Intrinsa Uniunea Europeană - cehă - EMA (European Medicines Agency)

intrinsa

warner chilcott uk ltd. - testosteron - sexuální dysfunkce, psychologické - pohlavní hormony a modulátory genitálního systému, - intrinsa je indikován k léčbě poruchy hypoactive sexuální touha (hsdd) vzájemně oophorectomised a samotnými (chirurgicky indukovaná menopauza) žen užívajících konkomitantní estrogeny.

Livensa Uniunea Europeană - cehă - EMA (European Medicines Agency)

livensa

warner chilcott  deutschland gmbh - testosteron - sexuální dysfunkce, psychologické - pohlavní hormony a modulátory genitálního systému, - livensa je indikován k léčbě poruchy hypoactive sexuální touha (hsdd) vzájemně oophorectomised a samotnými (chirurgicky indukovaná menopauza) žen užívajících konkomitantní estrogeny.

Zeffix Uniunea Europeană - cehă - EMA (European Medicines Agency)

zeffix

glaxosmithkline (ireland) limited - lamivudin - hepatitida b, chronická - antivirotika pro systémové použití - zeffix is indicated for the treatment of chronic hepatitis b in adults with: , compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (alt) levels and histological evidence of active liver inflammation and / or fibrosis. zahájení lamivudin léčba by měla být zvažováno pouze v případě použití alternativní antivirotikum s vyšší genetickou bariérou není dostupné nebo vhodné;, dekompenzovaným onemocněním jater v kombinaci s druhým agent bez zkřížené rezistence na lamivudin.

Pegasys Uniunea Europeană - cehă - EMA (European Medicines Agency)

pegasys

pharmaand gmbh - peginterferon alfa-2a - hepatitis c, chronic; hepatitis b, chronic - imunostimulancia, - 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 a 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. s ohledem na rozhodnutí o zahájení léčby u dětských pacientů viz body 4. 2, 4. 4 a 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 a 5. pro virus hepatitidy c (hcv) genotypu konkrétní činnosti, viz bod 4. 2 a 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. při rozhodování o zahájení léčby v dětství, je důležité zvážit, inhibice růstu vyvolané kombinací terapie. reverzibilita inhibice růstu je nejistá. rozhodnutí o léčbě by mělo být prováděno případ od případu (viz bod 4.

Bimzelx Uniunea Europeană - cehă - EMA (European Medicines Agency)

bimzelx

ucb pharma s.a.   - bimekizumab - psoriáza - imunosupresiva - plaque psoriasisbimzelx is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. psoriatic arthritisbimzelx, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (dmards). axial spondyloarthritisnon-radiographic axial spondyloarthritis (nr-axspa)bimzelx is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or magnetic resonance imaging (mri) who have responded inadequately or are intolerant to non-steroidal anti-inflammatory drugs (nsaids). ankylosing spondylitis (as, radiographic axial spondyloarthritis)bimzelx is indicated for the treatment of adults with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy.

Ciambra Uniunea Europeană - cehă - EMA (European Medicines Agency)

ciambra

menarini international operations luxembourg s.a. - pemetrexed disodný hemipentahydrát - carcinoma, non-small-cell lung; mesothelioma - antineoplastická činidla - malignant pleural mesothelioma ciambra in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. non-small cell lung cancer ciambra in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. ciambra je indikován jako monoterapie k udržovací léčbě lokálně pokročilým nebo metastazujícím nemalobuněčným karcinomem plic jiného, než predominantně z dlaždicových buněk u pacientů, jejichž onemocnění nepostoupila bezprostředně po chemoterapii na bázi platiny. ciambra je indikován jako monoterapie pro druhou linii léčby pacientů s lokálně pokročilým nebo metastazujícím nemalobuněčným karcinomem plic jiného, než predominantně z dlaždicových buněk.

Pemetrexed Pfizer (previously Pemetrexed Hospira) Uniunea Europeană - cehă - EMA (European Medicines Agency)

pemetrexed pfizer (previously pemetrexed hospira)

pfizer europe ma eeig - pemetrexed disodium, pemetrexed disodium hemipentahydrate - carcinoma, non-small-cell lung; mesothelioma - antineoplastická činidla - malignant pleural mesotheliomapemetrexed pfizer in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. non-small cell lung cancerpemetrexed pfizer in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. pemetrexed pfizer is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. pemetrexed pfizer is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.

Pemetrexed Baxter Uniunea Europeană - cehă - EMA (European Medicines Agency)

pemetrexed baxter

baxter holding b.v. - pemetrexed disodium heptahydrate - carcinoma, non-small-cell lung; mesothelioma - antineoplastická činidla - malignant pleural mesotheliomapemetrexed baxter in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. non-small cell lung cancerpemetrexed baxter in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5. pemetrexed baxter is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy (see section 5. pemetrexed baxter is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.