Sibnayal Evropska unija - slovenščina - EMA (European Medicines Agency)

sibnayal

advicenne s.a. - potassium citrate monohydrated, potassium hydrogen carbonate - acidosis, renal tubular - mineral supplements - sibnayal is indicated for the treatment of distal renal tubular acidosis (drta) in adults, adolescents and children aged one year and older.

Tracleer Evropska unija - slovenščina - EMA (European Medicines Agency)

tracleer

janssen-cilag international n.v.   - bosentan (as monohydrate) - scleroderma, systemic; hypertension, pulmonary - antihipertenzivi, - zdravljenje pljučne arterijske hipertenzije (pah) za izboljšanje telesne zmogljivosti in simptomov pri bolnikih s funkcionalnim razredom iii szo. efficacy has been shown in: , primary (idiopathic and familial) pah;, pah secondary to scleroderma without significant interstitial pulmonary disease;, pah associated with congenital systemic-to-pulmonary shunts and eisenmenger's physiology. nekatere izboljšave so tudi pokazale, pri bolnikih s pah, ki funkcijski razred ii. tracleer je bilo tudi navedeno, da se zmanjša število novih digitalnih razjede pri bolnikih s sistemsko sklerozo in tekoče digitalni razjede bolezni.

Zejula Evropska unija - slovenščina - EMA (European Medicines Agency)

zejula

glaxosmithkline (ireland) limited - niraparib (tosilate monohydrate) - fallopian tube neoplasms; peritoneal neoplasms; ovarian neoplasms - antineoplastična sredstva - 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.

Inrebic Evropska unija - slovenščina - EMA (European Medicines Agency)

inrebic

bristol myers squibb pharma eeig - fedratinib dihydrochloride monohydrate - myeloproliferative disorders; primary myelofibrosis - antineoplastična sredstva - inrebic is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis who are janus associated kinase (jak) inhibitor naïve or have been treated with ruxolitinib.

Lenalidomide Krka d.d. Novo mesto (previously Lenalidomide Krka) Evropska unija - slovenščina - EMA (European Medicines Agency)

lenalidomide krka d.d. novo mesto (previously lenalidomide krka)

krka, d.d., novo mesto  - lenalidomide hydrochloride monohydrate - multiple myeloma; lymphoma, follicular - imunosupresivi - multiple myelomalenalidomide krka d. novo mesto as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka d. novo mesto as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) je indiciran za zdravljenje odraslih bolnikov s predhodno nezdravljenih več plazmocitom, ki niso primerni za presaditev. lenalidomide krka d. novo mesto in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. follicular lymphomalenalidomide krka d. novo mesto in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a). multiple myelomalenalidomide krka d. novo mesto as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka d. novo mesto as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) je indiciran za zdravljenje odraslih bolnikov s predhodno nezdravljenih več plazmocitom, ki niso primerni za presaditev. lenalidomide krka d. novo mesto in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. follicular lymphomalenalidomide krka d. novo mesto in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).

Lenalidomide Krka (previously Lenalidomide Krka d.d. Novo mesto) Evropska unija - slovenščina - EMA (European Medicines Agency)

lenalidomide krka (previously lenalidomide krka d.d. novo mesto)

krka, d.d., novo mesto  - lenalidomide hydrochloride monohydrate - multiple myeloma; myelodysplastic syndromes; lymphoma, follicular; lymphoma, mantle-cell - imunosupresivi - multiple myelomalenalidomide krka as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) je indiciran za zdravljenje odraslih bolnikov s predhodno nezdravljenih več plazmocitom, ki niso primerni za presaditev. lenalidomide krka in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. myelodysplastic syndromeslenalidomide krka as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. mantle cell lymphomalenalidomide krka as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4. 4 in 5. follicular lymphomalenalidomide krka in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a). multiple myelomalenalidomide krka as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) je indiciran za zdravljenje odraslih bolnikov s predhodno nezdravljenih več plazmocitom, ki niso primerni za presaditev. lenalidomide krka in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. myelodysplastic syndromeslenalidomide krka as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. mantle cell lymphomalenalidomide krka as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4. 4 in 5. follicular lymphomalenalidomide krka in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).

Drovelis Evropska unija - slovenščina - EMA (European Medicines Agency)

drovelis

gedeon richter plc. - drospirenone, estetrol monohydrate - contraceptives, oral - spolni hormoni in zdravila genitalni sistem, - oral contraceptive.

Lydisilka Evropska unija - slovenščina - EMA (European Medicines Agency)

lydisilka

estetra sprl - estetrol monohydrate, drospirenone - contraceptives, oral - spolni hormoni in zdravila genitalni sistem, - peroralna kontracepcija. the decision to prescribe lydisilka should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (vte), and how the risk of vte with lydisilka compares with other combined hormonal contraceptives (chcs) (see sections 4. 3 and 4.