Appendix V - European Medicines Agency



30 August 2023 DOCPROPERTY DM_emea_doc_ref_id \* MERGEFORMAT EMA/67830/2013, Version 27Human Medicines DivisionAPPENDIX VList of details of the national reporting systems to communicate adverse reactions (side effects) for use in section 4.8 “Undesirable effects” of SmPC and section 4 “Possible side effects” of package leafletNo reference to the Appendix V should be included in the printed packaging materials. Only the actual details of the national reporting system (as listed within this Appendix V) of the concerned Member State(s) shall be displayed on the printed version.Bracketing convention: [text]: For guidance only. This text should not be included on the printed packaging materials.Belgi?/Belgique/Belgien[Dutch]Federaal Agentschap voor Geneesmiddelen en GezondheidsproductenAfdeling VigilantieGalileelaan 5/031210 BRUSSELPostbus 971000 BRUSSEL MadouWebsite: eenbijwerkingmelden.bee-mail: adr@fagg.be[French]Agence fédérale des médicaments et des produits de santéDivision Vigilance Avenue Galilée 5/031210 BRUXELLESBo?te Postale 971000 BRUXELLES MadouSite internet: notifieruneffetindesirable.bee-mail: adr@afmps.be[German]F?deralagentur für Arzneimittel und Gesundheitsprodukte Abteilung Vigilanz Avenue Galilée - Galileelaan 5/03 1210 BR?SSELPostfach 971000 BR?SSEL MadouWebsite: notifieruneffetindesirable.bee-mail: adr@fagg-afmps.be LietuvaValstybin? vaist? kontrol?s tarnyba prie Lietuvos Respublikos sveikatos apsaugos ministerijosTel.: 8 800 73568El. pa?tas: NepageidaujamaR@vvkt.lt[For SmPC]Prane?imo forma pildymui internetu: forma skelbiama [For package leaflet]Prane?imo forma pildymui internetu: forma skelbiama БългарияИзпълнителна агенция по лекарстватаул. ?Дамян Груев“ № 8 1303 София Teл.: +359 2 8903417уебсайт: bda.bgLuxembourg/LuxemburgCentre Régional de Pharmacovigilance de Nancy ou Division de la pharmacie et des médicaments de la Direction de la santé Site internet : guichet.lu/pharmacovigilance ?eská republikaStátní ústav pro kontrolu lé?iv?robárova 48100 41 Praha 10Webové stránky: sukl.cz/nahlasit-nezadouci-ucinekMagyarországNemzeti Népegészségügyi ésGyógyszerészeti K?zpontPostafiók 450H-1372 BudapestHonlap: .huelektronikus bejelent? form: : adr.box@.huDanmarkL?gemiddelstyrelsenAxel Heides Gade 1DK-2300 K?benhavn SWebsted: meldenbivirkning.dkMaltaADR Reporting Website: .mt/adrportalDeutschlandBundesinstitut für Arzneimittel und MedizinprodukteAbt. PharmakovigilanzKurt-Georg-Kiesinger-Allee 3D-53175 BonnWebsite: [For vaccines/biological medicinal products]Bundesinstitut für Impfstoffe und biomedizinische ArzneimittelPaul-Ehrlich-InstitutPaul-Ehrlich-Str. 51-5963225 LangenTel: +49 6103 77 0Fax: +49 6103 77 1234Website: pei.deNederlandNederlands Bijwerkingen Centrum LarebWebsite: lareb.nlEestiRavimiametKoduleht: ravimiamet.eeNorgeStatens legemiddelverk[For SmPC]Nettside: legemiddelverket.no/meldeskjema[For package leaflet] Nettside: legemiddelverket.no/pasientmeldingΕλλ?δαΕθνικ?? Οργανισμ?? Φαρμ?κωνΜεσογε?ων 284GR-15562 Χολαργ??, Αθ?ναΤηλ: + 30 21 32040380/337Φαξ: + 30 21 06549585 Ιστ?τοπο?: für Sicherheit im GesundheitswesenTraisengasse 51200 WIEN?STERREICHFax: + 43 (0) 50 555 36207Website: Espa?ol de Farmacovigilancia de Medicamentos de Uso Humano: notificaRAM.esPolskaDepartament Monitorowania Niepo??danych Dzia?ań Produktów Leczniczych Urz?du Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów BiobójczychAl. Jerozolimskie 181C PL-02 222 WarszawaTel.: + 48 22 49 21 301Faks: + 48 22 49 21 309Strona internetowa:? nationale de sécurité du médicament et des produits de santé (ANSM)et réseau des Centres Régionaux de Pharmacovigilance Site internet: ítio da internet: (preferencialmente) ou através dos seguintes contactos:Dire??o de Gest?o do Risco de MedicamentosParque da Saúde de Lisboa, Av. Brasil 531749-004 LisboaTel: +351 21 798 73 73Linha do Medicamento: 800222444 (gratuita)e-mail: farmacovigilancia@infarmed.ptHrvatskaAgencija za lijekove i medicinske proizvode (HALMED)Internetska stranica: halmed.hr ili potra?ite HALMED aplikaciju putem Google Play ili Apple App Store trgovineRom?niaAgen?ia Na?ional? a Medicamentului ?i a Dispozitivelor Medicale din Rom?niaStr. Aviator S?n?tescu nr. 48, sector 1Bucure?ti 011478- RO e-mail: adr@anm.roWebsite: anm.roIrelandHPRA PharmacovigilanceWebsite: hpra.ie SlovenijaJavna agencija Republike Slovenije za zdravila in medicinske pripomo?keSektor za farmakovigilancoNacionalni center za farmakovigilancoSloven?eva ulica 22SI-1000 LjubljanaTel: +386 (0)8 2000 500Faks: +386 (0)8 2000 510e-po?ta: h-farmakovigilanca@jazmp.sispletna stran: jazmp.si?slandtil Lyfjastofnunar, lyfjastofnun.isSlovenská republika?tátny ústav pre kontrolu lie?ivSekcia klinického skú?ania liekov a farmakovigilancieKvetná 11SK-825 08 BratislavaTel: + 421 2 507 01?206e-mail: neziaduce.ucinky@sukl.skTla?ivo na hlásenie podozrenia na ne?iaduci ú?inok lieku je na webovej stránke sukl.sk v??asti Bezpe?nos? liekov/Hlásenie podozrení na ne?iaduce ú?inky liekovFormulár na elektronické podávanie hlásení: ItaliaAgenzia Italiana del FarmacoSito web: [Finnish]www-sivusto: fimea.fiL??kealan turvallisuus- ja kehitt?miskeskus FimeaL??kkeiden haittavaikutusrekisteriPL 5500034 FIMEA[Swedish]webbplats: fimea.fiS?kerhets- och utvecklingscentret f?r l?kemedelsomr?det FimeaBiverkningsregistretPB 5500034 FIMEAΚ?προ?Φαρμακευτικ?? Υπηρεσ?ε?Υπουργε?ο Υγε?α?CY-1475 Λευκωσ?αΤηλ: +357 22608607Φαξ: + 357 22608669Ιστ?τοπο?: .cy/phsSverigeL?kemedelsverketBox 26751 03 UppsalaWebbplats: lakemedelsverket.seLatvijaZā?u valsts a?entūraJersikas iela 15Rīga, LV 1003 Tīmek?a vietne: .lvUnited Kingdom (Northern Ireland)Yellow Card SchemeWebsite: .uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store[for COVID-19 products/treatments]Yellow Card SchemeWebsite: or search for MHRA Yellow Card in the Google Play or Apple App Store ................
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