FrancophonIA/ELRC3.0 huggingface dataset:
English: Novo Nordisk Farma B.V. Flemingweg 18
Italian: Novo Nordisk Farma B.V.
English: • Skin and subcutaneous disorders: chloasma, erythema multiforme, erythema nodosum, vascular purpura
Italian: • Patologie della cute e del tessuto sottocutaneo: cloasma, eritema multiforme, eritema nodoso, porpora vascolare
English: NAME OF THE MEDICINAL PRODUCT Activelle and associated names (see Annex I) 0.5 mg/0.1 mg film-coated tablets [See Annex I - To be completed nationally]
Italian: DENOMINAZIONE DEL MEDICINALE Activelle e nomi associati (vedere Allegato I) 0,5 mg/0,1 mg compresse rivestite con film [Vedere Allegato I - Da completare a livello nazionale]
English: • Hepatobilitary disorders: Gallbladder disease, cholelithiasis, cholelithiasis aggravated, cholelithiasis re-occurrence
Italian: Patologie epatobiliari: malattia della colecisti, colelitiasi, colelitiasi aggravata, colelitiasi recidivante
English: cysts and polyps): Endometrial cancer
Italian: Neoplasie benigne e maligne (inclusi cisti e polipi): carcinoma endometriale
English: There are some evidence from clinical studies that use of oestrogen-only products for more than 5 years increases the risk of ovarian cancer among women who have had their womb removed.
Italian: Alcuni studi hanno indicato come l'assunzione di una TOS a base di soli estrogeni per almeno 5-10 anni, nelle donne che non hanno avuto la rimozione dell'utero, può aumentare leggermente il rischio di carcinoma ovarico rispetto alle donne che non hanno mai assunto TOS.
English: Iceland - Activelle® low 0.5 mg/0.1 mg tablets filmuhúðaðar töflur Ireland - Activelle low 0.5mg/0.1mg film-coated tablets Italy - Activelle® 0,5 mg/0,1 mg compresse film-rivestite Latvia - Noviana 0,5 mg/0,1 mg apvalkotās tabletes Lithuania - Activelle 0,5 mg / 0,1 mg plėvele dengtos tabletės Luxembourg - Activelle minor comprimés pelliculés The Netherlands - Activelle filmomhulde tabletten Norway - Noviana 0,5 mg/0,1 mg tablett filmdrasjert Portugal - 0,5mg Estradiol + 0.1 mg Acetato de Noretisterona Comprimidos revestidos por película Romania - Noviana comprimate filmate
Italian: Islanda - Activelle® low 0.5 mg/0.1 mg tablets filmuhúðaðar töflur Irlanda - Activelle low 0.5mg/0.1mg film-coated tablets Italia - Activelle® 0,5 mg/0,1 mg compresse rivestite con film
English: • If you have a kidney or heart disorder
Italian: • se ha insufficenza renale o cardiaca
English: In women with an intact womb, the risk of excessive growth of the womb lining (endometrial hyperplasia) is increased.
Italian: Eccessiva crescita della mucosa uterina (iperplasia endometriale) e carcinoma dell'endometrio In donne che hanno l'utero intatto, il rischio di un'eccessiva crescita della mucosa dell'utero (iperplasia endometriale) è aumentato.
English: • If you have had a miscarriage
Italian: • se ha abortito
English: Effects on the skin
Italian: Crampi alle gambe
English: 6.3 Shelf life 30 months.
Italian: 6.3 Periodo di validità
English: Alopecia Acne
Italian: Prurito o orticaria Alopecia Acne
English: • Dizziness
Italian: • Vertigini
English: • Sudden chest pain
Italian: • improvviso dolore al petto
English: The frequency of possible side effects listed below is defined using the following convention: Very common (affects more than 1 user in 10)
Italian: La frequenza dei possibili effetti indesiderati elencati sopra è definita usando la seguente convenzione: Molto comune(che si verificano in più di un paziente su 10) Comune (che si verificano da 1 a 10 pazienti su 100) Non comune (che si verificano da 1 a 10 pazienti su 1.000) Rara (che si verificano da 1 a 10 pazienti su 10.000) Molto rara (che si verificano in meno di un pazienti su 10.000) Non nota (non può essere definita sulla base dei dati disponibili).
English: • For 1000 current or recent users of HRT, the number of additional cases during the corresponding period will be o For users of oestrogen-only replacement therapy
Italian: • Per 1000 utilizzatrici di TOS in atto o recenti, il numero di casi aggiuntivi durante il periodo corrispondente sarà o Per le utilizzatrici della terapia sostitutiva con i soli estrogeni Tra 0 e 3 (stima migliore = 1,5) per un uso di 5 anni Tra 3 e 7 (stima migliore = 5) per un uso di 10 anni.
English: Back pain Neck pain Pain in extremity
Italian: Dolore al collo Dolori agli arti
English: If any of the following applies to you, talk to your doctor.
Italian: Se è in una delle condizioni elencate di seguito, avverta il medico.
English: Activelle and associated names (see Annex I) 0.5 mg/0.1 mg film-coated tablets [See Annex I - To be completed nationally]
Italian: Activelle e denominazione associate (vedere Allegato I) 0,5 mg/0,1 mg compresse rivestite con film [Vedere Allegato I - Completare con i dati nazionali]
English: • New onset of migraine-type headache
Italian: • Comparsa di cefalea tipo emicrania
English: Endometrial thickening
Italian: Ispessimento endometriale
English: Your doctor may ask you about any vaginal bleeding with Activelle at your regular check-ups.
Italian: • il sanguinamento continua dopo aver interrotto il trattamento Il medico può richiedere controlli regolari per il sanguinamento vaginale con Activelle.
English: If you have taken more Activelle than you should, or if for example a child has taken Activelle accidentally, talk to your doctor or hospital to assess the risk and for advice.
Italian: Se ha preso più compresse di Activelle di quanto dovrebbe, informi il medico o il farmacista.
English: Bulgaria - Noviana™ филмирани таблетки
Italian: Noviana™ филмирани таблетки
English: Ovarian cancer
Italian: Carcinoma mammario
English: If you stop taking Activelle
Italian: Se interrompe il trattamento con Activelle
English: No special requirements.
Italian: Non pertinente.
English: Noviana 0,5mg/0,1mg Filmtabletten
Italian: Activelle 0,5mg/0,1mg filmtabletten
English: • Leg cramps
Italian: • Crampi alle gambe
English: Activelle 0,5 mg/0,1 mg compresse filmrivestite
Italian: Activelle® 0,5 mg/0,1 mg compresse rivestite con film
English: B-1070 Brussel Belgium
Italian: ES-28033 Madrid Spagna
English: 1 x 28 film-coated tablets 3 x 28 film-coated tablets
Italian: FORMA FARMACEUTICA E CONTENUTO Compressa rivestita con film 1x28 compresse rivestite con film 3x28 compresse rivestite con film [Completare con i dati nazionali]
English: • Feeling sick
Italian: • Mal di pancia
English: • Heartburn (dyspepsia)
Italian: • Emicrania o cefalea (severa)
English: Estradiol (as hemihydrate) 0.5 mg + Norethisterone acetate 0.1 mg
Italian: Estradiolo (come emiidrato) 0.5 mg +
English: Novo Nordisk, A/S DNK Novo Allé,
Italian: Novo Nordisk A/S Novo Allé
English: Pack sizes:
Italian: Dimensioni della confezione:
English: Lactose monohydrate Maize starch Hydroxypropylcellulose Talc
Italian: Idrossipropilcellulosa
English: You are also more likely to get a blood clot:
Italian: E' più a rischio per la formazione di trombi:
English: Reasons for immediate withdrawal of therapy
Italian: Interruzione del trattamento con Activelle
English: • Swelling or discomfort of the abdomen (stomach)
Italian: • Gonfiore addominale o fastidio alla pancia
English: Noviana filmtabletta Estradiol (as hemihydrate) 0.5 mg + Norethisterone acetate 0.1 mg
Italian: 0,5mg Estradiol + 0.1 mg Acetato de Noretisterona Comprimidos revestidos por película
English: List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, marketing authorisation holders in the Member States
Italian: Elenco dei nomi dei medicinali, delle forme farmaceuticche, dei dosaggi, della via di somministrazione, dei titolari dell' autorizzazione all'immissione in commercio negli stati membri
English: Marszałka J. Piłsudskiego 5 95-200 Pabianice
Italian: Marszałka J. Piłsudskiego 5 95-200 Pabianice Poland
English: Belgium TEVA PHARMA BELGIUM NV Laarstraat 16
Italian: TEVA PHARMA BELGIUM NV Laarstraat 16
English: Amneal Pharma Europe Limited, 70 Sir John Rogerson's Quay, Dublin 2, Ireland
Italian: Regno Unito Amneal Pharma Europe Limited, 70 Sir John Rogerson's Quay, Dublin 2, Ireland
English: Ronda Isaac Peral, 6 Parque Tecnológico 46980 Paterna (Valencia) SPAIN
Italian: GENERFARMA, S.L. Ronda Isaac Peral, 6 Parque Tecnológico 46980 Paterna (Valencia) SPAIN
English: Sweden sanofi-aventis AB Box 14142
Italian: Svezia sanofi-aventis AB Box 14142
English: Latvia sanofi-aventis Latvia SIA, Kr.Valdemara 33-8 Riga, LV 1010, Latvia
Italian: Lettonia sanofi-aventis Latvia SIA, Kr.Valdemara 33-8 Riga, LV 1010, Latvia
English: Via Ponte della Fabbrica, 3/a, Abano Terme, Padova - 35031
Italian: FIDIA Farmaceutici S.p.a. Via Ponte della Fabbrica, 3/a, Abano Terme, Padova - 35031
English: Frederic Mompou, 5 , Sant Just Desvern (Barcelona).
Italian: LABORATORIO STADA, S.L. Frederic Mompou, 5 , Sant Just Desvern (Barcelona).
English: Meda AS, Solvang 8, DK-3450 Allerød, Denmark
Italian: Danimarca Meda AS, Solvang 8, DK-3450 Allerød, Denmark
English: Sandoz Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR
Italian: Regno Unito Sandoz Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR
English: PharmaCoDane ApS, Marielundvej 46 A, DK-2730 Herlev, Denmark
Italian: Danimarca PharmaCoDane ApS, Marielundvej 46 A, DK-2730 Herlev, Denmark
English: Germany neuraxpharm Arzneimittel GmbH Elisabeth-Selbert-Str. 23 40764 Langenfeld Germany
Italian: Germania neuraxpharm Arzneimittel GmbH Elisabeth-Selbert-Str. 23 40764 Langenfeld Germany
English: Luxembourg MYLAN BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart
Italian: Lussemburgo MYLAN BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart
English: Actavis UK Limited,Whiddon Valley, Barnstaple, North Devon EX32 8NS United Kingdom
Italian: Regno Unito Actavis UK Limited,Whiddon Valley, Barnstaple, North Devon EX32 8NS United Kingdom
English: Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex BN22 9AG United Kingdom
Italian: Regno Unito Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex BN22 9AG
English: Tillomed Laboratories Limited, 3 Howard Road, Eaton Socon, St Neots, Cambridgeshire PE19 8ET United Kingdom
Italian: Regno Unito Tillomed Laboratories Limited, 3 Howard Road, Eaton Socon, St Neots, Cambridgeshire PE19 8ET United Kingdom
English: HEXAL A/S, Kanalholmen 8-12, DK2650 Hvodovre, Denmark
Italian: Danimarca HEXAL A/S, Kanalholmen 8-12, DK2650 Hvodovre, Denmark
English: Bristol Laboratories Limited, Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire HP4 1EG United Kingdom
Italian: Regno Unito Bristol Laboratories Limited, Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire HP4
English: Luxembourg MEDA PHARMA Chaussee de la Hulpe 166 1170 Watermael-Boitsfort Belgium
Italian: Lussemburgo MEDA PHARMA Chaussee de la Hulpe 166 1170 Watermael-Boitsfort Belgium
English: Luxembourg SANOFI BELGIUM Airport Plaza, Montreal Building, Leonardo Da Vincilaan 19 1831 Diegem
Italian: Lussemburgo SANOFI BELGIUM Airport Plaza, Montreal Building, Leonardo Da Vincilaan 19 1831 Diegem
English: Belgium SANOFI BELGIUM Airport Plaza, Montreal Building, Leonardo Da Vincilaan 19 1831 Diegem
Italian: SANOFI BELGIUM Airport Plaza, Montreal Building, Leonardo Da Vincilaan 19 1831 Diegem
English: Luxembourg Genthon BV Microweg, 22
Italian: Lussemburgo Genthon BV Microweg, 22
English: Av. Tomás Ribeiro, 43 - Bloco 2, 3º F - Edifício Neopark
Italian: Av. Tomás Ribeiro, 43 - Bloco 2, 3º F - Edifício Neopark 2790-221 Carnaxide Portugal
English: Belgium MEDA PHARMA Chaussee de la Hulpe 166 1170 Watermael-Boitsfort Belgium
Italian: MEDA PHARMA Chaussee de la Hulpe 166 1170 Watermael-Boitsfort Belgium
English: Luxembourg Eurogenerics S.A. Esplanade Heysel, b22
Italian: Lussemburgo Eurogenerics S.A. Esplanade Heysel, b22
English: Belgium MYLAN BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart
Italian: MYLAN BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart Belgium
English: Belgium SANDOZ N.V. Telecom Gardens Medialaan 40
Italian: Telecom Gardens Medialaan 40
English: Via dei Lavoratori 54, 20092 Cinisello Balsamo, Milano - Italy
Italian: LIFEPHARMA S.P.A. Via dei Lavoratori 54, 20092 Cinisello Balsamo, Milano - Italy
English: The Netherlands ratiopharm Nederland B.V. Swensweg 5
Italian: Paesi Bassi ratiopharm Nederland B.V.
English: Meda Pharmaceuticals Limited, Skyway House, Parsonage Road, Takeley, Bishops Stortford CM22 6PU United Kingdom
Italian: Regno Unito Meda Pharmaceuticals Limited, Skyway House, Parsonage Road, Takeley, Bishops Stortford CM22
English: Plom 2-4, 5º Planta , Barcelona.
Italian: MYLAN PHARMACEUTICALS, S.L. Plom 2-4, 5º Planta , Barcelona.
English: Sanofi-Aventis Netherlands B.V. Kampenringweg 45 D-E 2803 PE GOUDA The Netherlands
Italian: Kampenringweg 45 D-E 2803 PE GOUDA The Netherlands
English: Denmark sanofi-aventis Denmark A/S, Slotsmarken 13, DK-2970 Hørsholm, Denmark
Italian: Danimarca sanofi-aventis Denmark A/S, Slotsmarken 13, DK-2970
English: - via Messina 3820154 Milano Italy
Italian: Teva Italia S.r.l. - via Messina 3820154 Milano Italy
English: Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS United Kingdom
Italian: Regno Unito Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS United Kingdom
English: Slovak Republic sanofi-aventis Slovakia s.r.o.
Italian: Slovacchia sanofi-aventis Slovakia s.r.o.
English: Czech Republic ALKALOID-INT d.o.o.
Italian: Regno Unito ALKALOID-INT d.o.o.
English: Edifícios Azevedos - Estrada Nacional 117-2, Alfragide
Italian: Edifícios Azevedos - Estrada Nacional 117-2, Alfragide 2614-504 Amadora Portugal
English: 10 mg/ml oral drops, solution oral use
Italian: 10 mg/ml gocce orali, soluzione
English: Aventis Pharma Limited, One Onslow Street, Guildford, Surrey GU1 4SY United Kingdom
Italian: Regno Unito Aventis Pharma Limited, One Onslow Street, Guildford, Surrey GU1 4SY
English: 110, Esplanade du Général de Gaulle 92931 Paris La Défense Cedex FRANCE
Italian: 92931 Paris La Défense Cedex FRANCE
English: Czech Republic Generics [UK] Ltd. Station Close
Italian: Danimarca Generics [UK] Ltd. Station Close
English: Takeda GmbH 2 Byk-Gulden Strasse 78467 Konstanz Germany
Italian: Takeda GmbH Byk-Gulden-Str. 2 78467 Konstanz Germany
English: UAB „SANOFI-AVENTIS LIETUVA“ A. Juozapavičiaus 6/2 g.
Italian: UAB „SANOFI-AVENTIS LIETUVA“ A. Juozapavičiaus 6/2 g. LT-09310 Vilnius Lithuania
English: Str. Izvor, Nr. 80, Et. 6-11
Italian: SANOFI-AVENTIS ROMÂNIA S.R.L. Str. Izvor, Nr. 80, Et. 6-11
English: Sanofi-Aventis Deutschland GmbH Industriepark Höchst, Gebäude K703 65926 Frankfurt am Main Germany
Italian: Sanofi-Aventis Deutschland GmbH Industriepark Höchst, Gebäude K703
English: Czech Republic MEDA Pharma s.r.o.
Italian: MEDA Pharma s.r.o.
English: Luxembourg Apotex Europe B.V. Darwinweg 20
Italian: Lussemburgo Apotex Europe B.V.
English: Zolpidem Genthion coated tablet oral use
Italian: Zolpidem Genthion compressa rivestita uso orale
English: VULM CZ, a.s. Olivova 1888 Ricany
Italian: Olivova 1888 Ricany
English: Zolpidem Eurogenerics bruis 10 mg bruistabletten, bruistabletten effervescent tablet oral use
Italian: Zolpidem Eurogenerics bruis 10 mg bruistabletten, bruistabletten compressa effervescente
English: - Viale Bodio 37/b, 20158 Milano Italy
Italian: ZENTIVA ITALIA S.R.L. - Viale Bodio 37/b, 20158 Milano Italy
English: Heumann Pharma GmbH & Co. Generica KG
Italian: Heumann Pharma GmbH & Co.
English: Czech Republic Vitabalans Oy Varastokatu 8
Italian: Danimarca Vitabalans Oy Varastokatu 8
English: Czech Republic ratiopharm GmbH Graf Arco Strasse 3
Italian: Regno Unito ratiopharm GmbH Graf Arco Strasse 3
English: INSOM 10 mg pezsgőtabletta effervescent tablet oral use
Italian: INSOM 10 mg pezsgőtabletta compressa effervescente
English: 110 00 Prague 10
Italian: Kodaňská 1441/46 110 00 Prague 10
English: Dodorest coated tablet oral use
Italian: Dodorest compressa rivestita uso orale
English: Turati 40, Milano - 20121 Italy
Italian: Doc Generici S.r.l. Turati 40, Milano - 20121 Italy
English: Czech Republic Takeda GmbH Byk-Gulden-Str. 2
Italian: Takeda GmbH 2 Byk-Gulden Strasse
English: Zolsana 10 mg coated tablets coated tablet oral use
Italian: Zolsana 10 mg coated tablets compressa rivestita uso orale
English: Zolpidemtartraat ADOH bruistabletten 10 mg, bruistabletten effervescent tablet oral use
Italian: Zolpidemtartraat ADOH bruistabletten 10 mg, bruistabletten compressa effervescente
English: Zolpidemtartraat ADOH 10 mg, bruistabletten effervescent tablet oral use
Italian: Zolpidemtartraat ADOH 10 mg, bruistabletten compressa effervescente
English: Stilnoct 10mg film-coated tablets coated tablet oral use
Italian: Stilnoct 10mg film-coated tablets compressa rivestita uso orale
English: Stilnoct, tabletten 10 mg tablet oral use
Italian: Stilnoct, tabletten 10 mg compressa
English: ADORMA 5 mg filmom obalené tablety 5 mg
Italian: ADORMA 5 mg filmom obalené tablety
English: Zolsana 5 mg coated tablets coated tablet oral use
Italian: Zolsana 5 mg coated tablets compressa rivestita uso orale
English: EDLUAR 10 mg nyelvalatti tabletta 10 mg sublingual tablet sublingual use
Italian: EDLUAR 10 mg nyelvalatti tabletta 10 mg compressa sublinguale uso sublinguale
English: Zolpidemtartraat Actavis 10 mg, tabletten tablet oral use
Italian: Zolpidemtartraat Actavis 10 mg, tabletten compressa
English: Zolpeduar sublingual tablet sublingual use
Italian: Zolpeduar compressa sublinguale uso sublinguale
English: Czech Republic SANDOZ s.r.o.
Italian: SANDOZ s.r.o.
English: Sanval 10 mg filmsko obožene tablete 10 mg
Italian: Sanval 10 mg filmsko obožene tablete
English: Zolpitop coated tablet oral use
Italian: Zolpitop compressa rivestita uso orale
English: Edluar sublingual tablet sublingual use
Italian: Edluar compressa sublinguale uso sublinguale
English: Zolpidem "Hexal" - Filmtabletten
Italian: Zolpidem "Hexal" - Filmtabletten 10 mg
English: Edluar 10 mg, tablet voor sublinguaal gebruik sublingual tablet sublingual use
Italian: Edluar 10 mg, tablet voor sublinguaal gebruik compressa sublinguale uso sublinguale
English: Stilnoct 5mg fiilm-coated tablets coated tablet oral use
Italian: Stilnoct 5mg film-coated tablets compressa rivestita uso orale
English: Edluar 5 mg, tablet voor sublinguaal gebruik sublingual tablet sublingual use
Italian: Edluar 5 mg, tablet voor sublinguaal gebruik compressa sublinguale uso sublinguale
English: Stilnoct tablet oral use
Italian: Stilnoct compressa rivestita uso orale
English: Sanval 10 mg filmom obložene tablete 10 mg
Italian: Sanval 10 mg filmom obložene tablete
English: Edluar 10 mg Sublingualtabletten 10 mg sublingual tablet sublingual use
Italian: Edluar 10 mg Sublingualtabletten 10 mg compressa sublinguale uso sublinguale
English: Zolpidemtartaat Actavis 5 mg, tabletten tablet oral use
Italian: Zolpidemtartaat Actavis 5 mg, tabletten compressa
English: Insom effervescent tablet oral use
Italian: Insom compressa effervescente
English: Lunata 10 mg filmom obložene tablete 10 mg
Italian: Lunata 10 mg filmom obložene tablete
English: EDLUAR 5 mg nyelvalatti tabletta sublingual tablet sublingual use
Italian: EDLUAR 5 mg nyelvalatti tabletta 5 mg compressa sublinguale uso sublinguale
English: Zolpidem-CT 5 mg Filmtabletten
Italian: Zolpidem-CT 5 mg Filmtabletten 5 mg
English: sublingual tablet sublingual use
Italian: compressa sublinguale uso sublinguale
English: coated tablet oral use
Italian: compressa rivestita uso orale
English: Zolpidem-Actavis 10 mg Filmtabletten 10 mg
Italian: Zolpidem-Actavis 10 mg Filmtabletten
English: Edluar 10 mg podjezične tablete sublingual tablet sublingual use
Italian: Edluar 10 mg podjezične tablete compressa sublinguale uso sublinguale
English: Zolpidem Sandoz 10 mg Filmtabletten 10 mg
Italian: Zolpidem Sandoz 10 mg Filmtabletten
English: Zoldem 10 mg film coated tablets
Italian: Zoldem 10 mg film coated tablets 10 mg
English: Edluar 10 mg sublingual tablets sublingual tablet sublingual use
Italian: Edluar 10 mg sublingual tablets compressa sublinguale uso sublinguale
English: Edluar 10 mg Sublingualtabletten 10 mg sublingual tablet oral use
Italian: Edluar 10 mg Sublingualtabletten 10 mg compressa sublinguale
English: Edluar 5 mg podjezične tablete sublingual tablet sublingual use
Italian: Edluar 5 mg podjezične tablete compressa sublinguale uso sublinguale
English: Edluar 5 mg sublingual tablets sublingual tablet sublingual use
Italian: Edluar 5 mg sublingual tablets compressa sublinguale uso sublinguale
English: Zolpidemtartraat ratiopharm 10 mg, tabletten tablet oral use
Italian: Zolpidemtartraat ratiopharm 10 mg, tabletten compressa
English: Zolpidemtartraat ratiopharm 5 mg, tabletten tablet oral use
Italian: Zolpidemtartraat ratiopharm 5 mg, tabletten compressa
English: Sweden ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
Italian: Svezia ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
English: Germany ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
Italian: Germania ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
English: Finland ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
Italian: Finlandia ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
English: Zolsana 5 mg filmsko obložene tablete 5 mg
Italian: Zolsana 5 mg filmsko obložene tablete
English: Zolsana 5 mg filmom obložene tablete 5 mg
Italian: Zolsana 5 mg filmom obložene tablete
English: Meda Pharma GmbH & Co. KG Benzstrasse 1
Italian: KG Benzstrasse 1
English: Edluar 5 mg Sublingualtabletten sublingual tablet sublingual use
Italian: Edluar 5 mg Sublingualtabletten 5 mg compressa sublinguale uso sublinguale
English: Edluar 5mg sublingual tablets sublingual tablet oral use
Italian: Edluar 5mg sublingual tablets compressa sublinguale
English: Edluar 10mg sublingual tablets sublingual tablet oral use
Italian: Edluar 10mg sublingual tablets compressa sublinguale
English: Edluar 10 mg sublingual tablets sublingual tablet oral use
Italian: Edluar 10 mg sublingual tablets compressa sublinguale
English: Edluar 5 mg sublingual tablets sublingual tablet oral use
Italian: Edluar 5 mg sublingual tablets compressa sublinguale
English: The European Commission issued a decision on 5 October 2010.
Italian: Il 5 ottobre 2010 la Commissione europea ha emesso una decisione.
English: The company wanted the authorisation to be recognised in Bulgaria, Germany, France, Ireland and Italy (the ‘concerned Member States').
Italian: La ditta voleva che l'autorizzazione fosse riconosciuta in Bulgaria, Germania, Francia, Irlanda e Italia (“Stati membri interessati”).
English: Daniela Melchiorri (Italy)
Italian: Daniela Melchiorri (Italia)
English: Kristina Dunder (Sweden)
Italian: Kristina Dunder (Svezia)
English: Procedure start date:
Italian: Data di inizio della procedura:
English: However, the Member States were not able to reach an agreement and the Swedish medicines regulatory agency referred the matter to the CHMP for arbitration on 29 April 2010.
Italian: Tuttavia gli Stati membri non sono pervenuti a un accordo, e il 29 aprile 2010 l'agenzia svedese di regolamentazione dei medicinali ha deferito la questione al CHMP per un arbitrato.
English: Co-rapporteur:
Italian: Correlatore:
English: What is Norsed Combi D?
Italian: Che cos'è Norsed Combi D?
English: Sanofi-aventis S.p.A. submitted Norsed Combi D for mutual recognition on the basis of the initial authorisation granted by Sweden on 3 October 2006.
Italian: Sanofi-aventis S.p.A. ha chiesto il mutuo riconoscimento di Norsed Combi D sulla base dell'autorizzazione inizialmente rilasciata dalla Svezia il 3 ottobre 2006.
English: Why was Norsed Combi D reviewed?
Italian: Perché Norsed Combi D è stato sottoposto a riesame?
English: 20 May 2010
Italian: 20 maggio 2010