Symkevi Европейски съюз - български - EMA (European Medicines Agency)

symkevi

vertex pharmaceuticals (ireland) limited - tezacaftor, ivacaftor - Кистозна фиброза - Други продукти на дихателната система - symkevi is indicated in a combination regimen with ivacaftor tablets for the treatment of patients with cystic fibrosis (cf) aged 6 years and older who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene: p67l, r117c, l206w, r352q, a455e, d579g, 711+3a→g, s945l, s977f, r1070w, d1152h, 2789+5g→a, 3272 26a→g, and 3849+10kbc→t.

Spikevax (previously COVID-19 Vaccine Moderna) Европейски съюз - български - EMA (European Medicines Agency)

spikevax (previously covid-19 vaccine moderna)

moderna biotech spain, s.l. - single-stranded, 5’-capped messenger rna (mrna) produced using a cell-free in vitro transcription from the corresponding dna templates, encoding the viral spike (s) protein of sars-cov-2 - covid-19 virus infection - Ваксини - spikevax is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 6 months of age and older. spikevax bivalent original/omicron ba. 1 is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 6 years of age and older who have previously received at least a primary vaccination course against covid-19. spikevax bivalent original/omicron ba. 4-5 is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 6 months of age and older.  spikevax xbb. 5 is indicated for active immunisation to prevent covid 19 caused by sars-cov-2 in individuals 6 months of age and older. the use of this vaccine should be in accordance with official recommendations.

Kevzara Европейски съюз - български - EMA (European Medicines Agency)

kevzara

sanofi winthrop industrie - sarilumab - Артрит, ревматоиден - Имуносупресори - kevzara в комбинация с метотрексат (mtx) е показан за лечение на умерено до силно активен ревматоиден артрит (ra) при възрастни пациенти, които са отговорили неподходящо, или които са непоносимост към един или повече болест-модифициращи анти ревматични лекарства (dmards). kevzara може да се прилага като монотерапия в случай на непоносимост към mtx или когато лечението с mtx е неподходящо.

Efficib Европейски съюз - български - EMA (European Medicines Agency)

efficib

merck sharp and dohme b.v - ситаглиптин, метформин хидрохлорид - Захарен диабет тип 2 - Лекарства, използвани при диабет - За пациенти с тип-2 захарен диабет:efficib е показан като допълнение към диетата и физическите упражнения за подобряване на гликемичния контрол при пациенти, недостатъчно контролирани за тяхното максимално переносимой доза само метформина или тези, които вече са подложени на лечение с комбинация от ситаглиптина и метформина. efficib е посочено в комбинация с сульфонилмочевины (аз. тройната комбинирана терапия) като допълнение към диета и упражнения при пациенти, недостатъчно контролирани за тяхното максимално переносимой дозата на метформина и сульфонилмочевины. efficib е посочено като тройна комбинирана терапия с агонист Рап (аз. тиазолидиндионом) като допълнение към диета и упражнения при пациенти, недостатъчно контролирани за тяхното максимално переносимой дозата на метформина и НПСР агонист. efficib също така е показано, като добавите към инсулин (аз. тройно комбинирано лечение) като допълнение към диета и физически упражнения за подобряване на гликемичния контрол при пациенти, при стабилна доза на инсулина и метформина сам не осигуряват адекватен гликемичен контрол.

Opdivo Европейски съюз - български - EMA (European Medicines Agency)

opdivo

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.

EFFIPRO duo 100 mg/120 mg разтвор спот-он за употреба за много едри котки България - български - БАБХ (Българска агенция по безопасност на храните)

effipro duo 100 mg/120 mg разтвор спот-он за употреба за много едри котки

virbac - Фипронил, Пирипроксифен - разтвор за прилагане върху ограничен участък - 100 mg/пипета; 120 mg/пипета - котки

EFFITIX 134 mg/1200 mg spot-on solution for medium dogs България - български - БАБХ (Българска агенция по безопасност на храните)

effitix 134 mg/1200 mg spot-on solution for medium dogs

virbac - fipronil; permethrin - разтвор за прилагане върху ограничен участък - 134.2 mg, 1199.00 mg/пипета - кучета

EFFITIX 26.8 mg/240 mg spot-on solution for very small dogs България - български - БАБХ (Българска агенция по безопасност на храните)

effitix 26.8 mg/240 mg spot-on solution for very small dogs

virbac - fipronil; permethrin - разтвор за прилагане върху ограничен участък - 26.84 mg; 239.8 mg/пипета - кучета

EFFITIX 268 mg/2400 mg spot-on solution for large dogs България - български - БАБХ (Българска агенция по безопасност на храните)

effitix 268 mg/2400 mg spot-on solution for large dogs

virbac - fipronil; permethrin - разтвор за прилагане върху ограничен участък - 268.4 mg; 2398.0 mg/пипета - кучета

EFFITIX 402 mg/3600 mg spot-on solution for very large dogs България - български - БАБХ (Българска агенция по безопасност на храните)

effitix 402 mg/3600 mg spot-on solution for very large dogs

virbac - fipronil; permethrin - разтвор за прилагане върху ограничен участък - 402.6 mg, 3597.0 mg/пипета - кучета