Europeiska unionen - svenska - EMA (European Medicines Agency)

resilience biomanufacturing ireland limited - influensavaccin (helvirion, inaktiverad) innehållande antigen av: a / vietnam / 1203/2004 (h5n1) - influenza, human; immunization; disease outbreaks - vacciner - profylax av influensa i en officiellt deklarerad pandemisk situation. pandemiskt influensavaccin ska användas enligt officiell vägledning.

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

horizon pharma ireland limited - interferon gamma-1b - injektionsvätska, lösning - 0,2 mg/ml - interferon gamma-1b 0,2 mg aktiv substans; mannitol hjälpämne - interferon gamma

Europeiska unionen - svenska - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - niraparib (tosilate monohydrate) - fallopian tube neoplasms; peritoneal neoplasms; ovarian neoplasms - antineoplastiska medel - zejula is indicated: , as monotherapy for the maintenance treatment of adult patients with advanced epithelial (figo stages iii and iv) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. , as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy.

Europeiska unionen - svenska - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - lumacaftor, ivacaftor - cystisk fibros - andra andningsorganprodukter - orkambi tabletter är indicerat för behandling av cystisk fibros (cf) hos patienter i åldern 6 år och äldre och som är homozygot för den f508del mutation i cftr-genen. orkambi granules are indicated for the treatment of cystic fibrosis (cf) in children aged 1 year and older who are homozygous for the f508del mutation in the cftr gene.

Europeiska unionen - svenska - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - tezacaftor, ivacaftor - cystisk fibros - andra andningsorganprodukter - symkevi is indicated in a combination regimen with ivacaftor tablets for the treatment of patients with cystic fibrosis (cf) aged 6 years and older who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (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.

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

theramex ireland limited - risedronatnatrium - enterotablett - 35 mg - risedronatnatrium 35 mg aktiv substans

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

bausch & lomb ireland limited - cefuroximnatrium - pulver till injektionsvätska, lösning - 50 mg - cefuroximnatrium 52,6 mg aktiv substans

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

recordati ireland limited - enalaprilmaleat; lerkanidipinhydroklorid, vattenfri - filmdragerad tablett - 20 mg/20 mg - enalaprilmaleat 20 mg aktiv substans; lerkanidipinhydroklorid, vattenfri 20 mg aktiv substans; laktosmonohydrat hjälpämne - enalapril och lerkanidipin

Europeiska unionen - svenska - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - maribavir - cytomegalovirusinfektioner - antivirala medel för systemisk användning - livtencity is indicated for the treatment of cytomegalovirus (cmv) infection and/or disease that are refractory (with or without resistance) to one or more prior therapies, including ganciclovir, valganciclovir, cidofovir or foscarnet in adult patients who have undergone a haematopoietic stem cell transplant (hsct) or solid organ transplant (sot). hänsyn bör tas till officiella riktlinjer för lämplig användning av antivirala medel.

Europeiska unionen - svenska - EMA (European Medicines Agency)

pfizer limited - sunitinib - gastrointestinal stromal tumors; carcinoma, renal cell; neuroendocrine tumors - antineoplastiska medel - gastrointestinal stromal tumour (gist)sutent is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (gist) in adults after failure of imatinib mesilate treatment due to resistance or intolerance. metastatic renal cell carcinoma (mrcc)sutent is indicated for the treatment of advanced/metastatic renal cell carcinoma (mrcc) in adults. pancreatic neuroendocrine tumours (pnet)sutent is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours with disease progression in adults. experience with sutent as first-line treatment is limited (see section 5.