European Union - English - EMA (European Medicines Agency)

merck sharp & dohme b.v. - ertapenem sodium - community-acquired infections; streptococcal infections; staphylococcal infections; gram-negative bacterial infections; surgical wound infection; pneumonia, bacterial - antibacterials for systemic use, - treatmenttreatment of the following infections when caused by bacteria known or very likely to be susceptible to ertapenem and when parenteral therapy is required:intra-abdominal infections;community-acquired pneumonia;acute gynaecological infections;diabetic foot infections of the skin and soft tissue.preventioninvanz is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery.consideration should be given to official guidance on the appropriate use of antibacterial agents.

European Union - English - EMA (European Medicines Agency)

astrazeneca ab - reassortant influenza virus (live attenuated) of the following strain: a/vietnam/1203/2004 (h5n1) strain - influenza, human - vaccines - prophylaxis of influenza in an officially declared pandemic situation in children and adolescents from 12 months to less than 18 years of age.pandemic influenza vaccine h5n1 astrazeneca should be used in accordance with official guidance

European Union - English - EMA (European Medicines Agency)

ology bioservices ireland ltd - influenza virus (whole virion, inactivated), containing antigen of: a/vietnam/1203/2004 (h5n1) - influenza, human; immunization; disease outbreaks - influenza vaccines - active immunisation against h5n1 subtype of influenza a virus. this indication is based on immunogenicity data from subjects from the age of 6 months onwards following administration of two doses of vaccine prepared with h5n1 subtype strains. vepacel should be used in accordance with official guidance.,

European Union - English - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - pneumococcal polysaccharide serotype 23f, pneumococcal polysaccharide serotype 4, pneumococcal polysaccharide serotype 5, pneumococcal polysaccharide serotype 6b, pneumococcal polysaccharide serotype 7f, pneumococcal polysaccharide serotype 9v, pneumococcal polysaccharide serotype 1, pneumococcal polysaccharide serotype 14, pneumococcal polysaccharide serotype 18c, pneumococcal polysaccharide serotype 19f - pneumococcal infections; immunization - vaccines - active immunisation against invasive disease and acute otitis media caused by streptococcus pneumoniae in infants and children from six weeks up to five years of age. see sections 4.4 and 5.1 in product information for information on protection against specific pneumococcal serotypes.the use of synflorix should be determined on the basis of official recommendations taking into consideration the impact of invasive disease in different age groups as well as the variability of serotype epidemiology in different geographical areas.

European Union - English - EMA (European Medicines Agency)

pfizer europe ma eeig - pneumococcal polysaccharide serotype 1, pneumococcal polysaccharide serotype 3, pneumococcal polysaccharide serotype 4, pneumococcal polysaccharide serotype 5, pneumococcal polysaccharide serotype 6a, pneumococcal polysaccharide serotype 6b, pneumococcal polysaccharide serotype 7f, pneumococcal polysaccharide serotype 9v, pneumococcal polysaccharide serotype 14, pneumococcal polysaccharide serotype 18c, pneumococcal polysaccharide serotype 19a, pneumococcal polysaccharide serotype 19f, pneumococcal polysaccharide serotype 23f - pneumococcal infections; immunization - vaccines - active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by streptococcus pneumoniae in infants, children and adolescents from 6 weeks to 17 years of age.active immunisation for the prevention of invasive disease caused by streptococcus pneumoniae in adults ≥18 years of age and the elderly.see sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes.the use of prevenar 13 should be determined on the basis of official recommendations taking into consideration the risk of invasive disease in different age groups, underlying comorbidities as well as the variability of serotype epidemiology in different geographical areas.

European Union - English - EMA (European Medicines Agency)

resilience biomanufacturing ireland limited - influenza vaccine (whole virion, inactivated) containing antigen of: a/vietnam/1203/2004 (h5n1) - influenza, human; immunization; disease outbreaks - vaccines - prophylaxis of influenza in an officially declared pandemic situation. pandemic influenza vaccine should be used in accordance with official guidance.

European Union - English - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - split influenza virus inactivated, containing antigen equivalent to a/california/07/2009 (h1n1)-derived strain used nymc x-179a - influenza, human; immunization; disease outbreaks - influenza vaccines - prophylaxis of influenza caused by a (h1n1)v 2009 virus. pandemrix should only be used if the recommended annual seasonal trivalent / quadrivalent influenza vaccines are not available and if immunisation against (h1n1)v is considered necessary (see sections 4.4 and 4.8).pandemrix should be used in accordance with official guidance.

European Union - English - EMA (European Medicines Agency)

novartis vaccines and diagnostics s.r.l. - influenza virus surface antigens (haemagglutinin and neuraminidase) of strain a/viet nam/1194/2004 (h5n1) - influenza, human - 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 the vaccine containing a/vietnam/1194/2004 (h5n1)-like strain.; prepandemic influenza vaccine (h5n1) novartis vaccines and diagnostic should be used in accordance with official recommendations.

European Union - English - EMA (European Medicines Agency)

pfizer limited - pneumococcal oligosaccharide serotype 18c, pneumococcal polysaccharide serotype 19f, pneumococcal polysaccharide serotype 23f, pneumococcal polysaccharide serotype 4, pneumococcal polysaccharide serotype 6b, pneumococcal polysaccharide serotype 9v, pneumococcal polysaccharide serotype 14 - pneumococcal infections; immunization - vaccines - active immunisation against disease caused by streptococcus pneumoniae serotypes 4, 6b, 9v, 14, 18c, 19f and 23f (including sepsis, meningitis, pneumonia, bacteraemia and acute otitis media) in infants and children from two months up to five years of age.the use of prevenar should be determined on the basis of official recommendations taking into consideration the impact of invasive disease in different age groups as well as variability of serotype epidemiology in different geographical areas.

European Union - English - EMA (European Medicines Agency)

merck sharp dohme ltd - human papillomavirus type 6 l1 protein, human papillomavirus type 11 l1 protein, human papillomavirus type 16 l1 protein, human papillomavirus type 18 l1 protein - papillomavirus infections; uterine cervical dysplasia; condylomata acuminata; immunization - vaccines - silgard is a vaccine for use from the age of 9 years for the prevention of:premalignant genital lesions (cervical, vulvar and vaginal), premalignant anal lesions, cervical cancers and anal cancers causally related to certain oncogenic human papillomavirus (hpv) types;genital warts (condyloma acuminata) causally related to specific hpv types.see sections 4.4 and 5.1 for important information on the data that support this indication.the use of silgard should be in accordance with official recommendations.