Euroopan unioni - suomi - EMA (European Medicines Agency)

sandoz gmbh - somatropiini - turner syndrome; prader-willi syndrome; dwarfism, pituitary - aivolisäkkeen ja hypotalamuksen hormonit ja analogit - pikkulapset, lapset ja adolescentsgrowth häiriö johtuu riittämättömästä kasvuhormonin (gh). kasvuhäiriöt, jotka liittyvät turnerin oireyhtymä. kasvuhäiriöt, jotka liittyvät krooniseen munuaisten vajaatoimintaan. kasvuhäiriö (nykyinen korkeus standardi-poikkeama pisteet (sds) < -2. 5 ja vanhempien säätää sds < -1) lyhyillä lapsilla / nuorilla, jotka ovat syntyneet pieninä gestaatioikäänsä (sga), joiden syntymäpaino ja / tai pituus alle -2 keskihajonnat (sds), joka ei näytä catch-up kasvua (korkeus nopeus (hv) sds < 0 viimeisen vuoden aikana) viimeistään neljän vuoden iässä tai myöhemmin. prader-willi-oireyhtymä (pws), parantaa kasvua ja kehon koostumus. se pws-diagnoosi tulee vahvistaa sopivalla geenitestillä. adultsreplacement hoito aikuisilla, joilla on selvästi havaittava kasvuhormonin vajaus. potilaat, joilla on vaikea aikuisiän kasvuhormonin vajaus, on määritelty potilaille, joilla on tunnettu hypotalamuksen tai aivolisäkkeen sairaus ja vähintään yksi tunnettu aivolisäkkeen hormonin vajaus, prolaktiinin. näille potilaille pitäisi tehdä yksi dynaaminen testi jotta diagnosoida tai sulkea pois kasvuhormonin puute. potilailla, joilla on lapsuudessa alkanut yksittäisen kasvuhormonin puute (ei näyttöä hypotalamuksen tai aivolisäkkeen sairaudesta tai kallon säteilytys), kaksi dynaamiset testit olisi suositeltavaa, paitsi niille, joilla on alhainen insulin-like-kasvu-tekijä-i (igf-i) pitoisuuksia (sds < -2), joka voi olla harkita yksi testi. cut-off-pisteen dynaaminen testi pitäisi olla tiukka.

Suomi - suomi - Fimea (Suomen lääkevirasto)

dentsply detrey gmbh - adrenaline hydrogen tartrate, lidocaine hydrochloride monohydrate - injektioneste, liuos - 20 mg/ml + 12.5 mikrog/ml - lidokaiini

Suomi - suomi - Fimea (Suomen lääkevirasto)

dentsply detrey gmbh - felypressin, prilocaine hydrochloride - injektioneste, liuos - 30 mg/ml + 0,54 mikrog/ml - prilokaiini

Euroopan unioni - suomi - EMA (European Medicines Agency)

pharmathen s.a. - enoksapariininatriumia - laskimotromboembolia - antitromboottiset aineet - thorinane on tarkoitettu aikuisille: - ehkäisyyn laskimoiden tromboembolia, erityisesti potilailla, joille tehtiin ortopedinen, yleinen tai onkologinen kirurgia. - ehkäisyyn laskimoiden tromboembolia potilailla, vuoteenomana, koska akuutti sairauksia, mukaan lukien akuutti sydämen vajaatoiminta, akuutti hengityksen vajaatoiminta, vakavia infektioita, sekä pahenemista reumasairauksien aiheuttaa immobilisaatio potilaan (koskee vahvuuksia 40 mg/0. 4 ml). - hoito syvä laskimotukos (dvt), komplisoitunut tai komplisoitumaton jonka keuhkoembolia. - epästabiilin angina pectoriksen ja non-q-aalto sydäninfarkti, yhdessä asetyylisalisyylihapon (asa). - akuutin st-nousuinfarktin (stemi), mukaan lukien potilaat, jotka voidaan hoitaa konservatiivisesti tai jotka myöhemmin tehdään pallolaajennus sepelvaltimoiden pallolaajennus (koskee vahvuuksia 60 mg/0. 6 ml, 80 mg/0. 8 ml ja 100 mg/1 ml). - veritulpan ehkäisyyn kehonulkoisen verenkierron aikana hemodialyysi. ehkäisyyn ja hoitoon eri sairauksia, jotka liittyvät veren hyytymistä aikuisilla.

Euroopan unioni - suomi - EMA (European Medicines Agency)

siga technologies netherlands b.v. - tecovirimat - poxviridae infections; cowpox; monkeypox; vaccinia; smallpox - antiviraalit systeemiseen käyttöön - tecovirimat siga is indicated for the treatment of the following viral infections in adults and children with body weight at least 13 kg:- smallpox- monkeypox- cowpoxtecovirimat siga is also indicated to treat complications due to replication of vaccinia virus following vaccination against smallpox in adults and children with body weight at least 13 kg (see sections 4. 4 ja 5. tecovirimat siga should be used in accordance with official recommendations.

Euroopan unioni - suomi - EMA (European Medicines Agency)

laboratorios hipra, s.a. - mycoplasma hyopneumoniae, strain 7304 (nexhyon), expressing the capsid protein of porcine circovirus type 2a, inactivated - immunologicals for suidae, inactivated viral and inactivated bacterial vaccines - siat - for the active immunisation of pigs:to reduce lung lesions associated with porcine enzootic pneumonia caused by mycoplasma hyopneumoniae. also, to reduce the incidence of these lesions (as observed in field studies). to reduce viraemia, virus load in lungs and lymphoid tissues and the duration of the viraemic period associated with diseases caused by porcine circovirus type 2 (pcv2). efficacy against pcv2 genotypes a, b and d has been demonstrated in field studies. to reduce culling rate and the loss of daily weight gain caused by mycoplasma hyopneumoniae and/or pcv2 related diseases (as observed at 6 months of age in field studies). mycoplasma hyopneumoniae: onset of immunity: 3 weeks after vaccinationduration of immunity: 23 weeks after vaccinationporcine circovirus type 2:onset of immunity: 2 weeks after vaccinationduration of immunity: 22 weeks after vaccinationin addition, a reduction in nasal and faecal shedding and the duration of nasal excretion of pcv2 was demonstrated in animals challenged at 4 weeks and at 22 weeks after vaccination.

Euroopan unioni - suomi - EMA (European Medicines Agency)

biogen netherlands b.v. - natalitsumabin - multippeliskleroosi - selektiiviset immunosuppressantit - tysabri is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for the following patient groups: , patients with highly active disease activity despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4. 4 ja 5. 1), , or, patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

Euroopan unioni - suomi - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - hemoglobinuria, paroxysmal - selektiiviset immunosuppressantit - paroxysmal nocturnal haemoglobinuria (pnh)ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with pnh:- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months (see section 5. atypical haemolytic uremic syndrome (ahus)ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with ahus who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab (see section 5. generalized myasthenia gravis (gmg)ultomiris is indicated as an add-on to standard therapy for the treatment of adult patients with gmg who are anti-acetylcholine receptor (achr) antibody-positive. neuromyelitis optica spectrum disorder (nmosd)ultomiris is indicated in the treatment of adult patients with nmosd who are anti-aquaporin 4 (aqp4) antibody-positive (see section 5. ultomiris is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh):- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. ultomiris is indicated in the treatment of adult patients with atypical haemolytic uremic syndrome (ahus) who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab.

Euroopan unioni - suomi - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; mesothelioma; colorectal neoplasms - antineoplastiset aineet - melanomaopdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older. relative to nivolumab monotherapy, an increase in progression free survival (pfs) and overall survival (os) for the combination of nivolumab with ipilimumab is established only in patients with low tumour pd-l1 expression. adjuvant treatment of melanomaopdivo as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. non-small cell lung cancer (nsclc)opdivo in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising egfr mutation or alk translocation. opdivo as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. malignant pleural mesothelioma (mpm)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. renal cell carcinoma (rcc)opdivo as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults. opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor risk advanced renal cell carcinoma. opdivo in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma. classical hodgkin lymphoma (chl)opdivo as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical hodgkin lymphoma after autologous stem cell transplant (asct) and treatment with brentuximab vedotin. squamous cell cancer of the head and neck (scchn)opdivo as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum based therapy. urothelial carcinomaopdivo as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum containing therapy. adjuvant treatment of urothelial carcinomaopdivo as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (miuc) with tumour cell pd-l1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of miuc. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)opdivo in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy. oesophageal squamous cell carcinoma (oscc)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy. adjuvant treatment of oesophageal or gastro-oesophageal junction cancer (oc or gejc)opdivo as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy. gastric, gastro‑oesophageal junction (gej) or oesophageal adenocarcinomaopdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first‑line treatment of adult patients with her2‑negative advanced or metastatic gastric, gastro‑oesophageal junction or oesophageal adenocarcinoma whose tumours express pd-l1 with a combined positive score (cps) ≥ 5.

Euroopan unioni - suomi - EMA (European Medicines Agency)

nova laboratories ireland limited - azathioprine - graft hylkääminen - immunosuppressantit - jayempi is indicated in combination with other immunosuppressive agents for the prophylaxis of transplant rejection in patients receiving allogenic kidney, liver, heart, lung or pancreas transplants. azathioprine is indicated in immunosuppressive regimens as an adjunct to immunosuppressive agents that form the mainstay of treatment (basis immunosuppression). jayempi is used as an immunosuppressant antimetabolite either alone or, more commonly, in combination with other agents (usually corticosteroids) and/ or procedures which influence the immune response. jayempi is indicated in patients who are intolerant to glucocorticosteroids or if the therapeutic response is inadequate despite treatment with high doses of glucocorticosteroids, in the following diseases:severe active rheumatoid arthritis (chronic polyarthritis) that cannot be kept under control by less toxic agents (disease-modifying anti-rheumatic -medicinal products – dmards)auto-immune hepatitis systemic lupus erythematosusdermatomyositispolyarteritis nodosapemphigus vulgaris and bullous pemphigoidbehçet’s diseaserefractory auto-immune haemolytic anaemia, caused by warm igg antibodieschronic refractory idiopathic thrombocytopenic purpurajayempi is used for the treatment of moderately severe to severe forms of chronic inflammatory bowel disease (ibd) (crohn’s disease or ulcerative colitis) in patients in whom glucocorticosteroid therapy is necessary, but where glucocorticosteroids are not tolerated, or in whom the disease is untreatable with other common means of first choice. it is also indicated in adult patients in relapsing multiple sclerosis, if an immunomodulatory therapy is indicated but beta interferon therapy is not possible, or a stable course has been achieved with previous treatment with azathioprine. 3jayempi is indicated for the treatment of generalised myasthenia gravis. depending on the severity of the disease, jayempi should be given in combination with glucocorticosteroids because of slow onset of action at the beginning of treatment and the glucocorticosteroid dose should be gradually reduced after several months of treatment.