Lynparza Evrópusambandið - íslenska - EMA (European Medicines Agency)

lynparza

astrazeneca ab - olaparib - Æxli í eggjastokkum - Æxlishemjandi lyf - blöðrur á cancerlynparza er ætlað eitt og sér fyrir:viðhald meðferð fullorðinn sjúklinga með langt (figo stigum iii og iv) brca1/2-stökkbreytt (germline og/eða líkamsvöxt) hágæða þekju blöðrur, eggjaleiðara eða aðal kviðarholi krabbamein sem eru í svar (heill eða hluta) eftir að ljúka fyrsta lína platínu-byggt lyfjameðferð. maintenance treatment of adult patients with platinum sensitive relapsed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy. lynparza in combination with bevacizumab is indicated for the:maintenance treatment of adult patients with advanced (figo stages iii and iv) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either a brca1/2 mutation and/or genomic instability (see section 5. breast cancerlynparza is indicated as:monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline brca1/2-mutations who have her2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4. 2 og 5. monotherapy for the treatment of adult patients with germline brca1/2-mutations, who have her2 negative locally advanced or metastatic breast cancer. sjúklingar að hefur áður verið meðhöndluð með anthracycline og taxane í (neo)viðbótar eða sjúklingum setja nema sjúklinga sem voru ekki henta til þessara meðferða (sjá kafla 5. sjúklingar með hormón viðtaka (hr)-jákvæð brjóstakrabbamein ætti líka að hafa gengið á eða eftir áður en annarra meðferð, eða að vera talin óhæf til annarra meðferð. adenocarcinoma of the pancreaslynparza is indicated as:monotherapy for the maintenance treatment of adult patients with germline brca1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. prostate cancerlynparza is indicated as:monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mcrpc) and brca1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mcrpc in whom chemotherapy is not clinically indicated (see section 5.

Targretin Evrópusambandið - íslenska - EMA (European Medicines Agency)

targretin

eisai gmbh - bexarótín - eitilæxli, t-frumur, húð - Æxlishemjandi lyf - targretin hylki eru ætlaðar til meðhöndlunar á einkennum í húð hjá sjúklingum með sjúkdóm í t-frumu eitilfrumugerð í langt gengnu stigi, sem eru ónæmir fyrir að minnsta kosti einum almennri meðferð.

Xarelto Evrópusambandið - íslenska - EMA (European Medicines Agency)

xarelto

bayer ag - rivaroxaban - arthroplasty, replacement; venous thromboembolism - blóðþurrðandi lyf - mælt, sam-gefið með asetýlsalisýlsýru (asa) einn eða með asa, plús eða eða tíclópidín, er ætlað til að fyrirbyggja atherothrombotic atburðum í fullorðinn sjúklinga eftir bráð kransæðastíflu (haft) með hækkun hjarta biomarkers. xarelto, 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. 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. 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. 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.

Rivaroxaban Accord Evrópusambandið - íslenska - EMA (European Medicines Agency)

rivaroxaban accord

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.

Rivaroxaban Viatris (previously Rivaroxaban Mylan) Evrópusambandið - íslenska - EMA (European Medicines Agency)

rivaroxaban viatris (previously rivaroxaban mylan)

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.

Eplerenon Bluefish Filmuhúðuð tafla 25 mg Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

eplerenon bluefish filmuhúðuð tafla 25 mg

bluefish pharmaceuticals ab - eplerenonum inn - filmuhúðuð tafla - 25 mg

Amlodipin Bluefish Tafla 10 mg Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

amlodipin bluefish tafla 10 mg

bluefish pharmaceuticals ab - amlodipinum besýlat - tafla - 10 mg

Escitalopram Bluefish Filmuhúðuð tafla 5 mg Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

escitalopram bluefish filmuhúðuð tafla 5 mg

bluefish pharmaceuticals ab - escitalopramum oxalat - filmuhúðuð tafla - 5 mg