Results for authorisation translation from French to Portuguese

pre-authorisation
adm inistration

legal-authorisation department
legal‑authorisation department

marketing authorisation number(s)
nÚmero( s) da autorizaÇÃo de introduÇÃo no mercado

name of the marketing authorisation holder
nome do titular da autorizaÇÃo de introduÇÃo no mercado

date of first authorisation: 10 mai 2010
data da primeira autorização: 10 maio 2010

date de première authorisation: 23/02/2012
data da primeira authorização: 23/02/2012

name and address of the marketing authorisation holder
nome e endereÇo do titular da autorizaÇÃo de introduÇÃo no mercado

titulaire de l’ authorisation de mise sur le marché
autorização de introdução no mercado

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

marketing authorisation holder takeda pharma ges. m. b. h.
takeda pharma ges. m. b. h.

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

excipients in the dossier for application for marketing authorisation for veterinary medicinal products.
excipients in the dossier for application for marketing authorisation for veterinary medicinal products

( b ) direct debit instructions carried out under a direct debit authorisation ;
( b ) direct debit instructions carried out under a direct debit authorisation ;

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 pre- authorisation evaluation of medicines for human use

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

notice to marketing authorisation holders (for inclusion in volume 9 of the rules governing medicinal products for human use)
linhas de orientação notice to marketing authorisation holders (for inclusion in volume 9 of the rules governing medicinal products for human use)

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.

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