You searched for: inimravimikomitee (Estniska - Engelska)

inimravimikomitee
committee for medicinal products for human use (chmp)

käesolevaga luuakse inimravimikomitee.
a committee for medicinal products for human use is hereby established.

oma arvamuse ettevalmistamiseks inimravimikomitee:
in order to prepare its opinion, the committee for medicinal products for human use:

milline oli sel ajal inimravimikomitee soovitus?
what was the recommendation of the chmp at that time?

mis olid inimravimikomitee ettevaatlikkuse peamised põhjused?
what were the main concerns of the chmp?

hindamine oli lõppenud ja inimravimikomitee oli andnud negatiivse arvamuse.
the evaluation had finished and the chmp had given a negative opinion.

inimravimikomitee arvas, et lacosamide pain ucb pharma kasulikkus ei ole tõendatud.
the chmp was concerned that the studies had not shown a meaningful benefit of lacosamide pain ucb pharma.

amet teavitab müügiloa taotlejat või omanikku viivitamata järgmistest inimravimikomitee arvamustest:
the agency shall forthwith inform the applicant if the opinion of the committee for medicinal products for human use is that:

inimravimikomitee inimravimitega seotud riskijuhtimissüsteemi juhendi kohaselt tuleb esitada uuendatud riskijuhtimiskava.
an updated risk management plan should be provided as per the chmp guideline on risk management system for medicinal products for human use.

võtab vastu arvamuse inimravimikomitee ja veterinaarravimikomitee töökorra kohta (artikkel 61);
adopt an opinion on the rules of procedures of the committee for medicinal products for human use and the committee for medicinal products for veterinary use (article 61);

inimravimikomitee oli ettevõttele esitatud küsimuste vastused läbi vaadanud, kuid mõni küsimus oli veel lahendamata.
after the chmp had assessed the responses from the company to a list of questions, there were still some unresolved issues outstanding.

inimravimikomitee otsustas, et müügiloa hoidja peab jätkama perioodiliste ohutusaruannete esitamist iga 6 kuu järel.
the chmp decided that the mah should continue to submit 6 monthly psurs.

selles selgitatakse, kuidas inimravimikomitee hindas tehtud uuringuid, et koostada ravimi kasutamise soovitused.
it explains how the committee for medicinal products for human use (chmp) assessed the studies performed, to reach their recommendations on how to use the medicine.

seetõttu leidis inimravimikomitee, et nagu ka neupogeni puhul, ületab tevagrastimist saadav kasulikkus ilmnenud riskid.
therefore, the chmp’s view was that, as for neupogen, the benefit outweighs the identified risk.

seetõttu leidis inimravimikomitee, et nagu ka neupogeni puhul, ületab filgrastim ratiopharmist saadav kasulikkus ilmnenud riskid.
therefore, the chmp’s view was that, as for neupogen, the benefit outweighs the identified risk.

ameti tegevdirektori või komisjoni esindaja taotlusel koostab inimravimikomitee ka arvamuse mis tahes teadusküsimuse kohta, mis puudutab inimravimite hindamist.
at the request of the executive director of the agency or the commission representative, the committee for medicinal products for human use shall also draw up an opinion on any scientific matter concerning the evaluation of medicinal products for human use.

a) inimravimikomitee, mis vastutab ameti arvamuse koostamise eest mis tahes inimravimite hindamist puudutava küsimuse kohta;
(a) the committee for medicinal products for human use, which shall be responsible for preparing the opinion of the agency on any question relating to the evaluation of medicinal products for human use;

inimravimikomitee ja veterinaarravimikomitee võivad juhul, kui nad peavad seda asjakohaseks, küsida juhtnööre olulistes üldistes teadus- või eetikaküsimustes.
the committee for medicinal products for human use and the committee for medicinal products for veterinary use may, if they consider it appropriate, seek guidance on important questions of a general scientific or ethical nature.

kui soovite lisateavet inimravimikomitee soovituste aluse kohta, lugege palun teadusliku arutelu kokkuvõtet (samuti euroopa avaliku hindamisaruande osa).
if you want more information on the basis of the chmp recommendations, read the scientific discussion (also part of the epar).

- seetõttu soovitas inimravimikomitee teha ravimi omaduste kokkuvõtte lõikudes 4. 1, 4. 2, 4. 3, 4. 4, 5. 1
- the chmp, as a consequence, recommended the amendment of the summary of product