Den europeiske union - rumensk - EMA (European Medicines Agency)

janssen-cilag international n.v.   - bosentan (as monohydrate) - scleroderma, systemic; hypertension, pulmonary - antihipertensive, - tratamentul hipertensiunii arteriale pulmonare (hap) pentru îmbunătățirea capacității de efort și a simptomelor la pacienții cu clasa funcțională iii a oms. 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. unele îmbunătățiri au fost, de asemenea, indicat la pacienții cu hap clasa funcțională oms ii. tracleer este indicat, de asemenea, pentru a reduce numărul de ulcere digitale noi la pacienții cu scleroză sistemică și ulcer digital evolutiv.

Den europeiske union - rumensk - EMA (European Medicines Agency)

teva pharma b.v. - budesonide, formoterol fumarate dihydrate - pulmonary disease, chronic obstructive; asthma - medicamente pentru afecțiuni obstructive ale căilor respiratorii, - vylaer spiromax este indicat la adulţi 18 ani şi mai în vârstă decât. asthmavylaer spiromax este indicat în tratamentul regulat al astmului bronșic, în cazul în care utilizați o combinație (corticosteroizi inhalatori și durată lungă de acțiune β2 adrenergic agonist) este necesar:la pacienții care nu sunt controlate în mod adecvat cu corticosteroizi inhalatori și "necesar" inhalatori cu acțiune scurtă β2 agoniști adrenergici. orin pacienții deja controlate în mod adecvat pe ambele corticosteroizi inhalatori și durată lungă de acțiune β2 agoniști adrenergici. copdsymptomatic tratamentul pacienților cu bpoc în formă severă (fev1 < 50% prezis normală) și cu istoric de exacerbări repetate, care au simptome semnificative, în ciuda regulate de terapie cu durată lungă de acțiune bronhodilatatoare.

Den europeiske union - rumensk - EMA (European Medicines Agency)

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

Den europeiske union - rumensk - EMA (European Medicines Agency)

accord healthcare s.l.u. - buprenorphine hydrochloride, naloxone hydrochloride dihydrate - tulburări legate de opioide - alte medicamente pentru sistemul nervos - tratamentul de substituție pentru dependența de droguri opioide, în cadrul unui tratament medical, social și psihologic. intenția componentei naloxone este de a descuraja utilizarea abuzivă intravenoasă. tratamentul este destinat utilizării la adulți și adolescenți cu vârsta peste 15 ani care au fost de acord să fie tratați pentru dependență.

Den europeiske union - rumensk - EMA (European Medicines Agency)

chiesi farmaceutici s.p.a. - formoterol fumarate dihydrate, glycopyrronium, beclometasone dipropionate - boala pulmonară, obstructivă cronică - medicamente pentru afecțiuni obstructive ale căilor respiratorii, - tratamentul de întreţinere la pacienţii adulţi cu moderată până la severă pulmonare obstructive cronice (bpoc), care nu sunt tratate în mod corespunzător de o combinaţie de un corticosteroizi inhalatori şi o acţiune prelungită beta2-agonist (pentru efecte pe controlul simptomelor şi prevenirea de exacerbari in sectiunea 5.

Moldova - rumensk - AMDM (Agenţia Medicamentului şi Dispozitivelor Medicale)

biofarm s.a. - paracetamolum + pseudoephedrinum + dextromethorphanum - capsule moi - 250 mg/30 mg/10 mg

Den europeiske union - rumensk - EMA (European Medicines Agency)

astrazeneca ab - formoterol fumarate dihydrate, glycopyrronium bromide, budesonide - boala pulmonară, obstructivă cronică - medicamente pentru afecțiuni obstructive ale căilor respiratorii, - 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 europeiske union - rumensk - EMA (European Medicines Agency)

bristol myers squibb pharma eeig - fedratinib dihydrochloride monohydrate - myeloproliferative disorders; primary myelofibrosis - agenți antineoplazici - 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.

Den europeiske union - rumensk - EMA (European Medicines Agency)

krka, d.d., novo mesto  - lenalidomide hydrochloride monohydrate - multiple myeloma; lymphoma, follicular - imunosupresoare - 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) este indicat pentru tratamentul pacienților adulți cu mielom multiplu netratați anterior, care nu sunt eligibili pentru transplant. 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) este indicat pentru tratamentul pacienților adulți cu mielom multiplu netratați anterior, care nu sunt eligibili pentru transplant. 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).

Den europeiske union - rumensk - EMA (European Medicines Agency)

krka, d.d., novo mesto  - lenalidomide hydrochloride monohydrate - multiple myeloma; myelodysplastic syndromes; lymphoma, follicular; lymphoma, mantle-cell - imunosupresoare - 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) este indicat pentru tratamentul pacienților adulți cu mielom multiplu netratați anterior, care nu sunt eligibili pentru transplant. 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 și 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) este indicat pentru tratamentul pacienților adulți cu mielom multiplu netratați anterior, care nu sunt eligibili pentru transplant. 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 și 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).