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Shifting towards needs-driven healthcare: highlights from the Belgian high-level conference
On 17 and 18 April, the Federal Agency for Medicines and Health Products (FAMHP), the National Institute for Health and Disability Insurance (NIHDI) and the Health Care Knowledge Centre (KCE) organised a high-level conference on health-related needs as drivers for healthcare policy and innovation. This conference was organised in the context of the Belgian presidency of the Council of the EU. The aim is to establish a research and innovation ecosystem that focuses on the most pressing health needs.
Glossary
Legal basis MDR : acronym meaning "Medical Devices Regulation". This is the European Regulation (EU) 2017/745 on medical devices. IVDR : acronym meaning "In Vitro Diagnostic Medical Devices Regulation". This is the European Regulation (EU) 2017/746 on in vitro diagnostic medical devices. Note: the MDR and IVDR are not the only legal bases for regulating devices. More information on the legislation governing devices is available on this page . Common words Devices : this word refers to all medical devices, custom-made medical devices, in vitro diagnostic medical devices, their accessories and certain products without an intended medical purpose. More information
Sotatercept
Active substance MK-7962 Holder Merck Sharp & Dohme LLC, A subsidiary of Merck & Co. Inc Status Running Indication Adult patients with Pulmonary Arterial Hypertension (PAH) Public documents Approbation Information for the patient Informed consent Last update 09/04/2024
Letter Of No Objection (LONO)
A Letter Of No Objection (LONO), also known as a No Objection Certificate (NOC), is a statement confirming that substances are not subject to an import or export licence. The Precursors team issues four types of LONOs: a LONO for non-scheduled substances. This declaration confirms that a firm's non-scheduled substances, whether registered or not, are exempt from import or export licensing requirements. The validity period of this LONO is maximum one year. a LONO for the import of scheduled substances This declaration confirms that scheduled substances of category 2, 3, and/or 4 from a firm, whether registered or not, are
Letter Of No Objection (LONO)
A Letter Of No Objection (LONO), also known as a No Objection Certificate (NOC), is a statement confirming that substances are not subject to an import or export licence. The Precursors team issues four types of LONOs: a LONO for non-scheduled substances. This declaration confirms that a firm's non-scheduled substances, whether registered or not, are exempt from import or export licensing requirements. The validity period of this LONO is maximum one year. a LONO for the import of scheduled substances This declaration confirms that scheduled substances of category 2, 3, and/or 4 from a firm, whether registered or not, are
BALVERSA
Active substance erdafitinib Holder Janssen-Cilag NV Status Running Indication This compassionate use program (CUP) is intended to provide early access to erdafitinib for the adult patients with locally advanced unresectable or metastatic urothelial carcinoma (UC), harboring susceptible FGFR3 genetic alterations with disease progression during or following at least one line of programmed death PD-1 or PD-L1 inhibitor in the locally advanced unresectable or metastatic treatment setting. Public documents Approbation Information for the patient Informed Consent Last update 03/04/2024
Fintepla for DS
Active substance Fenfluramine (as fenfluramine hydrochloride) Holder UCB PHARMA NV Status Running Indication Fintepla for the treatment of patients with Dravet syndrome who completed the open label study ZX008-1900 (EP0215; EudraCT number 2019-001331-31), or the open label study titled “Fenfluramine als anti-epilepticum bij Dravet syndroom en epileptische encephalopathieën” (EudraCT number 2011-004114-42), or the open label study EP0213 (ClinicalTrials.gov ID number NCT06118255) and, in the opinion and the clinical judgement of the treating physician, would continue to benefit from a treatment with Fintepla 2.2 mg/ml oral solution (fenfluramine), which is not yet commercially available in Belgium. Public documents Approbation Information for
Fintepla for LGS
Active substance Fenfluramine (as fenfluramine hydrochloride) Holder UCB PHARMA NV Status Running Indication Fintepla for the treatment of patients with Lennox-Gastaut syndrome who completed the open label study ZX008-1900 (EP0215, EudraCT number 2019-001331-31), or the open label study titled “Fenfluramine als anti-epilepticum bij Dravet syndroom en epileptische encephalopathieën” (EudraCT number 2011-004114-42) or the open label study FFA-LGS (EudraCT number 2015-004008-46) and, in the opinion and the clinical judgement of the treating physician, would continue to benefit from a treatment with Fintepla 2.2 mg/ml oral solution (fenfluramine), which is not yet commercially available in Belgium. Public documents Approbation Information for the
Warning of counterfeit ivermectin tablets sold via social media
The FAMHP and Sciensano are warning about counterfeit ivermectin tablets that are being used for self-medication against COVID-19. Investigations show that these counterfeit ivermectin tablets are systematically underdosed or seriously contaminated with bacteria. In 2021, a total of 12 529 counterfeit ivermectin tablets originating from postal packages were seized. These tablets are regularly found in postal packages to this day.
Fighting antimicrobial resistance: a new antimicrobial medicinal product marketed in Belgium
In the fight against antimicrobial resistance, it is important to improve the diversity of therapeutic treatments to enable medical doctors to make the most appropriate choice. Maribavir, a new viral active substance, has recently been launched on the Belgian market.