European Union - English - EMA (European Medicines Agency)

merck sharp and dohme b.v - sitagliptin, metformin hydrochloride - diabetes mellitus, type 2 - drugs used in diabetes - for patients with type-2 diabetes mellitus:efficib 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.efficib 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.efficib 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.efficib 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.

European Union - English - 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:janumet 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.janumet 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.janumet 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.janumet 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.

European Union - English - 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:ristfor 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.ristfor 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.ristfor is indicated as triple combination therapy with a peroxisome proliferator-activated-receptor-gamma (pparγ) 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 pparγ agonist.ristfor 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 dose of insulin and metformin alone do not provide adequate glycaemic control.

European Union - English - EMA (European Medicines Agency)

bayer ag - riociguat - hypertension, pulmonary - antihypertensives for pulmonary arterial hypertension - chronic thromboembolic pulmonary hypertension (cteph) adempas is indicated for the treatment of adult patients with who functional class (fc) ii to iii withinoperable cteph,persistent or recurrent cteph after surgical treatment,to improve exercise capacity. pulmonary arterial hypertension (pah) adempas, as monotherapy or in combination with endothelin receptor antagonists, is indicated for the treatment of adult patients with pulmonary arterial hypertension (pah) with who functional class (fc) ii to iii to improve exercise capacity. efficacy has been shown in a pah population including aetiologies of idiopathic or heritable pah or pah associated with connective tissue disease.

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.,

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

merck sharp & dohme (malaysia) sdn bhd - caspofungin acetate -

European Union - English - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - hepatitis b, recombinant surface antigen - hepatitis b; immunization - vaccines - 5 micrograms hbvaxpro is indicated for active immunisation against hepatitis-b-virus infection caused by all known subtypes in individuals from birth through 15 years of age considered at risk of exposure to hepatitis-b virus. the specific at-risk categories to be immunised are to be determined on the basis of the official recommendations. it can be expected that hepatitis d will also be prevented by immunisation with hbvaxpro as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis-b infection. 10 micrograms hbvaxpro is indicated for active immunisation against hepatitis-b-virus infection caused by all known subtypes in individuals 16 years of age or more considered at risk of exposure to hepatitis-b virus. the specific at-risk categories to be immunised are to be determined on the basis of the official recommendations. it can be expected that hepatitis d will also be prevented by immunisation with hbvaxpro as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis-b infection. 40 micrograms hbvaxpro is indicated for the active immunisation against hepatitis-b-virus infection caused by all known subtypes in predialysis and dialysis adult patients. it can be expected that hepatitis d will also be prevented by immunisation with hbvaxpro as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis b infection.,

European Union - English - EMA (European Medicines Agency)

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 - 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.

European Union - English - EMA (European Medicines Agency)

bayer ag - riociguat - hypertension, pulmonary - antihypertensives for pulmonary arterial hypertension - chronic thromboembolic pulmonary hypertension (cteph) adempas is indicated for the treatment of adult patients with who functional class (fc) ii to iii withinoperable cteph,persistent or recurrent cteph after surgical treatment,to improve exercise capacity. pulmonary arterial hypertension (pah) adempas, as monotherapy or in combination with endothelin receptor antagonists, is indicated for the treatment of adult patients with pulmonary arterial hypertension (pah) with who functional class (fc) ii to iii to improve exercise capacity. efficacy has been shown in a pah population including aetiologies of idiopathic or heritable pah or pah associated with connective tissue disease.