Evrópusambandið - íslenska - EMA (European Medicines Agency)

eagle laboratories ltd.    - topotecan (as hydrochloride) - carcinoma; small cell lung carcinoma - Æxlishemjandi og ónæmismælandi lyf - topotecan einlyfjameðferð er ætlað til meðferðar hjá sjúklingum með endurtekið lungnakrabbamein í litlum frumum (sclc) þar sem endurmeðferð með fyrsta línunni er ekki talin viðeigandi. tópótecan ásamt cisplatíni er ætlað fyrir sjúklinga með krabbamein í legháls endurtekin eftir geislameðferð og fyrir sjúklinga með stigi ivb sjúkdómur. sjúklingar með áður en útsetningu cisplatíni þurfa áframhaldandi meðferð frjáls bili til að réttlæta meðferð við samsetningu.

Evrópusambandið - íslenska - 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.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - afatinib - krabbamein, lungnakrabbamein - Æxlishemjandi lyf - giotrif eitt og sér er ætlað fyrir meðferð ofepidermal vöxt Þáttur viðtaka (egfr) tki-barnalegt fullorðinn sjúklinga með staðnum háþróaður eða sjúklingum ekki lítið klefi lungnakrabbamein (nsclc) með því að virkja egfr stökkbreytingu(s);staðnum háþróaður eða sjúklingum nsclc af æxli vefjasýni gengur á eða eftir platínu-byggt lyfjameðferð.

Evrópusambandið - íslenska - 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.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

mylan s.a.s. - dócetaxel - head and neck neoplasms; carcinoma, non-small-cell lung; adenocarcinoma; prostatic neoplasms; breast neoplasms - Æxlishemjandi lyf - meðferð brjóstakrabbamein, sérstaka mynd af lungnakrabbamein (ekki lítið-klefi lungnakrabbamein), krabbamein í blöðruhálskirtli, krabbamein í maga, eða höfðinu og hálsinn krabbamein.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

mylan s.a.s - sjúklingum - lifrarbólga c, langvinn - veirueyðandi lyf til almennrar notkunar - ribavirin mylan er ætlað til meðferðar við langvinna lifrarbólgu c og má aðeins nota sem hluti af samsettri meðferð með interferon alfa-2b (fullorðnir, börn (3 ára og eldri) og unglingar). ekki má nota ríbavírín einlyfjameðferð. engar upplýsingar liggja fyrir um öryggi eða verkun við notkun ríbavírin með öðrum tegundum interferóns (i. ekki alfa-2b). vinsamlegast skoðaðu einnig að fylgjast alfa-2b samantekt af einkenni vara (smpc) fyrir ávísun sérstaklega til að vara. barnaleg patientsadult patientsribavirin mylan er fram, ásamt fylgjast alfa-2b, fyrir meðferð fullorðinn sjúklingum við allar tegundir af langvarandi lifrarbólgu c nema arfgerð 1, ekki áður meðferð, án lifur lifrarbilun, með hækkun alanínamínótransferasa (alt), sem eru jákvæð fyrir blóðvatn lifrarbólgu-c-veira (hcv) rna. börn og adolescentsribavirin mylan er ætlað, í blöndu meðferð með sjúklinga alfa-2b, fyrir meðferð börn og unglingar þriggja ára og eldri, sem hafa allar tegundir af langvarandi lifrarbólgu c nema arfgerð 1, ekki áður meðferð, án lifur lifrarbilun, og hver eru jákvæð fyrir blóðvatn hcv rna. Þegar ákvörðun um að ekki á að fresta meðferð fyrr en fullorðinsár, það er mikilvægt að íhuga að samsetning meðferð völdum vöxt hindrunar. Á að baka vöxt hindrunar er óvíst. sú ákvörðun að meðhöndla ætti að vera á tilfelli grundvöllur (sjá kafla 4. Áður meðferð-bilun patientsadult patientsribavirin mylan er fram, ásamt fylgjast alfa-2b, fyrir meðferð fullorðinn sjúklinga með langvarandi lifrarbólgu c sem áður hafa brugðist (með normalisation alt í lok meðferð) til að fylgjast alfa sér en sem hafa fallið í kjölfarið.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

les laboratoires servier - strontíumranelat - beinþynning, eftir tíðahvörf - lyf til að meðhöndla beinsjúkdóma - meðferð við alvarlegum beinþynningu hjá konum eftir tíðahvörf sem eru í mikilli hættu á beinbrotum til að draga úr hættu á brotum á hryggjarliðum og mjöðmum. meðferð alvarlega beinbrot í fullorðnir menn á jókst hættan á beinbrot. sú ákvörðun að mæla strontíumranelati ætti að vera byggt á mat á sjúkling er heild áhættu.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

les laboratoires servier - strontíumranelat - beinþynning, eftir tíðahvörf - lyf til að meðhöndla beinsjúkdóma - meðferð við alvarlegum beinþynningu hjá konum eftir tíðahvörf sem eru í mikilli hættu á beinbrotum til að draga úr hættu á brotum á hryggjarliðum og mjöðmum. meðferð alvarlega beinbrot í fullorðnir menn á jókst hættan á beinbrot. sú ákvörðun að mæla strontíumranelati ætti að vera byggt á mat á sjúkling er heild áhættu.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

samsung bioepis nl b.v. - 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 - aybintio in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. aybintio 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). 1 of the smpc. aybintio 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 anthracyclinecontaining regimens in the adjuvant setting within the last 12 months should be excluded from treatment with aybintio in combination with capecitabine. nánari upplýsingar um her2 stöðu, sjá kafla 5. 1 of the smpc. aybintio, 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. aybintio, 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. 1 of the smpc). aybintio in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. aybintio, 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. 1 of the smpc). aybintio, 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. aybintio, in combination with 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. 1 of the smpc). aybintio, 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. 1 of the smpc).

Evrópusambandið - íslenska - EMA (European Medicines Agency)

samsung bioepis nl b.v. - 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 - onbevzi in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. onbevzi 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). onbevzi 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 onbevzi in combination with capecitabine. nánari upplýsingar um her2 stöðu, sjá kafla 5. onbevzi, 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. onbevzi, 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. onbevzi in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. onbevzi, 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. onbevzi, 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. onbevzi, in combination with 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. onbevzi, 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.