Traduction de «providing regulatory information in » (Néerlandais → Français) :

Op 22/02/2008 werd de 'Guidance for Industry on Providing Regulatory Information in Electronic format: Non-eCTD electronic Submissions (NeeS)' gepubliceerd op de EMEA website: [http ...]
Le document 'Guidance for Industry on Providing Regulatory Information in Electronic format: Non-eCTD electronic Submissions (NeeS)' a été publié sur le site de l’EMEA le 22/02/2008 : [http ...]

Exjade (USD 295 million, +35% lc), approved in more than 90 countries as the only once-daily oral therapy for transfusional iron overload, recently received regulatory approvals in Brazil, the US and Canada for a new dose of 40 mg/kg, which provides a new option for patients who require higher dose titration for iron chelation.
Exjade (USD 295 millions, +35% en m. l.), autorisé dans plus de 90 pays en tant que seul traitement par voie orale en prise unique quotidienne contre une surcharge en fer transfusionnelle chronique, a reçu des autorisations au Brésil, aux Etats-Unis et au Canada pour un nouveau dosage à 40 mg/kg afin de traiter les patients ayant besoin d’une chélation ferrique à dose plus élevée.

●● Providing scientific advice in a regulatory
●● Providing scientific advice in a regulatory

This information has also been submitted to European regulatory authorities.
Cette information a également été remise aux autorités réglementaires de l’Union européenne.

Selected projects awaiting regulatory decisions Completed submissions Product Indication US EU Japan News update ABF656 Hepatitis C Q4 2009 - Dossier for ABF656 at once-everytwo-weeks dosing was withdrawn in EU in April since additional information would be requested that could not be generated within required timeframe
Projets importants en attente de décisions réglementaires Demandes déposées Produit Indication USA UE Japon Mise à jour ABF656 Hépatite C T4 2009 - Le dossier d’ABF656 comportant une dose unique toutes les 2 semaines a été retiré de l’UE en avril, car l’information supplémentaire requise ne pouvait pas être fournie dans le délai imparti

Provision has been made for the organised exchange of information with the national scientific commissions which give final opinions (e.g. evaluation commissions for medicines) and with the representatives on the international scientific or regulatory committees (e.g. CHMP, CVMP, CMD(h), CMD(v), COMP, PDCO).
Provision has been made for the organised exchange of information with the national scientific commissions which give final opinions (e.g. evaluation commissions for medicines) and with the representatives on the international scientific or regulatory committees (e.g. CHMP, CVMP, CMD(h), CMD(v), COMP, PDCO).

In this context the FAMHP supports provision of pharmacotherapeutic information to care providers and has concluded partnerships with independent organisations providing objective information about medicines (for instance the Belgian Centre for Pharmacotherapeutic Information – BCFI-CBIP and Project Farmaka, not-for-profit organisations). This process needs to take into consideration the expectations of healthcare professionals in terms of information content on the one hand, and the ease of access and consultation of the data on the other.
In this context the FAMHP supports provision of pharmacotherapeutic information to care providers and has concluded partnerships with independent organisations providing objective information about medicines (for instance the Belgian Centre for Pharmacotherapeutic Information – BCFI-CBIP and Project Farmaka, not-for-profit organisations). This process needs to take into consideration the expectations of healthcare professionals in terms of information content on the one hand, and the ease of access and consultation of the data on the other.

- Contact) ●● Providing information about the legal context and procedures ●● Providing information about medicines and
- Contact) ●● Providing information about the legal context and procedures ●● Providing information about medicines and

In this age of the internet the speed of the information stream is an increasingly important factor in the eyes of the public and care providers. There is therefore also a need to be able to combine rapid, qualitative information.
In this age of the internet the speed of the information stream is an increasingly important factor in the eyes of the public and care providers. There is therefore also a need to be able to combine rapid, qualitative information.

The database can be used to look up extensive information about authorised medicines without having to contact those responsible for providing information, as is currently the case ●● Healthcare professionals and veterinarians
The database can be used to look up extensive information about authorised medicines without having to contact those responsible for providing information, as is currently the case ●● Healthcare professionals and veterinarians