Europeiska unionen - svenska - EMA (European Medicines Agency)

serb sas - telotristat etiprat - carcinoid tumor; neuroendocrine tumors - andra matsmältningsvägar och metabolismprodukter - xermelo är indicerat för behandling av karcinoid syndrom diarré i kombination med somatostatinanaloga (ssa) behandling hos vuxna som otillräckligt kontrolleras av ssa-terapi.

Europeiska unionen - svenska - EMA (European Medicines Agency)

laboratorios hipra, s.a. - eimeria acervulina, stam 003, eimeria maxima, stam 013, eimeria mitis, stam 006, eimeria praecox, stam 007, eimeria tenella, stam 004 - live parasitiska vacciner, immunologicals för aves - kyckling - för aktiv immunisering av kycklingar från 1 dag gammal för att minska tarm-lesioner och oocysts utgång i samband med koccidios som orsakas av eimeria acervulina, eimeria maxima, eimeria mitis, eimeria praecox och eimeria tenella och minska kliniska symtom (diarré) i samband med eimeria acervulina, eimeria maxima och eimeria tenella.

Europeiska unionen - svenska - EMA (European Medicines Agency)

virbac s.a. - halofuginon - medel mot protozoer - kalvar, nyfödda - in new born calves:- prevention of diarrhoea due to diagnosed cryptosporidium parvum, in farms with history of cryptosporidiosis,administration should start in the first 24 to 48 hours of age- reduction of diarrhoea due to diagnosed cryptosporidium parvum. administrering bör inledas inom 24 timmar efter uppkomsten av diarré. i båda fallen har minskningen av oocyter utsöndring visats.

Europeiska unionen - svenska - EMA (European Medicines Agency)

ceva santé animale - toltrazuril, järn (iii) jon - toltrazuril, kombinationer - grisar (grisar) - för samtidig förebyggande av järnbrist anemi och förebyggande av kliniska tecken på koccidios (diarré) samt minskning i oocyst utsöndring, smågrisar på gårdar med en bekräftad historia av koccidios som orsakas av cystoisospora suis.

Europeiska unionen - svenska - EMA (European Medicines Agency)

bayer animal health gmbh - iron(iii) ion, toltrazuril - toltrazuril, kombinationer - grisar (grisar) - för samtidig förebyggande av kliniska tecken på koccidios (diarré) i neonatal smågrisar på gårdar med en bekräftad historia av koccidios som orsakas av cystoisospora suis, och förebyggande av järnbrist anemi.

Europeiska unionen - svenska - 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.

Europeiska unionen - svenska - EMA (European Medicines Agency)

novartis europharm limited  - alpelisib - bröst-neoplasmer - antineoplastiska medel - piqray är indicerat i kombination med fulvestrant för behandling av postmenopausala kvinnor, och män, med hormon receptor (hr)-positiva, human epidermal growth factor receptor 2 (her2)-negativ, lokalt avancerad eller metastaserande bröstcancer med en pik3ca mutation efter att försämras i sin sjukdom efter endokrin terapi som monoterapi (se avsnitt 5.

Europeiska unionen - svenska - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor - cystisk fibros - andra andningsorganprodukter - kalydeco tablets are indicated:as monotherapy for the treatment of adults, adolescents, and children aged 6 years and older and weighing 25 kg or more with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 och 5. in a combination regimen with tezacaftor/ivacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the 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. in a combination regimen with ivacaftor/tezacaftor/elexacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who have at least one f508del mutation in the cftr gene (see section 5. kalydeco granules are indicated for the treatment of infants aged at least 4 months, toddlers and children weighing 5 kg to less than 25 kg with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cftr gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 och 5. in a combination regimen with ivacaftor/tezacaftor/elexacaftor for the treatment of cystic fibrosis (cf) in paediatric patients aged 2 to less than 6 years who have at least one f508del mutation in the cftr gene.

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

orifarm generics a/s - bromhexinhydroklorid - tablett - 8 mg - bromhexinhydroklorid 8 mg aktiv substans; laktosmonohydrat hjälpämne

Europeiska unionen - svenska - EMA (European Medicines Agency)

janssen-cilag international nv - darunavir - hiv-infektioner - antivirala medel för systemisk användning - 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.