FrancophonIA/ELRC3.0 huggingface dataset:
Bulgarian: Поради това СНМР препоръчва промяната в условията на разрешенията за употреба за лекарствени продукти, съдържащи нимезулид, за системна употреба, посочени в Приложение I и при спазване на условията, посочени в Приложение IV, за които измененията на кратката характеристика на продукта и листовката са посочени в Приложение III.
Latvian: • ņemot vērā iepriekš minēto, Komiteja uzskatīja, ka ilgstoša nimesulīda lietošana "simptomātiskai sāpes izraisoša osteoartrīta ārstēšanai" rada risku un secināja, ka sistēmiski lietojamu nimesulīdu saturošu zāļu riska-ieguvuma līdzsvars šīs indikācijas gadījumā vairs nav labvēlīgs, tādēļ CHMP ieteica grozīt reģistrācijas apliecību nosacījumus sistēmiski lietojamām nimesulīdu saturošām zālēm, kas norādītas I pielikumā, saskaņā ar IV pielikumā izklāstītajiem nosacījumiem, un šīm zālēm zāļu aprakstā un lietošanas instrukcijā veicamie grozījumi ir norādīti III pielikumā.
Bulgarian: Профилът на безопасност от гледна точка на хепатотоксичност и стомашно-чревна токсичност за нимезулид е показан като по-неблагоприятен от алтернативни НСПВС, като диклофенак и напроксен.
Latvian: Ir pierādīts, ka nimesulīda drošības profils attiecībā uz hepatotoksicitāti un gastrointestinālo toksicitāti ir sliktākas nekā citiem NPL, piemēram, diklofenakam un naproksēnam.
Bulgarian: А, В или парацетамол фулминантна чернодробна недостатъчност, която изисква чернодробна трансплантация в Ирландия, отколкото с който и да е друг лекарствен продукт.
Latvian: Ziņotie gadījumi liecināja, ka Īrijā, lietojot nimesulīdu, saistība ar ne-A ne-B ne-paracetamola izraisītu zibensveida aknu mazspēju, kuras dēļ nepieciešama aknu transplantācija, ir lielāka, nekā lietojot citas zāles.
Bulgarian: Не е демонстрирано недвусмислено и клинично значимо предимство пред други
Latvian: Netika pierādīts nepārprotams un klīniski nozīmīgs pārākums pār citiem NPL, tādēļ Komiteja uzskatīja, ka nimesulīda efektivitāte ir līdzīga citiem pieejamiem NPL.
Bulgarian: Съгласуваната дата за публикуване на писмото е 15 дни след становището на Европейската комисия.
Latvian: Saskaņotais šīs vēstules izsūtīšanas datums ir 15 darba dienu pēc Eiropas Komisijas lēmuma pieņemšanas.
Bulgarian: Притежателите на разрешенията за употреба трябва да информират здравните специалисти за резултата от това преразглеждане на нимезулид чрез „Директно съобщение до здравните специалисти" (DHPC), както е одобрено от СНМР.
Latvian: Reģistrācijas apliecību īpašniekiem jāinformē veselības aprūpes speciālisti par šā nimesulīda pārskata iznākumiem, izmantojot "Vēstuli veselības aprūpes speciālistam", par ko panākta vienošanās ar CHMP.
Bulgarian: Националните компетентни органи, координирани от референтната държава-членка, когато е подходящо, трябва да гарантират изпълнението на следните условия от притежателите на разрешенията за употреба:
Latvian: Valstu atbildīgajām iestādēm atsauces dalībvalsts virsvadībā (ja piemērojams) jānodrošina, lai reģistrācijas apliecības īpašnieki izpildītu šādus nosacījumus:
Bulgarian: План за съобщаване
Latvian: Saziņas plāns
Bulgarian: УСЛОВИЯ ЗА ИЗДАВАНЕ НА РАЗРЕШЕНИЯТА
Latvian: REĢISTRĀCIJAS APLIECĪBAS NOSACĪJUMI
Bulgarian: Условие за издаване на разрешенията за употреба
Latvian: Reģistrācijas apliecību nosacījums
Bulgarian: Списък на имената, лекарствените форми, количеството на активното вещество в дозова единица, пътищата на въвеждане на лекарствените продукти, притежателите на разрешение за употреба в страните членки
Latvian: I pielikums Zāļu nosaukumi, zāļu formas, stiprumi, lietošanas veids un reģistrācijas apliecību īpašnieki dalībvalstīs
Bulgarian: FR - Франция EG LABO - Laboratoires EuroGenerics "Le Quintet" - Bâtiment A
Latvian: FR - Francija EG LABO - Laboratoires EuroGenerics "Le Quintet" - Bâtiment A
Bulgarian: Rega Farma - Promoção de Produtos Farmacêuticos,
Latvian: PT - Portugāle Rega Farma - Promoção de Produtos Farmacêuticos,
Bulgarian: 0065 Fiano Romano (Roma) Italy
Latvian: 0065 Fiano Romano (Roma)
Bulgarian: FR - Франция CLL PHARMA Nice Premier - Arenas 455, promenade des Anglais 06299 NICE Cedex 03
Latvian: FR - Francija CLL PHARMA Nice Premier - Arenas 455, promenade des Anglais 06299 NICE Cedex 03
Bulgarian: Av. Tomás Ribeiro, 43 - Bloco 1, 4º BEdifício Neopark
Latvian: Tomás Ribeiro, 43 - Bloco 1, 4º BEdifício Neopark
Bulgarian: 2114 Aglantzia
Latvian: 2114 Aglantzia Lefkosia
Bulgarian: EL - Гърция ANTONIOS POLYCHRONIS OF MARINOU Ethnikis Antistaseos 6A
Latvian: EL - Grieķija ANTONIOS POLYCHRONIS OF MARINOU Ethnikis Antistaseos 6A
Bulgarian: 20092 Cinisello Balsamo (Milano) Italy
Latvian: 20092 Cinisello Balsamo (Milano)
Bulgarian: BG - България Chaikapharma - Highquality medicines AD, 1 G.M.Dimitrov Blvd
Latvian: BG - Bulgārija Chaikapharma - Highquality medicines AD, 1 G.M.Dimitrov Blvd
Bulgarian: EL - Гърция LEOVAN, M. LEWN & SIA EE Argonafton 22
Latvian: EL - Grieķija LEOVAN, M. LEWN & SIA EE Argonafton 22
Bulgarian: FR - Франция THERABEL LUCIEN PHARMA 19 rue Alphonse de Neuville 75017 PARIS
Latvian: FR - Francija THERABEL LUCIEN PHARMA 19 rue Alphonse de Neuville 75017 PARIS
Bulgarian: HU - Унгария PannonPharma Kft.
Latvian: HU - Ungārija PannonPharma Kft.
Bulgarian: SK - Словакия Zentiva k.s., Evropská 846/176a, 160 00, Praha
Latvian: SK - Slovākija Zentiva k.s., Evropská 846/176a, 160 00, Praha
Bulgarian: HU - Унгария Lab.
Latvian: HU - Ungārija Lab.
Bulgarian: BG - България Actavis EAD 29 Atanas Dukov str. Sofia 1407
Latvian: BG - Bulgārija Actavis EAD 29 Atanas Dukov str. Sofia 1407
Bulgarian: BG - България Sopharma AD 16 Iliensko shosse str. 1220 Sofia
Latvian: BG - Bulgārija Sopharma AD 16 Iliensko shosse str. 1220 Sofia
Bulgarian: IT - Италия New Research Srl Via della Tenuta di Torrenova, 142 00133 Roma
Latvian: New Research Srl Via della Tenuta di Torrenova, 142 00133 Roma
Bulgarian: HU - Унгария Eurodrug Lab.
Latvian: HU - Ungārija Eurodrug Lab.
Bulgarian: BG - България Inbiotech Ltd 5A Triaditza str.
Latvian: BG - Bulgārija Inbiotech Ltd 5A Triaditza str.
Bulgarian: BG - България CSC Pharmaceuticals Ltd-Bulgaria EOOD, 10 Assen Jordanov str.,
Latvian: BG - Bulgārija CSC Pharmaceuticals Ltd-Bulgaria EOOD, 10 Assen Jordanov str.,
Bulgarian: - Италия Selvi Laboratorio Bioterapico Spa Via Procoio, 28
Latvian: Selvi Laboratorio Bioterapico Spa Via Procoio, 28
Bulgarian: Damastown - Dublin
Latvian: Damastown - Dublin Ireland
Bulgarian: IT - Италия Benedetti & Co spa Via Bolognese,
Latvian: Benedetti & Co spa Via Bolognese,
Bulgarian: Mer Medicamentos, Lda.
Latvian: PT - Portugāle Mer Medicamentos, Lda.
Bulgarian: SI - Словения CSC Pharma d.o.o.
Latvian: SI - Slovēnija CSC Pharma d.o.o.
Bulgarian: - Италия Germed Pharma Spa Via Cesare Cantù, 11
Latvian: Germed Pharma Spa Via Cesare Cantù, 11
Bulgarian: RO - Румъния S.C. FARMEX COMPANY SRL Str.Drumul Potcoavei nr. 30, Pipera Voluntari, Jud. Ilfov,
Latvian: FARMEX COMPANY SRL Str.Drumul Potcoavei nr. 30, Pipera Voluntari, Jud.
Bulgarian: AT - Австрия CSC Pharmaceuticals Handels GmbH Gewerbestraße 18-20
Latvian: AT - Austrija CSC Pharmaceuticals Handels GmbH Gewerbestraße 18-20
Bulgarian: AT - Австрия CSC Pharmaceuticals Handels GmbH Heiligenstädter Straße 395 b A-1190 Wien
Latvian: AT - Austrija CSC Pharmaceuticals Handels GmbH Heiligenstädter Straße 395 b A-1190 Wien
Bulgarian: Rua João deDeus,19 Venda Nova
Latvian: Rua João deDeus,19
Bulgarian: EL - Гърция INTERMED ABEE Kalyftaki 27
Latvian: EL - Grieķija INTERMED ABEE Kalyftaki 27
Bulgarian: IT - Италия Magis Farmaceutici Spa Via Cacciamali, 34-36-38/B 25125 Brescia
Latvian: Magis Farmaceutici Spa Via Cacciamali, 34-36-38/B 25125 Brescia Italy
Bulgarian: CY - Кипър CODAL SYNTO LTD 33 Thekla Lysioti str.
Latvian: CODAL SYNTO LTD 33 Thekla Lysioti str.
Bulgarian: EL - Гърция MED-ONE S.A., HELLAS Parnithos Avenue 211
Latvian: EL - Grieķija MED-ONE S.A., HELLAS Parnithos Avenue 211
Bulgarian: EL - Гърция ANTOR EPE P. Mavromihali 1
Latvian: EL - Grieķija ANTOR EPE P. Mavromihali 1
Bulgarian: IT - Италия Francia Farmac.Ind.Far.Bio.Srl Via dei Pestagalli, 7
Latvian: Francia Farmac.Ind.Far.Bio.Srl Via dei Pestagalli, 7
Bulgarian: - Италия Farmac.Caber Spa Viale Città D'Europa, 681 00144 Roma
Latvian: Farmac.Caber Spa Viale Città D'Europa, 681 00144 Roma Italy
Bulgarian: 21040 Origgio Varese Italy
Latvian: Largo Boccioni 1 21040 Origgio Varese Italy
Bulgarian: RO - Румъния CSC PHARMACEUTICALS HANDELS GmbH Gewerbestrasse 18-20 Gewerbegebiet Klein-Engersdorf A-2102 Bisamberg Austria
Latvian: RO - Rumānija CSC PHARMACEUTICALS HANDELS GmbH Gewerbestrasse 18-20 Gewerbegebiet Klein-Engersdorf A-2102 Bisamberg Austria
Bulgarian: EL - Гърция RAFARM AEBE Korintou 12
Latvian: EL - Grieķija RAFARM AEBE Korintou 12
Bulgarian: EL - Гърция BROS EPE Avgis & Gallinis 15
Latvian: EL - Grieķija BROS EPE Avgis & Gallinis 15
Bulgarian: EL - Гърция KLEVA EPE Parnithos Avenue 189 Aharnai Attikis 13671 Greece
Latvian: EL - Grieķija KLEVA EPE Parnithos Avenue 189 Aharnai Attikis 13671 Greece
Bulgarian: IT - Италия C.T.Laboratorio Farmaceutico Srl Villa Sayonara - Strada Solaro, 75/77 18038 Sanremo (IM)
Latvian: C.T.Laboratorio Farmaceutico Srl Villa Sayonara - Strada Solaro, 75/77 18038 Sanremo (IM) Italy
Bulgarian: EL - Гърция COUP ABEE Agias Varvaras 53-55 Dafni, Athens 17235
Latvian: EL - Grieķija COUP ABEE Agias Varvaras 53-55 Dafni, Athens 17235
Bulgarian: Sandoz Farmacêutica, Lda. Alameda da Beloura, Edifício 1, 2ºEscritório 15
Latvian: Alameda da Beloura, Edifício 1, 2ºEscritório 15
Bulgarian: EL - Гърция HELP ABEE Valaoritou 10
Latvian: EL - Grieķija HELP ABEE Valaoritou 10
Bulgarian: Bluepharma Genéricos - Comércio de Medicamentos, S.A.
Latvian: PT - Portugāle Bluepharma Genéricos - Comércio de Medicamentos, S.A.
Bulgarian: IT - Италия Aurobindo Pharma Italia Srl Vicolo San Giovanni sul Muro, 9 20121 Milano
Latvian: Aurobindo Pharma Italia Srl Vicolo San Giovanni sul Muro, 9 20121 Milano
Bulgarian: IT - Италия So.Se.Pharm Srl Via dei Castelli Romani, 22 00040 Pomezia (Roma) Italy
Latvian: So.Se.Pharm Srl Via dei Castelli Romani, 22 00040 Pomezia (Roma)
Bulgarian: EL - Гърция VELKA HELLAS AEBE Kapodistriou & Korinthou 12 Neo Psychiko 15451
Latvian: EL - Grieķija VELKA HELLAS AEBE Kapodistriou & Korinthou 12 Neo Psychiko 15451
Bulgarian: Ciclum Farma Unipessoal, Lda.
Latvian: PT - Portugāle Ciclum Farma Unipessoal, Lda.
Bulgarian: IT - Италия Laboratori Alter Srl Via Egadi, 7
Latvian: Laboratori Alter Srl Via Egadi, 7
Bulgarian: Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda.
Latvian: PT - Portugāle Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda.
Bulgarian: 2700-487 Amadora Portugal
Latvian: 2700-487 Amadora
Bulgarian: D-83607 HolzkirchenGermany
Latvian: Industriestrasse, 25 D-83607 HolzkirchenGermany
Bulgarian: EL - Гърция MEDICHROM A.E. 6 Km Markopoulou-Koropi Avenue Markopoulo Mesogeion 19003 Greece
Latvian: EL - Grieķija MEDICHROM A.E. 6 Km Markopoulou-Koropi Avenue Markopoulo Mesogeion 19003 Greece
Bulgarian: Psychiko 15451
Latvian: N. Psychiko 15451
Bulgarian: 5 - 16131 Genova
Latvian: Semeria, 5 - 16131 Genova Italy
Bulgarian: 2700-451 Amadora Portugal
Latvian: 2700-451 Amadora
Bulgarian: EL - Гърция FARMILIA E.E. Favierou 48
Latvian: EL - Grieķija FARMILIA E.E. Favierou 48
Bulgarian: EL - Гърция MEDARTE PHARMACEUTICLS ABEE Spyrou Vretou 10
Latvian: EL - Grieķija MEDARTE PHARMACEUTICLS ABEE Spyrou Vretou 10
Bulgarian: Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda.
Latvian: PT - Portugāle Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda.
Bulgarian: EL - Гърция VIOFAR EPE Ethnikis Antistaseos & Trifyllias Aharnai 13671
Latvian: EL - Grieķija VIOFAR EPE Ethnikis Antistaseos & Trifyllias Aharnai 13671
Bulgarian: Via Padre G. Semeria,
Latvian: Via Padre G.
Bulgarian: S.A. Rua João Chagas, 53 - 3º 1495-764 Cruz Quebrada Portugal
Latvian: Rua João Chagas, 53 - 3º 1495-764 Cruz Quebrada
Bulgarian: IT - Италия Actavis Group PTC EHF Reykjavikurvegi 76-78
Latvian: Actavis Group PTC EHF Reykjavikurvegi 76-78 Hafnarf Joerdur Iceland
Bulgarian: EL - Гърция BALU EPE 30 Km Athens-Lavrion Markopoulo 19003
Latvian: EL - Grieķija BALU EPE 30 Km Athens-Lavrion Markopoulo 19003
Bulgarian: IT - Италия Aesculapius Farmaceutici Srl Via Cozzaglio, 24
Latvian: Aesculapius Farmaceutici Srl Via Cozzaglio, 24
Bulgarian: EL - Гърция BIOSPRAY ABEE 18TH Km Marathonos Avenue Pallini 15344
Latvian: EL - Grieķija BIOSPRAY ABEE 18TH Km Marathonos Avenue Pallini 15344
Bulgarian: Rua Quinta do PinheiroEdifício Tejo - 6º Piso
Latvian: Edifício Tejo - 6º Piso
Bulgarian: EL - Гърция FINIXFARM EPE Dervenakion 38 & Sahini Gerakas 15344
Latvian: EL - Grieķija FINIXFARM EPE Dervenakion 38 & Sahini Gerakas 15344
Bulgarian: EL - Гърция NORMA HELLAS A.E. Menandrou 54
Latvian: EL - Grieķija NORMA HELLAS A.E. Menandrou 54
Bulgarian: Baldacci - Portugal, S.A. Rua Cândido de Figueiredo, 84-B 1549-005 Lisboa Portugal
Latvian: Rua Cândido de Figueiredo, 84-B 1549-005 Lisboa
Bulgarian: Edifício Monsanto 2790-012 Portela de Carnaxide Portugal
Latvian: 2790-012 Portela de Carnaxide Portugal
Bulgarian: CY - Кипър CHR. K. UNIMED LTD 21 Davlou
Latvian: K. UNIMED LTD 21 Davlou
Bulgarian: EL - Гърция ARMEDICA A.E. Agias Markellis 17
Latvian: EL - Grieķija ARMEDICA A.E. Agias Markellis 17
Bulgarian: IT - Италия Dr Reddy's Srl Via Fernanda Wittengs, 3 20123 Milano
Latvian: Dr Reddy's Srl Via Fernanda Wittengs, 3 20123 Milano Italy
Bulgarian: GP - genéricos portugueses, Lda. Rua Henrique Paiva Couceiro, 29Venda Nova
Latvian: Rua Henrique Paiva Couceiro, 29Venda Nova
Bulgarian: Обвита таблетка
Latvian: Putojoša tablete
Bulgarian: Labesfal - Laboratórios Almiro, S.A.
Latvian: PT - Portugāle Labesfal - Laboratórios Almiro, S.A.
Bulgarian: AULIN, granule pentru suspensie orală, 100 mg/plic
Latvian: AULIN, granule pentru suspensie orală, 100 mg/plic mg/paciņa
Bulgarian: CY - Кипър CDL PHARMACEUTICAL LTD 5 Diomedous str.
Latvian: CDL PHARMACEUTICAL LTD 5 Diomedous str.
Bulgarian: EL - Гърция PHARMACEUTICAL INDUSTRY PROEL EPAM. G. KORONIS
Latvian: EL - Grieķija PHARMACEUTICAL INDUSTRY PROEL EPAM.
Bulgarian: EL - Гърция REMEDINA ABEE Gounari 25 & Areos Kamatero Attikis 13451
Latvian: EL - Grieķija REMEDINA ABEE Gounari 25 & Areos Kamatero Attikis 13451
Bulgarian: 3508 Lemessos
Latvian: 3508 Lemessos Cyprus
Bulgarian: 3505 Lemessos
Latvian: 3505 Lemessos Cyprus
Bulgarian: Zentiva k.s., U kabelovny 130, Dolní Měcholupy 102 37, Praha 10, Czech Republic
Latvian: RO - Rumānija Zentiva k.s., U kabelovny 130, Dolní Měcholupy 102 37, Praha 10, Czech Republic
Bulgarian: EL - Гърция REMEK PHARMACEUTICALS ABEE Pentelis 34
Latvian: EL - Grieķija REMEK PHARMACEUTICALS ABEE Pentelis 34
Bulgarian: IT - Италия Levofarma Srl Via Conforti, 42
Latvian: Levofarma Srl Via Conforti, 42
Bulgarian: Wynn Industrial Pharma, S.A. Rua Tierno Galvan, Torre 3, 16º Piso, Amoreiras
Latvian: Rua Tierno Galvan, Torre 3, 16º Piso,
Bulgarian: EL - Гърция GENEPHARM A.E.
Latvian: EL - Grieķija GENEPHARM A.E.
Bulgarian: APceuticals-Farmacêutica, Lda Av Aida, Edif. Garden-Bloco 9, Lj 910 2765-187 Estoril
Latvian: Garden-Bloco 9, Lj 910 2765-187 Estoril
Bulgarian: Cinfa Portugal, Lda.
Latvian: PT - Portugāle Cinfa Portugal, Lda.
Bulgarian: Laboratórios Inibsa, S.A.
Latvian: PT - Portugāle Laboratórios Inibsa, S.A.
Bulgarian: Arrowblue Produtos Farmacêuticos S.A. Av. D.
Latvian: PT - Portugāle Arrowblue Produtos Farmacêuticos S.A.
Bulgarian: 50 MG/5ML Перорална суспензия
Latvian: 50 MG/5ML Suspensija iekšķīgai lietošanai
Bulgarian: 20144 Milano
Latvian: 20144 Milano Italy
Bulgarian: RO - Румъния S.C. ARENA GROUP S.A. Str. Ştefan Mihăileanu, Nr. 31, Sector 2, Bucureşti,
Latvian: Ştefan Mihăileanu, Nr. 31, Sector 2, Bucureşti,
Bulgarian: EL - Гърция LAVIPHARM HELLAS A.E. Agias Marinas
Latvian: EL - Grieķija LAVIPHARM HELLAS A.E. Agias Marinas
Bulgarian: SK - Словакия Medicom International s.r.o. Páteřní 7
Latvian: SK - Slovākija Medicom International s.r.o.
Bulgarian: RO - Румъния S.C. MAGISTRA C&C S.R.L. B-dul Aurel Vlaicu nr. 82 A, Constanţa
Latvian: MAGISTRA C&C S.R.L. B-dul Aurel Vlaicu nr.
Bulgarian: IT - Италия Mylan Spa Via Vittor Pisani, 20 20124 Milano
Latvian: Mylan Spa Via Vittor Pisani, 20 20124 Milano Italy
Bulgarian: LV - Латвия Medochemie Ltd. Constantinoupoleos Str. 1-10 Limassol, CY-3011
Latvian: Constantinoupoleos Str. 1-10 Limassol, CY-3011
Bulgarian: São Martinho do Bispo 3045-016 Coimbra Portugal
Latvian: 3045-016 Coimbra
Bulgarian: ES - Испания HELSINN BIREX PHARMACEUTICALS LTD.
Latvian: ES - Spānija HELSINN BIREX PHARMACEUTICALS LTD.
Bulgarian: IT - Италия Almus Srl
Latvian: Almus Srl
Bulgarian: NIMESIL, granule pentru suspensie orală, 100 mg
Latvian: NIMESIL, granule pentru suspensie orală, 100 mg mg/paciņa
Bulgarian: Таблетка, диспергираща се в устата
Latvian: Mutē disperģējama tablete
Bulgarian: IT - Италия MDM Spa Viale Papiniano, 22/B 20100 Milano Italy
Latvian: Viale Papiniano, 22/B 20100 Milano Italy
Bulgarian: Lagoas Park, Edificio 5, Torre C, Piso 3
Latvian: PT - Portugāle Jaba Recordati, S. A. Lagoas Park, Edificio 5, Torre C, Piso 3
Bulgarian: Angelini Farmacêutica, Lda.
Latvian: PT - Portugāle Angelini Farmacêutica, Lda.
Bulgarian: - Полша Pabianickie Zakłady Farmaceutyczne Polfa S.A. Marszałka J. Piłsudskiego 5,
Latvian: Pabianickie Zakłady Farmaceutyczne Polfa S.A.
Bulgarian: 95-200 Pabianice
Latvian: Marszałka J. Piłsudskiego 5, 95-200 Pabianice
Bulgarian: Mylan, Lda.
Latvian: PT - Portugāle Mylan, Lda.
Bulgarian: EL - Гърция BOEHRINGER INGELHEIM HELLAS S.A.
Latvian: EL - Grieķija BOEHRINGER INGELHEIM HELLAS S.A. Ellinikou 2
Bulgarian: 2585 GD, The Hague, The Netherlands
Latvian: BV Laan Copes van Cattenbruch 74. 2585 GD, The Hague, The Netherlands
Bulgarian: - Италия Piam Farmaceutici Spa Via Padre G. Semeria, 5
Latvian: Piam Farmaceutici Spa Via Padre G. Semeria, 5 16131 Genova Italy
Bulgarian: IT - Италия Lab.Guidotti Spa Via Livornese, 897
Latvian: LT - Lietuva Laboratori Guidotti S.p.A. Via Livornese, 897
Bulgarian: EL - Гърция ELPEN A.E. PHARMACEUTICAL INDUSTRY, Marathonos Avenue 95
Latvian: PHARMACEUTICAL INDUSTRY, Marathonos Avenue 95
Bulgarian: EL - Гърция FARMANIC CHEMIPHARMA S.A. Fylis 137
Latvian: EL - Grieķija FARMANIC CHEMIPHARMA S.A.
Bulgarian: BG - България Zentiva k.s.
Latvian: BG - Bulgārija Zentiva k.s. U kabelovny 130
Bulgarian: EL - Гърция EVAGGELOS KALOFOLIAS & SIA O.E. Menandrou 54
Latvian: EL - Grieķija EVAGGELOS KALOFOLIAS & SIA O.E.
Bulgarian: LV - Латвия Laboratori Guidotti S.p.A.
Latvian: LV - Latvija Laboratori Guidotti S.p.A. Via Livornese
Bulgarian: Alter, S.A.
Latvian: S.A.
Bulgarian: Germed Farmacêutica, Lda.
Latvian: PT - Portugāle Germed Farmacêutica, Lda.
Bulgarian: LV - Латвия Zentiva k.s.
Latvian: LV - Latvija Zentiva k.s. U kabelovny 130
Bulgarian: Laboratori Guidotti, S.p.A.
Latvian: PT - Portugāle Laboratori Guidotti, S.p.A.
Bulgarian: Laboratórios Basi - Indústria Farmacêutica, S.A. Rua do Padrão, 98
Latvian: PT - Portugāle Laboratórios Basi - Indústria Farmacêutica, S.A.
Bulgarian: IT - Италия Sofar Spa Via Isonzo, 8
Latvian: Sofar Spa Via Isonzo, 8 20100 Milano Italy
Bulgarian: EL - Гърция FARMEDIA A.E. Athinas 22 & Apollonos Gerakas Attikis 15344
Latvian: Athinas 22 & Apollonos Gerakas Attikis 15344
Bulgarian: Medicom International, s.r.o. Páteřní 1216/7
Latvian: Páteřní 1216/7
Bulgarian: IT - Италия Sarda Pharmaceutica Srl Via Castiglione, 92/B
Latvian: Sarda Pharmaceutica Srl Via Castiglione, 92/B 09100 Cagliari Italy
Bulgarian: IT - Италия Union Health Srl Via Roccamandolfi, 1
Latvian: Union Health Srl Via Roccamandolfi, 1 00156 Roma Italy
Bulgarian: Almus,Lda.
Latvian: PT - Portugāle Almus,Lda.
Bulgarian: - Полша Medicom International s.r.o. Paterni 7
Latvian: Medicom International s.r.o.
Bulgarian: Highway Athens-Lamia 14565 Greece
Latvian: EL - Grieķija DEMO ABEE 21ST Km National Highway Athens-Lamia 14565 Greece
Bulgarian: CY - Кипър MEDOCHEMIE LTD 1-10 Constantinoupoleos str. P.O.Box 51409
Latvian: MEDOCHEMIE LTD 1-10 Constantinoupoleos str.
Bulgarian: Edifício D.
Latvian: FARMA A.E.
Bulgarian: Kifissia 14564
Latvian: N. Kifissia 14564
Bulgarian: IT - Италия Ranbaxy Italia Spa Piazza Filippo Meda, 3
Latvian: Ranbaxy Italia Spa Piazza Filippo Meda, 3 20121 Milano Italy
Bulgarian: IT - Италия Ratiopharm GmbH Graf-Arcostrasse, 2
Latvian: Ratiopharm GmbH Graf-Arcostrasse, 2 ULM D-89070
Bulgarian: Guidotti S.p.A.
Latvian: PIAM s.a.p.a.
Bulgarian: Ellinikou 2
Latvian: GREECE, Dervenakion 4
Bulgarian: EL - Гърция BIOMEDICA-CHEMICA A.E. G. Lyra 25
Latvian: EL - Grieķija BIOMEDICA-CHEMICA A.E.
Bulgarian: Medochemie Ltd. P.O. Box 51409 Limassol, CY-3505 Cyprus
Latvian: Limassol, CY-3505
Bulgarian: Amélia, Piso 1, Ala B 2770-229 Paço de Arcos Portugal
Latvian: 2770-229 Paço de Arcos
Bulgarian: Viale Fulvio Testi, 330
Latvian: Italfarmaco S.p.A. Viale Fulvio Testi, 330 20126 Milano Italy
Bulgarian: Фармацевтична форма Начин на приложение опаковка
Latvian: Zāļu forma
Bulgarian: EMEA номер
Latvian: Deva
Bulgarian: Измислено име концентрация
Latvian: EU Procedūras numurs Oriģinālais nosaukums
Bulgarian: Може да се нуждаете от медицинско наблюдение.
Latvian: Jums var būt nepieciešama medicīniska palīdzība.
Bulgarian: За да имате полза от лекарството, трябва да го приемате всеки ден.
Latvian: - Lai Jūsu zāles dotu labumu, tās jālieto katru dienu.
Bulgarian: Дата на последно подновяване: 16 Януари 2014 г.
Latvian: Pēdējās pārreģistrācijas datums: 2014. gada 16. janvāris
Bulgarian: Лечението обикновено започва с ниска доза.
Latvian: - Terapija parasti tiek sākta ar nelielu devu.
Bulgarian: Други лекарства и Nimvastid
Latvian: Citas zāles un Nimvastid
Bulgarian: Ако сте бременна, ползите от употребата на Nimvastid трябва да бъдат оценени спрямо възможните ефекти върху нероденото Ви дете.
Latvian: Ja esat grūtniece, jāizvērtē Nimvastid lietošanas ieguvumi un iespējamā ietekme uz Jūsu nedzimušo bērnu.
Bulgarian: (само на картонената кутия)
Latvian: (tikai klartona kastītei)
Bulgarian: Лекарственият продукт не изисква специални условия за съхранение.
Latvian: Zālēm nav nepieciešami īpaši uzglabāšanas apstākļi.
Bulgarian: Какво представлява Nimvastid и за какво се използва
Latvian: Kas ir Nimvastid un kādam nolūkam to lieto
Bulgarian: Изваждайте таблетката от опаковката както следва:
Latvian: Tableti no iepakojuma izņem šādi:
Bulgarian: плацебо n (%)
Latvian: Rivastigmīns n (%) Placebo n (%)
Bulgarian: Ако се почувствате замаяни или сънливи, не шофирайте, не работете с машини и не извършвайте други дейности, които изискват Вашето вниманието.
Latvian: Ja Jums ir reibonis vai esat miegains, Jūs nedrīkstat vadīt transportlīdzekļus, apkalpot mehānismus vai veikt citas darbības, kam nepieciešama uzmanība.
Bulgarian: При необходимост, може да се обмисли възможно коригиране на дозата или временно спиране на лечението.
Latvian: Ja nepieciešams, jāapsver iespēja veikt devas korekciju vai pagaidu ārstēšanas pārtraukšanu.
Bulgarian: Могат да се появят също забавяне на сърдечната дейност и припадъци.
Latvian: Iespējama arī palēnināta sirds darbība un ģībonis.
Bulgarian: Какво представлява Nimvastid и за какво се използва Какво трябва да знаете, преди да приемете Nimvastid Как да приемате Nimvastid
Latvian: Kas ir Nimvastid un kādam nolūkam to lieto Kas Jums jāzina pirms Nimvastid lietošanas Kā lietot Nimvastid
Bulgarian: Проучванията за токсичност при многократно прилагане при плъхове, мишки и кучета показват единствено ефекти, свързани със засилено фармакологично действие.
Latvian: Atkārtotu devu toksicitātes pētījumi ar žurkām, pelēm un suņiem uzrāda vienīgi efektus, kas saistīti ar pastiprinātu farmakoloģisko iedarbību.
Bulgarian: Вашият лекар ще Ви каже каква доза Nimvastid да приемете.
Latvian: Jūsu ārsts Jums pateiks, kāda Nimvastid deva Jums jālieto.
Bulgarian: Дехидратация (загуба на много течност)
Latvian: - Dehidratācija (liels šķidruma zudums)
Bulgarian: Как да съхранявате Nimvastid
Latvian: Kā uzglabāt Nimvastid
Bulgarian: Затова клиничната полза от ривастигмин трябва да се преоценява редовно, особено за пациентите, лекувани с дози под 3 mg два пъти на ден.
Latvian: Tādēļ rivastigmīna lietošanas sniegtais klīniskais ieguvums ir regulāri jāpārvērtē, jo īpaši, ja pacients lieto mazāk kā 3 mg divas reizes dienā.