Eiropas Savienība - poļu - EMA (European Medicines Agency)

immunocore ireland limited - tebentafusp - uveal neoplasms - Środki przeciwnowotworowe - kimmtrak is indicated as monotherapy for the treatment of human leukocyte antigen (hla)-a*02:01-positive adult patients with unresectable or metastatic uveal melanoma.

Eiropas Savienība - poļu - EMA (European Medicines Agency)

eli lilly nederland b.v. - tirzepatide - diabetes mellitus, type 2 - leki stosowane w cukrzycy - mounjaro is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise- as monotherapy when metformin is considered inappropriate due to intolerance or contraindications- in addition to other medicinal products for the treatment of diabetes. for study results with respect to combinations, effects on glycaemic control and the populations studied, see sections 4. 4, 4. 5 i 5.

Eiropas Savienība - poļu - EMA (European Medicines Agency)

janssen-cilag international n.v. - teclistamab - szpiczak mnogi - Środki przeciwnowotworowe - tecvayli is indicated as monotherapy 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.

Eiropas Savienība - poļu - EMA (European Medicines Agency)

merck europe b.v. - tepotinib hydrochloride monohydrate - rak, niedrobnokomórkowe płuca - Środki przeciwnowotworowe - tepmetko as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (nsclc) harbouring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (metex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

Eiropas Savienība - poļu - EMA (European Medicines Agency)

mylan ire healthcare limited - pretomanid - gruźlica, odporna na wiele leków - antybakterobakterie - dovprela is indicated in combination with bedaquiline and linezolid, in adults, for the treatment of pulmonary extensively drug resistant (xdr), or treatment-intolerant or nonresponsive multidrug-resistant (mdr) tuberculosis (tb). należy uwzględnić oficjalne zalecenia dotyczące właściwego stosowania antybiotyków agentów.

Eiropas Savienība - poļu - EMA (European Medicines Agency)

pierre fabre medicament - encorafenib - melanoma; colorectal neoplasms - Środki przeciwnowotworowe - encorafenib is indicated:in combination with binimetinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600 mutationin combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (crc) with a braf v600e mutation, who have received prior systemic therapy.

Eiropas Savienība - poļu - EMA (European Medicines Agency)

amgen europe b.v. - blinatumomab - prekursor komórkowy limfoblastyczny białaczka-chłoniak - Środki przeciwnowotworowe - blincyto is indicated as monotherapy for the treatment of adults with cd19 positive relapsed or refractory b precursor acute lymphoblastic leukaemia (all). patients with philadelphia chromosome positive b-precursor all should have failed treatment with at least 2 tyrosine kinase inhibitors (tkis) and have no alternative treatment options. blincyto is indicated as monotherapy for the treatment of adults with philadelphia chromosome negative cd19 positive b-precursor all in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with philadelphia chromosome negative cd19 positive b precursor all which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed philadelphia chromosome negative cd19 positive b-precursor all as part of the consolidation therapy (see section 4.

Eiropas Savienība - poļu - EMA (European Medicines Agency)

medac gesellschaft fuer klinische spezialpraeparate mbh - asparaginaza - prekursor komórkowy limfoblastyczny białaczka-chłoniak - Środki przeciwnowotworowe - preparat spectrila jest wskazany jako składnik przeciwnowotworowej terapii skojarzonej w leczeniu ostrej białaczki limfoblastycznej (all) u dzieci w wieku od urodzenia do 18 lat i dorosłych.

Polija - poļu - URPL (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych)

sandoz gmbh - orlistat - kapsułki twarde - 120 mg

Eiropas Savienība - poļu - EMA (European Medicines Agency)

roche registration gmbh  - entrectinib - cancer; carcinoma, non-small-cell lung - Środki przeciwnowotworowe - rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (ntrk) gene fusion,who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, andwho have not received a prior ntrk inhibitorwho have no satisfactory treatment options. rozlytrek as monotherapy is indicated for the treatment of adult patients with ros1 positive, advanced non small cell lung cancer (nsclc) not previously treated with ros1 inhibitors.