European Union - English - EMA (European Medicines Agency)

novartis europharm limited - vildagliptin, metformin hydrochloride - diabetes mellitus, type 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - icandra is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:in patients who are inadequately controlled with metformin hydrochloride alone.in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets.in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).

European Union - English - EMA (European Medicines Agency)

laboratorios syva, s.a.u. - inactivated bluetongue virus, serotype 1, strain alg2006/01 e1, inactivated bluetongue virus, serotype 4, strain btv-4/spa-1/2004, inactivated bluetongue virus, serotype 8, strain bel2006/01 - inactivated viral vaccines - cattle; sheep - for active immunisation of sheep to prevent viraemia and reduce clinical signs and lesions caused by bluetongue virus serotypes 1 and/or 8 and/or to reduce viraemia* and clinical signs and lesions caused by bluetongue virus serotype 4for active immunisation of cattle to prevent viraemia caused by bluetongue virus serotypes 1 and/or 8 and/or to reduce viraemia* caused by bluetongue virus serotype 4.

European Union - English - EMA (European Medicines Agency)

novartis europharm limited - vildagliptin - diabetes mellitus, type 2 - drugs used in diabetes - vildagliptin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:as monotherapy in patients in whom metformin is inappropriate due to contraindications or intolerance.in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).

European Union - English - EMA (European Medicines Agency)

laboratorios hipra s.a. - live attenuated bovine respiratory syncytial virus (brsv), strain lym-56 - immunologicals for bovidae, cattle, live viral vaccines, bovine respiratory syncytial virus (brsv) - cattle - active immunisation of cattle to reduce virus shedding and respiratory clinical signs caused by bovine respiratory syncytial virus infection.

European Union - English - EMA (European Medicines Agency)

laboratorios hipra, s.a. - inactivated rabbit haemorrhagic disease type 2 virus (rhdv2), strainv-1037 - inactivated viral vaccines - rabbits - for active immunisation of rabbits from the age of 30 days to reduce mortality caused by the rabbit haemorrhagic disease type 2 virus (rhdv2)

European Union - English - EMA (European Medicines Agency)

laboratorios hipra s.a - live ge- tk- double-gene-deleted bovine herpes virus type 1, strain ceddel: 106.3–107.3 ccid50 - immunologicals - cattle - for the active immunisation of cattle from three months of age against bovine herpes virus type 1 (bohv-1) to reduce the clinical signs of infectious bovine rhinotracheitis (ibr) and field virus excretion.onset of immunity: 21 days after completion of the basic vaccination scheme.duration of immunity: 6 months after completion of the basic vaccination scheme

European Union - English - EMA (European Medicines Agency)

pfizer europe ma eeig - respiratory syncytial virus, subgroup a, stabilized prefusion f protein / respiratory syncytial virus, subgroup b, stabilized prefusion f protein - respiratory syncytial virus infections - vaccines - abrysvo is indicated for:passive protection against lower respiratory tract disease caused by respiratory syncytial virus (rsv) in infants from birth through 6 months of age following maternal immunisation during pregnancy. see sections 4.2 and 5.1.active immunisation of individuals 60 years of age and older for the prevention of lower respiratory tract disease caused by rsv.the use of this vaccine should be in accordance with official recommendations.

European Union - English - EMA (European Medicines Agency)

virbac s.a. - purified p45 feline leukaemia virus envelope antigen, live feline calicivirus (strain f9), live feline viral rhinotracheitis virus (strain f2), live feline panleucopenia virus - live feline panleucopenia virus / parvovirus + live feline rhinotracheitis virus + live feline calicivirus + inactivated feline leukaemia virus - cats - for active immunisation of cats from eight weeks of age against:feline calicivirosis to reduce clinical signs.feline viral rhinotracheitis to reduce clinical signs and viral excretion.feline panleucopenia to prevent leucopenia and to reduce clinical signs.feline leukaemia to prevent persistent viraemia and clinical signs of the related disease.onset of immunity: 3 weeks after the primary vaccination for the panleucopenia and leukaemia components, and 4 weeks after the primary vaccination for the calicivirus and rhinotracheitis virus components.duration of immunity: one year after the primary vaccination for all components.

European Union - English - EMA (European Medicines Agency)

laboratorios hipra, s.a. - mycoplasma hyopneumoniae, strain 7304 (nexhyon), expressing the capsid protein of porcine circovirus type 2a, inactivated - immunologicals for suidae, inactivated viral and inactivated bacterial vaccines - pigs - for the active immunisation of pigs:to reduce lung lesions associated with porcine enzootic pneumonia caused by mycoplasma hyopneumoniae. also, to reduce the incidence of these lesions (as observed in field studies).to reduce viraemia, virus load in lungs and lymphoid tissues and the duration of the viraemic period associated with diseases caused by porcine circovirus type 2 (pcv2). efficacy against pcv2 genotypes a, b and d has been demonstrated in field studies.to reduce culling rate and the loss of daily weight gain caused by mycoplasma hyopneumoniae and/or pcv2 related diseases (as observed at 6 months of age in field studies).mycoplasma hyopneumoniae: onset of immunity: 3 weeks after vaccinationduration of immunity: 23 weeks after vaccinationporcine circovirus type 2:onset of immunity: 2 weeks after vaccinationduration of immunity: 22 weeks after vaccinationin addition, a reduction in nasal and faecal shedding and the duration of nasal excretion of pcv2 was demonstrated in animals challenged at 4 weeks and at 22 weeks after vaccination.

European Union - English - EMA (European Medicines Agency)

laboratorios hipra, s.a. - porcine parvovirus, strain nadl-2 and erysipelothrix rhusiopathiae, strain r32e11 (inactivated) - immunologicals for suidae, inactivated viral and inactivated bacterial vaccines - pigs - for the active immunisation of female pigs for the protection of progeny against transplacental infection caused by porcine parvovirus.for the active immunisation of male and female pigs to reduce clinical signs (skin lesions and fever) of swine erysipelas caused by erysipelothrix rhusiopathiae, serotype 1 and serotype 2.