Uniunea Europeană - română - EMA (European Medicines Agency)

takeda pharma a/s - alogliptină, benzoat de sodiu, clorhidrat de metformină - diabetul zaharat, tip 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - vipdomet is indicated in the treatment of adult patients aged 18 years and older with type-2 diabetes mellitus:as an adjunct to diet and exercise to improve glycaemic control in adult patients, inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of alogliptin and metformin;in combination with pioglitazone (i. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and pioglitazone;in combination with insulin (i. terapie triplă) ca adjuvant la dietă și exercițiu fizic pentru îmbunătățirea controlului glicemic, la pacienți atunci când insulina la o doză stabilă și metformin în monoterapie nu realizează un control glicemic adecvat.

Uniunea Europeană - română - EMA (European Medicines Agency)

bial portela & companhia s.a. - opicapone - boala parkinson - medicamente anti-parkinson - ontilyv is indicated as adjunctive therapy to preparations of levodopa/ dopa decarboxylase inhibitors (ddci) in adult patients with parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.

Uniunea Europeană - română - EMA (European Medicines Agency)

novartis europharm limited - vildagliptin, clorhidrat de metformină - diabetul zaharat, tip 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - eucreas is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:in patients who are inadequately controlled with metformin hydrochloride alone. in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control.

Uniunea Europeană - română - EMA (European Medicines Agency)

novartis europharm limited - vildagliptin, clorhidrat de metformină - diabetul zaharat, tip 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - icandra is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:in patients who are inadequately controlled with metformin hydrochloride alone. in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4. 4, 4. 5 și 5. 1 pentru datele disponibile pe diferite combinații).

Uniunea Europeană - română - EMA (European Medicines Agency)

takeda pharma a/s - alogliptină, pioglitazona - diabetul zaharat, tip 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - incresync is indicated as a second- or third-line treatment in adult patients aged 18 years and older with type-2 diabetes mellitus: , as an adjunct to diet and exercise to improve glycaemic control in adult patients (particularly overweight patients) inadequately controlled on pioglitazone alone, and for whom metformin is inappropriate due to contraindications or intolerance;, in combination with metformin (i. terapie triplă) ca adjuvant la dietă și exercițiu fizic pentru îmbunătățirea controlului glicemic, la pacienți adulți (în special pacienții supraponderali) controlați inadecvat cu doza maximă tolerată de metformin și pioglitazonă. În plus, incresync poate fi folosit pentru a înlocui formă de comprimate separate de alogliptină și pioglitazonă în acei pacienți adulți cu vârsta de 18 ani și peste cu diabet zaharat de tip 2 zaharat care au fost deja tratați cu combinația asta. după inițierea tratamentului cu incresync, pacienții ar trebui să fie revizuit după trei până la șase luni pentru a evalua caracterul adecvat al răspunsului la tratament (e. reducerea hba1c). la pacienții care nu reușesc să arate un răspuns adecvat, incresync ar trebui să fie întrerupt. În lumina riscurilor potențiale prelungit cu pioglitazonă, medicii ar trebui să confirme la ulterioare rutina de clienți care beneficiază de incresync este menținută (vezi secțiunea 4.

Uniunea Europeană - română - EMA (European Medicines Agency)

viiv healthcare bv - abacavir, lamivudină - infecții cu hiv - antivirals for treatment of hiv infections, combinations, antivirals for systemic use - kivexa este indicată în terapia antiretrovirală pentru tratamentul infecţiei cu virusul imunodeficienţei umane (hiv) la adulţi, adolescenţi şi copii cu o greutate de cel puţin 25 kg. Înainte de inițierea tratamentului cu abacavir, screening-ul pentru transportul de hla-b*5701 ar trebui să fie efectuate în orice hiv-infectate pacient, indiferent de originea rasială. abacavir nu trebuie utilizat la pacienții cunoscuți ca purtători ai alelei hla-b*5701.

Uniunea Europeană - română - EMA (European Medicines Agency)

merck sharp & dohme b.v. - ertugliflozin l-pyroglutamic acid, metformin hydrochloride - diabetul zaharat, tip 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - segluromet is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:in patients not adequately controlled on their maximally tolerated dose of metformin alonein patients on their maximally tolerated doses of metformin in addition to other medicinal products for the treatment of diabetesin patients already being treated with the combination of ertugliflozin and metformin as separate tablets.

Uniunea Europeană - română - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; mesothelioma; colorectal neoplasms - agenți antineoplazici - melanomaopdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older. relative to nivolumab monotherapy, an increase in progression free survival (pfs) and overall survival (os) for the combination of nivolumab with ipilimumab is established only in patients with low tumour pd-l1 expression. adjuvant treatment of melanomaopdivo as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. non-small cell lung cancer (nsclc)opdivo in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising egfr mutation or alk translocation. opdivo as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. malignant pleural mesothelioma (mpm)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. renal cell carcinoma (rcc)opdivo as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults. opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor risk advanced renal cell carcinoma. opdivo in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma. classical hodgkin lymphoma (chl)opdivo as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical hodgkin lymphoma after autologous stem cell transplant (asct) and treatment with brentuximab vedotin. squamous cell cancer of the head and neck (scchn)opdivo as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum based therapy. urothelial carcinomaopdivo as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum containing therapy. adjuvant treatment of urothelial carcinomaopdivo as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (miuc) with tumour cell pd-l1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of miuc. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)opdivo in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy. oesophageal squamous cell carcinoma (oscc)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy. adjuvant treatment of oesophageal or gastro-oesophageal junction cancer (oc or gejc)opdivo as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy. gastric, gastro‑oesophageal junction (gej) or oesophageal adenocarcinomaopdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first‑line treatment of adult patients with her2‑negative advanced or metastatic gastric, gastro‑oesophageal junction or oesophageal adenocarcinoma whose tumours express pd-l1 with a combined positive score (cps) ≥ 5.

Republica Moldova - română - AMDM (Agenţia Medicamentului şi Dispozitivelor Medicale)

alembic pharmaceuticals limited - telmisartanum + hydrochlorothiazidum - comprimate - 40 mg + 12,5 mg

Uniunea Europeană - română - EMA (European Medicines Agency)

nordic group b.v. - tegafur, gimeracil, oteracil - neoplasme de stomac - agenți antineoplazici - teysuno is indicated in adults:- for the treatment of advanced gastric cancer when given in combination with cisplatin (see section 5. - as monotherapy or in combination with oxaliplatin or irinotecan, with or without bevacizumab, for the treatment of patients with metastatic colorectal cancer for whom it is not possible to continue treatment with another fluoropyrimidine due to hand-foot syndrome or cardiovascular toxicity that developed in the adjuvant or metastatic setting.