Den Europæiske Union - dansk - EMA (European Medicines Agency)

pfizer europe ma eeig  - filgrastim - neutropenia; hematopoietic stem cell transplantation; cancer - immunostimulants, - filgrastim er indiceret til reduktion i varigheden af neutropeni og forekomst af febril neutropeni hos patienter behandlet med etablerede cytotoksisk kemoterapi for malignitet (med undtagelse af kronisk myeloid leukæmi og myelodysplastisk syndromer) og for reduktionen i varigheden af neutropeni i patienter gennemgår myeloablative behandling efterfulgt af knoglemarvstransplantation, anses for at være øget risiko for langvarig svær neutropeni. sikkerheden og effekten af ​​filgrastim er ens hos voksne og børn, der får cytotoksisk kemoterapi. filgrastim er indiceret til anvendelse af perifert blod progenitorceller (pbpcs). hos patienter, børn eller voksne, med alvorlige medfødte, cyklisk, eller idiopatisk neutropeni med en absolut neutrophil count (anc) ≤0. 5 x 109/l, og en historie af alvorlige eller tilbagevendende infektioner, langsigtet forvaltning af filgrastim er angivet til at øge neutrofile tæller, og for at mindske hyppigheden og varigheden af infektionen-relaterede begivenheder. filgrastim er indiceret til behandling af vedvarende neutropeni (anc ≤1. 0 x 109 / l) hos patienter med avanceret hiv-infektion for at reducere risikoen for bakterielle infektioner, når andre muligheder for at håndtere neutropeni er upassende.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

abbvie deutschland gmbh & co. kg - dalbavancin hydrochloride - soft tissue infections; skin diseases, bacterial - antibakterielle midler til systemisk brug, - behandling af akutte bakterielle hud- og hudstrukturinfektioner (absssi) hos voksne.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

bayer ag - rivaroxaban - arthroplasty, replacement; venous thromboembolism - antitrombotiske midler - xarelto, co-gives sammen med acetylsalicylsyre (asa) alene eller sammen med asa plus clopidogrel eller ticlopidin, der er indiceret til forebyggelse af atherothrombotic hændelser hos voksne patienter efter en akut koronar syndrom (acs) med forhøjet kardiale biomarkører. xarelto, co-administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (cad) or symptomatic peripheral artery disease (pad) at high risk of ischaemic events. forebyggelse af venøs tromboembolisme (vte) hos voksne patienter, der gennemgår valgfri hofte- eller knæskifteoperation. behandling af dyb venøs trombose (dvt) og lungeemboli (pe), og forebyggelse af recidiverende dvt og pe i voksne. adultsprevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

abbvie deutschland gmbh co. kg - glecaprevir, pibrentasvir - hepatitis c kronisk - antivirale midler til systemisk anvendelse - maviret is indicated for the treatment of chronic hepatitis c virus (hcv) infection in adults and children aged 3 years and older. maviret coated granules is indicated for the treatment of chronic hepatitis c virus (hcv) infection in children 3 years and older.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

pharmaand gmbh - rucaparib camsylate - Æggestokkene neoplasmer - antineoplastiske midler - rubraca is indicated as monotherapy for the maintenance treatment of adult patients with advanced (figo stages iii and iv) high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. rubraca er angivet som monoterapi til vedligeholdelse behandling af voksne patienter med platin-følsomme gået high-grade epitelial ovariecancer, æggeleder, eller primær peritoneal cancer, der er i reaktion (hel eller delvis) til platin-baseret kemoterapi.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

mundipharma corporation (ireland) limited - pegfilgrastim - neutropeni - immunostimulants, - reduktion i varigheden af neutropeni og forekomst af febril neutropeni hos voksne patienter behandlet med cytotoksisk kemoterapi for malignitet (med undtagelse af kronisk myeloid leukæmi og myelodysplastisk syndromer).

Den Europæiske Union - dansk - EMA (European Medicines Agency)

bayer ag - darolutamide - prostatic neoplasmer, kastration-resistent - endokrine terapi - nubeqa is indicated for the treatment of adult men with- non metastatic castration resistant prostate cancer (nmcrpc) who are at high risk of developing metastatic disease (see section 5. - metastatic hormone sensitive prostate cancer (mhspc) in combination with docetaxel and androgen deprivation therapy (see section 5.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

roche registration gmbh - pertuzumab, trastuzumab - bryst neoplasmer - antineoplastiske midler - early breast cancer (ebc)phesgo is indicated for use in combination with chemotherapy in:the neoadjuvant treatment of adult patients with her2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrencethe adjuvant treatment of adult patients with her2-positive early breast cancer at high risk of recurrencemetastatic breast cancer (mbc)phesgo is indicated for use in combination with docetaxel in adult patients with her2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-her2 therapy or chemotherapy for their metastatic disease.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

astrazeneca ab - formoterol fumarate dihydrate, glycopyrronium bromide, budesonide - pulmonal sygdom, kronisk obstruktiv - medicin for obstruktiv sygdomme, - trixeo aerosphere is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (copd) who are not adequately treated by a combination of an inhaled corticosteroid and a long acting beta2 agonist or combination of a long-acting beta2 agonist and a long acting muscarinic antagonist.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

bayer ag - vericiguat - hjertefejl - hjertetapi - treatment of symptomatic chronic heart failure.