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registracijas
date of first authorisation
Last Update: 2011-10-23
Usage Frequency: 1
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registracijas numurs
marketing authorisation number(s)
Last Update: 2012-04-10
Usage Frequency: 2
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registracijas apliecibas ipaŠnieks
marketing authorisation holder
Last Update: 2012-04-10
Usage Frequency: 4
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registracijas/ parregistracijas datums
9 date of first authorisation/ renewal of the authorisation
Last Update: 2012-04-10
Usage Frequency: 2
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registracijas apliecibas ipašnieks un ražotajs
marketing authorisation holder and manufacturer
Last Update: 2017-04-26
Usage Frequency: 3
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registracijas apliecibas ipaŠnieka nosaukums un adrese
name and address of the marketing authorisation holder
Last Update: 2012-04-10
Usage Frequency: 2
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16 zinatniskie sledzieni par grozijumiem registracijas aplieciba
16 scientific conclusions for the amendment of the marketing authorisation
Last Update: 2011-10-23
Usage Frequency: 1
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"darba likumdošanas modernizēšana" (zaļā gramata)
modernising labour law (green paper)
Last Update: 2017-04-06
Usage Frequency: 1
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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
Last Update: 2012-04-10
Usage Frequency: 2
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komisija 2010. gada jūlijā zalaja gramata izvirzīja vairākus risinājumus saskaņotākai pieejai līgumtiesībām.
in july 2010, the commission put forward several options in a green paper for a more coherent approach to contract law.
Last Update: 2017-04-26
Usage Frequency: 1
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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
Last Update: 2012-04-10
Usage Frequency: 2
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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.
Last Update: 2011-10-23
Usage Frequency: 1
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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.
Last Update: 2011-10-23
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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
Last Update: 2012-04-10
Usage Frequency: 2
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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),
Last Update: 2011-10-23
Usage Frequency: 1
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c) registracijas apliecibas ipašnieks nodrošinas, ka arstiem izsniegtajos materialos ir sniegta informacija par pectirdzniecibas uzraudzibas programmu un imunologisko reakciju uzraudzibas programmu.
c) the mah will ensure that material provided to physicians provides information on the post-marketing surveillance programme and the immunosurveillance programme.
Last Update: 2012-04-10
Usage Frequency: 2
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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.
Last Update: 2012-04-10
Usage Frequency: 2
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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.
Last Update: 2012-04-10
Usage Frequency: 2
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lietuviešu valodā licencija galioja … (išdavusioji valstybė narė) / mėsa skirta perdirbimui … [produktai a] [produktai b] (ištrinti nereikalingą) … (tikslus įmonės, kurioje bus perdirbama, pavadinimas ir registracijos nr.)
in lithuanian licencija galioja … (išdavusioji valstybė narė) / mėsa skirta perdirbimui … [produktai a] [produktai b] (ištrinti nereikalingą) … (tikslus įmonės, kurioje bus perdirbama, pavadinimas ir registracijos nr.)
Last Update: 2014-11-21
Usage Frequency: 5
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