Vertaling van "japan in april under " (Nederlands → Frans) :

Galvus was launched in Japan in April under the brand name Equa.
Galvus a été lancé en avril au Japon sous la marque Equa.

Japan (USD 0.7 billion, -4% cc) was impacted by a slowdown in demand ahead of the biennial price cuts in April, masking underlying momentum from the regulatory approvals of nine new medicines since 2009.
Le Japon (USD 0,7 milliard, -4% tcc) a été impacté par un ralentissement de la demande en prélude aux réductions bisannuelles de prix qui ont lieu en avril.

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

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Indication US EU Japan News update ABF656 Hepatitis C Q4 2009 - Dossier for ABF656 at once-everytwo-weeks dosing was withdrawn in EU in April since additional information would be requested that could not be generated within required timeframe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

Selected projects awaiting regulatory decisions Completed submissions Product Indication US EU Japan News update ABF656 Hepatitis C Q4 2009 - EU submission withdrawn in April 2010 for technical reasons
Projets pharmaceutiques importants en attente de décisions réglementaires Demandes déposées Produit Indication USA UE Japon Mise à jour ABF656 Hépatite C T4 2009 - Retrait en avril 2010 de la soumission dans l’UE pour des raisons techniques Exelon Patch Maladie Autorisé Autorisé T1 2010 d’Alzheimer

Galvus was approved in Japan in January 2010 under the brand name Equa.
Galvus a été homologué en janvier 2010 au Japon sous la marque Equa.

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.

1974 on the opening, transfer and merger of retail pharmacies Royal decree of 9 July 1984 on the provision of information and advertising relating to medicines Royal decree of 11 January 1993 determining the conditions under which medicines for human use may be supplied in sample form Royal decree of 7 April 1995 on the provision of information and advertising relating to medicines for human use Royal decree of 15 July 1997 on active implantable medical devices, transposing Directive 90/385 EEC (AIMD) Royal decree of 19 December 1997 on the control and analysis of the raw materials used by dispensing chemists Royal decree of 18 March 1999 on medical devices, transposing Directive 93/42/EEC of 14 June 1993 (MDD) Royal decree of 11 July 2003 determining the conditions under which medicines for veterinary use may be supplied in sample form Law of 16 December 2004 modifying the regulations on combating abuses in the promotion of medicines Royal decree of 10 June 2006 establishing the report point referred to in Article 10, § 5, of the law of 25 March 1964 on medicines Royal decree of 23 November 2006 implementing Article 10, § 3, of the law of 25 March 1964 on medicines Royal decree of 25 February 2007 recognising the institutions referred to in Article 10 § 3 of the law of 25 March 1964 on medicines
1974 on the opening, transfer and merger of retail pharmacies Royal decree of 9 July 1984 on the provision of information and advertising relating to medicines Royal decree of 11 January 1993 determining the conditions under which medicines for human use may be supplied in sample form Royal decree of 7 April 1995 on the provision of information and advertising relating to medicines for human use Royal decree of 15 July 1997 on active implantable medical devices, transposing Directive 90/385 EEC (AIMD) Royal decree of 19 December 1997 on the control and analysis of the raw materials used by dispensing chemists Royal decree of 18 March 1999 on medical devices, transposing Directive 93/42/EEC of 14 June 1993 (MDD) Royal decree of 11 July 2003 determining the conditions under which medicines for veterinary use may be supplied in sample form Law of 16 December 2004 modifying the regulations on combating abuses in the promotion of medicines Royal decree of 10 June 2006 establishing the report point referred to in Article 10, § 5, of the law of 25 March 1964 on medicines Royal decree of 23 November 2006 implementing Article 10, § 3, of the law of 25 March 1964 on medicines Royal decree of 25 February 2007 recognising the institutions referred to in Article 10 § 3 of the law of 25 March 1964 on medicines

“Comparative cost analysis: Community based services as an alternative to institutions" , tender no. VT/2005/021, Official Journal on 22 June 2005 N° 2005/S 119-117014 [http ...]
K. ; Paul R (Hrsg.) : Health Promoting Hospitals in Practice: Developing Projects and Networks – Conrad, Gamburg Inclusion Europe, Included in Society (2003-2004), projet réalisé dans le contexte du Fonds social européen ( [http ...]