Europäische Union - Deutsch - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - lumacaftor, ivacaftor - mukoviszidose - andere produkte für die atemwege - orkambi tabletten sind angezeigt für die behandlung von zystischer fibrose (cf) bei patienten im alter von 6 jahren und älter, die homozygot für die f508del-mutation im cftr-gen. orkambi granules are indicated for the treatment of cystic fibrosis (cf) in children aged 1 year and older who are homozygous for the f508del mutation in the cftr gene.

Deutschland - Deutsch - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

mylan ireland limited (8180065) - methylphenidathydrochlorid - retardtablette - teil 1 - retardtablette; methylphenidathydrochlorid (06085) 27 milligramm

Europäische Union - Deutsch - EMA (European Medicines Agency)

taw pharma (ireland) limited - clopidogrel-hydrochlorid - peripheral vascular diseases; stroke; myocardial infarction; acute coronary syndrome - antithrombotische mittel - , , , , 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. , , ,.

Europäische Union - Deutsch - EMA (European Medicines Agency)

novartis europharm limited - nateglinid - diabetes mellitus, typ 2 - drogen bei diabetes verwendet - nateglinid ist indiziert für die kombinationstherapie mit metformin bei typ-2-diabetikern, die trotz einer maximal tolerierten dosis von metformin allein nicht ausreichend kontrolliert werden.

Österreich - Deutsch - AGES (Agentur für Gesundheit und Ernährungssicherheit)

lundbeck pharmaceuticals ireland ltd - dactinomycin - dactinomycin

Europäische Union - Deutsch - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - tezacaftor, ivacaftor - mukoviszidose - andere produkte für die atemwege - symkevi is indicated in a combination regimen with ivacaftor tablets for the treatment of patients with cystic fibrosis (cf) aged 6 years and older who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene: p67l, r117c, l206w, r352q, a455e, d579g, 711+3a→g, s945l, s977f, r1070w, d1152h, 2789+5g→a, 3272 26a→g, and 3849+10kbc→t.

Österreich - Deutsch - AGES (Agentur für Gesundheit und Ernährungssicherheit)

mylan ireland limited - metformin hydrochlorid; pioglitazon hydrochlorid -

Österreich - Deutsch - AGES (Agentur für Gesundheit und Ernährungssicherheit)

recordati ireland limited - lercanidipin hydrochlorid; enalapril maleat -

Österreich - Deutsch - AGES (Agentur für Gesundheit und Ernährungssicherheit)

recordati ireland limited - enalapril maleat; lercanidipin hydrochlorid - enalapril und calciumka

Österreich - Deutsch - AGES (Agentur für Gesundheit und Ernährungssicherheit)

recordati ireland limited - lercanidipin hydrochlorid; enalapril maleat - enalapril und calciumka