Unione Europea - bulgaro - EMA (European Medicines Agency)

merck sharp dohme ltd  - пегинтерферон алфа-2b - Хепатит c, хроничен - Иммуностимуляторы, - adults (tritherapy)viraferonpeg in combination with ribavirin and boceprevir (tritherapy) is indicated for the treatment of chronic-hepatitis-c (chc) genotype-1 infection in adult patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy. Моля, консултирайте се с Рибавирин и боцепревир кратки характеристики на продукта (smpcs), когато viraferonpeg се използва в комбинация с тези лекарства. adults (bitherapy and monotherapy)viraferonpeg is indicated for the treatment of adult patients (18 years of age and older) with chc who are positive for hepatitis-c-virus rna (hcv-rna), including patients with compensated cirrhosis and / or co-infected with clinically stable hiv. viraferonpeg в комбинация с рибавирином (bitherapy) е показан за лечение на ХГС-инфекция при възрастни пациенти, по-рано не е получавала лечение, включително и на пациенти с клинично стабилна ХИВ-инфекция и при възрастни пациенти, които не предишно лечение интерфероном Алфа (пегилированным или пегилированным) и рибавирином комбинирана терапия или монотерапия интерфероном Алфа. Монотерапия интерфероном, включително viraferonpeg, се посочва в случай на непоносимост или противопоказания към рибавирину. Моля, обърнете се към Смпц рибавирином, когато viraferonpeg се използва в комбинация с рибавирином. paediatric population (bitherapy)viraferonpeg is indicated in a combination regimen with ribavirin for the treatment of children three years of age and older and adolescents, who have chronic hepatitis c, previously untreated, without liver decompensation, and who are positive for hcv-rna. При вземане на решение да не се отложи лечението до зряла възраст, е важно да се отчете, че комбинираната терапия предизвиква забавяне на растежа, който може да бъде необратим при някои пациенти. Решението трябва да бъде взето на индивидуална основа. Моля, обърнете се към Смпц Рибавирин капсули или перорален разтвор, когато viraferonpeg се използва в комбинация с рибавирином.

Unione Europea - bulgaro - EMA (European Medicines Agency)

ceva santé animale - influenza a virus/human strain: a/jena/vi5258/2009 (h1n1)pdm09, inactivated - Имунологични, инактивирани вирусни ваксини за прасета, вирус на свински грип - Прасета - Активна имунизация на свинете, на възраст от 8 седмици и след това срещу пандемичен грип h1n1 на свинския грип, за да се намали вирусния товар в белите дробове и вирусна экскреция. the vaccine can be used during pregnancy up to three weeks before expected farrowing and during lactation lactation.

Unione Europea - bulgaro - EMA (European Medicines Agency)

kite pharma eu b.v. - axicabtagene ciloleucel - lymphoma, follicular; lymphoma, large b-cell, diffuse - Антинеопластични средства - yescarta is indicated for the treatment of adult patients with diffuse large b cell lymphoma (dlbcl) and high-grade b-cell lymphoma (hgbl) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy. yescarta is indicated for the treatment of adult patients with relapsed or refractory (r/r) dlbcl and primary mediastinal large b cell lymphoma (pmbcl), after two or more lines of systemic therapy. yescarta is indicated for the treatment of adult patients with r/r follicular lymphoma (fl) after three or more lines of systemic therapy.

Unione Europea - bulgaro - EMA (European Medicines Agency)

regeneron ireland designated activity company (dac) - cemiplimab - Карцином, сквамозна клетка - Антинеопластични средства - cutaneous squamous cell carcinomalibtayo as monotherapy is indicated for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mcscc or lacscc) who are not candidates for curative surgery or curative radiation. basal cell carcinomalibtayo as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (labcc or mbcc) who have progressed on or are intolerant to a hedgehog pathway inhibitor (hhi). non-small cell lung cancerlibtayo as monotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (nsclc) expressing pd-l1 (in ≥ 50% tumour cells), with no egfr, alk or ros1 aberrations, who have:locally advanced nsclc who are not candidates for definitive chemoradiation, ormetastatic nsclc. libtayo in combination with platinum‐based chemotherapy is indicated for the first‐line treatment of adult patients with nsclc expressing pd-l1 (in ≥ 1% of tumour cells), with no egfr, alk or ros1 aberrations, who have:locally advanced nsclc who are not candidates for definitive chemoradiation, ormetastatic nsclc. cervical cancerlibtayo as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.

Unione Europea - bulgaro - EMA (European Medicines Agency)

a. menarini industrie farmaceutiche riunite s.r.l. - delafloxacin меглюмина - Инфекции, придобити от общността - Антибактериални средства за подаване на заявления, - quofenix is indicated for the treatment of the following infections in adults:acute bacterial skin and skin structure infections (absssi),community-acquired pneumonia (cap), when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the initial treatment of these infections (see sections 4. 4 и 5. Трябва да се вземат предвид официалните препоръки за правилното използване на антибактериални агенти.

Unione Europea - bulgaro - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - idecabtagene vicleucel - multiple myeloma; neoplasms; cancer; neoplasms, plasma cell; hemostatic disorders; vascular diseases; cardiovascular diseases; paraproteinemias; blood protein disorders; hematologic diseases; hemic and lymphatic diseases; hemorrhagic disorders; infectious mononucleosis; lymphoproliferative disorders; immunoproliferative disorders; immune system diseases - Антинеопластични средства - abecma is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti cd38 antibody and have demonstrated disease progression on the last therapy.

Unione Europea - bulgaro - EMA (European Medicines Agency)

deciphera pharmaceuticals (netherlands) b.v. - ripretinib - Стомашно-чревни стромални тумори - Антинеопластични средства - qinlock is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumour (gist) who have received prior treatment with three or more kinase inhibitors, including imatinib.

Unione Europea - bulgaro - EMA (European Medicines Agency)

janssen-cilag international nv - ciltacabtagene autoleucel - Множествена миелома - carvykti is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-cd38 antibody and have demonstrated disease progression on the last therapy.

Unione Europea - bulgaro - EMA (European Medicines Agency)

oncopeptides ab - melphalan flufenamide hydrochloride - Множествена миелома - Антинеопластични средства - pepaxti is indicated, in combination with dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-cd38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. for patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation (see section 4.

Unione Europea - bulgaro - EMA (European Medicines Agency)

janssen-cilag international n.v. - teclistamab - Множествена миелома - Антинеопластични средства - tecvayli is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-cd38 antibody and have demonstrated disease progression on the last therapy.