Euroopan unioni - suomi - EMA (European Medicines Agency)

medimmune llc - reassortant influenssa virus (elävä heikennetty) seuraavista viruskannoista:a/california/7/2009 (h1n1)pdm09-kaltainen kanta, a/victoria/361/2011 (h3n2) - kaltainen kanta, b/massachusetts/2/2012-kaltainen kanta - influenza, human; immunization - rokotteet - profylaksia influenssan yksilöiden 24 kk alle 18-vuotiaat. fluenz-valmisteen käytön tulisi perustua virallisiin suosituksiin.

Euroopan unioni - suomi - EMA (European Medicines Agency)

astrazeneca ab - (live attenuated) reassortant influenza virus (a / vietnam / 1203/2004 (h5n1) -kanta - influenssa, ihminen - rokotteet - influenssan ennaltaehkäisy virallisesti ilmoitetussa pandemiatilanteessa lapsilla ja nuorilla 12 kuukauden ikäisiltä alle 18-vuotiaille. pandemic influenza vaccine h5n1 astrazeneca tulee käyttää virallisen ohjeistuksen mukaisesti.

Euroopan unioni - suomi - EMA (European Medicines Agency)

astrazeneca ab - a/darwin/9/2021 (h3n2) - like strain (a/norway/16606/2021, medi 355293) / a/victoria/2570/2019 (h1n1)pdm09 - like strain (a/victoria/1/2020, medi 340505) / b/austria/1359417/2021 - like strain (b/austria/1359417/2021, medi 355292) / b/phuket/3073/2013 - like strain (b/phuket/3073/2013, medi 306444) - influenssa, ihminen - influenssa influenssa, elävä heikennetty - prophylaxis of influenza in children and adolescents from 24 months to less than 18 years of age. fluenz tetran käytön olisi perustuttava virallisiin suosituksiin.

Euroopan unioni - suomi - EMA (European Medicines Agency)

merck sharp & dohme b.v. - rotaviruksen serotyyppi g1, serotyyppi g2, serotyyppi g3, serotyyppi g4, serotyyppi p1 - immunization; rotavirus infections - vaccines, viral vaccines - rotateq on tarkoitettu kuuden viikon ikäisten pikkulasten aktiiviseen immunisointiin 32 viikkoon rotavirusinfektion aiheuttaman gastroenteriitin ehkäisyyn. rotateq: ia käytetään virallisten suositusten mukaisesti.

Suomi - suomi - Fimea (Suomen lääkevirasto)

aj vaccines a/s - corynebacterium diphtheriae toxoid, adsorbed, clostridium tetani toxoid, adsorbed, bordetella pertussis toxoid, adsorbed - injektioneste, suspensio, esitäytetty ruisku - hinkuyskärokote yhdistelmävalmisteena toksoidien kanssa

Euroopan unioni - suomi - EMA (European Medicines Agency)

bayer ag - darolutamide - eturauhasen kasvaimet, kastraatio-resistentin - endokriinihoito - nubeqa is indicated for the treatment of adult men with- non metastatic castration resistant prostate cancer (nmcrpc) who are at high risk of developing metastatic disease (see section 5. - metastatic hormone sensitive prostate cancer (mhspc) in combination with docetaxel and androgen deprivation therapy (see section 5.

Euroopan unioni - suomi - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - hepatiitti b, rekombinantti pinta-antigeeni - hepatitis b; immunization - rokotteet - 5 micrograms hbvaxpro is indicated for active immunisation against hepatitis-b-virus infection caused by all known subtypes in individuals from birth through 15 years of age considered at risk of exposure to hepatitis-b virus. erityinen riski luokat immunisoida määritetään perusteella virallisten suositusten. voidaan olettaa, että hepatiitti d on myös ehkäistä rokotuksella kanssa hbvaxpro, sillä hepatiitti d (delta-tekijän aiheuttama) infektiota esiintyy vain hepatiitti b-infektio. 10 micrograms hbvaxpro is indicated for active immunisation against hepatitis-b-virus infection caused by all known subtypes in individuals 16 years of age or more considered at risk of exposure to hepatitis-b virus. erityinen riski luokat immunisoida määritetään perusteella virallisten suositusten. voidaan olettaa, että hepatiitti d on myös ehkäistä rokotuksella kanssa hbvaxpro, sillä hepatiitti d (delta-tekijän aiheuttama) infektiota esiintyy vain hepatiitti b-infektio. 40 micrograms hbvaxpro is indicated for the active immunisation against hepatitis-b-virus infection caused by all known subtypes in predialysis and dialysis adult patients. voidaan olettaa, että hepatiitti d on myös ehkäistä rokotuksella kanssa hbvaxpro, sillä hepatiitti d (delta-tekijän aiheuttama) infektiota esiintyy vain hepatiitti b-infektio.

Euroopan unioni - suomi - EMA (European Medicines Agency)

merck sharp and dohme b.v - posakonatsoli - candidiasis; mycoses; coccidioidomycosis; aspergillosis - antimykoottiset aineet systeemiseen käyttöön - noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 ja 5. 1):- invasive aspergillosisnoxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections  4. 2 ja 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. vastareaktioita on määritelty, jos infektio etenee tai epäonnistuminen parantaa jälkeen vähintään 7 päivää ennen terapeuttisia annoksia tehokasta sienilääkitystä. noxafil gastro-resistant tablets are also indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections 4. 2 ja 5. 1):- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 ja 5. 1):- invasive aspergillosisnoxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adult and paediatric patients from 2 years of age (see sections 4. 2 ja 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. vastareaktioita on määritelty, jos infektio etenee tai epäonnistuminen parantaa jälkeen vähintään 7 päivää ennen terapeuttisia annoksia tehokasta sienilääkitystä. noxafil concentrate for solution for infusion is also indicated for prophylaxis of invasive fungal infections in the following adult and paediatric patients from 2 years of age (see sections 4. 2 ja 5. 1):- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease (gvhd) and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil gastro resistant powder and solvent for oral suspension is indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age (see sections 4. 2 ja 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. vastareaktioita on määritelty, jos infektio etenee tai epäonnistuminen parantaa jälkeen vähintään 7 päivää ennen terapeuttisia annoksia tehokasta sienilääkitystä. noxafil gastro-resistant powder and solvent for oral suspension is indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2  years of age:- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high  risk of developing invasive fungal infections;- haematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high  risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil oral suspension is indicated for use in the treatment of the following fungal infections in adults (see section 5. 1):- invasiivinen aspergilloosi potilailla, joiden sairauteen, joka on tulenkestävä amfoterisiini b tai itrakonatsoli eivät tehonneet tai kun potilaat eivät sietäneet näitä lääkkeitä;- epäilty fusarioosi potilailla, joilla on sairaus, joka on tulenkestävä amfoterisiini b: tä tai potilailla, jotka eivät siedä amfoterisiini b;- kromoblastomykoosi ja mysetooman hoidossa potilailla, joilla on sairaus, joka on tulenkestävä itrakonatsoli tai potilailla, jotka eivät siedä itrakonatsoli;- koksidioidomykoosi potilailla, joilla on sairaus, joka on tulenkestävä amfoterisiini b, itrakonatsoli tai flukonatsoli, tai potilailla, jotka eivät siedä näitä lääkkeitä;- suunielun kandidiaasi: ensilinjan lääkkeenä potilaille, joiden sairaus on vakava tai joiden immuunipuolustus on heikentynyt, ja vastaus paikalliseen hoitoon odotetaan olevan heikon. vastareaktioita on määritelty, jos infektio etenee tai epäonnistuminen parantaa jälkeen vähintään 7 päivää ennen terapeuttisia annoksia tehokasta sienilääkitystä. noxafil oral suspension is also indicated for prophylaxis of invasive fungal infections in the following patients:- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis.

Suomi - suomi - Fimea (Suomen lääkevirasto)

faes farma, s.a. - mesalazine - enterotabletti - 500 mg - mesalatsiini

Suomi - suomi - Fimea (Suomen lääkevirasto)

campuspharma ab - pyridoxine hydrochloride, doxylamine hydrogen succinate - enterotabletti - 10 mg / 10 mg - doksylamiini