Europos Sąjunga - rumunų - EMA (European Medicines Agency)

teva b.v. - salmeterol, propionat de fluticazonă - pulmonary disease, chronic obstructive; asthma - medicamente pentru afecțiuni obstructive ale căilor respiratorii, - airexar spiromax este indicat pentru utilizare la adulți în vârstă de numai 18 ani și peste. asthmaairexar spiromax is indicated for the regular treatment of patients with severe asthma where use of a combination product (inhaled corticosteroid and long-acting β2 agonist) is appropriate:- patients not adequately controlled on a lower strength corticosteroid combination productor- patients already controlled on a high dose inhaled corticosteroid and long-acting β2 agonist. boala pulmonară obstructivă cronică (bpoc)airexar spiromax este indicat pentru tratamentul simptomatic al pacienților cu bpoc, cu o fev1.

Europos Sąjunga - rumunų - EMA (European Medicines Agency)

merck sharp & dohme b.v. - sugammadex - blocaj blocant - toate celelalte produse terapeutice - inversarea blocadei neuromusculare indusă de rocuroniu sau vecuroniu. pentru populația pediatrică: sugammadex este recomandat numai pentru reversia de rutină de rocuronium-a indus blocada la copii și adolescenți.

Europos Sąjunga - rumunų - EMA (European Medicines Agency)

intervet international bv - virusul bolii limbii albastre, serotipul 8 (inactivat) - vaccinurilor virale inactivate, virusul bolii limbii albastre, oi - sheep; cattle - cattle to stimulate active immunity in sheep from 6 weeks of age against bluetongue virus serotype 8 to reduce viraemia sheep to stimulate active immunity in sheep from 1 month of age against bluetongue virus serotype 8 to prevent viraemia,.

Europos Sąjunga - rumunų - EMA (European Medicines Agency)

zoetis belgium sa - virusul febrei catarale ovine inactivat, serotipul 1 - immunologicals - bovine - imunizarea activă a bovinelor de la vârsta de 2½ luni pentru prevenirea viremiei cauzate de virusul bolii limbii albastre, serotipul 1. debutul imunității: la 15 zile după terminarea cursului de vaccinare primară. durata imunității: 12 luni.

Europos Sąjunga - rumunų - EMA (European Medicines Agency)

zoetis belgium sa - inactivat virusul bolii limbii albastre, serotipul 1 - immunologicals - oaie - imunizarea activă a ovinelor de la 1. vârsta de 5 luni pentru prevenirea viremiei cauzate de virusul bolii limbii albastre, serotipurile-1. debutul imunității: 21 de zile după terminarea schemei primare de vaccinare. durata imunității: 12 luni.

Europos Sąjunga - rumunų - EMA (European Medicines Agency)

zoetis belgium sa - inactivated bluetongue virus, serotype 1, strain btv-1/alg2006/01, inactivated bluetongue virus, serotype 8, strain btv-8/bel2006/02 - bluetongue virus, sheep, inactivated viral vaccines - oaie - imunizarea activă a ovinelor de la 1. 5 luni pentru a preveni viremia cauzată de virusul bolii limbii albastre, serotipurile 1 și 8. debutul imunității: 21 de zile după terminarea schemei primare de vaccinare. durata imunității: 12 luni.

Europos Sąjunga - rumunų - EMA (European Medicines Agency)

zoetis belgium - virus inactivat al bolii limbii albastre, serotip 8, tulpina btv-8/bel2006/02 - immunologicals - bovine - active immunisation of cattle from three months of age for the prevention of viraemia caused by bluetongue virus, serotype 8.

Europos Sąjunga - rumunų - EMA (European Medicines Agency)

zoetis belgium sa - virus inactivat al bolii limbii albastre, serotip 8, tulpina btv-8/bel2006/02 - immunologicals - oaie - imunizarea activă a ovinelor de la 1. vârsta de 5 luni pentru prevenirea viremiei cauzate de virusul bolii limbii albastre, serotipul 8.

Europos Sąjunga - rumunų - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - palifermin - mucozita - toate celelalte produse terapeutice - kepivance este indicat pentru a reduce incidenţa, durata şi severitatea mucositis orale la pacienţii adulţi cu tumori maligne hematologice primirea myeloablative radiochemotherapy asociate cu o incidenţă ridicată de mucositis severă şi care necesită suport autologe-hematopoietică-celule stem.

Europos Sąjunga - rumunų - 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.