Unione Europea - bulgaro - EMA (European Medicines Agency)

merck sharp & dohme b.v. - doravirine, lamivudine, tenofovir дизопроксил фумарат - ХИВ инфекции - Антивирусни средства за лечение на hiv инфекции, комбинации - delstrigo е показан за лечение на възрастни, заразени с ХИВ-1, Без да е минали или настоящи доказателства за резистентност към класа на ННИОТ, lamivudine или tenofovir. delstrigo is also indicated for the treatment of adolescents aged 12 years and older weighing at least 35 kg who are infected with hiv-1 without past or present evidence of resistance to the nnrti class, lamivudine, or tenofovir and who have experienced toxicities which preclude the use of other regimens that do not contain tenofovir disoproxil.

Unione Europea - bulgaro - EMA (European Medicines Agency)

merck sharp & dohme b.v. - doravirine - ХИВ инфекции - Антивирусни средства за системно приложение - pifeltro is indicated, in combination with other antiretroviral medicinal products, for the treatment of adults, and adolescents aged 12 years and older weighing at least 35 kg infected with hiv 1 without past or present evidence of resistance to the nnrti class.

Unione Europea - bulgaro - EMA (European Medicines Agency)

abbvie deutschland gmbh & co. kg - risankizumab - psoriasis; arthritis, psoriatic - Имуносупресори - plaque psoriasisskyrizi is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. psoriatic arthritisskyrizi, alone or in combination with methotrexate (mtx), is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (dmards). crohn's diseaseskyrizi is indicated for the treatment of adult patients with moderately to severely active crohn's disease who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy.

Bulgaria - bulgaro - БАБХ (Българска агенция по безопасност на храните)

intervet international b.v. - erysipelotrix rhusiopathiae, серотип 2, щам м2; парвовирус прасета щам 014, лептоспир interrogans, Тянитолкая серогруппы, серовара Портланд-Вэ,щам sa-12-000; виж ccc - инжекционна суспензия - ≥1ppd на 1 степен; ≥ 130 u на 2 степен; ≥ 2816 u на 2 степен; ≥210 u на 2 степен; ≥ 1704 u на 2 степен; ≥ 648 u на 2 степен; ≥ 1 - прасета

Unione Europea - bulgaro - EMA (European Medicines Agency)

accord healthcare s.l.u. - трастузумаб - breast neoplasms; stomach neoplasms - Антинеопластични средства - breast cancermetastatic breast cancer zercepac is indicated for the treatment of adult patients with her2 positive metastatic breast cancer (mbc):as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Преди химиотерапията трябва да бъдат включени най-малко антрациклина и таксана, ако пациентите не са подходящи за тези процедури. Хормон-рецептор-позитивни пациенти, също трябва да бъде не на хормоналната терапия, ако пациентите не са подходящи за тези процедури.                      in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable. в комбинация с доцетакселом за лечение на пациенти, които не са получавали химиотерапия за метастатичен болест. в комбинация с инхибитор на ароматаза инхибитори за лечение на пациенти след менопауза с хормон-рецептор позитивен ГБЦ, не по-рано от получаващи трастузумаб. early breast cancer zercepac is indicated for the treatment of adult patients with her2 positive early breast cancer (ebc). след операция, химиотерапия (неоадъювантной или помощните) и лъчетерапия (ако е приложимо). след помощните химиотерапия с доксорубицином и циклофосфамидом, в съчетание с паклитакселом или доцетакселом. в комбинация с помощните химиотерапия, състояща се от доцетаксела и карбоплатина. in combination with neoadjuvant chemotherapy followed by adjuvant zercepac therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter. zercepac should only be used in patients with metastatic or early breast cancer whose tumours have either her2 overexpression or her2 gene amplification as determined by an accurate and validated assay. metastatic gastric cancer zercepac in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with her2 positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease. zercepac should only be used in patients with metastatic gastric cancer (mgc) whose tumours have her2 overexpression as defined by ihc2+ and a confirmatory sish or fish result, or by an ihc 3+ result. Трябва да се използват точни и доказани методи за анализ .

Unione Europea - bulgaro - EMA (European Medicines Agency)

gilead sciences ireland uc, galapagos nv - filgotinib maleate - Артрит, ревматоиден - Имуносупресори - rheumatoid arthritisjyseleca is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (dmards). jyseleca may be used as monotherapy or in combination with methotrexate (mtx). ulcerative colitisjyseleca is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent.

Unione Europea - bulgaro - EMA (European Medicines Agency)

biontech manufacturing gmbh - single-stranded, 5’-capped messenger rna 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 - comirnaty 30 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older.  comirnaty 30 micrograms/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older.  comirnaty 10 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years.  comirnaty 3 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in infants and children aged 6 months to 4 years.  comirnaty original/omicron ba. 1 (15/15 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older who have previously received at least a primary vaccination course against covid-19. comirnaty original/omicron ba. 4-5 (15/15 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older. comirnaty original/omicron ba. 4-5 (5/5 micrograms)/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years. comirnaty original/omicron ba. 4-5 (5/5 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years.  comirnaty original/omicron ba. 4-5 (1. 5/1. 5 micrograms)/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in infants and children aged 6 months to 4 years.  comirnaty omicron xbb. 5 30 micrograms/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older. comirnaty omicron xbb. 5 10 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years. comirnaty omicron xbb. 5 10 micrograms/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years. comirnaty omicron xbb. 5 3 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in infants and children aged 6 months to 4 years. Използването на тази ваксина трябва да бъде приложена в съответствие с официалните препоръки.

Unione Europea - bulgaro - EMA (European Medicines Agency)

abbvie deutschland gmbh & co. kg - atogepant - Мигренозни разстройства - aquipta is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month.

Unione Europea - bulgaro - EMA (European Medicines Agency)

merz pharmaceuticals gmbh - мемантин хидрохлорид - Болест на Алцхаймер - Други лекарства против деменция - Лечение на пациенти с умерена до тежка болест на Алцхаймер.

Unione Europea - bulgaro - EMA (European Medicines Agency)

gedeon richter plc. - фолитропин алфа - Ановулация - Полови хормони и слиза на половата система, - in adult women:anovulation (including polycystic ovarian disease, pcod) in women who have been unresponsive to treatment with clomiphene citrate;stimulation of multifollicular development in patients undergoing superovulation for assisted reproductive technologies (art) such as in vitro fertilisation (ivf), gamete intra-fallopian transfer (gift) and zygote intra-fallopian transfer (zift);follitropin alfa in association with a luteinising hormone (lh) preparation is recommended for the stimulation of follicular development in women with severe lh and fsh deficiency. В клинични проучвания при тези пациенти са били идентифицирани ендогенен нивото на серумните нива на lh < 1. 2 iu / l. in adult men:follitropin alfa is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human chorionic gonadotrophin (hcg) therapy.