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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
FAMHP staff affected by identity theft for the illegal obtention of drug precursors
The FAMHP Precursor Unit has recently been affected by a case of identity theft.
Reporting quality defects in medicinal products via the FAMHP website
Quality defects in medicinal products can impact patients’ health or make it difficult for healthcare professionals to administer them. Quality defects can be reported via the FAMHP website.
Kadcyla
Active substance trastuzumab emtansine Holder NV Roche SA Status Closed Indication as a single agent for the adjuvant treatment of adult patients with HER2 positive early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy. Public documents Approbation Information for the patient Informed consent Laatste update 25/02/2021
Update on the guidance document to assist clinical trials sponsors as part of the pilot project of the FAMHP
Based on the evolution of the pilot project for the new Clinical Trial Regulation, the FAMHP made an update on the guidance document to assist clinical trials sponsors as part of the pilot project for clinical trials.
PRAC November 2019: recommendations for the medicinal products Lemtrada and Xeljanz
During the meeting of 28 - 31 October 2019, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) implemented measures to minimise risk of serious side effects with Lemtrada. Furthermore, the PRAC recommended Xeljanz to be used with caution for all patients at high risk of blood clots.
Diabetes medicines with metformin: traces or nitrosamine contamination detected
The European Medicines Agency (EMA) and the competent medicine authorities of the European member states, including the FAMHP, have been notified that in a small number of diabetes medicines based on metformin outside of the European Union, a nitrosamine contamination (NDMA, N-nitrosodimethylamine) has been detected. Currently, analyses are being performed on the medicines within the European Union.
Simplified composition of preparations for treating coughs and colds from 1 January 2020
As of 1 January 2020, medicines with only one active ingredient can be sold for treating coughs and colds.