FrancophonIA/ELRC3.0 huggingface dataset:
Greek: Η PRAC έκρινε ομοίως ότι η χρήση της κωδεΐνης δεν συνιστάται σε παιδιά ηλικίας 12 έως 18 ετών με δυνητικά επιβαρυμένη αναπνευστική λειτουργία, όπως και σε παιδιά με νευρομυϊκές διαταραχές, σοβαρές καρδιακές ή αναπνευστικές παθήσεις, λοιμώξεις της ανώτερης αναπνευστικής οδού ή των πνευμόνων, πολλαπλά τραύματα ή παιδιά τα οποία έχουν υποστεί εκτεταμένες χειρουργικές επεμβάσεις.
Bulgarian: Освен това PRAC счита, че кодеин не е препоръчителен за деца на възраст от 12 до 18 години, чиито дихателни функции могат да са компрометирани, включително деца с невромускулни нарушения, тежки сърдечни или дихателни заболявания, инфекции на горните дихателни пътища или белите дробове, множествена травма или тежки хирургични процедури, тъй като е възможно тези заболявания да влошат симптомите на морфинова токсичност.
Greek: Οι αντίστοιχες παράγραφοι της περίληψης των χαρακτηριστικών του προϊόντος και του φύλλου οδηγιών χρήσης αναφέρονται στο παράρτημα III της σύστασης της PRAC.
Bulgarian: Приложение I, като за целта в Приложение ІІІ от препоръката на PRAC са поместени съответните точки от кратката характеристика на продукта и листовката.
Greek: Η επανεξέταση κάλυψε όλα τα φαρμακευτικά προϊόντα που είναι εγκεκριμένα στην Ευρωπαϊκή Ένωση και περιέχουν κωδεΐνη, μόνη της ή σε συνδυασμό, για τη θεραπεία του βήχα ή/και του κρυολογήματος στον παιδιατρικό πληθυσμό.
Bulgarian: В преразглеждането са включени всички лекарствени продукти, съдържащи кодеин, разрешени за лечение на кашлица и/или настинка при педиатричната популация, включително единични и комбинирани продукти, разрешени за употреба в Европейския съюз.
Greek: Κατά συνέπεια, η PRAC εισηγήθηκε για όλα τα φαρμακευτικά προϊόντα που περιέχουν πόσιμη κωδεΐνη σε υγρή μορφή τη χρήση περιεκτών ασφαλείας για παιδιά.
Bulgarian: Поради това PRAC препоръча опаковки, защитени от деца (CRC), за всички перорални течни форми на лекарствените продукти, съдържащи кодеин.
Greek: Η δυνατότητα εφαρμογής του συγκεκριμένου μέτρου ελαχιστοποίησης στο εκάστοτε κράτος μέλος πρέπει συνεπώς να αποτελεί αντικείμενο συνεννόησης μεταξύ των εθνικών αρμόδιων αρχών των κρατών μελών και των κατόχων των αδειών κυκλοφορίας των φαρμακευτικών προϊόντων που περιέχουν κωδεΐνη και κυκλοφορούν σε μορφή πόσιμου σκευάσματος.
Bulgarian: Поради това притежателите на разрешения за употреба за перорални форми на лекарствени продукти, съдържащи кодеин, трябва да обсъдят с националните компетентни органи в държавите членки приложимостта на тези мерки за свеждане на риска до минимум на тяхна територия.
Greek: Οι μελέτες που εντοπίστηκαν στη βιβλιογραφία σχετικά με τη χρήση κωδεϊνούχων φαρμάκων για τη θεραπεία του βήχα σε παιδιά είναι μόλις τέσσερις.
Bulgarian: Като цяло могат да бъдат открити само четири публикувани проучвания, изследващи употребата на лекарства, съдържащи кодеин, за лечение на кашлица при деца.
Greek: 20 Μαΐου 2015
Bulgarian: 20 май 2015 г.
Greek: Έγκριση της συμφωνίας της CMDh:
Bulgarian: Приемане на споразумението на CMDh:
Greek: Δευτέρα, 20 Ιουλίου 2015
Bulgarian: 20 юли 2015 г.
Greek: Εφαρμογή της συμφωνίας από τα κράτη μέλη (υποβολή της τροποποίησης τύπου IΑ από τον κάτοχο της άδειας κυκλοφορίας):
Bulgarian: Изпълнение на споразумението от държавите членки (представяне на промяна от тип IA от притежателя на разрешението за употреба):
Greek: Διαβίβαση των μεταφράσεων των παραρτημάτων της συμφωνίας στις εθνικές αρμόδιες αρχές:
Bulgarian: Предаване на националните компетентни органи на преводите на приложенията към споразумението:
Greek: Παράρτημα IV Χρονοδιάγραμμα εφαρμογής της συμφωνίας
Bulgarian: Приложение IV График за изпълнение на споразумението
Greek: Συνεδρίαση της CMDh τον Απρίλιο του 2015
Bulgarian: април 2015 г., на среща на CMDh
Greek: 24 Ιουλίου 2013
Bulgarian: 24 юли 2013 г.
Greek: 1 Οκτωβρίου 2013
Bulgarian: 01 октомври 2013 г.
Greek: Διαβίβαση των μεταφράσεων των παραρτημάτων της συμφωνίας στις εθνικές αρμόδιες αρχές:
Bulgarian: Предаване на преводите на приложенията към споразумението на националните компетентни органи:
Greek: Εφαρμογή της συμφωνίας από τα κράτη μέλη (υποβολή της τροποποίησης από τον κάτοχο της άδειας κυκλοφορίας):
Bulgarian: Изпълнението на споразумението от страна на държавите членки (подаване на изменението от притежателя на разрешението за употреба):
Greek: Συνεδρίαση της CMDh τον Ιούνιο του 2013
Bulgarian: Заседание на CMDh, юни 2013 г.
Greek: Χρονοδιάγραμμα εφαρμογής της συμφωνίας
Bulgarian: График за прилагане на споразумението
Greek: Παράρτημα IV Χρονοδιάγραμμα εφαρμογής της συμφωνίας
Bulgarian: Приложение IV График за прилагане на споразумението
Greek: Φινλανδία Orion Oy Orionintie 1
Bulgarian: Финландия Orion Oy Orionintie 1
Greek: Budapest, H-1044
Bulgarian: Budapest, H-1044 Hungary
Greek: Citywest Business Campus
Bulgarian: Citywest Business
Greek: Παράρτημα I Λίστα με τις ονομασίες, τις φαρμακοτεχνικές μορφές, τις περιεκτικότητες των φαρμακευτικών προϊόντων, τις οδούς χορήγησης, τους κατόχους αδειών κυκλοφορίας στα Κράτη Μέλη
Bulgarian: Списък на имената, лекарствените форми, количествата на активното вещество в лекарствените продукти в дозова единица, пътищата на въвеждане, притежателите на разрешението за употреба в държавите членки
Greek: Γερμανία Hexal Aktiengesellschaft Industriestr.
Bulgarian: Германия Hexal Aktiengesellschaft Industriestr.
Greek: Πορτογαλία Confar - Consórcio Farmacêutico, Lda.
Bulgarian: Португалия Confar - Consórcio Farmacêutico, Lda.
Greek: POLERY ADULTES SANS SUCRE, sirop édulcoré à la saccharine sodique et au cyclamate de sodium
Bulgarian: ADULTES SANS SUCRE, sirop édulcoré à la saccharine sodique et au cyclamate de sodium
Greek: Σλοβενία ALKALOID-INT d.o.o.
Bulgarian: Словения ALKALOID-INT d.o.o.
Greek: Ουγγαρία ExtractumPharma zrt.
Bulgarian: ExtractumPharma zrt.
Greek: Φινλανδία Oy Leiras Takeda Pharmaceuticals AB Paciuksenkatu 21
Bulgarian: Финландия Oy Leiras Takeda Pharmaceuticals AB Paciuksenkatu 21
Greek: Πορτογαλία ITF Healthvita, Unipessoal Lda
Bulgarian: Португалия ITF Healthvita, Unipessoal Lda
Greek: Γερμανία Berlin-Chemie AG Glienicker Weg 125
Bulgarian: Германия Berlin-Chemie AG Glienicker Weg 125
Greek: Λουξεμβούργο Johnson & Johnson Consumer NV/SA
Bulgarian: Люксембург Johnson & Johnson Consumer NV/SA
Greek: Ολλανδία Ratiopharm Nederland B.V.
Bulgarian: Нидерландия Ratiopharm Nederland B.V.
Greek: K. Ulmaņa gatve 119 Mārupe, LV-2167 Latvia
Bulgarian: Ulmaņa gatve 119 Mārupe, LV-2167 Latvia
Greek: Pinewood Laboratories Ltd.
Bulgarian: Ирландия Pinewood Laboratories Ltd.
Greek: Bd-ul Aurel Vlaicu nr. 82
Bulgarian: Bd-ul Aurel Vlaicu nr. 82 A
Greek: Φινλανδία Vitabalans Oy Varastokatu 8
Bulgarian: Финландия Vitabalans Oy Varastokatu 8
Greek: C/ Anabel Segura, 11 Edificio Albatros B, 1ª planta
Bulgarian: TEVA PHARMA, S.L.U. C/ Anabel Segura, 11 Edificio Albatros B, 1ª planta
Greek: Phoenix Labs Ltd Unit 12 Bunkilla Plaza Bracetown Business Park Clonee, Co. Meath Ireland
Bulgarian: Ирландия Phoenix Labs Ltd Unit 12 Bunkilla Plaza Bracetown Business Park Clonee, Co. Meath Ireland
Greek: Ολλανδία OJG Consumer Care B.V Keyserswey 20
Bulgarian: Нидерландия OJG Consumer Care B.V Keyserswey 20
Greek: 19th km Nat. Road Athens-Lamia New Erythraia Greece 14671
Bulgarian: Road Athens-Lamia New Erythraia Greece 14671
Greek: MAGISTRA C & C S.R.L.
Bulgarian: S.C. MAGISTRA C & C S.R.L.
Greek: ARENA GROUP S.A. Str. Ştefan Mihăileanu nr.
Bulgarian: S.C. ARENA GROUP S.A. Str. Ştefan Mihăileanu nr. 31
Greek: TW8 9GS Brentford United Kingdom
Bulgarian: 9GS Brentford United Kingdom
Greek: Reckitt Benckiser Ireland Ltd.
Bulgarian: Ирландия Reckitt Benckiser Ireland Ltd.
Greek: Γερμανία Cassella-med GmbH & Co. KG
Bulgarian: Германия Cassella-med GmbH & Co. KG
Greek: 02101 Espoo
Bulgarian: 02101 Espoo Finland
Greek: Limited Linthwaite, Huddersfield, West Yorkshire, HD7 5QH United Kingdom.
Bulgarian: L.C.M. Limited Linthwaite, Huddersfield, West Yorkshire, HD7 5QH United Kingdom.
Greek: Sector 3 cod postal 032266,
Bulgarian: Sector 3 cod postal 032266, Bucureşti
Greek: 1 bis, rue de Plaisance 94130 Nogent Sur Marne France
Bulgarian: LABORATOIRE HEPATOUM 1 bis, rue de Plaisance 94130 Nogent Sur Marne
Greek: Ρουμανία SINTOFARM SA Str. Ziduri intre Vii nr. 22 Sector 2
Bulgarian: SINTOFARM SA Str. Ziduri intre Vii nr.
Greek: Γερμανία TUSSIN Pharma GmbH Menchestr.
Bulgarian: Германия TUSSIN Pharma GmbH Menchestr.
Greek: Sector 2 Bucureşti, cod postal
Bulgarian: Sector 2 Bucuresti, Cod postal
Greek: A. Menarini Industrie Farmaceutiche Riunite S.r.l.
Bulgarian: Menarini Industrie Farmaceutiche Riunite S.r.l.
Greek: Ρουμανία FARMACOM S.A. Str. Zizinului Nr. 112 cod postal 500407
Bulgarian: FARMACOM S.A. Str. Zizinului Nr. 112 cod postal 500407 Braşov
Greek: Ουγγαρία PharmaSwiss Ceska Republika s.r.o.
Bulgarian: PharmaSwiss Ceska Republika s.r.o.
Greek: Dampfærgevej 22 DK-2100 København Ø Denmark
Bulgarian: Amgros I/S Dampfærgevej 22 DK-2100 København
Greek: Broncho-Pectoralis Codeïne
Bulgarian: BronchoPectoralis Codeïne
Greek: GlaxoSmithKline Consumer Healthcare (Ireland) Limited Stonemasons Way Rathfarnam Dublin 16
Bulgarian: Ирландия GlaxoSmithKline Consumer Healthcare (Ireland) Limited Stonemasons Way Rathfarnam
Greek: Γερμανία MaxMedic Pharma GmbH Pasinger Str. 16
Bulgarian: Германия MaxMedic Pharma GmbH Pasinger Str. 16
Greek: Codeintropfen-CT 1mg / Tropfen
Bulgarian: CodeintropfenCT 1mg / Tropfen
Greek: Γερμανία AbZ-Pharma GmbH Graf-Arco-Str. 3
Bulgarian: Германия AbZ-Pharma GmbH Graf-Arco-Str. 3
Greek: Bucuresti, Cod postal
Bulgarian: Bucureşti, cod postal
Greek: Codeinum phosphoricum BerlinChemie
Bulgarian: Codeinum phosphoricum Berlin-Chemie
Greek: Κωδείνη φωσφορική Codeine Phosphate Oral Solution BP
Bulgarian: Codeine Phosphate Oral Solution BP
Greek: Clonmel Healthcare Ltd Waterford Road Clonmel
Bulgarian: Ирландия Clonmel Healthcare Ltd Waterford Road
Greek: Codipertussin 697 mg/100 ml Konzentrat - Tropfen
Bulgarian: Codipertussin 697 mg/100 ml KonzentratTropfen
Greek: Medgenix Benelux n.v.
Bulgarian: Medgenix Benelux n.v. Vliegveld 21
Greek: Rua Consiglieri Pedroso 123 - Queluz de Baixo 2730-056 Barcarena Portugal
Bulgarian: - Queluz de Baixo 2730-056 Barcarena Portugal
Greek: B-dul Theodor Pallady, nr. 44C
Bulgarian: SLAVIA PHARM S.R.L. B-dul Theodor Pallady, nr. 44C
Greek: Partyzancka 133/151 95-200 Pabianice Poland
Bulgarian: Aflofarm Farmacja Polska Sp. z o.o. ul. Partyzancka 133/151 95-200 Pabianice Poland
Greek: Πορτογαλία Ferraz Lynce, S.A. Rua Consiglieri Pedroso 123 - Queluz de Baixo P.O.
Bulgarian: Португалия Ferraz Lynce, S.A. Rua Consiglieri Pedroso 123
Greek: Λουξεμβούργο Meda Pharma sa Chaussée de la Hulpe,
Bulgarian: Люксембург Meda Pharma sa Chaussée de la Hulpe,
Greek: Latvia
Bulgarian: Латвия
Greek: Ουγγαρία GlaxoSmithKline Consumer Healthcare GlaxoSmithKline Export Ltd
Bulgarian: GlaxoSmithKline Consumer Healthcare GlaxoSmithKline Export Ltd
Greek: Codicaps mono 30 mg Weichkapsel
Bulgarian: Codicaps mono 30 mg
Greek: Ballymacarbry Clonmel
Bulgarian: Ballymacarbry
Greek: Κωδείνη φωσφορική Codeine Linctus BP
Bulgarian: Codeine Linctus BP
Greek: Κωδείνη φωσφορική Codinex Codeine Phosphate 15mg/5ml Oral Solution
Bulgarian: Codinex Codeine Phosphate 15mg/5ml Oral Solution
Greek: Mikołaja 65/68 50-951 Wrocław Poland
Bulgarian: Wrocławskie Zakłady Zielarskie "Herbapol" S.A. ul. Św. Mikołaja 65/68 50-951 Wrocław Poland
Greek: Κωδείνη φωσφορική Fludan Codeina 10mg/5 ml solución oral
Bulgarian: Fludan Codeina 10mg/5 ml solución oral
Greek: Κωδείνη φωσφορική Histaverin 10 mg/5 ml jarabe
Bulgarian: Histaverin 10 mg/5 ml jarabe
Greek: Diamentowa 25 20-471 Lublin Poland
Bulgarian: Herbapol Lublin S.A. ul. Diamentowa 25 20-471 Lublin Poland
Greek: Laboratoires THERICA 15, avenue Henry Dunant 27400 Louviers France
Bulgarian: Laboratoires THERICA 15, avenue Henry Dunant
Greek: Co Tipperary Ireland
Bulgarian: Co Tipperary
Greek: Panadol Ultra
Bulgarian: Panadol Ultra Rapide
Greek: Κωδείνη φωσφορική
Bulgarian: CODEINĂ FOSFORICĂ
Greek: Γερμανία OPTIMED Pharma GmbH Alfred-Nobel-Str. 5
Bulgarian: Германия OPTIMED Pharma GmbH Alfred-Nobel-Str.
Greek: 08970 Sant Joan Despi (Barcelona)
Bulgarian: Joan Despi (Barcelona)
Greek: Γερμανία Desma GmbH Peter-Sander-Str. 41b 55252 Mainz-Kastel Germany
Bulgarian: 41b 55252 Mainz-Kastel Germany
Greek: Takeda Belgium SCA-CVA Gentsesteenweg 615 1080 Brussels Belgium
Bulgarian: Gentsesteenweg 615 1080 Brussels Belgium
Greek: Panadol Ultra Rapide 500 mg 30 mg
Bulgarian: Panadol Ultra 500 mg 30 mg
Greek: Omega Pharma Poland Sp.
Bulgarian: Omega Pharma Poland Sp. z o.o.
Greek: Κωδείνη υδροχλωρική Bisoltus 2 mg/ml solución oral
Bulgarian: Кодеинов хидрохлорид Bisoltus 2 mg/ml
Greek: Γερμανία UCB Pharma GmbH Alfred-Nobel-Str. 10
Bulgarian: Германия UCB Pharma GmbH Alfred-Nobel-Str.
Greek: Σουλφογαιακόλη
Bulgarian: Weichkapsel
Greek: POLERY ADULTES, sirop 64 mg/100 ml
Bulgarian: TUSSIPAX, sirop 50 mg/100 ml
Greek: Κωδείνη φωσφορική CODEINĂ FOSFAT LPH 15 mg
Bulgarian: CODEINĂ FOSFAT LPH 15 mg
Greek: Str. Bega Nr. 4, TârguMureş cod postal 540390
Bulgarian: S.C. BIO EEL S.R.L. Str. Bega Nr. 4, TârguMureş cod postal 540390 România
Greek: Drosera tincture Grindelia tincture Lobelia inflata tincture Oregano tincture
Bulgarian: Гринделия тинктура Лобелия инфлата тинктура Риган тинктура
Greek: Κωδείνη Φαινυλτολοξαμίνη
Bulgarian: Кодеин Фенилтолоксамин
Greek: Ολλανδία Pharmachemie B.V.
Bulgarian: Нидерландия Pharmachemie B.V. Swensweg 5
Greek: Laboratoires Belges Pharmacobel SA Avenue de Scheut, 46-50 1070 Brussels Belgium
Bulgarian: Laboratoires Belges Pharmacobel SA Avenue de Scheut, 46
Greek: Bd.
Bulgarian: K.
Greek: Eucalytol
Bulgarian: Евкалиптол
Greek: Λουξεμβούργο Takeda Belgium SCA-CVA Gentsesteenweg 615
Bulgarian: Люксембург Takeda Belgium SCACVA
Greek: Κωδείνη φωσφορική CODEINĂ FOSFAT MCC 15 mg
Bulgarian: CODEINĂ FOSFAT MCC 15 mg
Greek: Box 1001
Bulgarian: - Queluz de Baixo P.O. Box 1001
Greek: PARACETAMOL/CODEIN E VITABALANS
Bulgarian: PARACETAMOL/C ODEINE
Greek: 600 mg/30ml 4500 mg/30ml
Bulgarian: HEDERIX PLAN 600 mg/30 ml 4500 mg/30 ml
Greek: Tusikern 2 mg/ml solución oral EFG
Bulgarian: Tusikern 2 mg/ml
Greek: Ηνωμένο Βασίλειο Trading as Sterling Health or
Bulgarian: Обединено кралство Trading as Sterling Health or
Greek: Πορτογαλία Johnson & Johnson, Lda.
Bulgarian: Португалия Johnson & Johnson, Lda.
Greek: Σλοβενία Alkaloid-Int.
Bulgarian: Словения Alkaloid-Int.
Greek: Hafnarfjörður Ισλανδία
Bulgarian: Hafnarfjörður Исландия
Greek: Σλοβενία Pliva Ljubljana d.o.o., Pot k sejmišču 35,
Bulgarian: Словения Pliva Ljubljana d.o.o., Pot k sejmišču 35,
Greek: Carnaxide Πορτογαλία
Bulgarian: Carnaxide Португалия
Greek: Νορβηγία ratiopharm Oy- Teva Group Menmber,
Bulgarian: Норвегия ratiopharm Oy- Teva Group Menmber,
Greek: 2 Ellinikou Str 16777,Elliniko, Athens Ελλάδα
Bulgarian: 2 Ellinikou Str 16777,Elliniko, Athens Гърция
Greek: 26.200 28700 San Sebastián de los Reyes (Madrid) Ισπανία
Bulgarian: 26.200 28700 San Sebastián de los Reyes (Madrid) Испания
Greek: Aktuapharma nv Ambachtenlaan 13E 3001 Leuven Βέλγιο
Bulgarian: Aktuapharma nv Ambachtenlaan 13E 3001 Leuven Белгия
Greek: Consiglieri Pedroso, 69
Bulgarian: Consiglieri Pedroso, 69 A
Greek: C A Papaellinas & Co ltd
Bulgarian: C A Papaellina & Co ltd
Greek: Νορβηγία Weifa AS, Hausmannsgate 6, P.O.Box 9113
Bulgarian: Норвегия Weifa AS, Hausmannsgate 6, P.O.Box 9113
Greek: Dr.-Robert-Pfleger-Str.
Bulgarian: Dr.-Robert-PflegerStr.
Greek: Souffelweyersheim Γαλλία
Bulgarian: Souffelweyersheim Франция
Greek: Ιρλανδία Sanofi-Aventis Ireland Limited, Citywest
Bulgarian: Ирландия Sanofi-Aventis Ireland Limited, Citywest
Greek: Site Apollo, Avenue 2-4-6, 1300 Wavre Βέλγιο
Bulgarian: Site Apollo, Avenue 2-4-6, 1300 Wavre Белгия
Greek: 08228 Tarrasa (Barcelona) Ισπανία
Bulgarian: 08228 Tarrasa (Barcelona) Испания
Greek: Φινλανδία Sanofi-aventis Oy Huopalahdentie 24
Bulgarian: Финландия Sanofi-aventis Oy Huopalahdentie 24
Greek: Farmacom S.A. Str. Zizinului Nr. 112, 2200 Braşov,
Bulgarian: S.C. Farmacom S.A. Str. Zizinului Nr. 112, 2200 Braşov,
Greek: Ολλανδία ratiopharm Nederland B.V.
Bulgarian: Нидерландия ratiopharm Nederland B.V.
Greek: Bayer Sante Familiale 33, Rue De L'industrie 74240 Gaillard Γαλλία
Bulgarian: Bayer Sante Familiale 33, Rue De L'industrie 74240 Gaillard Франция
Greek: B-1560 Hoeilaart Βέλγιο
Bulgarian: B-1560 Hoeilaart Белгия
Greek: Ziduri între Vii nr.22, Bucureşti, sector 3, 023324
Bulgarian: Ziduri între Vii nr.22, Bucureşti, sector 3, 023324 Румъния
Greek: Amgros I/S, Dampfærgevej 22, DK-2100 København Ø, Δανία
Bulgarian: Amgros I/S, Dampfærgevej 22, DK-2100 København Ø, Дания
Greek: 15, boulevard Charles de Gaulle
Bulgarian: Biogaran 15, boulevard Charles de Gaulle
Greek: Ιρλανδία Galen Limited, Seogoe Industiral Estate,
Bulgarian: Ирландия Galen Limited, Seogoe Industiral Estate,
Greek: Alternova A/S, Lodshusvej 11, DK4230 Skælskør, Δανία
Bulgarian: Alternova A/S, Lodshusvej 11, DK4230 Skælskør, Дания
Greek: Πορτογαλία Bayer Portugal, S.A. Rua Quinta do Pinheiro
Bulgarian: Португалия Bayer Portugal, S.A. Rua Quinta do
Greek: Takeda Pharma A/S, Langebjerg 1, DK4000 Roskilde Δανία
Bulgarian: Takeda Pharma A/S, Langebjerg 1, DK4000 Roskilde Дания
Greek: Πολωνία Reckitt Benckiser (Poland) S.A.
Bulgarian: Reckitt Benckiser (Poland) S.A.
Greek: TERAPIA S.A Str. Fabricii Nr.124, Cluj-Napoca, Judeţul Cluj, 400632
Bulgarian: S.C. TERAPIA S.A Str. Fabricii Nr.124, Cluj-Napoca, Judeţul Cluj, 400632
Greek: Σουηδία Evolan Pharma AB Box: 120
Bulgarian: Evolan Pharma AB Box: 120
Greek: 92700 Colombes Γαλλία
Bulgarian: 92700 Colombes Франция
Greek: FAES FARMA, S.A. Máximo Aguirre, 14 48940 Lamiaco-Lejona (Vizcaya)
Bulgarian: FAES FARMA, S.A. Máximo Aguirre, 14 48940 LamiacoLejona (Vizcaya)
Greek: Σουηδία sanofi-aventis AB Box: 14142
Bulgarian: Швеция sanofi-aventis AB Box: 14142
Greek: Παράρτημα I Κατάσταση με τις ονομασίες, τις φαρμακοτεχνικές μορφές, τις περιεκτικότητες των φαρμακευτικών προϊόντων, τις οδούς χορήγησης, τους Κατόχους της άδειας κυκλοφορίας στα Κράτη Μέλη
Bulgarian: Приложение I Списък на имената, лекарствени форми, количеството на активното вещество в дозова единица, пътища на въвеждане на лекарствените продукти, притежатели на разрешение за употреба в държавите членки
Greek: Aspar Pharmaceuticals Limited, 29-30 Capitol Way, Colindale, London NW9 0EQ Ηνωμένο Βασίλειο
Bulgarian: Aspar Pharmaceuticals Limited, 29-30 Capitol Way, Colindale, London NW9 0EQ
Greek: Ιρλανδία Bayer Limited, The Atrium, Blackthorn Road, Dublin 18,
Bulgarian: Ирландия Bayer Limited, The Atrium, Blackthorn Road, Dublin 18,
Greek: MEDA PHARMA 25 boulevard de l'amiral Bruix F-75016 Paris Γαλλία
Bulgarian: Люксембург MEDA PHARMA 25 boulevard de l'amiral Bruix F-75016 Paris Франция
Greek: 69151 Décines Cedex Γαλλία
Bulgarian: 69151 Décines Cedex
Greek: 2610 Wilrijk Βέλγιο
Bulgarian: 2610 Wilrijk Белгия
Greek: FARMALIDER, S.A. Aragoneses, 15 28108 Madrid Ισπανία
Bulgarian: FARMALIDER, S.A. Aragoneses, 15 28108 Madrid
Greek: de Burgos, 91 28050 Madrid Ισπανία
Bulgarian: de Burgos, 91 28050 Madrid Испания
Greek: Γερμανία Merck Serono GmbH Alsfelder Str. 17
Bulgarian: Германия Merck Serono GmbH Alsfelder Str. 17
Greek: Fabiol S.A, B-dul Timişoara nr. 50,
Bulgarian: S.C. Fabiol S.A, B-dul Timişoara nr. 50, Bucureşti,
Greek: Ιρλανδία UCB (Pharma) IrelandLimited, United Drug House, Magna Drive, Magna Business Park, Citywest Road, Dublin 24
Bulgarian: Ирландия UCB (Pharma) Ireland Limited, United Drug House, Magna Drive, Magna Business Park, Citywest Road, Dublin
Greek: GlaxoSmithKline Consumer Healthcare S.A. Site Apollo avenue Pascal 2-6 B1300 Wavre Βέλγιο
Bulgarian: Люксембург GlaxoSmithKline Consumer Healthcare S.A. Site Apollo avenue Pascal 2-6 B1300 Wavre
Greek: Γερμανία Dr. R. Pfleger Chemische Fabrik GmbH
Bulgarian: Германия Dr. R. Pfleger Chemische Fabrik GmbH
Greek: 167 14 Bromma
Bulgarian: 167 14 Bromma Швеция
Greek: 92517 Boulogne Billancourt Cedex Γαλλία
Bulgarian: 92517 Boulogne Billancourt Cedex
Greek: MAX REMEDIES LIMITED, Stoney Gate House, 2 Greenfield Road, Holmfirth, West Yorkshire, HD9 2JT, Ηνωμένο Βασίλειο
Bulgarian: MAX REMEDIES LIMITED, Stoney Gate House, 2 Greenfield Road, Holmfirth, West Yorkshire, HD9 2JT, Обединено кралство
Greek: Quintanavides, 15 28050 Madrid Ισπανία
Bulgarian: Quintanavides, 15 28050 Madrid Испания
Greek: FOURRTS (UK)PHARMACARE LIMITED, 30 Chaul End Lane, Luton, Bedfordshire, LU4 8EZ, Ηνωμένο Βασίλειο
Bulgarian: FOURRTS (UK)PHARMACARE LIMITED, 30 Chaul End Lane, Luton, Bedfordshire, LU4 8EZ,
Greek: Ιρλανδία Chefaro Ireland Limited, First Floor, Block A, The Crescent Building, Northwood Office Park, Dublin 9, Ιρλανδία
Bulgarian: Ирландия Chefaro Ireland Limited, First Floor, Block A, The Crescent Building, Northwood Office Park, Dublin 9, Ирландия
Greek: LABORATORIES (HOLDINGS)LIMITED, Unit 2A Sefton Business Park, Aintree, Liverpool, L30 1RD, Ηνωμένο Βασίλειο
Bulgarian: LABORATORIES (HOLDINGS)LIMITED, Unit 2A Sefton Business Park, Aintree, Liverpool, L30 1RD,
Greek: 2031 GA Haarlem Ολλανδία
Bulgarian: 2031 GA Haarlem
Greek: LABORATORIOS ASOCIADOS NUPEL, S.L.
Bulgarian: LABORATORIOS ASOCIADOS NUPEL, S.L. Rua
Greek: Cod., suppositoria 400 mg 9.6 mg
Bulgarian: A.C. Cod., suppositoria 400 mg 9.6 mg
Greek: INTERNACIONAL, S.A. Gran Vía Carlos III, 94 08028 Barcelona Ισπανία
Bulgarian: INTERNACIONAL, S.A. Gran Vía Carlos III, 94 08028 Barcelona Испания
Greek: CRESCENT PHARMA LTD, Polhampton Lane, Units 3&4, Quidhampton Business units, Overton, Hampshire, RG25 3ED, Ηνωμένο Βασίλειο
Bulgarian: CRESCENT PHARMA LTD, Polhampton Lane, Units 3&4, Quidhampton Business units, Overton, Hampshire, RG25 3ED,
Greek: HEALTHCARE, Conway street,Hove, East sussex, BN3 3LW Ηνωμένο Βασίλειο
Bulgarian: HEALTHCARE, Conway street,Hove, East sussex, BN3 3LW
Greek: Seton Products Ltd., Tubiton House, Medlock Street, Oldham, OL1 3HS, Ηνωμένο Βασίλειο
Bulgarian: Seton Products Ltd., Tubiton House, Medlock Street, Oldham, OL1 3HS, Обединено кралство
Greek: Bayer plc, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, Ηνωμένο Βασίλειο παρακεταμόλη + κωδεΐνη
Bulgarian: Bayer plc, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, Обединено кралство
Greek: C/ Anabel Segura, 11 Edificio Albatros B, 1ª planta
Bulgarian: TEVA PHARMA, S.L.U. C/ Anabel Segura, 11 Edificio Albatros B, 1ª planta 28108
Greek: Νορβηγία Vitabalans Oy, Varastokatu 8, 13500
Bulgarian: Норвегия Vitabalans Oy, Varastokatu 8, 13500
Greek: SINTOFARM S.A.Str.
Bulgarian: S.C. SINTOFARM S.A.Str.
Greek: Γερμανία ALIUD PHARMA GmbH Gottlieb-Daimler-Str.
Bulgarian: Германия ALIUD PHARMA GmbH Gottlieb-Daimler-Str.
Greek: Galen Limited, Seogoe Industiral Estate, Craigavon BT 63 5 UA, Ηνωμένο Βασίλειο
Bulgarian: Galen Limited, Seogoe Industiral Estate, Craigavon BT 63 5 UA,
Greek: ENNOGEN PHARMA LIMITED, Unit G4, Riverside Industrial Estate, Riverside Way, Dartford, DA1 5BS Ηνωμένο Βασίλειο
Bulgarian: ENNOGEN PHARMA LIMITED, Unit G4, Riverside Industrial Estate, Riverside Way, Dartford, DA1 5BS Обединено кралство
Greek: Γερμανία MEDA Manufacturing GmbH
Bulgarian: Германия MEDA Manufacturing GmbH
Greek: Ιρλανδία Clonmel Healthcare Ltd, Waterford Road, Conmel, Co. Tipperary Ιρλανδία
Bulgarian: Ирландия Clonmel Healthcare Ltd, Waterford Road, Conmel, Co. Tipperary Ирландия
Greek: EG LABOLaboratoires EuroGenerics "Le Quintet"bâtiment A 12, rue Danjou
Bulgarian: Quintet"bâtiment A 12, rue Danjou
Greek: Manx Pharma Limited, Taylor Group House, Wedgnock Lane, Warwick CV34 5YA Ηνωμένο Βασίλειο
Bulgarian: Manx Pharma Limited, Taylor Group House, Wedgnock Lane, Warwick CV34 5YA
Greek: Γερμανία Stadapharm GmbH Stadastr.
Bulgarian: Германия Stadapharm GmbH Stadastr.
Greek: 75014 Paris Γαλλία
Bulgarian: 75014 Paris Франция
Greek: Ιρλανδία McNeil Healthcare (Ireland) Ltd, Airton Road, Tallaght, Dublin
Bulgarian: Ирландия McNeil Healthcare (Ireland) Ltd, Airton Road, Tallaght, Dublin
Greek: 37, rue Saint-Romain 69379 Lyon Cedex 08 Γαλλία
Bulgarian: Merck Medication Familiale 37, rue Saint-Romain 69379 Lyon Cedex 08 Франция
Greek: BP 205 Valbonne 06904 Sophia Antipolis Cedex
Bulgarian: Elaiapharm 2881, Route des Crêtes BP 205 Valbonne 06904 Sophia Antipolis Cedex
Greek: 92302 LevalloisPerret Cedex Γαλλία
Bulgarian: 92302 LevalloisPerret Cedex
Greek: 13500 Hämeenlinna Φινλανδία
Bulgarian: 13500 HÄMEENLINNA Финландия
Greek: Vía F. Lli Cervi, 8 27010 Valle Salimbene (Pavia)
Bulgarian: TEOFARMA, S.R.L. Vía F. Lli Cervi, 8 27010 Valle Salimbene (Pavia)