Evrópusambandið - íslenska - EMA (European Medicines Agency)

nabriva therapeutics ireland dac - lefamulin acetate - pneumonia, bacterial; community-acquired infections - sýklalyf fyrir almenn nota, - xenleta is indicated for the treatment of community-acquired pneumonia (cap) in adults when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of cap or when these have failed. Íhuga ætti að opinbera leiðsögn á réttri notkun af sýklalyfjum.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

accord healthcare s.l.u. - rivaroxaban - acute coronary syndrome; coronary artery disease; peripheral arterial disease; venous thromboembolism; stroke; atrial fibrillation; pulmonary embolism - blóðþurrðandi lyf - til að koma í veg fyrir segareki í bláæðum (vte) hjá fullorðnum sjúklingum sem gangast undir valhimnubólgu eða meðhöndlun á hné. meðferð djúpt æð blóðtappa (hjá sjúklingum sem fengu) og í lungum stíflu (pe), og koma í veg fyrir endurteknum hjá sjúklingum sem fengu pe í fullorðnir. (see section 4. 4 for haemodynamically unstable pe patients. meðferð djúpt æð blóðtappa (hjá sjúklingum sem fengu) og í lungum stíflu (pe), og koma í veg fyrir endurteknum hjá sjúklingum sem fengu pe í fullorðnir. (see section 4. 4 fyrir haemodynamically óstöðug pe sjúklingar). adultsprevention 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. meðferð djúpt æð blóðtappa (hjá sjúklingum sem fengu) og í lungum stíflu (pe), og koma í veg fyrir endurteknum hjá sjúklingum sem fengu pe í fullorðnir. (see section 4. 4 for haemodynamically unstable pe patients. )paediatric populationtreatment 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. rivaroxaban accord, co administered with acetylsalicylic acid (asa) alone or with asa plus ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (acs) with elevated cardiac biomarkers (see sections 4. 3, 4. 4 og 5. rivaroxaban accord, 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. adultsprevention 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. meðferð djúpt æð blóðtappa (hjá sjúklingum sem fengu) og í lungum stíflu (pe), og koma í veg fyrir endurteknum hjá sjúklingum sem fengu pe í fullorðnir. (see section 4. 4 for haemodynamically unstable pe patients. )paediatric populationtreatment 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.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

secura bio limited - duvelisib - leukemia, lymphocytic, chronic, b-cell; lymphoma, follicular - Æxlishemjandi lyf - copiktra monotherapy is indicated for the treatment of adult patients with: relapsed or refractory chronic lymphocytic leukaemia (cll) after at least two prior therapies.  follicular lymphoma (fl) that is refractory to at least two prior  systemic therapies.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

mylan ireland limited - rivaroxaban - venous thromboembolism; pulmonary embolism; acute coronary syndrome; stroke; coronary artery disease; peripheral arterial disease; atrial fibrillation - blóðþurrðandi lyf - 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.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

astrazeneca ab - selumetinib sulfate - neurofibromatosis 1 - Æxlishemjandi lyf - koselugo as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (pn) in paediatric patients with neurofibromatosis type 1 (nf1) aged 3 years and above.

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

williams & halls ehf.* - rivaroxabanum inn - filmuhúðuð tafla - 10 mg

Evrópusambandið - íslenska - EMA (European Medicines Agency)

novartis europharm limited - everolimus - carcinoma, renal cell; breast neoplasms; pancreatic neoplasms - Æxlishemjandi lyf - hormón-viðtaka-jákvæð háþróaður barn cancerafinitor er ætlað fyrir meðferð hormón-viðtaka-jákvæðar, her2/afgangurinn-neikvæð háþróaður brjóstakrabbamein, ásamt exemestane, í tíðahvörf konur án einkenna innyflum sjúkdómur eftir endurkomu eða framvindu eftir ekki sterar arómatasatálmanum. taugakirtilsuppruna æxli í brisi originafinitor er ætlað fyrir meðferð unresectable eða sjúklingum, vel eða nokkuð þroskuð taugakirtilsuppruna æxli í brisi uppruna í fullorðnir með versnandi sjúkdómur. taugakirtilsuppruna æxli í maga eða lunga originafinitor er ætlað fyrir meðferð unresectable eða sjúklingum, vel þroskað (bekk 1 eða 2 bekk) virka ekki taugakirtilsuppruna æxli í maga eða lunga uppruna í fullorðnir með versnandi sjúkdómur. nýrna-klefi carcinomaafinitor er ætlað fyrir meðferð sjúklinga með langt nýrna-klefi krabbamein, sem sjúkdómurinn hefur gengið á eða eftir meðferð með vegf-miða meðferð.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

acino ag - klópídógrel - peripheral vascular diseases; acute coronary syndrome; myocardial infarction; stroke - blóðþurrðandi lyf - clopidogrel is indicated in adults for the prevention of atherothrombotic events in: , , , 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, 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, patients suffering from acute coronary syndrome. , ,.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

acino pharma gmbh - klópídógrel - peripheral vascular diseases; stroke; myocardial infarction - blóðþurrðandi lyf - eða er ætlað í fullorðnir til að fyrirbyggja atherothrombotic atburðum í:sjúklingar sem þjáist af kransæðastíflu (frá nokkrum dögum fyrr en minna en 35 dögum), blóðþurrðar heilablóðfall (frá 7 daga þar til að minna en 6 mánuðum) eða komið útlæga slagæð sjúkdómur. nánari upplýsingar er að vísa til kafla 5.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

acino pharma gmbh - klópídógrel - peripheral vascular diseases; stroke; myocardial infarction - blóðþurrðandi lyf - eða er ætlað í fullorðnir til að fyrirbyggja atherothrombotic atburðum í:sjúklingar sem þjáist af kransæðastíflu (frá nokkrum dögum fyrr en minna en 35 dögum), blóðþurrðar heilablóðfall (frá 7 daga þar til að minna en 6 mánuðum) eða komið útlæga slagæð sjúkdómur. nánari upplýsingar er að vísa til kafla 5.