients receiving organ transplants. azathioprine, either alone or more usually in combination with corticosteroids and/or other procedures, has been used with clinical benefit which may include reduction of dosage or discontinuation of corticosteroids, in a proportion of patients suffering from the following: severe rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis/polymyositis, autoimmune chronic active hepatitis, pemphigus vulgaris, polyarteritis nodosa, autoimmune haemolytic ana

United States - English - NLM (National Library of Medicine)

king bio inc. - aconitum napellus (unii: u0nq8555jd) (aconitum napellus - unii:u0nq8555jd), lycoperdon utriforme fruiting body (unii: k2a74u428f) (lycoperdon utriforme fruiting body - unii:k2a74u428f), bryonia alba root (unii: t7j046yi2b) (bryonia alba root - unii:t7j046yi2b), matricaria recutita (unii: g0r4ubi2zz) (matricaria recutita - unii:g0r4ubi2zz), cinchona officinalis bark (unii: s003a158sb) (cinchona officinalis bark - unii:s003a158sb), hops (unii: 01g73h6h83) (hops - unii:01g73h6h83), mercury (unii: fxs1by2 - uses for temporary relief of symptoms: skin rashes, skin discoloration, minor skin problems. uses for temporary relief of symptoms: - skin rashes - skin discoloration - minor skin problems

United States - English - NLM (National Library of Medicine)

king bio inc. - aconitum napellus (unii: u0nq8555jd) (aconitum napellus - unii:u0nq8555jd), lycoperdon utriforme fruiting body (unii: k2a74u428f) (lycoperdon utriforme fruiting body - unii:k2a74u428f), bryonia alba root (unii: t7j046yi2b) (bryonia alba root - unii:t7j046yi2b), matricaria recutita (unii: g0r4ubi2zz) (matricaria recutita - unii:g0r4ubi2zz), cinchona officinalis bark (unii: s003a158sb) (cinchona officinalis bark - unii:s003a158sb), hops (unii: 01g73h6h83) (hops - unii:01g73h6h83), mercury (unii: fxs1by2 - uses for temporary relief of symptoms: skin rashes, discoloration, minor skin problems. uses  ​for temporary relief of symptoms: - skin rashes - discoloration - minor skin problems

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

pharmaceutical works polfa in pabianice jsc - valerianae radix, melissae folium, lupuli strobilus, hyperici herba - capsules hard - 210mg+52,5mg+52,5mg+35mg

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

cambert(m) sdn bhd - vitex agni-casti extract; extract licorice; extr hum lupuli fld (hops); dioscores villosa; cimicifuga racemosa/black cohosh -

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

adamed pharma s.a. - valerianae radix, melissae folium, lupuli strobilus, hyperici herba - capsules hard - 210mg+ 52,5mg+ 52,5mg+ 35mg

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

adamed pharma s.a. - valerianae radix, melissae folium, lupuli strobilus, hyperici herba - capsules hard - 210mg+ 52,5mg+ 52,5mg+ 35mg