Den europeiske union - norsk - EMA (European Medicines Agency)

seqirus s.r.l.  - zoonotic influenza vaccine (h5n1) (surface antigen, inactivated, adjuvanted), influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: a/turkey/turkey/1/05 (h5n1)-like strain (nibrg-23) - influenza a virus, h5n1 subtype - vaksiner - active immunisation against h5 subtype of influenza a virus.

Den europeiske union - norsk - EMA (European Medicines Agency)

laboratorios hipra, s.a. - mycoplasma hyopneumoniae, strain 7304 (nexhyon), expressing the capsid protein of porcine circovirus type 2a, inactivated - immunologicals for suidae, inactivated viral and inactivated bacterial vaccines - griser - for the active immunisation of pigs:to reduce lung lesions associated with porcine enzootic pneumonia caused by mycoplasma hyopneumoniae. also, to reduce the incidence of these lesions (as observed in field studies). to reduce viraemia, virus load in lungs and lymphoid tissues and the duration of the viraemic period associated with diseases caused by porcine circovirus type 2 (pcv2). efficacy against pcv2 genotypes a, b and d has been demonstrated in field studies. to reduce culling rate and the loss of daily weight gain caused by mycoplasma hyopneumoniae and/or pcv2 related diseases (as observed at 6 months of age in field studies). mycoplasma hyopneumoniae: onset of immunity: 3 weeks after vaccinationduration of immunity: 23 weeks after vaccinationporcine circovirus type 2:onset of immunity: 2 weeks after vaccinationduration of immunity: 22 weeks after vaccinationin addition, a reduction in nasal and faecal shedding and the duration of nasal excretion of pcv2 was demonstrated in animals challenged at 4 weeks and at 22 weeks after vaccination.

Den europeiske union - norsk - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - regdanvimab - covid-19 virus infection - immune sera og immunglobuliner, - regdanvimab is indicated for the treatment of adults with coronavirus disease 2019 (covid-19) who do not require supplemental oxygen and who are at increased risk of progressing to severe covid-19.

Den europeiske union - norsk - EMA (European Medicines Agency)

novartis vaccines and diagnostics s.r.l. - influensavirusoverflateantigener (hemagglutinin og neuraminidase) av stamme a / viet nam / 1194/2004 (h5n1) - influenza, human; immunization; disease outbreaks - vaksiner - aktiv immunisering mot h5n1 subtype av influensa a-virus. , , this indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of the vaccine containing a/vietnam/1194/2004 (h5n1)-like strain. , , prepandemic influenza vaccine (h5n1) novartis vaccines and diagnostic should be used in accordance with official recommendations.

Den europeiske union - norsk - EMA (European Medicines Agency)

teva b.v. - imatinib mesilate - dermatofibrosarcoma; gastrointestinal stromal tumors; leukemia, myelogenous, chronic, bcr-abl positive - antineoplastiske midler - imatinib teva b. is indicated for the treatment of: , paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment. , paediatric pasienter med ph+ kml i kronisk fase etter svikt av interferon-alfa terapi, eller i akselerert fase eller sprenge krise. voksne pasienter med ph+ cml i blast-krisen. voksne og paediatric pasienter med nylig diagnostisert philadelphia kromosom positive akutt lymfoblastisk leukemi (ph+ all) integrert med kjemoterapi. voksne pasienter med tilbakefall eller ildfast ph+ alle som monoterapi. voksne pasienter med myelodysplastic/myeloproliferativ sykdom (mds/mpd) er forbundet med blodplate-avledet vekstfaktor reseptor (pdgfr) gene re-ordninger. voksne pasienter med avansert hypereosinophilic syndrom (hms) og/eller kronisk eosinofil leukemi (cel) med fip1l1-pdgfra omorganisering. effekten av imatinib på utfallet av bein marg transplantasjon har ikke fastsatt. imatinib teva b. is indicated for: , the treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). den adjuvant behandling av voksne pasienter som er i betydelig risiko for tilbakefall etter reseksjon av kit (cd117)-positive gist. pasienter som har en lav eller svært lav risiko for tilbakefall bør ikke får adjuvant behandling. behandling av voksne pasienter med inoperabel dermatofibrosarcoma protuberans (dfsp) og voksne pasienter med tilbakevendende og/eller metastatisk dfsp som ikke er kvalifisert for kirurgi. i voksen og paediatric pasienter, effektiviteten av imatinib er basert på overordnede haematological og cytogenetic respons priser og progresjon-fri overlevelse i cml, på haematological og cytogenetic respons priser i ph+ all, mds/mpd, på haematological respons priser i hms/cel og på objektive svar priser hos voksne pasienter med inoperabel og/eller metastatisk gist og dfsp og på gjentakelse-fri overlevelse i adjuvant gist. erfaring med imatinib hos pasienter med mds/mpd forbundet med pdgfr gene re-ordninger er svært begrenset. det er ingen kontrollerte studier som viser en klinisk nytte eller økt overlevelse for disse sykdommer.

Den europeiske union - norsk - EMA (European Medicines Agency)

sanofi winthrop industrie - isatuximab - multippelt myelom - antineoplastiske midler - sarclisa is indicated: in combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma (mm) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor (pi) and have demonstrated disease progression on the last therapy. in combination with carfilzomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (see section 5.

Den europeiske union - norsk - EMA (European Medicines Agency)

amicus therapeutics europe limited - cipaglucosidase alfa - glykogen storage sykdom type ii - andre alimentary tract and metabolism products, - pombiliti (cipaglucosidase alfa) is a long-term enzyme replacement therapy used in combination with the enzyme stabiliser miglustat for the treatment of adults with late-onset pompe disease (acid α-glucosidase [gaa] deficiency).

Den europeiske union - norsk - EMA (European Medicines Agency)

teva b.v. - rasagilin - parkinsonsykdom - anti-parkinson medisiner - azilect er indisert for behandling av idiopatisk parkinsons sykdom (pd) som monoterapi (uten levodopa) eller som tilleggsbehandling (med levodopa) hos pasienter med end-of-dose fluktuasjoner.

Den europeiske union - norsk - EMA (European Medicines Agency)

janssen-cilag international n.v. - daratumumab - multippelt myelom - monoclonal antibodies and antibody drug conjugates, antineoplastic agents - multiple myelomadarzalex is indicated: in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. i kombinasjon med bortezomib, thalidomid og dexamethasone for behandling av voksne pasienter med nydiagnostisert myelomatose som er kvalifisert for autologous stamcelletransplantasjon. i kombinasjon med lenalidomide og dexamethasone, eller bortezomib og dexamethasone, for behandling av voksne pasienter med myelomatose som har mottatt minst ett før behandling. in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy (see section 5. som monoterapi for behandling av voksne pasienter med tilbakefall og ildfaste myelomatose, som før terapi inkludert en proteasome hemmer og en immunmodulerende agent og som har vist progresjon av sykdommen på den siste terapi. al amyloidosisdarzalex is indicated in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic light chain (al) amyloidosis.

Den europeiske union - norsk - EMA (European Medicines Agency)

blueprint medicines (netherlands) b.v. - avapritinib - gastrointestinal stromal tumors - andre cytostatika, protein kinase hemmere - ayvakyt is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours (gist) harbouring the platelet-derived growth factor receptor alpha (pdgfra) d842v mutation.