Írland - enska - HPRA (Health Products Regulatory Authority)

fresenius kabi deutschland gmbh - thiotepa - powder for concentrate for solution for infusion - thiotepa

Írland - enska - HPRA (Health Products Regulatory Authority)

fresenius kabi deutschland gmbh - propofol - emulsion for injection/infusion - 2 percent - other general anesthetics; propofol

Malasía - enska - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

fresenius kabi malaysia sdn. bhd - zoledronic acid -

Ísrael - enska - Ministry of Health

neopharm (israel)1996 ltd - adalimumab - solution for injection - adalimumab 50 mg/ml - adalimumab - • rheumatoid arthritis: idacio in combination with methotrexate is indicated for:- the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.- the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. idacio can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. adalimumab has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function, when given in combination with methotrexate.• axial spondyloarthritis:-ankylosing spondylitis (as): idacio is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.-axial spondyloarthritis without radiographic evidence of as: idacio is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of as, but with objective signs of inflammation by radiological and/or laboratory tests including mri and serum crp levels, who have had an inadequate response to, or are intolerant to, non-steroidal anti-inflammatory drugs.• psoriatic arthritis: idacio is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti rheumatic drug therapy has been inadequate. adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function.• psoriasis: idacio is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.• hidradenitis suppurativa (hs): idacio is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adult patients with an inadequate response to conventional systemic hs therapy.• crohn’s disease: idacio is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active crohn’s disease who have had an inadequate response to conventional therapy. idacio is indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab. • ulcerative colitis: idacio is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. • uveitis:idacio is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate.• intestinal behcet's disease: idacio is indicated for the treatment of intestinal behcet’s disease in patients who have had an inadequate response to conventional therapy.

Malasía - enska - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

fresenius kabi malaysia sdn. bhd - paracetamol -

Malasía - enska - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

fresenius kabi malaysia sdn. bhd - rocuronium bromide -

Malasía - enska - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

fresenius kabi malaysia sdn. bhd - leucovorin calcium/calcium folinate -

Írland - enska - HPRA (Health Products Regulatory Authority)

fresenius kabi deutschland gmbh - soya bean oil, refined ph. eur.; medium chain triglycerides; refined olive oil; fish oil, rich in omega-3 acids; isoleucine; leucine ; methionine; lysine acetate; phenylalanine; threonine; tryptophan; valine; arginine ; histidine; alanine; glycine; proline; serine; tyrosine; taurine; calcium chloride dihydrate; sodium glycerophophate hydrate; magnesium sulphate heptahydrate ; potassium chloride; sodium acetate trihydrate ; zinc sulphate heptahydrate; glucose monohydrate - emulsion for infusion - solutions for parenteral nutrition; combinations

Írland - enska - HPRA (Health Products Regulatory Authority)

fresenius kabi deutschland gmbh - l-alanine; l-arginine; glycine; l-histidine; l-isoleucine; l-leucine; l-lysine acetate; l-methionine; l-phenylalanine; l-proline; l-serine; taurine; l-threonine; l-tryptophan; l-tyrosine; l-valine; glucose monohydrate; soya bean oil, refined; triglycerides, medium chain; olive oil, refined; fish oil, rich in omega-3 acids - emulsion for infusion - 0 gram(s) - solutions for parenteral nutrition; combinations

Írland - enska - HPRA (Health Products Regulatory Authority)

fresenius kabi deutschland gmbh - alanine; arginine ; glycine; histidine; isoleucine; leucine ; lysine acetate; methionine; phenylalanine; proline; serine; taurine; tryptophan; tyrosine; valine; glucose monohydrate; soya bean oil, refined; triglycerides medium-chain ; olive oil, refined; fish oil, rich in omega-3 acids - emulsion for infusion - solutions for parenteral nutrition; combinations