Kanada - angol - Health Canada

bles biochemicals inc - phospholipid; surfactant-associated proteins sp-b and sp-c - suspension - 27mg; 500mcg - phospholipid 27mg; surfactant-associated proteins sp-b and sp-c 500mcg - pulmonary surfactants

Kanada - angol - Health Canada

cipla ltd - phospholipid; surfactant-associated proteins sp-b and sp-c - suspension - 27mg; 500mcg - phospholipid 27mg; surfactant-associated proteins sp-b and sp-c 500mcg - pulmonary surfactants

Szingapúr - angol - HSA (Health Sciences Authority)

euroimmun (south east asia) pte. ltd. - immunology - test system for in vitro determination of autoantibodies against leucine-rich glioma-inactivated protein 1 and contactin-associated protein 2 in human serum or plasma

Kanada - angol - Health Canada

octapharma pharmazeutika produktionsges m b h - human plasma proteins - solution - 14g - human plasma proteins 14g - hemostatics

Malajzia - angol - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

grifols malaysia sdn. bhd. - human immunoglobulin proteins -

Európai Unió - angol - EMA (European Medicines Agency)

takeda gmbh - dengue virus, serotype 2, expressing dengue virus, serotype 1, surface proteins, live, attenuated, dengue virus, serotype 2, expressing dengue virus, serotype 3, surface proteins, live, attenuated, dengue virus, serotype 2, expressing dengue virus, serotype 4, surface proteins, live, attenuated, dengue virus, serotype 2, live, attenuated - dengue - vaccines - qdenga is indicated for the prevention of dengue disease in individuals from 4 years of age.the use of qdenga should be in accordance with official recommendations.

Új-Zéland - angol - Medsafe (Medicines Safety Authority)

rex medical ltd - bovine lung lipids 27 mg/ml (cont.phospholipids 27mg/proteins 176 to 500µg) - intratracheal suspension - 27 mg/ml - active: bovine lung lipids 27 mg/ml (cont.phospholipids 27mg/proteins 176 to 500µg) excipient: calcium chloride dihydrate nitrogen sodium chloride as saline for irrigation (0.9% nacl) water

Új-Zéland - angol - Medsafe (Medicines Safety Authority)

seqirus (nz) ltd - anti-d [rho] immunoglobulin 820 [iu] ((5% w/v human plasma proteins) immunoglobulin ex usa) - solution for injection - 300 mcg - active: anti-d [rho] immunoglobulin 820 [iu] ((5% w/v human plasma proteins) immunoglobulin ex usa) excipient: glycine polysorbate 80 sodium chloride thiomersal water for injection

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

daval australia pty ltd - serum proteins, quantity: 4.5 mg/ml - injection, solution - excipient ingredients: dibasic sodium phosphate heptahydrate; monobasic sodium phosphate; sodium chloride; water for injections - unlicensed medication under phase ii clinical trialing

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

octapharma australia pty ltd - factor x, quantity: 360 iu; plasma proteins, quantity: 260 mg; protein c, quantity: 140 iu; protein s, quantity: 140 iu; factor ii, quantity: 220 iu; factor vii, quantity: 180 iu; factor ix, quantity: 500 iu - injection, solution - excipient ingredients: water for injections - treatment of bleeding and perioperative prophylaxis of bleeding in acquired deficiency of the prothrombin complex coagulation factors, such as deficiency caused by treatment with vitamin k antagonists, or in case of overdose of vitamin k antagonists, when rapid correction of the deficiency is required. as a second line therapy for the control of bleeding episodes and surgical prophylaxis in patients with congenital factor vii deficiency, for whom recombinant human fviia has failed, is contraindicated or has been associated with unacceptable adverse effects.