Euroopan unioni - suomi - EMA (European Medicines Agency)

novartis europharm ltd - ofatumumab - leukemia, lymfosyyttinen, krooninen, b-solu - monoklonaaliset vasta-aineet - aiemmin hoitamaton krooninen lymfaattinen leukemia (kll): arzerra yhdessä klorambusiilin tai bendamustiinin on tarkoitettu hoitoon kroonista lymfaattista leukemiaa sairastavilla potilailla, jotka eivät ole saaneet aiempaa hoitoa ja jotka eivät ole oikeutettuja fludarabiini-pohjainen hoito. uusiutuneen kll: arzerra on tarkoitettu yhdessä fludarabiinin ja syklofosfamidin hoitoon aikuispotilaille, joilla on uusiutunut kll. refraktorinen kll: arzerra on tarkoitettu hoitoon kll-potilailla, jotka ovat sietäneet fludarabiinin ja alemtutsumabia.

Euroopan unioni - suomi - EMA (European Medicines Agency)

novartis ireland ltd - ofatumumab - multippeliskleroosi, relapsoiva-remittoiva - immunosuppressant - kesimpta is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (rms) with active disease defined by clinical or imaging features (see section 5.

Euroopan unioni - suomi - 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.

Euroopan unioni - suomi - EMA (European Medicines Agency)

janssen-cilag international n.v. - daratumumab - multiple myeloma - 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. yhdessä bortetsomibin kanssa, talidomidin ja deksametasonin hoitoon aikuispotilailla, joilla on äskettäin diagnosoitu multippeli myelooma, jotka ovat oikeutettuja autologisen kantasolujen siirto. yhdessä lenalidomidin ja deksametasonin tai bortetsomibi ja deksametasoni, hoitoon aikuisille potilaille, joilla on multippeli myelooma, jotka ovat saaneet vähintään yhtä aiempaa hoitoa. 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. monoterapiana aikuispotilaille, joilla oli uusiutunut ja refraktorinen multippeli myelooma, joiden aiempi hoito, mukana proteasomin estäjä ja immunomoduloivan aineen, ja jotka ovat osoittaneet taudin etenemistä viimeinen hoito. 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.

Euroopan unioni - suomi - EMA (European Medicines Agency)

amgen europe b.v. - carfilzomib - multiple myeloma - antineoplastiset aineet - kyprolis in combination with daratumumab and dexamethasone, with lenalidomide and dexamethasone, or with dexamethasone alone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

Euroopan unioni - suomi - EMA (European Medicines Agency)

secura bio limited - duvelisib - leukemia, lymphocytic, chronic, b-cell; lymphoma, follicular - antineoplastiset aineet - copiktra monotherapy is indicated for the treatment of adult patients with: relapsed or refractory chronic lymphocytic leukaemia (cll) after at least two prior therapies.  follicular lymphoma (fl) that is refractory to at least two prior  systemic therapies.

Euroopan unioni - suomi - EMA (European Medicines Agency)

janssen-cilag international nv - ibrutinib - lymphoma, mantle-cell; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents, protein kinase inhibitors - imbruvica as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl). imbruvica as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll) (see section 5. imbruvica as a single agent or in combination with bendamustine and rituximab (br) is indicated for the treatment of adult patients with cll who have received at least one prior therapy. imbruvica as a single agent is indicated for the treatment of adult patients with waldenström’s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo immunotherapy. imbruvica in combination with rituximab is indicated for the treatment of adult patients with wm.

Euroopan unioni - suomi - EMA (European Medicines Agency)

janssen-cilag international n.v. - teclistamab - multiple myeloma - antineoplastiset aineet - tecvayli is indicated as monotherapy 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.