Den Europæiske Union - dansk - EMA (European Medicines Agency)

mylan ireland limited - fingolimod hydrochlorid - multipel sklerose, recidiverende-remitterende - immunosuppressiva - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 og 5. 1) or patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

taw pharma (ireland) limited - clopidogrelhydrochlorid - peripheral vascular diseases; stroke; myocardial infarction; acute coronary syndrome - antitrombotiske midler - , , , , secondary prevention of atherothrombotic events, , clopidogrel is indicated in: , - adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 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 medically treated patients eligible for thrombolytic therapy. , , in patients with moderate to high-risk transient ischaemic attack (tia) or minor ischaemic 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.  , , prevention of atherothrombotic and thromboembolic events in atrial fibrillation, in adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with vitamin k antagonists (vka) and who have a low bleeding risk, clopidogrel is indicated in combination with asa for the prevention of atherothrombotic and thromboembolic events, including stroke. , , for further information please refer to section 5. , , ,.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

viatris healthcare limited - tobramycin - cystic fibrosis; respiratory tract infections - antibakterielle midler til systemisk brug, - tobi podhaler er indiceret til undertrykkende behandling af kronisk lunginfektion som følge af pseudomonas aeruginosa hos voksne og børn i alderen 6 år og ældre med cystisk fibrose. se afsnit 4. 4 og 5. 1 vedrørende data i forskellige aldersgrupper. det bør overvejes at officielle vejledning om hensigtsmæssig brug af antibakterielle midler..

Den Europæiske Union - dansk - EMA (European Medicines Agency)

mylan s.a.s - ritonavir - hiv infektioner - antivirale midler til systemisk anvendelse - ritonavir er indiceret i kombination med andre antiretrovirale midler til behandling af hiv 1-inficerede patienter (voksne og børn på 2 år og ældre).

Den Europæiske Union - dansk - EMA (European Medicines Agency)

mylan pharmaceuticals limited - zoledronsyre - frakturer, knogler - narkotika til behandling af knoglesygdomme - forebyggelse af skelet-relaterede hændelser (patologiske frakturer, spinal kompression, strålebehandling eller operation for at knogle, eller tumor-induceret hypercalcaemia) hos voksne patienter med fremskredne lidelser, der involverer knogle;behandling af voksne patienter med tumor-induceret hypercalcaemia (tih).

Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

mylan ireland limited - lidocainhydrochloridmonohydrat - injektionsvæske, opløsning - 20 mg/ml

Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

mylan ab - methylphenidathydrochlorid - depottabletter - 18 mg

Den Europæiske Union - dansk - EMA (European Medicines Agency)

viatris healthcare limited - imiquimod - condylomata acuminata; keratosis; keratosis, actinic; carcinoma, basal cell - antibiotika og kemoterapeutiske midler til dermatologisk brug - imiquimod cream is indicated for the topical treatment of :external genital and perianal warts (condylomata acuminata) in adults. small superficial basal cell carcinomas (sbccs) in adults. clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses (aks) on the face or scalp in immunocompetent adult patients when size or number of lesions limit the efficacy and/or acceptability of cryotherapy and other topical treatment options are contraindicated or less appropriate.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

mylan pharmaceuticals limited - darunavir - hiv infektioner - antivirale midler til systemisk anvendelse - darunavir, 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 (see section 4. darunavir mylan 75 mg, 150 mg, 300 mg and 600 mg tablets may be used to provide suitable dose regimens (see section 4. 2):til behandling af hiv-1 infektion i antiretroviral behandling (art)-erfarne voksne patienter, herunder dem, der har været meget forbehandlet. til behandling af hiv-1 infektion hos pædiatriske patienter fra en alder af 3 år og mindst 15 kg kropsvægt. i beslutter at indlede behandling med darunavir co-administreres med en lav dosis ritonavir, forsigtig, bør det overvejes, om den historie behandling af den enkelte patient og de mønstre af mutationer, der er forbundet med forskellige agenter. genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir (see sections 4. 2, 4. 4 og 5. darunavir co-administreres med en lav dosis ritonavir er indiceret i kombination med andre antiretrovirale lægemidler til behandling af patienter med human immundefekt virus (hiv-1) infektion.  darunavir 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) (see section 4.  darunavir mylan 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 (see section 4.  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. i beslutter at indlede behandling med darunavir i en sådan kunst-erfarne patienter, genotypiske test bør vejlede i brugen af darunavir (se afsnit 4. 2, 4. 3, 4. 4 og 5.

Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

mylan ireland limited - carboplatin - koncentrat til infusionsvæske, opløsning - 10 mg/ml