Alemanya - alemany - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

mylan germany gmbh (8185157) - buprenorphinhydrochlorid; naloxonhydrochlorid-dihydrat - sublingualtablette - teil 1 - sublingualtablette; buprenorphinhydrochlorid (20181) 8,64 milligramm; naloxonhydrochlorid-dihydrat (13441) 2,44 milligramm

Alemanya - alemany - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

mylan germany gmbh (8185157) - buprenorphinhydrochlorid; naloxonhydrochlorid-dihydrat - sublingualtablette - teil 1 - sublingualtablette; buprenorphinhydrochlorid (20181) 2,16 milligramm; naloxonhydrochlorid-dihydrat (13441) 0,61 milligramm

Unió Europea - alemany - EMA (European Medicines Agency)

mylan pharmaceuticals limited - prasugrel besilate - myocardial infarction; acute coronary syndrome; angina, unstable - antithrombotische mittel - prasugrel mylan, co-verabreicht mit acetylsalicylsäure (asa), ist indiziert für die prävention von atherothrombotischen ereignissen bei erwachsenen patienten mit akutem koronarsyndrom (ich. instabile angina pectoris, non-st-segment elevation myocardial infarction [ua/nstemi] oder st-segment elevation myocardial infarction [stemi]) unterziehen primäre oder verzögerte perkutane koronare intervention (pci).

Unió Europea - alemany - EMA (European Medicines Agency)

mylan pharmaceuticals limited - acetylsalicylic acid, clopidogrel hydrogen sulfate - acute coronary syndrome; myocardial infarction - antithrombotische mittel - clopidogrel/acetylsalicylsäure mylan ist indiziert für die sekundäre prävention von atherothrombotischen ereignissen bei erwachsenen patienten, die bereits unter beiden clopidogrel und acetylsalicylsäure (asa). clopidogrel/acetylsalicylsäure mylan ist ein fixed-dose combination arzneimittel für die fortsetzung der therapie in:non-st-segment elevation acute coronary syndrome (instabile angina pectoris oder non-q-wave-myokardinfarkt), einschließlich patienten, die sich einer stent-implantation folgenden perkutane koronare interventionst-segment elevation acute myocardial infarction in medizinisch behandelten patienten, für die eine thrombolytische therapie.

Unió Europea - alemany - EMA (European Medicines Agency)

mylan ireland limited - fingolimod hydrochloride - multiple sklerose, schubförmig-remittierender - immunsuppressiva - 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 und 5. 1)orpatients mit sich rasch entwickelnden schweren schubförmig remittierender multipler sklerose, definiert durch 2 oder mehr deaktivieren schübe in einem jahr, und mit 1 oder mehr gadolinium verbesserung läsionen auf gehirn-mrt oder eine signifikante zunahme der t2-läsionen laden als im vergleich zu einer früheren letzten mrt.

Unió Europea - alemany - EMA (European Medicines Agency)

mylan ireland limited - rivaroxaban - venous thromboembolism; pulmonary embolism; acute coronary syndrome; stroke; coronary artery disease; peripheral arterial disease; atrial fibrillation - antithrombotische mittel - rivaroxaban mylan co-administered with acetylsalicylic acid (asa) alone or with asa plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (acs) with elevated cardiac biomarkers.  rivaroxaban mylan co-administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (cad) or symptomatic peripheral artery disease (pad) at high risk of ischaemic events.  ------prevention of venous thromboembolism (vte) in adult patients undergoing elective hip or knee replacement surgery.  treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe), and prevention of recurrent dvt and pe in adults. -------adults prevention of stroke and systemic embolism in adult   patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

Unió Europea - alemany - EMA (European Medicines Agency)

mylan ireland limited - sugammadex sodium - neuromuskuläre blockade - alle anderen therapeutischen produkte - reversal of neuromuscular blockade induced by   rocuronium or vecuronium in adults. for the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.

Unió Europea - alemany - EMA (European Medicines Agency)

mylan ireland limited - fingolimod hydrochloride - multiple sklerose, schubförmig-remittierender - immunsuppressiva - 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 und 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.

Alemanya - alemany - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

mylan germany gmbh (8185157) - lacosamid - filmtablette - 100 mg - teil 1 - filmtablette; lacosamid (31188) 100 milligramm

Alemanya - alemany - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

mylan germany gmbh (8185157) - lacosamid - filmtablette - 150 mg - teil 1 - filmtablette; lacosamid (31188) 150 milligramm