検索ワード: registracijas (ラトビア語 - 英語)

registracijas
date of first authorisation

registracijas numurs
marketing authorisation number(s)

registracijas numurs( i)
marketing authorisation number(s)

registracijas apliecibas ipaŠnieks
marketing authorisation holder

registracijas/ parregistracijas datums
9 date of first authorisation/ renewal of the authorisation

registracijas apliecibas ipašnieks un ražotajs
marketing authorisation holder and manufacturer

registracijas apliecibas ipaŠnieka nosaukums un adrese
name and address of the marketing authorisation holder

16 zinatniskie sledzieni par grozijumiem registracijas aplieciba
16 scientific conclusions for the amendment of the marketing authorisation

ipaŠas saistibas, kas jaizpilda registracijas apliecibas ipaŠniekam
specific obligations to be fulfilled by the marketing authorisation holder

nosacijumi un ierobeŽojumi attieciba uz piegadi un lietoŠanu, kas uzlikti registracijas apliecibas ipaŠniekam
conditions or restrictions regarding supply and use imposed on the marketing authorisation holder

registracijas apliecibas ipašnieks nodrošina farmakovigilances sistemas ieviešanu un funkcionešanu pirms produkta nonakšanas tirgu.
the mah must ensure that the system of pharmacovigilance is in place and functioning before the product is placed on the market.

izvertejot pozitivos petijuma rezultatus, tiks nodrošinatas nepieciešamas registracijas variacijas dozešanas un indikaciju paplašinašanai grutniecem.
2. post-marketing surveillance a) prior to launch in any eu member state, the mah will set up a post-marketing surveillance programme to collect the following information about congenital at deficient patients treated with atryn

registracijas apliecibas ipašnieks apnemas veikt petijumus, ka ari papildus farmakovigilances pasakumus, noraditos farmakovigilances plana.
the mah commits to performing the studies and additional pharmacovigilance activities detailed in the pharmacovigilance plan.

registracijas apliecibas ipašnieks leo pharma a/ s, industriparken 55, dk- 2750 ballerup, danija.
marketing authorisation holder leo pharma a/s, industriparken 55, dk-2750 ballerup, denmark.

zalu nosaukumu, formu, stiprumu, lietoŠanas veida, dalibvalstu, norvegijas un islandes registracijas apliecibas ipaŠnieku saraksts
list of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, and marketing authorisation holders in the member states and norway and iceland

saglabajas labveliga un registracijas apliecibam ir japaliek speka atbilstoši parskatitajiem zalu aprakstiem (pievienoti iii pielikuma pie chmp sledziena),
the agreed indications remains favourable and the marketing authorisations should be maintained according to revised summaries of product characteristics (attached in annex iii of the chmp opinion),

registracijas apliecibas ipašnieks (mah) apnemas veikt globalu kardiovaskularo petijumu, lai apstiprinatu celecoxib ilgtermina kardiovaskularo drošibu.
the mah commits to performing a global cv study to confirm long term cv safety of celecoxib.

registracijas apliecibas ipašniekam ir jaizpilda sekojoša petijumu programma noteiktaja laika posma, un tas rezultati bus par pamatu ikgadejai ieguvumu/ riska profila novertešanai.
the marketing authorisation holder shall complete the following programme of studies within the specified time frame, the results of which shall form the basis of the annual reassessment of the benefit/ risk profile.

antivielu parbaude javeic pec arsta pieprasijuma, ka ari tad, kad registracijas apliecibas ipašnieks ir sanemis zinojumu, kas varetu liecinat par iespejamam imunologiskam reakcijam vai medikamenta neefektivitati.
this antibody testing should be provided upon request of a physi cian and when the mah receives a report suggestive of a possible immune reaction or lack of efficacy.

b) pirms produkta ieviešanas jebkura es dalibvalsti registracijas apliecibas ipašnieks ieviesis imunologiskas uzraudzibas programmu, ka ari nodrošinas arstiem antivielu pret anti- atryn parbaudes iespejas.
b) prior to launch in any eu member state, the mah will set up an immunosurveillance programme and provide antibody testing for anti-atryn antibodies to physicians.