Vertaling van "received eu approval in january " (Nederlands → Frans) :

Rasilez HCT, a singlepill combination with a diuretic, received EU approval in January 2009, while a decision in Switzerland is expected in 2009.
Rasilez HCT, un comprimé associant un diurétique, a été homologué par l’Union européenne en janvier 2009, tandis qu’une décision de l’autorité réglementaire suisse est attendue en 2009.

Exforge received regulatory approval in Japan in January 2010, while Exforge HCT, which adds a diuretic in a single pill, has been a key growth driver in both the US and Europe.
Exforge a reçu en janvier 2010 une autorisation de mise sur le marché au Japon, tandis qu’Exforge HCT, qui y ajoute un diurétique en un seul comprimé, a été un moteur-clé de la croissance tant aux Etats-Unis qu’en Europe.

Exjade, currently approved in more than 100 countries as the only once-daily oral therapy for transfusional iron overload, received regulatory approvals in 2009 in the US, Europe, Switzerland and other countries extending the dose range to 40 mg/kg.
Exjade, actuellement homologué dans plus d’une centaine de pays en tant que seul traitement par voie orale en prise unique quotidienne contre une surcharge en fer transfusionnelle, a été autorisé en 2009 aux Etats-Unis, en Europe, en Suisse et dans d'autres pays pour élever le dosage à 40 mg/kg.

Exjade, currently approved in more than 100 countries as the only once-daily oral therapy for transfusional iron overload, received regulatory approvals in 2009 in the US, Europe, Switzerland and other countries, extending the dose range to 40 mg/kg.
Exjade, actuellement homologué dans plus d’une centaine de pays en tant que seul traitement par voie orale en prise unique quotidienne contre une surcharge en fer transfusionnelle, a été autorisé en 2009 aux Etats-Unis, en Europe, en Suisse et dans d'autres pays pour élever le dosage à 40 mg/kg.

Exjade (USD 652 million, +27% lc), currently approved in more than 90 countries as the only once-daily oral therapy for transfusional iron overload, received regulatory approvals in 2009 in the US, Europe, Switzerland and other countries to extend the dose range to 40 mg/kg.
Exjade (USD 652 millions, +27% 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, a été homologué en 2009 aux Etats-Unis, en Europe, en Suisse et dans d'autres pays pour élever le dosage à 40 mg/kg.

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.

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.

narcotics and concerning risk limitation and therapeutic advice and of 22 January 1998 governing certain psychotropic substances and concerning risk limitation and therapeutic advice and of 12 April 1974 containing certain provisions relating to substances with hormonal, antihormonal, anabolic, beta-adrenergic, anti-infectious, antiparasitic and anti-inflammatory action Law of 15 July 1985 on the use in animals of substances with hormonal, anti-hormonal, beta-adrenergic or production stimulating action Law of 13 June 1986 on the removal and transplanting of organs, with regard to cells and tissues Law of 28 August 1991 on the practice of veterinary medicine, regarding the provision of medicines to animal carers Law of 5 July 1994 on blood and blood derivatives of human origin Law of 7 May 2004 on experiments on the human person Royal decree of 31 May 1885 approving new instructions for physicians, pharmacists and druggists Royal decree of 22 September 1966 on the conditions and arrangements for the recognition of laboratories for the analysis and checking of medicines Royal decree of 6 June 1960 on the production, preparation and wholesale distribution and delivery of medicines Royal decree no. 78 of 10 November 1967 on the practice of the healthcare professions regarding the dispensing of medicines to the public and Royal decree of 25 September
narcotics and concerning risk limitation and therapeutic advice and of 22 January 1998 governing certain psychotropic substances and concerning risk limitation and therapeutic advice and of 12 April 1974 containing certain provisions relating to substances with hormonal, antihormonal, anabolic, beta-adrenergic, anti-infectious, antiparasitic and anti-inflammatory action Law of 15 July 1985 on the use in animals of substances with hormonal, anti-hormonal, beta-adrenergic or production stimulating action Law of 13 June 1986 on the removal and transplanting of organs, with regard to cells and tissues Law of 28 August 1991 on the practice of veterinary medicine, regarding the provision of medicines to animal carers Law of 5 July 1994 on blood and blood derivatives of human origin Law of 7 May 2004 on experiments on the human person Royal decree of 31 May 1885 approving new instructions for physicians, pharmacists and druggists Royal decree of 22 September 1966 on the conditions and arrangements for the recognition of laboratories for the analysis and checking of medicines Royal decree of 6 June 1960 on the production, preparation and wholesale distribution and delivery of medicines Royal decree no. 78 of 10 November 1967 on the practice of the healthcare professions regarding the dispensing of medicines to the public and Royal decree of 25 September

Since 1 January 2007, the law has been in force requiring a preliminary approval for the payment by pharmaceutical companies or producers of medical devices of the participation costs of healthcare professionals in scientific events involving at least one night’s accommodation.
Since 1 January 2007, the law has been in force requiring a preliminary approval for the payment by pharmaceutical companies or producers of medical devices of the participation costs of healthcare professionals in scientific events involving at least one night’s accommodation.

If no comments have been received within this timeframe, it is tacitly assumed that the FAMHP has approved the commencement of the clinical trial.
If no comments have been received within this timeframe, it is tacitly assumed that the FAMHP has approved the commencement of the clinical trial.