Unione Europea - olandese - EMA (European Medicines Agency)

teva b.v.  - nevirapine - hiv-infecties - antivirale middelen voor systemisch gebruik - nevirapine teva is geïndiceerd in combinatie met andere anti-retrovirale geneesmiddelen voor de behandeling van met hiv-1 geïnfecteerde volwassenen, adolescenten en kinderen van elke leeftijd.. de meeste van de ervaring met nevirapine is in combinatie met nucleoside reverse transcriptase-remmers (nrtis). de keuze van een volgende behandeling na nevirapine moet worden gebaseerd op de klinische ervaring en het testen van de weerstand.

Unione Europea - olandese - EMA (European Medicines Agency)

merck sharp and dohme b.v - posaconazol - candidiasis; mycoses; coccidioidomycosis; aspergillosis - antimycotica voor systemisch gebruik - noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 en 5. 1):- invasive aspergillosisnoxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections  4. 2 en 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. ongevoeligheid is gedefinieerd als de progressie van infectie of niet verbeteren na een minimum van 7 dagen voorafgaande therapeutische doses van de effectieve antifungale therapie. noxafil gastro-resistant tablets are also indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections 4. 2 en 5. 1):- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 en 5. 1):- invasive aspergillosisnoxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adult and paediatric patients from 2 years of age (see sections 4. 2 en 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. ongevoeligheid is gedefinieerd als de progressie van infectie of niet verbeteren na een minimum van 7 dagen voorafgaande therapeutische doses van de effectieve antifungale therapie. noxafil concentrate for solution for infusion is also indicated for prophylaxis of invasive fungal infections in the following adult and paediatric patients from 2 years of age (see sections 4. 2 en 5. 1):- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease (gvhd) and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil gastro resistant powder and solvent for oral suspension is indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age (see sections 4. 2 en 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. ongevoeligheid is gedefinieerd als de progressie van infectie of niet verbeteren na een minimum van 7 dagen voorafgaande therapeutische doses van de effectieve antifungale therapie. noxafil gastro-resistant powder and solvent for oral suspension is indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2  years of age:- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high  risk of developing invasive fungal infections;- haematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high  risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil oral suspension is indicated for use in the treatment of the following fungal infections in adults (see section 5. 1):- invasive aspergillosis in patiënten met een ziekte die ongevoelig is voor amfotericine b of itraconazol of bij patiënten die intolerant zijn voor deze geneesmiddelen;- fusariosis bij patiënten met een ziekte die ongevoelig is voor amfotericine b of bij patiënten die intolerant zijn voor amfotericine b;- chromoblastomycosis en mycetoma bij patiënten met een ziekte die ongevoelig zijn voor itraconazol of bij patiënten die intolerant zijn voor itraconazol;- coccidioidomycosis bij patiënten met een ziekte die ongevoelig is voor amfotericine b, itraconazol of fluconazol of bij patiënten die intolerant zijn voor deze geneesmiddelen;- orofaryngeale candidiasis: als eerstelijns therapie bij patiënten die een ernstige ziekte of immuungecompromitteerde, bij wie de respons op lokale therapie is naar verwachting slecht. ongevoeligheid is gedefinieerd als de progressie van infectie of niet verbeteren na een minimum van 7 dagen voorafgaande therapeutische doses van de effectieve antifungale therapie. noxafil oral suspension is also indicated for prophylaxis of invasive fungal infections in the following patients:- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis.

Unione Europea - olandese - EMA (European Medicines Agency)

gilead sciences ireland uc - elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate - hiv-infecties - antivirals for treatment of hiv infections, combinations, antivirals for systemic use - behandeling van humaan immunodeficiëntievirus 1 (hiv 1) -infectie bij volwassenen van 18 jaar en ouder die antiretroviraal behandelingsnaïef hebben of zijn geïnfecteerd met hiv 1 zonder bekende mutaties geassocieerd met resistentie tegen een van de drie antiretrovirale middelen in stribild.

Unione Europea - olandese - EMA (European Medicines Agency)

viiv healthcare bv - dolutegravir - hiv-infecties - antivirale middelen voor systemisch gebruik - tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (hiv) infected adults, adolescents and children of at least 6 years of age or older and weighing at least 14 kg. tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (hiv) infected adults, adolescents and children of at least 4 weeks of age or older and weighing at least 3 kg.

Unione Europea - olandese - EMA (European Medicines Agency)

merck sharp dohme ltd - boceprevir - hepatitis c, chronisch - antivirale middelen voor systemisch gebruik - victrelis is geïndiceerd voor de behandeling van chronische hepatitis-c (chc) genotype 1 infectie, in combinatie met peginterferon alfa en ribavirine, bij volwassen patiënten met gecompenseerd leverziekte die eerder onbehandeld of die hebben gefaald vorige therapie.

Unione Europea - olandese - EMA (European Medicines Agency)

sanofi winthrop industrie - clopidogrel waterstofsulfaat - stroke; peripheral vascular diseases; atrial fibrillation; myocardial infarction; acute coronary syndrome - antitrombotische middelen - secondary prevention of atherothrombotic eventsclopidogrel is indicated in:adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from seven days until less than six months) or established peripheral arterial disease;adult patients suffering from acute coronary syndrome:non-st-segment-elevation acute coronary syndrome (unstable angina or non-q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (asa);st-segment-elevation acute myocardial infarction, in combination with asa in patients undergoing percutaneous coronary intervention (including patients undergoing a stent replacement) or medically treated patients eligible for thrombolytic/fibrinolytic therapy. in patients with moderate to high-risk transient ischemic attack (tia) or minor ischemic stroke (is)clopidogrel in combination with asa is indicated in:adult patients with moderate to high-risk tia (abcd2  score ≥4) or minor is (nihss  ≤3) within 24 hours of either the tia or is event. preventie van atherothrombotic en trombo-embolische gebeurtenissen in atriale fibrillationin volwassen patiënten met atriumfibrilleren die ten minste één risicofactor voor vasculaire gebeurtenissen, zijn niet geschikt voor behandeling met vitamine-k-antagonisten en die hebben een lage bloeden risico, clopidogrel is geïndiceerd in combinatie met asa voor de preventie van atherothrombotic en trombo-embolische voorvallen, waaronder beroerte.

Unione Europea - olandese - EMA (European Medicines Agency)

janssen-cilag international nv - darunavir - hiv-infecties - antivirale middelen voor systemisch gebruik - prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). in deciding to initiate treatment with prezista co administered with cobicistat or low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista 75 mg, 150 mg, and 600 mg tablets may be used to provide suitable dose regimens:for the treatment of hiv 1 infection in antiretroviral treatment (art) experienced adult patients, including those that have been highly pre treated. for the treatment of hiv 1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight. in deciding to initiate treatment with prezista co administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). prezista 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of hiv 1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:antiretroviral therapy (art) naïve. art experienced with no darunavir resistance associated mutations (drv rams) and who have plasma hiv 1 rna < 100,000 copies/ml and cd4+ cell count ≥ 100 cells x 106/l. in deciding to initiate treatment with prezista in such art experienced patients, genotypic testing should guide the use of prezista.

Unione Europea - olandese - EMA (European Medicines Agency)

janssen-cilag international n.v. - darunavir, cobicistat - hiv-infecties - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - rezolsta is geïndiceerd in combinatie met andere antiretrovirale geneesmiddelen voor de behandeling van een infectie met het humaan immunodeficiëntievirus 1 (hiv 1) bij volwassenen van 18 jaar of ouder. genotypische testen moet de leidraad zijn voor het gebruik van rezolsta.

Unione Europea - olandese - EMA (European Medicines Agency)

janssen-cilag international nv - bedaquiline-fumaraat - tuberculose, multiresistente - antimycobacteriële - sirturo is geïndiceerd voor gebruik als onderdeel van een geschikte combinatie regime voor pulmonale multiresistente tuberculose (mdr-tb) in volwassenen en adolescente patiënten van 12 jaar tot minder dan 18 jaar van de leeftijd en een gewicht van ten minste 30 kg) als een effectieve behandeling regime kan niet anders worden samengesteld om redenen van resistentie of tolerantie. aandacht moet worden gegeven aan de officiële richtlijnen betreffende het juiste gebruik van antibacteriële agentia.

Unione Europea - olandese - EMA (European Medicines Agency)

bioprojet pharma - pitolisant - narcolepsie - andere medicijnen voor het zenuwstelsel - wakix is indicated in adults, adolescents and children from the age of 6 years for the treatment of narcolepsy with or without cataplexy (see also section 5.