FrancophonIA/ELRC3.0 huggingface dataset:
Danish: - PRAC's anbefaling
Latvian: 1. - PRAC ieteikums
Danish: I denne forbindelse anbefalede PRAC ændringer af produktinformationen, herunder skærpelse af ordlyden, så den afspejler den nuværende viden om risiciene for udviklingsforstyrrelser og medfødte misdannelser, og en direkte henvendelse til sundhedspersoner (DHPC).
Latvian: Šajā sakarā PRAC ieteica veikt grozījumus zāļu informācijā, pastiprinot tekstu par pašreizējām zināšanām par attīstības traucējumu un iedzimtu anomāliju risku, un informēt veselības aprūpes speciālistus, nosūtot vēstuli veselības aprūpes speciālistiem.
Danish: Risikoen synes at være dosisafhængig, men ud fra de foreliggende data kan der ikke fastlægges en dosis, hvorunder der ikke er nogen risiko.
Latvian: Risks ir atkarīgs no devas, bet sliekšņa devu, zem kuras riska nav, pamatojoties uz pieejamajiem datiem, nav iespējams noteikt.
Danish: PRAC bemærkede, at valproat anses for at være et effektivt middel til behandling af epilepsi og manisk episode ved bipolær sygdom, som er alvorlige sygdomme, der kan være livstruende, hvis de ikke kontrolleres sufficient.
Latvian: PRAC ņēma vērā, ka valproātu uzskata par efektīvām zālēm epilepsijas un bipolāru traucējumu mānijas epizožu ārstēšanā.
Danish: CMD(h) (koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker) har gennemgået nedenstående anbefaling fra PRAC for lægemidler indeholdende valproat og relaterede stoffer:
Latvian: CMDh izskatīja turpmāk minēto PRAC ieteikumu attiecībā uz valproātu un tam radniecīgas vielas saturošām zālēm:
Danish: - Detaljeret videnskabelig begrundelse for afvigelserne fra PRAC's anbefaling
Latvian: 2. - Atšķirību no PRAC ieteikuma zinātniskā pamatojuma detalizēts skaidrojums
Danish: Desuden tog PRAC de synspunkter i betragtning, der var udtrykt af patienter, familier og omsorgsgivere, og sundhedspersoners syn på kendskabet til og bevidstheden om risiciene ved eksponering in utero for valproat.
Latvian: PRAC ņēma vērā arī pacientu, viņu ģimenes locekļu un aprūpētāju, kā arī veselības aprūpes speciālistu domas par to, kāda ir izpratne un informētība par risku, kas saistīts ar valproāta iedarbību in utero;
Danish: PRAC gennemgik alle foreliggende data fra prækliniske undersøgelser, farmakoepidemiologiske undersøgelser, den publicerede litteratur, spontane indberetninger samt udtalelser fra de relevante eksperter (dvs. i neurologi, psykiatri, børneneuropsykiatri, obstetrik mv.) om sikkerheden og virkningen af valproat og relaterede stoffer hos pigebørn, kvinder i den fødedygtige alder og gravide kvinder.
Latvian: PRAC pārskatīja visus datus, kas pieejami no preklīniskiem pētījumiem, farmakoepidemioloģiskiem pētījumiem, publikācijām literatūrā, spontāniem ziņojumiem, kā arī atbilstošo ekspertu (t.
Danish: Meador KJ,et al.; NEAD Study Group.
Latvian: Meador KJ,et al.;
Danish: Videnskabelige konklusioner og begrundelse for ændring af markedsføringstilladelserne på visse betingelser samt detaljeret redegørelse for den videnskabelige begrundelse for afvigelserne fra anbefalingen fra PRAC (Det Europæiske Lægemiddelagenturs Udvalg for Risikovurdering inden for Lægemiddelvurdering)
Latvian: Zinātniskie secinājumi un ar nosacījumiem izsniegto reģistrācijas apliecību nosacījumu izmaiņu pamatojums, kā arī detalizēts skaidrojums par atšķirībām no PRAC ieteikuma
Danish: Undersøgelsen skal udføres i mere end én medlemsstat.
Latvian: Pētījums jāveic vairāk nekā vienā dalībvalstī.
Danish: Protokollen skal forelægges i overensstemmelse med artikel 107n, stk. 1), i direktiv 2001/83/EF:
Latvian: Protokols jāiesniedz saskaņā ar Direktīvas 2001/83/EK 107.n panta 1. punkta noteikumiem:
Danish: Senest den 12. januar
Latvian: līdz 2015. gada 12. janvārim
Danish: Senest 6 måneder efter at koordinationsgruppen er nået til enighed
Latvian: sešu mēnešu laikā pēc vienošanās panākšanas ar koordinācijas grupu.
Danish: Yderligere interimsrapporter indsendes derefter til PRAC hver sjette måned i de første 2 år.
Latvian: Turpmākie starpziņojumi jāiesniedz PRAC reizi sešos mēnešos pirmos divus gadus.
Danish: Materialet indsendes til de nationale kompetente myndigheder:
Latvian: Šie materiāli jāiesniedz valstu kompetentajām iestādēm:
Danish: Den første interimsrapport indsendes til PRAC:
Latvian: Pirmais starpziņojums jāiesniedz PRAC:
Danish: Den endelige undersøgelsesrapport indsendes til PRAC:
Latvian: Pētījuma galīgais ziņojums jāiesniedz PRAC:
Danish: De nationale kompetente myndigheder i medlemsstaten (-staterne) eller i givet fald i referencemedlemsstaten (-staterne) sikrer, at indehaverne af markedsføringstilladelse opfylder følgende betingelser:
Latvian: Dalībvalsts(-u) vai atsauces dalībvalsts(-u), ja piemērojams, nacionālajām kompetentajām iestādēm jānodrošina, lai reģistrācijas apliecības īpašnieks(-i) izpildītu šādus nosacījumus:
Danish: Undersøgelsen skal være udformet med henblik på at vurdere og kvantificere effektiviteten af risikominimeringsforanstaltningerne og skal analysere og vurdere forholdene før og efter implementering.
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.
Danish: Dette materiale skal sikre, at den ordinerende læge informeres om og patienterne får kendskab til og erkender de risici, der forbundet med eksponeringen for valproat in utero.
Latvian: Šiem materiāliem jānodrošina, lai zāļu parakstītāji būtu informēti un pacienti izprastu un apzinātos risku, kas saistīts ar valproāta iedarbību in utero.
Danish: Indehaverne af markedsføringstilladelse for valproat og relaterede stoffer udarbejder og indsender oplysningsmateriale svarende til de vedtagne hovedelementer.
Latvian: Valproāta un tam radniecīgo vielu reģistrācijas apliecību īpašniekiem saskaņā ar apstiprinātajiem pamatelementiem jāizstrādā un jāiesniedz izglītojoši materiāli.
Danish: Indehaverne af markedsføringstilladelse for valproat og relaterede stoffer udfører en undersøgelse af lægemiddelanvendelse til vurdering af effektiviteten af risikominimeringsforanstaltningerne og til yderligere karakterisering af ordinationsmønstrene for valproat.
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.
Danish: 2015 Strovolos Nicosia Cyprus
Latvian: 2015 Strovolos Nicosia Kipra
Danish: Fortegnelse over lægemidlernes navne, lægemiddelformer, styrker, indgivelsesveje, indehavere af markedsføringstilladelser i medlemsstaterne
Latvian: Zāļu nosaukumi, zāļu formas, stiprumi, lietošanas veidi, reģistrācijas apliecības īpašnieki dalībvalstīs
Danish: H-1045 Budapest Hungary
Latvian: H-1045 Budapest Ungārija
Danish: 17 Bonifraterska Str. 00-203 Warsaw Poland
Latvian: 17 Bonifraterska Str. 00-203 Warsaw Polija
Danish: PSC 170 00 Holesovice Czech Republic
Latvian: PSC 170 00 Holesovice Čehijas Republika
Danish: 85101 Bratislava Slovak Republic
Latvian: 85101 Bratislava Slovākijas Republika
Danish: 17674 Kallithea, Athens Greece
Latvian: 17674 Kallithea, Athens Grieķija
Danish: 92300 Levallois-Perret France
Latvian: 92300 Levallois-Perret Francija
Danish: Swensweg 5 2031 GA HAARLEM The Netherlands
Latvian: Swensweg 5 2031 GA HAARLEM Nīderlande
Danish: Nieuwe Donk 3 4879 AC ETTEN LEUR The Netherlands
Latvian: Nieuwe Donk 3 4879 AC ETTEN LEUR Nīderlande
Danish: 11-15 Quai Dion Bouton 92800 Puteaux
Latvian: 11-15 Quai Dion Bouton 92800 Puteaux Francija
Danish: Frankrig MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France
Latvian: MYLAN SAS 117, allée des Parcs 69800 Saint-Priest Francija
Danish: 1220 Wien Austria
Latvian: 1220 Wien Austrija
Danish: Largo Umberto Boccioni, 1 21040 Origgio (Varese) Italy
Latvian: Largo Umberto Boccioni, 1 21040 Origgio (Varese) Itālija
Danish: 92700 Colombes France
Latvian: 92700 Colombes Francija
Danish: 104 25 Stockholm Sweden
Latvian: 104 25 Stockholm Zviedrija
Danish: Norton Healthcare Limited Ridings Point, Whistler Drive
Latvian: Lielbritānija Norton Healthcare Limited Ridings Point, Whistler Drive
Danish: Desitin Arzneimittel GmbH Postfach 630164
Latvian: Norvēģija Desitin Arzneimittel GmbH Postfach 630164
Danish: Veluwezoom 22 1327 AH ALMERE The Netherlands
Latvian: Veluwezoom 22 1327 AH ALMERE Nīderlande
Danish: 11317 Tallinn
Latvian: 11317 Tallinn Igaunija
Danish: 1099-036 Lisboa Portugal
Latvian: 1099-036 Lisboa
Danish: 28230 Las Rozas (Madrid) Spain
Latvian: Oficina D 28230 Las Rozas (Madrid)
Danish: Via Scarlatti Domenico, 31 20124 Milano Italy
Latvian: Via Scarlatti Domenico, 31 20124 Milano Itālija
Danish: 00350 Helsinki Finland
Latvian: 00350 Helsinki Somija
Danish: Belgien Eurogenerics N.V.
Latvian: Eurogenerics N.V.
Danish: Teva UK Limited Brampton Road, Hampden Park
Latvian: Lielbritānija Teva UK Limited Brampton Road, Hampden Park
Danish: Grækenland DEMO ABEE 21st Km Athens-Lamias National Highway 14568 Kryoneri Greece
Latvian: DEMO ABEE 21st Km Athens-Lamias National Highway 14568 Kryoneri Grieķija
Danish: Orion Corporation Orionintie 1 A FI-02200 Espoo Finland
Latvian: Orion Corporation Orionintie 1 A FI-02200 Espoo Somija
Danish: 90449 Nürnberg
Latvian: 90449 Nürnberg Vācija
Danish: Sandoz GmbH Biochemiestrasse 10 6250 Kundl Austria
Latvian: Sandoz GmbH Biochemiestrasse 10 6250 Kundl Austrija
Danish: 86156 Augsburg
Latvian: 86156 Augsburg Vācija
Danish: Rumænien GEROT PHARMAZEUTIKA Ges.m.b.H.
Latvian: Rumānija GEROT PHARMAZEUTIKA Ges.m.b.H.
Danish: Estland Sanofi-Aventis Estonia OÜ Pärnu mnt 139E/2
Latvian: Sanofi-Aventis Estonia OÜ Pärnu mnt 139E/2
Danish: Grækenland Sanofi-Aventis AEBE 348 Syngrou Avenue, Building A'
Latvian: Sanofi-Aventis AEBE 348 Syngrou Avenue, Building A'
Danish: Tyskland IIP - Institut für industrielle Pharmazie Forschungs- und Entwicklungsgesellschaft mbH
Latvian: IIP - Institut für industrielle Pharmazie Forschungs- und Entwicklungsgesellschaft mbH
Danish: Finland Sanofi Oy Huopalahdentie 24 PL 22
Latvian: Sanofi Oy Huopalahdentie 24 PL 22
Danish: DK-2970 Hørsholm
Latvian: DK-2970 Hørsholm Dānija
Danish: Darwinweg 20 2333 CR LEIDEN The Netherlands
Latvian: Darwinweg 20 2333 CR LEIDEN Nīderlande
Danish: 61118 Bad Vilbel
Latvian: 61118 Bad Vilbel Vācija
Danish: Cypern Remedica Ltd Aharnon Street Limassol Industrial Estate 3056 Lemesos Cyprus
Latvian: Remedica Ltd Aharnon Street Limassol Industrial Estate 3056 Lemesos Kipra
Danish: Frankrig Arrow Generiques 26, avenue Tony Garnier 69007 Lyon
Latvian: Arrow Generiques 26, avenue Tony Garnier 69007 Lyon
Danish: Sanofi AB Box 30052
Latvian: Zviedrija Sanofi AB Box 30052
Danish: Frankrig Biogaran 15, boulevard Charles de Gaulle
Latvian: 15, boulevard Charles de Gaulle
Danish: 53757 Sankt Augustin Germany
Latvian: 1 53757 Sankt Augustin Vācija
Danish: Østrig sanofi-aventis GmbH SATURN Tower, Vienna DC Leonard-Bernstein-Straße
Latvian: Austrija sanofi-aventis GmbH SATURN Tower, Vienna DC Leonard-Bernstein-Straße
Danish: 08019 Barcelona
Latvian: 08019 Barcelona Spānija
Danish: 27472 Cuxhaven
Latvian: 5 27472 Cuxhaven Vācija
Danish: Frankrig Laboratoire AGUETTANT 1, rue Alexander Fleming 69007 Lyon
Latvian: Laboratoire AGUETTANT 1, rue Alexander Fleming 69007 Lyon
Danish: Valproinsyre Convulex gelule gastro résistante
Latvian: Valproiskābe Convulex gelule gastro résistante
Danish: Tyskland Mylan dura GmbH Wittichstr.
Latvian: Mylan dura GmbH Wittichstr.
Danish: Belgien Sanofi Belgium Leonardo Da Vincilaan 19 1831 Diegem
Latvian: Sanofi Belgium Leonardo Da Vincilaan 19 1831 Diegem Beļģija
Danish: Luxembourg Takeda Belgium Chaussée de Gand 615 1080 Bruxelles
Latvian: Takeda Belgium Chaussée de Gand 615 1080 Bruxelles Beļģija
Danish: Winthrop Pharmaceuticals UK Limited
Latvian: Lielbritānija Winthrop Pharmaceuticals UK Limited
Danish: 1000 Ľubľana Slovenia
Latvian: 1000 Ľubľana Slovēnija
Danish: Tyskland Stadapharm GmbH Stadastr 2-18
Latvian: Stadapharm GmbH Stadastr 2-18
Danish: Danmark Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark
Latvian: Edvard Thomsens Vej 14 DK-2300 København S Dānija
Danish: 83607 Hozkirchen
Latvian: 83607 Hozkirchen Vācija
Danish: Sanofi - Produtos Farmacêuticos, Lda.
Latvian: Portugāle Sanofi - Produtos Farmacêuticos, Lda.
Danish: 63741 Aschaffenburg Germany
Latvian: 63741 Aschaffenburg Vācija
Danish: Rua Tierno GalvanAmoreiras - Torre 3 - 12º Lisboa
Latvian: Amoreiras - Torre 3 - 12º Lisboa
Danish: Ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany
Latvian: Ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Vācija
Danish: 75014 PARIS France
Latvian: 75014 PARIS Francija
Danish: 40764 Langelfeld
Latvian: 23 40764 Langelfeld Vācija
Danish: Gebäude K703
Latvian: Industriepark Höchst Gebäude K703
Danish: Frankrig Ranbaxy Pharmacie Génériques
Latvian: Ranbaxy Pharmacie Génériques
Danish: Tyskland Dolorgiet GmbH & Co.KG Otto-von-Guericke-Str. 1
Latvian: Dolorgiet GmbH & Co.KG Otto-von-Guericke-Str.
Danish: Litauen UAB „SANOFI-AVENTIS LIETUVA"
Latvian: UAB „SANOFI-AVENTIS LIETUVA"
Danish: D-22311 HAMBURG Deutschland
Latvian: D-22311 HAMBURG
Danish: Danmark Sanofi-aventis Denmark A/S
Latvian: Sanofi-aventis Denmark A/S
Danish: Bulgarien Sanofi-Aventis Bulgaria EOOD
Latvian: Bulgārija Sanofi-Aventis Bulgaria EOOD
Danish: 02101 Espoo
Latvian: 02101 Espoo Somija
Danish: Belgien Mylan BVBA/SPRL Terhulpsesteenweg 6 box A 1560 Hoeilaart
Latvian: Mylan BVBA/SPRL Terhulpsesteenweg 6 box A 1560 Hoeilaart Beļģija
Danish: Finland Sandoz A/S C. F. Tietgens Boulevard 40 5220 ODENSE SØ Denmark
Latvian: F. Tietgens Boulevard 40 5220 ODENSE SØ Dānija
Danish: Generics UK Limited Station Close, Potter's Bar Hertfordshire EN6 1TL
Latvian: Lielbritānija Generics UK Limited Station Close, Potter's Bar Hertfordshire
Danish: Holland Apotex Europe B.V.
Latvian: Nīderlande Apotex Europe B.V.
Danish: Letland sanofi-aventis Latvia SIA Kr.Valdemara 33-8
Latvian: Latvija sanofi-aventis Latvia SIA Kr.Valdemara 33-8 Riga LV1010
Danish: Holland Sanofi-Aventis Netherlands B.V.
Latvian: Nīderlande Sanofi-Aventis Netherlands B.V.
Danish: Generis Farmacêutica, S.A. Rua João de Deus, 19 Amadora
Latvian: Rua João de Deus, 19
Danish: Tyskland Sanofi-Aventis Deutschland GmbH
Latvian: Sanofi-Aventis Deutschland GmbH
Danish: Spanien Genfarma Laboratorio, S.L.
Latvian: Genfarma Laboratorio, S.L.
Danish: Cypern Sanofi-Aventis Cyprus Ltd Charalambou Mouskou 14
Latvian: Sanofi-Aventis Cyprus Ltd Charalambou Mouskou 14 Street
Danish: 65926 Frankurt am main Germany
Latvian: 65926 Frankurt am main Vācija
Danish: 65926 Frankfurt am Main Germany
Latvian: 65926 Frankfurt am Main Vācija
Danish: Desitin Arzneimittel Gmbh Weg beim Jaeger 214 DE-22335 Hamburg Germany
Latvian: Desitin Arzneimittel Gmbh Weg beim Jaeger 214 DE-22335 Hamburg Vācija
Danish: Luxembourg Hexal AG Industriestrasse 25 83067 Holzkirchen Germany
Latvian: Industriestrasse 25 83067 Holzkirchen Vācija
Danish: 89150 Laichingen
Latvian: 19 89150 Laichingen Vācija
Danish: Valpromid Depamide
Latvian: Valpromīds Depamide
Danish: Valproinsyre Ácido Valpróico Generis
Latvian: Valproiskābe Ácido Valpróico Generis
Danish: Holland Teva Nederland B.V.
Latvian: Nīderlande Teva Nederland B.V.
Danish: Zentiva Italia Srl Viale Bodio 37/B 20158 Milano Italy
Latvian: Zentiva Italia Srl Viale Bodio 37/B 20158 Milano Itālija
Danish: A-8502 Lannach Austria
Latvian: A-8502 Lannach Austrija
Danish: Tyskland Neuraxpharm Arzneimittel GmbH
Latvian: Neuraxpharm Arzneimittel GmbH
Danish: 2740-245 Porto Salvo Portugal
Latvian: 2740-245 Porto Salvo Portugāle
Danish: Holland Pharmachemie B.V.
Latvian: Nīderlande Pharmachemie B.V.
Danish: Wockhardt UK Limited Ash Road North Wrexham Industrial Estate Wrexham, LL13 9UF United Kingdom
Latvian: Wrexham Industrial Estate Wrexham, LL13 9UF Lielbritānija
Danish: Sanofi-Aventis SpA Viale Luigi Bodio, 37/B 20158 Milano Italy
Latvian: Sanofi-Aventis SpA Viale Luigi Bodio, 37/B 20158 Milano Itālija
Danish: Holland Centrafarm B.V.
Latvian: Nīderlande Centrafarm B.V.
Danish: Danmark Orion Corporation Orionintie 1 A
Latvian: Zviedrija Orion Corporation Orionintie 1 A
Danish: Valproinsyre VALPROATE SODIUM SANDOZ 500MG
Latvian: Valproiskābe VALPROATE SODIUM SANDOZ 500MG
Danish: Holland Sandoz B.V.
Latvian: Nīderlande Sandoz B.V.
Danish: Luxembourg Eurogenerics SA Esplanade Heysel b22
Latvian: Eurogenerics SA Esplanade Heysel b22 1020 Bruxelles Beļģija
Danish: Finland Orion Pharma Orionintie 1
Latvian: Orion Pharma Orionintie 1 PL 65
Danish: Valproinsyre Diplexil
Latvian: Valproiskābe Diplexil
Danish: Rumænien Sanofi-Aventis France 1-13 Boulevard Romain Rolland
Latvian: Rumānija Sanofi-Aventis France 1-13 Boulevard Romain Rolland
Danish: Valproinsyre Depakine Chrono 300
Latvian: Valproiskābe Depakine Chrono 300
Danish: Calcium divalproate
Latvian: Kalcija divalproāts
Danish: 64295 Darmstadt Germany valprodura 150mg
Latvian: 64295 Darmstadt Vācija valprodura 150mg
Danish: Valproinsyre DEPAKINE 100 mg/ml por és oldószer oldatos injekcióhoz
Latvian: Valproiskābe DEPAKINE 100 mg/ml por és oldószer oldatos injekcióhoz
Danish: Ungarn Sanofi-Aventis zrt.
Latvian: Sanofi-Aventis zrt.
Danish: Tyskland ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19
Latvian: ALIUD PHARMA GmbH Gottlieb-Daimler-Str.
Danish: Bulgarien G.L.
Latvian: Bulgārija G.L.
Danish: Valproinsyre Depakine Chrono 500
Latvian: Valproiskābe Depakine Chrono 500
Danish: 64295 Darmstadt Germany valprodura 600 mg
Latvian: 64295 Darmstadt Vācija valprodura 600 mg
Danish: Frankrig LABORATOIRES ALTER 3, avenue de la Baltique, ZI de Courtaboeuf
Latvian: LABORATOIRES ALTER 3, avenue de la Baltique, ZI de Courtaboeuf 91140 Villebon Sur Yvette Francija
Danish: Spanien G.E.S.
Latvian: G.E.S.
Danish: Kroatien Sanofi-Aventis Croatia d.o.o.
Latvian: Horvātija Sanofi-Aventis Croatia d.o.o.
Danish: Valproinsyre CONVULEX 50 mg/ml szirup gyermekeknek
Latvian: Valproiskābe CONVULEX 50 mg/ml szirup gyermekeknek
Danish: 64295 Darmstadt Germany valprodura 300 mg
Latvian: 64295 Darmstadt Vācija valprodura 300 mg
Danish: Tyskland Ratiopharm GmbH Graf-Arco-Strasse 3
Latvian: Lielbritānija Ratiopharm GmbH Graf-Arco-Strasse 3
Danish: Valproinsyre Convulex 50 mg/ml - Sirup für Kinder
Latvian: Valproiskābe Convulex 50 mg/ml - Sirup für Kinder
Danish: Valpromid Depamide 300 mg comprimidos gastrorresistentes
Latvian: Valpromide Depamide 300 mg comprimidos gastrorresistentes
Danish: Tyskland Winthrop Arzneimittel GmbH
Latvian: Winthrop Arzneimittel GmbH
Danish: Valproinsyre ORFIRIL SAFT
Latvian: Valproiskābe ORFIRIL SAFT
Danish: Valproinsyre Valproat "Sandoz"
Latvian: Valproiskābe Valproat "Sandoz"
Danish: United Kingdom
Latvian: LIELBRITĀNIJA
Danish: LT-09310 Vilnius
Latvian: A. Juozapavičiaus g. 6/2 LT-09310 Vilnius Lietuva
Danish: Valproinsyre Diplexil 1000
Latvian: Valproiskābe Diplexil 1000
Danish: Pulver til injektionsvæske
Latvian: Pulveris injekcijām Intravenozai lietošanai
Danish: Slovenien Sanofi-Aventis d.o.o.
Latvian: Slovēnija Sanofi-Aventis d.o.o.
Danish: Tyskland Aristo Pharma GmbH Wallenroder Str. 8-10
Latvian: Aristo Pharma GmbH Wallenroder Str. 8-10 13435 Berlin Vācija
Danish: Valproinsyre Convulex 100 mg/mlInjektionslösung
Latvian: Valproiskābe Convulex 100 mg/mlInjektionslösung
Danish: Tyskland betapharm Arzneimittel GmbH
Latvian: betapharm Arzneimittel GmbH
Danish: Avenida Professor Doutor Cavaco Silva, 10 E 2740-255 Porto Salvo Portugal
Latvian: Avenida Professor Doutor Cavaco Silva, 10 E
Danish: Valpromid DEPAMIDE 300 mg, comprimé pelliculé gastro-résistant
Latvian: Valpromīds DEPAMIDE 300 mg, comprimé pelliculé gastro-résistant
Danish: 2a
Latvian: Benzstr. 2a
Danish: Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda Lagos Park, Edíficio 5A, Piso 2
Latvian: Lagos Park, Edíficio 5A, Piso 2
Danish: Valproinsyre Diplexil 150
Latvian: Valproiskābe Diplexil 150
Danish: Valproinsyre Orfiril Long
Latvian: Valproiskābe Orfiril Long
Danish: Valproinsyre DEPAKINE 50 mg/ml szirup 50 mg/ml
Latvian: Valproiskābe DEPAKINE 50 mg/ml szirup 50 mg/ml
Danish: Rektal anvendelse
Latvian: Rectal use
Danish: Valproinsyre Depakine 400 mg/4 ml
Latvian: Valproiskābe Depakine 400 mg/4 ml
Danish: Valproinsyre Orfiril Retard
Latvian: Valproiskābe Orfiril Retard
Danish: One Onslow Street Guildford, Surrey GU1 4YS
Latvian: Guildford, Surrey
Danish: Heizel Esplanade b22
Latvian: Heizel Esplanade b22 1020 Brussels Beļģija
Danish: Aventis Pharma Limited One Onslow Street Guildford, Surrey GU1 4SY
Latvian: Lielbritānija Aventis Pharma Limited One Onslow Street
Danish: Injektionvæske, opløsning/ Koncentrat til infusionsvæske, opløsning
Latvian: Šķīdums injekcijām/koncentr āts infūziju šķīduma pagatavošanai
Danish: Valproinsyre Convulex 300 mg - Kapseln 300 mg
Latvian: Valproiskābe Convulex 300 mg - Kapseln 300 mg
Danish: Valproinsyre Delepsine
Latvian: Valproiskābe Delepsine
Danish: Tyskland 1 A Pharma GmbH Keltenring 1 + 3
Latvian: 1 A Pharma GmbH Keltenring 1 + 3 82041 Oberhaching Vācija
Danish: Valproinsyre ORFIRIL 150
Latvian: Valproiskābe ORFIRIL 150
Danish: Valproinsyre Diplexil 300
Latvian: Valproiskābe Diplexil 300
Danish: Valproinsyre Diplexil 500
Latvian: Valproiskābe Diplexil 500
Danish: Valproinsyre ORFIRIL 600
Latvian: Valproiskābe ORFIRIL 600
Danish: Valproinsyre Convulex
Latvian: Valproiskābe CONVULEX
Danish: Valproinsyre CONVULEX
Latvian: Valproiskābe Convulex
Danish: Valproinsyre Convulex 150
Latvian: Valproiskābe Convulex 150
Danish: Valproinsyre, Natriumvalpr oat
Latvian: Valproid Acid, Nātrija valproāts
Danish: Valproinsyre Convulex 500 mg - Kapseln 500 mg
Latvian: Valproiskābe Convulex 500 mg - Kapseln 500 mg
Danish: Valproinsyre CONVULEX 100 mg/ml oldatos injekció
Latvian: Valproiskābe CONVULEX 100 mg/ml oldatos injekció
Danish: Valproinsyre Convulex 150 mg - Kapseln 150 mg
Latvian: Valproiskābe Convulex 150 mg - Kapseln 150 mg
Danish: Valproinsyre CONVULEX RETARD 500MG 500 mg
Latvian: Valproiskābe CONVULEX RETARD 500MG 500 mg
Danish: Valproinsyre CONVULEX RETARD 300MG 300 mg
Latvian: Valproiskābe CONVULEX RETARD 300MG 300 mg
Danish: 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
Danish: Valproinsyre Depakine chrono 300 mg tablete s podaljšanim sproščanjem
Latvian: Valproiskābe Depakine chrono 300 mg tablete s podaljšanim sproščanjem
Danish: Valproinsyre Absenor 500 mg tablety s predĺženým uvoľňovaním
Latvian: Valproiskābe Absenor 500 mg tablety s predĺženým uvoľňovaním
Danish: Valproinsyre Depakine Chronosphere
Latvian: Valproiskābe Depakine Chronosphere
Danish: Valproinsyre Absenor 300 mg tablety s predĺženým uvoľňovaním
Latvian: Valproiskābe Absenor 300 mg tablety s predĺženým uvoľňovaním
Danish: Valproinsyre ORFIRIL 300
Latvian: Valproiskābe ORFIRIL 300
Danish: Valproinsyre CONVULEX 300 mg gyomornedv-ellenálló lágy kapszula
Latvian: Valproiskābe CONVULEX 300 mg gyomornedv-ellenálló lágy kapszula
Danish: Valproinsyre Convulex Capsules 150mg 150 mg
Latvian: Valproiskābe Convulex Capsules 150mg 150 mg
Danish: Oplysningsmaterialet skal indsendes på samme tidspunkt som ansøgningen om ændring af produktinformationen.
Latvian: Izglītojošie materiāli jāiesniedz vienlaicīgi ar izmaiņu pieteikumu zāļu informācijā.
Danish: Den 12. januar 2015
Latvian: 2015. gada 12. janvāris
Danish: Aftalen gennemføres i medlemsstaterne (indsendelse af ændringsansøgningen med henblik på gennemførelse af de ændringer, markedsføringstilladelsesindehaveren har foretaget i produktinformationen):
Latvian: Vienošanās īstenošana dalībvalstīs (variācijas pieteikuma iesniegšana, lai reģistrācijas apliecības īpašnieks varētu ieviest izmaiņas zāļu informācijā):
Danish: CMD(h)'s møde i november 2014
Latvian: CMDh 2014. gada novembra sanāksme
Danish: • Hvis der er behov for yderligere tilbagekaldelser eller andre foranstaltninger, vil de nationale myndigheder informere dig om, hvad der skal gøres.
Latvian: • Ja ir nepieciešami turpmāki atsaukumi vai citi pasākumi, valsts iestādes informēs jūs par veicamajiem pasākumiem.
Danish: 17. april 2019 EMA/248364/2019 Rev 1
Latvian: 2019. gada 17. aprīlis EMA/248364/2019 Rev1
Danish: Du kan også kontakte de danske lægemiddelmyndigheder.
Latvian: Jūs varat arī sazināties ar savas valsts zāļu iestādi.