Você procurou por: biosimilar (Inglês - Estoniano)

omnitrope is a ‘biosimilar’ medicine.
omnitrope on bioekvivalentne ravim.

‘inflectra is a ‘biosimilar’ medicine.
inflectra on bioloogiliselt sarnane ravim.

abasaglar is a biosimilar medicinal product.
abasaglar on bioloogiliselt sarnane ravim.

filgrastim hexal is a ‘biosimilar’ medicine.
filgrastim hexal on bioloogiliselt sarnane ravim.

epoetin alfa hexal is a ‘biosimilar’ medicine.
epoetin alfa hexal on bioloogiliselt sarnane ravim.

flixabi contains the active substance infliximab and is a ‘biosimilar medicine’.
flixabi sisaldab toimeainena infliksimabi ja on bioloogiliselt sarnane ravim.

for more information on biosimilar medicines, see the question-and-answer document here.
lisateavet bioekvivalentsete ravimite kohta leiate teabedokumendist siin.

accofil, which contains the active substance filgrastim, is a ‘biosimilar medicine’.
accofil, mis sisaldab toimeainena filgrastiimi, on bioloogiliselt sarnane ravim.

at this point in time, the chmp was of the opinion that alpheon could not be considered as a biosimilar medicine of roferon-a, the reference medicinal product.
inimtervishoius kasutatavate ravimite komitee jäi seisukohale, et alpheoni ei saa pidada originaalravimiga roferon- a bioloogiliselt sarnaseks ravimiks.

the agency will implement a number of adopted guidelines relating to similar biological (biosimilar) medicinal products, and will consolidate procedures for generic medicines.
emea rakendab mitmeid seoses bioloogiliselt sarnaste ravimitega vastu võetud suuniseid ja konsolideerib geneeriliste ravimite menetluskorrad.

bemfola is a biosimilar medicinal product, i.e. a medicine that has been demonstrated to be similar in quality, safety and efficacy to the reference medicinal product gonal-f.
bemfola on bioloogiliselt sarnane ravim, st ravim, mis sarnaneb kvaliteedilt, ohutuselt ja efektiivsuselt võrdlusravimiga gonal-f.

risk management plans are normally required for new active substances, biosimilars, medicinal products for paediatric use and for medicinal products for human use involving a significant change in the marketing authorisation, including a new manufacturing process of a biotechnologically-derived medicinal product.
riskijuhtimiskavasid nõutakse tavaliselt uute toimeainete, bioloogiliselt sarnaste ravimite, pediaatrias kasutatavate ravimite ja inimtervishoius kasutatavate ravimite puhul, mis nõuavad olulise muudatuse tegemist müügiloas, kaasa arvatud uus tootmisprotsess biotehnoloogiliselt toodetud ravimite puhul.