Avrupa Birliği - Lehçe - EMA (European Medicines Agency)

mylan pharmaceuticals limited - anagrelide chlorowodorek - trombocytemia, essential - Środki przeciwnowotworowe - anagrelide jest wskazany w celu zmniejszenia podwyższonego poziomu płytek krwi, przy znacznej thrombocythaemia ryzyka (t) pacjentów, którzy nie tolerują ich bieżącej terapii lub u których podwyższony poziom płytek krwi nie spadnie do akceptowalnego poziomu ich obecnej terapii. an at-risk patientan at-risk essential thrombocythaemia patient is defined by one or more of the following features:>60 years of age ora platelet count >1,000 x 10⁹/l ora history of thrombo-haemorrhagic events.

Avrupa Birliği - Lehçe - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - ozanimod chlorowodorek - multiple sclerosis, relapsing-remitting; colitis, ulcerative - leki immunosupresyjne - multiple sclerosiszeposia is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (rrms) with active disease as defined by clinical or imaging features. ulcerative colitiszeposia is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (uc) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.

Avrupa Birliği - Lehçe - EMA (European Medicines Agency)

accord healthcare s.l.u. - trastuzumab - breast neoplasms; stomach neoplasms - Środki przeciwnowotworowe - breast cancermetastatic breast cancer zercepac is indicated for the treatment of adult patients with her2 positive metastatic breast cancer (mbc):as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. do chemioterapii powinny być zawarte co najmniej антрациклина i таксана, jeśli pacjenci nie nadają się do tych procedur. hormon-receptor-pozytywnych pacjentów również musi być terapii hormonalnej, jeśli pacjenci nie nadają się do tych procedur.                      in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable. w połączeniu z docetakselem w leczeniu pacjentów, którzy nie otrzymywali chemioterapii w rozsiana choroba. w połączeniu z inhibitorem aromatazy w leczeniu pacjentów w menopauzie z hormon-receptor pozytywne rozrzadu, nie wcześniej otrzymujących trastuzumab. early breast cancer zercepac is indicated for the treatment of adult patients with her2 positive early breast cancer (ebc). po operacji, chemioterapii (neoadiuwantowej lub uzupełniające) i radioterapii (jeśli dotyczy). po chemioterapii adjuwantowej z doksorubicyną i cyklofosfamidem, w połączeniu z mzios lub docetaxel. w połączeniu z adjuwantowej chemioterapii składającej się z docetaksela i carboplatina. in combination with neoadjuvant chemotherapy followed by adjuvant zercepac therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter. zercepac should only be used in patients with metastatic or early breast cancer whose tumours have either her2 overexpression or her2 gene amplification as determined by an accurate and validated assay. metastatic gastric cancer zercepac in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with her2 positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease. zercepac should only be used in patients with metastatic gastric cancer (mgc) whose tumours have her2 overexpression as defined by ihc2+ and a confirmatory sish or fish result, or by an ihc 3+ result. należy użyć dokładne i sprawdzone metody analizy .

Avrupa Birliği - Lehçe - EMA (European Medicines Agency)

novartis ireland ltd - ofatumumab - stwardnienie rozsiane, Рецидивно-znika - immunosuppressant - kesimpta is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (rms) with active disease defined by clinical or imaging features (see section 5.

Avrupa Birliği - Lehçe - EMA (European Medicines Agency)

janssen-cilag international n.v.    - ponesimod - stwardnienie rozsiane, Рецидивно-znika - leki immunosupresyjne - ponvory is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (rms) with active disease defined by clinical or imaging features.

Avrupa Birliği - Lehçe - EMA (European Medicines Agency)

mylan ireland limited - fingolimod jest chlorowodorek - stwardnienie rozsiane, Рецидивно-znika - leki immunosupresyjne - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 i 5. 1) or patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

Avrupa Birliği - Lehçe - EMA (European Medicines Agency)

neuraxpharm pharmaceuticals s.l. - ublituximab - multiple sclerosis, relapsing-remitting; multiple sclerosis - leki immunosupresyjne - briumvi is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (rms) with active disease defined by clinical or imaging features.

Avrupa Birliği - Lehçe - EMA (European Medicines Agency)

sandoz gmbh - natalizumab - multiple sclerosis, relapsing-remitting; multiple sclerosis - leki immunosupresyjne - tyruko is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis (rrms) for the following patient groups: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4. 4 i 5. 1), or, patients with rapidly evolving severe rrms defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain magnetic resonance imaging (mri) or a significant increase in t2 lesion load as compared to a previous recent mri.