European Union - English - 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.

European Union - English - 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.,

European Union - English - EMA (European Medicines Agency)

merck sharp & dohme b.v. - elbasvir, grazoprevir - hepatitis c, chronic - direct acting antivirals, antivirals for systemic use, , antivirals for treatment of hcv infections - zepatier is indicated for the treatment of chronic hepatitis c (chc) in adult and paediatric patients 12 years of age and older who weigh at least 30 kg (see sections 4.2, 4.4 and 5.1). for hepatitis c virus (hcv) genotype-specific activity see sections 4.4 and 5.1.,

European Union - English - 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.,

European Union - English - 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.

European Union - English - EMA (European Medicines Agency)

mcm vaccine b.v. - diphtheria toxoid, tetanus toxoid, bordetella pertussis antigens: pertussis toxoid, filamentous haemagglutinin, pertactin, fimbriae types 2 and 3, hepatitis b surface antigen produced in yeast cells, poliovirus (inactivated): type 1 (mahoney), type 2 (mef-1), type 3 (saukett) produced in vero cells/ haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) conjugated to meningococcal protein. - meningitis, haemophilus; poliomyelitis; tetanus; diphtheria; whooping cough; hepatitis b - vaccines - vaxelis (dtap-hb-ipv-hib) is indicated for primary and booster vaccination in infants and toddlers from the age of 6 weeks, against diphtheria, tetanus, pertussis, hepatitis b, poliomyelitis and invasive diseases caused by haemophilus influenzae type b (hib). the use of vaxelis should be in accordance with official recommendations.

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merck sharp & dohme b.v. - peginterferon alfa-2b - hepatitis c, chronic - immunostimulants, - adults (tritherapy)pegintron in combination with ribavirin and boceprevir (tritherapy) is indicated for the treatment of chronic-hepatitis-c (chc) genotype-1 infection in adult patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy.please refer to the ribavirin and boceprevir summaries of product characteristics (smpcs) when pegintron is to be used in combination with these medicines.adults (bitherapy and monotherapy)pegintron is indicated for the treatment of adult patients (18 years of age and older) with chc who are positive for hepatitis-c-virus rna (hcv-rna), including patients with compensated cirrhosis and / or co-infected with clinically stable hiv.pegintron in combination with ribavirin (bitherapy) is indicated for the treatment of chc infection in adult patients who are previously untreated including patients with clinically stable hiv co-infection and in adult patients who have failed previous treatment with interferon-alpha (pegylated or non-pegylated) and ribavirin combination therapy or interferon-alpha monotherapy.interferon monotherapy, including pegintron, is indicated mainly in case of intolerance or contraindication to ribavirin.please refer to the ribavirin smpc when pegintron is to be used in combination with ribavirin.paediatric population (bitherapy)pegintron is indicated in a combination regimen with ribavirin for the treatment of children three years of age and older and adolescents who have chc, previously untreated, without liver decompensation, and who are positive for hcv-rna.when deciding not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition that may be irreversible in some patients. the decision to treat should be made on a case-by-case basis.please refer to the ribavirin smpc for capsules or oral solution when pegintron is to be used in combination with ribavirin.

European Union - English - EMA (European Medicines Agency)

merck sharp dohme ltd - laropiprant, nicotinic acid - dyslipidemias - lipid modifying agents - pelzont is indicated for the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia (characterised by elevated levels of low-density-lipoprotein (ldl) cholesterol and triglycerides and low high-density-lipoprotein (hdl)cholesterol) and in patients with primary hypercholesterolaemia (heterozygous familial and non-familial).pelzont should be used in patients in combination with 3-hydroxy-3-methylglutaryl-coenzyme-a (hmg-coa)-reductase inhibitors (statins), when the cholesterol lowering effect of hmg-coa-reductase inhibitor monotherapy is inadequate. it can be used as monotherapy only in patients in whom hmg-coa-reductase inhibitors are considered inappropriate or not tolerated. diet and other non-pharmacological treatments (e.g. exercise, weight reduction) should be continued during therapy with pelzont.

European Union - English - EMA (European Medicines Agency)

sanofi pasteur msd, snc - polyribosylribitol phosphate from haemophilus influenzae type b as prp-ompc, outer membrane protein complex of neisseria meningitidis (outer membrane protein complex of the b11 strain of neisseria meningitidis subgroup b), adsorbed hepatitis b surface antigen produced in recombinant yeast cells (saccharomyces cerevisiae) - hepatitis b; meningitis, haemophilus; immunization - vaccines - procomvax is indicated for vaccination against invasive disease caused by haemophilus influenzae type b and against infection caused by all known subtypes of hepatitis b virus in infants 6 weeks to 15 months of age.,

European Union - English - EMA (European Medicines Agency)

merck sharp and dohme b.v - ribavirin - hepatitis c, chronic - antivirals for systemic use, antivirals for treatment of hcv infections - rebetol is indicated in combination with other medicinal products for the treatment of chronic hepatitis c (chc) in adults.rebetol is indicated in combination with other medicinal products for the treatment of chronic hepatitis c (chc) for paediatric patients (children 3 years of age and older and adolescents) not previously treated and without liver decompensation.