Polonia - poloneză - URPL (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych)

hameln pharma gmbh - clindamycini phosphas - roztwór do wstrzykiwań lub infuzji - 150 mg/ml

Polonia - poloneză - URPL (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych)

zentiva, k.s. - dimetindeni maleas - krople doustne, roztwór - 1 mg/ml

Uniunea Europeană - poloneză - EMA (European Medicines Agency)

sandoz pharmaceuticals d.d. - kwas zoledronowy - osteoporosis; osteitis deformans; osteoporosis, postmenopausal - leki stosowane w leczeniu chorób kości - treatment of osteoporosis: , in post-menopausal women;, in men; , at increased risk of fracture, including those with a recent low-trauma hip fracture. leczenie osteoporozy, związanego z długim systemowych glikokortykosteroidów terapii u kobiet po menopauzie i u mężczyzn ze zwiększonym ryzykiem złamań. leczenie choroby pageta kości.

Uniunea Europeană - poloneză - EMA (European Medicines Agency)

takeda pharma a/s - Брентуксимаб ведотин - lymphoma, non-hodgkin; hodgkin disease - Środki przeciwnowotworowe - hodgkin lymphomaadcetris is indicated for adult patients with previously untreated cd30+ stage iv hodgkin lymphoma (hl) in combination with doxorubicin, vinblastine and dacarbazine (avd). adcetris is indicated for the treatment of adult patients with cd30+ hl at increased risk of relapse or progression following autologous stem cell transplant (asct). Адцетриса jest wskazany do leczenia dorosłych pacjentów z nawracającą lub oporną na leczenie cd30+ chłoniak hodgkina (ЛХ):po terapii, orfollowing co najmniej dwóch przed terapią po terapii lub мультиагентной chemioterapii-to nie jest opcja leczenia . systemowa komórek gwiaździaka lymphomaadcetris w połączeniu z cyklofosfamid, doksorubicyna i prednizon (chp) jest wskazany dla osób dorosłych pacjentów wcześniej nie leczonych leczenia systemowego anaplastic wielki komórki lymphoma (salcl). adcetris is indicated for the treatment of adult patients with relapsed or refractory salcl. cutaneous t cell lymphomaadcetris is indicated for the treatment of adult patients with cd30+ cutaneous t cell lymphoma (ctcl) after at least 1 prior systemic therapy.

Uniunea Europeană - poloneză - EMA (European Medicines Agency)

teva pharma b.v. - kwas ibandronowy - breast neoplasms; neoplasm metastasis; fractures, bone; osteoporosis, postmenopausal - leki stosowane w leczeniu chorób kości - Ибандронатом 50mgibandronic kwasu teva jest wskazany do zapobiegania szkieletowych zdarzeń (złamań patologicznych, powikłania kostne wymagające napromieniania terapii lub operacji) u pacjentów z rakiem piersi i przerzutami do kości . ibandronic acid 150mgtreatment of osteoporosis in postmenopausal women at increased risk of fracture. zmniejszenie ryzyka złamań kręgów wykazano skuteczność na złamań szyjki kości udowej nie jest zainstalowany.

Uniunea Europeană - poloneză - EMA (European Medicines Agency)

merck sharp & dohme b.v. - Пембролизумаб - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; endometrial neoplasms - Środki przeciwnowotworowe - melanomakeytruda as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma. keytruda as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with stage iib, iic, or with stage iii melanoma and lymph node involvement who have undergone complete resection. non small cell lung carcinoma (nsclc)keytruda as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum based chemotherapy (for selection criteria, see section 5. keytruda as monotherapy is indicated for the first line treatment of metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 50% tumour proportion score (tps) with no egfr or alk positive tumour mutations. keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non squamous non small cell lung carcinoma in adults whose tumours have no egfr or alk positive mutations. keytruda, in combination with carboplatin and either paclitaxel or nab paclitaxel, is indicated for the first line treatment of metastatic squamous non small cell lung carcinoma in adults. keytruda  as monotherapy is indicated for the treatment of locally advanced or metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 1% tps and who have received at least one prior chemotherapy regimen. pacjenci z egfr lub АЛК pozytywnej guza mutacje muszą także otrzymywali таргетную terapię aż do uzyskania Кейтруда. classical hodgkin lymphoma (chl)keytruda as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical hodgkin lymphoma who have failed autologous stem cell transplant (asct) or following at least two prior therapies when asct is not a treatment option. urothelial carcinomakeytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum containing chemotherapy. keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin containing chemotherapy and whose tumours express pd l1 with a combined positive score (cps) ≥ 10. head and neck squamous cell carcinoma (hnscc)keytruda, as monotherapy or in combination with platinum and 5 fluorouracil (5 fu) chemotherapy, is indicated for the first line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a cps ≥ 1. keytruda as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a ≥ 50% tps and progressing on or after platinum containing chemotherapy. renal cell carcinoma (rcc)keytruda, in combination with axitinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults. keytruda  as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (for selection criteria, please see section 5. microsatellite instability high (msi-h) or mismatch repair deficient (dmmr) cancerscolorectal cancer (crc)keytruda as monotherapy is indicated for theadults with msi-h or dmmr colorectal cancer in the following settings:first line treatment of metastatic microsatellite instability high (msi h) or mismatch repair deficient (dmmr) colorectal cancer in adults;treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine based combination therapy.  non-colorectal cancerskeytruda as monotherapy is indicated for the treatment of the following msi h or dmmr tumours in adults with:advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation;unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. oesophageal carcinomakeytruda, in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus or her-2 negative gastroesophageal junction adenocarcinoma, in adults whose tumours express pd l1 with a cps ≥ 10. triple negative breast cancer (tnbc)keytruda, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence. keytruda, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express pd l1 with a cps ≥ 10 and who have not received prior chemotherapy for metastatic disease. endometrial carcinoma (ec)keytruda, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. cervical cancerkeytruda, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express pd l1 with a cps ≥ 1. gastric or gastro-oesophageal junction (gej) adenocarcinomakeytruda, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic her2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express pd-l1 with a cps ≥ 1.

Uniunea Europeană - poloneză - EMA (European Medicines Agency)

pharmaand gmbh - peginterferon alfa-2a - hepatitis c, chronic; hepatitis b, chronic - Иммуностимуляторы, - chronic hepatitis b adult patients pegasys is indicated for the treatment of hepatitis b envelope antigen (hbeag)-positive or hbeag-negative chronic hepatitis b (chb) in adult patients with compensated liver disease and evidence of viral replication, increased alanine aminotransferase (alt) and histologically verified liver inflammation and/or fibrosis (see sections 4. 4 i 5. paediatric patients 3 years of age and older pegasys is indicated for the treatment of hbeag-positive chb in non-cirrhotic children and adolescents 3 years of age and older with evidence of viral replication and persistently elevated serum alt levels. z szacunkiem do rozwiązania rozpocząć leczenie dzieci chorych patrz rozdziały 4. 2, 4. 4 i 5. chronic hepatitis c adult patients pegasys is indicated in combination with other medicinal products, for the treatment of chronic hepatitis c (chc) in patients with compensated liver disease (see sections 4. 2, 4. 4 i 5. wirus zapalenia wątroby typu c (hcv) genotypu danego rodzaju działalności, patrz rozdziały 4. 2 i 5. paediatric patients 5 years of age and older pegasys in combination with ribavirin is indicated for the treatment of chc in treatment-naïve children and adolescents 5 years of age and older who are positive for serum hcv-rna. przy rozwiązywaniu rozpocząć leczenie w dzieciństwie, ważne jest, aby wziąć pod uwagę zahamowanie wzrostu, wywołane połączenie terapii. odwracalność hamowanie wzrostu pewności. decyzja musi być podjęta indywidualnie (patrz punkt 4.

Polonia - poloneză - URPL (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych)

actavis group ptc ehf. - bendamustini hydrochloridum - proszek do sporządzania koncentratu roztworu do infuzji - 2,5 mg/ml

Polonia - poloneză - URPL (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych)

pharmaswiss Česká republika s.r.o. - cetirizini dihydrochloridum - tabletki powlekane - 10 mg

Polonia - poloneză - URPL (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych)

bausch health ireland ltd. - octenidini dihydrochloridum + phenoxyethanol - aerozol na skórę, roztwór - (1 mg + 20 mg)/ml