Usted buscó: authorisation (Español - Alemán)

post-authorisation
post-authorisation

marketing authorisation holder
1a, lt- 09312 vilnius, litauen

marketing authorisation number(s)
zulassungsnummer(n)

fecha de la primera authorisation: 10 mayo 2010
datum der zulassung: 10 mai 2010

notice to marketing authorisation holders – pharmacovigilance guidlines
notice to marketing authorisation holders – pharmacovigilance guidlines

stability testing for variation to a marketing authorisation type ii marzo de 1997
stability testing for variation to a marketing authorisation type ii nahme im märz 1997

european medicines agency post-authorisation evaluation of medicines for human use
european medicines agency post-authorisation evaluation of medicines for human use

the european medicines agency pre-authorisation evaluation of medicines for human use
the european medicines agency pre-authorisation evaluation of medicines for human use

date of first authorisation: 21 february 1997 date of latest renewal: 21 february 2007
datum der erteilung der zulassung: 21 februar 1997

standard operating procedure on the release of assessment reports to applicants / marketing authorisation holders
standard operating procedure on the release of assessment reports to applicants / marketing authorisation holders

the european agency for the evaluation of medicinal products pre-authorisation evaluation of medicines for human use
the european agency for the evaluation of medicinal products beurteilung von humanarzneimitteln vor der zulassung

pre-authorisation studies to assess the potential for resistance resulting from the use of antimicrobial veterinary medicinal products
pre-authorisation studies to assess the potential for resistance resulting from the use of antimicrobial veterinary medicinal products

carcinogenicity testing pre-authorisation studies to assess the potential for resistance resulting from the use of antimicrobial veterinary medicinal products
carcinogenicity testing pre-authorisation studies to assess the potential for resistance resulting from the use of antimicrobial veterinary medicinal products

cpmp/ qwp/ 576/ 96 note for guidance on stability testing for a type ii variation to a marketing authorisation
note for guidance on stability testing for a type ii variation to a marketing authorisation

position paper on the regulatory requirements for the authorisation of low-dose modified release asa formulations in the secondary prevention of cardiovascular events.
position paper on the regulatory requirements for the authorisation of low-dose modified release asa formulations in the secondary prevention of cardiovascular events.

http://ec.europa.eu/food/plant/gmo/authorisation/index_en.htm.
http://ec.europa.eu/food/plant/gmo/authorisation/index_en.htm

contribution to part s.2.3 of the structure of the dossier for applications for marketing authorisation – control of starting materials for the production of plasma-derived medicinal products
contribution to part s.2.3 of the structure of the dossier for applications for marketing authorisation – control of starting materials for the production of plasma-derived medicinal products

authorisation of chemicals- registro,evaluación y autorización de productos químicos) es garantizar que las sustanciasquímicas usadas en los productos de cadadía son seguras para el ser humano y parael medio ambiente.
manche dieser stoffe,etwa ddt und pcb, sind in europa seit jahrzehnten verboten, wegen ihrer langle-bigkeit jedoch immer noch in der umweltvorhanden. letztes jahr führte der wwfeinen ähnlichen versuch bei 156 personendurch, darunter auch bei der früheren umweltkommissarin margot wallström.

el calendario de toda evaluación del riesgo o impacto debería ser coherente con la creciente demanda de evaluación del riesgo de los productos químicos en virtud de reach (registration, evaluation and authorisation of chemicals).
der zeitplan für etwaige risikobewertungen oder verträglichkeitsprüfungen sollte mit dem steigenden bedarf an risikobewertungen für chemikalien im zuge der verordnung zu chemischen stoffen "reach" (registrierung, bewertung und zulassung von chemischen stoffen) vereinbar sein.

concept paper on the development of an addendum on the clinical requirements of modified release medicinal products submitted as a line-extension of an existing marketing authorisation to the cpmp note for guidance on modified release oral and transdermal dosage forms: section ii (pharmacokinetic and clinical evaluation) (cpmp/ewp/280/96)
concept paper on the development of an addendum on the clinical requirements of modified release medicinal products submitted as a line-extension of an existing marketing authorisation to the cpmp note for guidance on modified release oral and transdermal dosage forms: section ii (pharmacokinetic and clinical evaluation) (cpmp/ewp/280/96)