Европейски съюз - български - EMA (European Medicines Agency)

tesaro bio netherlands b.v. - rolapitant - vomiting; nausea; cancer - Антиеметични и antinauseants, - Предотвратяване на забавено гадене и повръщане, свързано със силно и умерено еметогенна химиотерапия при рак при възрастни. varuby се дава в състава на комплексната терапия.

България - български - Изпълнителна агенция по лекарствата

Байер България ЕООД - Лоратадин - 10 mg tablets 

България - български - Изпълнителна агенция по лекарствата

Байер България ЕООД - Лоратадин - 1 mg/ml syrup

Европейски съюз - български - 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 - Антинеопластични средства - 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.

Европейски съюз - български - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - ozanimod хидрохлорид - multiple sclerosis, relapsing-remitting; colitis, ulcerative - Имуносупресори - multiple sclerosiszeposia is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (rrms) with active disease as defined by clinical or imaging features. ulcerative colitiszeposia is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (uc) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.

Европейски съюз - български - EMA (European Medicines Agency)

teva gmbh - диметил фумарат - multiple sclerosis, relapsing-remitting; multiple sclerosis - Имуносупресори - dimethyl fumarate teva is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (rrms).

Европейски съюз - български - EMA (European Medicines Agency)

accord healthcare s.l.u. - диметил фумарат - multiple sclerosis, relapsing-remitting; multiple sclerosis - Имуносупресори - dimethyl fumarate accord is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (rrms).

Европейски съюз - български - EMA (European Medicines Agency)

neuraxpharm pharmaceuticals s.l. - ublituximab - multiple sclerosis, relapsing-remitting; multiple sclerosis - Имуносупресори - briumvi is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (rms) with active disease defined by clinical or imaging features.

Европейски съюз - български - EMA (European Medicines Agency)

sandoz gmbh - натализумаб - multiple sclerosis, relapsing-remitting; multiple sclerosis - Имуносупресори - tyruko is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis (rrms) for the following patient groups: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4. 4 и 5. 1), or, patients with rapidly evolving severe rrms defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain magnetic resonance imaging (mri) or a significant increase in t2 lesion load as compared to a previous recent mri.

Европейски съюз - български - EMA (European Medicines Agency)

merck sharp & dohme b.v. - Апрепитант - vomiting; postoperative nausea and vomiting; cancer - Антиеметични и antinauseants, - emend 40 mg твърди капсули е показан за профилактика на постоперативно гадене и повръщане (ponv) при възрастни. Да се направят промени и се предлага под формата на капсули по 80 mg и 125 мг твърд за предотвратяване на гадене и повръщане при високо и умерено emetogenic рак на химиотерапия при възрастни и юноши на 12 години (виж отделно описание на характеристиките на продукта). Да се направят промени и 165 mg твърди капсули за профилактика на остра и отсроченной на гадене и повръщане при високо emetogenic на рак с химиотерапия на базата на цисплатина при възрастни и профилактика на гадене и повръщане, свързани с умерено emetogenic рак на химиотерапия при възрастни. Да се направят промени и се предлага под формата на прах за устната спиране за предотвратяване на гадене и повръщане при високо и умерено emetogenic рак на химиотерапия при бебета, малки деца и бебета на възраст от 6 месеца до 12 години. Да се направят промени на 80 mg, 125 mg 165 mg твърди капсули и да се направят промени на прах за устната суспензия са в състава на комплексната терапия.