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Legislation - Substances
The regulations can be found in the royal decree of 06.09.2017 regulating narcotics and psychotropic substances in application of the law dated 24 February 1921 regarding the trade of hazardous substances, sleeping agents, narcotics, psychotropic substances, disinfectants and antiseptics and of substances that could be used to manufacture illegal narcotics and psychotropics. Only the annexes and their amendments published in the Official Gazette have official legal value. However, this publication does not provide consolidated versions. If in doubt, please consult the updated versions of annexes I to V, prepared by the Team Narcotics. Please note: this consolidated version has no
eCTD format mandatory for MRP-procedures
From 1st of January 2018 the eCTD format will become mandatory for variations of human medicines via the Mutual Recognition Procedure (MRP).
Publication of the updated CTFG Q&A-Reference Safety Information (RSI) document
The Q&A-RSI document provides updated details on RSI requirements based on shared experiences since 2013.
Reporting the commercialisation of medicinal products to the FAMHP
Notice to pharmaceutical companies concerning the reporting of the commercialisation of medicinal products to the FAMHP.
iNOmax®
Active substance iNOmax Holder Fluidda nv Status closed Indication patients who suffer from pulmonary hypertension associated with COPD and who participated in the PULSE-COPD-007 study Public documents Approbation Information for the patient informed consent Last update 28/08/2023
Alecensa®
Active substance Alectinib Holder Roche Status Closed Indication First-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) Public documents Approbation Information for the patient Informed consent Last update 03/09/2018
December 18, 2017: final date for submitting dossiers during the Christmas holidays
During the Christmas holidays, the FAMHP will be closed from Monday December 25, 2017 until Monday January 1, 2018 included.
Revlimid
Active substance lenalidomide Holder Celgene sprl Status closed Indication diffuse large B cell lymphoma in patients who already received at least two prior treatment lines Public documents Approbation Information for the patient Informed consent Last update 29/06/2022
Delivery status of medicinal products on the FAMHP website: call for verification by marketing authorisations holders
In the interest of transparency, as of March 2018, the FAMHP will include the subcategories of the legal status of medicinal products with restricted medical prescription in the public database on the FAMHP website. From that date, the subcategory for medicinal products with restricted medical prescription will be offered to the physicians and pharmacists software. Holders of a marketing authorisation for a medicinal product (MA) may verify the legal status of their medicinal products before publication.
2016
Scientific publications You will find below the summary of the scientific publications to which employees of the famhp contributed. Publication date Article/advice Journal/public institution Authors 10.2016 Cell-based therapies for cardiac repair: a meeting report on scientific observations and European regulatory viewpoints. Eur J Heart Fail. 2016 Feb;18(2):133-41. doi: 10.1002/ejhf.422. Epub 2015 Oct 16. Schüssler-Lenz M, Beuneu C, Menezes-Ferreira M, Jekerle V, Bartunek J, Chamuleau S, Celis P, Doevendans P, O'Donovan M, Hill J, Hystad M, Jovinge S, Kyselovič J, Lipnik-Stangelj M, Maciulaitis R, Prasad K, Samuel A, Tenhunen O, Tonn T, Rosano G, Zeiher A, Salmikangas P. 10.2016 Residues in