Európska únia - islandčina - EMA (European Medicines Agency)

zoetis belgium s.a. - canine parainfluenza virus, leptospira and rabies virus. - Ónæmislyf fyrir canidae, lifandi og óvirkt veiru og bakteríu bóluefni - hundar - virk bólusetningar hundar frá sex vikur aldri til að koma í veg fyrir klínískum merki og draga úr veiru skilst að valda með því að hundur inflúensubróðir veira, til að koma í veg fyrir klínískum merki, sýkingum og þvagi valda með því að leptospira serovars bratislava, canicola, grippotyphosa og icterohaemorrhagiae og að koma í veg fyrir dauða, klínískum merki og sýking valda með hundaæði veira.

Európska únia - islandčina - 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.

Európska únia - islandčina - EMA (European Medicines Agency)

sloan pharma s.a.r.l - botulinum eiturefni tegund b - torticollis - vöðvaslakandi lyf - neurobloc er ætlað til meðferðar á leghálsi (torticollis). sjá kafla 5. 1 fyrir gögn um virkni í sjúklingar móttækilegur / þola að botox tegund.

Európska únia - islandčina - EMA (European Medicines Agency)

merck sharp & dohme b.v. - pembrolizumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; endometrial neoplasms - Æxlishemjandi lyf - melanomakeytruda as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma. keytruda as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with stage iib, iic, or with stage iii melanoma and lymph node involvement who have undergone complete resection. non small cell lung carcinoma (nsclc)keytruda as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum based chemotherapy (for selection criteria, see section 5. keytruda as monotherapy is indicated for the first line treatment of metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 50% tumour proportion score (tps) with no egfr or alk positive tumour mutations. keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non squamous non small cell lung carcinoma in adults whose tumours have no egfr or alk positive mutations. keytruda, in combination with carboplatin and either paclitaxel or nab paclitaxel, is indicated for the first line treatment of metastatic squamous non small cell lung carcinoma in adults. keytruda  as monotherapy is indicated for the treatment of locally advanced or metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 1% tps and who have received at least one prior chemotherapy regimen. sjúklingar með egfr eða t jákvæð æxli stökkbreytingar ætti líka að hafa fengið miða meðferð áður en þú færð keytruda. classical hodgkin lymphoma (chl)keytruda as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical hodgkin lymphoma who have failed autologous stem cell transplant (asct) or following at least two prior therapies when asct is not a treatment option. urothelial carcinomakeytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum containing chemotherapy. keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin containing chemotherapy and whose tumours express pd l1 with a combined positive score (cps) ≥ 10. head and neck squamous cell carcinoma (hnscc)keytruda, as monotherapy or in combination with platinum and 5 fluorouracil (5 fu) chemotherapy, is indicated for the first line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a cps ≥ 1. keytruda as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a ≥ 50% tps and progressing on or after platinum containing chemotherapy. renal cell carcinoma (rcc)keytruda, in combination with axitinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults. keytruda  as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (for selection criteria, please see section 5. microsatellite instability high (msi-h) or mismatch repair deficient (dmmr) cancerscolorectal cancer (crc)keytruda as monotherapy is indicated for theadults with msi-h or dmmr colorectal cancer in the following settings:first line treatment of metastatic microsatellite instability high (msi h) or mismatch repair deficient (dmmr) colorectal cancer in adults;treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine based combination therapy.  non-colorectal cancerskeytruda as monotherapy is indicated for the treatment of the following msi h or dmmr tumours in adults with:advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation;unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. oesophageal carcinomakeytruda, in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus or her-2 negative gastroesophageal junction adenocarcinoma, in adults whose tumours express pd l1 with a cps ≥ 10. triple negative breast cancer (tnbc)keytruda, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence. keytruda, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express pd l1 with a cps ≥ 10 and who have not received prior chemotherapy for metastatic disease. endometrial carcinoma (ec)keytruda, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. cervical cancerkeytruda, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express pd l1 with a cps ≥ 1. gastric or gastro-oesophageal junction (gej) adenocarcinomakeytruda, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic her2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express pd-l1 with a cps ≥ 1.

Európska únia - islandčina - 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.

Európska únia - islandčina - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - mönnum papillomavirus1 tegund 16 l1 prótín, hpv tegund 18 l1 prótín - papillomavirus infections; uterine cervical dysplasia; immunization - bóluefni - cervarix er bóluefni fyrir nota frá 9 ára ár til að koma í veg forstigsbreytingar engin-kynfærum sár (legháls, sköpum, par og endaþarms) og legháls og endaþarms krabbamein causally tengjast ákveðnum krabbameins hpv (tÍÐahvÖrf) tegundir. sjá kafla 4. 4 og 5. 1 fyrir mikilvægar upplýsingar um gögnin sem styðja þessa ábendingu. notkun cervarix ætti að vera í samræmi við opinbera tillögur.

Európska únia - islandčina - EMA (European Medicines Agency)

merck sharp & dohme b.v. - bólusetningar úr manni papillomavirus [tegundir 6, 11, 16, 18, 31, 33, 45, 52, 58] (raðbrigða, aðsogað) - condylomata acuminata; papillomavirus infections; immunization; uterine cervical dysplasia - mannapapillomaveiru bóluefni - gardasil 9 er ætlað fyrir virk bólusetningar einstaklinga frá 9 ára ár gegn eftir tÍÐahvÖrf sjúkdóma:forstigsbreytingar sár og krabbamein hafa áhrif legháls, sköpum, leggöng og ríða af völdum bóluefni tÍÐahvÖrf typesgenital vörtur (condyloma acuminata ósatíta) af völdum sérstakur tÍÐahvÖrf tegundir. sjá kafla 4. 4 og 5. 1 fyrir mikilvægar upplýsingar um gögn sem styðja þessar vísbendingar. notkun gardasil 9 ætti að vera í samræmi við opinbera tillögur.

Európska únia - islandčina - EMA (European Medicines Agency)

medac gesellschaft fuer klinische spezialpraeparate mbh - asparaginasi - forvarnarfrumuæxli-eitilfrumuhvítblæði - Æxlishemjandi lyf - spectrila er ætlað sem hluti af æxlishemjandi samsettri meðferð til meðhöndlunar á bráðum eitilfrumuhvítblæði (all) hjá börnum frá fæðingu til 18 ára og fullorðna.

Európska únia - islandčina - EMA (European Medicines Agency)

eurogenerics holdings b.v. - teriparatíð - beinþynning - kalsíumsterastasis - qutavina is indicated in adults. meðferð við beinþynningu hjá konum eftir tíðahvörf og karlar við aukna hættu á beinbrotum. in postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures have been demonstrated. meðferð beinbrot tengslum við viðvarandi almenn sykurstera meðferð í konur og menn á jókst hættan fyrir beinbrot.

Európska únia - islandčina - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - hpv tegund 6 l1 prótín, hpv tegund 11 l1 prótín, hpv tegund 16 l1 prótín, hpv tegund 18 l1 prótín - papillomavirus infections; uterine cervical dysplasia; condylomata acuminata; immunization - bóluefni - gardasil er bóluefni fyrir nota frá 9 ára ár til að koma í veg:forstigsbreytingar kynfærum sár (legháls, sköpum og leggöngum), forstigsbreytingar endaþarms sár, legháls krabbamein og endaþarms krabbamein causally tengjast ákveðnum krabbameins hpv (tÍÐahvÖrf) gerðir;kynfærum vörtur (condyloma acuminata ósatíta) causally tengist tilteknu tÍÐahvÖrf tegundir. sjá kafla 4. 4 og 5. 1 fyrir mikilvægar upplýsingar um gögnin sem styðja þessa ábendingu. notkun gardasil ætti að vera í samræmi við opinbera tillögur.