Europeiska unionen - ungerska - EMA (European Medicines Agency)

mendelikabs europe ltd - nitizinonnal - tyrosinemias - egyéb táplálkozási traktus pedig anyagcsere termékek, - kezelés légútbiztosító (minden korosztály) a betegek örökletes tyrosinemia megerősített diagnózisa együtt étrendi megszorítás, fenil-alanin és tirozin írja be az 1 (ht-1).

Europeiska unionen - ungerska - EMA (European Medicines Agency)

mundipharma corporation (ireland) limited - a naloxon-hidroklorid-dihidrát - opioidhoz kapcsolódó rendellenességek - minden más terápiás készítmény - a nyxoid azonnali beadásra szolgál az ismert vagy feltételezett opioid túladagolás sürgősségi terápiájánál, melyet légzési és / vagy központi idegrendszeri depresszió jelent, mind a nem orvosi, mind az egészségügyi ellátásban. nyxoid is indicated in adults and adolescents aged 14 years and over. nyxoid is not a substitute for emergency medical care.

Europeiska unionen - ungerska - EMA (European Medicines Agency)

gilead sciences ireland uc - sofosbuvir, velpatasvir, voxilaprevi - hepatitis c, krónikus - vírusellenes szerek szisztémás alkalmazásra - vosevi is indicated for the treatment of chronic hepatitis c virus (hcv) infection in patients aged 12 years and older and weighing at least 30 kg. (lásd 4. 2, 4. 4 és 5.

Europeiska unionen - ungerska - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - niraparib (tosilate monohydrate) - fallopian tube neoplasms; peritoneal neoplasms; ovarian neoplasms - daganatellenes szerek - zejula is indicated: , as monotherapy for the maintenance treatment of adult patients with advanced epithelial (figo stages iii and iv) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. , as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy.

Europeiska unionen - ungerska - EMA (European Medicines Agency)

gilead sciences ireland uc - bictegravir, emtricitabint, tenofovir alafenamide, - fumarát - hiv fertőzések - vírusellenes szerek szisztémás alkalmazásra - biktarvy is indicated for the treatment of human immunodeficiency virus 1 (hiv 1) infection in adults and paediatric patients at least 2 years of age and weighing at least 14 kg i without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir. (lásd az 5. részt.

Europeiska unionen - ungerska - EMA (European Medicines Agency)

takeda pharma a/s - brigatinib - karcinóma, nem kissejtes tüdő - daganatellenes szerek - alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (alk)‑positive advanced non‑small cell lung cancer (nsclc) previously not treated with an alk inhibitor. alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase alkpositive advanced nsclc previously treated with crizotinib.

Europeiska unionen - ungerska - EMA (European Medicines Agency)

ecuphar - hidrokortizon-aceponát - kortikoszteroidok, dermatológiai készítmények - kutyák - a gyulladásos és viszkető dermatózusok tüneti kezelésére kutyáknál. for alleviation of clinical signs associated with atopic dermatitis in dogs.

Europeiska unionen - ungerska - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - hemoglobinuria, paroxysmal - szelektív immunszuppresszánsok - paroxysmal nocturnal haemoglobinuria (pnh)ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with pnh:- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months (see section 5. atypical haemolytic uremic syndrome (ahus)ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with ahus who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab (see section 5. generalized myasthenia gravis (gmg)ultomiris is indicated as an add-on to standard therapy for the treatment of adult patients with gmg who are anti-acetylcholine receptor (achr) antibody-positive. neuromyelitis optica spectrum disorder (nmosd)ultomiris is indicated in the treatment of adult patients with nmosd who are anti-aquaporin 4 (aqp4) antibody-positive (see section 5. ultomiris is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh):- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. ultomiris is indicated in the treatment of adult patients with atypical haemolytic uremic syndrome (ahus) who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab.

Europeiska unionen - ungerska - EMA (European Medicines Agency)

nova laboratories ireland limited - hidroxi- - anémia, sarlósejt - daganatellenes szerek - megelőzés, a vaso-elnyelő szövődmények a sarlósejtes betegség, a betegek több mint 2 év.

Europeiska unionen - ungerska - EMA (European Medicines Agency)

regeneron ireland designated activity company (dac) - cemiplimab - karcinóma, squamous cell - daganatellenes szerek - cutaneous squamous cell carcinomalibtayo as monotherapy is indicated for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mcscc or lacscc) who are not candidates for curative surgery or curative radiation. basal cell carcinomalibtayo as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (labcc or mbcc) who have progressed on or are intolerant to a hedgehog pathway inhibitor (hhi). non-small cell lung cancerlibtayo as monotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (nsclc) expressing pd-l1 (in ≥ 50% tumour cells), with no egfr, alk or ros1 aberrations, who have:locally advanced nsclc who are not candidates for definitive chemoradiation, ormetastatic nsclc. libtayo in combination with platinum‐based chemotherapy is indicated for the first‐line treatment of adult patients with nsclc expressing pd-l1 (in ≥ 1% of tumour cells), with no egfr, alk or ros1 aberrations, who have:locally advanced nsclc who are not candidates for definitive chemoradiation, ormetastatic nsclc. cervical cancerlibtayo as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.