New Zealand - Tiếng Anh - Medsafe (Medicines Safety Authority)

seqirus (nz) ltd - influenza virus a (h1n1) haemagglutinin 15ug (a/wisconsin/67/2022 (h1n1)pdm09-like virus (a/georgia/12/2022 (cvr-167))); influenza virus a (h3n2) haemagglutinin 15ug (a/massachusetts/18/2022 (h3n2)-like virus (a/sydney/1304/2022)); influenza virus b (victoria) haemagglutinin 15ug (b/austria/1359417/2021-like virus (b/victoria lineage) (b/singapore/wuh4618/2021)); influenza virus b (yamagata) haemagglutinin 15ug (b/phuket/3073/2013-like virus (b/yamagata lineage) (b/singapore/inftt-16-0610/2016)) - suspension for injection - 60 mcg/0.5ml - active: influenza virus a (h1n1) haemagglutinin 15ug (a/wisconsin/67/2022 (h1n1)pdm09-like virus (a/georgia/12/2022 (cvr-167))) influenza virus a (h3n2) haemagglutinin 15ug (a/massachusetts/18/2022 (h3n2)-like virus (a/sydney/1304/2022)) influenza virus b (victoria) haemagglutinin 15ug (b/austria/1359417/2021-like virus (b/victoria lineage) (b/singapore/wuh4618/2021)) influenza virus b (yamagata) haemagglutinin 15ug (b/phuket/3073/2013-like virus (b/yamagata lineage) (b/singapore/inftt-16-0610/2016)) excipient: dibasic sodium phosphate dihydrate magnesium chloride hexahydrate monobasic potassium phosphate potassium chloride sodium chloride water for injection - flucelvax quad is indicated for the prevention of influenza caused by influenza virus types a and b contained in the vaccine. the vaccine is indicated for use in individuals 6 months of age and above. for full details regarding recommendations for influenza vaccination, please refer to the relevant national immunisation guidelines.

Israel - Tiếng Anh - Ministry of Health

sanofi israel ltd - a/michigan/45/2015 (h1n1)pdm09 – like strain; a/singapore/infimh-16-0019/2016 (h3n2) - like virus; b/colorado/06/2017- like virus (b/victoria/2/87 lineage); b/phuket/3073/2013 like strain - suspension for injection - b/phuket/3073/2013 like strain 60 mcg / 0.7 ml; b/colorado/06/2017- like virus (b/victoria/2/87 lineage) 60 mcg / 0.7 ml; a/singapore/infimh-16-0019/2016 (h3n2) - like virus 60 mcg / 0.7 ml; a/michigan/45/2015 (h1n1)pdm09 – like strain 60 mcg / 0.7 ml - influenza, inactivated, split virus or surface antigen - active immunisation in adults 65 years of age and older for the prevention of influenza disease. בקשה לשינוי משטר מינון: 9/3/2022active immunisation in adults 60 years of age and older for the prevention of influenza disease.

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

novimmune sa - emapalumab (unii: 3s252o2z4x) (emapalumab - unii:3s252o2z4x) - gamifant is indicated for the treatment of adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (hlh) with refractory, recurrent or progressive disease or intolerance with conventional hlh therapy. none. risk summary there are no available data on gamifant use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. in an animal reproduction study, a murine surrogate anti-mouse ifnγ antibody administered to pregnant mice throughout gestation crossed the placental barrier, and no fetal harm was observed (see data). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data in a mouse embryo-fetal development s

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - azacitidine, quantity: 100 mg - injection, powder for - excipient ingredients: mannitol - azacitidine accord is indicated for the treatment of patients with,? intermediate-2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss), ,? chronic myelomonocytic leukemia (cmmol (10-29 percent marrow blasts without myeloproliferative disorder)), ,? acute myeloid leukemia (aml) with 20-30 percent blasts and multi-lineage dysplasia, according to world health organisation classification (who), ,in whom allogenic stem cell transplantation is not indicated.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - azacitidine, quantity: 100 mg - injection, powder for - excipient ingredients: mannitol - azacitidine juno is indicated for the treatment of patients with intermediate-2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss), chronic myelomonocytic leukemia (cmmol (10-29 percent marrow blasts without myeloproliferative disorder)), acute myeloid leukemia (aml) with 20-30 percent blasts and multi-lineage dysplasia, according to world health organisation classification (who), in whom allogenic stem cell transplantation is not indicated.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - azacitidine, quantity: 100 mg - injection, powder for - excipient ingredients: mannitol - azadine is indicated for the treatment of patients with intermediate-2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss), chronic myelomonocytic leukemia (cmmol (10-29 percent marrow blasts without myeloproliferative disorder)), acute myeloid leukemia (aml) with 20-30 percent blasts and multi-lineage dysplasia, according to world health organisation classification (who), in whom allogenic stem cell transplantation is not indicated.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

celgene pty ltd - azacitidine, quantity: 100 mg - injection, powder for - excipient ingredients: mannitol - a)intermediate-2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss), b)chronic myelomonocytic leukemia (cmmol 10%-29% marrow blasts without myeloproliferative disorder)), c) acute myeloid leukemia (aml) with 20-30% blasts and multi-lineage dysplasia, according to world health organisation classification (who). in whom allogenic stem cell transplantation is not indicated.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - azacitidine, quantity: 100 mg - injection, powder for - excipient ingredients: monobasic sodium phosphate monohydrate; dibasic sodium phosphate dihydrate; sucrose - azacitidine-teva is indicated for the treatment of patients with: intermediate-2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss), chronic myelomonocytic leukemia [cmmol (10 percent-29 percent marrow blasts without myeloproliferative disorder)], acute myeloid leukemia (aml) with 20-30 percent blasts and multi-lineage dysplasia, according to world health organisation classification (who), in whom allogenic stem cell transplantation is not indicated

Liên Minh Châu Âu - Tiếng Anh - EMA (European Medicines Agency)

celgene europe bv - azacitidine - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - antineoplastic agents - azacitidine celgene is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (hsct) with:intermediate 2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss),chronic myelomonocytic leukaemia (cmml) with 10 29 % marrow blasts without myeloproliferative disorder,acute myeloid leukaemia (aml) with 20 30 % blasts and multi-lineage dysplasia, according to world health organisation (who) classification,aml with >30% marrow blasts according to the who classification.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - azacitidine, quantity: 100 mg - injection, powder for - excipient ingredients: mannitol - azacitidine is indicated for the treatment of patients with: ? intermediate-2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss), ? chronic myelomonocytic leukemia [cmmol (10%-29% marrow blasts without myeloproliferative disorder)], ? acute myeloid leukemia (aml) with 20-30% blasts and multi-lineage dysplasia, according to world health organisation classification (who), in whom allogenic stem cell transplantation is not indicated.