Polska - polski - URPL (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych)

merck sp. z o.o. - rivaroxabanum - tabletki powlekane - 20 mg

Unia Europejska - polski - EMA (European Medicines Agency)

kite pharma eu b.v. - autologous peripheral blood t cells cd4 and cd8 selected and cd3 and cd28 activated transduced with retroviral vector expressing anti-cd19 cd28/cd3-zeta chimeric antigen receptor and cultured (brexucabtagene autoleucel) - chłoniak, mantle-cell - Środki przeciwnowotworowe - mantle cell lymphomatecartus is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl) after two or more lines of systemic therapy including a bruton’s tyrosine kinase (btk) inhibitor. acute lymphoblastic leukaemiatecartus is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory b-cell precursor acute lymphoblastic leukaemia (all).

Polska - polski - URPL (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych)

lupin europe gmbh - fingolimodum - kapsułki twarde - 0,5 mg

Unia Europejska - polski - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - idecabtagene vicleucel - multiple myeloma; neoplasms; cancer; neoplasms, plasma cell; hemostatic disorders; vascular diseases; cardiovascular diseases; paraproteinemias; blood protein disorders; hematologic diseases; hemic and lymphatic diseases; hemorrhagic disorders; infectious mononucleosis; lymphoproliferative disorders; immunoproliferative disorders; immune system diseases - Środki przeciwnowotworowe - abecma is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti cd38 antibody and have demonstrated disease progression on the last therapy.

Unia Europejska - polski - EMA (European Medicines Agency)

janssen-cilag international nv - ciltacabtagene autoleucel - szpiczak mnogi - carvykti is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-cd38 antibody and have demonstrated disease progression on the last therapy.

Unia Europejska - polski - EMA (European Medicines Agency)

novartis europharm limited  - gozetotide - obrazowanie radionuklidami - diagnostyczne radiofarmaceutyki - ten produkt leczniczy jest przeznaczony wyłącznie do celów diagnostycznych. locametz, after radiolabelling with gallium 68, is indicated for the detection of prostate specific membrane antigen (psma) positive lesions with positron emission tomography (pet) in adults with prostate cancer (pca) in the following clinical settings:primary staging of patients with high risk pca prior to primary curative therapy,suspected pca recurrence in patients with increasing levels of serum prostate specific antigen (psa) after primary curative therapy,identification of patients with psma positive progressive metastatic castration resistant prostate cancer (mcrpc) for whom psma targeted therapy is indicated (see section 4.

Unia Europejska - polski - EMA (European Medicines Agency)

curium pet france - piflufolastat (18f) - nowotwory stercza - diagnostyczne radiofarmaceutyki - ten produkt leczniczy jest przeznaczony wyłącznie do celów diagnostycznych. pylclari is indicated for the detection of prostate-specific membrane antigen (psma) positive lesions with positron emission tomography (pet) in adults with prostate cancer (pca) in the following clinical settings:primary staging of patients with high-risk pca prior to initial curative therapy,to localize recurrence of pca in patients with a suspected recurrence based on increasing serum prostate-specific antigen (psa) levels after primary treatment with curative intent. pylclari is indicated for use with positron emission tomography (pet).

Unia Europejska - polski - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - tocilizumab - arthritis, rheumatoid; cytokine release syndrome; arthritis, juvenile rheumatoid; covid-19 virus infection; giant cell arteritis - leki immunosupresyjne - tyenne, in combination with methotrexate (mtx), is indicated for- the treatment of severe, active and progressive rheumatoid arthritis (ra) in adults not previously treated with mtx. - the treatment of moderate to severe active ra in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (dmards) or tumour necrosis factor (tnf) antagonists. in these patients, tyenne can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. tocilizumab has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function when given in combination with methotrexate. tyenne is indicated for the treatment of coronavirus disease 2019 (covid-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. tyenne is indicated for the treatment of active systemic juvenile idiopathic arthritis (sjia) in patients 1 year of age and older, who have responded inadequately to previous therapy with nsaids and systemic corticosteroids. tyenne can be given as monotherapy (in case of intolerance to mtx or where treatment with mtx is inappropriate) or in combination with mtx. tyenne in combination with methotrexate (mtx) is indicated for the treatment of juvenile idiopathic polyarthritis (pjia; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with mtx. tyenne can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. tyenne is indicated for the treatment of chimeric antigen receptor (car) t cell-induced severe or life-threatening cytokine release syndrome (crs) in adults and paediatric patients 2 years of age and older. tyenne is indicated for the treatment of giant cell arteritis (gca) in adult patients.

Unia Europejska - polski - EMA (European Medicines Agency)

accord healthcare s.l.u. - Апиксабан - venous thromboembolism; stroke; arthroplasty - Środki przeciwzakrzepowe - prevention of venous thromboembolic events (vte) in adult patients who have undergone elective hip or knee replacement surgery. profilaktyka udaru mózgu i zatorowości systemowej u dorosłych pacjentów z неклапанной migotaniem przedsionków (nvaf), z jednym lub więcej czynników ryzyka, takich jak udar mózgu lub przemijający atak niedokrwienny (tia); wiek ≥ 75 lat; nadciśnienie tętnicze; cukrzyca; objawowa niewydolność serca (klasa nyha ≥ drugi). leczenie zakrzepicy żył głębokich (dvt) i zatorowości płucnej (ТЭЛА) i zapobiegania nawrotom zakrzepicy żył głębokich i ТЭЛА u dorosłych (patrz punkt 4. 4 hemodynamicznie niestabilna ТЭЛА pacjentów). prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (nvaf), with one or more risk factors, such as prior stroke or transient ischaemic attack (tia); age≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (nyha class ≥ ii). leczenie zakrzepicy żył głębokich (dvt) i zatorowości płucnej (ТЭЛА) i zapobiegania nawrotom zakrzepicy żył głębokich i ТЭЛА u dorosłych (patrz punkt 4. 4 hemodynamicznie niestabilna ТЭЛА pacjentów).