Evrópusambandið - íslenska - EMA (European Medicines Agency)

merck sharp & dohme b.v. - letermovir - cytomegalovirus sýkingar - veirueyðandi lyf til almennrar notkunar - prevymis er ætlað til að fyrirbyggja cmv (cmv) endurvakning og sjúkdómurinn í fullorðinn cmv-mótefni viðtakendur [r+] af ósamgena skurðaðgerðir stafa klefi grætt (hsct). Íhuga ætti að opinbera leiðsögn á réttri notkun af veirum.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

takeda pharma a/s - darvadstrocel - endaþarm notast - Ónæmisbælandi lyf - alofisel er ætlað fyrir meðferð flókið endaþarminum fistulas í fullorðinn sjúklinga með ekki-virk/dálítið virk luminal crohn-sjúkdóm, þegar fistulas hafa sýnt ófullnægjandi svar að minnsta kosti einn hefðbundnum eða líffræðileg meðferð. alofisel ætti að nota eftir ástand notast.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

medac gesellschaft für klinische spezialpräparate mbh - carmustine - hodgkin disease; lymphoma, non-hodgkin - Æxlishemjandi lyf - carmustine is indicated n adults in the following malignant neoplasms as a single agent or in combination with other antineoplastic agents and/or other therapeutic measures (radiotherapy, surgery): , brain tumours (glioblastoma, brain-stem gliomas, medulloblastoma, astrocytoma and ependymoma), brain metastases, secondary therapy in non-hodgkin’s lymphoma and hodgkin’s disease, as conditioning treatment prior to autologous haematopoietic progenitor cell transplantation (hpct) in malignant haematological diseases (hodgkin’s disease / non-hodgkin’s lymphoma).

Evrópusambandið - íslenska - EMA (European Medicines Agency)

kite pharma eu b.v. - axicabtagene ciloleucel - lymphoma, follicular; lymphoma, large b-cell, diffuse - Æxlishemjandi lyf - yescarta is indicated for the treatment of adult patients with diffuse large b cell lymphoma (dlbcl) and high-grade b-cell lymphoma (hgbl) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy. yescarta is indicated for the treatment of adult patients with relapsed or refractory (r/r) dlbcl and primary mediastinal large b cell lymphoma (pmbcl), after two or more lines of systemic therapy. yescarta is indicated for the treatment of adult patients with r/r follicular lymphoma (fl) after three or more lines of systemic therapy.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

regeneron ireland designated activity company (dac) - cemiplimab - krabbamein, squamous cell - Æxlishemjandi lyf - cutaneous squamous cell carcinomalibtayo as monotherapy is indicated for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mcscc or lacscc) who are not candidates for curative surgery or curative radiation. basal cell carcinomalibtayo as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (labcc or mbcc) who have progressed on or are intolerant to a hedgehog pathway inhibitor (hhi). non-small cell lung cancerlibtayo as monotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (nsclc) expressing pd-l1 (in ≥ 50% tumour cells), with no egfr, alk or ros1 aberrations, who have:locally advanced nsclc who are not candidates for definitive chemoradiation, ormetastatic nsclc. libtayo in combination with platinum‐based chemotherapy is indicated for the first‐line treatment of adult patients with nsclc expressing pd-l1 (in ≥ 1% of tumour cells), with no egfr, alk or ros1 aberrations, who have:locally advanced nsclc who are not candidates for definitive chemoradiation, ormetastatic nsclc. cervical cancerlibtayo as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

adienne s.r.l. s.u. - melphalan hydrochloride - multiple myeloma; hodgkin disease; lymphoma, non-hodgkin; precursor cell lymphoblastic leukemia-lymphoma; leukemia, myeloid, acute; neuroblastoma; ovarian neoplasms; hematopoietic stem cell transplantation - Æxlishemjandi lyf - high-dose of phelinun used alone or in combination with other cytotoxic medicinal products and/or total body irradiation is indicated in the treatment of:multiple myeloma,malignant lymphoma (hodgkin, non-hodgkin lymphoma),acute lymphoblastic and myeloblastic leukemia,childhood neuroblastoma,ovarian cancer,mammary adenocarcinoma. phelinun in combination with other cytotoxic medicinal products is indicated as reduced intensity conditioning (ric) treatment prior to allogeneic haematopoietic stem cell transplantation (allo-hsct) in malignant haematological diseases in adults. phelinun in combination with other cytotoxic medicinal products is indicated as conditioning regimen prior to allogeneic haematopoietic stem cell transplantation in haematological diseases in the paediatric population as:myeloablative conditioning (mac) treatment in case of malignant haematological diseasesric treatment in case of non-malignant haematological diseases.

Evrópusambandið - íslenska - 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) - eitilfrumukrabbamein, mantle-cell - Æxlishemjandi lyf - 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).

Evrópusambandið - íslenska - EMA (European Medicines Agency)

orchard therapeutics (netherlands) bv - atidarsagene autotemcel - leukodystrophy, metachromatic - Önnur lyf í taugakerfinu - libmeldy is indicated for the treatment of metachromatic leukodystrophy (mld) characterized by biallelic mutations in the arysulfatase a (arsa) gene leading to a reduction of the arsa enzymatic activity:in children with late infantile or early juvenile forms, without clinical manifestations of the disease,in children with the early juvenile form, with early clinical manifestations of the disease, who still  have the ability to walk independently and before the onset of cognitive decline.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

bluebird bio (netherlands) b.v. - elivaldogene autotemcel - adrenoleukodystrophy - Önnur lyf í taugakerfinu - treatment of early cerebral adrenoleukodystrophy in patients less than 18 years of age, with an abcd1 genetic mutation, and for whom a human leukocyte antigen (hla) matched sibling haematopoietic stem cell donor is not available.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - dostarlimab - endometrial neoplasms - antineoplastic agents and antibody drug conjugates - jemparli is indicated as monotherapy for the treatment of adult patients with mismatch repair deficient (dmmr)/microsatellite instability-high (msi h) recurrent or advanced endometrial cancer (ec) that has progressed on or following prior treatment with a platinum-containing regimen.