Ευρωπαϊκή Ένωση - Βουλγαρικά - 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.

Ευρωπαϊκή Ένωση - Βουλγαρικά - EMA (European Medicines Agency)

viatris healthcare limited - имиквимод - condylomata acuminata; keratosis; keratosis, actinic; carcinoma, basal cell - Антибиотици и химиотерапевтици за дерматологично приложение - imiquimod cream is indicated for the topical treatment of :external genital and perianal warts (condylomata acuminata) in adults. small superficial basal cell carcinomas (sbccs) in adults. clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses (aks) on the face or scalp in immunocompetent adult patients when size or number of lesions limit the efficacy and/or acceptability of cryotherapy and other topical treatment options are contraindicated or less appropriate.

Ευρωπαϊκή Ένωση - Βουλγαρικά - EMA (European Medicines Agency)

bayer ag - radium (223ra) dichloride - Простатни неоплазми - Терапевтични радиофармацевтици - xofigo е показан за лечение на възрастни с кастрационен резистентен рак на простатата, симптоматични костни метастази и без известни висцерални метастази.

Ευρωπαϊκή Ένωση - Βουλγαρικά - EMA (European Medicines Agency)

pinnacle biologics b.v.  - натрий porfimer - Хранопровод На Барет - Антинеопластични средства - Фотодинамична терапия (ФДТ) с photobarr е предназначен за: премахване на тежка дисплазия (ГГД) при пациенти с хранопровода на Барет (БО).

Βουλγαρία - Βουλγαρικά - БАБХ (Българска агенция по безопасност на храните)

virbac - Празиквантел, ivermectin - таблетки за дъвчене - 150 mg/таблетка, 20 mg/таблетка - коне

Ευρωπαϊκή Ένωση - Βουλγαρικά - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - мелоксикам - oxicams - horses; dogs; cattle; cats; pigs; guinea pigs - Котки:облекчаване на лека до умерена постоперативна болка и възпаление след хирургични интервенции, e. ортопедия и хирургия на меките тъкани . Облекчаване на болка и възпаление при остри и хронични заболявания на опорно-двигателния апарат. Намаляване на постоперативна болка след овариогистерэктомии и малка хирургия на меките тъкани . cattle:for use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs. За употреба при диария в комбинация с орална рехидратираща терапия за намаляване на клиничните признаци при телета на възраст над една седмица и на млади, нелектирани говеда. За облекчаване на следоперативната болка след обезводняване на телета. За допълнителна терапия при лечение на остър мастит, в комбинация с антибиотична терапия. dogs:alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders. Намаляване на следоперативната болка и възпаление след ортопедична и мека тъканна хирургия. horses:for use in the alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders. За облекчаване на болка, свързана с колики от коне. Облекчаване на възпалението и облекчаване на болката при остри и хронични опорно-двигателния апарат. Свине: за използване в неинфекционной патология на опорно-двигателния апарат, за да се намалят симптомите на куцота и възпаления. За вендузи постоперативна болка, свързани с незначителни хирургия на меките тъкани, като например кастрацията. За допълнителна терапия при лечението на пуперперна септицемия и токсемия (синдром на мастит-метрит-агалактия) с подходяща антибиотична терапия. Морските свинчета са:облекчаване на лека до умерена постоперативна болка, свързани с хирургия на меките тъкани, като например кастрация на мъжки.

Ευρωπαϊκή Ένωση - Βουλγαρικά - EMA (European Medicines Agency)

accord healthcare s.l.u. - doxorubicin hydrochloride, liposomal - ovarian neoplasms; sarcoma, kaposi; multiple myeloma - doxorubicin - zolsketil pegylated liposomal is a medicine used to treat the following types of cancer in adults:• breast cancer that has spread to other parts of the body in patients at risk of heart problems. zolsketil pegylated liposomal is used on its own for this disease;• advanced ovarian cancer in women whose previous treatment including a platinum-based cancer medicine has stopped working;• multiple myeloma (a cancer of the white blood cells in the bone marrow), in patients with progressive disease who have received at least one other treatment in the past and have already had, or are unsuitable for, a bone marrow transplantation. zolsketil pegylated liposomal is used in combination with bortezomib (another cancer medicine);• kaposi’s sarcoma in patients with aids who have a very damaged immune system. kaposi’s sarcoma is a cancer that causes abnormal tissue to grow under the skin, on moist body surfaces or on internal organs. zolsketil pegylated liposomal contains the active substance doxorubicin and is a ‘hybrid medicine’. this means that it is similar to a ‘reference medicine’ containing the same active substance called adriamycin. however, in zolsketil pegylated liposomal the active substance is enclosed in tiny fatty spheres called liposomes, whereas this is not the case for adriamycin.

Ευρωπαϊκή Ένωση - Βουλγαρικά - 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.