Euroopa Liit - poola - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - tezacaftor, ivacaftor - zwłóknienie torbielowate - inne produkty układu oddechowego - symkevi is indicated in a combination regimen with ivacaftor tablets for the treatment of patients with cystic fibrosis (cf) aged 6 years and older who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene: p67l, r117c, l206w, r352q, a455e, d579g, 711+3a→g, s945l, s977f, r1070w, d1152h, 2789+5g→a, 3272 26a→g, and 3849+10kbc→t.

Euroopa Liit - poola - 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.

Euroopa Liit - poola - 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.

Euroopa Liit - poola - EMA (European Medicines Agency)

mylan pharmaceuticals limited - teriflunomide - stwardnienie rozsiane, Рецидивно-znika - leki immunosupresyjne - teriflunomide mylan is indicated for the treatment of adult patients and paediatric patients aged 10 years and older (body weight > 40 kg) with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 of the smpc for important information on the population for which efficacy has been established).

Euroopa Liit - poola - 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.

Euroopa Liit - poola - 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.

Euroopa Liit - poola - 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.

Euroopa Liit - poola - 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.

Poola - poola - URPL (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych)

fortis pharmaceuticals sp. z o.o. s.k. - ksylometazoliny chlorowodorek - aerozol do nosa, roztwór - 1 mg/ml

Euroopa Liit - poola - 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.