natgillin/translations-raw huggingface dataset:
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated ) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated ) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports) 
Kõrvaltoimete esinemissagedus on defineeritud järgnevalt: - Väga sage (kõrvaltoime(d) ilmnes(id) rohkem kui 1-l loomal 10-st ravitud loomast) - Sage (rohkem kui 1-l, kuid vähem kui 10-l loomal 100-st ravitud loomast) - Aeg-ajalt (rohkem kui 1-l, kuid vähem kui 10-l loomal 1000-st ravitud loomast) - Harv (rohkem kui 1-l, kuid vähem kui 10-l loomal 10000-st ravitud loomast) - Väga harv (vähem kui 1-l loomal 10000-st ravitud loomast, kaasaarvatud üksikjuhud).
EXPIRY DATE EXP {month/year} Once opened, use by 6 months. 
EXP Pärast esmast avamist, kasutada kuni 6 kuud.
Pharmacotherapeutic group: Glucorticosteroids, dermatological preparations. 
Farmakoterapeutiline rühm: glükokortikosteroidid, dermatoloogilised preparaadid ATCvet kood: QD07AC.
MANUFACTURER'S BATCH NUMBER Batch {number} 
TOOTJAPOOLNE PARTII NUMBER Lot
SPECIAL STORAGE CONDITIONS Not applicable. 
SÄILITAMISE ERITINGIMUSED Ei ole.
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY AND USE 
TARNIMIS- JA KASUTAMISTINGIMUSED VÕI PIIRANGUD
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER VIRBAC 
MÜÜGILOA HOIDJA NIMI JA AADRESS VIRBAC
CONTRAINDICATIONS Do not use on cutaneous ulcers. 
VASTUNÄIDUSTUSED Mitte kasutada nahahaavandite korral.
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release VIRBAC 
Ravimipartii väljastamise eest vastutava(te) tootja(te) nimi (nimed) ja aadress(id) VIRBAC
PHARMACEUTICAL FORM Cutaneous spray, solution. 
RAVIMVORM Nahasprei, lahus.
METHOD AND ROUTE(S) OF ADMINISTRATION Cutaneous use. 
MANUSTAMISVIIS JA -TEE(D) Naha pinnale manustamiseks.
D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
D. MUUD TINGIMUSED JA NÕUDED MÜÜGILOALE Ei kohaldata.
Hydrocortisone aceponate 0.584 mg/ml For the full list of excipients, see section 6.1 
0,584 mg/ml Abiainete täielik loetelu on esitatud lõigus 6.1.
HDPE bottle of 76ml: EU/2/06/069/004 
76 ml HDPE pudel EU/2/06/069/004
INDICATIONS For symptomatic treatment of inflammatory and pruritic dermatoses in dogs. 
NÄIDUSTUS(ED) Põletiku ja sügelusega kulgeva dermatoosi sümptomaatiliseks raviks koertel.
ATCvet code: QD07AC. 
FARMATSEUTILISED ANDMED 6.1.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton box with a bottle of 31 ml 
VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED Pappkarp 31 ml pudeliga
MARKETING AUTHORISATION NUMBER(S) PET bottle of 76ml: EU/2/06/069/001 
MÜÜGILOA NUMBER (NUMBRID) 76 ml PET pudel EU/2/06/069/001
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton box with a bottle of 76 ml 
VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED Pappkarp 76 ml pudeliga
THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only. 
MÄRGE „AINULT VETERINAARSEKS KASUTAMISEKS” Ad. us. vet.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottle of 31 ml 
MINIMAALSED ANDMED, MIS PEAVAD OLEMA VÄIKESEL VAHETUL SISEPAKENDIL
NAME OF THE VETERINARY MEDICINAL PRODUCT CORTAVANCE 0.584 mg/ml cutaneous spray solution for dogs Hydrocortisone aceponate 
VETERINAARRAVIMI NIMETUS CORTAVANCE 0,584 mg/ml nahasprei lahus koertele Hydrocortisoni aceponas
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottle of 76 ml 
SISEPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED Pudel - 76 ml
Carton box with a PET bottle of 31ml Carton box with a PET bottle of 76ml Carton box with a HDPE bottle of 31ml Carton box with a HDPE bottle of 76ml 
Kartongkarp, milles on üks 76 ml HDPE pudel.
NAME OF THE VETERINARY MEDICINAL PRODUCT CORTAVANCE 0.584 mg/ml cutaneous spray solution for dogs 
VETERINAARRAVIMI NIMETUS CORTAVANCE 0,584 mg/ml nahasprei lahus koertele Hüdrokortisoonatseponaat
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
ESMASE MÜÜGILOA VÄLJASTAMISE / MÜÜGILOA PIKENDAMISE KUUPÄEV Esmase müügiloa väljastamise kuupäev: 09/01/2007
PACKAGE LEAFLET CORTAVANCE 0.584 mg/ml cutaneous spray solution for dogs 
CORTAVANCE 0,584 mg/ml nahasprei lahus koertele
WITHDRAWAL PERIOD(S) Not applicable. 
C. RAVIMJÄÄKIDE PIIRNORMID Ei kohaldata.
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 
A. BIOLOOGILIS(T)E TOIMEAINE(TE) TOOTJA JA RAVIMIPARTII VABASTAMISE
MARKETING AUTHORISATION NUMBER(S) Carton box with a PET bottle of 76ml: EU/2/06/069/001 
MÜÜGILOA NUMBER (NUMBRID) Kartongkarp 76 ml PET pudeliga EU/2/06/069/001 Kartongkarp 76 ml HDPE pudeliga EU/2/06/069/004
STATEMENT OF ACTIVE SUBSTANCES Hydrocortisone aceponate 0.584 mg/ml 
0,584 mg/ml
MARKETING AUTHORISATION NUMBER(S) Carton with a PET bottle of 31ml: EU/2/06/069/002 
MÜÜGILOA NUMBER (NUMBRID) Kartongkarp 31 ml PET pudeliga EU/2/06/069/002 Kartongkarp 31 ml HDPE pudeliga EU/2/06/069/003
VIRBAC 1ère avenue 2065 m LID 06516 Carros FRANCE 
VIRBAC 1ère avenue 2065 m LID 06516 Carros Prantsusmaa
6.1 List of excipients 
KÕLBLIKKUSAEG EXP
MABO FARMA, S.ACarretera M-300 Km 30,500. 
ES - Hispaania MABO FARMA, S.ACarretera M-300 Km 30,500.
(Invented) Name 
(Väljamõeldud) Nimetus
BG - Bulgaria Tchaikapharma High Quality Medicines, 1, G.M. 
BG - Bulgaaria Tchaikapharma High Quality Medicines, 1, G.M.
DE - Germany KSK-Pharma Vertriebs AG Finkenstr. 
DE - Saksamaa KSK-Pharma Vertriebs AG Finkenstr.
ZYDUS FRANCE 25, rue des Peupliers ZAC Les Hautes PâturesParc d'Activités des Peupliers 
FR - Prantsusmaa ZYDUS FRANCE 25, rue des Peupliers ZAC Les Hautes PâturesParc d'Activités des Peupliers
Pol. Industrial Alcobendas 28108 Alcobendas 
Industrial Alcobendas 28108
103, blvd Al. Stamboliyski Office Building Sofia Tower Level 8, 1303 Sofia Bulgaria 
103, blvd Al. Stamboliyski Office Building Sofia Tower Level 8, 1303 Sofia
DE - Germany C.H.R. 
DE - Saksamaa C.H.R.
DE - Germany Basics GmbH Hemmelrather Weg 201 
DE - Saksamaa Basics GmbH Hemmelrather Weg 201
92000 Nanterre FRANCE 
92000 Nanterre
PHARMEMMA Unit 2, Ashbourne Manufacturing Park Ashbourne County Meath IRLANDE 
FR - Prantsusmaa PHARMEMMA Unit 2, Ashbourne Manufacturing Park Ashbourne County Meath IRLANDE
DE - Germany HEXAL AG Industriestr. 
DE - Saksamaa HEXAL AG Industriestr.
DE - Germany axcount Generika AG Max-Planck-Str. 36b 
DE - Saksamaa axcount Generika AG Max-Planck-Str. 36b
Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states 
Lisa I Nimetuste, ravimvormide, ravimpreparaadi tugevuste, manustamisteede, liikmesriikides müügiloa hoidjate nimekiri
Verge de Montserrat, 6 08820 El Prat de Llobregat 
Montserrat, 6 08820 El Prat de Llobregat
SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 
FR - Prantsusmaa SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland
LU - Luxembourg Bayer s.a. 14, J.E. 
LU - Luksenburg Bayer s.a. 14, J.E.
RO - Romania DR. REDDY'S LABORATORIES 
RO - Rumeenia DR. REDDY'S LABORATORIES
LU - Luxembourg EUROGENERICS S.A ESPLANADE HEYSEL, B.22 
LU - Luksenburg EUROGENERICS S.A ESPLANADE HEYSEL, B.22
Kemofarmacija d.d., cesta na Brdo 100, SI-1000 
SI - Sloveenia Kemofarmacija d.d., cesta na Brdo 100, SI-1000
RO - Romania BAYER SCHERING PHARMA OY, 
RO - Rumeenia BAYER SCHERING PHARMA OY,
GEDEON RICHTER ROMÂNIA S.A. , România 
RO - Rumeenia GEDEON RICHTER ROMÂNIA S.A. , România
Str. Izvor, nr 80, etajele 611, sector 5 Bucharest, Romania 
Str. Izvor, nr 80, etajele 611, sector 5 Bucharest,
LABORATORIOS NORMON, S.A.Ronda de Valdecarrizo, 6 28760 Tres Cantos 
ES - Hispaania LABORATORIOS NORMON, S.A.Ronda de Valdecarrizo, 6 28760 Tres Cantos
3, avenue de la Baltique ZI de Courtaboeuf 91140 Villebon Sur Yvette FRANCE 
FR - Prantsusmaa ALTER 3, avenue de la Baltique ZI de Courtaboeuf 91140 Villebon Sur Yvette FRANCE
LV - Latvia sanofi-aventis Latvia SIA, Kr.Valdemara iela 33-8, Riga LV 1010, Latvia 
LV - Läti sanofi-aventis Latvia SIA, Kr.Valdemara iela 33-8, Riga LV 1010, Latvia
LABORATORIOS COMBIX, S.L.San Rafael, 3. 
ES - Hispaania LABORATORIOS COMBIX, S.L.San Rafael, 3.
FARMALIDER, S.A.Aragoneses, 15 28108 Alcobendas 
ES - Hispaania FARMALIDER, S.A.Aragoneses, 15 28108 Alcobendas
Ind. Malpica Calle C, Nº 4 50016 Zaragoza 
Ind. Malpica Calle C, Nº 4 50016
Via Morolense, 87 - 03010 
Via Morolense, 87 - 03010 Ferentino
SK - Slovakia medac GmbH Theaterstraße 6 
SK - Slovakkia medac GmbH Theaterstraße 6
STADA Hemofarm SRL Zugrav Nedelcu nr.3, Timişoara, Romania 
RO - Rumeenia STADA Hemofarm SRL Zugrav Nedelcu nr.3, Timişoara, Romania
15, boulevard Charles de Gaulle 
FR - Prantsusmaa BIOGARAN 15, boulevard Charles de Gaulle
C/ Anabel Segura, 11, Edificio Albatros B, 1ª planta 28108 Alcobendas 
C/ Anabel Segura, 11, Edificio Albatros B, 1ª planta 28108
Intramuscular, Intravenous 
Intramuskulaarne, intravenoosne
PENSA PHARMA, S.A.U Jorge Comín (médico pediatra), 3 - bajos 46015 Valencia 
ES - Hispaania PENSA PHARMA, S.A.U Jorge Comín (médico pediatra), 3 - bajos 46015
SINTEXLINE S.A.Polígono Industrial La Red, Calle 11 nº 2 41500 Alcalá de Guadaira 
ES - Hispaania SINTEXLINE S.A.Polígono Industrial La Red, Calle 11 nº 2 41500 Alcalá de
NL - Netherlands ratiopharm Nederland bv Florapark 4 
NL - Holland ratiopharm Nederland bv Florapark 4
ARROW GENERIQUES 26, avenue Tony Garnier 69007 Lyon 
FR - Prantsusmaa ARROW GENERIQUES 26, avenue Tony Garnier 69007 Lyon
Pliva Ljubljana d.o.o., pot k sejmišču 35, SI-1231 
SI - Sloveenia Pliva Ljubljana d.o.o., pot k sejmišču 35, SI-1231
52, boulevard du Parc 92521 Neuilly-sur-Seine Cedex 
FR - Prantsusmaa ROCHE 52, boulevard du Parc 92521 Neuilly-sur-Seine Cedex
DE - Germany Roche Pharma AG Emil-Barell-Str. 1 
DE - Saksamaa Roche Pharma AG Emil-Barell-Str. 1
TEVA GENERICOS ESPAÑOLA, S.L. 
ES - Hispaania TEVA GENERICOS ESPAÑOLA, S.L.
LU - Luxembourg HOSPIRA BENELUX SPRL 63, RUE DE STALLE 
LU - Luksenburg HOSPIRA BENELUX SPRL 63, RUE DE STALLE
FI - Finland sanofi-Aventis Oy, Huopalahdentie 24, PL 22, 00350 Helsinki, Finland 
FI - Soome sanofi-Aventis Oy, Huopalahdentie 24, PL 22, 00350 Helsinki, Finland
MERCK S.L.María de Molina, 40 28006 Madrid 
ES - Hispaania MERCK S.L.María de Molina, 40 28006 Madrid
LU - Luxembourg TEVA PHARMA BELGIUM S.A. 
LU - Luksenburg TEVA PHARMA BELGIUM S.A.
1010 Vienna 
1010 Vienna Austria
DE - Germany Bayer Vital GmbH Kaiser-Wilhelm-Allee 
DE - Saksamaa Bayer Vital GmbH Kaiser-Wilhelm-Allee
BE - Belgium Mylan BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart 
Mylan BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart Belgium
LABORATORIOS PEREZ GIMENEZ, S.A.Pol. 
ES - Hispaania LABORATORIOS PEREZ GIMENEZ, S.A.Pol.
DK - Denmark Bayer AB, Postbox 606, Gustav III:s Boulevard 56, SE-16926 Solna 
Bayer AB, Postbox 606, Gustav III:s Boulevard 56, SE-16926 Solna
KERN PHARMA, S.L.Venus, 72. 
ES - Hispaania KERN PHARMA, S.L.Venus, 72.
KORHISPANA S.L.Carretera de Castellvell, 24 43206 Reus 
ES - Hispaania KORHISPANA S.L.Carretera de Castellvell, 24 43206
QUIMICA FARMACEUTICA BAYER, S.L.Av. 
ES - Hispaania QUIMICA FARMACEUTICA BAYER, S.L.Av.
MERCK SHARP & DOHME ROMÂNIA S.R.L.Bucharest Business ParkŞos. 
RO - Rumeenia MERCK SHARP & DOHME ROMÂNIA S.R.L.Bucharest Business ParkŞos.
PAMIDRONATO DISODICO HIKMA Attenzione: E' Hospira 
PAMIDRONATO DISODICO HIKMA Attenzione: E' Hospira süstelahus
DE - Germany MSD Sharp & Dohme GmbH Lindenplatz 1 
DE - Saksamaa MSD Sharp & Dohme GmbH Lindenplatz 1
NOVARTIS FARMACEUTICA, S.A.Gran Via de les Corts Catalanes, 764 08013 Barcelona 
ES - Hispaania NOVARTIS FARMACEUTICA, S.A.Gran Via de les Corts Catalanes, 764 08013
DE - Germany 1 A Pharma GmbH Keltenring 1 + 3 
DE - Saksamaa 1 A Pharma GmbH Keltenring 1 + 3
RANBAXY PHARMACIE GENERIQUES 11-15 Quai Dion Bouton 92800 Puteaux FRANCE 
11-15 Quai Dion Bouton 92800 Puteaux
LU - Luxembourg Merck Sharp & Dohme 5, Clos du Linx 
LU - Luksenburg Merck Sharp & Dohme 5, Clos du Linx
LAREQ PHARMA S.L Laguna, 66-68-70. 
ES - Hispaania LAREQ PHARMA S.L Laguna, 66-68-70.
Slow intravenous infusion 
Aeglane intravenoosne infusioon
DE - Germany Orion Corporation Orionintie 1 
DE - Saksamaa Orion Corporation Orionintie 1
Sanofi-Aventis Bulgaria EOOD 
BG - Bulgaaria Sanofi-Aventis Bulgaria EOOD
SE - Sweden Teva Sweden AB Box 1070 
Teva Sweden AB Box 1070
Poligono Empresarial La Marina 28703 San Sebastian de los Reyes 
Poligono Empresarial La Marina 28703 San
NL - Netherlands All-gen Pharmaceuticals & Generics B.V. 
NL - Holland All-gen Pharmaceuticals & Generics B.V.
70 mg + 91,37 mg tablets 
70 mg + 91,37 mg tablett
DK - Denmark Sanofi-Aventis Denmark A/S, Slotsmarken 13, DK3970 Hørsholm, Denmark 
Sanofi-Aventis Denmark A/S, Slotsmarken 13, DK3970 Hørsholm, Denmark
Sanofi-aventis d.o.o., Dunajska cesta 151, SI1000 Ljubljana 
SI - Sloveenia Sanofi-aventis d.o.o., Dunajska cesta 151, SI1000 Ljubljana
DE - Germany Warner Chilcott Deutschland GmbH 
DE - Saksamaa Warner Chilcott Deutschland GmbH
LABORATOARELE PROF. Dr. MORAIT, Str. Sperantei nr.29, Bucuresti sector 2, Romania 
RO - Rumeenia LABORATOARELE PROF. Dr. MORAIT, Str. Sperantei nr.29, Bucuresti sector 2, Romania
DK - Denmark Helm AG, Nordkanalstrasse 28D, DE-20097 Hamburg, Germany 
Helm AG, Nordkanalstrasse 28D, DE-20097 Hamburg, Germany
DK - Denmark Procter & Gamble Pharmaceuticals UK Ltd., Rusham Park Technical Centre, Whitehall Lane, GBTW20 9 NW Egham, Surrey, England 
Procter & Gamble Pharmaceuticals UK Ltd., Rusham Park Technical Centre, Whitehall Lane, GBTW20 9 NW Egham, Surrey, England
3, avenue Hoche 75114 Paris Cedex 08 FRANCE 
75114 Paris Cedex 08
Poligono Industrial Colon II.08228 Tarrasa 
Colon II.08228 Tarrasa
Tablet + granulate combination package 
Tablett + granulaadi kombinatsioonpakk
DE - Germany Onkovis GmbH Grube 45 
DE - Saksamaa Onkovis GmbH Grube 45
LABORATORIES , Str. Av. Petre Creţu nr. 74, et. 1, ap. 2, sect. 
RO - Rumeenia Dr. REDDY'S LABORATORIES , Str. Av. Petre Creţu nr. 74, et. 1, ap. 2, sect.
CANTABRIA PHARMA, S.L.c/ Ribera del Loira, 46 edificio 2 28042 Madrid Spain 
ES - Hispaania CANTABRIA PHARMA, S.L.c/ Ribera del Loira, 46 edificio 2 28042 Madrid
LU - Luxembourg Sanofi-Aventis Belgium NV Culliganlaan 1C 
LU - Luksenburg Sanofi-Aventis Belgium NV Culliganlaan 1C
DE - Germany esparma GmbH Seepark 7 
DE - Saksamaa esparma GmbH Seepark 7
47879 AC Etten-Leur 
47879 AC Etten-Leur Netherlands
TEVA GENERICOS ESPAÑOLA, S.L.Guzmán el Bueno 133, Edificio Britania 4ºIzq.28003 Madrid 
ES - Hispaania TEVA GENERICOS ESPAÑOLA, S.L.Guzmán el Bueno 133, Edificio Britania 4ºIzq.28003 Madrid
LABORATORIOS ALTER, S.A.Mateo Inurria, 30 28036 Madrid 
ES - Hispaania LABORATORIOS ALTER, S.A.Mateo Inurria, 30 28036
Pio XII, 92, Edificio Ural A, Planta 16-4 28036 Madrid 
Pio XII, 92, Edificio Ural A, Planta 16-4
49, avenue Georges Pompidou 
FR - Prantsusmaa SANDOZ 49, avenue Georges Pompidou
SE - Sweden Meda AB 170 09 Solna 
Meda AB 170 09 Solna Sweden
SANOFI AVENTIS, S.A.Josep Plá, 2 08019 Barcelona 
ES - Hispaania SANOFI AVENTIS, S.A.Josep Plá, 2 08019 Barcelona
LU - Luxembourg arner Chilcott 
LU - Luksenburg arner Chilcott
Warner Chilcott France Immeuble "Le Jean Monnet" 11, Place des Vosges 92061 Paris La Défense Cedex 
FR - Prantsusmaa Warner Chilcott France Immeuble "Le Jean Monnet" 11, Place des Vosges
Teva Pharmaceuticals N.V.Gogol 15 
BG - Bulgaaria Teva Pharmaceuticals N.V.Gogol 15
06796 Brehna 
06796 Brehna Germany
NL - Netherlands Ceft Limited 65 Delamere Road, Hayes Middlesex UB4 0NN Belgium 
NL - Holland Ceft Limited 65 Delamere Road, Hayes Middlesex UB4 0NN Belgium
LABORATORIOS DAVUR, S.L.Teide, 4-planta baja. 
ES - Hispaania LABORATORIOS DAVUR, S.L.Teide, 4-planta baja.
DK - Denmark Meda AS, Solvang 8, DK3450 Allerød, Denmark 
Meda AS, Solvang 8, DK3450 Allerød, Denmark
BE - Belgium Procter & Gamble Pharmaceuticals SA.NV. 
Procter & Gamble Pharmaceuticals SA.NV.
LABORATORIOS VIÑAS, S.A. Provenza, 386 08025 Barcelona 
ES - Hispaania LABORATORIOS VIÑAS, S.A. Provenza, 386 08025
DK - Denmark 1A Farma, Herstedøstervej 27-29, DK-2620 
1A Farma, Herstedøstervej 27-29, DK-2620
DE - Germany HIKMA Farmaceutica (Portugal) S.A. 
DE - Saksamaa HIKMA Farmaceutica (Portugal) S.A.
Merck Sharp& Dohme, inovativna zdravila d.o.o., Šmartinska cesta 140, SI1000 Ljubljana 
SI - Sloveenia Merck Sharp& Dohme, inovativna zdravila d.o.o., Šmartinska cesta 140, SI1000 Ljubljana
FI-02101 Espoo 
FI-02101 Espoo Finland
DE - Germany Orifarm Generixs A/S Energivej 15 
DE - Saksamaa Orifarm Generixs A/S Energivej 15
DE - Germany Sandoz Pharmaceuticals GmbH 
DE - Saksamaa Sandoz Pharmaceuticals GmbH
Actavis Group PTC ehf Dalshraun 1 
SK - Slovakkia Actavis Group PTC ehf Dalshraun 1
DE - Germany TECNIMEDE - Sociedade Técnico-Medicinal, S.A. (BS 
DE - Saksamaa TECNIMEDE - Sociedade Técnico-Medicinal, S.A. (BS
LU - Luxembourg W Pharmaceuticals Pegasuslaan 5 
LU - Luksenburg W Pharmaceuticals Pegasuslaan 5
NL - Netherlands mibe GmbH Arzneimittel Münchener Str. 15 
NL - Holland mibe GmbH Arzneimittel Münchener Str. 15
DE - Germany Accord Healthcare Limited Sage House, 319, Pinner Road 
DE - Saksamaa Accord Healthcare Limited Sage House, 319, Pinner Road
GENERIS FARMACÉUTICA, S.A.MOIÁ, 1, 2º 08006 BARCELONA 
ES - Hispaania GENERIS FARMACÉUTICA, S.A.MOIÁ, 1, 2º 08006
DE - Germany Volkspharma GmbH August-Wessels-Str. 5 
DE - Saksamaa Volkspharma GmbH August-Wessels-Str. 5
LABORATORIOS RANBAXY, S.L. 
ES - Hispaania LABORATORIOS RANBAXY, S.L.
Disodium clodronate tetrahydrate tablet 
Disodium clodronate tetrahydrate
DK - Denmark Hexal AG, Industriestrasse 25, DE-83607 Holzkirchen, Germany 
Hexal AG, Industriestrasse 25, DE-83607 Holzkirchen, Germany
QUALIMED (LYON) 117, allée des Parcs 69800 Saint-Priest FRANCE 
FR - Prantsusmaa QUALIMED (LYON) 117, allée des Parcs 69800 Saint-Priest
DE - Germany AWD.pharma GmbH & Co.KG 
DE - Saksamaa AWD.pharma GmbH & Co.KG
NL - Netherlands WILL-PHARMA Wilgenlaan 5 
WILL-PHARMA Wilgenlaan 5
Galex, d.d., Tišinska ulica 29g, Murska Sobota, Slovenia 
SI - Sloveenia Galex, d.d., Tišinska ulica 29g, Murska Sobota,
Valea Lupului nr. 1, 707410 Iaşi, Romania 
RO - Rumeenia Antibiotice S.A. Valea Lupului nr. 1, 707410 Iaşi, Romania
THERAMEX 6, avenue Albert II Zone F - Bloc B 98000 Monaco MONACO 
FR - Prantsusmaa THERAMEX 6, avenue Albert II Zone F - Bloc B
1A PHARMA GMBH Eduard Kittenberger Gasse, 56 A1235 Viena 
ES - Hispaania 1A PHARMA GMBH Eduard Kittenberger Gasse, 56 A1235 Viena
DE - Germany Winthrop Arzneimittel GmbH Urmitzer Str. 5 
DE - Saksamaa Winthrop Arzneimittel GmbH Urmitzer Str. 5
SE - Sweden CT Arzneimittel GmbH, Lengeder Strasse 42 a, DE13407 Berlin, Germany 
CT Arzneimittel GmbH, Lengeder Strasse 42 a, DE13407 Berlin, Germany
Sanofi-aventis Slovakia s.r.o. 
SK - Slovakkia Sanofi-aventis Slovakia s.r.o.
Ostac® 520, filmcaoted tablets 520 mg filmcoated tablets 
Ostac® 520, filmcaoted tablets 520 mg
LABORATORIO STADA, S.L. 
ES - Hispaania LABORATORIO STADA, S.L.
RO - Romania TORREX CHIESI PHARMA GmbH Gonzagagasse 
RO - Rumeenia TORREX CHIESI PHARMA GmbH Gonzagagasse
NL - Netherlands Hospira Benelux BVBA, Stallestraat 63 
NL - Holland Hospira Benelux BVBA, Stallestraat 63
DE - Germany CT Arzneimittel GmbH Lengeder Str. 42a 
DE - Saksamaa CT Arzneimittel GmbH Lengeder Str. 42a
B-dul Ion Mihalache, nr. 11 Sector 1, Cod 011171, Bucureşti, Romania 
Sector 1, Cod 011171, Sector 1, Cod 011171, Bucureşti, Romania
DE - Germany betapharm Arzneimittel GmbH 
DE - Saksamaa betapharm Arzneimittel GmbH
NL - Netherlands Procter & Gamble Pharmaceuticals Nederland B.V. 
Procter & Gamble Pharmaceuticals Nederland B.V.
DE - Germany ratiopharm GmbH Graf-Arco-STr. 3 
DE - Saksamaa ratiopharm GmbH Graf-Arco-STr. 3
DE - Germany Mylan dura GmbH Wittichstr. 
DE - Saksamaa Mylan dura GmbH Wittichstr.
DE - Germany Stadapharm GmbH Stadastr. 
DE - Saksamaa Stadapharm GmbH Stadastr.
DE - Germany Heumann Pharma GmbH & Co. Generica KG 
DE - Saksamaa Heumann Pharma GmbH & Co. Generica KG
SANOFI-AVENTIS ROMÂNIA S.R.L. 
RO - Rumeenia SANOFI-AVENTIS ROMÂNIA S.R.L.
NL - Netherlands Apothecon B.V. Nijverheidsweg 3, 3771 ME Barneveld 
Nijverheidsweg 3, 3771 ME Barneveld
RATIOPHARM (ALLEMAGNE) Graf Arco Strasse 3 
FR - Prantsusmaa RATIOPHARM (ALLEMAGNE) Graf Arco Strasse 3
DE - Germany AbZ-Pharma GmbH Dr.Georg-Spohn-Str. 7 
DE - Saksamaa AbZ-Pharma GmbH Dr.Georg-Spohn-Str. 7
2012 HK Haarlem 
2012 HK Haarlem Netherlands
HEXAL PHARMA GMBH Carlberger Gasse, 44 A1235 Viena 
ES - Hispaania HEXAL PHARMA GMBH Carlberger Gasse, 44 A1235 Viena
ACIDE TILUDRONIQUE SANOFI PHARMA 200 mg, comprimé tablet 
ACIDE TILUDRONIQUE SANOFI PHARMA 200 mg, comprimé
DK - Denmark Actavis Group PTC ehf., Postbox 425, 
Actavis Group PTC ehf., Postbox 425,
LABORATOIRE RPGRANBAXY PHARMACIE GENERIQUES 4, place Louis Armand 75012 Paris FRANCE 
4, place Louis Armand 75012 Paris
Sanofi-aventis AB Gustavslundsvägen 139, Box 141 42, 167 14 
RO - Rumeenia Sanofi-aventis AB Gustavslundsvägen 139, Box 141 42, 167 14
DE - Germany Cancernova GmbH onkologische Arzneimittel Lil-Dagover-Ring 7 
DE - Saksamaa Cancernova GmbH onkologische Arzneimittel Lil-Dagover-Ring 7
Clodron beta 800mg 1000 mg 
Clodron beta 800mg
SE - Sweden Ranbaxy (UK) Ltd 3rd floor, CP house 97-107, Uxbridge Road Ealing, London W5 5TL United Kngdom 
Ranbaxy (UK) Ltd 3rd floor, CP house 97-107, Uxbridge Road Ealing, London W5 5TL United Kngdom
Alendronat STADA 
Risedronat Stada
SE - Sweden Mylan AB Box 23033 
Mylan AB Box 23033
SE - Sweden Sanofi-aventis AB Box 14142 
SE - Rootsi sanofi-aventis AB Box 14142
DE - Germany TEVA Deutschland GmbH Wasastr. 
DE - Saksamaa TEVA Deutschland GmbH Wasastr.
HU - Hungary Medac GmbH Fehlandstrasse 3. 
Medac GmbH Fehlandstrasse 3.
Poligono Industrial Colon II. 
Colon II.
BE - Belgium Bayer SA.NV. 
Bayer SA.NV.
SKELID 200 mg comprimidos tablets 
SKELID 200 mg comprimidos
RATIOPHARM ESPAÑA, S.A .Avda. 
ES - Hispaania RATIOPHARM ESPAÑA, S.A .Avda.
Torrex Chiesi Slovenija d.o.o., Trdinova 4, SI-1000 Ljubljana, Slovenia 
SI - Sloveenia Torrex Chiesi Slovenija d.o.o., Trdinova 4, SI-1000
PL - Poland medac Gesellschaft fur klinische Specialpraparate mbH 
PL - Poola medac Gesellschaft fur klinische Specialpraparate mbH
Viale Luigi Bodio 37/b IT-20158 Milano 
Viale Luigi Bodio 37/b IT-20158 Milano Italy
Sanofi-aventis zrt. 
HU - Ungari sanofi-aventis zrt.
RATIOPHARM ESPAÑA, S.A.Avda. 
ES - Hispaania RATIOPHARM ESPAÑA, S.A.Avda.
Merck Sharp & Dohme B.V. Waarderweg 39 
Merck Sharp & Dohme BV Waarderweg 39
BEXAL FARMACEUTICA, S.A Centro Empresarial Osa Mayor. 
ES - Hispaania BEXAL FARMACEUTICA, S.A Centro Empresarial Osa
(Invented) Name Strength 
(Väjamõeldud) Nimetus
DE - Germany cell Pharm GmbH Theodor-Heuss-Str. 52 
DE - Saksamaa cell Pharm GmbH Theodor-Heuss-Str. 52
DE - Germany Juta Pharma GmbH Gutenbergstr. 
DE - Saksamaa Juta Pharma GmbH Gutenbergstr.
Generis Farmacêutica, S.A. Office Park da Beloura, Edificio 4 - Piso 1, Escrit. 
Office Park da Beloura, Edificio 4 - Piso 1, Escrit.
ACOST COMERCIAL GENERIC-PHARMA, S.L.Centro Empresarial Osa Mayor. 
S.L.Centro Empresarial Osa Mayor.
CLODRONATE DE SODIUM G GAM 800 mg, comprimé pelliculé tablet 
CLODRONATE DE SODIUM G GAM 800 mg, comprimé pelliculé
DE - Germany axios Pharma GmbH Hauptstr. 
DE - Saksamaa axios Pharma GmbH Hauptstr.
DE - Germany ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 
DE - Saksamaa ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19
MYLAN PHARMACEUTICALS, S.L. 
ES - Hispaania MYLAN PHARMACEUTICALS, S.L.
BONEFOS 800 mg, capsules capsules 
BONEFOS 800 mg, capsules kapsel
DE - Germany biomo pharma GmbH Josef-Diezgen-Str 3 
DE - Saksamaa biomo pharma GmbH Josef-Diezgen-Str 3
Osa Mayor, 4Aravaca 28023 (Madrid) 
4Aravaca 28023 (Madrid)
SE - Sweden STADA Arzneimittel AG Stadastrasse 2-18 
SK - Slovakkia STADA Arzneimittel AG Stadastrasse 2-18
DE - Germany Novartis Pharma GmbH Roonstr. 
DE - Saksamaa Novartis Pharma GmbH Roonstr.
DE - Germany mibe GmbH Arznzemittel Münchener Str. 15 
DE - Saksamaa mibe GmbH Arznzemittel Münchener Str. 15
Baix Llobregat, 3-5 08970 Sant Joan Despi 
Llobregat, 3-5 08970 Sant Joan Despi
DE - Germany Hospira Deutschland GmbH Rablstr. 
DE - Saksamaa Hospira Deutschland GmbH Rablstr.
CLASTOBAN 400 mg, gélule capsule 
CLASTOBAN 400 mg, gélule kapsel
NL - Netherlands acis Arzneimittel GmbH Lil-Dagover-Ring 7 
NL - Holland acis Arzneimittel GmbH Lil-Dagover-Ring 7