Європейський Союз - польська - EMA (European Medicines Agency)

regeneron ireland designated activity company (dac) - cemiplimab - rak, płaskonabłonkowy - Środki przeciwnowotworowe - 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.

Європейський Союз - польська - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - belantamab mafodotin - szpiczak mnogi - Środki przeciwnowotworowe - blenrep is indicated as monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-cd38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

Європейський Союз - польська - EMA (European Medicines Agency)

eli lilly nederland b.v. - tadalafil - nadciśnienie tętnicze, płucne - urologiczne - adultstreatment of pulmonary arterial hypertension (pah) classified as who functional class ii and iii, to improve exercise capacity (see section 5. wykazano skuteczność w idiopatycznym pah (ipah) i w pah związane z kolagenozę. paediatric populationtreatment of paediatric patients aged 2 years and above with pulmonary arterial hypertension (pah) classified as who functional class ii and iii.

Європейський Союз - польська - EMA (European Medicines Agency)

amryt pharmaceuticals dac - dry extract from birch bark (der 5-10 : 1), extraction solvent n-heptane 95% (w/w) - epidermolysis bullosa dystrophica; epidermolysis bullosa, junctional - preparaty do leczenia ran i owrzodzeń - treatment of partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa (eb) in patients 6 months and older.

Європейський Союз - польська - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - maribavir - zakażenia cytomegalowirusem - Środki przeciwwirusowe do użytku ogólnoustrojowego - livtencity is indicated for the treatment of cytomegalovirus (cmv) infection and/or disease that are refractory (with or without resistance) to one or more prior therapies, including ganciclovir, valganciclovir, cidofovir or foscarnet in adult patients who have undergone a haematopoietic stem cell transplant (hsct) or solid organ transplant (sot). należy uwzględnić oficjalne zalecenia dotyczące właściwego stosowania leków przeciwwirusowych.

Європейський Союз - польська - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - niraparib (tosilate monohydrate) - fallopian tube neoplasms; peritoneal neoplasms; ovarian neoplasms - Środki przeciwnowotworowe - 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.

Європейський Союз - польська - EMA (European Medicines Agency)

paion deutschland gmbh - angiotensyna ii octan - hypotension; shock - Środki działające na układ renina-angiotensyna - giapreza jest wskazany do leczenia opornej tętnicze u dorosłych z osadnikiem lub innych dystrybucji uderzeń, które pozostają tętnicze, pomimo odpowiedniej restytucji zakresu i stosowania katecholamin i innych dostępnych вазопрессорной terapii.

Європейський Союз - польська - EMA (European Medicines Agency)

paion deutschland gmbh - remimazolam besilate - Świadoma sedacja - psycholeptyki - remimazolam is indicated in adults for procedural sedation. remimazolam 50 mg is indicated in adults for intravenous induction and maintenance of general anaesthesia.

Європейський Союз - польська - EMA (European Medicines Agency)

idorsia pharmaceuticals deutschland gmbh - daridorexant hydrochloride - zaburzenia inicjacji snu i utrzymania - psycholeptyki - quviviq is indicated for the treatment of adult patients with insomnia characterised by symptoms present for at least 3 months and considerable impact on daytime functioning.

Європейський Союз - польська - EMA (European Medicines Agency)

sfl pharmaceuticals deutschland gmbh - nyxthracis - anthrax - odporne surowicy i immunoglobuliny, - obiltoxaximab sfl is indicated in combination with appropriate antibacterial drugs in all age groups for treatment of inhalational anthrax due to bacillus anthracis (see section 5. obiltoxaximab sfl is indicated in all age groups for post-exposure prophylaxis of inhalational anthrax when alternative therapies are not appropriate or are not available (see section 5.