Europos Sąjunga - lenkų - EMA (European Medicines Agency)

mylan ireland limited - octan abirateronu - nowotwory stercza - endocrine therapy, other hormone antagonists and related agents - abiraterone mylan is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt). the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated. the treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

Europos Sąjunga - lenkų - EMA (European Medicines Agency)

biogen netherlands b.v. - diroximel fumarate (biib098) - stwardnienie rozsiane, Рецидивно-znika - leki immunosupresyjne - vumerity is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (see section 5. 1 for important information on the populations for which efficacy has been established).

Europos Sąjunga - lenkų - EMA (European Medicines Agency)

deciphera pharmaceuticals (netherlands) b.v. - ripretinib - guzy stromal żołądkowo-jelitowe - Środki przeciwnowotworowe - qinlock is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumour (gist) who have received prior treatment with three or more kinase inhibitors, including imatinib.

Europos Sąjunga - lenkų - EMA (European Medicines Agency)

siga technologies netherlands b.v. - tecovirimat - poxviridae infections; cowpox; monkeypox; vaccinia; smallpox - Środki przeciwwirusowe do użytku ogólnoustrojowego - tecovirimat siga is indicated for the treatment of the following viral infections in adults and children with body weight at least 13 kg:- smallpox- monkeypox- cowpoxtecovirimat siga is also indicated to treat complications due to replication of vaccinia virus following vaccination against smallpox in adults and children with body weight at least 13 kg (see sections 4. 4 i 5. tecovirimat siga should be used in accordance with official recommendations.

Lenkija - lenkų - URPL (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych)

solinea sp. z o.o. sp.k. - chlorhexidini dihydrochloridum + benzocainum - tabletki do ssania - 5 mg + 1,5 mg

Europos Sąjunga - lenkų - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - voclosporin - lupus nephritis - leki immunosupresyjne - lupkynis is indicated in combination with mycophenolate mofetil for the treatment of adult patients with active class iii, iv or v (including mixed class iii/v and iv/v) lupus nephritis (ln).

Europos Sąjunga - lenkų - EMA (European Medicines Agency)

alnylam netherlands b.v. - vutrisiran sodium - amyloid neuropathies, familial - inne leki na układ nerwowy - treatment of hereditary transthyretin-mediated amyloidosis (hattr amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.

Europos Sąjunga - lenkų - EMA (European Medicines Agency)

taiho pharma netherlands b.v. - futibatinib - cholangiocarcinoma - środki agenci - lytgobi monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (fgfr2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

Europos Sąjunga - lenkų - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a.  - respiratory syncytial virus recombinant glycoprotein f stabilised in the pre-fusion conformation (rsvpref3) produced in chinese hamster ovary (cho) cells by recombinant dna technology - infekcje wirusem oddechowym - szczepionki - arexvy is indicated for active immunisation for the prevention of lower respiratory tract disease (lrtd) caused by respiratory syncytial virus in adults 60 years of age and older. stosowanie tej szczepionki powinno odbywać się zgodnie z oficjalnymi zaleceniami.

Europos Sąjunga - lenkų - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - cedazuridine, decitabine - białaczka, szpikowe - Środki przeciwnowotworowe - inaqovi is indicated as monotherapy for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (aml) who are ineligible for standard induction chemotherapy.