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markaðssetningar

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IJslands

Engels

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IJslands

nýlegrar markaðssetningar lyfsins (júní 2011)

Engels

recent marketing of the veterinary medicinal product (june 2011)

Laatste Update: 2017-04-26
Gebruiksfrequentie: 1
Kwaliteit:

IJslands

ecdc ljóstrar ekki upp um persónuupplýsingar þínar í tilgangi markaðssetningar.

Engels

ecdc will not divulge your personal data for direct marketing purposes.

Laatste Update: 2014-06-03
Gebruiksfrequentie: 1
Kwaliteit:

Waarschuwing:
Deze centrering kan foutief zijn.
Gelieve het te verwijderen indien je dit meent.

IJslands

markaðsleyfishafinn skal upplýsa framkvæmdastjórn evrópusambandsins um markaðssetningar- áætlanir fyrir lyfið.

Engels

the holder of this marketing authorisation must inform the european commission about the marketing plans for the medicinal product authorised by this decision.

Laatste Update: 2017-04-26
Gebruiksfrequentie: 1
Kwaliteit:

IJslands

er hér átt við alla virðiskeðjuna frá veiðum, fiskeldi og vinnslu, til markaðssetningar og sölu fiskafurða.

Engels

this applies to the whole value chain; from fishing, aquaculture and processing, to marketing and sale of fish products.

Laatste Update: 2017-09-15
Gebruiksfrequentie: 1
Kwaliteit:

Referentie: Agwingate

IJslands

markaðsleyfishafinn verður að fallast á útlit og innihald ofangreinds efnis ásamt lyfjastofnun áður en til markaðssetningar kemur.

Engels

the marketing authorisation holder shall agree the format and content of the above material with the national competent authority prior to launch in the member state.

Laatste Update: 2017-04-26
Gebruiksfrequentie: 1
Kwaliteit:

Referentie: Agwingate

IJslands

markmið heilbrigðistengdrar samfélagslegrar markaðssetningar er að bæta heilsu fólks og lífsgæði í raunverulegu félagslegu, pólitísku og efnahagslegu umhverfi.

Engels

health-related social marketing aims at improving people’s health and quality of their life in concrete social, political and economic environment.

Laatste Update: 2014-06-03
Gebruiksfrequentie: 1
Kwaliteit:

Referentie: Agwingate
Waarschuwing:
Deze centrering kan foutief zijn.
Gelieve het te verwijderen indien je dit meent.

IJslands

4 Þessi aukaverkun kom fram við öryggiseftirlit í kjölfar markaðssetningar hvað varðar ýmist efavírenz, emtrícítabín eða tenófóvír tvísóproxíl fúmarat.

Engels

4 this adverse reaction was identified through post-marketing surveillance for either efavirenz, emtricitabine or tenofovir disoproxil fumarate.

Laatste Update: 2017-04-26
Gebruiksfrequentie: 1
Kwaliteit:

Referentie: Agwingate

IJslands

2 Þessi aukaverkun kom fram við öryggiseftirlit í kjölfar markaðssetningar en ekki varð vart við hana í slembiröðuðum klínískum samanburðarrannsóknum eða við undanþágumeðferð með tenófóvír tvísóproxíl fúmarati.

Engels

2 this adverse reaction was identified through post-marketing surveillance but not observed in randomised controlled clinical trials or the tenofovir disoproxil fumarate expanded access program.

Laatste Update: 2017-04-26
Gebruiksfrequentie: 1
Kwaliteit:

Referentie: Agwingate

IJslands

3 Þessarar aukaverkunar sem kom fram við öryggiseftirlit í kjölfar markaðssetningar varð ekki vart í slembiröðuðum klínískum samanburðarrannsóknum á emtrícítabíni hjá fullorðnum eða í klínískum hiv rannsóknum á emtrícítabíni hjá börnum.

Engels

3 this adverse reaction, which was identified through post-marketing surveillance, was not observed in randomised controlled clinical trials in adults or paediatric hiv clinical trials of emtricitabine.

Laatste Update: 2017-04-26
Gebruiksfrequentie: 1
Kwaliteit:

Referentie: Agwingate

IJslands

tafla 1: tafla með samantekt á aukaverkunum tengdum adefóvír tvípívoxíli, byggt á reynslu af klínískri rannsókn og í kjölfar markaðssetningar.

Engels

table 1: tabulated summary of adverse reactions associated with adefovir dipivoxil based on clinical study and post-marketing experience

Laatste Update: 2017-04-26
Gebruiksfrequentie: 1
Kwaliteit:

Referentie: Agwingate

IJslands

7 Þessi aukaverkun kom fram við öryggiseftirlit í kjölfar markaðssetningar á eviplera (föst samsetning) en ekki í slembiröðuðum klínískum samanburðarrannsóknum á eviplera.

Engels

7 this adverse reaction was identified through post-marketing surveillance for eviplera (fixed-dose combination) but not observed in randomised controlled clinical studies for eviplera.

Laatste Update: 2017-04-26
Gebruiksfrequentie: 1
Kwaliteit:

Referentie: Agwingate

IJslands

3 Þessi aukaverkun kom fram við öryggiseftirlit í kjölfar markaðssetningar en ekki varð vart við hana í slembiröðuðum klínískum samanburðarrannsóknum hjá fullorðnum eða klínískum hiv rannsóknum hjá börnum hvað varðar emtricitabin eða í slembiröðuðum klínískum samanburðarrannsóknum eða við undanþágumeðferð með tenofovir disoproxili hvað varðar tenofovir disoproxil.

Engels

3 this adverse reaction was identified through post-marketing surveillance but not observed in randomised controlled clinical studies in adults or paediatric hiv clinical studies for emtricitabine or in randomised controlled clinical studies or the tenofovir disoproxil expanded access program for tenofovir disoproxil.

Laatste Update: 2017-04-26
Gebruiksfrequentie: 1
Kwaliteit:

Referentie: Agwingate

IJslands

byggt á gögnum í kjölfar markaðssetningar getur langtímameðferð með adefóvír tvípívoxíli leitt til stigvaxandi breytingar á nýrnastarfsemi og síðan valdið því að nýrnastarfsemi skerðist (sjá kafla 4.4).

Engels

based on post-marketing data, long-term treatment with adefovir dipivoxil may lead to progressive alteration of renal function resulting in renal impairment (see section 4.4).

Laatste Update: 2017-04-26
Gebruiksfrequentie: 1
Kwaliteit:

Referentie: Agwingate

IJslands

3 Þessi aukaverkun kom fram við öryggiseftirlit í kjölfar markaðssetningar en ekki varð vart við hana í slembiröðuðum klínískum samanburðarrannsóknum hjá fullorðnum eða klínískum hiv-rannsóknum hjá börnum hvað varðar emtrícítabín eða í slembiröðuðum klínískum samanburðarrannsóknum eða við undanþágumeðferð með tenófóvír tvísóproxíl fúmarati hvað varðar tenófóvír tvísóproxíl fúmarat.

Engels

3 this adverse reaction was identified through post-marketing surveillance but not observed in randomised controlled clinical studies in adults or paediatric hiv clinical studies for emtricitabine or in randomised controlled clinical studies or the tenofovir disoproxil fumarate expanded access program for tenofovir disoproxil fumarate.

Laatste Update: 2017-04-26
Gebruiksfrequentie: 1
Kwaliteit:

Referentie: Agwingate

IJslands

Þær aukaverkanir sem taldar voru (að minnsta kosti hugsanlega) tengdar meðferð hjá fullorðnum í klínískri rannsókn og í kjölfar markaðssetningar eru taldar upp hér á eftir í töflu 2, skipt í flokka eftir líffærakerfum og tíðni.

Engels

the adverse reactions with suspected (at least possible) relationship to treatment in adults from clinical trial and post-marketing experience are listed in table 2 below by body system organ class and frequency.

Laatste Update: 2017-04-26
Gebruiksfrequentie: 1
Kwaliteit:

Referentie: Agwingate

IJslands

aukaverkanir eru skilgreindar eftir tíðni sem mjög algengar (≥ 1/10), algengar (≥ 1/100, < 1/10) eða tíðni ekki þekkt (komu fram við lyfjagát í kjölfar markaðssetningar og ekki er hægt að áætla tíðni út frá fyrirliggjandi gögnum).

Engels

frequencies are defined as very common (≥ 1/10), common (≥ 1/100, < 1/10) or not known (identified through post-marketing safety surveillance and the frequency cannot be estimated from the available data).

Laatste Update: 2017-04-26
Gebruiksfrequentie: 1
Kwaliteit:

Referentie: Agwingate
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