Europeiska unionen - isländska - EMA (European Medicines Agency)

ceva santé animale - dregið úr lifandi bólusetningarbólusveiruveiru, spbn-gasi álagi - Ónæmislyf fyrir canidae, lifandi veiru bóluefni - red foxes (vulpes vulpes); raccoon dogs (nyctereutes procyonoides) - fyrir virkan ónæmisaðgerð refur og raccoon hundar gegn hundaæði til að koma í veg fyrir sýkingu og dánartíðni.

Europeiska unionen - isländska - EMA (European Medicines Agency)

merck sharp and dohme b.v - posakónazól - candidiasis; mycoses; coccidioidomycosis; aspergillosis - sveppalyf fyrir almenn nota - noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 og 5. 1):- invasive aspergillosisnoxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections  4. 2 og 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. svara ekki meðferð er skilgreint eins og framgangi sýkingu eða bilun til að bæta eftir að minnsta kosti 7 daga áður en lækninga skammta af árangri mikla meðferð. noxafil gastro-resistant tablets are also indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections 4. 2 og 5. 1):- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 og 5. 1):- invasive aspergillosisnoxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adult and paediatric patients from 2 years of age (see sections 4. 2 og 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. svara ekki meðferð er skilgreint eins og framgangi sýkingu eða bilun til að bæta eftir að minnsta kosti 7 daga áður en lækninga skammta af árangri mikla meðferð. noxafil concentrate for solution for infusion is also indicated for prophylaxis of invasive fungal infections in the following adult and paediatric patients from 2 years of age (see sections 4. 2 og 5. 1):- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease (gvhd) and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil gastro resistant powder and solvent for oral suspension is indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age (see sections 4. 2 og 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. svara ekki meðferð er skilgreint eins og framgangi sýkingu eða bilun til að bæta eftir að minnsta kosti 7 daga áður en lækninga skammta af árangri mikla meðferð. noxafil gastro-resistant powder and solvent for oral suspension is indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2  years of age:- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high  risk of developing invasive fungal infections;- haematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high  risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil oral suspension is indicated for use in the treatment of the following fungal infections in adults (see section 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products;- oropharyngeal candidiasis: as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor. svara ekki meðferð er skilgreint eins og framgangi sýkingu eða bilun til að bæta eftir að minnsta kosti 7 daga áður en lækninga skammta af árangri mikla meðferð. noxafil oral suspension is also indicated for prophylaxis of invasive fungal infections in the following patients:- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis.

Europeiska unionen - isländska - EMA (European Medicines Agency)

accord healthcare s.l.u. - posakónazól - mycoses - sveppalyf fyrir almenn nota - posaconazole ahcl mixtúru er ætlað til að nota í meðferð eftirfarandi sveppasýkingu í fullorðnir:innrásar aspergillosis í sjúklinga með sjúkdóm sem svarar til amfótericín b eða ítrakónazól eða í sjúklingar sem þola þessi lyf;fusariosis í sjúklinga með sjúkdóm sem svarar til amfótericín b eða í sjúklingar sem þola amfótericín b;chromoblastomycosis og mycetoma í sjúklinga með sjúkdóm sem svarar til ítrakónazól eða í sjúklingar sem þola ítrakónazól;coccidioidomycosis í sjúklinga með sjúkdóm sem svarar til amfótericín b, ítrakónazól eða flúkónazól eða í sjúklingar sem þola þessi lyf. koki sveppasýkingu: eins og fyrsta lína meðferð í sjúklingar sem hafa alvarlegan sjúkdóm eða eru ónæmiskerfi, sem svar við útvortis meðferð er gert ráð fyrir að vera fátækur. svara ekki meðferð er skilgreint eins og framgangi sýkingu eða bilun til að bæta eftir að minnsta kosti 7 daga áður en lækninga skammta af árangri mikla meðferð. posaconazole ahcl mixtúru er einnig ætlað til að fyrirbyggja innrásar sveppasýkingu í eftirfarandi sjúklingar:sjúklingar fá fyrirgefningu-framkalla lyfjameðferð fyrir bráð kyrningahvítblæði (aml) eða myelodysplastic heilkennum (stýrð útgjöld) gert ráð fyrir að leiða í langvarandi mæði í tengslum og hver ert í mikilli hættu að fá innrásar sveppasýkingu;blóðmyndandi stafa klefi grætt (hsct) viðtakendur sem eru að verða hár-skammt ónæmisbælandi meðferð fyrir ígræðslu móti gestgjafi sjúkdómur og hver ert í mikilli hættu að fá innrásar sveppasýkingu.

Europeiska unionen - isländska - EMA (European Medicines Agency)

nova laboratories ireland limited - azathioprine - graft rejection - Ónæmisbælandi lyf - jayempi is indicated in combination with other immunosuppressive agents for the prophylaxis of transplant rejection in patients receiving allogenic kidney, liver, heart, lung or pancreas transplants. azathioprine is indicated in immunosuppressive regimens as an adjunct to immunosuppressive agents that form the mainstay of treatment (basis immunosuppression). jayempi is used as an immunosuppressant antimetabolite either alone or, more commonly, in combination with other agents (usually corticosteroids) and/ or procedures which influence the immune response. jayempi is indicated in patients who are intolerant to glucocorticosteroids or if the therapeutic response is inadequate despite treatment with high doses of glucocorticosteroids, in the following diseases:severe active rheumatoid arthritis (chronic polyarthritis) that cannot be kept under control by less toxic agents (disease-modifying anti-rheumatic -medicinal products – dmards)auto-immune hepatitis systemic lupus erythematosusdermatomyositispolyarteritis nodosapemphigus vulgaris and bullous pemphigoidbehçet’s diseaserefractory auto-immune haemolytic anaemia, caused by warm igg antibodieschronic refractory idiopathic thrombocytopenic purpurajayempi is used for the treatment of moderately severe to severe forms of chronic inflammatory bowel disease (ibd) (crohn’s disease or ulcerative colitis) in patients in whom glucocorticosteroid therapy is necessary, but where glucocorticosteroids are not tolerated, or in whom the disease is untreatable with other common means of first choice. it is also indicated in adult patients in relapsing multiple sclerosis, if an immunomodulatory therapy is indicated but beta interferon therapy is not possible, or a stable course has been achieved with previous treatment with azathioprine. 3jayempi is indicated for the treatment of generalised myasthenia gravis. depending on the severity of the disease, jayempi should be given in combination with glucocorticosteroids because of slow onset of action at the beginning of treatment and the glucocorticosteroid dose should be gradually reduced after several months of treatment.

Europeiska unionen - isländska - EMA (European Medicines Agency)

norbrook laboratories (ireland) limited - meloxicam - anti-inflammatory and anti-rheumatic products, non-steroids - dogs; cats; cattle; pigs - dogsalleviation bólgu og sársauka í bæði bráð og langvarandi stoðkerfi kvilla. til að draga úr verkjum og bólgu eftir aðgerð og bæklunaraðgerðir. catsalleviation bólgu og sársauka í langvarandi stoðkerfi ringulreið í kettir. til að draga úr verkja eftir aðgerð eftir eggjastokkaræxli og minniháttar mjúkvefskurðaðgerð. cattlefor nota í bráðar sýkingu með viðeigandi sýklalyf meðferð til að draga úr klínískum merki í nautgripum. til notkunar í niðurgangi í samsettri meðferð með endurþrýstingi til inntöku til að draga úr klínískum einkennum í kálfum sem eru eldri en einum viku og ungir, ekki mjólkandi nautgripir. til viðbótarmeðferðar við meðferð bráðrar bólgu í munnholi ásamt sýklalyfjameðferð. pigsfor nota í noninfectious locomotor kvilla til að draga úr einkenni helti og bólgu. til viðbótarmeðferðar við meðhöndlun á blóðsykursfalli og ofnæmisblóðsýringu (bólgusjúkdómur-mígrenisbólga) með viðeigandi sýklalyfjameðferð. horsesfor nota í lina bólgu og draga úr sársauka í bæði bráð og langvarandi stoðkerfi kvilla. til að draga úr sársauka í tengslum við hrossakolbik.

Europeiska unionen - isländska - EMA (European Medicines Agency)

cp-pharma handelsgesellschaft mbh - meloxicam - stoðkerfi - dogs; cats; guinea pigs - hundar:lina bólgu og sársauka í bæði bráð og langvarandi stoðkerfi ringulreið í hunda. kettir:lina vægt til í meðallagi eftir aðgerð sársauka og bólgu eftir skurðaðgerðir í kettir, e. orthopaedic og mjúkur vefjum skurðaðgerð. lina sársaukann og bólgu í langvarandi stoðkerfi ringulreið í kettir. naggrísum:lina vægt til í meðallagi eftir aðgerð sársauka tengslum með mjúkum vefjum aðgerð eins og karl gelding.

Europeiska unionen - isländska - EMA (European Medicines Agency)

dechra regulatory b.v. - meloxicam - musculo-skeletal system, anti-inflammatory and anti-rheumatic products, non-steroids - dogs; cats - catsalleviation bólgu og sársauka í langvarandi stoðkerfi kvilla. dogsalleviation bólgu og sársauka í bæði bráð og langvarandi stoðkerfi kvilla.

Europeiska unionen - isländska - 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.

Europeiska unionen - isländska - EMA (European Medicines Agency)

swedish orphan biovitrum international ab - nitisinón - tyrosinemias - Önnur meltingarvegi og efnaskipti vörur, - hereditary tyrosinemia type 1 (ht 1)orfadin is indicated for the treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (ht 1) in combination with dietary restriction of tyrosine and phenylalanine. alkaptonuria (aku)orfadin is indicated for the treatment of adult patients with alkaptonuria (aku).

Europeiska unionen - isländska - EMA (European Medicines Agency)

ceva santé animale - meloxicam - oxicams - dogs; cats; cattle; pigs; horses - dogsalleviation bólgu og sársauka í bæði bráð og langvarandi stoðkerfi kvilla. minnkun á verkjum og bólgu eftir aðgerð eftir bæklunar og mjúkvefskurðaðgerð. catsreduction eftir aðgerð sársauka eftir ovariohysterectomy og minniháttar mjúk-vefjum skurðaðgerð. cattlefor nota í bráðar sýkingu með viðeigandi sýklalyf meðferð til að draga úr klínískum merki í nautgripum. til notkunar í niðurgangi í samsettri meðferð með endurþrýstingi til inntöku til að draga úr klínískum einkennum í kálfum sem eru eldri en einum viku og ungir, ekki mjólkandi nautgripir. til viðbótarmeðferðar við meðferð bráðrar bólgu í munnholi ásamt sýklalyfjameðferð. pigsfor nota ekki smitandi locomotor kvilla til að draga úr einkenni helti og bólgu. til viðbótarmeðferðar við meðhöndlun á blóðsykursfalli og ofnæmisblóðsýringu (bólgusjúkdómur-mígrenisbólga) með viðeigandi sýklalyfjameðferð. horsesfor nota í lina bólgu og draga úr sársauka í bæði bráð og langvarandi stoðkerfi kvilla. til að draga úr sársauka í tengslum við hrossakolbik.