Europska Unija - engleski - EMA (European Medicines Agency)

merck sharp & dohme b.v. - sugammadex - neuromuscular blockade - all other therapeutic products - reversal of neuromuscular blockade induced by rocuronium or vecuronium.for the peadiatric population: sugammadex is only recommended for routine reversal of rocuronium-induced blockade in children and adolescents.

Europska Unija - engleski - EMA (European Medicines Agency)

merck sharp & dohme b.v. - indinavir sulfate ethanolate - hiv infections - antivirals for systemic use - crixivan is indicated in combination with antiretroviral nucleoside analogues for the treatment of hiv-1 infected adults.,

Europska Unija - engleski - EMA (European Medicines Agency)

merck sharp & dohme b.v. - aprepitant - vomiting; postoperative nausea and vomiting; cancer - antiemetics and antinauseants, - emend 40 mg hard capsules is indicated for the prevention of postoperative nausea and vomiting (ponv) in adults.emend is also available as 80 mg and 125 mg hard capsules for the prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults and adolescents from the age of 12 (see separate summary of product characteristics).emend is also available as 165 mg hard capsules for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin based cancer chemotherapy in adults and the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults.emend is also available as powder for oral suspension for the prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in children, toddlers and infants from the age of 6 months to less than 12 years.emend 80 mg, 125 mg, 165 mg hard capsules and emend powder for oral suspension are given as part of combination therapy.

Europska Unija - engleski - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - 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 - gardasil 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 gardasil should be in accordance with official recommendations.

Europska Unija - engleski - EMA (European Medicines Agency)

merck sharp & dohme b.v. - human papillomavirus vaccine [types 6, 11, 16, 18, 31, 33, 45, 52, 58] (recombinant, adsorbed) - condylomata acuminata; papillomavirus infections; immunization; uterine cervical dysplasia - papillomavirus vaccines - gardasil 9 is indicated for active immunisation of individuals from the age of 9 years against the following hpv diseases:premalignant lesions and cancers affecting the cervix, vulva, vagina and anus caused by vaccine hpv typesgenital warts (condyloma acuminata) caused by specific hpv types.see sections 4.4 and 5.1 for important information on the data that support these indications.the use of gardasil 9 should be in accordance with official recommendations.

Europska Unija - engleski - EMA (European Medicines Agency)

merck sharp & dohme b.v. - interferon alfa-2b - carcinoid tumor; leukemia, hairy cell; lymphoma, follicular; hepatitis b, chronic; hepatitis c, chronic; leukemia, myelogenous, chronic, bcr-abl positive; melanoma; multiple myeloma - immunostimulants, - chronic hepatitis btreatment of adult patients with chronic hepatitis b associated with evidence of hepatitis-b viral replication (presence of dna of hepatitis-b virus (hbv-dna) and hepatitis-b antigen (hbeag), elevated alanine aminotransferase (alt) and histologically proven active liver inflammation and / or fibrosis.chronic hepatitis cbefore initiating treatment with introna, consideration should be given to the results from clinical trials comparing introna with pegylated interferon.adult patientsintrona is indicated for the treatment of adult patients with chronic hepatitis c who have elevated transaminases without liver decompensation and who are positive for hepatitis-c virus-rna (hcv-rna).the best way to use introna in this indication is in combination with ribavirin.children three years of age and older and adolescentsintrona is indicated, in a combination regimen with ribavirin, for the treatment of children three years of age and older and adolescents, who have chronic hepatitis c, not previously treated, 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 resulted in reduced final adult height in some patients.the decision to treat should be made on a case-by-case basis.hairy-cell leukaemiatreatment of patients with hairy cell leukaemia.chronic myelogenous leukaemiamonotherapytreatment of adult patients with philadelphia-chromosome- or bcr/abl-translocation-positive chronic myelogenous leukaemia.clinical experience indicates that a haematological and cytogenetic major / minor response is obtainable in the majority of patients treated. a major cytogenetic response is defined by < 34 % ph+ leukaemic cells in the bone marrow, whereas a minor response is ≥ 34 %, but < 90 % ph+ cells in the marrow.combination therapythe combination of interferon alfa-2b and cytarabine (ara-c) administered during the first 12 months of treatment has been demonstrated to significantly increase the rate of major cytogenetic responses and to significantly prolong the overall survival at three years when compared to interferon alfa-2b monotherapy.multiple myelomaas maintenance therapy in patients who have achieved objective remission (more than 50% reduction in myeloma protein) following initial induction chemotherapy.current clinical experience indicates that maintenance therapy with interferon alfa-2b prolongs the plateau phase; however, effects on overall survival have not been conclusively demonstrated.follicular lymphomatreatment of high-tumour-burden follicular lymphoma as adjunct to appropriate combination induction chemotherapy such as a chop-like regimen. high tumour burden is defined as having at least one of the following: bulky tumour mass (> 7 cm), involvement of three or more nodal sites (each > 3 cm), systemic symptoms (weight loss > 10 %, pyrexia > 38°c for more than eight days, or nocturnal sweats), splenomegaly beyond the umbilicus, major organ obstruction or compression syndrome, orbital or epidural involvement, serous effusion, or leukaemia.carcinoid tumourtreatment of carcinoid tumours with lymph node or liver metastases and with 'carcinoid syndrome'.malignant melanomaas adjuvant therapy in patients who are free of disease after surgery but are at high risk of systemic recurrence, e.g. patients with primary or recurrent (clinical or pathological) lymph-node.

Europska Unija - engleski - EMA (European Medicines Agency)

n.v. organon - nomegestrol acetate, estradiol - contraception - sex hormones and modulators of the genital system, - oral contraception.

Europska Unija - engleski - EMA (European Medicines Agency)

merck sharp & dohme b.v. - fosaprepitant - vomiting; cancer - antiemetics and antinauseants, - prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults and paediatric patients aged 6 months and older.ivemend 150 mg is given as part of a combination therapy.

Europska Unija - engleski - EMA (European Medicines Agency)

merck sharp and dohme b.v - sitagliptin - diabetes mellitus, type 2 - drugs used in diabetes - for adult patients with type-2 diabetes mellitus, januvia 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;a 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.januvia 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.

Europska Unija - engleski - EMA (European Medicines Agency)

merck sharp & dohme b.v. - insulin glargine - diabetes mellitus - drugs used in diabetes - treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.,