Agenerase European Union - English - EMA (European Medicines Agency)

agenerase

glaxo group ltd. - amprenavir - hiv infections - antivirals for systemic use - agenerase, in combination with other antiretroviral agents, is indicated for the treatment of protease inhibitor (pi) experienced hiv-1 infected adults and children above the age of 4 years. agenerase capsules should normally be administered with low dose ritonavir as a pharmacokinetic enhancer of amprenavir (see sections 4.2 and 4.5). the choice of amprenavir should be based on individual viral resistance testing and treatment history of patients (see section 5.1).the benefit of agenerase boosted with ritonavir has not been demonstrated in pi nave patients (see section 5.1)

Quixidar European Union - English - EMA (European Medicines Agency)

quixidar

glaxo group ltd. - fondaparinux sodium - venous thrombosis; pulmonary embolism; myocardial infarction; angina, unstable - antithrombotic agents - 1.5 mg/0.3 ml and 2.5 mg/0.5 ml, solution for injection:, prevention of venous thromboembolic events (vte) in patients undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee surgery or hip replacement surgery., prevention of venous thromboembolic events (vte) in patients undergoing abdominal surgery who are judged to be at high risk of thromboembolic complications, such as patients undergoing abdominal cancer surgery (see section 5.1)., prevention of venous thromboembolic events (vte) in medical patients who are judged to be at high risk for vte and who are immobilised due to acute illness such as cardiac insufficiency and/or acute respiratory disorders, and/or acute infectious or inflammatory disease., , 2.5 mg/0.5 ml, solution for injection:, treatment of unstable angina or non-st segment elevation myocardial infarction (ua/nstemi) in patients for whom urgent (< 120 mins) invasive management (pci) is not indicated (see sections 4.4 and 5.1)., treatment of st segment elevation myocardial infarction (stemi) in patients who are managed with thrombolytics or who initially are to receive no other form of reperfusion therapy., , 5 mg/0.4 ml, 7.5 mg/0.6 ml and 10 mg/0.8 ml solution for injection:, treatment of acute deep vein thrombosis (dvt) and treatment of acute pulmonary embolism (pe), except in haemodynamically unstable patients or patients who require thrombolysis or pulmonary embolectomy.,

Altargo European Union - English - EMA (European Medicines Agency)

altargo

glaxo group ltd - retapamulin - impetigo; staphylococcal skin infections - antibiotics and chemotherapeutics for dermatological use - short term treatment of the following superficial skin infections: , impetigo;, infected small lacerations, abrasions or sutured wounds. , see sections 4.4 and 5.1 for important information regarding the clinical activity of retapamulin against different types of staphylococcus aureus. consideration should be given to official guidance on the appropriate use of antibacterial agents.,

Alisade European Union - English - EMA (European Medicines Agency)

alisade

glaxo group ltd. - fluticasone furoate - rhinitis, allergic, perennial; rhinitis, allergic, seasonal - nasal preparations - adults, adolescents (12 years and over) and children (6 - 11 years). alisade is indicated for the treatment of the symptoms of allergic rhinitis.

NIMENRIX Meningococcal (Groups A, C, W-135, Y) Polysaccharide Tetanus Toxoid Conjugate Vaccine, injection vial and diluent syringe Australia - English - Department of Health (Therapeutic Goods Administration)

nimenrix meningococcal (groups a, c, w-135, y) polysaccharide tetanus toxoid conjugate vaccine, injection vial and diluent syringe

pfizer australia pty ltd - meningococcal polysaccharide group c, quantity: 5 microgram; meningococcal polysaccharide group y, quantity: 5 microgram; meningococcal polysaccharide group w135, quantity: 5 microgram; meningococcal polysaccharide group a, quantity: 5 microgram; tetanus toxoid, quantity: 44 microgram - injection, powder for - excipient ingredients: sucrose; trometamol hydrochloride - nimenrix is indicated for active immunisation of individuals from 6 weeks of age against invasive meningococcal diseases caused by neisseria meningitidis groups a, c, w-135 and y.

MENVEO Israel - English - Ministry of Health

menveo

glaxo smith kline (israel) ltd - meningococcal vaccines group a; meningococcal vaccines group c; meningococcal vaccines group w; meningococcal vaccines group y - powder and solution for solution for injection - meningococcal vaccines group y 5 mcg / 0.5 ml; meningococcal vaccines group w 5 mcg / 0.5 ml; meningococcal vaccines group c 5 mcg / 0.5 ml; meningococcal vaccines group a 10 mcg / 0.5 ml - other meningococcal monovalent purified polysaccharides antigen - other meningococcal monovalent purified polysaccharides antigen - menveo is indicated for active immunization of children (2 years of age and above), adolescents and adults up to the age of 55 years, at risk of exposure to neisseria meningitidis groups a, c, w135 and y, to prevent invasive disease. the use of this vaccine should be in accordance with official recommendations.

BEXSERO Israel - English - Ministry of Health

bexsero

glaxo smith kline (israel) ltd - neisseria meningitides group b strain nz98/254; neisseria meningitidis group b fhbp fusion protein; neisseria meningitidis group b nada protein; neisseria meningitidis group b nhba fusion protein - suspension for injection - neisseria meningitides group b strain nz98/254 25 mcg; neisseria meningitidis group b fhbp fusion protein 50 mcg; neisseria meningitidis group b nada protein 50 mcg; neisseria meningitidis group b nhba fusion protein 50 mcg - meningococcus b, outer membrane vesicle vaccine - bexsero is indicated for active immunization of individuals from 2 months of age and older against invasive meningococcal disease caused by neisseria meningitidis group b.

Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals European Union - English - EMA (European Medicines Agency)

prepandemic influenza vaccine (h5n1) (split virion, inactivated, adjuvanted) glaxosmithkline biologicals

glaxosmithkline biologicals s.a. - split influenza virus, inactivated, containing antigen: a/vietnam/1194/2004 (h5n1) like strain used (nibrg-14) - influenza, human; immunization; disease outbreaks - vaccines - active immunisation against h5n1 subtype of influenza a virus.this indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of vaccine prepared from a/vietnam/1194/2004 nibrg-14 (h5n1) (see section 5.1).prepandemic influenza vaccine (h5n1) (split virion, inactivated, adjuvanted) glaxosmithkline biologicals 3.75 µg should be used in accordance with official guidance.

MENVEO meningococcal (Groups A, C, W Australia - English - Department of Health (Therapeutic Goods Administration)

menveo meningococcal (groups a, c, w

glaxosmithkline australia pty ltd - diphtheria crm197 protein, quantity: 16.7 microgram; meningococcal oligosaccharide group a, quantity: 10 microgram - injection, powder for - excipient ingredients: sucrose; monobasic potassium phosphate - menveo is indicated for active immunisation of infants and children (from 2 months of age), adolescents and adults to prevent invasive disease caused by neisseria meningitidis serogroups a, c, w-135 and y. the use of this vaccine should be in accordance with official recommendations.

MENVEO meningococcal (Groups A, C, W-135 and Y) oligosaccharide CRM197 conjugate vaccine Australia - English - Department of Health (Therapeutic Goods Administration)

menveo meningococcal (groups a, c, w-135 and y) oligosaccharide crm197 conjugate vaccine

glaxosmithkline australia pty ltd - meningococcal oligosaccharide group y, quantity: 5 microgram; meningococcal oligosaccharide group c, quantity: 5 microgram; diphtheria crm197 protein, quantity: 16 microgram; meningococcal oligosaccharide group w135, quantity: 5 microgram - injection, solution - excipient ingredients: sodium chloride; water for injections; monobasic sodium phosphate monohydrate; dibasic sodium phosphate dihydrate - menveo is indicated for active immunisation of infants and children (from 2 months of age), adolescents and adults to prevent invasive disease caused by neisseria meningitidis serogroups a, c, w-135 and y. the use of this vaccine should be in accordance with official recommendations.