Vertaling van "approval in june " (Nederlands → Frans) :

In the US, where Genentech holds the rights to Lucentis, the treatment of macular edema following retinal vein occlusion (RVO) was approved in June.
Cette indication est actuellement examinée par les autorités réglementaires de l’UE. Aux Etats-Unis, où Genentech détient les droits de Lucentis, le traitement de l’œdème maculaire à la suite d’une occlusion veineuse rétinienne a été autorisé en juin.

Ilaris (canakinumab, formerly ACZ885), a human antibody targeting IL-1 beta, received US regulatory approval in June as a new therapy to treat children as young as four years old and adults with CAPS (Cryopyrin-Associated Periodic Syndromes), a group of serious life-long auto-inflammatory diseases.
Ilaris (canakinumab, anciennement ACZ885), un anticorps humain ciblant IL-1 bêta, a été autorisé en juin aux Etats-Unis comme nouveau traitement chez les enfants de plus de quatre ans et les adultes atteints des syndromes périodiques associés à la cryopyrine (CAPS), un groupe de maladies auto-inflammatoires sévères durant toute la vie.

A single-pill combination with valsartan was also submitted for European approval in June 2009, matching a US submission in late 2008.
Une demande d’autorisation pour une combinaison avec valsartan en un seul comprimé a également été déposée en juin 2009 en Europe et à fin 2008 aux Etats-Unis.

Certican (everolimus), an oral inhibitor of the mTOR pathway, was submitted for US regulatory approval in June for use in kidney transplant patients.
Certican (évérolimus), inhibiteur par voie orale de la voie mTOR, a fait l’objet, en juin, d’une demande d’homologation au Etats-Unis pour les transplantations du rein.

Reclast/Aclasta, approved for five indications, gained additional US approval in May as the only therapy to prevent postmenopausal osteoporosis with convenient, less-frequent dosing, while European approval was granted in June for treatment of osteoporosis caused by steroid treatment in men and postmenopausal women, an indication already approved in the US.
Autorisé pour cinq indications, Aclasta/Reclast a obtenu en mai des autorisations supplémentaires aux Etats-Unis en tant que seul traitement pratique et peu fréquent destiné à prévenir l’ostéoporose postménopausique. En Europe, l’autorisation a été accordée en juin pour le traitement de l’ostéoporose provoquée par des stéroïdes chez l’homme et la femme postménopausée, indication déjà homologuée aux Etats-Unis.

Q2 2010 selected major approvals: US, Europe and Japan Product Active ingredient Indication Approval date Certican Everolimus Kidney transplantation US – April Diovan Valsartan Pediatric hypertension EU – April Tasigna Nilotinib Newly diagnosed CML US – June
Autorisations importantes au deuxième trimestre 2010, USA, Europe et Japon Produit Substance active Indication Date d’autorisation Certican Evérolimus Transplantation rénale USA, avril Diovan Valsartan Hypertension pédiatrique UE, avril Tasigna Nilotinib LMC diagnostiquée précocement USA, juin

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

In June, following priority review, the US FDA approved Tasigna for the treatment of adult patients with newly diagnosed CML in the chronic phase.
Faisant suite à une revue prioritaire, la FDA a autorisé, en juin, Tasigna pour le traitement de patients adultes atteints d’une LMC chronique décelée précocement.