Traduction de «july approved » (Néerlandais → Français) :

- Japan filing achieved in July Approved Q4 2009 Q1 2010 - Positive Committee for Medicinal Products for Human Use (CHMP) opinion received in September
- Dépôt en juillet d’une demande au Japon Autorisé T4 2009 T1 2010 - Avis favorable émis en septembre par le Comité des médicaments à usage humain (CHMP)

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

R&D maintains momentum: Anti-cancer therapy Afinitor introduced in the US, awaiting EU approval; new biologic Ilaris and OTC brand Prevacid 24HR gain US approvals; clinical trials set to start in July for A(H1N1) pandemic flu vaccine
R&D maintient son élan: Afinitor, traitement anticancer lancé aux USA et en attente d’homologation dans l’Union européenne; Ilaris, nouveau médicament biologique, et Prevacid 24HR, vendu sans ordonnance, tous deux autorisés aux Etats-Unis; début en juillet des essais cliniques d’un vaccin contre la pandémie de grippe A(H1N1)

In July 2009, Ilaris received a positive opinion for European Union regulatory approval.
En juillet 2009, Ilaris a reçu un avis positif de l’Union européenne favorable à une homologation.

Submission for US approval of Diovan (valsartan) for the prevention of new onset diabetes in hypertensive patients with impaired glucose tolerance and increased cardiovascular risk was achieved in July.
médicament qui prévient l’apparition du diabète et une hausse des risques cardiovasculaires chez les patients présentant une tolérance au glucose diminuée.

A dossier for EU approval of Afinitor (everolimus) in patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis was also filed in July 2010; the FDA granted everolimus priority review for this indication. The FDA action date is October 29.
contre l’astrocytome sous épendymaire à cellules géantes associé à une sclérose tubéreuse; la FDA a accordé à évérolimus le statut de revue prioritaire pour cette indication, et sa décision est attendue pour le 29 octobre.

On July 14, 2010, the SDNY preliminarily approved a class action settlement agreement between NPC and the plaintiffs to end the ongoing proceedings.
Le 14 juillet 2010, le SDNY a donné son approbation préliminaire à un accord de règlement de la plainte collective conclu entre NPC et les demanderesses pour mettre fin à la procédure.

Nevertheless, in view of the fact that this type of drink is already allowed in several European countries and taking into account the European regulations concerning this type of product, in the end, the competent French authorities have been obliged to give their approval (Decree of the European Court of Justice, Press release No. 12/04, 2004) for this beverage, which was marketed on 15 July 2008.
Néanmoins, considérant que ce type de boisson est déjà autorisé dans plusieurs pays d’européens et compte tenu de la réglementation européenne sur ce type de produit, les autorités compétentes françaises ont finalement dû l’autoriser (Arrêt de la Cour de Justice européenne, Communiqué de presse n° 12/04, 2004). Sa commercialisation a effectivement débuté en date du 15 juillet 2008.

The US approved Exforge in July 2008 as a first-line therapy, providing a new growth opportunity.
En juillet 2008, les Etats-Unis ont autorisé Exforge en tant que traitement de première ligne ce qui a impulsé sa croissance.