Euroopan unioni - suomi - EMA (European Medicines Agency)

mylan pharmaceuticals limited - entekaviirimonohydraatti - b-hepatiitti - antiviraalit systeemiseen käyttöön - entecavir mylan is indicated for the treatment of chronic hepatitis b virus (hbv) infection in adults with:compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (alt) levels and histological evidence of active inflammation and/or fibrosis. dekompensoitu maksasairaus. sekä kompensoitu ja dekompensoitu maksasairaus, tämä käyttöaihe perustuu kliinisen lääketutkimuksen tiedot, nukleosidi-naiivi potilailla, joilla on hbeag-positiivinen tai hbeag-negatiivinen hbv-infektio. mitä tulee lamivudiinihäiriötöntä hepatiitti b: tä sairastaviin potilaisiin. entekaviiri mylan on tarkoitettu myös kroonisen hbv-infektio, nukleosidi-naiivi lapsipotilaat 2.

Euroopan unioni - suomi - EMA (European Medicines Agency)

mylan ire healthcare limited - pretomanid - tuberkuloosi, monilääkeresistenssi - mykobakteerilÄÄkkeet - dovprela is indicated in combination with bedaquiline and linezolid, in adults, for the treatment of pulmonary extensively drug resistant (xdr), or treatment-intolerant or nonresponsive multidrug-resistant (mdr) tuberculosis (tb). on otettava huomioon viralliset ohjeet antibioottien tarkoituksenmukaisesta käytöstä.

Euroopan unioni - suomi - EMA (European Medicines Agency)

mylan ireland limited - lenalidomidi - multiple myeloma - immunosuppressantit - multiple myelomalenalidomide mylan as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide mylan as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. lenalidomide mylan in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. follicular lymphomalenalidomide mylan in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1-3a).

Euroopan unioni - suomi - EMA (European Medicines Agency)

mylan ireland limited - fingolimod hydrochloride - multippeliskleroosi, relapsoiva-remittoiva - immunosuppressantit - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older:patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 ja 5. 1)orpatients kanssa vaikea ja nopeasti etenevä relapsoiva-remittoiva multippeliskleroosi on määritelty 2 tai enemmän invaliditeettiin sairauden pahenemisvaiheita on yksi vuosi, ja 1 tai enemmän gadolinium parantaa vaurioita aivojen mri tai merkittävä kasvu t2-leesio kuormitus verrattuna aiempaan tuoreeseen magneettikuvaukseen.

Euroopan unioni - suomi - EMA (European Medicines Agency)

mylan ireland limited - fingolimod hydrochloride - multippeliskleroosi, relapsoiva-remittoiva - immunosuppressantit - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (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)

gilead sciences ireland uc - idelalisib - lymphoma, non-hodgkin; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents, other antineoplastic agents - zydelig is indicated in combination with an anti‑cd20 monoclonal antibody (rituximab or ofatumumab) for the treatment of adult patients with chronic lymphocytic leukaemia (cll):who have received at least one prior therapy, oras first line treatment in the presence of 17p deletion or tp53 mutation in patients who are not eligible for any other therapies. zydelig is indicated as monotherapy for the treatment of adult patients with follicular lymphoma (fl) that is refractory to two prior lines of treatment.

Euroopan unioni - suomi - EMA (European Medicines Agency)

secura bio limited - duvelisib - leukemia, lymphocytic, chronic, b-cell; lymphoma, follicular - antineoplastiset aineet - copiktra monotherapy is indicated for the treatment of adult patients with: relapsed or refractory chronic lymphocytic leukaemia (cll) after at least two prior therapies.  follicular lymphoma (fl) that is refractory to at least two prior  systemic therapies.

Euroopan unioni - suomi - EMA (European Medicines Agency)

gilead sciences ireland uc - sacituzumab govitecan - breast neoplasms; triple negative breast neoplasms - antineoplastiset aineet - trodelvy as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (mtnbc) who have received two or more prior systemic therapies, including at least one of them for advanced disease.

Euroopan unioni - suomi - EMA (European Medicines Agency)

amicus therapeutics europe limited - cipaglucosidase alfa - glykogeenin varastointitaudin tyyppi ii - muut ruuansulatuselimistön sairauksien ja aineenvaihduntasairauksien lääkkeet, - pombiliti (cipaglucosidase alfa) is a long-term enzyme replacement therapy used in combination with the enzyme stabiliser miglustat for the treatment of adults with late-onset pompe disease (acid α-glucosidase [gaa] deficiency).

Euroopan unioni - suomi - EMA (European Medicines Agency)

merck sharp dohme limited - lamivudiini ja raltegraviiri kaliumia - hiv-infektiot - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - dutrebis on tarkoitettu käytettäväksi yhdessä muiden anti‑retroviral lääkkeiden hoitoon infektio immuunikatoviruksen (hiv‑1) aikuiset, nuoret ja lapset alle 6 vuotta ja painaa vähintään 30 kg ilman nykyisin tai aiemmin näyttöä viral vastustuskyvyn viruslääkkeiden oikeussuojakeinoista (integraasientsyymin strand siirtää estäjä) ja nrti (nucleoside käänteiskopioijaentsyymin estäjä) luokat (ks. kohdat 4. 2, 4. 4 ja 5.