Europeiska unionen - svenska - EMA (European Medicines Agency)

accord healthcare s.l.u. - azacitidin - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - antineoplastiska medel - azacitidine accord är indicerat för behandling av vuxna patienter som inte är berättigade till hematopoetisk stamcellstransplantation (hsct) med:- intermediär-2 och hög risk myelodysplastiskt syndrom (mds) enligt internationella prognostiska scoring system (ipss), kronisk myelomonocytic leukemi (cmml) med 10-29 % märg blaster utan myeloproliferativ sjukdom, akut myeloisk leukemi (aml) med 20-30 % blaster och multi-lineage dysplasi, enligt world health organisation (who) klassificering,- aml med >30% märg blaster enligt who-klassificering.

Europeiska unionen - svenska - EMA (European Medicines Agency)

virbac s.a. - tulatromycin - antibakteriella medel för systemisk användning - cattle; pigs; sheep - cattle: treatment and metaphylaxis of bovine respiratory disease (brd) associated with mannheimia haemolytica, pasteurella multocida, histophilus somni and mycoplasma bovis susceptible to tulathromycin. förekomsten av sjukdomen i besättningen bör fastställas före metafylaktisk behandling. treatment of infectious bovine keratoconjunctivitis (ibk) associated with moraxella bovis susceptible to tulathromycin. pigs: treatment and metaphylaxis of swine respiratory disease (srd) associated with actinobacillus pleuropneumoniae, pasteurella multocida, mycoplasma hyopneumoniae, haemophilus parasuis and bordetella bronchiseptica susceptible to tulathromycin. förekomsten av sjukdomen i besättningen bör fastställas före metafylaktisk behandling. the product should only be used if pigs are expected to develop the disease within 2–3 days. får: behandling av de tidiga stadierna av infektiös pododermatit (fotrot) i samband med virulent dichelobacter nodosus som kräver systemisk behandling.

Europeiska unionen - svenska - EMA (European Medicines Agency)

ceva santé animale - tulatromycin - antibakteriella medel för systemisk användning - cattle; pigs; sheep - cattle: treatment and metaphylaxis of bovine respiratory disease (brd) associated with mannheimia haemolytica, pasteurella multocida, histophilus somni and mycoplasma bovis susceptible to tulathromycin. förekomsten av sjukdomen i besättningen bör fastställas före metafylaktisk behandling. treatment of infectious bovine keratoconjunctivitis (ibk) associated with moraxella bovis susceptible to tulathromycin. pigs: treatment and metaphylaxis of swine respiratory disease (srd) associated with actinobacillus pleuropneumoniae, pasteurella multocida, mycoplasma hyopneumoniae, haemophilus parasuis and bordetella bronchiseptica susceptible to tulathromycin. förekomsten av sjukdomen i besättningen bör fastställas före metafylaktisk behandling. the product should only be used if pigs are expected to develop the disease within 2–3 days. får: behandling av de tidiga stadierna av infektiös pododermatit (fotrot) i samband med virulent dichelobacter nodosus som kräver systemisk behandling.

Europeiska unionen - svenska - EMA (European Medicines Agency)

kite pharma eu b.v. - autologous peripheral blood t cells cd4 and cd8 selected and cd3 and cd28 activated transduced with retroviral vector expressing anti-cd19 cd28/cd3-zeta chimeric antigen receptor and cultured (brexucabtagene autoleucel) - lymfom, mantelcell - antineoplastiska medel - mantle cell lymphomatecartus is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl) after two or more lines of systemic therapy including a bruton’s tyrosine kinase (btk) inhibitor. acute lymphoblastic leukaemiatecartus is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory b-cell precursor acute lymphoblastic leukaemia (all).

Europeiska unionen - svenska - EMA (European Medicines Agency)

dechra regulatory b.v. - tulatromycin - antibakteriella medel för systemisk användning - cattle; pigs; sheep - cattle: treatment and metaphylaxis of bovine respiratory disease (brd) associated with mannheimia haemolytica, pasteurella multocida, histophilus somni and mycoplasma bovis susceptible to tulathromycin. förekomsten av sjukdomen i besättningen bör fastställas före metafylaktisk behandling. treatment of infectious bovine keratoconjunctivitis (ibk) associated with moraxella bovis susceptible to tulathromycin. pigs: treatment and metaphylaxis of swine respiratory disease (srd) associated with actinobacillus pleuropneumoniae, pasteurella multocida, mycoplasma hyopneumoniae, haemophilus parasuis and bordetella bronchiseptica susceptible to tulathromycin. förekomsten av sjukdomen i besättningen bör fastställas före metafylaktisk behandling. the product should only be used if pigs are expected to develop the disease within 2–3 days. får: behandling av de tidiga stadierna av infektiös pododermatit (fotrot) i samband med virulent dichelobacter nodosus som kräver systemisk behandling.

Europeiska unionen - svenska - EMA (European Medicines Agency)

janssen-cilag international nv - ciltacabtagene autoleucel - multipelt myelom - carvykti is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-cd38 antibody and have demonstrated disease progression on the last therapy.

Europeiska unionen - svenska - EMA (European Medicines Agency)

ptc therapeutics international limited - eladocagene exuparvovec - aminosyrametabolism, infödda fel - enzymes, other alimentary tract and metabolism products - upstaza is indicated for the treatment of patients aged 18 months and older with a clinical, molecular, and genetically confirmed diagnosis of aromatic l amino acid decarboxylase (aadc) deficiency with a severe phenotype (see section 5.

Europeiska unionen - svenska - EMA (European Medicines Agency)

swedish orphan biovitrum ab - loncastuximab tesirine - lymphoma, large b-cell, diffuse; lymphoma, b-cell - antineoplastiska medel - zynlonta as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large b-cell lymphoma (dlbcl) and high-grade b-cell lymphoma (hgbl), after two or more lines of systemic therapy.

Europeiska unionen - svenska - EMA (European Medicines Agency)

hipra human health s.l. - sars-cov-2 virus recombinant spike (s) protein receptor binding domain (rbd) fusion heterodimer – b.1.351-b.1.1.7 strains - covid-19 virus infection - vacciner - bimervax is indicated as a booster for active immunisation to prevent covid-19 in individuals 16 years of age and older who have previously received a mrna covid-19 vaccine.

Europeiska unionen - svenska - EMA (European Medicines Agency)

incyte biosciences distribution b.v. - ruxolitinib phosphate - vitiligo - andra dermatologiska preparat - opzelura is indicated for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.