FrancophonIA/ELRC3.0 huggingface dataset:
Italian: entro 6 mesi dall'accordo del gruppo di coordinamento
Latvian: sešu mēnešu laikā pēc vienošanās panākšanas ar koordinācijas grupu.
Italian: Ulteriori relazioni provvisorie devono essere presentate al PRAC successivamente a cadenza semestrale per i primi due anni.
Latvian: Turpmākie starpziņojumi jāiesniedz PRAC reizi sešos mēnešos pirmos divus gadus.
Italian: I materiali devono essere presentati alle autorità nazionali competenti:
Latvian: Šie materiāli jāiesniedz valstu kompetentajām iestādēm:
Italian: La relazione finale dello studio deve essere presentata al PRAC:
Latvian: Pētījuma galīgais ziņojums jāiesniedz PRAC:
Italian: La prima relazione provvisoria deve essere presentata al PRAC:
Latvian: Pirmais starpziņojums jāiesniedz PRAC:
Italian: Le autorità nazionali competenti dello o degli Stati membri o, se pertinente, dello o degli Stati membri di riferimento garantiscono che il o i titolari dell'autorizzazione all'immissione in commercio provveda(no) a soddisfare le condizioni seguenti:
Latvian: Dalībvalsts(-u) vai atsauces dalībvalsts(-u), ja piemērojams, nacionālajām kompetentajām iestādēm jānodrošina, lai reģistrācijas apliecības īpašnieks(-i) izpildītu šādus nosacījumus:
Italian: Il disegno dello studio deve essere finalizzato a valutare e quantificare l'efficacia delle misure di minimizzazione del rischio nonché comprendere un'analisi e una valutazione pre- e postattuazione.
Latvian: Pētījuma plānojumam jābūt tādam, lai novērtētu un kvantitatīvā veidā izteiktu riska mazināšanas pasākumu efektivitāti, un tam jāietver analīze un novērtējums pirms un pēc pasākumu īstenošanas.
Italian: I titolari dell'autorizzazione all'immissione in commercio di valproato e sostanze correlate devono sviluppare e presentano materiali didattici secondo gli elementi essenziali concordati.
Latvian: Valproāta un tam radniecīgo vielu reģistrācijas apliecību īpašniekiem saskaņā ar apstiprinātajiem pamatelementiem jāizstrādā un jāiesniedz izglītojoši materiāli.
Italian: Questi materiali devono garantire che i medici prescriventi siano informati e che le pazienti comprendano e riconoscano i rischi associati all'esposizione a valproato in utero.
Latvian: Šiem materiāliem jānodrošina, lai zāļu parakstītāji būtu informēti un pacienti izprastu un apzinātos risku, kas saistīts ar valproāta iedarbību in utero.
Italian: I titolari dell'autorizzazione all'immissione in commercio di valproato e sostanze correlate devono effettuare uno studio sull'utilizzazione del medicinale, per valutare l'efficacia delle misure di minimizzazione del rischio e caratterizzare ulteriormente i modelli di prescrizione per valproato.
Latvian: Valproāta un tam radniecīgo vielu reģistrācijas apliecības īpašniekiem ir jāveic zāļu lietojamības pētījums, lai novērtētu riska mazināšanas pasākumu efektivitāti un sīkāk raksturotu valproāta parakstīšanas ieradumus.
Italian: 2015 Strovolos Nicosia Cyprus
Latvian: 2015 Strovolos Nicosia Kipra
Italian: Oficina D 28230 Las Rozas (Madrid) Spain
Latvian: Oficina D 28230 Las Rozas (Madrid)
Italian: H-1045 Budapest Hungary
Latvian: H-1045 Budapest Ungārija
Italian: MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France
Latvian: MYLAN SAS 117, allée des Parcs 69800 Saint-Priest Francija
Italian: PSC 170 00 Holesovice Czech Republic
Latvian: PSC 170 00 Holesovice Čehijas Republika
Italian: 1220 Wien Austria
Latvian: 1220 Wien Austrija
Italian: 11-15 Quai Dion Bouton 92800 Puteaux France
Latvian: 11-15 Quai Dion Bouton 92800 Puteaux Francija
Italian: 17 Bonifraterska Str. 00-203 Warsaw Poland
Latvian: 17 Bonifraterska Str. 00-203 Warsaw Polija
Italian: 17674 Kallithea, Athens Greece
Latvian: 17674 Kallithea, Athens Grieķija
Italian: 92300 Levallois-Perret France
Latvian: 92300 Levallois-Perret Francija
Italian: A. Juozapavičiaus g. 6/2 LT-09310 Vilnius Lithuania
Latvian: A. Juozapavičiaus g. 6/2 LT-09310 Vilnius Lietuva
Italian: Norvegia Desitin Arzneimittel GmbH Postfach 630164
Latvian: Norvēģija Desitin Arzneimittel GmbH Postfach 630164
Italian: Nieuwe Donk 3 4879 AC ETTEN LEUR The Netherlands
Latvian: Nieuwe Donk 3 4879 AC ETTEN LEUR Nīderlande
Italian: 92700 Colombes France
Latvian: 92700 Colombes Francija
Italian: Largo Umberto Boccioni, 1 21040 Origgio (Varese) Italy
Latvian: Largo Umberto Boccioni, 1 21040 Origgio (Varese) Itālija
Italian: 167 14 Bromma Sweden
Latvian: 167 14 Bromma Zviedrija
Italian: 104 25 Stockholm Sweden
Latvian: 104 25 Stockholm Zviedrija
Italian: Swensweg 5 2031 GA HAARLEM The Netherlands
Latvian: Swensweg 5 2031 GA HAARLEM Nīderlande
Italian: LABORATOIRES ALTER 3, avenue de la Baltique, ZI de Courtaboeuf 91140 Villebon Sur Yvette France
Latvian: LABORATOIRES ALTER 3, avenue de la Baltique, ZI de Courtaboeuf 91140 Villebon Sur Yvette Francija
Italian: Regno Unito Norton Healthcare Limited Ridings Point, Whistler Drive
Latvian: Lielbritānija Norton Healthcare Limited Ridings Point, Whistler Drive
Italian: 08019 Barcelona Spain
Latvian: 08019 Barcelona Spānija
Italian: Veluwezoom 22 1327 AH ALMERE The Netherlands
Latvian: Veluwezoom 22 1327 AH ALMERE Nīderlande
Italian: Via Scarlatti Domenico, 31 20124 Milano Italy
Latvian: Via Scarlatti Domenico, 31 20124 Milano Itālija
Italian: DEMO ABEE 21st Km Athens-Lamias National Highway 14568 Kryoneri Greece
Latvian: DEMO ABEE 21st Km Athens-Lamias National Highway 14568 Kryoneri Grieķija
Italian: 00350 Helsinki Finland
Latvian: 00350 Helsinki Somija
Italian: Regno Unito Aventis Pharma Limited One Onslow Street
Latvian: Lielbritānija Aventis Pharma Limited One Onslow Street
Italian: Orion Corporation Orionintie 1 A FI-02200 Espoo Finland
Latvian: Orion Corporation Orionintie 1 A FI-02200 Espoo Somija
Italian: Romania GEROT PHARMAZEUTIKA Ges.m.b.H.
Latvian: Rumānija GEROT PHARMAZEUTIKA Ges.m.b.H.
Italian: 90449 Nürnberg
Latvian: 90449 Nürnberg Vācija
Italian: Convulex gelule gastro résistante
Latvian: Valproiskābe Convulex gelule gastro résistante
Italian: 61118 Bad Vilbel
Latvian: 61118 Bad Vilbel Vācija
Italian: Portogallo Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda
Latvian: Portugāle Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda
Italian: 86156 Augsburg
Latvian: 86156 Augsburg Vācija
Italian: Finlandia Sanofi Oy Huopalahdentie 24 PL 22
Latvian: Sanofi Oy Huopalahdentie 24 PL 22
Italian: Remedica Ltd Aharnon Street Limassol Industrial Estate 3056 Lemesos Cyprus
Latvian: Remedica Ltd Aharnon Street Limassol Industrial Estate 3056 Lemesos Kipra
Italian: Germania IIP - Institut für industrielle Pharmazie Forschungs- und Entwicklungsgesellschaft mbH
Latvian: IIP - Institut für industrielle Pharmazie Forschungs- und Entwicklungsgesellschaft mbH
Italian: DK-2970 Hørsholm
Latvian: DK-2970 Hørsholm Dānija
Italian: Regno Unito Teva UK Limited Brampton Road, Hampden Park
Latvian: Lielbritānija Teva UK Limited Brampton Road, Hampden Park
Italian: Darwinweg 20 2333 CR LEIDEN The Netherlands
Latvian: Darwinweg 20 2333 CR LEIDEN Nīderlande
Italian: Kampenringweg 45 D-E 2803 PE GOUDA The Netherlands
Latvian: Kampenringweg 45 D-E 2803 PE GOUDA
Italian: Lettonia sanofi-aventis Latvia SIA Kr.Valdemara 33-8 Riga LV1010
Latvian: Latvija sanofi-aventis Latvia SIA Kr.Valdemara 33-8 Riga LV1010
Italian: Regno Unito Generics UK Limited Station Close, Potter's Bar Hertfordshire
Latvian: Lielbritānija Generics UK Limited Station Close, Potter's Bar Hertfordshire
Italian: Sanofi Belgium Leonardo Da Vincilaan 19 1831 Diegem Belgium
Latvian: Sanofi Belgium Leonardo Da Vincilaan 19 1831 Diegem Beļģija
Italian: Sanofi AB Box 30052
Latvian: Zviedrija Sanofi AB Box 30052
Italian: 85101 Bratislava
Latvian: 85101 Bratislava Slovākijas Republika
Italian: Wrexham Industrial Estate Wrexham, LL13 9UF United Kingdom
Latvian: Wrexham Industrial Estate Wrexham, LL13 9UF Lielbritānija
Italian: 53757 Sankt Augustin Germany
Latvian: 1 53757 Sankt Augustin Vācija
Italian: Heizel Esplanade b22 1020 Brussels Belgium
Latvian: Heizel Esplanade b22 1020 Brussels Beļģija
Italian: Austria sanofi-aventis GmbH SATURN Tower, Vienna DC Leonard-Bernstein-Straße
Latvian: Austrija sanofi-aventis GmbH SATURN Tower, Vienna DC Leonard-Bernstein-Straße
Italian: 27472 Cuxhaven
Latvian: 5 27472 Cuxhaven Vācija
Italian: Ácido Valpróico Generis
Latvian: Valproiskābe Ácido Valpróico Generis
Italian: Regno Unito Winthrop Pharmaceuticals UK Limited
Latvian: Lielbritānija Winthrop Pharmaceuticals UK Limited
Italian: Mylan BVBA/SPRL Terhulpsesteenweg 6 box A 1560 Hoeilaart Belgium
Latvian: Mylan BVBA/SPRL Terhulpsesteenweg 6 box A 1560 Hoeilaart Beļģija
Italian: 1000 Ľubľana
Latvian: 1000 Ljubljana
Italian: Germania Heumann Pharma GmbH & Co.
Latvian: Heumann Pharma GmbH & Co.
Italian: Germania Stadapharm GmbH Stadastr 2-18
Latvian: Stadapharm GmbH Stadastr 2-18
Italian: Takeda Belgium Gentsesteenweg 615 1080 Brussels Belgium
Latvian: Takeda Belgium Gentsesteenweg 615 1080 Brussels Beļģija
Italian: 83607 Hozkirchen
Latvian: 83607 Hozkirchen Vācija
Italian: Ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany
Latvian: Ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Vācija
Italian: 63741 Aschaffenburg Germany
Latvian: 63741 Aschaffenburg Vācija
Italian: 40764 Langelfeld
Latvian: 23 40764 Langelfeld Vācija
Italian: 75014 PARIS France
Latvian: 75014 PARIS Francija
Italian: Germania Dolorgiet GmbH & Co.KG Otto-von-Guericke-Str. 1
Latvian: Dolorgiet GmbH & Co.KG Otto-von-Guericke-Str.
Italian: Danimarca Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark
Latvian: Edvard Thomsens Vej 14 DK-2300 København S Dānija
Italian: 02101 Espoo
Latvian: 02101 Espoo Somija
Italian: Portogallo Sanofi - Produtos Farmacêuticos, Lda.
Latvian: Portugāle Sanofi - Produtos Farmacêuticos, Lda.
Italian: Danimarca Sanofi-aventis Denmark A/S
Latvian: Sanofi-aventis Denmark A/S
Italian: Gebäude K703
Latvian: Industriepark Höchst Gebäude K703
Italian: Lussemburgo Takeda Belgium Chaussée de Gand 615 1080 Bruxelles
Latvian: Takeda Belgium Chaussée de Gand 615 1080 Bruxelles Beļģija
Italian: Finlandia Sandoz A/S C. F. Tietgens Boulevard 40 5220 ODENSE SØ Denmark
Latvian: F. Tietgens Boulevard 40 5220 ODENSE SØ Dānija
Italian: Germania Sanofi-Aventis Deutschland GmbH
Latvian: Sanofi-Aventis Deutschland GmbH
Italian: 65926 Frankurt am main Germany
Latvian: 65926 Frankurt am main Vācija
Italian: 65926 Frankfurt am Main Germany
Latvian: 65926 Frankfurt am Main Vācija
Italian: Lussemburgo Hexal AG Industriestrasse 25 83067 Holzkirchen Germany
Latvian: Industriestrasse 25 83067 Holzkirchen Vācija
Italian: Desitin Arzneimittel Gmbh Weg beim Jaeger 214 DE-22335 Hamburg Germany
Latvian: Desitin Arzneimittel Gmbh Weg beim Jaeger 214 DE-22335 Hamburg Vācija
Italian: Slovacchia Sandoz Pharmaceuticals d.d
Latvian: Sandoz Pharmaceuticals d.d
Italian: 89150 Laichingen
Latvian: 19 89150 Laichingen Vācija
Italian: Romania Sanofi-Aventis France 1-13 Boulevard Romain Rolland
Latvian: Rumānija Sanofi-Aventis France 1-13 Boulevard Romain Rolland
Italian: Zentiva Italia Srl Viale Bodio 37/B 20158 Milano Italy
Latvian: Zentiva Italia Srl Viale Bodio 37/B 20158 Milano Itālija
Italian: Sanofi-Aventis Bulgaria EOOD
Latvian: Bulgārija Sanofi-Aventis Bulgaria EOOD
Italian: Slovacchia Orion Corporation Orionintie 1 A
Latvian: Zviedrija Orion Corporation Orionintie 1 A
Italian: Ungheria Sanofi-Aventis zrt.
Latvian: Sanofi-Aventis zrt.
Italian: Germania Neuraxpharm Arzneimittel GmbH
Latvian: Neuraxpharm Arzneimittel GmbH
Italian: Uso rettale
Latvian: Rectal use
Italian: Portogallo Generis Farmacêutica, S.A. Rua João de Deus, 19
Latvian: Rua João de Deus, 19
Italian: Regno Unito G.L.
Latvian: Lielbritānija G.L.
Italian: Germania TAD Pharma GmbH Heinz-Lohmann-Str. 5
Latvian: TAD Pharma GmbH Heinz-Lohmann-Str.
Italian: 2740-244 Porto Salvo Portugal
Latvian: 2740-244 Porto Salvo Portugāle
Italian: Germania ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19
Latvian: ALIUD PHARMA GmbH Gottlieb-Daimler-Str.
Italian: Sanofi-Aventis SpA Viale Luigi Bodio, 37/B 20158 Milano Italy
Latvian: Sanofi-Aventis SpA Viale Luigi Bodio, 37/B 20158 Milano Itālija
Italian: 64295 Darmstadt Germany valprodura 150mg
Latvian: 64295 Darmstadt Vācija valprodura 150mg
Italian: 2740-245 Porto Salvo Portugal
Latvian: 2740-245 Porto Salvo Portugāle
Italian: Sanofi-Aventis S.P.A. Viale Luigi Bodio 37/b 20158 Milano Italy
Latvian: Sanofi-Aventis S.P.A. Viale Luigi Bodio 37/b 20158 Milano Itālija
Italian: 2740-255 Porto Salvo Portugal
Latvian: 2740-255 Porto Salvo Portugāle
Italian: 64295 Darmstadt Germany valprodura 600 mg
Latvian: 64295 Darmstadt Vācija valprodura 600 mg
Italian: DEPAKINE 100 mg/ml por és oldószer oldatos injekcióhoz
Latvian: Valproiskābe DEPAKINE 100 mg/ml por és oldószer oldatos injekcióhoz
Italian: Verovškova 57 SI-1000 Ljubljana Slovenia
Latvian: SI-1000 Ljubljana Slovēnija
Italian: VALPROATE SODIUM SANDOZ 500MG
Latvian: Valproiskābe VALPROATE SODIUM SANDOZ 500MG
Italian: Slovacchia Sanofi-Aventis Slovakia s r.o.
Latvian: Sanofi-Aventis Slovakia s r.o.
Italian: Polvere per iniezione
Latvian: Pulveris injekcijām Intravenozai lietošanai
Italian: Germania Winthrop Arzneimittel GmbH
Latvian: Winthrop Arzneimittel GmbH
Italian: 64295 Darmstadt Germany valprodura 300 mg
Latvian: 64295 Darmstadt Vācija valprodura 300 mg
Italian: CONVULEX 50 mg/ml szirup gyermekeknek
Latvian: Valproiskābe CONVULEX 50 mg/ml szirup gyermekeknek
Italian: Regno Unito Ratiopharm GmbH Graf-Arco-Strasse 3
Latvian: Lielbritānija Ratiopharm GmbH Graf-Arco-Strasse 3
Italian: Dunajska cesta 151 1000 Ljubljana Slovenia
Latvian: Dunajska cesta 151
Italian: Diplexil 1000
Latvian: Valproiskābe Diplexil 1000
Italian: Convulex 50 mg/ml - Sirup für Kinder
Latvian: Valproiskābe Convulex 50 mg/ml - Sirup für Kinder
Italian: Depakine 400 mg/4 ml
Latvian: Valproiskābe Depakine 400 mg/4 ml
Italian: Germania betapharm Arzneimittel GmbH
Latvian: betapharm Arzneimittel GmbH
Italian: Sanofi-Aventis Croatia d.o.o.
Latvian: Horvātija Sanofi-Aventis Croatia d.o.o.
Italian: Valpromide DEPAMIDE 300 mg, comprimé pelliculé gastro-résistant
Latvian: Valpromīds DEPAMIDE 300 mg, comprimé pelliculé gastro-résistant
Italian: Delepsine Retard
Latvian: Valproiskābe Delepsine Retard
Italian: United Kingdom
Latvian: LIELBRITĀNIJA
Italian: Lussemburgo Eurogenerics SA Esplanade Heysel b22
Latvian: Eurogenerics SA Esplanade Heysel b22 1020 Bruxelles Beļģija
Italian: Deprakine Retard
Latvian: Valproiskābe Deprakine Retard
Italian: CONVULEX 100 mg/ml oldatos injekció
Latvian: Valproiskābe CONVULEX 100 mg/ml oldatos injekció
Italian: Convulex 300 mg - Kapseln 300 mg
Latvian: Valproiskābe Convulex 300 mg - Kapseln 300 mg
Italian: 2a
Latvian: Benzstr. 2a
Italian: Convulex 100 mg/mlInjektionslösung
Latvian: Valproiskābe Convulex 100 mg/mlInjektionslösung
Italian: DEPAKINE 50 mg/ml szirup 50 mg/ml
Latvian: Valproiskābe DEPAKINE 50 mg/ml szirup 50 mg/ml
Italian: Valproat "Sandoz"
Latvian: Valproiskābe Valproat "Sandoz"
Italian: Convulex 500 mg - Kapseln 500 mg
Latvian: Valproiskābe Convulex 500 mg - Kapseln 500 mg
Italian: Convulex Capsules 150mg 150 mg
Latvian: Valproiskābe Convulex Capsules 150mg 150 mg
Italian: Convulex 150 mg - Kapseln 150 mg
Latvian: Valproiskābe Convulex 150 mg - Kapseln 150 mg
Italian: CONVULEX RETARD 500MG 500 mg
Latvian: Valproiskābe CONVULEX RETARD 500MG 500 mg
Italian: 13435 Berlin espa-valept 300 mg retard 199.8 mg, 87 mg
Latvian: Aristo Pharma GmbH Wallenroder Str. 8-10 13435 Berlin Vācija espa-valept 300 mg retard 199,8 mg, 87 mg
Italian: CONVULEX RETARD 300MG 300 mg
Latvian: Valproiskābe CONVULEX RETARD 300MG 300 mg
Italian: Absenor 300 mg tablety s predĺženým uvoľňovaním
Latvian: Valproiskābe Absenor 300 mg tablety s predĺženým uvoľňovaním
Italian: Convulex 300 mg gastroresistant capsules, soft
Latvian: Valproiskābe Convulex 300 mg gastroresistant capsules, soft
Italian: Germania 1 A Pharma GmbH Keltenring 1 + 3
Latvian: 1 A Pharma GmbH Keltenring 1 + 3 82041 Oberhaching Vācija
Italian: Convulex 300 mg/ml - Lösung zum Einnehmen
Latvian: Convulex 300 mg/mlLösung zum Einnehmen
Italian: CONVULEX 300 mg gyomornedv-ellenálló lágy kapszula
Latvian: Valproiskābe CONVULEX 300 mg gyomornedv-ellenálló lágy kapszula
Italian: Convulex 150 mg gastroresistant capsules, soft
Latvian: Valproiskābe Convulex 150 mg gastroresistant capsules, soft
Italian: Depakine chrono 300 mg tablete s podaljšanim sproščanjem
Latvian: Valproiskābe Depakine chrono 300 mg tablete s podaljšanim sproščanjem
Italian: Convulex 500 mg gastroresistant capsules, soft
Latvian: Valproiskābe Convulex 500 mg gastroresistant capsules, soft
Italian: CONVULEX 150 mg gyomornedv-ellenálló lágy kapszula
Latvian: Valproiskābe CONVULEX 150 mg gyomornedv-ellenálló lágy kapszula
Italian: Depakine chrono 500 mg tablete s podaljšanim sproščanjem
Latvian: Valproiskābe Depakine chrono 500 mg tablete s podaljšanim sproščanjem
Italian: Convulex Capsules 300mg 500 mg
Latvian: Valproiskābe Convulex Capsules 300mg 500 mg
Italian: Diplexil 500
Latvian: Valproiskābe Diplexil 500
Italian: CONVULEX 500 mg gyomornedv-ellenálló lágy kapszula
Latvian: Valproiskābe CONVULEX 500 mg gyomornedv-ellenálló lágy kapszula
Italian: I materiali didattici devono essere presentati contestualmente alla domanda di variazione delle informazioni sul prodotto.
Latvian: Izglītojošie materiāli jāiesniedz vienlaicīgi ar izmaiņu pieteikumu zāļu informācijā.
Italian: 12 gennaio 2015
Latvian: 2015. gada 12. janvāris
Italian: Trasmissione delle traduzioni degli allegati all'accordo alle autorità nazionali competenti:
Latvian: Vienošanās pielikumu tulkojumu nodošana valstu kompetentajām iestādēm:
Italian: riunione del CMDh di novembre 2014
Latvian: CMDh 2014. gada novembra sanāksme
Italian: Attuazione dell'accordo da parte degli Stati membri (presentazione della variazione a fini di integrazione delle modifiche alle informazioni sul prodotto da parte del titolare dell'autorizzazione all'immissione in commercio):
Latvian: Vienošanās īstenošana dalībvalstīs (variācijas pieteikuma iesniegšana, lai reģistrācijas apliecības īpašnieks varētu ieviest izmaiņas zāļu informācijā):
Italian: 17 aprile 2019 EMA/248364/2019 Rev1
Latvian: 2019. gada 17. aprīlis EMA/248364/2019 Rev1
Italian: Inoltre è possibile contattare la propria autorità nazionale per i medicinali.
Latvian: Jūs varat arī sazināties ar savas valsts zāļu iestādi.
Italian: Sul sito web dell'EMA è stata pubblicata una relazione di valutazione contenente ulteriori dettagli sulla revisione.
Latvian: EMA tīmekļa vietnē ir publicēts novērtējuma ziņojums ar sīkāku informāciju par pārskatīšanu.
Italian: • Qualora si rendano necessari ulteriori ritiri o altre misure, le autorità nazionali forniranno informazioni sulle misure da adottare.
Latvian: • Ja ir nepieciešami turpmāki atsaukumi vai citi pasākumi, valsts iestādes informēs jūs par veicamajiem pasākumiem.
Italian: Esami da effettuare durante e dopo il periodo transitorio
Latvian: Testēšana pārejas periodā un pēc tā beigām
Italian: Dopo gli esami alcuni medicinali sono stati ritirati dalle farmacie e non sono più utilizzati nell'UE.
Latvian: Pēc testiem dažas zāles tika atsauktas no aptiekām un vairs netiek lietotas ES.
Italian: Le stime sono state estrapolate da studi sugli animali e sono assai ridotte rispetto al rischio di cancro nell'arco di vita nell'Unione europea (1 su 2).
Latvian: Aplēses ir ekstrapolētas no pētījumiem ar dzīvniekiem un ir ļoti zemas, salīdzinot ar ES aprēķināto risku dzīves laikā saslimt ar vēzi (1 no 2).
Italian: La revisione dei medicinali contenenti valsartan è stata avviata dalla Commissione europea il 5 luglio 2018 ai sensi dell'articolo 31 della direttiva 2001/83/CE.
Latvian: Valsartāna zāļu pārskatīšanu uzsāka 2018. gada 5. jūlijā pēc Eiropas Komisijas lūguma saskaņā ar Direktīvas 2001/83/EK 31. pantu.
Italian: • Sin dal momento in cui tali impurezze sono state rilevate per la prima volta in alcuni medicinali contenenti sartani, le autorità di regolamentazione nell'UE si sono attivate per proteggere la salute dei pazienti.
Latvian: • Kopš šos piemaisījumus pirmoreiz konstatēja dažās sartānus saturošās zālēs, ES regulatīvās iestādes ir strādājušas, lai aizsargātu pacientu veselību.
Italian: Le raccomandazioni dell'EMA relative alla NDMA e alla NDEA sono state inviate alla Commissione europea che ha emesso decisioni giuridicamente vincolanti.
Latvian: EMA ieteikumus par NDMA un NDEA nosūtīja Eiropas Komisijai, kas izdeva juridiski saistošus lēmumus.
Italian: Principio attivo (dose massima giornaliera)
Latvian: Aktīvā viela (maksimālā dienas deva)
Italian: Il parere del CHMP è stato trasmesso alla Commissione europea che, tra il 2 aprile e il 17 aprile 2019, ha emesso decisioni definitive giuridicamente vincolanti per i medicinali interessati, applicabili in tutti gli Stati membri dell'UE.
Latvian: CHMP nosūtīja atzinumu Eiropas Komisijai, kas laikā starp 2019. gada 2. aprīli un 17. aprīli izdeva par attiecīgajām zālēm galīgos juridiski saistošos lēmumus, kuri piemērojami visās ES dalībvalstīs.
Italian: Le autorità dell'UE, inoltre, rifletteranno sugli insegnamenti che si possono trarre da questa revisione per migliorare le modalità di individuazione e trattamento delle impurezze nei medicinali.
Latvian: ES iestādes arī apsvērs pieredzi, ko var gūt no šīs pārskatīšanas, lai uzlabotu piemaisījumu identificēšanas un apstrādes veidu zālēs.
Italian: Una fase analoga, che coinvolge la dietilammina (DEA), è collegata alla presenza di NDEA.
Latvian: Līdzīga stadija ar dietilamīnu (DEA) ir saistīta ar NDEA klātbūtni.
Italian: 2 Linea guida della Conferenza internazionale sull'armonizzazione dei requisiti tecnici per la registrazione di medicinali per uso umano (ICH): M7(R1).
Latvian: 2 Starptautiskās padomes tehnisko prasību saskaņošanai cilvēkiem paredzētajām zālēm (ICH) vadlīnijas M7(R1)
Italian: La presenza della NDEA in questi medicinali potrebbe provocare 8 casi supplementari in 100 000 pazienti che assumessero il medicinale alla dose più alta ogni giorno per 4 anni1.
Latvian: NDEA šajās zālēs varētu izraisīt 8 papildu gadījumus uz 100 000 pacientu, kuri lieto zāles ar vislielāko devu katru dienu 4 gadus.1
Italian: Come si sono prodotte le impurezze nei sartani?
Latvian: Kā ir radušies piemaisījumi sartānos
Italian: • Ora l'EMA sta adottando ulteriori misure per scongiurare la presenza di tali impurezze nei futuri lotti di medicinali contenenti sartani.
Latvian: • EMA patlaban veic turpmākus pasākumus, lai novērstu šo piemaisījumu klātbūtni nākamajās sartānus saturošo zāļu partijās.
Italian: La revisione è stata condotta dal comitato per i medicinali per uso umano (CHMP) dell'EMA, responsabile delle questioni legate ai medicinali per uso umano, il quale ha adottato il parere dell'Agenzia.
Latvian: Pārskatīšanu veica Cilvēkiem paredzēto zāļu komiteja (CHMP), kas ir atbildīga par jautājumiem saistībā ar cilvēkiem paredzētām zālēm un kas pieņēma Aģentūras galīgo atzinumu.
Italian: I limiti si basano sull'assunzione giornaliera massima di ciascuna impurezza, ricavata dagli studi sugli animali: 96,0 nanogrammi per la NDMA e 26,5 nanogrammi per la NDEA.
Latvian: Ierobežojumi ir pamatoti ar maksimālo dienas devu katram piemaisījumam, kas noteikta pētījumos ar dzīvniekiem - 96,0 nanogrami NDMA un 26,5 nanogrami NDEA.
Italian: Ora le ditte devono adottare misure volte a scongiurare la presenza di tali impurezze ed effettuare esami rigorosi sui propri prodotti.
Latvian: Uzņēmumiem tagad ir jāveic pasākumi, lai novērstu šo piemaisījumu klātbūtni, kā arī rūpīgi jāpārbauda savi produkti.
Italian: Dopo il periodo transitorio, le ditte devono escludere anche la presenza di livelli inferiori di NDEA o NDMA nei propri prodotti (< 0,03 parti per milione).
Latvian: Pēc pārejas perioda beigām uzņēmumiem ir jānovērš pat zemāku NDEA vai NDMA līmeņu klātbūtne to produktos (< 0,03 ppm).
Italian: Nella maggior parte dei medicinali contenenti sartani non sono state riscontrate impurezze o ne sono stati rilevati livelli bassissimi.
Latvian: Lielākajā daļā sartānus saturošo zāļu šie piemaisījumi nebija konstatējami vai bija ļoti zemā līmenī.
Italian: Inoltre è possibile che le impurezze fossero presenti in alcuni sartani perché i fabbricanti avevano inavvertitamente utilizzato nel processo di produzione attrezzature o reagenti contaminati.
Latvian: Turklāt ir iespējams, ka dažos sartānos piemaisījumi radušies, ražotājiem ražošanas procesā nejauši izmantojot piesārņotu aprīkojumu vai reaģentus.