Islanda - islandeză - LYFJASTOFNUN (Icelandic Medicines Agency)

astellas pharma a/s* - tamsulosinum hýdróklóríð - hart hylki með breyttan losunarhraða - 0,4 mg

Uniunea Europeană - islandeză - EMA (European Medicines Agency)

janssen-cilag international nv - simeprevir - lifrarbólga c, langvinn - veirueyðandi lyf til almennrar notkunar - olysio er ætlað í samsettri meðferð með öðrum lyfjum til meðferðar við langvarandi lifrarbólgu c (chc) hjá fullorðnum sjúklingum. fyrir lifrarbólgu c veira (hcv) arfgerð ákveðna virkni.

Uniunea Europeană - islandeză - EMA (European Medicines Agency)

menarini international operations luxembourg s.a. - avanafil - ristruflanir - lyf notuð við ristruflanir - meðferð við ristruflunum hjá fullorðnum körlum. Í röð fyrir spedra að vera virkt, kynferðislega örvun er krafist.

Uniunea Europeană - islandeză - EMA (European Medicines Agency)

scipharm sàrl - treprostinil járn - háþrýstingur, lungnabólga - blóðþurrðandi lyf - treatment of adult patients with who functional class (fc) iii or iv and:inoperable chronic thromboembolic pulmonary hypertension (cteph), orpersistent or recurrent cteph after surgical treatmentto improve exercise capacity.

Uniunea Europeană - islandeză - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - telmisartan - háþrýstingur - hjarta og æðakerfi - meðferð háþrýstingi í fullorðnir:bæta á therapyonduarp er ætlað í fullorðnir sem blóðþrýstingur er ekki nægilega stjórn á meðferð. skipti therapyadult sjúklingar fá efnaskipti og meðferð frá sér töflur getur stað fá töflur onduarp inniheldur sama hluti skömmtum.

Uniunea Europeană - islandeză - EMA (European Medicines Agency)

pfizer ltd. - sitaxentan natríum - háþrýstingur, lungnabólga - háþiýstingslækkandi - meðferð sjúklinga með lungnaháþrýsting (pah) flokkuð sem who starfrækslaflokkur iii, til að bæta æfingargetu. verkun hefur verið sýnd við frumháþrýsting og lungnaháþrýsting í tengslum við blóðfrumusjúkdóm.

Uniunea Europeană - islandeză - EMA (European Medicines Agency)

gilead sciences ireland uc - idelalisib - lymphoma, non-hodgkin; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents, other antineoplastic agents - zydelig is indicated in combination with an anti‑cd20 monoclonal antibody (rituximab or ofatumumab) for the treatment of adult patients with chronic lymphocytic leukaemia (cll):who have received at least one prior therapy, oras first line treatment in the presence of 17p deletion or tp53 mutation in patients who are not eligible for any other therapies. zydelig is indicated as monotherapy for the treatment of adult patients with follicular lymphoma (fl) that is refractory to two prior lines of treatment.

Uniunea Europeană - islandeză - EMA (European Medicines Agency)

janssen-cilag international n.v.   - macitentan - háþrýstingur, lungnabólga - háþiýstingslækkandi - opsumit, eitt og sér eða saman, er ætlað til lengri tíma meðferð lungum slagæð háan blóðþrýsting (pah) í fullorðinn sjúklingum sem hagnýtur bekknum (ÍÞrÓtta) ii að iii. verkun hefur verið sýnt fram í pah íbúa þar á meðal sjálfvakin og arfgengum pah, pah tengslum við tengdum vef ringulreið, og pah tengslum við leiðrétt einfalt meðfæddan hjartasjúkdóm.

Uniunea Europeană - islandeză - EMA (European Medicines Agency)

mylan pharmaceuticals limited - darunavir - hiv sýkingar - veirueyðandi lyf til almennrar notkunar - 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):fyrir meðferð hiv-1 sýkingu í andretróveirumeðferð (list)-reynda hjá fullorðnum, þar á meðal þeirra sem hafa verið mjög fyrir fengu. fyrir meðferð hiv-1 sýkingu í börn sjúklingar frá 3 ára og að minnsta kosti 15 kg. Í ákveðið að hefja meðferð með darunavir co-gefið með lítinn skammt rítónavír, vandlega íhugun ætti að meðferð sögu sjúklingur og mynstur stökkbreytingar tengslum með mismunandi lyf. 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-gefið með lítinn skammt rítónavír er ætlað ásamt öðrum antiretroviral lyf til meðferð við sjúklinga með hiv veira (hiv-1) sýkingu.  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. Í ákveðið að hefja meðferð með darunavir í svona list-upplifað sjúklingar, arfgerðar prófa ætti að fylgja því að nota darunavir (sjá kafla 4. 2, 4. 3, 4. 4 og 5.

Uniunea Europeană - islandeză - EMA (European Medicines Agency)

janssen-cilag international nv - darunavir - hiv sýkingar - veirueyðandi lyf til almennrar notkunar - prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight. prezista, 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). in deciding to initiate treatment with prezista co administered with cobicistat or low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, 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. prezista 75 mg, 150 mg, and 600 mg tablets may be used to provide suitable dose regimens:for the treatment of hiv 1 infection in antiretroviral treatment (art) experienced adult patients, including those that have been highly pre treated. for the treatment of hiv 1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight. in deciding to initiate treatment with prezista co administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, 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. prezista, 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). prezista 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. 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. in deciding to initiate treatment with prezista in such art experienced patients, genotypic testing should guide the use of prezista.