Evropska unija - romunščina - EMA (European Medicines Agency)

merial s.a.s.  - gripal inactivat-un virus, porcine - immunologicals - porci - imunizarea activă a porcilor începând de la vârsta de 56 de zile, începând inclusiv scroafele gestante împotriva gripei porcine cauzată de subtipurile h1n1, h3n2 și h1n2 pentru a reduce semnele clinice și virale pulmonare sarcină după infecție. debutul imunității: 7 zile după vaccinarea primară. durata imunității: 4 luni de la porcine vaccinate între vârsta de 56 de ani și 96 de zile și de 6 luni de la porcine vaccinate pentru prima dată la 96 de zile și de mai sus. imunizarea activă a scroafelor gestante după ce a terminat de imunizare primară prin administrarea unei doze unice de 14 zile înainte de fătare pentru a dezvolta de înaltă colostral imunitate care oferă protecție clinică de purcei pentru cel puțin 33 de zile după naștere.

Evropska unija - romunščina - EMA (European Medicines Agency)

ceva santé animale - virusul influenza-a inactivat / porcine - immunologicals - porci - imunizarea activă a porcilor începând de la vârsta de 56 de zile încoace, inclusiv scroafele gestante, împotriva gripei porcine cauzată de subtipurile h1n1, h3n2 și h1n2 pentru a reduce semnele clinice și virale pulmonare sarcină după infecție. debutul imunității: 7 zile după prima vaccinationduration imunității: 4 luni de la porcine vaccinate între vârsta de 56 de ani și 96 de zile și de 6 luni de la porcine vaccinate pentru prima dată la 96 de zile și de mai sus. imunizarea activă a scroafelor gestante după ce a terminat de imunizare primară prin administrarea unei doze unice de 14 zile înainte de fătare pentru a dezvolta de înaltă colostral imunitate, care oferă protecție clinică de purcei pentru cel puțin 33 de zile după naștere.

Moldavija - romunščina - AMDM (Agenţia Medicamentului şi Dispozitivelor Medicale)

farmak sap - combinaţie plante - sirop

Moldavija - romunščina - AMDM (Agenţia Medicamentului şi Dispozitivelor Medicale)

compania farmaceutică "zdorovie" srl - planta centauri + root levistici + frunze rosmarini - capsule - 18 mg/18 mg/18 mg

Evropska unija - romunščina - EMA (European Medicines Agency)

elanco gmbh - monensin (ca monensin sodiu) - medicamente pentru prevenirea și/sau tratamentul de acetonemie - bovine (vaci și juninci) - pentru reducerea incidenței cetozei în vaca / juninca de lapte peri-parturient care se așteaptă să dezvolte cetoză.

Evropska unija - romunščina - EMA (European Medicines Agency)

merck sharp & dohme b.v. - pembrolizumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; endometrial neoplasms - agenți antineoplazici - melanomakeytruda as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma. keytruda as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with stage iib, iic, or with stage iii melanoma and lymph node involvement who have undergone complete resection. non small cell lung carcinoma (nsclc)keytruda as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum based chemotherapy (for selection criteria, see section 5. keytruda as monotherapy is indicated for the first line treatment of metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 50% tumour proportion score (tps) with no egfr or alk positive tumour mutations. keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non squamous non small cell lung carcinoma in adults whose tumours have no egfr or alk positive mutations. keytruda, in combination with carboplatin and either paclitaxel or nab paclitaxel, is indicated for the first line treatment of metastatic squamous non small cell lung carcinoma in adults. keytruda  as monotherapy is indicated for the treatment of locally advanced or metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 1% tps and who have received at least one prior chemotherapy regimen. pacienții cu egfr sau alk pozitiv de tumoră mutații ar trebui să, de asemenea, au primit terapie vizate înainte de a primi keytruda. classical hodgkin lymphoma (chl)keytruda as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical hodgkin lymphoma who have failed autologous stem cell transplant (asct) or following at least two prior therapies when asct is not a treatment option. urothelial carcinomakeytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum containing chemotherapy. keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin containing chemotherapy and whose tumours express pd l1 with a combined positive score (cps) ≥ 10. head and neck squamous cell carcinoma (hnscc)keytruda, as monotherapy or in combination with platinum and 5 fluorouracil (5 fu) chemotherapy, is indicated for the first line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a cps ≥ 1. keytruda as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a ≥ 50% tps and progressing on or after platinum containing chemotherapy. renal cell carcinoma (rcc)keytruda, in combination with axitinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults. keytruda  as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (for selection criteria, please see section 5. microsatellite instability high (msi-h) or mismatch repair deficient (dmmr) cancerscolorectal cancer (crc)keytruda as monotherapy is indicated for theadults with msi-h or dmmr colorectal cancer in the following settings:first line treatment of metastatic microsatellite instability high (msi h) or mismatch repair deficient (dmmr) colorectal cancer in adults;treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine based combination therapy.  non-colorectal cancerskeytruda as monotherapy is indicated for the treatment of the following msi h or dmmr tumours in adults with:advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation;unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. oesophageal carcinomakeytruda, in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus or her-2 negative gastroesophageal junction adenocarcinoma, in adults whose tumours express pd l1 with a cps ≥ 10. triple negative breast cancer (tnbc)keytruda, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence. keytruda, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express pd l1 with a cps ≥ 10 and who have not received prior chemotherapy for metastatic disease. endometrial carcinoma (ec)keytruda, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. cervical cancerkeytruda, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express pd l1 with a cps ≥ 1. gastric or gastro-oesophageal junction (gej) adenocarcinomakeytruda, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic her2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express pd-l1 with a cps ≥ 1.

Evropska unija - romunščina - EMA (European Medicines Agency)

ucb pharma sa - lacosamid - epilepsie - antiepileptice, - vimpat este indicat ca monoterapie şi terapie adjuvantă în tratarea parţială-debutul convulsii cu sau fara generalizare secundara la adulţi, adolescenţi şi copii de 4 ani cu epilepsie.

Evropska unija - romunščina - EMA (European Medicines Agency)

roche registration gmbh - vemurafenib - melanomul - agenți antineoplazici - vemurafenib este indicat in monoterapie pentru tratamentul pacienţilor adulţi cu braf v600 mutaţie pozitiv unresectable sau metastatic melanom.

Evropska unija - romunščina - EMA (European Medicines Agency)

serono europe limited - efalizumab - psoriazis - imunosupresoare - tratamentul pacienţilor adulţi cu moderată până la psoriazis în plăci cronic sever care nu au reuşit să răspundă la, sau care au o contraindicaţie la, sau sunt intoleranta la alte tratamente sistemice, inclusiv ciclosporină, metotrexatul si puva (vezi sectiunea 5. 1 - eficacitate clinică).

Evropska unija - romunščina - EMA (European Medicines Agency)

ucb pharma s.a. - lacosamid - epilepsii, parțiale - antiepileptice, - lacosamid ucb este indicat ca monoterapie și terapie adjuvantă în tratamentul crizelor convulsive parțiale cu sau fără generalizare secundară, la adulți, adolescenți și copii de la vârsta de 4 ani cu epilepsie.