Umoja wa Ulaya - Kiaisilandi - EMA (European Medicines Agency)

krka, d.d., novo mesto  - lenalidomide hydrochloride monohydrate - multiple myeloma; lymphoma, follicular - Ónæmisbælandi lyf - multiple myelomalenalidomide krka d. novo mesto as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka d. novo mesto as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) er ætlað fyrir meðferð fullorðinn sjúklinga með áður ómeðhöndlað margar forráðamenn sem eru ekki rétt fyrir ígræðslu. lenalidomide krka d. novo mesto in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. follicular lymphomalenalidomide krka d. novo mesto in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a). multiple myelomalenalidomide krka d. novo mesto as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka d. novo mesto as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) er ætlað fyrir meðferð fullorðinn sjúklinga með áður ómeðhöndlað margar forráðamenn sem eru ekki rétt fyrir ígræðslu. lenalidomide krka d. novo mesto in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. follicular lymphomalenalidomide krka d. novo mesto in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).

Umoja wa Ulaya - Kiaisilandi - EMA (European Medicines Agency)

krka, d.d., novo mesto  - lenalidomide hydrochloride monohydrate - multiple myeloma; myelodysplastic syndromes; lymphoma, follicular; lymphoma, mantle-cell - Ónæmisbælandi lyf - multiple myelomalenalidomide krka as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) er ætlað fyrir meðferð fullorðinn sjúklinga með áður ómeðhöndlað margar forráðamenn sem eru ekki rétt fyrir ígræðslu. lenalidomide krka in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. myelodysplastic syndromeslenalidomide krka as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. mantle cell lymphomalenalidomide krka as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4. 4 og 5. follicular lymphomalenalidomide krka in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a). multiple myelomalenalidomide krka as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) er ætlað fyrir meðferð fullorðinn sjúklinga með áður ómeðhöndlað margar forráðamenn sem eru ekki rétt fyrir ígræðslu. lenalidomide krka in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. myelodysplastic syndromeslenalidomide krka as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. mantle cell lymphomalenalidomide krka as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4. 4 og 5. follicular lymphomalenalidomide krka in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).

Umoja wa Ulaya - Kiaisilandi - EMA (European Medicines Agency)

janssen-cilag international n.v.    - amivantamab - krabbamein, lungnakrabbamein - Æxlishemjandi lyf - rybrevant as monotherapy is indicated for treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating epidermal growth factor receptor (egfr) exon 20 insertion mutations, after failure of platinum-based chemotherapy.

Umoja wa Ulaya - Kiaisilandi - EMA (European Medicines Agency)

astrazeneca ab - anifrolumab - lupus erythematosus, systemic - Ónæmisbælandi lyf - saphnelo is indicated as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (sle), despite standard therapy.

Umoja wa Ulaya - Kiaisilandi - EMA (European Medicines Agency)

astellas pharma europe b.v. - enfortumab vedotin - carcinoma, transitional cell; urologic neoplasms - Æxlishemjandi lyf - padcev as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor 1 or programmed death ligand 1 inhibitor.

Umoja wa Ulaya - Kiaisilandi - EMA (European Medicines Agency)

swedish orphan biovitrum ab - loncastuximab tesirine - lymphoma, large b-cell, diffuse; lymphoma, b-cell - Æxlishemjandi lyf - 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.

Umoja wa Ulaya - Kiaisilandi - EMA (European Medicines Agency)

neuraxpharm pharmaceuticals s.l. - ublituximab - multiple sclerosis, relapsing-remitting; multiple sclerosis - Ónæmisbælandi lyf - briumvi is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (rms) with active disease defined by clinical or imaging features.

Umoja wa Ulaya - Kiaisilandi - EMA (European Medicines Agency)

janssen-cilag international n.v. - daratumumab - mergæxli - 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. ásamt bortezomib, dauða og leiðbeina fyrir meðferð fullorðinn sjúklinga með nýlega greind margar forráðamenn sem eru rétt fyrir samgena stafa klefi grætt. ásamt lenalídómíði og leiðbeina, eða bortezomib og leiðbeina, fyrir meðferð fullorðinn sjúklinga með mörgum forráðamenn sem hafa fengið að minnsta kosti einn áður en meðferð. 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. eitt og sér fyrir meðferð fullorðinn sjúklinga með fallið og svarar margar forráðamenn, sem áður en meðferð fylgir proteasome hemil og virkt efni og sem hafa sýnt sjúkdóms á síðustu meðferð. 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.

Umoja wa Ulaya - Kiaisilandi - EMA (European Medicines Agency)

instituto grifols s.a. - mönnum eðlilegt að notkun - mucocutaneous lymph node syndrome; guillain-barre syndrome; bone marrow transplantation; purpura, thrombocytopenic, idiopathic; immunologic deficiency syndromes - Ónæmiskerfið sera og mótefni, - replacement therapy in adults, children and adolescents (0-18 years) in: , primary immunodeficiency syndromes with impaired antibody production;, hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic luekaemia, in whom prophylactic antibiotics have failed;, hypogammaglobulinaemia and recurrent bacterial infections in plateau-phase-multiple-myeloma patients who failed to respond to pneumococcal immunisation;, hypogammaglobulinaemia in patients after allogenic haematopoietic-stem-cell transplantation (hsct);, congenital aids with recurrent bacterial infections. , immunomodulation in adults, children and adolescents (0-18 years) in: , primary immune thrombocytopenia (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count;, guillain barré syndrome;, kawasaki disease.

Umoja wa Ulaya - Kiaisilandi - EMA (European Medicines Agency)

santen oy - ciclosporin - kviðsjúkdómar - augnlækningar - meðferð við alvarlegum glærubólgu hjá fullorðnum sjúklingum með þurr auganu, sem hefur ekki batnað þrátt fyrir meðferð með tárubólgu.