Ευρωπαϊκή Ένωση - Ισλανδικά - EMA (European Medicines Agency)

biosimilar collaborations ireland limited - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - Æxlishemjandi lyf - abevmy in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. abevmy in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. sjá nánar í kafla 5 til að fá nánari upplýsingar varðandi húðþéttni vaxtarþáttar viðtaka 2 (her2). abevmy in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with abevmy in combination with capecitabine. nánari upplýsingar um her2 stöðu, sjá kafla 5. abevmy, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. abevmy, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations (see section 5. abevmy in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. abevmy, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (international federation of gynecology and obstetrics [figo] stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. abevmy, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents. abevmy in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents (see section 5. abevmy, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.

Ευρωπαϊκή Ένωση - Ισλανδικά - EMA (European Medicines Agency)

mylan ire healthcare limited - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - Æxlishemjandi lyf - treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.

Ευρωπαϊκή Ένωση - Ισλανδικά - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - Æxlishemjandi lyf - vegzelma in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. vegzelma in combination with paclitaxel is indicated for first line treatment of adult patients with metastatic breast cancer. sjá nánar í kafla 5 til að fá nánari upplýsingar varðandi húðþéttni vaxtarþáttar viðtaka 2 (her2). vegzelma in combination with capecitabine is indicated for first line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with vegzelma in combination with capecitabine. nánari upplýsingar um her2 stöðu, sjá kafla 5. vegzelma, in addition to platinum based chemotherapy, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non small cell lung cancer (nsclc) other than predominantly squamous cell histology. vegzelma, in combination with erlotinib, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent nsclc with epidermal growth factor receptor (egfr) activating mutations (see section 5. vegzelma, in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. vegzelma, in combination with carboplatin and paclitaxel is indicated for the front line treatment of adult patients with advanced (international federation of gynecology and obstetrics (figo) stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. vegzelma, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vascular endothelial growth factor (vegf) inhibitors or vegf receptor–targeted agents. vegzelma in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents (see section 5. vegzelma, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.

Ευρωπαϊκή Ένωση - Ισλανδικά - EMA (European Medicines Agency)

novartis europharm limited  - pazópaníb - krabbamein, nýrnafrumur - Æxlishemjandi lyf - nýrna-klefi krabbamein (rcc)votrient er ætlað í fullorðnir í fyrsta-línu meðferð háþróaður nýrna-klefi krabbamein (rcc) og fyrir sjúklinga sem hafa fengið áður en frumuboða meðferð fyrir háþróaður sjúkdómur. mjúkur-vefjum sarkmein (l)votrient er ætlað fyrir meðferð fullorðinn sjúklinga með vali flokkar af háþróaður mjúk-vefjum sarkmein (l) sem hafa fengið áður en lyfjameðferð fyrir sjúklingum sjúkdóm eða sem hafa gengið innan 12 mánuðum eftir (neo)viðbótar meðferð. verkun og öryggi hafa aðeins verið stofnað í ákveðnum l vefja æxli flokkar.

Ευρωπαϊκή Ένωση - Ισλανδικά - EMA (European Medicines Agency)

ceft biopharma s.r.o. - ibritumomab tiuxetan - eitilæxli, follicular - heilsueyðandi lyf - zevalin er ætlað fullorðnum. [90y]-sprauta zevalin er ætlað eins og sameiningu meðferð eftir fyrirgefningar framkalla í áður ómeðhöndlað sjúklinga með tíðahvörf eitlaæxli. Þágu zevalin eftir rítúxímab ásamt lyfjameðferð hefur ekki verið staðfest. [90y]-sprauta zevalin er ætlað fyrir meðferð fullorðinn sjúklinga með rítúxímab relapsedorrefractory cd20+ tíðahvörf b-klefi ekki hodgkins (fÓtbolta).

Ισλανδία - Ισλανδικά - LYFJASTOFNUN (Icelandic Medicines Agency)

accord healthcare b.v. - bendamustinum hýdróklóríð - stofn fyrir innrennslisþykkni, lausn - 2,5 mg/ml

Ευρωπαϊκή Ένωση - Ισλανδικά - EMA (European Medicines Agency)

roche registration gmbh - polatuzumab vedotin - eitlaæxli, b-klefi - Æxlishemjandi lyf - polivy ásamt bendamustine og rítúxímab er ætlað fyrir meðferð fullorðinn sjúklinga með fallið/svarar dreifð stór b-eitlaæxli (dlbcl) sem eru ekki mönnum fyrir skurðaðgerðir stafa klefi grætt. polivy in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (r-chp) is indicated for the treatment of adult patients with previously untreated diffuse large b-cell lymphoma (dlbcl).

Ευρωπαϊκή Ένωση - Ισλανδικά - EMA (European Medicines Agency)

roche registration gmbh - obinutuzumab - kyrningahvítblæði, eitilfrumnafæð, langvarandi, b-frumur - Æxlishemjandi lyf - langvarandi eitilfrumuhvítblæði (cll)gazyvaro ásamt klórambúcíl er ætlað fyrir meðferð fullorðinn sjúklinga með áður ómeðhöndlað langvarandi eitilfrumuhvítblæði (cll) og við sjúkdóma að gera þá ekki við hæfi fyrir fullt-skammt flúdarabín byggt meðferð (sjá kafla 5. tíðahvörf eitlaæxli (fl)gazyvaro ásamt lyfjameðferð, eftir gazyvaro viðhald meðferð í sjúklingar að ná svar, er ætlað fyrir sjúklinga með áður ómeðhöndlað háþróaður tíðahvörf eitlaæxli. gazyvaro ásamt bendamustine eftir gazyvaro viðhald er ætlað fyrir sjúklinga með tíðahvörf eitlaæxli (fl) sem ekki bregðast eða hver gengið á eða upp í 6 mánuði eftir meðferð með rítúxímab eða rítúxímab-inniheldur meðferð.

Ευρωπαϊκή Ένωση - Ισλανδικά - 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).

Ευρωπαϊκή Ένωση - Ισλανδικά - 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).