For another medicine, Lutrate Depot, the PRAC recommended that instructions for handling the medicine be revised to make them easier to follow and its packaging changed so the instructions are easier to find. Leuprorelin-containing depot medicinal products. It is thought that Xofigo, which is taken up by the bone, accumulates at sites where the bone is already damaged, for example by osteoporosis or micro-fractures, increasing the risk of fracture. The Bulgarian Drug Agency is administration to the Minister of Health, whose competences, functions and activities are set out in three laws: According to the Law on Medicinal Products in Humane Medicine (LMPHM) BDA is a specialized body to the Minister of Health to supervise the quality, effectiveness and safety of medicines. +359 2 890 35 55 Fax +359 2 890 34 34 E-mail: bda@bda.bg www.bda.bg Croatia Agency for medicinal products and medical devices of Croatia 10 000 Zagreb However, the reasons for a possible earlier death in this study are not fully understood. "Bulgarian Drug Agency" can be abbreviated as BDA. There will be enough vaccines for the entire population, assured CEO of the Bulgarian Drug Agency (BDA) Bogdan Kirilov in the morning program of BNT. Pharmacovigilance / «Medical specialists», New measures to avoid handling errors with leuprorelin depot medicines, Reporting suspected side effects of medicines in patients with COVID-19, Restrictions in use of cyproterone due to meningioma risk, PRAC confirms four-week limit for use of high-strength estradiol creams, PRAC recommends measures to minimise risk of serious side effects with Lemtrada for multiple sclerosis, PRAC recommends cautious use of Xeljanz for all patients at high risk of blood clots, PRAC recommends new measures to avoid dosing errors with methotrexate, PRAC recommends restricting use of prostate cancer medicine Xofigo, PRAC recommends new measures to minimise risk of rare but serious liver injury with Esmya for fibroids, EMA reviewing risk of dosing errors with methotrexate - Review prompted by continued reports of overdose, Prostate cancer medicine Xofigo must not be used with Zytiga and prednisone/prednisolone. EMA’s safety committee PRAC has recommended restricting the use of the cancer medicine Xofigo (radium-223 dichloride) to patients who have had two previous treatments for metastatic prostate cancer (prostate cancer that has spread to the bone) or who cannot receive other treatments. EMA is monitoring the situation closely and will review any new information that becomes available on this issue in the context of the pandemic. 55, Para. The Bulgarian Drug Agency (BDA) is associated with the country's Ministry of Health. The PRAC recommends that the prescribing information for these creams will be updated with the new recommendations. The risk increases with increasing cumulative doses (the total amount of medicine a patient has taken over time). The BDA inspects laboratories, drugs, and medical devices in order to ensure the quality and safety of drug use. An authorized representative anywhere from the EU region is required to enter the region and without the updated … It is responsible for overseeing the safe production of medicines in Bulgaria. Background: Since 2012, in compliance with the changes in the European legislation, the Bulgarian Drug Agency (BDA) has been receiving adverse drug reaction (ADR) reports directly from patients as well as from healthcare professionals and marketing authorization holders (MAH). An authorized representative anywhere from the EU region is required to enter the region and without the updated Bulgarian … Once higher doses have started working, the dose should be gradually reduced to the lowest effective dose. Post updated: November 2020. “At this stage there is no indication that vaccination with the AstraZeneca vaccine should be stopped,” said Bogdan Kirilov, Director of the Bulgarian Drug Agency in … One of the definitions of BDA is "Bulgarian Drug Agency". “In the coming months there will be much larger quantities of vaccines so that people will certainly be able to make a choice,” Bogdan Kirilov, executive director of the Bulgarian Drug Agency said for BNT. A warning that the medicine is to be used for a single treatment period of up to 4 weeks only will be placed on the outer and inner packaging and the size of the tube will be limited to 25 grams to prevent use for longer than recommended. This restriction is already in place for the higher dose medicines. EMA is aware of reports, especially on social media, which raise questions about whether non-steroidal anti-inflammatory medicines (NSAIDs) such as ibuprofen could worsen coronavirus disease (COVID-19). Pharmaceuticals with Marketing Authorization in the Republic of Bulgaria. We have the pleasure to present to your attention our first Clinical Trials Information System newsletter “CTIS Highlights”, which will be published twice a year. In addition, 29% of patients who received the Xofigo combination had fractures, compared with 11% of patients given placebo. The recommendations reflect PRAC’s review of reports concerning rare but serious effects, including deaths, from immune-mediated conditions (caused by the body’s defence system not working properly) and serious disorders of the heart, circulation and bleeding. Chief Expert; Advertisement. Write for The Engine or share your articles, papers and research Add your content Add your content Overall, this side effect is rare: it may affect between 1 and 10 in 10,000 people, depending on the dose and duration of treatment. National Agency for Drug and Food Control (NADFC) (Badan Pengawas Obat dan Makanan Republik Indonesia) Jl. 13, No. China - State Food and Drug Administration (SFDA) 12. The PRAC recommended that Xeljanz should be used with caution in patients at high risk of blood clots. Bulgarian drug agency's web site as a source of information and communication. Read more: Reporting suspected side effects of medicines in patients with COVID-19. The product information of many NSAIDs already contains warnings that their anti-inflammatory effects may hide the symptoms of a worsening infection. Vaccination with the AstraZeneca vaccine may continue in all EU countries from tomorrow, Bogdan Kirilov, executive director of the Bulgarian Drug Agency said on … Bulgarian Drug Agency Address 8, Damyan Gruev Str. He pointed out … The PRAC also confirmed its previous interim recommendation that the medicine must not be used with Zytiga and prednisone/prednisolone. The approval of the Bulgarian Drug Agency is also required for clinical trials with medicinal products (Article 109). Bulgaria Drug Agency. The approval of the Bulgarian Drug Agency is also required for clinical trials The regulatory application for this modification should be submitted by October 2021. View Bulgarian Drug Agency (www.bda.bg) location in Sofia-Capital, Bulgaria , revenue, industry and description. BDA - Bulgarian Drug Agency. Contribute You're the expert! Chile - Ministry of Health (MOH) 11. EMA and the national competent authorities are reminding patients with confirmed or suspected coronavirus disease (COVID-19) to report suspected side effects that they experience with any of the medicines they are taking. (the above link), List of medicinal products under additional monitoring, EMA: Medicines under additional monitoring. Lemtrada for multiple sclerosis: measures to minimise risk of serious side effects. This is according to a document with detailed information from the European Medicines Agency (EMA), translated into Bulgarian and published on the website of the Bulgarian Drug Agency. EMA’s safety committee (PRAC) recommended restricting Lemtrada for use in adults with relapsing remitting multiple sclerosis that is highly active despite adequate treatment with at least one disease-modifying therapy or if the disease is worsening rapidly with at least two disabling relapses in a year and brain-imaging showing new damage. In addition, the maintenance doses of 10 mg twice daily should not be used in patients with ulcerative colitis who are at high risk unless there is no suitable alternative treatment. The CMDh is a body representing EU Member States as well as Iceland, Liechtenstein and Norway. “Bulgaria’s decision regarding the different vaccines is for a balanced portfolio that includes all vaccines developed, so as to guarantee effectiveness,” he added. Colombia - Ministry of Health (MOH) 13. EMA’s safety committee (PRAC) has recommended that medicines with daily doses of 10 mg or more of cyproterone should only be used for androgen-dependent conditions such as hirsutism (excessive hair growth), alopecia (hair loss), acne and seborrhoea (excessively oily skin) once other treatment options, including treatment with lower doses, have failed. Ongoing clinical study shows an increased risk of death and fractures with the combination, TO THE APPLICANTS, MARKETING AUTHORIZATION HOLDERS AND THEIR REPRESENTATIVES, PRAC recommends updating measures for pregnancy prevention during retinoid use Warning on possible risk of neuropsychiatric disorders also to be included for all oral retinoids, PRAC recommends new measures to avoid valproate exposure in pregnancy New restrictions on use; pregnancy prevention programme to be put in place, Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing, TO ALL APPLICANTS, MARKETING AUTHORIZATION HOLDERS AND THEIR LOCAL REPRESENTATIVES, PRAC recommends suspending hydroxyethyl-starch solutions for infusion from the market, Warning about use of prostate cancer medicine Xofigo in combination with Zytiga and prednisone or prednisolone, List of medicinal products under additional monitoring, EMA: Medicines under additional monitoring. The Marketing Authorizations are valid for all countries from the European Union, including Bulgaria. The Bulgarian Drug Agency (BDA) is associated with the country's Ministry of Health. We believe that the information it provides will be interesting and useful for your work. More information is available on the hyperlink below: Cyproterone-containing medicinal products. Bulgarian Drug Agency 8 Damyan Gruev Str. Vaccination with the AstraZeneca vaccine may continue in all EU countries from tomorrow, Bogdan Kirilov, executive director of the Bulgarian Drug Agency said on March 18. In addition, the company marketing Eligard must replace the current device used to administer the medicine with one that is easier to handle. article . The study showed an increased risk of blood clots in deep veins and in the lungs with both the 5 mg and 10 mg twice daily doses of Xeljanz as compared with patients taking TNF-inhibitors (medicines that help reduce inflammation). Overview With recent reforms in health system, Bulgaria stands a good bet for medicine and medical device investments. To obtain market access, manufacturers must get authorizations from the Bulgarian Drug Agency, under the supervision of Ministry of Health, Bulgaria. Bulgarian Drug Agency listed as BDA Looking for abbreviations of BDA? Canada - Health Canada (HC) 10. Bulgaria - Bulgarian Drug Agency (BDA) 9. Register of pharmaceuticals with Marketing Authorization via the Centralized procedure pursue to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004. Bulgaria is expecting 4,000 Moderna vaccine doses next week, according to Bogdan Kirilov, head of the Bulgarian Drug Agency. Patients older than 65 years of age should be treated with Xeljanz only when there is no other appropriate treatment. In the study, patients given Xofigo with Zytiga (abiraterone acetate) and prednisone/prednisolone died on average 2.6 months earlier than those given placebo with Zytiga and prednisone/prednisolone. Overview With recent reforms in health system, Bulgaria stands a good bet for medicine and medical device investments. The PRAC recommendations will now be sent to the CMDh to make a decision about their implementation. Starting on 1 July 2019, the Bulgarian Drug Agency (BDA) announced they will accept submissions via CESP, the Common European Submission Portal. HMA and CMDh/v are in the process of making appropriate changes to this website. Eligard must replace the Current device used to administer the medicine with one that is easier handle! Inject these medicines themselves is associated with the new recommendations available data to see if additional! Received the Xofigo combination had fractures, compared with 11 % of patients who the. 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