Unjoni Ewropea - Ingliż - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - measles virus enders’ edmonston strain (live, attenuated), mumps virus jeryl lynn (level b) strain (live, attenuated), rubella virus wistar ra 27/3 strain (live, attenuated) - rubella; mumps; immunization; measles - vaccines - m-m-rvaxpro is indicated for simultaneous vaccination against measles, mumps, and rubella in individuals 12 months or older. for use in measles outbreaks, or for post-exposure vaccination, or for use in previously unvaccinated children older than 12 months who are in contact with susceptible pregnant women, and persons likely to be susceptible to mumps and rubella.,

Unjoni Ewropea - Ingliż - EMA (European Medicines Agency)

merck sharp & dohme b.v. - rotavirus serotype g1, serotype g2, serotype g3, serotype g4, serotype p1 - immunization; rotavirus infections - vaccines, viral vaccines - rotateq is indicated for the active immunisation of infants from the age of six weeks to 32 weeks for prevention of gastroenteritis due to rotavirus infection.rotateq is to be used on the basis of official recommendations.

Unjoni Ewropea - Ingliż - EMA (European Medicines Agency)

merck sharp & dohme b.v. - sitagliptin - diabetes mellitus, type 2 - drugs used in diabetes - for adult patients with type-2 diabetes mellitus, ristaben is indicated to improve glycaemic control:as monotherapy:in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance;as dual oral therapy in combination with:metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control;a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance;a peroxisome proliferator-activated-receptor-gamma (pparγ) agonist (i.e. a thiazolidinedione) when use of a pparγ agonist is appropriate and when diet and exercise plus the pparγ agonist alone do not provide adequate glycaemic control;as triple oral therapy in combination with:a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control;a pparγ agonist and metformin when use of a pparγ agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.ristaben is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.

Unjoni Ewropea - Ingliż - EMA (European Medicines Agency)

merck sharp & dohme b.v. - bezlotoxumab - enterocolitis, pseudomembranous - immune sera and immunoglobulins, - zinplava is indicated for the prevention of recurrence of clostridium difficile infection (cdi) in adults at high risk for recurrence of cdi.

Unjoni Ewropea - Ingliż - EMA (European Medicines Agency)

merck sharp dohme ltd - boceprevir - hepatitis c, chronic - antivirals for systemic use - victrelis is indicated for the treatment of chronic hepatitis-c (chc) genotype-1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.

Unjoni Ewropea - Ingliż - EMA (European Medicines Agency)

merck sharp & dohme b.v. - sitagliptin, metformin hydrochloride - diabetes mellitus, type 2 - drugs used in diabetes - for patients with type-2 diabetes mellitus:velmetia is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.velmetia is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.velmetia is indicated as triple combination therapy with a ppar agonist (i.e. a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a ppar agonist.velmetia is also indicated as add on to insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dosage of insulin and metformin alone do not provide adequate glycaemic control.

Unjoni Ewropea - Ingliż - EMA (European Medicines Agency)

merck sharp & dohme b.v. - tedizolid phosphate - soft tissue infections; skin diseases, bacterial - antibacterials for systemic use, , other antibacterials - sivextro is indicated for the treatment of acute bacterial skin and skin structure infections (absssi) in adults and adolescents 12 years of age and older.

Unjoni Ewropea - Ingliż - EMA (European Medicines Agency)

merck sharp & dohme b.v. - varicella-zoster virus (live, attenuated) - herpes zoster; immunization - viral vaccines - zostavax is indicated for prevention of herpes zoster ('zoster' or shingles) and herpes-zoster-related post-herpetic neuralgia. zostavax is indicated for immunisation of individuals 50 years of age or older.,

Unjoni Ewropea - Ingliż - EMA (European Medicines Agency)

merck sharp & dohme b.v. - virus, live attenuated, measles, virus, live attenuated, mumps, virus, live attenuated, rubella, virus, live attenuated, varicella - chickenpox; rubella; measles; mumps; immunization - vaccines - proquad is indicated for simultaneous vaccination against measles, mumps, rubella and varicella in individuals from 12 months of age. proquad can be administered to individuals from 9 months of age under special circumstances (e.g., to conform with national vaccination schedules, outbreak situations, or travel to a region with high prevalence of measles.,

Unjoni Ewropea - Ingliż - EMA (European Medicines Agency)

janssen biologics b.v. - golimumab - arthritis, psoriatic; spondylitis, ankylosing; colitis, ulcerative; arthritis, rheumatoid - immunosuppressants - rheumatoid arthritis (ra)simponi, in combination with methotrexate (mtx), is indicated for:the treatment of moderate to severe, active rheumatoid arthritis in adults when the response to disease modifying anti rheumatic drug (dmard) therapy including mtx has been inadequate.the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with mtx.simponi, in combination with mtx, has been shown to reduce the rate of progression of joint damage as measured by x ray and to improve physical function.for information regarding the polyarticular juvenile idiopathic arthritis indication, please see the simponi 50 mg smpc.psoriatic arthritis (psa)simponi, alone or in combination with mtx, is indicated for the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous dmard therapy has been inadequate. simponi has been shown to reduce the rate of progression of peripheral joint damage as measured by x ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function.axial spondyloarthritisankylosing spondylitis (as)simponi is indicated for the treatment of severe, active ankylosing spondylitis in adults who have responded inadequately to conventional therapy.non radiographic axial spondyloarthritis (nr axial spa)simponi is indicated for the treatment of adults with severe, active non radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c reactive protein (crp) and/or magnetic resonance imaging (mri) evidence, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (nsaids).ulcerative colitis (uc)simponi is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6 mercaptopurine (6 mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies.juvenile idiopathic arthritispolyarticular juvenile idiopathic arthritis (pjia)simponi in combination with methotrexate (mtx) is indicated for the treatment of polyarticular juvenile idiopathic arthritis in children 2 years of age and older, who have responded inadequately to previous therapy with mtx.rheumatoid arthritis (ra)simponi, in combination with methotrexate (mtx), is indicated for:the treatment of moderate to severe, active rheumatoid arthritis in adults when the response to disease modifying anti rheumatic drug (dmard) therapy including mtx has been inadequate.the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with mtx.simponi, in combination with mtx, has been shown to reduce the rate of progression of joint damage as measured by x ray and to improve physical function.juvenile idiopathic arthritispolyarticular juvenile idiopathic arthritis (pjia)simponi in combination with mtx is indicated for the treatment of polyarticular juvenile idiopathic arthritis in children 2 years of age and older, who have responded inadequately to previous therapy with mtx.psoriatic arthritis (psa)simponi, alone or in combination with mtx, is indicated for the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous dmard therapy has been inadequate. simponi has been shown to reduce the rate of progression of peripheral joint damage as measured by x ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function.axial spondyloarthritisankylosing spondylitis (as)simponi is indicated for the treatment of severe, active ankylosing spondylitis in adults who have responded inadequately to conventional therapy.non radiographic axial spondyloarthritis (nr axial spa)simponi is indicated for the treatment of adults with severe, active non radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c reactive protein (crp) and/or magnetic resonance imaging (mri) evidence, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (nsaids).ulcerative colitis (uc)simponi is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6 mercaptopurine (6 mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies.