Kisplyx Evrópusambandið - íslenska - EMA (European Medicines Agency)

kisplyx

eisai gmbh - lenvatinib mesilat - krabbamein, nýrnafrumur - Æxlishemjandi lyf - kisplyx is indicated for the treatment of adults with advanced renal cell carcinoma (rcc):in combination with pembrolizumab, as first-line treatment (see section 5. in combination with everolimus, following one prior vascular endothelial growth factor (vegf)-targeted therapy.

Xtandi Evrópusambandið - íslenska - EMA (European Medicines Agency)

xtandi

astellas pharma europe b.v. - enzalutamíð - blöðruhálskirtli - innkirtla meðferð - xtandi is indicated for:the treatment of adult men with metastatic hormone-sensitive prostate cancer (mhspc) in combination with androgen deprivation therapy (see section 5. the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (crpc) (see section 5. the treatment of adult men with metastatic crpc who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5. the treatment of adult men with metastatic crpc whose disease has progressed on or after docetaxel therapy.

Oyavas Evrópusambandið - íslenska - EMA (European Medicines Agency)

oyavas

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

Abiraterone Krka Evrópusambandið - íslenska - EMA (European Medicines Agency)

abiraterone krka

krka, d.d., novo mesto - abirateron asetat - blöðruhálskirtli - innkirtla meðferð - abiraterone krka is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt) (see section 5. 1)the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5. 1)the treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.

Bondenza (previously Ibandronic Acid Roche) Evrópusambandið - íslenska - EMA (European Medicines Agency)

bondenza (previously ibandronic acid roche)

roche registration ltd. - ibandrónsýra - beinþynning, eftir tíðahvörf - lyf til að meðhöndla beinsjúkdóma - meðferð beinþynningar hjá konum eftir tíðahvörf við aukna hættu á beinbrotum. lækkun í hættu á hryggbrot hefur verið sýnt. verkun á lærlegg-háls beinbrot hefur ekki verið staðfest.

Valsartan/Hydrochlorothiazide Krka Filmuhúðuð tafla 160 mg/12,5 mg Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

valsartan/hydrochlorothiazide krka filmuhúðuð tafla 160 mg/12,5 mg

krka sverige ab - hydrochlorothiazide; valsartanum inn - filmuhúðuð tafla - 160 mg/12,5 mg

Valsartan/Hydrochlorothiazide Krka Filmuhúðuð tafla 160 mg/25 mg Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

valsartan/hydrochlorothiazide krka filmuhúðuð tafla 160 mg/25 mg

krka sverige ab - hydrochlorothiazide; valsartanum inn - filmuhúðuð tafla - 160 mg/25 mg

Valsartan/Hydrochlorothiazide Krka Filmuhúðuð tafla 80 mg/12,5 mg Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

valsartan/hydrochlorothiazide krka filmuhúðuð tafla 80 mg/12,5 mg

krka sverige ab - valsartanum inn; hydrochlorothiazide - filmuhúðuð tafla - 80 mg/12,5 mg

Ibandronic acid WH Stungulyf, lausn 3 mg Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

ibandronic acid wh stungulyf, lausn 3 mg

williams & halls ehf - acidum ibandronicum mónónatríum - stungulyf, lausn - 3 mg

Bonviva Evrópusambandið - íslenska - EMA (European Medicines Agency)

bonviva

atnahs pharma netherlands b.v. - ibandrónsýra - beinþynning, eftir tíðahvörf - lyf til að meðhöndla beinsjúkdóma - meðferð beinbrot í tíðahvörf konur á jókst hættan á beinbrot (sjá kafla 5. lækkun í hættu á hryggbrot hefur verið sýnt fram á, virkni á lærlegg háls beinbrot hefur ekki verið staðfest.