Nieuw-Zeeland - Engels - Medsafe (Medicines Safety Authority)

novo nordisk pharmaceuticals ltd - estradiol hemihydrate 2.07mg (adjustment for water content 3.2 %);  ;  ;  ; norethisterone acetate 1mg;  ;  ;  ; estradiol hemihydrate 2.07mg (adjustment for water content 3.2 %); norethisterone acetate 1mg - film coated tablet - active: estradiol hemihydrate 2.07mg (adjustment for water content 3.2 %)       norethisterone acetate 1mg       excipient: hyprolose hypromellose lactose monohydrate magnesium stearate maize starch purified talc purified water triacetin active: estradiol hemihydrate 2.07mg (adjustment for water content 3.2 %) norethisterone acetate 1mg

Nieuw-Zeeland - Engels - Medsafe (Medicines Safety Authority)

novo nordisk pharmaceuticals ltd - estradiol hemihydrate 1.03mg equivalent to 1 mg oestradiol;  ;  ;  ; norethisterone acetate 0.5mg;  ;  ;   - film coated tablet - active: estradiol hemihydrate 1.03mg equivalent to 1 mg oestradiol       norethisterone acetate 0.5mg       excipient: copovidone hypromellose lactose monohydrate magnesium stearate maize starch purified talc triacetin

Maleisië - Engels - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

sanofi-aventis (malaysia) sdn. bhd. - pertussis toxoid (pt); filamentous haemagglutinin (fha); pertactin (prn); diphtheria toxoid; tetanus toxoid; inactivated poliomyelitis virus,type 1; inactivated poliomyelitis virus,type 2; inactivated poliomyelitis virus,type 3; fimbriae types 2 and 3 (fim) -

Singapore - Engels - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - (acellular pertussis) filamentous haemagglutinin adsorbed (fha); (acellular pertussis) fimbriae type 2 and 3 adsorbed (fim); (acellular pertussis) pertactin adsorbed (prn); (acelullar pertussis) pertussis toxoid adsorbed (pt); diphtheria toxoid adsorbed; inactivated poliomyelitis vaccine (ipv) type 1 mahoney; inactivated poliomyelitis vaccine (ipv) type 2 (mef-1); inactivated poliomyelitis vaccine (ipv) type 3 (saukett); tetanus toxoid adsorbed - injection, suspension - (acellular pertussis) filamentous haemagglutinin adsorbed (fha) 5 µg/ 0.5 ml; (acellular pertussis) fimbriae type 2 and 3 adsorbed (fim) 5 µg/0.5 ml; (acellular pertussis) pertactin adsorbed (prn) 3 µg/0.5 ml; (acelullar pertussis) pertussis toxoid adsorbed (pt) 2.5 µg/ 0.5 ml; diphtheria toxoid adsorbed 2lf; inactivated poliomyelitis vaccine (ipv) type 1 mahoney 40 d-antigen units; inactivated poliomyelitis vaccine (ipv) type 2 (mef-1) 8 d-antigen units; inactivated poliomyelitis vaccine (ipv) type 3 (saukett) 32 d-antigen units; tetanus toxoid adsorbed 5lf

Israël - Engels - Ministry of Health

dexcel ltd, israel - adalimumab - solution for injection - adalimumab 50 mg/ml - adalimumab - rheumatoid arthritis: hulio 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.hulio 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): hulio 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: hulio 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: hulio 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: hulio is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.hidradenitis suppurativa (hs): hulio 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:hulio 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. hulio 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: hulio 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: hulio 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: hulio is indicated for the treatment of intestinal behcet’s disease in patients who have had an inadequate response to conventional therapy.

Nieuw-Zeeland - Engels - Medsafe (Medicines Safety Authority)

carsl consulting - remestemcel-l (100 million human mesenchymal stem cells in 15ml) - solution for infusion - 100 million cells in 15ml - active: remestemcel-l (100 million human mesenchymal stem cells in 15ml) excipient: albumin dimethyl sulfoxide plasma-lyte a - prochymal is indicated for the rescue of patients nlt 6 months to 17 years of age with acute graft versus host disease (agvhd), refractory to treatment with systemic corticosteroid therapy or other immunosuppressive agents. prochymal use under these conditions is limited to grades b to d of the disease.

Europese Unie - Engels - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - diphtheria toxoid, tetanus toxoid, bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin), hepatitis b surface antigen, poliovirus (inactivated) (type-1 (mahoney strain), type-2 (mef-1 strain), type-3 (saukett strain)), haemophilus influenzae type b polysaccharide - hepatitis b; tetanus; immunization; meningitis, haemophilus; whooping cough; poliomyelitis; diphtheria - vaccines - infanrix hexa is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis b, poliomyelitis and disease caused by haemophilus influenzae type-b.

Canada - Engels - Health Canada

aventis pasteur limited - diphtheria toxoid; tetanus toxoid; pertussis vaccine; poliomyelitis vaccine (inactivated) - liquid - 25lf; 5lf; 12unit; 80unit - diphtheria toxoid 25lf; tetanus toxoid 5lf; pertussis vaccine 12unit; poliomyelitis vaccine (inactivated) 80unit - toxoids

Canada - Engels - Health Canada

aventis pasteur limited - diphtheria toxoid; inactivated poliomyelitis vaccine (d.c.o.) type 2 mef1; inactivated poliomyelitis vaccine (d.c.o.) type 3 saukett; tetanus toxoid; inactivated poliomyelitis vaccine (d.c.o.) type 1 mahoney - suspension - 25lf; 8unit; 32unit; 5lf; 40unit - diphtheria toxoid 25lf; inactivated poliomyelitis vaccine (d.c.o.) type 2 mef1 8unit; inactivated poliomyelitis vaccine (d.c.o.) type 3 saukett 32unit; tetanus toxoid 5lf; inactivated poliomyelitis vaccine (d.c.o.) type 1 mahoney 40unit - vaccines

Australië - Engels - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - poliovirus, quantity: 26 dagu; poliovirus, quantity: 7 dagu; pertactin, quantity: 3 microgram; tetanus toxoid, quantity: 20 iu; diphtheria toxoid, quantity: 2 iu; pertussis toxoid, quantity: 2.5 microgram; pertussis filamentous haemagglutinin, quantity: 5 microgram; pertussis fimbriae 2 + 3, quantity: 5 microgram; poliovirus, quantity: 29 dagu - injection, suspension - excipient ingredients: aluminium phosphate; formaldehyde; polysorbate 80; neomycin; water for injections; phenoxyethanol; streptomycin sulfate; polymyxin b sulfate; glutaral; ethanol - adacel polio is indicated for active immunisation against diphtheria, tetanus, pertussis and poliomyelitis in adults, adolescents and children aged 4 years and older as a booster following primary immunisation.,children 4-6 years of age should have already received four doses of dtpa and ipv or opv.,adacel polio is not intended for primary immunisation.,adacel polio may be administered during pregnancy for prevention of pertussis in young infants via transplacental antibody transfer from the pregnant woman to the fetus.,the use of adacel polio should be determined on the basis of official recommendations. for further information, refer to the current immunisation handbook.