Euroopan unioni - suomi - EMA (European Medicines Agency)

hra pharma rare diseases - ketokonatsoli - cushing-oireyhtymä - antimykoottiset aineet systeemiseen käyttöön - ketokonatsoli hra on tarkoitettu endogeenisen cushingin oireyhtymän hoitoon aikuisille ja yli 12-vuotiaille nuorille.

Euroopan unioni - suomi - 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 - antineoplastiset aineet - 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. potilailla, joilla egfr-tai alk positiivinen kasvain mutaatioita olisi myös saanut täsmähoitoihin ennen kuin saa 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.

Euroopan unioni - suomi - EMA (European Medicines Agency)

takeda manufacturing austria ag - normaali ihmisen immunoglobuliini (ivig) - purpura, thrombocytopenic, idiopathic; bone marrow transplantation; immunologic deficiency syndromes; guillain-barre syndrome; mucocutaneous lymph node syndrome - immunoseerumit ja immunoglobuliinit, - korvaushoito aikuisilla sekä lapsilla ja nuorilla (0-18-vuotiaille): * primääri immuunipuutos oireyhtymiä, joilla on heikentynyt vasta-aineiden tuotantoa;hypogammaglobulinemia ja toistuvat bakteeri-infektiot potilailla, joilla on krooninen lymfosyyttinen leukemia, antibioottiprofylaksi on epäonnistunut;hypogammaglobulinemia ja toistuvat bakteeri-infektiot plateau-vaihe-useita myelooma potilailla, jotka ovat epäonnistuneet vastaamaan pneumokokki rokotukset;hypogammaglobulinemia potilailla jälkeen allogeenisen hematopoieettisen-kantasolujen siirto (hsct);synnynnäinen aids ja toistuvia bakteeri-infektioita. immunomodulaatio aikuisilla sekä lapsilla ja nuorilla (0-18-vuotiaille): * primääri immuunitrombosytopenia (itp) potilailla, joilla on suuri verenvuotoriski, tai ennen leikkausta korjaamaan verihiutaleiden määrä;guillain-barrén oireyhtymä;kawasakin tauti;multifokaalinen motorinen neuropatia (vai mitä).

Euroopan unioni - suomi - EMA (European Medicines Agency)

viiv healthcare bv - abakaviiri, lamivudiini - hiv-infektiot - antivirals for treatment of hiv infections, combinations, antivirals for systemic use - kivexa on merkitty antiretroviraalisessa yhdistelmähoidossa ihmisen immuunikatoviruksen (hiv) infektioiden hoitoon aikuisilla, nuorilla ja alle 25 kg painavilla lapsilla. ennen hoidon aloittamista abakaviirin kanssa, seulonta kuljetettavaksi hla-b*5701-testaus tulisi suorittaa kaikille hiv-potilaille, riippumatta etnisestä taustasta. abakaviiria ei pidä käyttää potilaille, joiden tiedetään kantavan hla-b*5701-alleelia.

Euroopan unioni - suomi - EMA (European Medicines Agency)

sanofi-aventis deutschland gmbh - glargininsuliini - diabetes mellitus - diabeetilla käytettävät lääkkeet - diabetes mellituksen hoito aikuisilla, nuorilla ja kahdella tai useammalla lapsella.

Euroopan unioni - suomi - EMA (European Medicines Agency)

novo nordisk a/s - detemirinsuliinin - diabetes mellitus - diabeetilla käytettävät lääkkeet - diabetes mellituksen hoito aikuisilla, nuorilla ja yli 1-vuotiailla lapsilla.

Euroopan unioni - suomi - EMA (European Medicines Agency)

pfizer europe ma eeig - levetirasetaami - epilepsia - epilepsialääkkeet, - levetiracetam hospira ilmoitetaan monoterapiana hoitoon kohtausten kanssa tai ilman toissijainen yleistys aikuisille ja nuorille 16-vuotiaille hiljattain diagnosoitu epilepsia. levetiracetam hospira on tarkoitettu yhdessä therapyin paikallisalkuisten kohtausten toissijaisesti yleistyvä tai yleistymätön kohtaus aikuisille, nuorille ja lapsille 4-vuotiaille, joilla on epilepsia. hoidossa myoklonisia kohtauksia aikuisilla ja yli 12-vuotiaat nuoruusiän myokloninen epilepsia. hoidossa yleistyvien toonis-kloonisten kohtausten hoitoon aikuisille ja yli 12-vuotiaille lapsille, joilla on idiopaattinen yleistynyt epilepsia. levetiracetam hospira-konsentraatti on vaihtoehto potilaille, kun suun kautta antaminen ei ole tilapäisesti mahdollista.

Euroopan unioni - suomi - EMA (European Medicines Agency)

teva b.v. - levetirasetaami - epilepsia - hermosto - levetiracetam teva on merkitty monoterapiana hoidettaessa osittaisia ​​kohtauksia, joissa on tai ei ole sekundaarista yleistystä aikuisilla ja 16-vuotiailla nuorilla, joilla on äskettäin diagnosoitu epilepsia. levetiracetam teva on tarkoitettu lisähoitona:hoidossa osittainen puhkeamista takavarikot tai eivät ole toissijaisesti yleistyviä aikuisille, nuorille, lapsille ja vauvoille 1 kuukauden iästä lähtien epilepsia;hoitoon myoklonisia kohtauksia aikuisilla ja yli 12-vuotiaat nuoruusiän myokloninen epilepsia;hoitoon yleistyvien toonis-kloonisten kohtausten hoitoon aikuisille ja yli 12-vuotiaille lapsille, joilla on idiopaattinen yleistynyt epilepsia.

Euroopan unioni - suomi - EMA (European Medicines Agency)

pfizer europe ma eeig - etanersepti - arthritis, psoriatic; spondylitis, ankylosing; psoriasis - immunosuppressantit - nivelreuma;juveniili idiopaattinen arthritispsoriatic niveltulehdus;aksiaalinen spondyloartriitti;läiskäpsoriaasi;läiskäpsoriaasi lapsilla.

Euroopan unioni - suomi - EMA (European Medicines Agency)

merck sharp & dohme b.v. - glargininsuliini - diabetes mellitus - diabeetilla käytettävät lääkkeet - diabetes mellituksen hoito aikuisilla, nuorilla ja yli 2-vuotiailla lapsilla.