Europese Unie - Fins - EMA (European Medicines Agency)

serb sa - amifampridiinia - lambert-eatonin myasteeninen oireyhtymä - muut hermoston huumeet - lambert-eatonin myasteeninen oireyhtymä (institutionaali) aikuisilla oireenmukaista hoitoa.

Europese Unie - Fins - EMA (European Medicines Agency)

novartis europharm limited - travoprosti - ocular hypertension; glaucoma, open-angle - ophthalmologicals, antiglaucoma preparations and miotics - kohonnut silmänpaineen lasku aikuispotilailla, joilla on silmänpainetauti tai avoin kulma glaukooma (ks. kohta 5. vähentää kohonnut silmänpaine lapsipotilailla iältään 3 vuotta alle 18-vuotta, jossa kohonnut silmänpaine tai glaukooma lapsilla.

Europese Unie - Fins - EMA (European Medicines Agency)

roche registration ltd. - nelfinaviiri - hiv-infektiot - antiviraalit systeemiseen käyttöön - viracept on antiretroviraalista yhdistelmähoitoa ihmisen immuunikatoviruksen (hiv-1) infektoituneille aikuisille, nuorille ja kolmevuotiaille ja sitä vanhemmille lapsille. vuonna proteaasi-inhibiittori (pi)-kokenut potilaiden valinta nelfinaviiri olisi perustuttava yksittäisten virusresistenssitestauksen ja hoidon historia.

Europese Unie - Fins - EMA (European Medicines Agency)

recordati rare diseases - sinkki - hepatolentulaarinen rappeuma - muut ruuansulatuselimistön sairauksien ja aineenvaihduntasairauksien lääkkeet, - wilsonin taudin hoito.

Europese Unie - Fins - EMA (European Medicines Agency)

olympus biotech international limited - eptotermiini alfa - spondylolisthesis - lääkkeet luusairauksien hoitoon - opgenra on tarkoitettu posterolateralisen lannerangan fuusioon aikuispotilailla, joilla on spondylolisthesis, jos autograft on epäonnistunut tai on vasta-aiheinen.

Finland - Fins - Fimea (Suomen lääkevirasto)

sandoz a/s - efavirenz - tabletti, kalvopäällysteinen - 600 mg - efavirentsi

Europese Unie - Fins - EMA (European Medicines Agency)

gilead sciences ireland uc - efavirentsia, emtrisitabiinia, tenofoviiridisoproksiilifumaraattia - hiv-infektiot - antiviraalit systeemiseen käyttöön - atripla on kiinteä annos yhdistelmä efavirentsia, emtrisitabiinia ja tenofoviiridisoproksiilifumaraattia. se on tarkoitettu hoitoon human-immunodeficiency-virus-1 (hiv-1) infektion hoitoon aikuisilla, joiden virologinen vaste hiv-1-rna-tasot < 50 kopiota/ml niiden nykyisellä retroviruslääkkeiden yhdistelmähoidolla ja yli kolme kuukautta. potilailla ei saa olla virologisesti epäonnistunut mitään aiempaa antiretroviraalista hoitoa, ja sen on oltava tiedossa ei ole sellaisia viruskantoja, joiden mutaatiot aiheuttaisivat merkitsevää resistenssiä jollekin kolmesta komponenttien sisältämien atripla ennen hoidon aloittamista heidän ensimmäinen antiretroviraalinen hoito. esittelyn hyöty atripla-perustuu ensisijaisesti 48 viikon jälkeen saatuihin tietoihin kliinisessä tutkimuksessa, jossa potilailla, joilla on vakaa virologinen vaste on antiretroviraalinen hoito siirtyivät atripla-hoitoon. tällä hetkellä ei ole tietoa saatavilla kliinisistä tutkimuksista, joissa atripla-hoito-naiivi tai raskaasti esikäsitelty potilaat. tietoja ei ole saatavilla tukea yhdistelmä atripla ja muiden antiretroviruslääkkeiden.

Europese Unie - Fins - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - flutikasonifuroaatti - rhinitis, allergic, seasonal; rhinitis, allergic, perennial - nenän valmisteet, kortikosteroidit - aikuiset, nuoret (yli 12-vuotiaat) ja lapset (6-11-vuotiaat). avamys on tarkoitettu allergisen nuhan oireiden hoitoon.

Europese Unie - Fins - EMA (European Medicines Agency)

bayer ag - aflibersepti - wet macular degeneration; macular edema; diabetes complications - silmätautien - eylea on tarkoitettu aikuisten hoitoon:neovaskulaarisen (kostean) ikään liittyvä silmänpohjan rappeuma (amd);näön huonontuminen makulaarisen ödeeman takia, toissijainen verkkokalvon laskimotukos (branch rvo tai keski-rvo);näkövamman vuoksi diabeettinen makulaturvotus (dme);näkövamma, koska likinäköinen suonikalvon uudissuonittumisesta (likinäköinen cnv).

Europese Unie - Fins - 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.