LIITE I LUETTELO LÄÄKEVALMISTEIDEN NIMISTÄ, LÄÄKEMUODOISTA, VAHVUUKSISTA, ANTOREITEISTÄ JA MYYNTILUVAN HALTIJOISTA JÄSENVALTIOISSA

Transkriptio

1 LIITE I LUETTELO LÄÄKEVALMISTEIDEN NIMISTÄ, LÄÄKEMUODOISTA, VAHVUUKSISTA, ANTOREITEISTÄ JA MYYNTILUVAN HALTIJOISTA JÄSENVALTIOISSA 1

2 Alendronihappoa sisältävät lääkevalmisteet, joilla on myyntilupa Euroopan Unionissa AT - Itävalta AB-Consult Handels- und Betriebsberatungs GmbH, Eichenstraße 32, A-1120 Wien, Austria Alemol 70 mg - einmal wöchentlich Tabletten AT - Itävalta AB-Consult Handels- und Betriebsberatungs GmbH, Eichenstraße 32, A-1120 Wien, Austria Alenat 70 mg - einmal wöchentlich Tabletten 7o mg Tabletti AT - Itävalta Hexal Pharma GmbH, Stella- Klein-Löw-Weg 17, A-1020 Wien, Austria Alendrohexal 70 mg - einmal wöchentlich Filmtabletten 70 mg Tabletti, AT - Itävalta Genericon Pharma GmbH, Hafnerstraße 211, A-8054 Graz, Austria Alendronorm 70 mg - einmal wöchentlich Tabletten AT - Itävalta Accord Healthcare Ltd, Sage House, 319 Pinner Road, North Harrow, Middlesex HA1 4HF, UK Alendronsäure Accord 70 mg einmal wöchentlich Tabletten AT - Itävalta Accord Healthcare Ltd, Sage House, 319 Pinner Road, North Harrow, Middlesex HA1 4HF, UK Alendronsäure Accord 10 mg Tabletten 10 mg Tabletti 2

3 AT - Itävalta Actavis Group PTC ehf, Reykjavikurvegur 76-78, 220 Hafnarfjördur, Iceland Alendronsäure Actavis 70 mg einmal wöchentlich Tabletten AT - Itävalta Arcana Arzneimittel GmbH, Hütteldorfer Straße 299, A-1140 Wien, Austria Alendronsäure 'Arcana' 70 mg - einmal wöchentlich - Tabletten AT - Itävalta Bluefish Pharmaceuticals AB, Torsgatan 11, Stockholm, Sweden Alendronsäure Bluefish 70 mg einmal wöchentlich Tabletten AT - Itävalta Interpharm Produktions GmbH, Effingergasse 21, A Wien, Austria Alendronsäure 'Interpharm' 70 mg einmal wöchentlich - Tabletten AT - Itävalta Interpharm Produktions GmbH, Effingergasse 21, A Wien, Austria Alendronsäure 'Interpharm' 10 mg - Tabletten 10 mg Tabletti AT - Itävalta 1A Pharma GmbH, Stella- Klein-Löw-Weg 17, A-1020 Wien, Austria Alendronsäure 1A Pharma 70 mg - einmal wöchentlich Filmtabletten 70 mg Tabletti, 3

4 AT - Itävalta Ratiopharm Arzneimittel Vertriebs-GmbH Albert-Schweitzer Gasse 3 A-1140 Wien Austria Alendronsäure 'ratiopharm' 70 mg - einmal wöchentlich Tabletten AT - Itävalta Sandoz GmbH, Biochemiestraße 10 A-6250 Kundl, Austria Alendronsäure Sandoz 70 mg - einmal wöchentlich Filmtabletten 70 mg Tabletti, AT - Itävalta Stada Arzneimittel GmbH Muthgasse 36 A-1190 Wien Austria Alendronstad 70 mg einmal wöchentlich Tabletten AT - Itävalta AT - Itävalta BE - Belgia Merck Sharp & Dohme GmbH, EURO PLAZA Gebäude G, 5.Stock, Am Euro Platz 2, A-1120 Wien, Austria Merck Sharp & Dohme GmbH, EURO PLAZA Gebäude G, 5.Stock, Am Euro Platz 2, A-1120 Wien, Austria Arrow Generics Limited 2 Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, United Kingdom Fosamax einmal wöchentlich 70 mg Tabletten Fosamax 10 mg - Tabletten Alendronate Arrow Generics 10 mg Tabletti 10 mg Tabletit 4

5 BE - Belgia Arrow Generics Limited 2 Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, United Kingdom Alendronate Arrow Generics 70 mg Tabletit BE - Belgia Eurogenerics N.V. Heizel Esplanade b Brussels Belgium Alendronate EG 10 mg Tabletit BE - Belgia Eurogenerics N.V. Heizel Esplanade b Brussels Belgium Alendronate EG 70 mg Tabletit BE - Belgia Mylan BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart Belgium Alendronate Mylan 10 mg Tabletit BE - Belgia Mylan BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart Belgium Alendronate Mylan 70 mg Tabletit BE - Belgia Teva Pharma Belgium N.V. Laarstraat Wilrijk Belgium Alendronate teva 70 mg Tabletit 5

6 BE - Belgia Merck Sharp & Dohme B.V. Clos du Lynx, Brussels, Belgium Fosamax hebdomadaire 70 mg Tabletit BE - Belgia Merck Sharp & Dohme B.V. Clos du Lynx, Brussels, Belgium Fosamax 10 mg Tabletit BG - Bulgaria Tchaikapharma 1172 Sofia 1 G. M. Dimitrov Blvd Sofia Bulgaria Fosanate 70 mg Kalvopäällysteiset BG - Bulgaria Betapharm Arzneimittel GmbH, Kobelweg 95, Augsburg, Germany Instrel 70 mg Tabletit BG - Bulgaria Smarjeska cesta 6, 8501 Novo mesto Slovenia Lindron 10 mg Tabletit BG - Bulgaria Teva Pharmaceuticals N.V.Gogol 15 ЕООД Sofia Bulgaria Tevanate 70 mg Tabletit 6

7 BG - Bulgaria Actavis Group PTC ehf, Iceland Reykjavikurvegur 76-78, IS-220, Hafnarfjordur Alendronat Actavis 70 mg Tabletit BG - Bulgaria Sandoz GmbH, 10 Biochemie strasse, A-6250 Kundl, Austria Forosa 70 mg Kalvopäällysteiset BG - Bulgaria CY - Kypros Merck Sharp & Dohme Bulgaria 55, Nicola Vaptzarov blvd. EXPO st floor-east wing, sections B1&B2 Sofia 1407 Bulgaria. Merck Sharp & Dohme BV, Waarderweg 39, 2031 bn Haarlem, The Netherlands Fosamax OW 70 mg Tabletit Fosamax tablet 70mg 70mg Tabletit CY - Kypros Pharmanel Pharmaceuticals SA, 106 Marathons Avenue, Athens, Greece Difonate tablet 70mg 70mg Tabletit CY - Kypros Farmanic-Chemipharma SA, 137 Filis Avenue, Kamatero, Attikis, Greece Ledronin tablet 70mg 70mg Tabletit 7

8 CY - Kypros Arrow Generics Limited, Unit 2 Eastman Way,Hertfordshire, SG1 4SZ,Stevenage,UK Alendronic -Acid Arrow tablet 10mg 10mg Tabletit CY - Kypros Arrow Generics Limited, Unit 2 Eastman Way,Hertfordshire, SG1 4SZ,Stevenage,UK Alendronic -Acid Arrow tablet 70mg 70mg Tabletit CY - Kypros Aurobindo Pharma (Malta) Limited, 46/2 South street, Valetta, Malta Alendronic Acid Aurobindo tablet 70mg 70mg Tabletit CZ - Tsekki Orion Corporation, Orionintie 1A, FI Espoo, Finland Aldrion 70mg 70mg Tabletti CZ - Tsekki Generics Ltd., Mylan Albany Gate, Darkes Lane, Potters Bar Hertfordshire EN6 1AG United Kingdom Alendrogen 70mg 70mg Tabletti CZ - Tsekki Actavis Group hf. Reykavikurvegi Hafnarfirdi Iceland Alendronat Actavis 70mg 70mg Tabletti 8

9 CZ - Tsekki CZ - Tsekki CZ - Tsekki Accord Healthcare Ltd Sage House Pinner Road Harrow Middlesex HA1 4HF United Kingdom Accord Healthcare Ltd Sage House Pinner Road Harrow Middlesex HA1 4HF United Kingdom Sandoz GmbH, Biochemiestraße Kundl, Austria Alendronát Natrium Accord 10mg Alendronát Natrium Accord 70mg 10mg Tabletti 70mg Tabletti Alendronat Sandoz 70 70mg Tabletti CZ - Tsekki Ratiopharm GmbH, Graf- Arco-Straße Ulm, Germany Alendronat- Ratiopharm 70mg 70mg Tabletti CZ - Tsekki Teva Pharmaceuticals CR, s.r.o., Radlická 3185/1c Praha 5 Cezch Republic Alendronate_Teva 70mg 70mg Tabletti 9

10 CZ - Tsekki Arrow Generics Ltd 2 Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, United Kingdom Alenwin 70 70mg Tabletti CZ - Tsekki Apotex Nederland BV Bio Science Park Archimedesweg CN Leiden, Netherlands Apo-Alendronat 70mg 70mg Tabletti CZ - Tsekki Merck Sharp & Dohme BV Waarderweg 39, 2031 BN Haarlem, Netherlands Fosamax 70mg 1xtýdně 70mg Tabletti CZ - Tsekki Arrow Generics Ltd 2 Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, United Kingdom Fosteofos 70 70mg Tabletti CZ - Tsekki Bentley Pharmaceuticals Ireland Ltd, 25/28 North Wall Quay, Dublin 1, Ireland Gendron 70mg 70mg Tabletti CZ - Tsekki Richter Gedeon Nyrt. Gyömrői út H-1103 Budapest Hungary Siranin 70mg potahované tablety 70mg Tabletti 10

11 DE - Saksa TEVA Deutschland GmbH Wasastr. 50 D Radebeul Tevanate 10 mg Tabletten 10 mg Tabletti DE - Saksa TEVA Deutschland GmbH Wasastr. 50 D Radebeul Tevanate 70 mg Tabletten DE - Saksa TEVA Deutschland GmbH Wasastr. 50 D Radebeul Tevabone-4 70 mg Tabletten und 1 Mikrogramm Weichkapseln 70 mg 1 µ Tabletti ja kapseli, pehmeä DE - Saksa TEVA Deutschland GmbH Wasastr. 50 D Radebeul Tevabone-5 70 mg Tabletten und 1 Mikrogramm Weichkapseln 70 mg 1 µ Tabletti ja kapseli, pehmeä DE - Saksa TEVA Deutschland GmbH Wasastr. 50 D Radebeul Tevabone-3 70 mg Tabletten und 1 Mikrogramm Weichkapseln 70 mg 1 µ Tabletti ja kapseli, pehmeä DE - Saksa TEVA Deutschland GmbH Wasastr. 50 D Radebeul Tevabone-2 70 mg Tabletten und 1 Mikrogramm Weichkapseln 70 mg 1 µ Tabletti ja kapseli, pehmeä 11

12 DE - Saksa TEVA Deutschland GmbH Wasastr. 50 D Radebeul Tevabone 70 mg Tabletten und 1 Mikrogramm Weichkapseln 70 mg 1 µ Tabletti ja kapseli, pehmeä DE - Saksa 1 A Pharma GmbH Keltenring D Oberhaching Alendronsäure - 1 A Pharma 70 mg Filmtabletten 70 mg Tabletti, DE - Saksa AbZ-Pharma GmbH Dr.Georg-Spohn-Str. 7 D Blaubeuren Alendronsäure AbZ 70 mg Tabletten DE - Saksa Accord Healthcare Limited Sage House, 319, Pinner Road GB-HA1 4HF NORTH HARROW, MIDDLESEX Alendronsäure Accord 70 mg Tabletten DE - Saksa Accord Healthcare Limited Sage House, 319, Pinner Road GB-HA1 4HF NORTH HARROW, MIDDLESEX Alendronsäure Accord 10 mg Tabletten 10 mg Tabletti DE - Saksa acis Arzneimittel GmbH Lil-Dagover-Ring 7 D Grünwald Alendronat acis 70 mg Tabletten 12

13 DE - Saksa Actavis Group PTC ehf Reykjavikurvegur IS-220 Hafnarfjördur Alendronsäure-Actavis 70 mg Tabletten DE - Saksa ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 D Laichingen Alendronsäure AL 70 mg Tabletten DE - Saksa AWD.pharma GmbH & Co.KG Wasastr. 50 D Radebeul Alendronsäure AWD 70 mg Tabletten DE - Saksa AWD.pharma GmbH & Co.KG Wasastr. 50 D Radebeul Alendronsäure AWD 10 mg Tabletten 10 mg Tabletti DE - Saksa axcount Generika AG Max-Planck-Str. 36b D Friedrichsdorf Alendronsäure axcount 70 mg DE - Saksa Basics GmbH Hemmelrather Weg 201 D Leverkusen ALENDRONSÄURE BASICS einmal wöchentlich 70 mg Tabletten 13

14 DE - Saksa betapharm Arzneimittel GmbH Kobelweg 95 D Augsburg Alendron beta einmal wöchentlich 70 mg Tabletten DE - Saksa betapharm Arzneimittel GmbH Kobelweg 95 D Augsburg Alendron 10 mg Tabletten 10 mg Tabletti DE - Saksa biomo pharma GmbH Josef-Diezgen-Str 3 D Hennef Alendronsäure-biomo 70 mg Tabletten DE - Saksa Bluefish Pharmaceuticals AB Torsgatan 11 S Stockholm Alendronsäure Bluefish 70 mg Tabletten DE - Saksa CT Arzneimittel GmbH Lengeder Str. 42a D Berlin Alendronsäure-CT 70 mg Tabletten DE - Saksa esparma GmbH Seepark 7 D Magdeburg Alendron esparma 70 mg einmal wöchentlich Tabletten 14

15 DE - Saksa Gedeon Richter Plc. Gyömröi ut H-1103 Budapest Alendronate Richter 70 mg Filmtabletten 70 mg Tabletti, DE - Saksa Heumann Pharma GmbH & Co. Generica KG Südwestpark 50 D Nürnberg Alendronsäure Heumann 10 mg Tabletten 10 mg Tabletti DE - Saksa Heumann Pharma GmbH & Co. Generica KG Südwestpark 50 D Nürnberg Alendronsäure Heumann 70 mg Tabletten DE - Saksa HEXAL AG Industriestr. 25 D Holzkirchen Alendron-Hexal 10 mg Tabletten 10 mg Tabletti DE - Saksa DE - Saksa DE - Saksa DE - Saksa HEXAL AG Industriestr. 25 D Holzkirchen Juta Pharma GmbH Gutenbergstr. 13 D Flensburg Juta Pharma GmbH Gutenbergstr. 13 D Flensburg KSK-Pharma Vertriebs AG Finkenstr. 1 D Pfinztal- Berghausen Alendron-Hexal 10 einmal wöchentlich 70 mg Tabletten Alendro-Q 70 mg Tablette Alendro-Q 10 mg Tabletten 10 mg Tabletti Alendro-KSK 70 mg 15

16 DE - Saksa DE - Saksa DE - Saksa DE - Saksa DE - Saksa DE - Saksa DE - Saksa DE - Saksa DE - Saksa DE - Saksa DE - Saksa mibe GmbH Arznzemittel Münchener Str. 15 D Brehna MSD Sharp & Dohme GmbH Lindenplatz 1 D Haar MSD Sharp & Dohme GmbH Lindenplatz 1 D Haar Mylan dura GmbH Wittichstr. 6 D Darmstadt Mylan dura GmbH Wittichstr. 6 D Darmstadt Mylan dura GmbH Wittichstr. 6 D Darmstadt Orion Corporation Orionintie 1 FIN-=2200 ESPOO Ovamex Limited 118 larch crescent GB-UB4 9EB HAYES, MIDDLESEX Ovamex Limited 118 larch crescent GB-UB4 9EB HAYES, MIDDLESEX ratiopharm GmbH Graf-Arco-STr. 3 D Ulm Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 Alendromed 70 mg FOSAMAX 10mg Tabletten FOSAMAX einmal wöchentlich 70 mg Tabletten Alendronsäure Mylan 70 mg Tabletten Alendrosäure dura 70 mg Tabletten 10 mg Tabletti Alendrossa 10 mg 10 mg Tabletti Alendronsäure Orion 70 mg Tabletten Alendronsäure Ovamex 70 mg Tabletten Alendronsäure Ovamex 10 mg Tabletten Alendronsäureratiopharm 70 mg Tabletten Alendron-Sandoz einmal wöchentlich 70 mg Tabletten 10 mg Tabletti 16

17 D Holzkirchen DE - Saksa DE - Saksa DE - Saksa DE - Saksa Stadapharm GmbH Stadastr D Bad Vilbel Stadapharm GmbH Stadastr D Bad Vilbel Winthrop Arzneimittel GmbH Urmitzer Str. 5 D Mülheim-Kärlich Mylan dura GmbH Wittichstr. 6 D Darmstadt Alendronsäure STADA 10 mg Tabletten Alendronsäure STADA 70 mg Tabletten Alendron Winthrop einmal wöchentlich 70 mg Tabletten Alendrokit dura 10 mg Tabletti 91,36 mg 1495,5 mg Tabletti ja tabletti, DE - Saksa DE - Saksa DK - Tanska DK - Tanska TECNIMEDE - Sociedade Técnico-Medicinal, S.A. (BS 2) Rua da Tapada Grande, n2 P ABRUNHEIRA, SINTRA Volkspharma GmbH August-Wessels-Str. 5 D Augsburg 1A Farma, Herstedøstervej 27-29, DK-2620 Albertslund, Denmark Actavis Group PTC ehf., Reykjavikurvegi 76-78, P.O. 425, IS-220 Hafnarfjördur, Iceland Alendronsäure Tecnimede 70 mg Filmtabletten Alendronsäure 70 mg Volkspharma Tabletten 4 mg 70 mg Tabletti, Alendronat "1A Farma" 70 mg Kalvopäällysteiset Alendronat "Actavis" 70 mg Tabletit 17

18 DK - Tanska Arrow Generics Limited, Unit 2, Eastman Way Stevenage, SG1 4SZ Hertfordshire, England DK - Tanska Arrow Generics Limited, Unit 2, Eastman Way Stevenage, SG1 4SZ Hertfordshire, England DK - Tanska BLUEFISH PHARMACEUTICALS AB, Torsgatan 11, Stockholm, Sweden DK - Tanska Mylan AB, P.O.box 23033, Ynglingagatan 14, SE Stockholm; Sweden DK - Tanska Mylan AB, P.O.box 23033, Ynglingagatan 14, SE Stockholm; Sweden DK - Tanska Orifarm Generics A/S, Energivej 15, DK-5260 Odense S., Denmark DK - Tanska Orion Corporation Orion Pharma, Orionintie 1, FI Espoo, Finland DK - Tanska Pharmachemie B.V., PO Box 552, Swensweg 5, NL-2031 GA Haarlem, Nederlands DK - Tanska Ranbaxy (UK) Ltd., 20 Balderton Street, W1K 6TL London, UK DK - Tanska Sandoz A/S, C.F. Tietgens Boulevard 40, DK-5220 Odense SØ, Denmark DK - Tanska Stada Arzneimittel AG, Stadastrasse 2-8, DE Bad Vilbel, Germany Alendronat "Arrow" 10 mg Tabletit Alendronat "Arrow" 70 mg Tabletit Alendronat "Bluefish" 70 mg Tabletit Alendronat "Mylan" 10 mg Tabletit Alendronat "Mylan" 70 mg Tabletit Alendronat "Orifarm" 70 mg Tabletit Alendronat "Orion" 70 mg Tabletit Alendronat "PCH" 10 mg Tabletit Alendronat "Ranbaxy" 70 mg Tabletit Alendronat "Sandoz" 70 mg Kalvopäällysteiset Alendronat "Stada" 70 mg Tabletit 18

19 DK - Tanska DK - Tanska DK - Tanska DK - Tanska DK - Tanska EL - Kreikka EL - Kreikka EL - Kreikka EL - Kreikka EL - Kreikka Teva Denmark A/S, Parallelvej 10-12, DK-2800 Kongens Lyngby, Denmark ratiopharm GmbH, Graf- Arco-Strasse 3, DE Ulm, Germany Merck Sharp & Dohme B.V., PO Box 581, Waarderweg 39, NL-2031 BN Haarlem, Nederlands Stada Arzneimittel AG, Stadastrasse 2-8, DE Bad Vilbel, Germany Teva Denmark A/S, Parallelvej 10-12, DK-2800 Kongens Lyngby, Denmark VIANEX S.A. TATIOIOU STREET Nea Erythrea VIANEX S.A. TATIOIOU STREET Nea Erythrea VIANEX S.A. TATIOIOU STREET Nea Erythrea FARAN ABEE PRODUCTION AND COMMERCE OF MEDICINAL PRODUCTS ACHAIAS AND TROIZINIAS, KIFISSIA BIOMEDICA-CHEMICA S.A. G. LYRA 25 KATW KIFISSIA Alendronat "Teva" 70 mg Tabletit Alendronat "ratiopharm" 70 mg Tabletit Fasamax Ugetablet 70 mg Tabletit Alendronat "Stada" 10 mg Tabletit Alendronat "Teva" 10 mg Tabletit FOSAMAX 10 MG/TAB TABLETTI SUUN KAUTTA FOSAMAX 5 MG/TAB TABLETTI SUUN KAUTTA FOSAMAX ONCE WEEKLY 70 MG/TAB TABLETTI SUUN KAUTTA OSASTON 70 MG/TAB TABLETTI SUUN KAUTTA AMPINE 70 MG/TAB TABLETTI SUUN KAUTTA 19

20 EL - Kreikka EL - Kreikka EL - Kreikka EL - Kreikka EL - Kreikka EL - Kreikka EL - Kreikka KLEVA AFBEE PARNITHOS AVENUE 189 ACHARNES ATTIKIS MED-ONE AFBEE AGIOU PETROU 30 & EPAMEINONDA ACHARNES GENERICS PHARMA HELLAS ΕΠΕ VOULIAGMENIS AVENUE 577A ARGYROUPOLI P.O. BOX GENERICS PHARMA HELLAS ΕΠΕ VOULIAGMENIS AVENUE 577A ARGYROUPOLI P.O. BOX ALAPIS ABEE AUTOKRATOROS NIKOLAOU 2 ATHENS VELKA HELLAS AEBE KAPODISTRIOU AND KORINTHOU 12 NEO PSYCHIKO ARROW GENERICS LIMITED, HERTS, UNITED KINGDOM Unit 2, Eastman Way, Stevenage, Herts United Kingdom DARGOL 70 MG/TAB TABLETTI SUUN KAUTTA DEBENAL 70 MG/TAB TABLETTI SUUN KAUTTA ALENDRONATE / GENERICS ALENDRONATE / GENERICS 70 MG/TAB TABLETTI SUUN KAUTTA 10 MG/TAB TABLETTI SUUN KAUTTA MELDOZ 70 MG/TAB TABLETTI SUUN KAUTTA OSTAVEN 70 MG/TAB TABLETTI SUUN KAUTTA ALENDRONIC ACID/ARROW 10 MG/TAB TABLETTI SUUN KAUTTA 20

21 EL - Kreikka EL - Kreikka EL - Kreikka EL - Kreikka EL - Kreikka EL - Kreikka EL - Kreikka EL - Kreikka EL - Kreikka ARROW GENERICS LIMITED, HERTS, UNITED KINGDOM Unit 2, Eastman Way, Stevenage, Herts United Kingdom PHARMANEL PHARMACEUTICALS S.A. MARATHONOS 106, GERAKAS MEDARTE PHARMACEUTICALS ΑΒΕΕ SPYROU VRETTOU 10 METAMORFOSI VOCATE PHARMACEUTICALS S.A. GOUNARI 150, GLYFADA GENEPHARM S.A. 18km MARATHONOS AVENUE PALLINI ATTIKIS SANTA PHARMA S.A. ASKLIPIOU 4 KRYONERI ATTIKIS IASIS PHARMAC.HELLAS 137 FYLIS AVENUE KAMATERO PHARMANEL PHARMACEUTICALS S.A. MARATHONOS 106, GERAKAS ANFARM HELLAS S.A. PERIKLEOUS GERAKAS ATTIKIS ALENDRONIC ACID/ARROW 70 MG/TAB TABLETTI SUUN KAUTTA OSTEONAT 70 MG/TAB TABLETTI SUUN KAUTTA OSTALERT 70 MG/TAB TABLETTI SUUN KAUTTA FOSAZOM 70 MG/TAB TABLETTI SUUN KAUTTA FOSALEN 70 MG/TAB TABLETTI SUUN KAUTTA ALEFOS 70 MG/TAB TABLETTI SUUN KAUTTA LEDRONIN 70 MG/TAB TABLETTI SUUN KAUTTA DIFONATE 70 MG/TAB TABLETTI SUUN KAUTTA RIDON 70 MG/TAB TABLETTI SUUN KAUTTA 21

22 EL - Kreikka EL - Kreikka EL - Kreikka EL - Kreikka EL - Kreikka EL - Kreikka EL - Kreikka EL - Kreikka AURORA PHARMACEUTICALS S.A. EVROU 4 & MESSINIAS 2 GERAKAS VIOFAR LTD ETHNIKIS ANTISTASEWS & TRIZINIAS ACHARNES BIOSPRAY ABEE 18KM MARATHONOS AVENUE PALLINI FARMATHEN HELLAS ABEE MARATHONOS AVENUE 144 PALLINI SANDOZ GMBH, KUNDL, AUSTRIA Biochemiestrasse 10, A-6250, Kundl Tirol, Austria RAFARM AEBE KORINTHOU 12 NEO PSYCHIKO ROTTAPHARM HELLAS S.A. PRDUCTION AND COMMERCE OF PHARMACEUTICALS ACHAIAS AND TRIZINIAS NEA KIFISSIA DELEGANT HOLDINGS LTD, CYPRUS AGIAS ELENIS 36 COMMERCIAL CENTRE GALAXY 401 NICOSIA 1061 CYPRUS AURODREN 70 MG/TAB TABLETTI SUUN KAUTTA DEPAREX 70 MG/TAB TABLETTI SUUN KAUTTA ALENDRAL 70 MG/TAB TABLETTI SUUN KAUTTA POROCALM 70 MG/TAB TABLETTI SUUN KAUTTA FOROSA 70 MG/TAB TABLETTI SUUN KAUTTA MOSMASS 70 MG/TAB TABLETTI SUUN KAUTTA LOZOSTUN 70 MG/TAB TABLETTI SUUN KAUTTA DELFOZA 70 MG/TAB TABLETTI SUUN KAUTTA 22

23 EL - Kreikka EL - Kreikka EL - Kreikka EL - Kreikka EL - Kreikka EL - Kreikka EL - Kreikka EL - Kreikka EL - Kreikka EL - Kreikka SPECIFAR ABEE 28TH OCTOBER 1 AGIA VARVARA EVANGELOS KALOFOLIAS & CO IAPHARM MENANDROU 54 ATHENS TARGET PHARMA LTD MENANDROU 54 ATHENS VIVAX PHARMACEUTICALS LTD, DERVENAKION 38 GERAKAS ATTIKIS PHARMANEL PHARMACEUTICALS S.A. MARATHONOS 106, GERAKAS FARMEX S.A. KIFISSOU AVENUE 132 ATHENS ALET PHARMACEUTICALS ABEE AIDINIOU 26, CHALANDRI PHARMA LINE S.A. TH. PETALA 41 NEA CHALKIDONA VERISFIELD (UK) LTD, U.K. 41 Chalton street, London, NW1 1JD, United Kingdom HELP ΑΒΕΕ VALAORITOU 10 METAMORFOSI ATTIKIS DROFAZ 70 MG/TAB TABLETTI SUUN KAUTTA FOSANDRON 70 MG/TAB TABLETTI SUUN KAUTTA ARTHROPLUS 70 MG/TAB TABLETTI SUUN KAUTTA EN-POR 70 MG/TAB TABLETTI SUUN KAUTTA MORALEN 70 MG/TAB TABLETTI SUUN KAUTTA ENIMON 70 MG/TAB TABLETTI SUUN KAUTTA ALEDROLET 70 MG/TAB TABLETTI SUUN KAUTTA ZULGAR 70 MG/TAB TABLETTI SUUN KAUTTA ZEMAROS 70 MG/TAB TABLETTI SUUN KAUTTA OSTEOS 70 MG/TAB TABLETTI SUUN KAUTTA 23

24 EL - Kreikka EL - Kreikka EL - Kreikka ES - Espanja ES - Espanja ES - Espanja ES - Espanja ES - Espanja ES - Espanja ES - Espanja FARMEDIA AE ATHINAS 22 & APOLLONOS GERAKAS ATTIKIS FARMAZAK S.A. NAOUSSIS 31 VOTANIKOS TEVA PHARMA B.V., UTRECHT, THE NETHERLANDS Computerweg 10, 3542 DR, Utrecht, The Netherlands MERCK SHARP AND DOHME DE ESPAÑA, S.A.Josefa Valcarcel, MADRID MERCK SHARP AND DOHME DE ESPAÑA, S.A.Josefa Valcarcel, MADRID MYLAN PHARMACEUTICALS, S.L.Plom 2-4, 5º Planta Barcelona LABORATORIOS ALTER, S.A.Mateo Inurria, Madrid MERCK S.L.María de Molina, Madrid LABORATORIOS ALTER, S.A.Mateo Inurria, Madrid LABORATORIO STADA, S.L.Frederic Mompou, Sant Just Desvern Barcelona FARMEMAX 70 MG/TAB TABLETTI SUUN KAUTTA ZAKODRONATE 70 MG/TAB TABLETTI SUUN KAUTTA TEVANATE 70 MG/TAB TABLETTI SUUN KAUTTA FOSAMAX Semanal 70 mg comprimidos FOSAMAX 10 mg Comprimidos ÁCIDO ALENDRÓNICO SEMANAL MYLAN 70 mg comprimidos ÁCIDO ALENDRÓNICO SEMANAL ALTER 70 mg comprimidos CALBION SEMANAL 70 mg comprimidos BIFOAL SEMANAL 70 mg comprimidos ÁCIDO ALENDRÓNICO SEMANAL STADA 70 mg comprimidos 70 mg Tabletti, 10 mg Tabletit 70 mg Tabletit 70 mg Tabletit 70 mg Tabletit 70 mg Tabletit 70 mg Tabletit 24

25 ES - Espanja ES - Espanja ES - Espanja ES - Espanja ES - Espanja ES - Espanja ES - Espanja ES - Espanja RATIOPHARM ESPAÑA, S.A.Avda. de Burgos, 16 D - 5ª Planta Madrid LABORATORIOS EDIGEN, S.A Chile 8, 2º Oficina 203.Edificio Euromadrid Las Matas Madrid LABORATORIOS EDIGEN, S.A Chile 8, 2º Oficina 203.Edificio Euromadrid Las Matas Madrid TEVA GENERICOS ESPAÑOLA, S.L.Guzmán el Bueno 133, Edificio Britania 4ºIzq Madrid MABO FARMA, S.ACarretera M-300 Km 30, Alcalá de Henares CANTABRIA PHARMA, S.L.c/ Ribera del Loira, 46 edificio Madrid Spain SANDOZ FARMACEUTICA, S.A.Avda. Osa Mayor, 4Aravaca (Madrid) LABORATORIOS NORMON, S.A.Ronda de Valdecarrizo, Tres Cantos ACIDO ALENDRONICO SEMANAL RATIOPHARM 70 mg comprimidos ÁCIDO ALENDRÓNICO EDIGEN 10 mg comprimidos ÁCIDO ALENDRÓNICO EDIGEN 70 mg comprimidos ACIDO ALENDRONICO TEVA 70 mg comprimidos ÁCIDO ALENDRÓNICO SEMANAL MABO 70 mg COMPRIMIDOS ALENDROCARE SEMANAL 70 mg comprimidos ÁCIDO ALENDRÓNICO SEMANAL SANDOZ 70 mg comprimidos ACIDO ALENDRONICO SEMANAL NORMON 70 mg Comprimidos 70 mg Tabletit 70 mg Tabletit 70 mg Tabletit 70 mg Tabletit 70 mg Tabletit 70 mg Tabletit 70 mg Tabletit 70 mg Tabletit 25

26 ES - Espanja TECNIMEDE ESPAÑA, INDUSTRIA FARMACEUTICA, S.A. Avda. Pio XII, 92, Edificio Ural A, Planta Madrid ACIDO ALENDRONICO SEMANAL TECNIGEN 70 mg comprimidos 70 mg Tabletit ES - Espanja PHARMAGENUS, S.A. Avda. Camí Real, Palau-solita i Plegamans Barcelona ES - Espanja LABORATORIOS RANBAXY, S.L.Passeig de Gracia, Barcelona ES - Espanja TEVA PHARMA S.L.U. C/ Anabel Segura, 11, Edificio Albatros B, 1ª planta Alcobendas ES - Espanja QUALIGEN, S.L.Avda. Barcelona, Sant Joan Despi ES - Espanja LABORATORIOS DAVUR, S.L.Teide, 4-planta baja. Poligono Empresarial La Marina San Sebastian de los Reyes ES - Espanja RIMAFAR, S.L.Pol. Ind. Malpica Calle C, Nº Zaragoza ES - Espanja KERN PHARMA, S.L.Venus, 72. Poligono Industrial Colon II Tarrasa ES - Espanja KORHISPANA S.L.Carretera de Castellvell, Reus ACIDO ALENDRONICO SEMANAL PHARMAGENUS 70 mg comprimidos ÁCIDO ALENDRÓNICO SEMANAL RANBAXY 70 mg comprimidos SEMANDROL SEMANAL 70 mg comprimidos ACIDO ALENDRÓNICO SEMANAL QUALIGEN 70 mg comprimidos ÁCIDO ALENDRÓNICO SEMANAL DAVUR 70 mg comprimidos ÁCIDO ALENDRÓNICO SEMANAL RIMAFAR 70 mg comprimidos ÁCIDO ALENDRÓNICO SEMANAL KERN PHARMA 70 mg Comprimidos ACIDO ALENDRONICO SEMANAL KORHISPANA 70 mg 70 mg Tabletit 70 mg Tabletit 70 mg Tabletit 70 mg Tabletit 70 mg Tabletit 70 mg Tabletit 70 mg Tabletit 70 mg Tabletit 26

27 comprimidos ES - Espanja ES - Espanja ES - Espanja ES - Espanja ES - Espanja ES - Espanja ES - Espanja GERVASI FARMACIA, S.L.Juan XXIII, Esplugues de Llobregat LABORATORIOS ALACAN INDUSTRIAS QUIMICO FARMACEUTICAS, S.A.Sagitario, Alicante FARMALIDER, S.A.Aragoneses, Alcobendas SINTEXLINE S.A.Polígono Industrial La Red, Calle 11 nº Alcalá de Guadaira FARMALIDER, S.A.Aragoneses, Alcobendas LABORATORIOS COMBIX, S.L.San Rafael, 3. Pol. Industrial Alcobendas Alcobendas ALMUS FARMACEUTICA, S.A.Avda. Verge de Montserrat, El Prat de Llobregat LEFOSAN SEMANAL 70 mg comprimidos ADELAN SEMANAL 70 mg Comprimidos ACIDO ALENDRONICO SEMANAL FARMALIDER 70 mg comprimidos recubiertos con película ALENDROGYN 70 mg comprimidos recubiertos con película ALENDROFARM 70 mg comprimidos recubiertos con pelicula ACIDO ALENDRONICO SEMANAL COMBIX 70 mg comprimidos recubiertos con película ACIDO ALENDRONICO SEMANAL ALMUS 70 mg comprimidos recubiertos con película 70 mg Tabletit 70 mg Tabletit 70 mg Kalvopäällysteiset 70 mg Kalvopäällysteiset 70 mg Kalvopäällysteiset 70 mg Kalvopäällysteiset 70 mg Kalvopäällysteiset 27

28 ES - Espanja ES - Espanja ES - Espanja ES - Espanja ES - Espanja ES - Espanja ES - Espanja ES - Espanja PENSA PHARMA, S.A.U Jorge Comín (médico pediatra), 3 - bajos Valencia LABORATORIOS RANBAXY, S.L.Passeig de Gracia, Barcelona LABORATORIOS RANBAXY, S.L.Passeig de Gracia, Barcelona LAREQ PHARMA S.L Laguna, Poligono Industrial Urtinsa II Alcorcón LABORATORIOS PEREZ GIMENEZ, S.A.Pol. Ind. Los Mochos. Polígono 8 - Parcela 20. Crta. A-431, Km Almodovar del Río INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.Laguna, Poligono Industrial Urtinsa II Alcorcón BEXAL FARMACEUTICA, S.A Centro Empresarial Osa Mayor. Avda. Osa Mayor, 4 - Area B Aravaca (Madrid) ACOST COMERCIAL GENERIC-PHARMA, S.L.Centro Empresarial Osa Mayor. Osa Mayor, 4 Area B Aravaca (Madrid) ÁCIDO ALENDRÓNICO SEMANAL PENSA 70 mg comprimidos ACIDO ALENDRONICO SEMANAL RANBAXYGEN 70 mg Comprimidos ÁCIDO ALENDRÓNICO SEMANAL CINFA 70 mg comprimidos ACIDO ALENDRONICO SEMANAL LAREQ 70 mg comprimidos ÁCIDO ALENDRÓNICO SEMANAL CUVE 70 mg comprimidos ACIDO ALENDRONICO SEMANAL VIR 70 mg comprimidos ACIDO ALENDRONICO SEMANAL BEXAL 70 mg comprimidos recubiertos con película ACIDO ALENDRONICO SEMANAL ACOST 70 mg comprimidos recubiertos con película 70 mg Tabletit 70 mg Tabletit 70 mg Tabletit 70 mg Tabletit 70 mg Tabletit 70 mg Tabletit 70 mg Tabletit 70 mg Tabletit 28

29 ES - Espanja ES - Espanja ET - Viro ET - Viro ET - Viro ET - Viro ET - Viro ET - Viro INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.Laguna, Poligono Industrial Urtinsa II Alcorcón Apotex Europe BV Darwinweg CR Leiden Netherlands Merck Sharp & Dohme OÜ Peterburi tee Tallinn ESTONIA Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow HA1 4HF, Middlesex UNITED KINGDOM Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow HA1 4HF, Middlesex UNITED KINGDOM Actavis Group PTC ehf Reykjavikurvegi Hafnarfjördur ICELAND Gedeon Richter Plc. Gyömrõi ut Budapest HUNGARY KRKA d.d., Novo Mesto Shmarjeshka cesta 6, 8501 Novo Mesto SLOVENIA ALENVIR SEMANAL 70 mg comprimidos ÁCIDO ALENDRÓNICO APOTEX 70 mg comprimidos 70 mg Tabletit 70 mg Tabletit FOSAMAX 70 MG ALENDRONIC ACID ACCORD 70MG ALENDRONIC ACID ACCORD 10MG 10mg Tabletti LENDRATE SEDRON 70 mg Tabletti, LINDRON 10mg Tabletti 29

30 ET - Viro MEPHA Lda. Lagoas Park Edifico 5-A, Piso 2, Porto Salvo PORTUGAL ET - Viro Orion Corporation Orionintie 1 FIN Espoo FINLAND ET - Viro Ranbaxy (UK) Limited 20 Balderton Street, London W1K 6TL UNITED KINGDOM ET - Viro Teva Pharma B.V. Computerweg DR Utrecht THE NETHERLANDS ET - Viro Teva Pharma B.V. Computerweg DR Utrecht THE NETHERLANDS FI - Suomi Ranbaxy UK Ltd, 20 Balderton Street, LONDON W1K 6TL, United Kingdom FI - Suomi Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220 HAFNARFJORDUR, Iceland FI - Suomi Arrow Generics Limited, Unit 2, Eastman Way Stevenage, HERTS SG14SZ, United Kingdom FI - Suomi Arrow Generics Limited, Unit 2, Eastman Way Stevenage, HERTS SG14SZ, United Kingdom DENSIDRON 70 mg Tabletti, ALENDROONHAPE ORION RALENOST 70MG ALENOTOP TEVANATE 70 MG Alendronat Ranbaxy Alendronat Actavis Alendronat Arrow 10 mg Tabletti Alendronat Arrow 30

31 FI - Suomi Bluefish Pharmaceuticals AB, Torsgatan 11, STOCKHOLM, Sweden FI - Suomi Hexal A/S, Kanalholmen 8-12, 2650 HVIDOVRE, Denmark FI - Suomi Mylan AB, BOX 23033, STOCKHOLM, Sweden FI - Suomi Orifarm Generics A/S, Energivej 15, 5260 ODENSE S, Denmark FI - Suomi Orion Corporation, Orion Pharma, Orionintie 1, Espoo, Finland FI - Suomi ratiopharm GmbH, Graf- Arco-Strasse 3, Ulm, Germany FI - Suomi Sandoz A/S, C. F. Tietgens Boulevard 40, 5220 ODENSE SØ, Denmark FI - Suomi Merck Sharp & Dohme B.V., Waarderweg 39, P.O.BOX 581, 2031 BN HAARLEM, Netherlands FI - Suomi Merck Sharp & Dohme B.V., Waarderweg 39, P.O.BOX 581, 2031 BN HAARLEM, Netherlands FR - Ranska ARROW GENERIQUES 26, avenue Tony Garnier Lyon FRANCE Alendronat Bluefish Alendronat Hexal 70 mg Tabletti, Alendronat Mylan Alendronat Orifarm Alendronat Orion Alendronat ratiopharm 70 mg Tabletti, Alendronat Sandoz 70 mg Tabletti, Fosamax 10 mg Tabletti Fosamax ACIDE ALENDRONIQUE ALMUS 10 mg, comprimé 10 mg Tabletti 31

32 FR - Ranska FR - Ranska FR - Ranska FR - Ranska FR - Ranska FR - Ranska FR - Ranska ARROW GENERIQUES 26, avenue Tony Garnier Lyon FRANCE ALTER 3, avenue de la Baltique ZI de Courtaboeuf Villebon Sur Yvette FRANCE ARROW GENERIQUES 26, avenue Tony Garnier Lyon FRANCE ARROW GENERIQUES 26, avenue Tony Garnier Lyon FRANCE BIOGARAN 15, boulevard Charles de Gaulle Colombes FRANCE BIOGARAN 15, boulevard Charles de Gaulle Colombes FRANCE EG LABO - LABORATOIRES EUROGENERICS "Le Quintet" - bâtiment A 12, rue Danjou Boulogne Billancourt Cedex FRANCE ACIDE ALENDRONIQUE ALMUS 70 mg, comprimé ACIDE ALENDRONIQUE ALTER 70 mg, comprimé pelliculé ACIDE ALENDRONIQUE ARROW 10 mg, comprimé ACIDE ALENDRONIQUE ARROW 70 mg, comprimé ACIDE ALENDRONIQUE BIOGARAN 10 mg, comprimé ACIDE ALENDRONIQUE BIOGARAN 70 mg, comprimé ACIDE ALENDRONIQUE EG 10 mg, comprimé 10 mg Tabletti 10 mg Tabletti 10 mg Tabletti 32

33 FR - Ranska EG LABO - LABORATOIRES EUROGENERICS "Le Quintet" - bâtiment A 12, rue Danjou Boulogne Billancourt Cedex FRANCE ACIDE ALENDRONIQUE EG 70 mg, comprimé FR - Ranska FR - Ranska FR - Ranska FR - Ranska FR - Ranska FR - Ranska MYLAN SAS 117, allée des Parcs Saint-Priest FRANCE TEVA SANTE Le Palatin 1 1 cours du Triangle Paris la Défense Cedex FRANCE KROMME RIJN APOTHEEK Langstraat 4C 3981 EV BUNNIK PAYS-BAS QUALIMED (LYON) 117, allée des Parcs Saint-Priest FRANCE RATIOPHARM (ALLEMAGNE) Graf Arco Strasse Ulm ALLEMAGNE SANDOZ 49, avenue Georges Pompidou Levallois-Perret FRANCE ACIDE ALENDRONIQUE MYLAN, 70 mg, comprimé ACIDE ALENDRONIQUE PHR LAB 70 mg, comprimé ACIDE ALENDRONIQUE QUALIHEALTH 70 mg, comprimé ACIDE ALENDRONIQUE QUALIMED 70 mg, comprimé ACIDE ALENDRONIQUE RATIOPHARM 70 mg, comprimé ACIDE ALENDRONIQUE SANDOZ 70 mg, comprimé 33

34 FR - Ranska FR - Ranska FR - Ranska FR - Ranska FR - Ranska FR - Ranska SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland Paris FRANCE SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland Paris FRANCE ZYDUS FRANCE 25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d Activités des Peupliers Nanterre FRANCE PHARMEMMA Unit 2, Ashbourne Manufacturing Park Ashbourne County Meath IRLANDE THERAMEX 6, avenue Albert II Zone F - Bloc B Monaco MONACO PHARMEMMA Unit 2, Ashbourne Manufacturing Park Ashbourne County Meath IRLANDE ACIDE ALENDRONIQUE WINTHROP 10 mg, comprimé ACIDE ALENDRONIQUE WINTHROP 70 mg, comprimé ACIDE ALENDRONIQUE ZYDUS 70 mg, comprimé ARONADE 70 mg, comprimé AURENA 70 mg, comprimé DRONACID 70 mg, comprimé 10 mg Tabletti 34

35 FR - Ranska MERCK SHARP & DOHME CHIBRET 3, avenue Hoche Paris Cedex 08 FRANCE FR - Ranska MERCK SHARP & DOHME CHIBRET 3, avenue Hoche Paris Cedex 08 FRANCE FR - Ranska MERCK SHARP & DOHME CHIBRET 3, avenue Hoche Paris Cedex 08 FRANCE FR - Ranska RANBAXY PHARMACIE GENERIQUES Quai Dion Bouton Puteaux FRANCE FR - Ranska LABORATOIRE RPG - RANBAXY PHARMACIE GENERIQUES 4, place Louis Armand Paris FRANCE FR - Ranska RANBAXY PHARMACIE GENERIQUES Quai Dion Bouton Puteaux FRANCE FR - Ranska TEVA SANTE Le Palatin 1 1 cours du Triangle Paris la Défense Cedex FOSAMAX 10 mg, comprimé FOSAMAX 70 mg, comprimé FOSATROL 70 mg, comprimé ACIDE ALENDRONIQUE BIOGALENIQUE 70 mg, comprimé ACIDE ALENDRONIQUE RANBAXY 70 mg, comprimé ACIDE ALENDRONIQUE RPG 70 mg, comprimé ACIDE ALENDRONIQUE TEVA 70 mg, comprimé 35

36 FRANCE FR - Ranska HU - Unkari TEVA SANTE Le Palatin 1 1 cours du Triangle Paris la Défense Cedex FRANCE Generics (UK) Ltd. Albany Gate, Darkes Lane, Potters bar EN61AG Hertfordshire UK ALENDRONATE TEVA 10 mg, comprimé ALENDIS 70 mg tabletta 10 mg Tabletti 70.0 mg Alendronic acid [in the form of mg sodium alendronate ] Tabletti HU - Unkari Arrow Generics Ltd. Stevenage SG14SZ Hertfordshire UK ALENDROMAX 70 mg tabletta 70.0 mg Alendronic acid [in the form of mg sodium alendronate trihydrate] Tabletti HU - Unkari Sandoz Hungária Kft., 1114 Budapest, Bartók Béla út Hungary ALENDRON HEXAL 70 mg tabletta 70.0 mg Alendronic acid [in the form of mg sodium alendronate trihydrate] Tabletti 36

37 HU - Unkari Bluefish Pharmaceuticals ABTorsgatan Stockholm Sweden ALENDRONAT BLUEFISH 70 mg tabletta 70.0 mg Alendronic acid [in the form of mg sodium alendronate trihydrate] Tabletti HU - Unkari Orion Corporation Orionintie Espoo Finland ALENDRONAT ORION 70 mg tabletta 70.0 mg Alendronic acid [in the form of mg sodium alendronate trihydrate] Tabletti HU - Unkari Pliva Hungária Kft. Galagonya u Budapest Hungary ( The company is the member of TEVA Group Teva Magyarország zrt,1134budapest, Róbert Károly krt.59)) ALENDRONAT PLIVA 70 mg tabletta 70.0 mg Alendronic acid [in the form of mg alendronate trihydrate] Tabletti HU - Unkari Ratiopharm Hungária Kft. Uzsoki u. 36/A 1145 Budapest Hungary ALENDRONAT- RATIOPHARM 70 mg tabletta 70.0 mg Alendronic acid [in the form of mg sodium alendronate trihydrate] Tabletti 37

38 HU - Unkari Richter Gedeon nyrt. Gyömrői út Budapest Hungary ALENDRONAT- RICHTER 70 mg filmtabletta 70.0 mg Alendronic acid [in the form of mg sodium alendronate trihydrate] Tabletti, HU - Unkari Sandoz Hungária Kft., 1114 Budapest, Bartók Béla út Hungary ALENDRONAT- SANDOZ 70 mg filmtabletta 70.0 mg Alendronic acid [in the form of mg sodium alendronate] Tabletti, HU - Unkari Apotex Europe B.V. Darwinweg CR Leiden Holland ALENDRONSAV APOTEX 70 mg tabletta 70.0 mg Alendronic acid [in the form of mg sodium alendronate trihydrate] Tabletti HU - Unkari Richter Gedeon nyrt. Gyömrői út Budapest Hungary Calcisedron-D filmtabletta 70.0 mg Alendronic acid [in the form of mg sodium alendronate trihydrate] Tabletti, 38

39 HU - Unkari Richter Gedeon nyrt. Gyömrői út Budapest Hungary Calcisedron-D Trio filmtabletta 70.0 mg Alendronic acid [in the form of mg sodium alendronate trihydrate] Tabletti, HU - Unkari Aramis Pharma Kft. Mester u. 28. III/ Budapest Hungary DRONAVIC 70 mg tabletta 70.0 mg Alendronic acid [in the form of mg sodium alendronate trihydrate] Tabletti HU - Unkari Apotex Europe B.V. Darwinweg CR Leiden Holland EPOLAR 70 mg tabletta 70.0 mg Alendronic acid [in the form of mg sodium alendronate] Tabletti HU - Unkari Apotex Europe B.V. Darwinweg CR Leiden Holland EPOLAR Trio 70 mg tabletta és rágótabletta 70.0 mg Alendronic acid [in the form of mg sodium alendronate] Tabletti ja purutabletti 39

40 HU - Unkari Actavis Group PTC ehf. Reykjavikurvegur Hafnarfjordur Iceland FLADOR 70 mg tabletta 70.0 mg Alendronic acid [in the form of mg sodium alendronate trihydrate] Tabletti HU - Unkari Medico Uno Pharma Kft. Viadukt u Biatorbágy Hungary FORTIMAX tabletta 70.0 mg Alendronic acid [in the form of mg sodium alendronate trihydrate] Tabletti HU - Unkari Merck Sharp & Dohme Magyarország Kft. Alkotás u Budapest Hungary FOSAMAX 70 mg tabletta 70.0 mg Alendronic acid [in the form of mg sodium alendronate] Tabletti HU - Unkari Richter Gedeon nyrt. Gyömrői út Budapest Hungary HANTRUX 70 mg filmtabletta 70.0 mg Alendronic acid [in the form of mg sodium alendronate trihydrate] Tabletti, 40

41 HU - Unkari Vera Pharma Kft. Rákos köz Budapest Hungary MASSIDRON 70 mg tabletta 70.0 mg Alendronic acid [in the form of 81.2 mg mg sodium alendronate monohydrate] Tabletti HU - Unkari Richter Gedeon nyrt. Gyömrői út Budapest Hungary MATEKIT 70 mg filmtabletta 70.0 mg Alendronic acid [in the form of mg sodium alendronate trihydrate] Tabletti, HU - Unkari Richter Gedeon nyrt. Gyömrői út Budapest Hungary SEDRON 70 mg filmtabletta 70.0 mg Alendronic acid [in the form of mg sodium alendronate trihydrate] Tabletti, HU - Unkari Teva Magyarország Zrt Gödöllő, Repülőtéri út 5. TRABECAN-TEVA 70 mg tabletta 70.0 mg Alendronic acid [in the form of 81.2 mg mg sodium alendronate monohydrate] Tabletti 41

42 HU - Unkari Teva Magyarország Zrt Gödöllő, Repülőtéri út 5. TRABECAN Duo TEVA tabletta és lágy kapszula 70.0 mg Alendronic acid [in the form of 81.2 mg mg sodium alendronate monohydrate] Tabletti ja kapseli, pehmeä HU - Unkari Richter Gedeon nyrt. Gyömrői út Budapest Hungary UTERITRIN 70 mg filmtabletta 70.0 mg Alendronic acid [in the form of mg sodium alendronate trihydrate] Tabletti, IE - Irlanti IE - Irlanti IE - Irlanti Merck Sharp & Dohme Limited Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom Merck Sharp & Dohme Limited Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom Clonmel Healthcare Limited Waterford Road Clonmel Co. Tipperary Ireland Fosamax 10mg Tabletti Fosamax Osteomel Once weekly 42

43 IE - Irlanti IE - Irlanti IE - Irlanti IE - Irlanti PLIVA Pharma Ltd. Vision House Bedford Road Petersfield Hants, GU32 3QB United Kingdom Rowex Ltd Bantry Co. Cork Laboratorios Davur S.L.U. C/Anabel Segura 11 Edificio Albatros B 1a planta Alcobendas Madrid Spain McDermott Laboratories Ltd. t/a Gerard Laboratories 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13 Fosalen Once Weekly 70mg Tablets Romax Once Weekly 70 mg Tablets Alendronic Acid Once Weekly 70mg Tablets Fostepor 10mg Tablets 10mg Tabletit IE - Irlanti McDermott Laboratories Ltd. t/a Gerard Laboratories 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13 McDermott Laboratories Ltd. t/a Gerard Laboratories 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13 Fostepor Once Weekly 70mg Tablets 10mg Tabletit McDermott Laboratories Ltd. t/a Gerard Laboratories 35/36 Baldoyle Industrial 43

44 Estate, Grange Road, Dublin 14 IE - Irlanti IE - Irlanti IE - Irlanti IE - Irlanti IE - Irlanti IE - Irlanti PLIVA Pharma Ltd. Vision House, Bedford Road, Petersfield, Hants, GU32 3QB, United Kingdom PLIVA Pharma Ltd. Vision House, Bedford Road, Petersfield, Hants, GU32 3QB, United Kingdom Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, The Netherlands Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, The Netherlands Bluefish Pharmaceuticals AB, Torsgatan 11, Stockholm, Sweden. Actavis Group PTC ehf; Reykjavikurvegi 76-78, 220 Hafnarfjordur Iceland Fosalen 10 mg Tablets 10mg Tabletit Fosalen Once Weekly 70mg Tablets Tevanate Once Weekly 70mg Tablets Fosalen Once Weekly 70mg Tablets Alendronic Acid Bluefish Once weekly 70 mg Tablets Fostolin Once Weekly 70mg Tablets 70mg Tabletit 70mg Tabletit 70mg Tabletit 70mg Tabletit 70 mg Tabletit IS - Islanti Arrow Generics Ltd., Unit 2 Eastman Way Stevenage, Hertz SG1 4SZ U.K Alendroarrow 10 mg Tabletti 44

45 IS - Islanti Arrow Generics Ltd., Unit 2 Eastman Way Stevenage, Hertz SG1 4SZ U.K IS - Islanti Actavis Group PTC ehf., Reykjavíkurvegi 76-78, 220 Hafnarfjordur, Iceland IS - Islanti Ranbaxy (UK) Limited, C.P. House Uxbridge Road, Ealing Londo W5 5TL U.K IS - Islanti Merck Sharp & Dohme B.V., Waaderveg 39, PC Haarlem, The Netherlands IS - Islanti Williams & Halls ehf, Hverfisgata Reykjavík, Iceland ABIOGEN PHARMA SpA Via Meucci, Ospedaletto (PI) ABIOGEN PHARMA SpA Via Meucci, Ospedaletto (PI) ACCORD HEALTHCARE LIMITED Sage House,319 Pinner Road North Harrow Middlesex ACTAVIS GROUP PTC EHF Reykjavikurvegi Alendroarrow week tablet Alendronat Actavis Alendronat Ranbaxy Fosamax week tablet Ostacid 70 mg Tabletti, ALENDROS 10 mg Tabletit ALENDROS 70 mg Tabletit ALENDRONATO AHCL 10 mg Tabletit ALENDRONATO ACTAVIS 70 mg Tabletit AGIPS FARMACEUTICI Srl Via Amendola Rapallo (GE) GLAMOR 70 mg Kalvopäällysteiset 45

46 ALMUS Srl Via Cesarea, 11/ Genova ALENDRONATO ALMUS 70 mg Kalvopäällysteiset ARROW GENERICS LTD Unit 2, Eastman way Stevenage, Herts SG1 4SZ ARROW GENERICS LTD Unit 2, Eastman way Stevenage, Herts SG1 4SZ BENTLEY PHARMACEUTICALS IRELAND LTD North Wall Uay Dublin 1 - Ireland BIOHEALTH PHARMACEUTICALS Srl Via Bolognese, 250 Pistoia - Italy BIOMEDICA FOSCAMA INDUSTRIA CHIMICA FARMACEUTICA SpA Via Morolense, Ferentino (FR) ALENDRONATO ARROW ALENDRONATO ARROW ALENDRONATO BENTLEY PHARMACEUTICALS IRELAND 10 MG Tabletit 70 mg Tabletit 70 mg Tabletit ASTON 70 mg Kalvopäällysteiset ALOST 70 mg Tabletit LABORATORIO PRODOTTI FARMACEUTICI BONISCONTRO & GAZZONE Srl Via Pavia, Milano - Italy DOC GENERICI Srl Via Manuzio, Milano DORYX 70 mg Tabletit ALENDRONATO DOC GENERICI 70 mg Tabletit 46

47 DOC GENERICI Srl Via Manuzio, Milano ALENDRONATO DOC 70 mg Tabletit DR REDDY'S Srl Via Fernanada Wittgens, Milano EG SpA Via Pavia, Milano - Italy ALENDRONATO DR REDDY'S 70 mg Tabletit ALENDRONATO EG 10 mg Tabletit EG SpA Via Pavia, Milano - Italy ALENDRONATO EG 70 mg Tabletit EPIFARMA Srl Via San Rocco, Episcopia (PZ) EPIFARMA Srl Via San Rocco, Episcopia (PZ) FG Srl Via San Rocco, Episcopia (PZ) FIDIA FARMACEUTICI SpA Via Ponte D/Fabbrica, 3/A Abano Terme (PD) GERMED PHARMA SpA Via Cesare Cantù, Cinisello Balsamo (MI) ALENIC 70 mg Tabletit ACIDO ALENDRONICO EPIFARMA ACIDO ALENDRONICO FG ACIDO ALENDRONICO FIDIA ALENDRONATO GERMED 70 mg Tabletit 70 mg Tabletit 70 mg Tabletit 10 mg Tabletit 47

48 GERMED PHARMA SpA Via Cesare Cantù, Cinisello Balsamo (MI) ALENDRONATO GERMED 70 mg Tabletit HEXAL SpA Via Paracelso, Agrate Brianza (MI) ALENDRONATO HEXAL 70 mg Tabletit ISTITUTO CHIMICO INTERNAZIONALE DR. GIUSEPPE RENDE Srl Via Salaria, Roma REALEN 70 mg Tabletit ISTITUTO GENTILI SpA Via San Giuseppe Cottolengo, Milano GENALEN 10 mg Tabletit ISTITUTO GENTILI SpA Via San Giuseppe Cottolengo, Milano GENALEN 70 mg Tabletit LABORATORI ALTER Srl Via Lomellina, Milano MERCK SHARP & DOHME Ltd Hertford Road, Hoddesdon Hertfordshire EN119BU ALENDRONATO ALTER 70 mg Tabletit FOSAMAX 10 mg Tabletit 48

49 MERCK SHARP & DOHME Ltd Hertford Road, Hoddesdon Hertfordshire EN119BU MYLAN SpA Via Vittor Pisani, Milano NEOPHARMED Srl Via San Giuseppe Cottolengo, Milano FOSAMAX 70 mg Tabletit ALENDRONATO MYLAN GENERICS 70 mg Tabletit ADRONAT 10 mg Tabletit NEOPHARMED Srl Via San Giuseppe Cottolengo, Milano ADRONAT 70 mg Tabletit PENSA PHARMA SpA Via Rossellini Ippolito, Milano PHARMEG Srl Via dei Giardini, Episcopia (PZ) RANBAXY ITALIA SpA p.zza Filippo Meda, Milano RATIOPHARM GMBH Graf Arco-strasse, 3 Ulm D S.F.GROUP Srl Via Beniamino Segre, Roma Italy ALENDRONATO PENSA 70 mg Tabletit PORODRON 70 mg Tabletit ALENDRONATO RANBAXY ITALIA ALENDRONATO RATIOPHARM 70 mg Tabletit 70 mg Tabletit NOFRATTIL 70 mg Kalvopäällysteiset 49

50 LT - Liettua SANDOZ SpA L.go U. Boccioni, Origgio (VA) SEGIX ITALIA Srl Via Del Mare, Pomezia (RM) SEGIX ITALIA Srl Via Del Mare, Pomezia (RM) SIGMATAU GENERICS SpA Via Pontina Km30, Pomezia (RM) SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE SpA Viale Shakespeare, Roma SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE SpA Viale Shakespeare, Roma SO.SE.PHARM Srl Via dei Castelli Romani, Pomezia (RM) TEVA ITALIA Srl Via Messina, Milano - Italy ACCORD HEALTHCARE LIMITED Sage House,319 Pinner Road North Harrow Middlesex KRKA d.d., Šmarješka Cesta Novo mesto, Slovenia ALENDRONATO SANDOZ 70 mg Tabletit DRALENOS 10 mg Tabletit DRALENOS 70 mg Tabletit ACIDO ALENDRONICO SIGMA TAU GENERICS 70 mg Tabletit DRONAL 10 mg Tabletit DRONAL 70 mg Tabletit LOSS 70 mg Kalvopäällysteiset ALENDRONATO TEVA 70 mg Tabletit ALENDRONATO AHCL 70 mg Tabletit Lindron 10 mg Tabletti 50

51 LT - Liettua Sandoz d.d., Verovškova 57 SI-1000 Ljubljana Slovenia Alendon LT - Liettua LT - Liettua Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220 Hafnarfjordur, Iceland Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom Lendrate Alendronic acid Accord LT - Liettua Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom Alendronic acid Accord 10 mg Tabletti LT - Liettua Teva Pharma B.V., Computerweg DR Utrecht, The Netherlands Alenotop LT - Liettua Teva Pharma B.V., Computerweg DR Utrecht, The Netherlands Tevanate LT - Liettua Mepha Lda., Lagoas Park, Edificio 5-A, Piso 2, Porto Salvo, Portugal Densidron 51

52 LT - Liettua Ranbaxy UK Ltd., 20 Balderton Street London W1K 6TL, United Kingdom Ralenost LT - Liettua Gedeon Richter Plc., 1103 Budapest Gyömrői út 19-21, Hungary Sedron 70 mg Tabletti, LT - Liettua Pharmaceutical Works POLPHARMA SA, 19 Pelplińska Street Starogard Gdański, Poland Ostemax LT - Liettua UAB Merck Sharp & Dohme, Kęstučio 59/27, LT Vilnius, Lithuania Fosamax LT - Liettua Orion Corporation, Orionintie 1, FI Espoo, Finland Alendorion LU - Luxemburg Merck Sharp & Dohme 5, Clos du Linx B-1200 Bruxelles Fosamax-70 Hebdomadaire 70 mg Tabletit LV - Latvia Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, united Kingdom Alendronate sodium Accord 10 mg Tabletit 52

53 LV - Latvia Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, united Kingdom LV - Latvia Orion Corporation, Orionintie 1, FI Espoo Finland LV - Latvia Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, Netherlands LV - Latvia Mepha Lda., Lagoas Park, Porto Salvo, Portugal LV - Latvia Gedeon Richter Plc., 1103 Budapest, Gyomroi ut 19-21, Hungary LV - Latvia Pharmaceutical Works Polpharma SA., 19 Pelplinska Str., Starogard Gdanski, Poland LV - Latvia Actavis Group PTC ehf., Reykjavikurvegi 76-78, 220 Hafnarfjordur, Iceland LV - Latvia SIA"Merck Sharp & Dohme Latvija", Skanstes iela 13, Riga LV-1013, Latvia MT - Malta Mepha - Investigação, Desenvolvimento e Fabricação Farmaceutica, Lda. MT - Malta Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, UK Alendronate sodium Accord 70 mg Tabletit Alendorion 70 mg Tabletit Alenotop 70 mg Tabletit Densidron 70 mg Kalvopäällysteiset Sedron 70 mg Kalvopäällysteiset Ostemax 70 mg Tabletit Lendrate 70 mg Tabletit Fosamax 70 mg Tabletit Densidron 70mg Kalvopäällysteiset Fosamax 70mg Tabletit 53

54 MT - Malta Arrow Generics Limited, Unit 2, Eastman Way, Stevenage, Hertfordshire SG1 4SZ, United kingdom. Alendronic Acid 10mg tablets 10mg Tabletti MT - Malta Arrow Generics Limited, Unit 2, Eastman Way, Stevenage, Hertfordshire SG1 4SZ, United kingdom. Alendronic Acid 70mg tablets 70mg Tabletti MT - Malta Aurobindo Pharma (Malta) Ltd, 46/2 South Street, Valletta VLT11, Malta Alendronic Acid 70mg tablet 70mg Tabletti MT - Malta Accord Healthcare Limited Sage House 319, Pinner Road North Harrow Middlesex HA1 4 HF United Kingdom Alendronate Sodium Accord 10 mg Tablets 10mg Tabletit MT - Malta Accord Healthcare Limited Sage House 319, Pinner Road North Harrow Middlesex HA1 4 HF United Kingdom Alendronate Sodium Accord 70 mg Tablets 70mg Tabletit MT - Malta NL - Alankomaat Actavis Group PTC ehf; Reykjavikurvegi 76-78, 220 Hafnarfjordur Iceland acis Arzneimittel GmbH Lil-Dagover-Ring Grünwald, Germany Lendrate 70 mg Tabletit Osteonorm 70 mg 54

55 NL - Alankomaat NL - Alankomaat NL - Alankomaat NL - Alankomaat NL - Alankomaat NL - Alankomaat NL - Alankomaat NL - Alankomaat ratiopharm Nederland bv Florapark HK Haarlem Netherlands Sandoz B.V., Veluwezoom AH Almere Netherlands Iono Limited 65 Delamere Road, Hayes Middlesex UB4 ONN United Kingdom Iono Limited 65 Delamere Road, Hayes Middlesex UB4 ONN United Kingdom Pharmachemie B.V. Swensweg GA Haarlem Netherlands Pharmachemie B.V. Swensweg GA Haarlem Netherlands Centrafarm Services B.V. Nieuwe Donk AC Etten-Leur Netherlands Genericon Pharma Gesellschaft m.b.h. Hafnerstraße Graz Austria Alendroninezuur ratiopharm 70 mg Alendroninezuur Sandoz 70 mg Alendroninezuur Iono 70 mg Alendroninezuur Iono 10 mg Alendroninezuur 10 PCH Alendroninezuur 70 PCH Alendroninezuur CF 70 mg 10 mg Tabletti 10 mg Tabletti Alendronorm 70 mg 55

56 NL - Alankomaat NL - Alankomaat NL - Alankomaat NL - Alankomaat NL - Alankomaat NL - Alankomaat NL - Alankomaat NL - Alankomaat Bentley Pharmaceuticals Limited, 25/28 North Wall Quay Dublin 1 Ireland Biomedica Foscama Industria Chimico- Farmaceutica S.p.A. Via Morolense, Ferentino Arrow Generics Limited Unit 2, Eastman Way, Stevenage, Hertfordshire, SG1 4SZ United Kingdom Apotex Europe BV Darwinweg CR Leiden Netherlands Ranbaxy Belgium NV Leuvensestraat 28b 1800 Vilvoorde Belgium Ranbaxy Belgium NV Leuvensestraat 28b 1800 Vilvoorde Belgium Ranbaxy Belgium NV Leuvensestraat 28b 1800 Vilvoorde Belgium Sandoz B.V., Veluwezoom AH Almere Netherlands Alendroninezuur Bentley 70 mg Dronatex 70 mg Alendroninezuur Arrow 70 mg Alendroninezuur Apotex 70 mg Alendratol 10 mg 10 mg Tabletti Alendratol 70 mg Randronate 70 mg Alendroninezuur Sandoz 10 mg 10 mg Tabletti 56

57 NL - Alankomaat NL - Alankomaat NL - Alankomaat NL - Alankomaat NL - Alankomaat NL - Alankomaat NL - Alankomaat NL - Alankomaat NL - Alankomaat Sandoz B.V., Veluwezoom AH Almere Netherlands Mylan BV Dieselweg LB Bunschoten Netherlands Mylan BV Dieselweg LB Bunschoten Netherlands Apothecon B.V. Nijverheidsweg 3, 3771 ME Barneveld Netherlands mibe GmbH Arzneimittel Münchener Str Brehna Germany Actavis Group PTC ehf Reykjavikurvegur 76-78,220 Hafnarfjordur Centrafarm Services B.V. Nieuwe Donk AC Etten-Leur Netherlands Bluefish Pharmaceuticals AB, Torsgatan Stockholm Sweden WILL-PHARMA Wilgenlaan JK Zwanenburg Netherlands Alendroninezuur Sandoz 70 mg Alendroninezuur Mylan 10 mg Alendroninezuur Mylan 70 mg 10 mg Tabletti Alendroninezuur 70A Ostadil 70 mg Alendroninezuur Actavis 70 mg Alendroninezuur CF 10 mg Akendroninezuur Bluefish 70 mg Bonendro 70 mg / 1000 mg / 880 IU 10 mg Tabletti Tabletti + rakeet yhdistelmäpakkaus 57