Europos Sąjunga - suomių - EMA (European Medicines Agency)

basilea pharmaceutica deutschland gmbh - isavuconazole - aspergilloosi - cresemba on tarkoitettu aikuisten hoitoon:invasiivisia aspergillosismucormycosis potilailla, joille amfoterisiini b ei inappropriateconsideration olisi otettava huomioon viralliset ohjeet sienilääkkeiden asianmukaisesta käytöstä on.

Europos Sąjunga - suomių - EMA (European Medicines Agency)

tillotts pharma gmbh - fidaxomicin - clostridium-infektiot - ripulilääkkeet, suoliston antiinflammatory / antiinfective agents - dificlir-kalvopäällysteiset tabletit on tarkoitettu hoitoon clostridioides difficile-infektio (cdi) tunnetaan myös nimellä c. difficile liittyvää ripulia (cdad) aikuisilla ja lapsilla, joiden paino on vähintään 12. 5 kg. on otettava huomioon viralliset ohjeet tarkoituksenmukaisesta käytöstä. dificlir rakeet oraalisuspensiota varten on tarkoitettu hoitoon clostridioides difficile-infektio (cdi) tunnetaan myös nimellä c. difficile liittyvää ripulia (cdad) aikuisilla ja lapsilla syntymästä < 18-vuotiaille. on otettava huomioon viralliset ohjeet tarkoituksenmukaisesta käytöstä.

Europos Sąjunga - suomių - EMA (European Medicines Agency)

valneva sweden ab - rekombinantti koleratoksiinin b-alayksikkö, vibrio cholerae 01 - cholera; immunization - rokotteet - dukoral on tarkoitettu aktiivista immunisaatiota taudin aiheuttamien vibrio cholerae serotyyppi o1 aikuisille ja lapsille 2-vuotias, jotka vierailevat endeeminen/epidemia-alueilla. dukoralin käyttöä olisi määritettävä sen perusteella, viralliset suositukset huomioon ottaen vaihtelu epidemiologian ja riski sairastua tautiin eri maantieteellisillä alueilla ja matkalla ehtoja. dukoralia ei korvata standardin suojatoimenpiteitä. jos ripuli toimenpiteitä nesteytys on aloitettava.

Europos Sąjunga - suomių - EMA (European Medicines Agency)

gilead sciences ireland uc - adefoviiridipivoksiili - hepatiitti b, krooninen - nukleosidi- ja nukleotidikäänteistranskriptaasi-inhibiittorit - hepsera on tarkoitettu kroonisen hepatiitti b aikuisilla, joilla on:maksasairaus ja viitteitä aktiivisesta virusten replikaatiosta, pysyvästi kohonneet seerumin alat-arvo (alaniiniaminotransferaasi) tasot ja histologista näyttöä aktiivisesta maksan tulehdus ja fibroosi. aloittamisen hepsera-hoitoa tulisi harkita vain, kun käyttää vaihtoehtoista antiviraalista agentti suurempi geneettinen este resistenssin ei ole käytettävissä tai asianmukainen (ks. kohta 5. 1);dekompensoitu maksasairaus yhdessä toinen agentti ilman ristiresistenssiä hepsera.

Europos Sąjunga - suomių - EMA (European Medicines Agency)

intervet international b.v - fluralaner - ulkoloislääkkeet systeemiseen käyttöön, isoxazolines - dogs; cats - koirat:- hoitoon puutiais-ja kirpputartuntojen;tuotetta voidaan käyttää osana hoidon strategia valvonta-flea allergy dermatitis (fad). - hoitoon demodikoosi demodex canis;- sillä syyhypunkkitartuntojen hoito (sarcoptes scabiei var. canis) tartuntoja. - for reduction of the risk of infection with babesia canis canis via transmission by dermacentor reticulatus. [chewable tablets only]cats:- for the treatment of tick and flea infestations;the product can be used as part of a treatment strategy for the control of flea allergy dermatitis (fad). - hoitoon tartuntoja kanssa korvapunkkitartunnan (otodectes cynotis).

Europos Sąjunga - suomių - EMA (European Medicines Agency)

zoetis belgium sa - inaktivoitu schmallenberg-virus, kanta bh80 / 11-4 - immunologisia valmisteita varten bovidae, inaktivoidut virusrokotteet - cattle; sheep - nautaeläinten ja lampaiden aktiivinen immunisointi 3. 5-vuotiailla lapsilla, jotta voidaan estää schmallenbergin aiheuttaman infektion aiheuttama viraemia.

Europos Sąjunga - suomių - 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.

Europos Sąjunga - suomių - EMA (European Medicines Agency)

jenson pharmaceutical services limited - dekstrometorfaani, kinidiini - neurobehavioral ilmenemismuodot - muut hermoston huumeet - nuedexta on tarkoitettu aikuisten pseudobulbaari-vaikutuksen (pba) oireenmukaiseen hoitoon. tehoa on tutkittu vain potilailla, joilla on amyotrofinen lateraaliskleroosi tai multippeliskleroosi.

Europos Sąjunga - suomių - EMA (European Medicines Agency)

glaxo group limited  - retigabiinille - epilepsia - epilepsialääkkeet, - trobalt on ilmoitettu lisähoitona lääkeresistentti osittainen-kohtausten kanssa tai ilman toissijainen yleistys potilaille 18 vuotta tai vanhempia, joilla epilepsia, jossa muut asianmukaiset huumeiden yhdistelmät ovat osoittautuneet riittämättömiksi tai ei ole sietää.

Europos Sąjunga - suomių - EMA (European Medicines Agency)

janssen-cilag international n.v. - paliperidoni-palmitaatti - skitsofrenia - psyykenlääkkeiden - xeplion on tarkoitettu skitsofrenian ylläpitohoitoa varten aikuispotilailla, jotka on stabiloitu paliperidoniin tai risperidoniin. in selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, xeplion may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed.