Traduction de «medicine which has not already » (Néerlandais → Français) :

Each new homeopathic medicine which has not already been notified needs to be authorised/registered before it can be marketed.
Each new homeopathic medicine which has not already been notified needs to be authorised/registered before it can be marketed.

This medicine, which has the same active ingredient as Afinitor (everolimus), has been shown to have good immunosuppressive efficacy and a manageable side-effect profile.
Ce médicament qui contient de l’évérolimus, la même substance active qu’Afinitor, a démontré une bonne efficacité immunosuppressive et un profil d’effets secondaires gérables.

Some achievements and figures for Unit II in 2007 Rapid alerts relating to the quality of medicines The Rapid Alerts System or RAS network is an international network whose purpose is to circulate information as quickly as possible about batches of medicines that have been identified as nonconforming, which were produced in non-GMP conditions or which do not belong to the distribution circuit that complies with the GDP.
Some achievements and figures for Unit II in 2007 Rapid alerts relating to the quality of medicines The Rapid Alerts System or RAS network is an international network whose purpose is to circulate information as quickly as possible about batches of medicines that have been identified as nonconforming, which were produced in non-GMP conditions or which do not belong to the distribution circuit that complies with the GDP.

Applications for already notified homeopathic medicines will have to be submitted in line with a timetable which will be set by the Minister of Public Health in accordance with article 14 of the royal decree of 23 June 1999.
Applications for already notified homeopathic medicines will have to be submitted in line with a timetable which will be set by the Minister of Public Health in accordance with article 14 of the royal decree of 23 June 1999.

Omnitrope, the pioneering biosimilar of the recombinant human growth hormone somatropin, has received regulatory approval as the first-ever biosimilar in Japan under the brand name Somatropin BS S.C. This approval paves the way for greater access to high-quality biopharmaceuticals in the world’s second-largest pharmaceuticals market and comes about three months after Japanese authorities published guidelines for a biosimilar regulatory pathway, which is based on similar scientific principles already in place in the European Union.
Omnitrope, biosimilaire pionnier de la somatropine, une hormone de croissance humaine recombinante, a obtenu une autorisation au Japon sous la marque Somatropin BS S.C. Il s’agit du premier biosimilaire à avoir été homologué dans ce pays.

In anticipation of changes to the product portfolio in the US, which includes expected approvals for a number of new specialty medicines but also the loss of market exclusivity for Diovan and other medicines in the next few years, Novartis has further streamlined its US business in Pharmaceuticals to maximize the potential of the changing portfolio in both primary care and specialty markets.
Novartis anticipe les changements qui vont intervenir au cours des années à venir dans son portefeuille de produits aux Etats-Unis, notamment les autorisations attendues pour de nouvelles spécialités mais aussi la perte de l’exclusivité du marché pour Diovan et d’autres médicaments. C’est ainsi que Pharmaceuticals a encore rationalisé ses opérations américaines pour maximiser le potentiel d’un portefeuille en plein changement, à la fois dans les soins de santé primaires et dans les marchés des spécialités.

At present there are five agents who belong to the internal FAMHP team and ten agents who are supplied by the ICT service of the FPS Public Health, with which an SLA has been concluded in order to bring to a successful conclusion the transfer of tools and IT skills from the former DG Medicinal Products to the FAMHP and ensure the continuity of service provision.
At present there are five agents who belong to the internal FAMHP team and ten agents who are supplied by the ICT service of the FPS Public Health, with which an SLA has been concluded in order to bring to a successful conclusion the transfer of tools and IT skills from the former DG Medicinal Products to the FAMHP and ensure the continuity of service provision.

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).

Every new homeopathic medicine that has not yet been notified must be authorised/registered before being marketed.
Every new homeopathic medicine that has not yet been notified must be authorised/registered before being marketed.

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.