Uniunea Europeană - norvegiană - EMA (European Medicines Agency)

mylan pharmaceuticals limited - deferasiroks - iron overload; beta-thalassemia - strykejern chelatdannere - deferasirox mylan er angitt forthe behandling av kronisk jern overbelastning på grunn av hyppige blodoverføringer (≥7 ml/kg/måned pakket røde blodlegemer) hos pasienter med beta thalassaemia store alderen 6 år og olderthe behandling av kronisk jern overbelastning på grunn av blodoverføringer når deferoxamine behandling er kontraindisert eller utilstrekkelig i følgende pasientgrupper:i paediatric pasienter med beta thalassaemia store med jern overbelastning på grunn av hyppige blodoverføringer (≥7 ml/kg/måned pakket røde blodceller) i alderen 2 til 5 år,i voksen og paediatric pasienter med beta thalassaemia store med jern overbelastning på grunn av sjeldne blodoverføringer (.

Uniunea Europeană - norvegiană - EMA (European Medicines Agency)

mylan pharmaceuticals limited - acetylsalicylic acid, clopidogrel hydrogen sulfate - acute coronary syndrome; myocardial infarction - antithrombotic agents - clopidogrel/acetylsalisylsyre mylan er indikert for sekundær forebygging av atherothrombotic hendelser hos voksne pasienter som allerede tar både klopidogrel og acetylsalisylsyre (asa). clopidogrel/acetylsalisylsyre mylan er en fast dose kombinasjon legemiddel for videreføring av behandling i:ikke-st-segment elevasjon akutt koronar syndrom (ustabil angina eller non-q-bølge myocardial infarction) inkludert pasienter som gjennomgår en stent plassering etter perkutan koronar interventionst segment elevasjon akutte myocardial infarction i medisinsk behandlede pasienter kvalifisert for trombolytisk behandling.

Uniunea Europeană - norvegiană - EMA (European Medicines Agency)

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 - antineoplastiske midler - 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. for ytterligere informasjon om human epidermal growth factor receptor 2 (her2) status, se avsnitt 5. 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. for ytterligere informasjon om her2-status, se avsnitt 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.

Uniunea Europeană - norvegiană - EMA (European Medicines Agency)

bioprojet pharma - pitolisant - sleep apnea, obstructive - andre nervesystemet narkotika - ozawade is indicated to improve wakefulness and reduce excessive daytime sleepiness (eds) in adult patients with obstructive sleep apnoea (osa).

Uniunea Europeană - norvegiană - EMA (European Medicines Agency)

sun pharmaceutical industries (europe) b.v. - ertapenemnatrium - bakterielle infeksjoner - 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. det bør vurderes å offisielle retningslinjer for riktig bruk av antibakterielle midler.

Uniunea Europeană - norvegiană - EMA (European Medicines Agency)

mylan pharmaceuticals limited - teriflunomide - multippel sklerose, relapsing-remitting - immunsuppressive - teriflunomide mylan is indicated for the treatment of adult patients and paediatric patients aged 10 years and older (body weight > 40 kg) with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 of the smpc for important information on the population for which efficacy has been established).

Uniunea Europeană - norvegiană - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - teriparatide - osteoporosis; osteoporosis, postmenopausal - kalsiumhomeostase - 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.

Uniunea Europeană - norvegiană - EMA (European Medicines Agency)

astrazeneca ab - tremelimumab - carcinoma, hepatocellular - antineoplastiske midler - imjudo in combination with durvalumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (hcc). imjudo in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (nsclc) with no sensitising egfr mutations or alk positive mutations.

Uniunea Europeană - norvegiană - EMA (European Medicines Agency)

astrazeneca ab - tremelimumab - karsinom, ikke-småcellet lunge - antineoplastiske midler - tremelimumab astrazeneca in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (nsclc) with no sensitising egfr mutations or alk positive mutations.

Uniunea Europeană - norvegiană - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - rituximab - lymphoma, non-hodgkin; microscopic polyangiitis; leukemia, lymphocytic, chronic, b-cell; wegener granulomatosis - antineoplastiske midler - rituzena er angitt i voksne for følgende indikasjoner:non-hodgkins lymfom (nhl)rituzena er angitt for behandling av tidligere ubehandlede pasienter med stadium iii-iv follicular lymfom i kombinasjon med kjemoterapi. rituzena monoterapi er indisert for behandling av pasienter med stadium iii-iv follicular lymfom som er kjemoterapi resistente eller er i sitt andre eller senere tilbakefall etter kjemoterapi. rituzena er indisert for behandling av pasienter med cd20-positive diffuse store b-celle non hodgkins lymfom i kombinasjon med chop (cyklofosfamid, doxorubicin, vinkristin, prednisolon) kjemoterapi. kronisk lymfatisk leukemi (cll)rituzena i kombinasjon med kjemoterapi er indisert for behandling av pasienter med tidligere ubehandlet og tilbakefall/ildfast cll. bare begrensede data på effekt og sikkerhet for pasienter som tidligere er behandlet med monoklonale antistoffer inkludert rituzenaor pasienter med refraktære til forrige rituzena pluss kjemoterapi. granulomatosis med polyangiitis og mikroskopiske polyangiitisrituzena, i kombinasjon med glukokortikoider, er indikert for induksjon av remisjon hos voksne pasienter med alvorlig, aktiv granulomatosis med polyangiitis (wegener ' s) (gpa) og mikroskopiske polyangiitis (mpa).