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)

sun pharmaceutical industries europe b.v. - sitagliptin fumarate - sykursýki, tegund 2 - lyf notuð við sykursýki - for adult patients with type 2 diabetes mellitus, sitagliptin sun is indicated to improve glycaemic control:as monotherapy:- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. as dual oral therapy in combination with:- metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control. - a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance. - a peroxisome proliferator-activated receptor gamma (pparγ) agonist (i. a thiazolidinedione) when use of a pparγ agonist is appropriate and when diet and exercise plus the pparγ agonist alone do not provide adequate glycaemic control. as triple oral therapy in combination with:- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. - a pparγ agonist and metformin when use of a pparγ agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. sitagliptin sun is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - sitagliptin fumarate, metformin hydrochloride - sykursýki, tegund 2 - lyf notuð við sykursýki - for adult patients with type 2 diabetes mellitus:sitagliptin/metformin hydrochloride sun is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. sitagliptin/metformin hydrochloride sun is indicated in combination with a sulphonylurea (i. , þrefaldur samsetning meðferð) sem viðbót til að fæði og æfing í sjúklingar ekki nægilega stjórn á eigin hámarks þolað skammt af sjúklingar og sulphonylurea. sitagliptin/metformin hydrochloride sun is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (pparγ) agonist (i. , a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a pparγ agonist. sitagliptin/metformin hydrochloride sun is also indicated as add-on to insulin (i. , triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

sun pharmaceutical industries (europe) b.v. - natríum ertapenem - bakteríusýkingar - ertapenem - treatmentertapenem sun is indicated in paediatric patients (3 months to 17 years of age) and in adults for the treatment of the following infections when caused by bacteria known or very likely to be susceptible to ertapenem and when parenteral therapy is required (see sections 4. 4 og 5. 1):- intra-abdominal infections- community acquired pneumonia- acute gynaecological infections- diabetic foot infections of the skin and soft tissue (see section 4. 4)preventionertapenem sun is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery (see section 4. Íhuga ætti að opinbera leiðsögn á réttri notkun af sýklalyfjum.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - teriparatíð - osteoporosis; osteoporosis, postmenopausal - kalsíumsterastasis - teriparatide sun is indicated in adults. treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture (see section 5. in postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated. treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture (see section 5.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

sandoz gmbh - rituximab - lymphoma, non-hodgkin; arthritis, rheumatoid; microscopic polyangiitis; wegener granulomatosis - Æxlishemjandi lyf - riximyo is indicated in adults for the following indications:non-hodgkin’s lymphoma (nhl)riximyo is indicated for the treatment of previously untreated adult patients with stage iii-iv follicular lymphoma in combination with chemotherapy. riximyo maintenance therapy is indicated for the treatment of adult follicular lymphoma patients responding to induction therapy. riximyo monotherapy is indicated for treatment of adult patients with stage iii-iv follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy. riximyo is indicated for the treatment of adult patients with cd20 positive diffuse large b cell non-hodgkin’s lymphoma in combination with chop (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy. riximyo in combination with chemotherapy is indicated for the treatment of paediatric patients (aged ≥ 6 months to < 18 years old) with previously untreated advanced stage cd20 positive diffuse large b-cell lymphoma (dlbcl), burkitt lymphoma (bl)/burkitt leukaemia (mature b-cell acute leukaemia) (bal) or burkitt-like lymphoma (bll). chronic lymphocytic leukaemia (cll)riximyo in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukaemia. aðeins takmörkuð gögn eru í boði á virkni og öryggi fyrir sjúklinga áður meðhöndluð með sjúklingum sem mótefni þar á meðal rítúxímab eða sjúklingar svarar til fyrri rítúxímab plús lyfjameðferð. sjá kafla 5. 1 fyrir frekari upplýsingar. rheumatoid arthritisriximyo in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs (dmard) including one or more tumour necrosis factor (tnf) inhibitor therapies. rítúxímab hefur verið sýnt fram á að draga úr framvindu sameiginlega skaða sem mæla með x-ray og til að bæta líkamlega virka, þegar gefið ásamt stendur. granulomatosis with polyangiitis and microscopic polyangiitisriximyo, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (wegener’s) (gpa) and microscopic polyangiitis (mpa). riximyo, in combination with glucocorticoids, is indicated for the induction of remission in paediatric patients (aged ≥ 2 to < 18 years old) with severe, active gpa (wegener’s) and mpa. pemphigus vulgarisriximyo is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (pv).

Evrópusambandið - íslenska - EMA (European Medicines Agency)

pfizer europe ma eeig  - pegfilgrastim - daufkyrningafæð - Ónæmisörvandi, - lækkun á lengd mæði í tengslum og tíðni hita og mæði í tengslum í fullorðinn sjúklinga með frumudrepandi lyfjameðferð fyrir illkynja (með undantekning langvarandi merg hvítblæði og myelodysplastic heilkennum).

Evrópusambandið - íslenska - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - idecabtagene vicleucel - multiple myeloma; neoplasms; cancer; neoplasms, plasma cell; hemostatic disorders; vascular diseases; cardiovascular diseases; paraproteinemias; blood protein disorders; hematologic diseases; hemic and lymphatic diseases; hemorrhagic disorders; infectious mononucleosis; lymphoproliferative disorders; immunoproliferative disorders; immune system diseases - Æxlishemjandi lyf - abecma is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti cd38 antibody and have demonstrated disease progression on the last therapy.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

roche registration gmbh - mosunetuzumab - eitilæxli, follicular - antineoplastic agents, monoclonal antibodies - lunsumio as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (fl) who have received at least two prior systemic therapies.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

janssen-cilag international nv - ciltacabtagene autoleucel - mergæxli - carvykti is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-cd38 antibody and have demonstrated disease progression on the last therapy.