Европейски съюз - полски - EMA (European Medicines Agency)

alexion europe sas - sebelipase alfa - metabolizm lipidów, wrodzone błędy - inne przewodu pokarmowego i przemianę materii narzędzia, - kanuma jest wskazana w długoterminowej terapii zastępczej enzymem (ert) u pacjentów w każdym wieku z niedoborem lipazy lizosomalnej (lal).

Европейски съюз - полски - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - hemoglobinuria, paroksysmal - selektywne leki immunosupresyjne - 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.

Европейски съюз - полски - EMA (European Medicines Agency)

alexion europe sas - Экулизумаб - hemoglobinuria, paroksysmal - leki immunosupresyjne - Солирис wskazany dla dorosłych i dzieci w leczeniu:napadowa nocna hemoglobinuria (pnh). dowodów na efekt kliniczny objawia się u pacjentów z hemolizy z kliniczny objaw(y), świadczy o dużej aktywności choroby, niezależnie od historii transfuzji (patrz rozdział 5. nietypowy zespół hemolityczno-mocznicowy (Агус). Солирис jest wskazany u dorosłych w leczeniu:ogniotrwałe uogólnione z miastenią (ГГМ) u pacjentów z anty-ацетилхолиновому receptora (АЧР) przeciwciała (patrz rozdział 5. zaburzenia neuromyelitis nerwu widma (nmosd) u pacjentów, którzy są anty-akwaporyna-4 (aqp4) przeciwciała z nawracającymi upływem choroby.

Европейски съюз - полски - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - trastuzumab deruxtecan - nowotwory piersi - Środki przeciwnowotworowe - breast cancerher2-positive breast cancerenhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic her2-positive breast cancer who have received one or more prior anti-her2-based regimens. her2-low breast cancerenhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic her2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy (see section 4. non-small cell lung cancer (nsclc)enhertu as monotherapy is indicated for the treatment of adult patients with advanced nsclc whose tumours have an activating her2 (erbb2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy. gastric cancerenhertu as monotherapy is indicated for the treatment of adult patients with advanced her2-positive gastric or gastroesophageal junction (gej) adenocarcinoma who have received a prior trastuzumab-based regimen.

Полша - полски - URPL (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych)

aspen pharma trading ltd. - lidocainum + prilocainum - krem - 25 mg/g + 25 mg/g

Полша - полски - URPL (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych)

przedsiębiorstwo produkcji farmaceutycznej hasco-lek s.a. - quetiapini fumaras - tabletki powlekane - 200 mg

Полша - полски - URPL (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych)

przedsiębiorstwo produkcji farmaceutycznej hasco-lek s.a. - quetiapini fumaras - tabletki powlekane - 300 mg

Полша - полски - URPL (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych)

przedsiębiorstwo produkcji farmaceutycznej hasco-lek s.a. - quetiapini fumaras - tabletki powlekane - 100 mg

Полша - полски - URPL (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych)

przedsiębiorstwo produkcji farmaceutycznej hasco-lek s.a. - quetiapini fumaras - tabletki powlekane - 25 mg

Европейски съюз - полски - EMA (European Medicines Agency)

astrazeneca ab - durvalumab - rak, niedrobnokomórkowe płuca - Środki przeciwnowotworowe - non-small cell lung cancer (nsclc)imfinzi as monotherapy is indicated for the treatment of locally advanced, unresectable non small cell lung cancer (nsclc) in adults whose tumours express pd-l1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum based chemoradiation therapy (see section 5. imfinzi in combination with tremelimumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic nsclc with no sensitising egfr mutations or alk positive mutations. small cell lung cancer (sclc)imfinzi in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of adults with extensive-stage small cell lung cancer (es-sclc). biliary tract cancer (btc)imfinzi in combination with gemcitabine and cisplatin is indicated for the first line treatment of adults with unresectable or metastatic biliary tract cancer (btc). hepatocellular carcinoma (hcc)imfinzi in combination with tremelimumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (hcc).