Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2011 to 31 August 2011 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC )
Date: 2011-10-28
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2011316EN.01001801.xml










28.10.2011   


EN


Official Journal of the European Union


C 316/18





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2011 to 31 August 2011

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC
 (1)
or Article 38 of Directive 2001/82/EC
 (2)
)

2011/C 316/02
—   Issuing, maintenance or modification of a national marketing authorization










Date of the decision


Name(s) of the medicinal product


Holder(s) of the marketing authorization


Member State concerned


Date of notification




24.8.2011


Clavudale


See Annex I


See Annex I


25.8.2011




20.7.2011


Kytril


See Annex II


See Annex II


22.7.2011




13.7.2011


Doxycycline 50 % WSP and associated names


See Annex III


See Annex III


14.7.2011




13.7.2011


Doxyfar 50 % and associated names


See Annex IV


See Annex IV


14.7.2011




13.7.2011


alendronic acid, clodronic acid, etidronic acid, ibandronic acid, neridronic acid, pamidronic acid, risedronic acid and tiludronic acid


See Annex V


See Annex V


15.7.2011




13.7.2011


Dianeal PD4 and Extraneal and associated names


See Annex VI


See Annex VI


15.7.2011




7.7.2011


Docetaxel Teva Generics and associated names


See Annex VII


See Annex VII


8.7.2011







—   Refusal of a national marketing authorization










Date of the decision


Name(s) of the medicinal product


Holder(s) of the marketing authorization


Member State concerned


Date of notification




5.8.2011


Combimox Lactating Cow Intramammary Suspension and associated names


See Annex VIII


See Annex VIII


9.8.2011




5.8.2011


Combisyn Lactating Cow Intramammary suspension


See Annex IX


See Annex IX


9.8.2011




5.8.2011


Nisamox Lactating Cow Intramammary Suspension


See Annex X


See Annex X


8.8.2011







—   Suspension of a national marketing authorization










Date of the decision


Name(s) of the medicinal product


Holder(s) of the marketing authorization


Member State concerned


Date of notification




5.8.2011


Combimox Lactating Cow Intramammary Suspension and associated names


See Annex VIII


See Annex VIII


9.8.2011




5.8.2011


Combisyn Lactating Cow Intramammary suspension


See Annex IX


See Annex IX


9.8.2011




5.8.2011


Nisamox Lactating Cow Intramammary Suspension


See Annex X


See Annex X


8.8.2011






(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.


ANNEX I

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, APPLICANT/MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES













Member State EU/EEA


Applicant/Marketing Authorisation Holder


Name


Pharmaceutical form


Strengths


Animal species


Frequency and route of administration


Recommended dose




Austria


Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom


Clavudale 50 mg tablet for cats and dogs


Tablet


Amoxicillin 40 mg
Clavulanic acid 10 mg


Cats and dogs


Oral administration, twice daily for 5-7 days


Standard dose rate of 10 mg amoxicillin/2,5 mg clavulanic acid/kg bodyweight




Belgium


Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom


Clavudale 50 mg tablet for cats and dogs


Tablet


Amoxicillin 40 mg
Clavulanic acid 10 mg


Cats and dogs


Oral administration, twice daily for 5-7 days


Standard dose rate of 10 mg amoxicillin/2,5 mg clavulanic acid/kg bodyweight




Czech Republic


Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom


Clavudale 50 mg tablet for cats and dogs


Tablet


Amoxicillin 40 mg
Clavulanic acid 10 mg


Cats and dogs


Oral administration, twice daily for 5-7 days


Standard dose rate of 10 mg amoxicillin/2,5 mg clavulanic acid/kg bodyweight




Denmark


Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom


Clavudale 40 mg/10 mg tablet for cats and dogs


Tablet


Amoxicillin 40 mg
Clavulanic acid 10 mg


Cats and dogs


Oral administration, twice daily for 5-7 days


Standard dose rate of 10 mg amoxicillin/2,5 mg clavulanic acid/kg bodyweight




Finland


Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom


Clavudale 40 mg/10 mg tablet for cats and dogs


Tablet


Amoxicillin 40 mg
Clavulanic acid 10 mg


Cats and dogs


Oral administration, twice daily for 5-7 days


Standard dose rate of 10 mg amoxicillin/2,5 mg clavulanic acid/kg bodyweight




France


Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom


Clavudale 50 mg tablet for cats and dogs


Tablet


Amoxicillin 40 mg
Clavulanic acid 10 mg


Cats and dogs


Oral administration, twice daily for 5-7 days


Standard dose rate of 10 mg amoxicillin/2,5 mg clavulanic acid/kg bodyweight




Germany


Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom


Clavudale 40 mg/10 mg tablet for cats and dogs


Tablet


Amoxicillin 40 mg
Clavulanic acid 10 mg


Cats and dogs


Oral administration, twice daily for 5-7 days


Standard dose rate of 10 mg amoxicillin/2,5 mg clavulanic acid/kg bodyweight




Greece


Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom


Clavudale 40 mg/10 mg tablet for cats and dogs


Tablet


Amoxicillin 40 mg
Clavulanic acid 10 mg


Cats and dogs


Oral administration, twice daily for 5-7 days


Standard dose rate of 10 mg amoxicillin/2,5 mg clavulanic acid/kg bodyweight




Hungary


Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom


Clavudale 50 mg tablet for cats and dogs


Tablet


Amoxicillin 40 mg
Clavulanic acid 10 mg


Cats and dogs


Oral administration, twice daily for 5-7 days


Standard dose rate of 10 mg amoxicillin/2,5 mg clavulanic acid/kg bodyweight




Iceland


Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom


Clavudale 40 mg/10 mg tablet for cats and dogs


Tablet


Amoxicillin 40 mg
Clavulanic acid 10 mg


Cats and dogs


Oral administration, twice daily for 5-7 days


Standard dose rate of 10 mg amoxicillin/2,5 mg clavulanic acid/kg bodyweight




Ireland


Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom


Clavudale 50 mg tablet for cats and dogs


Tablet


Amoxicillin 40 mg
Clavulanic acid 10 mg


Cats and dogs


Oral administration, twice daily for 5-7 days


Standard dose rate of 10 mg amoxicillin/2,5 mg clavulanic acid/kg bodyweight




Luxembourg


Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom


Clavudale 50 mg tablet for cats and dogs


Tablet


Amoxicillin 40 mg
Clavulanic acid 10 mg


Cats and dogs


Oral administration, twice daily for 5-7 days


Standard dose rate of 10 mg amoxicillin/2,5 mg clavulanic acid/kg bodyweight




The Netherlands


Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom


Clavudale 40 mg/10 mg tablet for cats and dogs


Tablet


Amoxicillin 40 mg
Clavulanic acid 10 mg


Cats and dogs


Oral administration, twice daily for 5-7 days


Standard dose rate of 10 mg amoxicillin/2,5 mg clavulanic acid/kg bodyweight




Norway


Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom


Clavudale 40 mg/10 mg tablet for cats and dogs


Tablet


Amoxicillin 40 mg
Clavulanic acid 10 mg


Cats and dogs


Oral administration, twice daily for 5-7 days


Standard dose rate of 10 mg amoxicillin/2,5 mg clavulanic acid/kg bodyweight




Poland


Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom


Clavudale 50 mg tablet for cats and dogs


Tablet


Amoxicillin 40 mg
Clavulanic acid 10 mg


Cats and dogs


Oral administration, twice daily for 5-7 days


Standard dose rate of 10 mg amoxicillin/2,5 mg clavulanic acid/kg bodyweight




Portugal


Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom


Clavudale 40 mg/10 mg tablet for cats and dogs


Tablet


Amoxicillin 40 mg
Clavulanic acid 10 mg


Cats and dogs


Oral administration, twice daily for 5-7 days


Standard dose rate of 10 mg amoxicillin/2,5 mg clavulanic acid/kg bodyweight




Slovak Republic


Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom


Clavudale 50 mg tablet for cats and dogs


Tablet


Amoxicillin 40 mg
Clavulanic acid 10 mg


Cats and dogs


Oral administration, twice daily for 5-7 days


Standard dose rate of 10 mg amoxicillin/2,5 mg clavulanic acid/kg bodyweight




Spain


Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom


Clavudale 40 mg/10 mg tablet for cats and dogs


Tablet


Amoxicillin 40 mg
Clavulanic acid 10 mg


Cats and dogs


Oral administration, twice daily for 5-7 days


Standard dose rate of 10 mg amoxicillin/2,5 mg clavulanic acid/kg bodyweight




Sweden


Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom


Clavudale 40 mg/10 mg tablet for cats and dogs


Tablet


Amoxicillin 40 mg
Clavulanic acid 10 mg


Cats and dogs


Oral administration, twice daily for 5-7 days


Standard dose rate of 10 mg amoxicillin/2,5 mg clavulanic acid/kg bodyweight




United Kingdom


Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom


Clavudale 50 mg tablet for cats and dogs


Tablet


Amoxicillin 40 mg
Clavulanic acid 10 mg


Cats and dogs


Oral administration, twice daily for 5-7 days


Standard dose rate of 10 mg amoxicillin/2,5 mg clavulanic acid/kg bodyweight







ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES












Member State EU/EEA


Marketing Authorisation Holder


(Invented) Name


Strength


Pharmaceutical form


Route of administration


Content concentration




Austria







Roche Austria GmbH, Engelhorngasse 3, 1211 Wien




Austria






Kytril 3 mg - Injektionslösung


3 mg/3 ml


Solution for injection


Intravenous use


3 ml




Austria







Roche Austria GmbH, Engelhorngasse 3, 1211 Wien




Austria






Kytril 2 mg - Filmtabletten


2 mg


Film-coated tablet


Oral use


 




Belgium







N.V. Roche S.A.




Rue Dante 75




1070 Bruxelles




Belgium






Kytril 1 mg/1 ml solution injectable


1 mg


Solution for injection


Intravenous use


1 mg/1 ml




Belgium







N.V. Roche S.A.




Rue Dante 75




1070 Bruxelles




Belgium






Kytril 3 mg/3 ml solution injectable


3 mg


Solution for injection


Intravenous use


3 mg/3 ml




Belgium







N.V. Roche S.A.




Rue Dante 75




1070 Bruxelles




Belgium






Kytril 1 mg comprimés pelliculés


1 mg


Film-coated tablet


Oral use


 




Bulgaria







Roche Bulgaria EOOD,




16 Bialo Pole Str.




1618 Sofia




Bulgaria






Kytril


1 mg/ml


Solution for injection/infusion


Intravenous use


1 ml (1 mg/ml)
3 ml (1 mg/ml)




Bulgaria







Roche Bulgaria EOOD,




16 Bialo Pole Str.




1618 Sofia




Bulgaria






Kytril


2 mg


Film-coated tablet


Oral use


 




Czech Republic







Roche s.r.o.,




Dukelských hrdinů 52




170 00 Praha 7




Czech Republic






Kytril 2 mg


2 mg


Film-coated tablet


Oral use


 




Czech Republic







Roche s.r.o.,




Dukelských hrdinů 52




170 00 Praha 7




Czech Republic






Kytril inj./inf


1 mg/ml


Solution for injection/infusion


Intravenous use


1 mg/1 ml




Estonia







Roche Eesti OÜ




Lõõtsa 2, 11415




Tallinn




Estonia






Kytril


1 mg/ml


Concentrate for solution for injection/infusion


Intravenous use


1 mg/ml (1 ml and 3 ml)




Estonia







Roche Eesti OÜ




Lõõtsa 2, 11415




Tallinn




Estonia






Kytril


1 mg


Film-coated tablet


Oral use


 




Finland







Roche Oy




PL 12




02181 Espoo




Finland






Kytril


1 mg


Film-coated tablet


Oral use


 




Finland







Roche Oy




PL 12




02181 Espoo




Finland






Kytril


2 mg


Film-coated tablet


Oral use


 




Finland







Roche Oy




PL 12




02181 Espoo




Finland






Kytril


1 mg/ml


Solution for injection


Intravenous use


5 × 1 ml and 5 × 3 ml




France







ROCHE




52 Boulevard du Parc




92521 NEUILLY SUR SEINE cedex




France






Kytril 3 mg/3 ml solution injectable pour voie intraveineuse


3 mg/3 ml


Solution for injection


Intravenous use


3 mg/3 ml




France







ROCHE




52 Boulevard du Parc




92521 NEUILLY SUR SEINE cedex




France






Kytril 1 mg/comprimé pelliculé


1 mg


Film-coated tablet


Oral use


 




France







ROCHE




52 Boulevard du Parc




92521 NEUILLY SUR SEINE cedex




France






Kytril 2 mg comprimé pelliculé


2 mg


Film-coated tablet


Oral use


 




Germany







Roche Pharma AG




Emil-Barell-Straße 1




79639 Grenzach-Wyhlen




Germany






Kevatril
1 mg/1 ml Injektionslösung


1 mg


Solution for injection


Intravenous use


1 ml




Germany







Roche Pharma AG




Emil-Barell-Straße 1




79639 Grenzach-Wyhlen




Germany






Kevatril
Filmtabletten 2 mg


2 mg


Film-coated tablet


Oral use


 




Germany







Roche Pharma AG




Emil-Barell-Straße 1




79639 Grenzach-Wyhlen




Germany






Kevatril
3 mg/3 ml Injektionslösung


3 mg


Solution for injection


Intravenous use


3 ml




Greece







Roche (Hellas )




A.E.




Alamanas 4 & Delfon, 15125 Maroussi




Greece






Kytril


1 mg


Film-coated tablet


Oral use


 




Greece







Roche (Hellas )




A.E.




Alamanas 4 & Delfon, 15125 Maroussi




Greece






Kytril


2 mg


Film-coated tablet


Oral use


 




Greece







Roche (Hellas )




A.E.




Alamanas 4 & Delfon, 15125 Maroussi




Greece






Kytril


1 mg/1 ml


Solution for injection


Intravenous use


1 mg/1 ml




Greece







Roche (Hellas )




A.E.




Alamanas 4 & Delfon, 15125 Maroussi




Greece






Kytril


3 mg/3 ml


Solution for injection


Intravenous use


3 mg/3 ml




Hungary







Roche (Hungary) Ltd




H-2040 Budaörs




Edison u. 1.




Hungary






Kytril


1 mg


Film-coated tablet


Oral use


 




Hungary







Roche (Hungary) Ltd




H-2040 Budaörs




Edison u. 1.




Hungary






Kytril


3 mg/3 ml


Solution for injection


Intravenous use


3 mg/3 ml




Ireland







Roche Products Limited,




6 Falcon Way, Shire Park




Welwyn Garden City




AL7 1TW, United Kingdom






Kytril Tablets 1 mg


1 mg


Film-coated tablet


Oral use


 




Ireland







Roche Products Limited,




6 Falcon Way, Shire Park




Welwyn Garden City




AL7 1TW, United Kingdom






Kytril Tablets 2 mg


2 mg


Film-coated tablet


Oral use


 




Ireland







Roche Products Limited,




6 Falcon Way, Shire Park




Welwyn Garden City




AL7 1TW, United Kingdom






Kytril Ampoules 1 mg/1 ml concentrate for solution for infusion or injection


1 mg/1 ml


Concentrate for solution for infusion/injection


Intravenous use


1 ml contains 1 mg granisetron (hydrochloride)
1 mg contains 9 mg sodium chloride = 3.54 mg sodium




Ireland







Roche Products Limited,




6 Falcon Way, Shire Park




Welwyn Garden City




AL7 1TW, United Kingdom






Kytril Infusion 3 mg/3 ml concentrate for solution for infusion or injection


3 mg/3 ml


Concentrate for solution for infusion/injection


Intravenous use


3 ml contains 3 mg granisetron (hydrochloride)
3 ml contains 27 mg sodium chloride = 10.62 mg sodium




Italy







Roche S.p.A.




Piazza Durante 11




20131 Milano




Italy






Kytril


3 mg/3 ml


Solution for injection


Intravenous use


3 mg/3 ml




Italy







Roche S.p.A.




Piazza Durante 11




20131 Milano




Italy






Kytril


1 mg/1 ml


Solution for injection


Intravenous use


1 mg/1 ml




Italy







Roche S.p.A.




Piazza Durante 11




20131 Milano




Italy






Kytril


3 mg/5 ml


Solution for injection


Intravenous use


3 mg/5 ml




Italy







Roche S.p.A.




Piazza Durante 11




20131 Milano




Italy






Kytril


1 mg


Film-coated tablet


Oral use


 




Italy







Roche S.p.A.




Piazza Durante 11




20131 Milano




Italy






Kytril


2 mg


Film-coated tablet


Oral use


 




Latvia







Roche Latvija SIA




G. Astras 8b




Riga, LV-1082




Latvia






Kytril 1 mg/ml solution for injection


1 mg/ml


Solution for injection


Intravenous use


1 mg/ml




Latvia







Roche Latvija SIA




G. Astras 8b




Riga, LV-1082




Latvia






Kytril 1 mg film-coated tablets


1 mg


Film-coated tablet


Oral use


 




Lithuania







UAB ‘Roche Lietuva’




J. Jasinskio 16b, LT-01112 Vilnius




Lithuania






Kytril


1 mg


Film-coated tablet


Oral use


 




Lithuania







UAB ‘Roche Lietuva’




J. Jasinskio 16b, LT-01112 Vilnius




Lithuania






Kytril


1 mg/ml


Solution for injection/infusion


Intravenous use


1 mg/1 ml




Lithuania







UAB ‘Roche Lietuva’




J. Jasinskio 16b, LT-01112 Vilnius




Lithuania






Kytril


3 mg/3 ml


Solution for injection/infusion


Intravenous use


3 mg/3 ml




Luxembourg







N.V. Roche S.A.




Rue Dante 75




1070 Bruxelles




Belgium






Kytril 1 mg/1 ml solution injectable


1 mg


Solution for injection


Intravenous use


1 mg/1 ml




Luxembourg







N.V. Roche S.A.




Rue Dante 75




1070 Bruxelles




Belgium






Kytril 3 mg/3 ml solution injectable


3 mg


Solution for injection


Intravenous use


3 mg/3 ml




Luxembourg







N.V. Roche S.A.




Rue Dante 75




1070 Bruxelles




Belgium






Kytril 1 mg comprimés pelliculés


1 mg


Film-coated tablet


Oral use


 




Malta







Roche Products Limited,




6 Falcon Way, Shire Park




Welwyn Garden City




AL7 1TW, United Kingdom






Kytril Tablets 1 mg


1 mg


Film-coated tablet


Oral use


 




Malta







Roche Products Limited,




6 Falcon Way, Shire Park




Welwyn Garden City




AL7 1TW, United Kingdom






Kytril Injection 3 mg/3 ml


3 mg/3 ml


Concentrate for solution for infusion/injection


Intravenous use


1 ml contains 1 mg granisetron (hydrochloride)




Netherlands







Roche Nederland B.V., Postbus 44, 3440 AA Woerden




Netherlands






Kytril i.v. 3 mg = 3 ml, oplossing voor injectie 1 mg/ml


1 mg/ml


Solution for injection


Intravenous use


1 mg/ml




Netherlands







Roche Nederland B.V., Postbus 44, 3440 AA Woerden




Netherlands






Kytril i.v. 1 mg = 1 ml, oplossing voor injectie 1 mg/ml


1 mg/ml


Solution for injection


Intravenous use


1 mg/ml




Netherlands







Roche Nederland B.V., Postbus 44, 3440 AA Woerden




Netherlands






Kytril 1 mg tabletten, omhulde tabletten


1 mg


Film-coated tablet


Oral use


 




Netherlands







Roche Nederland B.V., Postbus 44, 3440 AA Woerden




Netherlands






Kytril 2 mg tabletten, omhulde tabletten


2 mg


Film-coated tablet


Oral use


 




Portugal







Roche Farmacêutica Química, Lda




Estrada nacional 249-1, 2720-413, Amadora




Portugal






Kytril


1 mg


Film-coated tablet


Oral use


 




Portugal







Roche Farmacêutica Química, Lda




Estrada nacional 249-1, 2720-413, Amadora




Portugal






Kytril


2 mg


Film-coated tablet


Oral use


 




Portugal







Roche Farmacêutica Química, Lda




Estrada nacional 249-1, 2720-413, Amadora




Portugal






Kytril


1 mg/1 ml


Solution for injection


Intravenous use


1 ml (1 mg/1 ml)




Portugal







Roche Farmacêutica Química, Lda




Estrada nacional 249-1, 2720-413, Amadora




Portugal






Kytril


3 mg/3 ml


Solution for injection


Intravenous use


3 ml (3 mg/3 ml)




Romania







Roche Romania SRL




9-9A Dimitrie Pompei Street, Building 19, Entrance B, 3rd Floor, Sector (District) 2, Bucharest




Romania






Kytril 1 mg


1 mg


Film-coated tablet


Oral use


 




Romania







Roche Romania SRL




9-9A Dimitrie Pompei Street, Building 19, Entrance B, 3rd Floor, Sector (District) 2, Bucharest




Romania






Kytril


3 mg/3 ml


Solution for injection


Intravenous use


3 mg/3 ml (1 mg/ml)




Slovak Republic







Roche Slovensko s.r.o.




Cintorínska 3/A




Bratislava




Slovak Republic






Kytril 1 mg


1 mg


Film-coated tablet


Oral use


 




Slovak Republic







Roche Slovensko s.r.o.




Cintorínska 3/A




Bratislava




Slovak Republic






Kytril 2 mg


2 mg


Film-coated tablet


Oral use


 




Slovak Republic







F.Hoffmann-La Roche Ltd.




Basel, Switzerland






Kytril INJ/INF


1 mg/1 ml


Concentrate for solution for infusion/injection


Intravenous use


1 mg/1 ml




Slovenia







Roche farmacevtska družba d.o.o.




Vodovodna cesta 109




1000 Ljubljana




Slovenia






Kytril 2 mg filmsko obložene tablete


2 mg


Film-coated tablet


Oral use


 




Slovenia







Roche farmacevtska družba d.o.o.




Vodovodna cesta 109




1000 Ljubljana




Slovenia






Kytril 1 mg/1 ml raztopina za injiciranje


1 mg/1 ml


Solution for injection


Intravenous use


1 mg/ml




Slovenia







Roche farmacevtska družba d.o.o.




Vodovodna cesta 109




1000 Ljubljana




Slovenia






Kytril 3 mg/3 ml raztopina za injiciranje


3 mg/3 ml


Solution for injection


Intravenous use


1 mg/ml




Spain







Roche Farma S.A.




C/Eucalipto 33




28016 Madrid




Spain






Kytril 1 mg comprimidos recubiertos con película


1 mg


Film-coated tablet


Oral use


 




Spain







Roche Farma S.A.




C/Eucalipto 33




28016 Madrid




Spain






Kytril 1 mg/1 ml solución inyectable


1 mg/1 ml


Solution for injection


Intravenous use


1 mg/ml




Spain







Roche Farma S.A.




C/Eucalipto 33




28016 Madrid




Spain






Kytril 3 mg/3 ml solución inyectable


3 mg/3 ml


Solution for injection


Intravenous use


1 mg/ml




Sweden







Roche AB




Box 47327




100 74 Stockholm




Sweden






Kytril


1 mg


Film-coated tablet


Oral use


 




Sweden







Roche AB




Box 47327




100 74 Stockholm




Sweden






Kytril


2 mg


Film-coated tablet


Oral use


 




Sweden







Roche AB




Box 47327




100 74 Stockholm




Sweden






Kytril


1 mg/ml


Solution for injection


Intravenous use


5 × 1 ml
5 × 3 ml




United Kingdom







Roche Products Limited,




6 Falcon Way, Shire Park




Welwyn Garden City




AL7 1TW




United Kingdom






Kytril Tablets 1 mg


1 mg


Film-coated tablet


Oral use


 




United Kingdom







Roche Products Limited,




6 Falcon Way, Shire Park




Welwyn Garden City




AL7 1TW




United Kingdom






Kytril Tablets 2 mg


2 mg


Film-coated tablet


Oral use


 




United Kingdom







Roche Products Limited,




6 Falcon Way, Shire Park




Welwyn Garden City




AL7 1TW




United Kingdom






Kytril Ampoule 1 mg/1 ml


1 mg/1 ml


Concentrate for solution for infusion/injection


Intravenous use


1 ml contains 1 mg granisetron (hydrochloride




United Kingdom







Roche Products Limited,




6 Falcon Way, Shire Park




Welwyn Garden City




AL7 1TW




United Kingdom






Kytril Infusion 3 mg/ml


3 mg/3 ml


Concentrate for solution for infusion/injection


Intravenous use


1 mg of granisetron per 1 ml solution







ANNEX III

LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, APPLICANT/MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES











Member State EU/EEA


Applicant/Marketing Authorisation Holder


Name


INN & Strength


Pharmaceutical form


Animal species




Belgium







Dopharma Research BV




Zalmweg 24




4941 VX Raamsdonksveer




The Netherlands






Doxycycline 50 % Dopharma


Doxycycline hyclate
500 mg/g


Water Soluble Powder


Non-ruminating calves
Pigs
Non-laying poultry




Bulgaria







Dopharma B.V.




Zalmweg 24




4941 VX Raamsdonksveer




The Netherlands






Doxycycline 50 %
WSP


Doxycycline hyclate
500 mg/g


Water Soluble Powder


Calves, pigs, poultry




Denmark







Dopharma Research B.V.




Zalmweg 24




4941 VX Raamsdonksveer




The Netherlands






Doxylin Vet.


Doxycycline hyclate
500 mg/g


Water Soluble Powder


Pigs




Greece







Dopharma B.V.




Zalmweg 24




4941 VX Raamsdonksveer




The Netherlands






Doxycycline 50 % Dopharma


Doxycycline hyclate
500 mg/g


Water Soluble Powder


Chickens (broilers)
Calves
Pigs




Hungary







Dopharma B.V.




Zalmweg 24




4941 VX Raamsdonksveer




The Netherlands






Doxycycline 50 % WSP


Doxycycline hyclate
500 mg/g


Powder for oral solution


Calves, pigs, chicken




Lithuania







Dopharma B.V.




Zalmweg 24




4941 VX Raamsdonksveer




The Netherlands






Doxycycline 50 %


Doxycycline hyclate
500 mg/g


Powder for oral solution


Calves, pigs and poultry




The Netherlands







Dopharma Research B.V.




Zalmweg 24




4941 VX Raamsdonksveer




The Netherlands






Doxycycline 50 % WSP


Doxycycline hyclate
500 mg/g


Powder for administration in drinking water


Non-egg laying chickens




Poland







Dopharma B.V.




Zalmweg 24




4941 VX Raamsdonksveer




The Netherlands






Doxymed 50


Doxycycline hyclate
500 mg/g


Water Soluble Powder


Calves, chicken, pigs




Portugal







Dopharma Research B.V.




Zalmweg 24




4941 VX Raamsdonksveer




The Netherlands






Vetadoxi 50


Doxycycline hyclate
500 mg/g


Water Soluble Powder


Cattle (calves), swine, birds




Romania







Dopharma B.V.




Zalmweg 24




4941 VX Raamsdonksveer




The Netherlands






Doxycycline 50 % WSP


Doxycycline hyclate
500 mg/g


Water Soluble Powder


Poultry
(not for use in animals from which eggs are produced for human consumption)
Calves
Pig







ANNEX IV

LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, APPLICANT/MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES











Member State EU/EEA


Applicant/Marketing Authorisation Holder


Name


INN & Strength


Pharmaceutical form


Animal species




Austria







Eurovet Animal Health B.V.,




Handelsweg 25, 5531 AE Bladel,




The Netherlands






Soludox 500 mg/g Pulver zum Eingeben über das Trinkwasser für Hühner


Doxycycline hyclate
500 mg/g


Powder for use in drinking water


Chicken




Austria







Eurovet Animal Health B.V.,




Handelsweg 25,




5531 AE Bladel,




The Netherlands






Soludox 500 mg/g Pulver zum Eingeben über das Trinkwasser für Schweine


Doxycycline hyclate
500 mg/g


Powder for use in drinking water


Pigs




Belgium







Eurovet N.V.




Poorthoevestraat 4, 3




550 Heusen-Zolder




Belgium






Soludox 50 %


Doxycycline hyclate
500 mg/g


Water Soluble Powder for oral administration


Pigs
Chickens




Czech Republic







Eurovet Animal Health B.V.,




Handelsweg 25,




5531 AE Bladel,




The Netherlands






Soludox 500 mg/g prášek pro podání v pitné vodě pro prasata


Doxycycline hyclate
500 mg/g


Powder for use in drinking water


Pigs




Denmark







Eurovet Animal Health B.V.,




P.O. 179,




Handelsweg 25,




NL-5531 AE Bladel,




The Netherlands






Soludox Vet.


Doxycycline hyclate
500 mg/g


Water Soluble Powder


Pigs




Estonia







Eurovet Animal Health B.V.,




Handelsweg 25,




5531 AE Bladel,




The Netherlands






Soludox, 500 mg/g, suukaudse lahuse pulber sigadele


Doxycycline hyclate
500 mg/g


Powder for use in drinking water


Pigs




Estonia







Eurovet Animal Health B.V.,




Handelsweg 25,




5531 AE Bladel,




The Netherlands






Soludox, 500 mg/g, suukaudse lahuse pulber kanadele


Doxycycline hyclate
500 mg/g


Powder for use in drinking water


Chickens




Finland







Eurovet Animal Health B.V.,




Handelsweg 25,




5531 AE Bladel,




The Netherlands






Soludox 500 mg/g jauhe juomaveteen sekoitettavaksi sioille


Doxycycline hyclate
500 mg/g


Powder for use in drinking water


Pig




Finland







Eurovet Animal Health B.V.,




Handelsweg 25,




5531 AE Bladel,




The Netherlands






Soludox 500 mg/g jauhe juomaveteen sekoitettavaksi kanoille


Doxycycline hyclate
500 mg/g


Powder for use in drinking water


Chicken




France







Eurovet Animal Health B.V.,




Handelsweg 25,




5531 AE Bladel,




The Netherlands






Soludox 433 mg/g poudre pour administration dans l'eau de boisson pour poulets


Doxycycline (as hyclate)
433 mg/g


Powder for use in drinking water


Chicken




France







Eurovet Animal Health B.V.,




Handelsweg 25,




5531 AE Bladel,




The Netherlands






Soludox 433 mg/g poudre pour administration dans l'eau de boisson pour porcs.


Doxycycline (as hyclate)
433 mg/g


Powder for use in drinking water


Pigs




Germany







Eurovet Animal Health B.V.,




Handelsweg 25,




5531 AE Bladel,




The Netherlands






Soludox 500 mg/g Pulver zum Eingeben


Doxycycline hyclate
500 mg/g


Powder for use in drinking water


Chicken




Germany







Eurovet Animal Health B.V.,




Handelsweg 25,




5531 AE Bladel,




The Netherlands






Soludox 500 mg/g Pulver zum Eingeben über das Trinkwasser für Schweine


Doxycycline hyclate
500 mg/g


Powder for use in drinking water


Pigs




Greece







Eurovet Animal Health B.V.,




Handelsweg 25,




5531 AE Bladel,




The Netherlands






Soludox 500 mg/g κόνις για χρήση στο πόσιμο νερό για όρνιθες.


Doxycycline hyclate
500 mg/g


Powder for use in drinking water


Chicken




Hungary







Eurovet Animal Health B.V.,




P.O. 179,




Handelsweg 25,




NL-5531 AE Bladel,




The Netherlands






Soludox 50 % pulvis A.U.V.


Doxycycline hyclate
500 mg/g


Powder for oral solution


Chicken




Italy







Eurovet Animal Health B.V.,




Handelsweg 25,




5531 AE Bladel,




The Netherlands






Soludox 500 mg/g polvere per uso in acqua di bevanda per suini


Doxycycline hyclate
500 mg/g


Powder for use in drinking water


Pigs




Italy







Eurovet Animal Health B.V.,




Handelsweg 25,




5531 AE Bladel,




The Netherlands






Soludox 500 mg/g polvere per uso in acqua di bevanda per polli.


Doxycycline hyclate
500 mg/g


Powder for use in drinking water


Chicken




Latvia







Eurovet Animal Health B.V.,




Handelsweg 25,




5531 AE Bladel,




The Netherlands






Soludox 500 mg/g pulveris lietošanai ar dzeramo ūdeni cūkām


Doxycycline hyclate
500 mg/g


Powder for use in drinking water


Pigs




Latvia







Eurovet Animal Health B.V.,




Handelsweg 25,




5531 AE Bladel,




The Netherlands






Soludox 500 mg/g pulveris lietošanai ar dzeramo ūdeni vistām


Doxycycline hyclate
500 mg/g


Powder for use in drinking water


Chicken




Lithuania







Eurovet Animal Health B.V.




Handelsveg 25 - PO Box 179,




5530 AD Bladel




The Netherlands






SOLUDOX 500 mg/g, geriamieji milteliai,


Doxycycline hyclate
500 mg/g


Powder for oral solution


Pigs and chicken




The Netherlands







Eurovet Animal Health B.V.




Handelsveg 25 - PO Box 179,




5530 AD Bladel




The Netherlands






DOXY ORT 50 %
Poeder voor toediening aan het drinkwater van varkens en kippen


Doxycycline hyclate
500 mg/g


Powder for administration in the drinking water


Pigs and non-egg laying chickens.




The Netherlands







Eurovet Animal Health B.V.




Handelsveg 25 - PO Box 179,




5530 AD Bladel




The Netherlands






DOXYFAR 50 %
Poeder voor toediening aan het drinkwater van varkens en kippen


Doxycycline hyclate
500 mg/g


Powder for administration in the drinking water


Pigs and non-egg laying chickens.




The Netherlands







Eurovet Animal Health B.V.




Handelsveg 25 - PO Box 179




5530 AD Bladel




The Netherlands






SOLUDOX 50 %, poeder voor toediening via het drinkwater aan varkens en kippen


Doxycycline hyclate
500 mg/g


Powder for administration in the drinking water


Pigs and non-egg laying chickens.




The Netherlands







Eurovet Animal Health B.V.,




Handelsweg 25,




5531 AE Bladel,




The Netherlands






Soludox 500 mg per gram voor gebruik in drinkwater voor kippen


Doxycycline hyclate
500 mg/g


Powder for use in drinking water


Chicken




Poland







Eurovet Animal Health B.V.,




Handelsweg 25,




5531 AE Bladel,




The Netherlands






Soludox 50 %; 500 mg/g proszek do podawania w wodzie do picia dla swiń i kur


Doxycycline hyclate
500 mg/g


Powder for use in drinking water


pigs, chickens (non-egg laying)




Slovakia







Eurovet Animal Health B.V.,




Handelsweg 25,




5531 AE Bladel,




The Netherlands






Soludox 500 mg/g prášok pre užívanie s pitnou vodou pre ošípané


Doxycycline hyclate
500 mg/g


Powder for use in drinking water


Pigs




Spain







Eurovet Animal Health B.V.,




Handelsweg 25,




5531 AE Bladel,




The Netherlands






Soludox 500 mg/g polvo para administración en agua de bebida para porcino


Doxycycline hyclate
500 mg/g


Powder for use in drinking water


Pigs




Spain







Eurovet Animal Health B.V.,




Handelsweg 25,




5531 AE Bladel,




The Netherlands






Soludox 500 mg/g polvo para administración en agua de bebida para pollos.


Doxycycline hyclate
500 mg/g


Powder for use in drinking water


Chickens




UK







Eurovet Animal Health B.V.,




Handelsweg 25,




5531 AE Bladel,




The Netherlands






Soludox, 500 mg/g, Water Soluble Powder for Pigs


Doxycycline hyclate
500 mg/g


Water Soluble Powder


Pigs




UK







Eurovet Animal Health B.V.,




Handelsweg 25,




5531 AE Bladel,




The Netherlands






Soludox 500 mg/g powder for use in drinking water for chickens


Doxycycline hyclate
500 mg/g


Powder for use in drinking water


Chickens




UK







Eurovet Animal Health B.V.,




Handelsweg 25,




5531 AE Bladel,




The Netherlands






Soludox 500 mg/g powder for use in drinking water for pigs


Doxycycline hyclate
500 mg/g


Powder for use in drinking water


Pigs







ANNEX V

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES


Alendronic acid containing medicinal products with Marketing Authorisation in the European Union











Member State EU/EEA


Marketing authorisation holder


(Invented) Name


Strength


Pharmaceutical form


Route of administration




AT - Austria


AB-Consult Handels- und Betriebsberatungs GmbH, Eichenstraße 32, A-1120 Wien, Austria


Alemol 70 mg - einmal wöchentlich Tabletten


70 mg


tablet


Oral Use




AT - Austria


AB-Consult Handels- und Betriebsberatungs GmbH, Eichenstraße 32, A-1120 Wien, Austria


Alenat 70 mg - einmal wöchentlich Tabletten


70 mg


tablet


Oral Use




AT - Austria


Hexal Pharma GmbH, Stella-Klein-Löw-Weg 17, A-1020 Wien, Austria


Alendrohexal 70 mg - einmal wöchentlich Filmtabletten


70 mg


film-coated tablet


Oral Use




AT - Austria


Genericon Pharma GmbH, Hafnerstraße 211, A-8054 Graz, Austria


Alendronorm 70 mg - einmal wöchentlich Tabletten


70 mg


tablet


Oral Use




AT - Austria


Accord Healthcare Ltd, Sage House, 319 Pinner Road, North Harrow, Middlesex HA1 4HF, UK


Alendronsäure Accord 70 mg einmal wöchentlich Tabletten


70 mg


tablet


Oral Use




AT - Austria


Accord Healthcare Ltd, Sage House, 319 Pinner Road, North Harrow, Middlesex HA1 4HF, UK


Alendronsäure Accord 10 mg Tabletten


10 mg


tablet


Oral Use




AT - Austria


Actavis Group PTC ehf, Reykjavikurvegur 76-78, 220 Hafnarfjördur, Iceland


Alendronsäure Actavis 70 mg einmal wöchentlich Tabletten


70 mg


tablet


Oral Use




AT - Austria







Arcana Arzneimittel GmbH,




Hütteldorfer Straße 299,




A-1140 Wien,




Austria






Alendronsäure ‧Arcana‧ 70 mg - einmal wöchentlich - Tabletten


70 mg


tablet


Oral Use




AT - Austria


Bluefish Pharmaceuticals AB, Torsgatan 11, 111 23 Stockholm, Sweden


Alendronsäure Bluefish 70 mg einmal wöchentlich Tabletten


70 mg


tablet


Oral Use




AT - Austria


Interpharm Produktions GmbH, Effingergasse 21, A-1160 Wien, Austria


Alendronsäure ‧Interpharm‧ 70 mg einmal wöchentlich - Tabletten


70 mg


tablet


Oral Use




AT - Austria


Interpharm Produktions GmbH, Effingergasse 21, A-1160 Wien, Austria


Alendronsäure ‧Interpharm‧ 10 mg - Tabletten


10 mg


tablet


Oral Use




AT - Austria


1A Pharma GmbH, Stella-Klein-Löw-Weg 17, A-1020 Wien, Austria


Alendronsäure 1A Pharma 70 mg - einmal wöchentlich Filmtabletten


70 mg


film-coated tablet


Oral Use




AT - Austria







Ratiopharm Arzneimittel Vertriebs-GmbH




Albert-Schweitzer Gasse 3




A-1140 Wien




Austria






Alendronsäure ‧ratiopharm‧ 70 mg - einmal wöchentlich Tabletten


70 mg


tablet


Oral Use




AT - Austria


Sandoz GmbH, Biochemiestraße 10 A-6250 Kundl, Austria


Alendronsäure Sandoz 70 mg - einmal wöchentlich Filmtabletten


70 mg


film-coated tablet


Oral Use




AT - Austria







Stada Arzneimittel GmbH




Muthgasse 36




A-1190 Wien




Austria






Alendronstad 70 mg einmal wöchentlich Tabletten


70 mg


tablet


Oral Use




AT - Austria


Merck Sharp & Dohme GmbH, EURO PLAZA Gebäude G, 5.Stock, Am Euro Platz 2, A-1120 Wien, Austria


Fosamax einmal wöchentlich 70 mg Tabletten


70 mg


tablet


Oral Use




AT - Austria


Merck Sharp & Dohme GmbH, EURO PLAZA Gebäude G, 5.Stock, Am Euro Platz 2, A-1120 Wien, Austria


Fosamax 10 mg - Tabletten


10 mg


tablet


Oral Use




BE - Belgium







Arrow Generics Limited




2 Eastman Way, Stevenage,




Hertfordshire, SG1 4SZ, United Kingdom






Alendronate Arrow Generics


10 mg


Tablets


Oral Use




BE - Belgium







Arrow Generics Limited




2 Eastman Way, Stevenage,




Hertfordshire, SG1 4SZ, United Kingdom






Alendronate Arrow Generics


70 mg


Tablets


Oral Use




BE - Belgium







Eurogenerics N.V.




Heizel Esplanade b22




1020 Brussels




Belgium






Alendronate EG


10 mg


Tablets


Oral Use




BE - Belgium







Eurogenerics N.V.




Heizel Esplanade b22




1020 Brussels




Belgium






Alendronate EG


70 mg


Tablets


Oral Use




BE - Belgium







Mylan BVBA/SPRL




Terhulpsesteenweg 6A




1560 Hoeilaart




Belgium






Alendronate Mylan


10 mg


Tablets


Oral Use




BE - Belgium







Mylan BVBA/SPRL




Terhulpsesteenweg 6A




1560 Hoeilaart




Belgium






Alendronate Mylan


70 mg


Tablets


Oral Use




BE - Belgium







Teva Pharma Belgium N.V.




Laarstraat 16




2610 Wilrijk




Belgium






Alendronate teva


70 mg


Tablets


Oral Use




BE - Belgium







Merck Sharp & Dohme B.V.




Clos du Lynx, 5- 1200 Brussels, Belgium






Fosamax hebdomadaire


70 mg


Tablets


Oral Use




BE - Belgium







Merck Sharp & Dohme B.V.




Clos du Lynx, 5- 1200 Brussels, Belgium






Fosamax


10 mg


Tablets


Oral Use




BG - Bulgaria







Tchaikapharma




1172 Sofia




1 G. M. Dimitrov Blvd




Sofia




Bulgaria






Fosanate


70 mg


film-coated tablets


Oral Use




BG - Bulgaria


Betapharm Arzneimittel GmbH, Kobelweg 95, 86156 Augsburg, Germany


Instrel


70 mg


tablets


Oral Use




BG - Bulgaria







Smarjeska cesta 6, 8501 Novo mesto –




Slovenia






Lindron


10 mg


tablets


Oral Use




BG - Bulgaria







Teva Pharmaceuticals




N.V.Gogol 15




ЕООД




Sofia




Bulgaria






Tevanate


70 mg


tablets


Oral Use




BG - Bulgaria


Actavis Group PTC ehf, Iceland Reykjavikurvegur 76-78, IS-220, Hafnarfjordur


Alendronat Actavis


70 mg


tablets


Oral Use




BG - Bulgaria


Sandoz GmbH, 10 Biochemie strasse, A-6250 Kundl, Austria


Forosa


70 mg


film - coated tablets


Oral Use




BG - Bulgaria







Merck Sharp & Dohme Bulgaria




55, Nicola Vaptzarov blvd. EXPO 2000 1st floor-east wing, sections B1&B2




Sofia 1407 Bulgaria.






Fosamax OW


70 mg


tablets


Oral Use




CY - Cyprus


Merck Sharp & Dohme BV, Waarderweg 39, 2031 bn Haarlem, The Netherlands


Fosamax tablet 70 mg


70 mg


tablets


Oral Use




CY - Cyprus


Pharmanel Pharmaceuticals SA, 106 Marathons Avenue, Athens, Greece


Difonate tablet 70 mg


70 mg


tablets


Oral Use




CY - Cyprus


Farmanic-Chemipharma SA, 137 Filis Avenue, 13451 Kamatero, Attikis, Greece


Ledronin tablet 70 mg


70 mg


tablets


Oral Use




CY - Cyprus


Arrow Generics Limited, Unit 2 Eastman Way,Hertfordshire, SG1 4SZ, Stevenage, UK


Alendronic -Acid Arrow tablet 10 mg


10 mg


tablets


Oral Use




CY - Cyprus


Arrow Generics Limited, Unit 2 Eastman Way,Hertfordshire, SG1 4SZ, Stevenage, UK


Alendronic -Acid Arrow tablet 70 mg


70 mg


tablets


Oral Use




CY - Cyprus


Aurobindo Pharma (Malta) Limited, 46/2 South street, Valetta, Malta


Alendronic Acid Aurobindo tablet 70 mg


70 mg


tablets


Oral Use




CZ - Czech Republic


Orion Corporation, Orionintie 1A, FI-02200 Espoo, Finland


Aldrion 70 mg


70 mg


Tablet


Oral Use




CZ - Czech Republic







Generics Ltd., Mylan




Albany Gate, Darkes Lane,




Potters Bar




Hertfordshire




EN6 1AG




United Kingdom






Alendrogen 70 mg


70 mg


Tablet


Oral Use




CZ - Czech Republic







Actavis Group hf.




Reykavikurvegi 76-78




220 Hafnarfirdi




Iceland






Alendronat Actavis 70 mg


70 mg


Tablet


Oral Use




CZ - Czech Republic







Accord Healthcare Ltd




Sage House




Pinner Road




Harrow




Middlesex




HA1 4HF




United Kingdom






Alendronát Natrium Accord 10 mg


10 mg


Tablet


Oral Use




CZ - Czech Republic







Accord Healthcare Ltd




Sage House




Pinner Road




Harrow




Middlesex




HA1 4HF




United Kingdom






Alendronát Natrium Accord 70 mg


70 mg


Tablet


Oral Use




CZ - Czech Republic







Sandoz GmbH, Biochemiestraße 10




6250 Kundl, Austria






Alendronat Sandoz 70


70 mg


Tablet


Oral Use




CZ - Czech Republic







Ratiopharm GmbH, Graf-Arco-Straße 3




89079 Ulm, Germany






Alendronat-Ratiopharm 70 mg


70 mg


Tablet


Oral Use




CZ - Czech Republic







Teva Pharmaceuticals CR, s.r.o., Radlická 3185/1c




150 00 Praha 5




Cezch Republic






Alendronate_Teva 70 mg


70 mg


Tablet


Oral Use




CZ - Czech Republic







Arrow Generics Ltd




2 Eastman Way, Stevenage,




Hertfordshire, SG1 4SZ, United Kingdom






Alenwin 70


70 mg


Tablet


Oral Use




CZ - Czech Republic







Apotex Nederland BV




Bio Science Park




Archimedesweg 2




2333 CN Leiden, Netherlands






Apo-Alendronat 70 mg


70 mg


Tablet


Oral Use




CZ - Czech Republic







Merck Sharp & Dohme BV




Waarderweg 39, 2031 BN Haarlem, Netherlands






Fosamax 70 mg 1xtýdně


70 mg


Tablet


Oral Use




CZ - Czech Republic







Arrow Generics Ltd




2 Eastman Way, Stevenage,




Hertfordshire, SG1 4SZ, United Kingdom






Fosteofos 70


70 mg


Tablet


Oral Use




CZ - Czech Republic


Bentley Pharmaceuticals Ireland Ltd, 25/28 North Wall Quay, Dublin 1, Ireland


Gendron 70 mg


70 mg


Tablet


Oral Use




CZ - Czech Republic







Richter Gedeon Nyrt.




Gyömrői út 19-21.




H-1103 Budapest




Hungary






Siranin 70 mg potahované tablety


70 mg


Tablet


Oral Use




DE - Germany







TEVA Deutschland GmbH




Wasastr. 50




D-01445 Radebeul






Tevanate 10 mg Tabletten


10 mg


Tablet


Oral Use




DE - Germany







TEVA Deutschland GmbH




Wasastr. 50




D-01445 Radebeul






Tevanate 70 mg Tabletten


70 mg


Tablet


Oral Use




DE - Germany







TEVA Deutschland GmbH




Wasastr. 50




D-01445 Radebeul






Tevabone-4 70 mg Tabletten und 1 Mikrogramm Weichkapseln


70 mg
1 μ


Tablet and Capsule soft


Oral Use




DE - Germany







TEVA Deutschland GmbH




Wasastr. 50




D-01445 Radebeul






Tevabone-5 70 mg Tabletten und 1 Mikrogramm Weichkapseln


70 mg
1 μ


Tablet and Capsule soft


Oral Use




DE - Germany







TEVA Deutschland GmbH




Wasastr. 50




D-01445 Radebeul






Tevabone-3 70 mg Tabletten und 1 Mikrogramm Weichkapseln


70 mg
1 μ


Tablet and Capsule soft


Oral Use




DE - Germany







TEVA Deutschland GmbH




Wasastr. 50




D-01445 Radebeul






Tevabone-2 70 mg Tabletten und 1 Mikrogramm Weichkapseln


70 mg
1 μ


Tablet and Capsule soft


Oral Use




DE - Germany







TEVA Deutschland GmbH




Wasastr. 50




D-01445 Radebeul






Tevabone 70 mg Tabletten und 1 Mikrogramm Weichkapseln


70 mg
1 μ


Tablet and Capsule soft


Oral Use




DE - Germany







1 A Pharma GmbH




Keltenring 1 + 3




D-82041 Oberhaching






Alendronsäure - 1 A Pharma 70 mg Filmtabletten


70 mg


Film-coated tablet


Oral Use




DE - Germany







AbZ-Pharma GmbH




Dr.Georg-Spohn-Str. 7




D-89143 Blaubeuren






Alendronsäure AbZ 70 mg Tabletten


70 mg


Tablet


Oral Use




DE - Germany







Accord Healthcare Limited




Sage House, 319, Pinner Road




GB-HA1 4HF NORTH HARROW, MIDDLESEX






Alendronsäure Accord 70 mg Tabletten


70 mg


Tablet


Oral Use




DE - Germany







Accord Healthcare Limited




Sage House, 319, Pinner Road




GB-HA1 4HF NORTH HARROW, MIDDLESEX






Alendronsäure Accord 10 mg Tabletten


10 mg


Tablet


Oral Use




DE - Germany







acis Arzneimittel GmbH




Lil-Dagover-Ring 7




D-82031 Grünwald






Alendronat acis 70 mg Tabletten


70 mg


Tablet


Oral Use




DE - Germany







Actavis Group PTC ehf




Reykjavikurvegur 76 - 78




IS-220 Hafnarfjördur






Alendronsäure-Actavis 70 mg Tabletten


70 mg


Tablet


Oral Use




DE - Germany







ALIUD PHARMA GmbH




Gottlieb-Daimler-Str. 19




D-89150 Laichingen






Alendronsäure AL 70 mg Tabletten


70 mg


Tablet


Oral Use




DE - Germany







AWD.pharma GmbH & Co.KG




Wasastr. 50




D-01445 Radebeul






Alendronsäure AWD 70 mg Tabletten


70 mg


Tablet


Oral Use




DE - Germany







AWD.pharma GmbH & Co.KG




Wasastr. 50




D-01445 Radebeul






Alendronsäure AWD 10 mg Tabletten


10 mg


Tablet


Oral Use




DE - Germany







axcount Generika AG




Max-Planck-Str. 36b




D-61381 Friedrichsdorf






Alendronsäure axcount 70 mg


70 mg


Tablet


Oral Use




DE - Germany







Basics GmbH




Hemmelrather Weg 201




D-51377 Leverkusen






ALENDRONSÄURE BASICS einmal wöchentlich 70 mg Tabletten


70 mg


Tablet


Oral Use




DE - Germany







betapharm Arzneimittel GmbH




Kobelweg 95




D-86156 Augsburg






Alendron beta einmal wöchentlich 70 mg Tabletten


70 mg


Tablet


Oral Use




DE - Germany







betapharm Arzneimittel GmbH




Kobelweg 95




D-86156 Augsburg






Alendron 10 mg Tabletten


70 mg


Tablet


Oral Use




DE - Germany







biomo pharma GmbH




Josef-Diezgen-Str 3




D-53773 Hennef






Alendronsäure-biomo 70 mg Tabletten


70 mg


Tablet


Oral Use




DE - Germany







Bluefish Pharmaceuticals AB




Torsgatan 11




S-111 23 Stockholm






Alendronsäure Bluefish 70 mg Tabletten


70 mg


Tablet


Oral Use




DE - Germany







CT Arzneimittel GmbH




Lengeder Str. 42a




D-13407 Berlin






Alendronsäure-CT 70 mg Tabletten


70 mg


Tablet


Oral Use




DE - Germany







esparma GmbH




Seepark 7




D-39116 Magdeburg






Alendron esparma 70 mg einmal wöchentlich Tabletten


70 mg


Tablet


Oral Use




DE - Germany







Gedeon Richter Plc.




Gyömröi ut 19 - 21




H-1103 Budapest






Alendronate Richter 70 mg Filmtabletten


70 mg


Film-coated tablet


Oral Use




DE - Germany







Heumann Pharma GmbH & Co. Generica KG




Südwestpark 50




D-90449 Nürnberg






Alendronsäure Heumann 10 mg Tabletten


10 mg


Tablet


Oral Use




DE - Germany







Heumann Pharma GmbH & Co. Generica KG




Südwestpark 50




D-90449 Nürnberg






Alendronsäure Heumann 70 mg Tabletten


70 mg


Tablet


Oral Use




DE - Germany







HEXAL AG




Industriestr. 25




D-83607 Holzkirchen






Alendron-Hexal 10 mg Tabletten


10 mg


Tablet


Oral Use




DE - Germany







HEXAL AG




Industriestr. 25




D-83607 Holzkirchen






Alendron-Hexal 10 einmal wöchentlich 70 mg Tabletten


70 mg


Tablet


Oral Use




DE - Germany







Juta Pharma GmbH




Gutenbergstr. 13




D-24941 Flensburg






Alendro-Q 70 mg Tablette


70 mg


Tablet


Oral Use




DE - Germany







Juta Pharma GmbH




Gutenbergstr. 13




D-24941 Flensburg






Alendro-Q 10 mg Tabletten


10 mg


Tablet


Oral Use




DE - Germany







KSK-Pharma Vertriebs AG




Finkenstr. 1




D-76327 Pfinztal-Berghausen






Alendro-KSK 70 mg


70 mg


Tablet


Oral Use




DE - Germany







mibe GmbH Arznzemittel




Münchener Str. 15




D-06796 Brehna






Alendromed 70 mg


70 mg


Tablet


Oral Use




DE - Germany







MSD Sharp & Dohme GmbH




Lindenplatz 1




D-85540 Haar






FOSAMAX 10 mg Tabletten


10 mg


Tablet


Oral Use




DE - Germany







MSD Sharp & Dohme GmbH




Lindenplatz 1




D-85540 Haar






FOSAMAX einmal wöchentlich 70 mg Tabletten


70 mg


Tablet


Oral Use




DE - Germany







Mylan dura GmbH




Wittichstr. 6




D-64295 Darmstadt






Alendronsäure Mylan 70 mg Tabletten


70 mg


Tablet


Oral Use




DE - Germany







Mylan dura GmbH




Wittichstr. 6




D-64295 Darmstadt






Alendrosäure dura 70 mg Tabletten


70 mg


Tablet


Oral Use




DE - Germany







Mylan dura GmbH




Wittichstr. 6




D-64295 Darmstadt






Alendrossa 10 mg


10 mg


Tablet


Oral Use




DE - Germany







Orion Corporation




Orionintie 1




FIN-=2200 ESPOO






Alendronsäure Orion 70 mg Tabletten


70 mg


Tablet


Oral Use




DE - Germany







Ovamex Limited




118 larch crescent




GB-UB4 9EB HAYES, MIDDLESEX






Alendronsäure Ovamex 70 mg Tabletten


70 mg


Tablet


Oral Use




DE - Germany







Ovamex Limited




118 larch crescent




GB-UB4 9EB HAYES, MIDDLESEX






Alendronsäure Ovamex 10 mg Tabletten


10 mg


Tablet


Oral Use




DE - Germany







ratiopharm GmbH




Graf-Arco-STr. 3




D-89079 Ulm






Alendronsäure-ratiopharm 70 mg Tabletten


70 mg


Tablet


Oral Use




DE - Germany







Sandoz Pharmaceuticals GmbH




Raiffeisenstr. 11




D-83607 Holzkirchen






Alendron-Sandoz einmal wöchentlich 70 mg Tabletten


70 mg


Tablet


Oral Use




DE - Germany







Stadapharm GmbH




Stadastr. 2 - 18




D-61118 Bad Vilbel






Alendronsäure STADA 10 mg Tabletten


10 mg


Tablet


Oral Use




DE - Germany







Stadapharm GmbH




Stadastr. 2 - 18




D-61118 Bad Vilbel






Alendronsäure STADA 70 mg Tabletten


70 mg


Tablet


Oral Use




DE - Germany







Winthrop Arzneimittel GmbH




Urmitzer Str. 5




D-56218 Mülheim-Kärlich






Alendron Winthrop einmal wöchentlich 70 mg Tabletten


70 mg


Tablet


Oral Use




DE - Germany







Mylan dura GmbH




Wittichstr. 6




D-64295 Darmstadt






Alendrokit dura


91,36 mg
1 495,5 mg
4 mg


Tablet and film-coated tablet


Oral Use




DE - Germany







TECNIMEDE - Sociedade Técnico-Medicinal, S.A. (BS 2)




Rua da Tapada Grande, n2




P-2710-089 ABRUNHEIRA, SINTRA






Alendronsäure Tecnimede 70 mg Filmtabletten


70 mg


Film-coated tablet


Oral Use




DE - Germany







Volkspharma GmbH




August-Wessels-Str. 5




D-86154 Augsburg






Alendronsäure 70 mg Volkspharma Tabletten


70 mg


Tablet


Oral Use




DK - Denmark


1A Farma, Herstedøstervej 27-29, DK-2620 Albertslund, Denmark


Alendronat "1A Farma"


70 mg


Film-coated tablets


Oral Use




DK - Denmark


Actavis Group PTC ehf., Reykjavikurvegi 76-78, P.O. 425, IS-220 Hafnarfjördur, Iceland


Alendronat "Actavis"


70 mg


Tablets


Oral Use




DK - Denmark


Arrow Generics Limited, Unit 2, Eastman Way Stevenage, SG1 4SZ Hertfordshire, England


Alendronat "Arrow"


10 mg


Tablets


Oral Use




DK - Denmark


Arrow Generics Limited, Unit 2, Eastman Way Stevenage, SG1 4SZ Hertfordshire, England


Alendronat "Arrow"


70 mg


Tablets


Oral Use




DK - Denmark


BLUEFISH PHARMACEUTICALS AB, Torsgatan 11, 111 23 Stockholm, Sweden


Alendronat "Bluefish"


70 mg


Tablets


Oral Use




DK - Denmark


Mylan AB, P.O.box 23033, Ynglingagatan 14, SE-104 35 Stockholm; Sweden


Alendronat "Mylan"


10 mg


Tablets


Oral Use




DK - Denmark


Mylan AB, P.O.box 23033, Ynglingagatan 14, SE-104 35 Stockholm; Sweden


Alendronat "Mylan"


70 mg


Tablets


Oral Use




DK - Denmark


Orifarm Generics A/S, Energivej 15, DK-5260 Odense S., Denmark


Alendronat "Orifarm"


70 mg


Tablets


Oral Use




DK - Denmark


Orion Corporation Orion Pharma, Orionintie 1, FI-02200 Espoo, Finland


Alendronat "Orion"


70 mg


Tablets


Oral Use




DK - Denmark


Pharmachemie B.V., PO Box 552, Swensweg 5, NL-2031 GA Haarlem, Nederlands


Alendronat "PCH"


10 mg


Tablets


Oral Use




DK - Denmark


Ranbaxy (UK) Ltd., 20 Balderton Street, W1K 6TL London, UK


Alendronat "Ranbaxy"


70 mg


Tablets


Oral Use




DK - Denmark


Sandoz A/S, C.F. Tietgens Boulevard 40, DK-5220 Odense SØ, Denmark


Alendronat "Sandoz"


70 mg


Film-coated tablets


Oral Use




DK - Denmark


Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118 Bad Vilbel, Germany


Alendronat "Stada"


70 mg


Tablets


Oral Use




DK - Denmark


Teva Denmark A/S, Parallelvej 10-12, DK-2800 Kongens Lyngby, Denmark


Alendronat "Teva"


70 mg


Tablets


Oral Use




DK - Denmark


ratiopharm GmbH, Graf-Arco-Strasse 3, DE-89079 Ulm, Germany


Alendronat "ratiopharm"


70 mg


Tablets


Oral Use




DK - Denmark


Merck Sharp & Dohme B.V., PO Box 581, Waarderweg 39, NL-2031 BN Haarlem, Nederlands


Fasamax Ugetablet


70 mg


Tablets


Oral Use




DK - Denmark


Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118 Bad Vilbel, Germany


Alendronat "Stada"


10 mg


Tablets


Oral Use




DK - Denmark


Teva Denmark A/S, Parallelvej 10-12, DK-2800 Kongens Lyngby, Denmark


Alendronat "Teva"


10 mg


Tablets


Oral Use




EL - Greece







VIANEX S.A.




TATIOIOU STREET




Nea Erythrea 14671






FOSAMAX


10 MG/TAB


TABLET


Oral Use




EL - Greece







VIANEX S.A.




TATIOIOU STREET




Nea Erythrea 14671






FOSAMAX


5 MG/TAB


TABLET


Oral Use




EL - Greece







VIANEX S.A.




TATIOIOU STREET




Nea Erythrea 14671






FOSAMAX ONCE WEEKLY


70 MG/TAB


TABLET


Oral Use




EL - Greece







FARAN ABEE PRODUCTION AND COMMERCE OF MEDICINAL PRODUCTS




ACHAIAS AND TROIZINIAS, KIFISSIA 14564






OSASTON


70 MG/TAB


TABLET


Oral Use




EL - Greece







BIOMEDICA-CHEMICA S.A.




G. LYRA 25




KATW KIFISSIA






AMPINE


70 MG/TAB


TABLET


Oral Use




EL - Greece







KLEVA AFBEE




PARNITHOS AVENUE 189




ACHARNES ATTIKIS 13675






DARGOL


70 MG/TAB


TABLET


Oral Use




EL - Greece







MED-ONE AFBEE




AGIOU PETROU 30 & EPAMEINONDA




ACHARNES 13675






DEBENAL


70 MG/TAB


TABLET


Oral Use




EL - Greece







GENERICS PHARMA HELLAS ΕΠΕ




VOULIAGMENIS AVENUE 577A




16451 ARGYROUPOLI




P.O. BOX 72571






ALENDRONATE / GENERICS


70 MG/TAB


TABLET


Oral Use




EL - Greece







GENERICS PHARMA HELLAS ΕΠΕ




VOULIAGMENIS AVENUE 577A




16451 ARGYROUPOLI




P.O. BOX 72572






ALENDRONATE / GENERICS


10 MG/TAB


TABLET


Oral Use




EL - Greece







ALAPIS ABEE




AUTOKRATOROS NIKOLAOU 2




ATHENS 17671






MELDOZ


70 MG/TAB


TABLET


Oral Use




EL - Greece







VELKA HELLAS AEBE




KAPODISTRIOU AND KORINTHOU 12




NEO PSYCHIKO 15451






OSTAVEN


70 MG/TAB


TABLET


Oral Use




EL - Greece







ARROW GENERICS LIMITED, HERTS, UNITED KINGDOM




Unit 2, Eastman Way,




Stevenage,




Herts




United Kingdom






ALENDRONIC ACID/ARROW


10 MG/TAB


TABLET


Oral Use




EL - Greece







ARROW GENERICS LIMITED, HERTS, UNITED KINGDOM




Unit 2, Eastman Way,




Stevenage,




Herts




United Kingdom






ALENDRONIC ACID/ARROW


70 MG/TAB


TABLET


Oral Use




EL - Greece







PHARMANEL PHARMACEUTICALS S.A.




MARATHONOS 106,




GERAKAS 15344






OSTEONAT


70 MG/TAB


TABLET


Oral Use




EL - Greece







MEDARTE PHARMACEUTICALS ΑΒΕΕ




SPYROU VRETTOU 10




METAMORFOSI 14452






OSTALERT


70 MG/TAB


TABLET


Oral Use




EL - Greece







VOCATE PHARMACEUTICALS S.A.




GOUNARI 150,




GLYFADA 16674






FOSAZOM


70 MG/TAB


TABLET


Oral Use




EL - Greece







GENEPHARM S.A.




18km MARATHONOS AVENUE




PALLINI ATTIKIS 15351






FOSALEN


70 MG/TAB


TABLET


Oral Use




EL - Greece







SANTA PHARMA S.A.




ASKLIPIOU 4




KRYONERI ATTIKIS 14568






ALEFOS


70 MG/TAB


TABLET


Oral Use




EL - Greece







IASIS PHARMAC.HELLAS




137 FYLIS AVENUE




KAMATERO 13451






LEDRONIN


70 MG/TAB


TABLET


Oral Use




EL - Greece







PHARMANEL PHARMACEUTICALS S.A.




MARATHONOS 106,




GERAKAS 15344






DIFONATE


70 MG/TAB


TABLET


Oral Use




EL - Greece







ANFARM HELLAS S.A.




PERIKLEOUS 53-57




GERAKAS ATTIKIS 15344






RIDON


70 MG/TAB


TABLET


Oral Use




EL - Greece







AURORA PHARMACEUTICALS S.A.




EVROU 4 & MESSINIAS 2




GERAKAS 15344






AURODREN


70 MG/TAB


TABLET


Oral Use




EL - Greece







VIOFAR LTD




ETHNIKIS ANTISTASEWS & TRIZINIAS




ACHARNES 13671






DEPAREX


70 MG/TAB


TABLET


Oral Use




EL - Greece







BIOSPRAY ABEE




18KM MARATHONOS AVENUE




PALLINI 15344






ALENDRAL


70 MG/TAB


TABLET


Oral Use




EL - Greece







FARMATHEN HELLAS ABEE




MARATHONOS AVENUE 144




PALLINI 15351






POROCALM


70 MG/TAB


TABLET


Oral Use




EL - Greece







SANDOZ GMBH, KUNDL, AUSTRIA




Biochemiestrasse 10,




A-6250, Kundl




Tirol, Austria






FOROSA


70 MG/TAB


TABLET


Oral Use




EL - Greece







RAFARM AEBE




KORINTHOU 12




NEO PSYCHIKO 15451






MOSMASS


70 MG/TAB


TABLET


Oral Use




EL - Greece







ROTTAPHARM HELLAS S.A.




PRDUCTION AND COMMERCE OF PHARMACEUTICALS




ACHAIAS AND TRIZINIAS




NEA KIFISSIA 14564






LOZOSTUN


70 MG/TAB


TABLET


Oral Use




EL - Greece







DELEGANT HOLDINGS LTD, CYPRUS




AGIAS ELENIS 36




COMMERCIAL CENTRE GALAXY 401




NICOSIA 1061




CYPRUS






DELFOZA


70 MG/TAB


TABLET


Oral Use




EL - Greece







SPECIFAR ABEE




28TH OCTOBER 1




AGIA VARVARA 123 51






DROFAZ


70 MG/TAB


TABLET


Oral Use




EL - Greece







EVANGELOS KALOFOLIAS & CO IAPHARM




MENANDROU 54




ATHENS 10431






FOSANDRON


70 MG/TAB


TABLET


Oral Use




EL - Greece







TARGET PHARMA LTD




MENANDROU 54




ATHENS 10431






ARTHROPLUS


70 MG/TAB


TABLET


Oral Use




EL - Greece







VIVAX PHARMACEUTICALS LTD,




DERVENAKION 38




GERAKAS ATTIKIS 15344






EN-POR


70 MG/TAB


TABLET


Oral Use




EL - Greece







PHARMANEL PHARMACEUTICALS S.A.




MARATHONOS 106,




GERAKAS 15344






MORALEN


70 MG/TAB


TABLET


Oral Use




EL - Greece







FARMEX S.A.




KIFISSOU AVENUE 132




ATHENS 12131






ENIMON


70 MG/TAB


TABLET


Oral Use




EL - Greece







ALET PHARMACEUTICALS ABEE




AIDINIOU 26,




CHALANDRI 12461






ALEDROLET


70 MG/TAB


TABLET


Oral Use




EL - Greece







PHARMA LINE S.A.




TH. PETALA 41




NEA CHALKIDONA 14343






ZULGAR


70 MG/TAB


TABLET


Oral Use




EL - Greece







VERISFIELD (UK) LTD, U.K.




41 Chalton street,




London, NW1 1JD,




United Kingdom






ZEMAROS


70 MG/TAB


TABLET


Oral Use




EL - Greece







HELP ΑΒΕΕ




VALAORITOU 10




METAMORFOSI ATTIKIS 14452






OSTEOS


70 MG/TAB


TABLET


Oral Use




EL - Greece







FARMEDIA AE




ATHINAS 22 & APOLLONOS




GERAKAS ATTIKIS 15344






FARMEMAX


70 MG/TAB


TABLET


Oral Use




EL - Greece







FARMAZAK S.A.




NAOUSSIS 31




VOTANIKOS 10447






ZAKODRONATE


70 MG/TAB


TABLET


Oral Use




EL - Greece







TEVA PHARMA B.V., UTRECHT, THE NETHERLANDS




Computerweg 10,




3542 DR, Utrecht,




The Netherlands






TEVANATE


70 MG/TAB


TABLET


Oral Use




ES - Spain


MERCK SHARP AND DOHME DE ESPAÑA, S.A.Josefa Valcarcel, 38 28027 MADRID


FOSAMAX Semanal 70 mg comprimidos


70 mg


Film coated tablet


Oral Use




ES - Spain


MERCK SHARP AND DOHME DE ESPAÑA, S.A.Josefa Valcarcel, 38 28027 MADRID


FOSAMAX 10 mg Comprimidos


10 mg


tablets


Oral Use




ES - Spain


MYLAN PHARMACEUTICALS, S.L. Plom 2-4, 5o Planta 08038 Barcelona


ÁCIDO ALENDRÓNICO SEMANAL MYLAN 70 mg comprimidos


70 mg


tablets


Oral Use




ES - Spain


LABORATORIOS ALTER, S.A. Mateo Inurria, 30 28036 Madrid


ÁCIDO ALENDRÓNICO SEMANAL ALTER 70 mg comprimidos


70 mg


tablets


Oral Use




ES - Spain


MERCK S.L.María de Molina, 40 28006 Madrid


CALBION SEMANAL 70 mg comprimidos


70 mg


tablets


Oral Use




ES - Spain


LABORATORIOS ALTER, S.A. Mateo Inurria, 30 28036 Madrid


BIFOAL SEMANAL 70 mg comprimidos


70 mg


tablets


Oral Use




ES - Spain







LABORATORIO STADA, S.L. Frederic Mompou, 5 08960 Sant Just Desvern




Barcelona






ÁCIDO ALENDRÓNICO SEMANAL STADA 70 mg comprimidos


70 mg


tablets


Oral Use




ES - Spain


RATIOPHARM ESPAÑA, S.A. Avda. de Burgos, 16 D - 5a Planta 28036 Madrid


ACIDO ALENDRONICO SEMANAL RATIOPHARM 70 mg comprimidos


70 mg


tablets


Oral Use




ES - Spain







LABORATORIOS EDIGEN, S.A Chile 8, 2o Oficina 203.Edificio Euromadrid 28290 Las Matas




Madrid






ÁCIDO ALENDRÓNICO EDIGEN 10 mg comprimidos


70 mg


tablets


Oral Use




ES - Spain







LABORATORIOS EDIGEN, S.A Chile 8, 2o Oficina 203.Edificio Euromadrid 28290 Las Matas




Madrid






ÁCIDO ALENDRÓNICO EDIGEN 70 mg comprimidos


70 mg


tablets


Oral Use




ES - Spain


TEVA GENERICOS ESPAÑOLA, S.L. Guzmán el Bueno 133, Edificio Britania 4oIzq.28003 Madrid


ACIDO ALENDRONICO TEVA 70 mg comprimidos


70 mg


tablets


Oral Use




ES - Spain


MABO FARMA, S.A Carretera M-300 Km 30,500. 28802 Alcalá de Henares


ÁCIDO ALENDRÓNICO SEMANAL MABO 70 mg COMPRIMIDOS


70 mg


tablets


Oral Use




ES - Spain







CANTABRIA PHARMA, S.L.c/Ribera del Loira, 46 edificio 2 28042 Madrid




Spain






ALENDROCARE SEMANAL 70 mg comprimidos


70 mg


tablets


Oral Use




ES - Spain


SANDOZ FARMACEUTICA, S.A. Avda. Osa Mayor, 4Aravaca 28023 (Madrid)


ÁCIDO ALENDRÓNICO SEMANAL SANDOZ 70 mg comprimidos


70 mg


tablets


Oral Use




ES - Spain


LABORATORIOS NORMON, S.A. Ronda de Valdecarrizo, 6 28760 Tres Cantos


ACIDO ALENDRONICO SEMANAL NORMON 70 mg Comprimidos


70 mg


tablets


Oral Use




ES - Spain


TECNIMEDE ESPAÑA, INDUSTRIA FARMACEUTICA, S.A. Avda. Pio XII, 92, Edificio Ural A, Planta 16-4 28036 Madrid


ACIDO ALENDRONICO SEMANAL TECNIGEN 70 mg comprimidos


70 mg


tablets


Oral Use




ES - Spain







PHARMAGENUS, S.A. Avda. Camí Real, 51-57 08184 Palau-solita i Plegamans




Barcelona






ACIDO ALENDRONICO SEMANAL PHARMAGENUS 70 mg comprimidos


70 mg


tablets


Oral Use




ES - Spain


LABORATORIOS RANBAXY, S.L. Passeig de Gracia, 9 08007 Barcelona


ÁCIDO ALENDRÓNICO SEMANAL RANBAXY 70 mg comprimidos


70 mg


tablets


Oral Use




ES - Spain


TEVA PHARMA S.L.U. C/ Anabel Segura, 11, Edificio Albatros B, 1a planta 28108 Alcobendas


SEMANDROL SEMANAL 70 mg comprimidos


70 mg


tablets


Oral Use




ES - Spain


QUALIGEN, S.L.Avda. Barcelona, 69 08970 Sant Joan Despi


ACIDO ALENDRÓNICO SEMANAL QUALIGEN 70 mg comprimidos


70 mg


tablets


Oral Use




ES - Spain


LABORATORIOS DAVUR, S.L.Teide, 4-planta baja. Poligono Empresarial La Marina 28703 San Sebastian de los Reyes


ÁCIDO ALENDRÓNICO SEMANAL DAVUR 70 mg comprimidos


70 mg


tablets


Oral Use




ES - Spain


RIMAFAR, S.L.Pol. Ind. Malpica Calle C, No 4 50016 Zaragoza


ÁCIDO ALENDRÓNICO SEMANAL RIMAFAR 70 mg comprimidos


70 mg


tablets


Oral Use




ES - Spain


KERN PHARMA, S.L.Venus, 72. Poligono Industrial Colon II.08228 Tarrasa


ÁCIDO ALENDRÓNICO SEMANAL KERN PHARMA 70 mg Comprimidos


70 mg


tablets


Oral Use




ES - Spain


KORHISPANA S.L.Carretera de Castellvell, 24 43206 Reus


ACIDO ALENDRONICO SEMANAL KORHISPANA 70 mg comprimidos


70 mg


tablets


Oral Use




ES - Spain


GERVASI FARMACIA, S.L.Juan XXIII, 15-19 08950 Esplugues de Llobregat


LEFOSAN SEMANAL 70 mg comprimidos


70 mg


tablets


Oral Use




ES - Spain


LABORATORIOS ALACAN INDUSTRIAS QUIMICO FARMACEUTICAS, S.A.Sagitario, 14 03006 Alicante


ADELAN SEMANAL 70 mg Comprimidos


70 mg


tablets


Oral Use




ES - Spain


FARMALIDER, S.A.Aragoneses, 15 28108 Alcobendas


ACIDO ALENDRONICO SEMANAL FARMALIDER 70 mg comprimidos recubiertos con película


70 mg


Film coated tablets


Oral Use




ES - Spain


SINTEXLINE S.A.Polígono Industrial La Red, Calle 11 no 2 41500 Alcalá de Guadaira


ALENDROGYN 70 mg comprimidos recubiertos con película


70 mg


Film coated tablets


Oral Use




ES - Spain


FARMALIDER, S.A.Aragoneses, 15 28108 Alcobendas


ALENDROFARM 70 mg comprimidos recubiertos con pelicula


70 mg


Film coated tablets


Oral Use




ES - Spain


LABORATORIOS COMBIX, S.L.San Rafael, 3. Pol. Industrial Alcobendas 28108 Alcobendas


ACIDO ALENDRONICO SEMANAL COMBIX 70 mg comprimidos recubiertos con película


70 mg


Film coated tablets


Oral Use




ES - Spain


ALMUS FARMACEUTICA, S.A.Avda. Verge de Montserrat, 6 08820 El Prat de Llobregat


ACIDO ALENDRONICO SEMANAL ALMUS 70 mg comprimidos recubiertos con película


70 mg


Film coated tablets


Oral Use




ES - Spain


PENSA PHARMA, S.A.U Jorge Comín (médico pediatra), 3 - bajos 46015 Valencia


ÁCIDO ALENDRÓNICO SEMANAL PENSA 70 mg comprimidos


70 mg


tablets


Oral Use




ES - Spain


LABORATORIOS RANBAXY, S.L.Passeig de Gracia, 9 08007 Barcelona


ACIDO ALENDRONICO SEMANAL RANBAXYGEN 70 mg Comprimidos


70 mg


tablets


Oral Use




ES - Spain


LABORATORIOS RANBAXY, S.L.Passeig de Gracia, 9 08007 Barcelona


ÁCIDO ALENDRÓNICO SEMANAL CINFA 70 mg comprimidos


70 mg


tablets


Oral Use




ES - Spain


LAREQ PHARMA S.L Laguna, 66-68-70. Poligono Industrial Urtinsa II 28923 Alcorcón


ACIDO ALENDRONICO SEMANAL LAREQ 70 mg comprimidos


70 mg


tablets


Oral Use




ES - Spain


LABORATORIOS PEREZ GIMENEZ, S.A.Pol. Ind. Los Mochos. Polígono 8 - Parcela 20. Crta. A-431, Km 19 14720 Almodovar del Río


ÁCIDO ALENDRÓNICO SEMANAL CUVE 70 mg comprimidos


70 mg


tablets


Oral Use




ES - Spain


INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.Laguna, 66-68-70. Poligono Industrial Urtinsa II 28923 Alcorcón


ACIDO ALENDRONICO SEMANAL VIR 70 mg comprimidos


70 mg


tablets


Oral Use




ES - Spain


BEXAL FARMACEUTICA, S.A Centro Empresarial Osa Mayor. Avda. Osa Mayor, 4 - Area B Aravaca (Madrid)


ACIDO ALENDRONICO SEMANAL BEXAL 70 mg comprimidos recubiertos con película


70 mg


tablets


Oral Use




ES - Spain


ACOST COMERCIAL GENERIC-PHARMA, S.L.Centro Empresarial Osa Mayor. Osa Mayor, 4 Area B Aravaca (Madrid)


ACIDO ALENDRONICO SEMANAL ACOST 70 mg comprimidos recubiertos con película


70 mg


tablets


Oral Use




ES - Spain


INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.Laguna, 66-68-70. Poligono Industrial Urtinsa II 28923 Alcorcón


ALENVIR SEMANAL 70 mg comprimidos


70 mg


tablets


Oral Use




ES - Spain







Apotex Europe BV




Darwinweg 20




2333 CR Leiden Netherlands






ÁCIDO ALENDRÓNICO APOTEX 70 mg comprimidos


70 mg


tablets


Oral Use




ET - Estonia







Merck Sharp & Dohme OÜ Peterburi tee 46




11415 Tallinn ESTONIA






FOSAMAX 70 MG


70 mg


Tablet


Oral Use




ET - Estonia


Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow HA1 4HF, Middlesex UNITED KINGDOM


ALENDRONIC ACID ACCORD 70 MG


70 mg


Tablet


Oral Use




ET - Estonia


Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow HA1 4HF, Middlesex UNITED KINGDOM


ALENDRONIC ACID ACCORD 10 MG


10 mg


Tablet


Oral Use




ET - Estonia







Actavis Group PTC ehf Reykjavikurvegi 76-78




220 Hafnarfjördur ICELAND






LENDRATE


70 mg


Tablet


Oral Use




ET - Estonia







Gedeon Richter Plc. Gyömrõi ut 19-21




1103 Budapest HUNGARY






SEDRON


70 mg


Film-coated tablet


Oral Use




ET - Estonia







KRKA d.d., Novo Mesto Shmarjeshka cesta 6,




8501 Novo Mesto SLOVENIA






LINDRON


10 mg


Tablet


Oral Use




ET - Estonia


MEPHA Lda. Lagoas Park Edifico 5-A, Piso 2, 2740-298 Porto Salvo PORTUGAL


DENSIDRON


70 mg


Film-coated tablet


Oral Use




ET - Estonia







Orion Corporation Orionintie 1




FIN-02200 Espoo FINLAND






ALENDROONHAPE ORION


70 mg


Tablet


Oral Use




ET - Estonia


Ranbaxy (UK) Limited 20 Balderton Street, London W1K 6TL UNITED KINGDOM


RALENOST 70 MG


70 mg


Tablet


Oral Use




ET - Estonia







Teva Pharma B.V. Computerweg 10




3542 DR Utrecht THE NETHERLANDS






ALENOTOP


70 mg


Tablet


Oral Use




ET - Estonia







Teva Pharma B.V. Computerweg 10




3542 DR Utrecht THE NETHERLANDS






TEVANATE 70 MG


70 mg


Tablet


Oral Use




FI - Finland


Ranbaxy UK Ltd, 20 Balderton Street, LONDON W1K 6TL, United Kingdom


Alendronat Ranbaxy


70 mg


tablet


Oral Use




FI - Finland


Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220 HAFNARFJORDUR, Iceland


Alendronat Actavis


70 mg


tablet


Oral Use




FI - Finland


Arrow Generics Limited, Unit 2, Eastman Way Stevenage, HERTS SG14SZ, United Kingdom


Alendronat Arrow


10 mg


tablet


Oral Use




FI - Finland


Arrow Generics Limited, Unit 2, Eastman Way Stevenage, HERTS SG14SZ, United Kingdom


Alendronat Arrow


70 mg


tablet


Oral Use




FI - Finland


Bluefish Pharmaceuticals AB, Torsgatan 11, 11123 STOCKHOLM, Sweden


Alendronat Bluefish


70 mg


tablet


Oral Use




FI - Finland


Hexal A/S, Kanalholmen 8-12, 2650 HVIDOVRE, Denmark


Alendronat Hexal


70 mg


film-coated tablet


Oral Use




FI - Finland


Mylan AB, BOX 23033, 10435 STOCKHOLM, Sweden


Alendronat Mylan


70 mg


tablet


Oral Use




FI - Finland


Orifarm Generics A/S, Energivej 15, 5260 ODENSE S, Denmark


Alendronat Orifarm


70 mg


tablet


Oral Use




FI - Finland


Orion Corporation, Orion Pharma, Orionintie 1, 02200 Espoo, Finland


Alendronat Orion


70 mg


tablet


Oral Use




FI - Finland


ratiopharm GmbH, Graf-Arco-Strasse 3, 89079 Ulm, Germany


Alendronat ratiopharm


70 mg


film-coated tablet


Oral Use




FI - Finland


Sandoz A/S, C. F. Tietgens Boulevard 40, 5220 ODENSE SØ, Denmark


Alendronat Sandoz


70 mg


film-coated tablet


Oral Use




FI - Finland


Merck Sharp & Dohme B.V., Waarderweg 39, P.O.BOX 581, 2031 BN HAARLEM, Netherlands


Fosamax


10 mg


tablet


Oral Use




FI - Finland


Merck Sharp & Dohme B.V., Waarderweg 39, P.O.BOX 581, 2031 BN HAARLEM, Netherlands


Fosamax


70 mg


tablet


Oral Use




FR - France







ARROW GENERIQUES




26, avenue Tony Garnier




69007 Lyon




FRANCE






ACIDE ALENDRONIQUE ALMUS 10 mg, comprimé


10 mg


tablet


Oral Use




FR - France







ARROW GENERIQUES




26, avenue Tony Garnier




69007 Lyon




FRANCE






ACIDE ALENDRONIQUE ALMUS 70 mg, comprimé


70 mg


tablet


Oral Use




FR - France







ALTER




3, avenue de la Baltique




ZI de Courtaboeuf




91140 Villebon Sur Yvette




FRANCE






ACIDE ALENDRONIQUE ALTER 70 mg, comprimé pelliculé


70 mg


tablet


Oral Use




FR - France







ARROW GENERIQUES




26, avenue Tony Garnier




69007 Lyon




FRANCE






ACIDE ALENDRONIQUE ARROW 10 mg, comprimé


10 mg


tablet


Oral Use




FR - France







ARROW GENERIQUES




26, avenue Tony Garnier




69007 Lyon




FRANCE






ACIDE ALENDRONIQUE ARROW 70 mg, comprimé


70 mg


tablet


Oral Use




FR - France







BIOGARAN




15, boulevard Charles de Gaulle




92700 Colombes




FRANCE






ACIDE ALENDRONIQUE BIOGARAN 10 mg, comprimé


10 mg


tablet


Oral Use




FR - France







BIOGARAN




15, boulevard Charles de Gaulle




92700 Colombes




FRANCE






ACIDE ALENDRONIQUE BIOGARAN 70 mg, comprimé


70 mg


tablet


Oral Use




FR - France







EG LABO - LABORATOIRES EUROGENERICS




"Le Quintet" - bâtiment A




12, rue Danjou




92517 Boulogne Billancourt Cedex




FRANCE






ACIDE ALENDRONIQUE EG 10 mg, comprimé


10 mg


tablet


Oral Use




FR - France







EG LABO - LABORATOIRES EUROGENERICS




"Le Quintet" - bâtiment A




12, rue Danjou




92517 Boulogne Billancourt Cedex




FRANCE






ACIDE ALENDRONIQUE EG 70 mg, comprimé


70 mg


tablet


Oral Use




FR - France







MYLAN SAS




117, allée des Parcs




69800 Saint-Priest




FRANCE






ACIDE ALENDRONIQUE MYLAN, 70 mg, comprimé


70 mg


tablet


Oral Use




FR - France







TEVA SANTE




Le Palatin 1




1 cours du Triangle




92936 Paris la Défense Cedex




FRANCE






ACIDE ALENDRONIQUE PHR LAB 70 mg, comprimé


70 mg


tablet


Oral Use




FR - France







KROMME RIJN APOTHEEK




Langstraat 4C




3981 EV BUNNIK




PAYS-BAS






ACIDE ALENDRONIQUE QUALIHEALTH 70 mg, comprimé


70 mg


tablet


Oral Use




FR - France







QUALIMED (LYON)




117, allée des Parcs




69800 Saint-Priest




FRANCE






ACIDE ALENDRONIQUE QUALIMED 70 mg, comprimé


70 mg


tablet


Oral Use




FR - France







RATIOPHARM (ALLEMAGNE)




Graf Arco Strasse 3




89079 Ulm




ALLEMAGNE






ACIDE ALENDRONIQUE RATIOPHARM 70 mg, comprimé


70 mg


tablet


Oral Use




FR - France







SANDOZ




49, avenue Georges Pompidou




92300 Levallois-Perret




FRANCE






ACIDE ALENDRONIQUE SANDOZ 70 mg, comprimé


70 mg


tablet


Oral Use




FR - France







SANOFI AVENTIS FRANCE




1-13, boulevard Romain Rolland




75014 Paris




FRANCE






ACIDE ALENDRONIQUE WINTHROP 10 mg, comprimé


10 mg


tablet


Oral Use




FR - France







SANOFI AVENTIS FRANCE




1-13, boulevard Romain Rolland




75014 Paris




FRANCE






ACIDE ALENDRONIQUE WINTHROP 70 mg, comprimé


70 mg


tablet


Oral Use




FR - France







ZYDUS FRANCE




25, rue des Peupliers




ZAC Les Hautes Pâtures - Parc d'Activités des Peupliers




92000 Nanterre




FRANCE






ACIDE ALENDRONIQUE ZYDUS 70 mg, comprimé


70 mg


tablet


Oral Use




FR - France







PHARMEMMA




Unit 2, Ashbourne Manufacturing Park




Ashbourne County Meath




IRLANDE






ARONADE 70 mg, comprimé


70 mg


tablet


Oral Use




FR - France







THERAMEX




6, avenue Albert II




Zone F - Bloc B




98000 Monaco




MONACO






AURENA 70 mg, comprimé


70 mg


tablet


Oral Use




FR - France







PHARMEMMA




Unit 2, Ashbourne Manufacturing Park




Ashbourne County Meath




IRLANDE






DRONACID 70 mg, comprimé


70 mg


tablet


Oral Use




FR - France







MERCK SHARP & DOHME CHIBRET




3, avenue Hoche




75114 Paris Cedex 08




FRANCE






FOSAMAX 10 mg, comprimé


70 mg


tablet


Oral Use




FR - France







MERCK SHARP & DOHME CHIBRET




3, avenue Hoche




75114 Paris Cedex 08




FRANCE






FOSAMAX 70 mg, comprimé


70 mg


tablet


Oral Use




FR - France







MERCK SHARP & DOHME CHIBRET




3, avenue Hoche




75114 Paris Cedex 08




FRANCE






FOSATROL 70 mg, comprimé


70 mg


tablet


Oral Use




FR - France







RANBAXY PHARMACIE GENERIQUES




11-15 Quai Dion Bouton




92800 Puteaux




FRANCE






ACIDE ALENDRONIQUE BIOGALENIQUE 70 mg, comprimé


70 mg


tablet


Oral Use




FR - France







LABORATOIRE RPG - RANBAXY PHARMACIE GENERIQUES




4, place Louis Armand




75012 Paris




FRANCE






ACIDE ALENDRONIQUE RANBAXY 70 mg, comprimé


70 mg


tablet


Oral Use




FR - France







RANBAXY PHARMACIE GENERIQUES




11-15 Quai Dion Bouton




92800 Puteaux




FRANCE






ACIDE ALENDRONIQUE RPG 70 mg, comprimé


70 mg


tablet


Oral Use




FR - France







TEVA SANTE




Le Palatin 1




1 cours du Triangle




92936 Paris la Défense Cedex




FRANCE






ACIDE ALENDRONIQUE TEVA 70 mg, comprimé


70 mg


tablet


Oral Use




FR - France







TEVA SANTE




Le Palatin 1




1 cours du Triangle




92936 Paris la Défense Cedex




FRANCE






ALENDRONATE TEVA 10 mg, comprimé


10 mg


tablet


Oral Use




HU - Hungary







Generics (UK) Ltd.




Albany Gate, Darkes Lane, Potters bar




EN61AG Hertfordshire




UK






ALENDIS 70 mg tabletta


70,0 mg Alendronic acid
[in the form of 91,37 mg sodium alendronate]


tablet


Oral Use




HU - Hungary







Arrow Generics Ltd.




Stevenage




SG14SZ Hertfordshire




UK






ALENDROMAX 70 mg tabletta


70,0 mg Alendronic acid
[in the form of 91,36 mg sodium alendronate trihydrate]


tablet


Oral Use




HU - Hungary







Sandoz Hungária Kft.,




1114 Budapest, Bartók Béla út 43-47.




Hungary






ALENDRON HEXAL 70 mg tabletta


70,0 mg Alendronic acid
[in the form of 91,36 mg sodium alendronate trihydrate]


tablet


Oral Use




HU - Hungary







Bluefish Pharmaceuticals ABTorsgatan 11




111 23 Stockholm




Sweden






ALENDRONAT BLUEFISH 70 mg tabletta


70,0 mg Alendronic acid
[in the form of 91,37 mg sodium alendronate trihydrate]


tablet


Oral Use




HU - Hungary







Orion Corporation




Orionintie 1.




2200 Espoo




Finland






ALENDRONAT ORION 70 mg tabletta


70,0 mg Alendronic acid
[in the form of 91,36 mg sodium alendronate trihydrate]


tablet


Oral Use




HU - Hungary







Pliva Hungária Kft.




Galagonya u. 5.




1036 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 91,36 mg alendronate trihydrate]


tablet


Oral Use




HU - Hungary







Ratiopharm Hungária Kft.




Uzsoki u. 36/A




1145 Budapest




Hungary






ALENDRONAT-RATIOPHARM 70 mg tabletta


70,0 mg Alendronic acid
[in the form of 91,36 mg sodium alendronate trihydrate]


tablet


Oral Use




HU - Hungary







Richter Gedeon nyrt.




Gyömrői út 19-21.




1103 Budapest




Hungary






ALENDRONAT-RICHTER 70 mg filmtabletta


70,0 mg Alendronic acid
[in the form of 91,35 mg sodium alendronate trihydrate]


film coated tablet


Oral Use




HU - Hungary







Sandoz Hungária Kft.,




1114 Budapest, Bartók Béla út 43-47.




Hungary






ALENDRONAT-SANDOZ 70 mg filmtabletta


70,0 mg Alendronic acid
[in the form of 91,35 mg sodium alendronate]


film coated tablet


Oral Use




HU - Hungary







Apotex Europe B.V.




Darwinweg 20.




2333 CR Leiden




Holland






ALENDRONSAV APOTEX 70 mg tabletta


70,0 mg Alendronic acid
[in the form of 91,35 mg sodium alendronate trihydrate]


tablet


Oral Use




HU - Hungary







Richter Gedeon nyrt.




Gyömrői út 19-21.




1103 Budapest




Hungary






Calcisedron-D filmtabletta


70,0 mg Alendronic acid
[in the form of 91,35 mg sodium alendronate trihydrate]


film-coated tablet


Oral Use




HU - Hungary







Richter Gedeon nyrt.




Gyömrői út 19-21.




1103 Budapest




Hungary






Calcisedron-D Trio filmtabletta


70,0 mg Alendronic acid
[in the form of 91,35 mg sodium alendronate trihydrate]


film-coated tablet


Oral Use




HU - Hungary







Aramis Pharma Kft.




Mester u. 28. III/5.




1095 Budapest




Hungary






DRONAVIC 70 mg tabletta


70,0 mg Alendronic acid
[in the form of 91,37 mg sodium alendronate trihydrate]


tablet


Oral Use




HU - Hungary







Apotex Europe B.V.




Darwinweg 20.




2333 CR Leiden




Holland






EPOLAR 70 mg tabletta


70,0 mg Alendronic acid
[in the form of 91,35 mg sodium alendronate]


tablet


Oral Use




HU - Hungary







Apotex Europe B.V.




Darwinweg 20.




2333 CR Leiden




Holland






EPOLAR Trio 70 mg tabletta és rágótabletta


70,0 mg Alendronic acid
[in the form of 91,35 mg sodium alendronate]


tablet and chewing tablet


Oral Use




HU - Hungary







Actavis Group PTC ehf.




Reykjavikurvegur 76-78.




220 Hafnarfjordur




Iceland






FLADOR 70 mg tabletta


70,0 mg Alendronic acid
[in the form of 91,37 mg sodium alendronate trihydrate]


tablet


Oral Use




HU - Hungary







Medico Uno Pharma Kft.




Viadukt u. 12.




2051 Biatorbágy




Hungary






FORTIMAX tabletta


70,0 mg Alendronic acid
[in the form of 91,37 mg sodium alendronate trihydrate]


tablet


Oral Use




HU - Hungary







Merck Sharp & Dohme Magyarország Kft.




Alkotás u. 48-50.




1123 Budapest




Hungary






FOSAMAX 70 mg tabletta


70,0 mg Alendronic acid
[in the form of 91,37 mg sodium alendronate]


tablet


Oral Use




HU - Hungary







Richter Gedeon nyrt.




Gyömrői út 19-21.




1103 Budapest




Hungary






HANTRUX 70 mg filmtabletta


70,0 mg Alendronic acid
[in the form of 91,35 mg sodium alendronate trihydrate]


film coated tablet


Oral Use




HU - Hungary







Vera Pharma Kft.




Rákos köz 22.




1028 Budapest




Hungary






MASSIDRON 70 mg tabletta


70,0 mg Alendronic acid
[in the form of 81,2 mg mg sodium alendronate monohydrate]


tablet


Oral Use




HU - Hungary







Richter Gedeon nyrt.




Gyömrői út 19-21.




1103 Budapest




Hungary






MATEKIT 70 mg filmtabletta


70,0 mg Alendronic acid
[in the form of 91,35 mg sodium alendronate trihydrate]


film coated tablet


Oral Use




HU - Hungary







Richter Gedeon nyrt.




Gyömrői út 19-21.




1103 Budapest




Hungary






SEDRON 70 mg filmtabletta


70,0 mg Alendronic acid
[in the form of 91,35 mg sodium alendronate trihydrate]


film coated tablet


Oral Use




HU - Hungary







Teva Magyarország Zrt.




2100 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]


tablet


Oral Use




HU - Hungary







Teva Magyarország Zrt.




2100 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]


tablet and soft capsules


Oral Use




HU - Hungary







Richter Gedeon nyrt.




Gyömrői út 19-21.




1103 Budapest




Hungary






UTERITRIN 70 mg filmtabletta


70,0 mg Alendronic acid
[in the form of 91,35 mg sodium alendronate trihydrate]


film coated tablet


Oral Use




IE - Ireland







Merck Sharp & Dohme Limited




Hertford Road




Hoddesdon




Hertfordshire EN11 9BU




United Kingdom






Fosamax


10 mg


Tablet


Oral Use




IE - Ireland







Merck Sharp & Dohme Limited




Hertford Road




Hoddesdon




Hertfordshire EN11 9BU




United Kingdom






Fosamax


70 mg


Tablet


Oral Use




IE - Ireland







Clonmel Healthcare Limited




Waterford Road




Clonmel




Co. Tipperary




Ireland






Osteomel Once weekly


70 mg


Tablet


Oral Use




IE - Ireland







PLIVA Pharma Ltd.




Vision House




Bedford Road




Petersfield




Hants, GU32 3QB




United Kingdom






Fosalen Once Weekly 70 mg Tablets


70 mg


Tablet


Oral Use




IE - Ireland







Rowex Ltd




Bantry




Co. Cork






Romax Once Weekly 70 mg Tablets


70 mg


Tablet


Oral Use




IE - Ireland







Laboratorios Davur S.L.U.




C/Anabel Segura 11




Edificio Albatros B




1a planta




Alcobendas




28108 Madrid




Spain






Alendronic Acid Once Weekly 70 mg Tablets


70 mg


Tablet


Oral Use




IE - Ireland


McDermott Laboratories Ltd. t/a Gerard Laboratories 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13


Fostepor 10 mg Tablets


10 mg


tablets


Oral Use




IE - Ireland


McDermott Laboratories Ltd. t/a Gerard Laboratories 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13


Fostepor Once Weekly 70 mg Tablets


10 mg


tablets


Oral Use




IE - Ireland


PLIVA Pharma Ltd. Vision House, Bedford Road, Petersfield, Hants, GU32 3QB, United Kingdom


Fosalen 10 mg Tablets


10 mg


tablets


Oral Use




IE - Ireland


PLIVA Pharma Ltd. Vision House, Bedford Road, Petersfield, Hants, GU32 3QB, United Kingdom


Fosalen Once Weekly 70 mg Tablets


70 mg


tablets


Oral Use




IE - Ireland


Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, The Netherlands


Tevanate Once Weekly 70 mg Tablets


70 mg


Tablets


Oral Use




IE - Ireland


Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, The Netherlands


Fosalen Once Weekly 70 mg Tablets


70 mg


tablets


Oral Use




IE - Ireland


Bluefish Pharmaceuticals AB, Torsgatan 11, 111 23 Stockholm, Sweden.


Alendronic Acid Bluefish Once weekly 70 mg Tablets


70 mg


tablets


Oral Use




IE - Ireland







Actavis Group PTC ehf; Reykjavikurvegi 76-78,




220 Hafnarfjordur




Iceland






Fostolin Once Weekly 70 mg Tablets


70 mg


tablets


Oral Use




IS - Iceland


Arrow Generics Ltd., Unit 2 Eastman Way Stevenage, Hertz SG1 4SZ U.K


Alendroarrow


10 mg


Tablet


Oral Use




IS - Iceland


Arrow Generics Ltd., Unit 2 Eastman Way Stevenage, Hertz SG1 4SZ U.K


Alendroarrow week tablet


70 mg


Tablet


Oral Use




IS - Iceland


Actavis Group PTC ehf., Reykjavíkurvegi 76-78, 220 Hafnarfjordur, Iceland


Alendronat Actavis


70 mg


Tablet


Oral Use




IS - Iceland


Ranbaxy (UK) Limited, C.P. House 97-107 Uxbridge Road, Ealing Londo W5 5TL U.K


Alendronat Ranbaxy


70 mg


Tablet


Oral Use




IS - Iceland


Merck Sharp & Dohme B.V., Waaderveg 39, PC Haarlem, The Netherlands


Fosamax week tablet


70 mg


Tablet


Oral Use




IS - Iceland


Williams & Halls ehf, Hverfisgata 105 101 Reykjavík, Iceland


Ostacid


70 mg


film-coated tablet


Oral Use




IT - Italy







ABIOGEN PHARMA SpA




Via Meucci, 36 - 56014




Ospedaletto (PI)






ALENDROS


10 mg


tablets


Oral Use




IT - Italy







ABIOGEN PHARMA SpA




Via Meucci, 36 - 56014




Ospedaletto (PI)






ALENDROS


70 mg


tablets


Oral Use




IT - Italy







ACCORD HEALTHCARE LIMITED




Sage House,319




Pinner Road




North Harrow Middlesex






ALENDRONATO AHCL


10 mg


tablets


Oral use




IT - Italy







ACTAVIS GROUP PTC EHF




Reykjavikurvegi 76-78






ALENDRONATO ACTAVIS


70 mg


tablets


Oral use




IT - Italy







AGIPS FARMACEUTICI Srl




Via Amendola 4 - 16035




Rapallo (GE)






GLAMOR


70 mg


film coated tablets


Oral use




IT - Italy







ALMUS Srl




Via Cesarea, 11/10 - 16121




Genova






ALENDRONATO ALMUS


70 mg


film coated tablets


Oral use




IT - Italy







ARROW GENERICS LTD




Unit 2, Eastman way




Stevenage, Herts SG1 4SZ






ALENDRONATO ARROW


10 MG


tablets


Oral use




IT - Italy







ARROW GENERICS LTD




Unit 2, Eastman way




Stevenage, Herts SG1 4SZ






ALENDRONATO ARROW


70 mg


tablets


Oral use




IT - Italy







BENTLEY PHARMACEUTICALS IRELAND LTD




25-28 North Wall Uay




Dublin 1 – Ireland






ALENDRONATO BENTLEY PHARMACEUTICALS IRELAND


70 mg


tablets


Oral use




IT - Italy







BIOHEALTH PHARMACEUTICALS Srl




Via Bolognese, 250




Pistoia – Italy






ASTON


70 mg


film coated tablets


Oral use




IT - Italy







BIOMEDICA FOSCAMA INDUSTRIA CHIMICA FARMACEUTICA SpA




Via Morolense, 87 - 03013




Ferentino (FR)






ALOST


70 mg


tablets


Oral use




IT - Italy







LABORATORIO PRODOTTI FARMACEUTICI BONISCONTRO & GAZZONE Srl




Via Pavia, 6 - 20136




Milano – Italy






DORYX


70 mg


tablets


Oral use




IT - Italy







DOC GENERICI Srl




Via Manuzio, 7 - 20124




Milano






ALENDRONATO DOC GENERICI


70 mg


tablets


Oral use




IT - Italy







DOC GENERICI Srl




Via Manuzio, 7 - 20124




Milano






ALENDRONATO DOC


70 mg


tablets


Oral use




IT - Italy







DR REDDY'S Srl




Via Fernanada Wittgens, 6 - 20123




Milano






ALENDRONATO DR REDDY'S


70 mg


tablets


Oral use




IT - Italy







EG SpA




Via Pavia, 6 - 20136




Milano - Italy






ALENDRONATO EG


10 mg


tablets


Oral use




IT - Italy







EG SpA




Via Pavia, 6 - 20136




Milano - Italy






ALENDRONATO EG


70 mg


tablets


Oral use




IT - Italy







EPIFARMA Srl




Via San Rocco, 6 - 85033




Episcopia (PZ)






ALENIC


70 mg


tablets


Oral use




IT - Italy







EPIFARMA Srl




Via San Rocco, 6 - 85033




Episcopia (PZ)






ACIDO ALENDRONICO EPIFARMA


70 mg


tablets


Oral use




IT - Italy







FG Srl




Via San Rocco, 6 - 85033




Episcopia (PZ)






ACIDO ALENDRONICO FG


70 mg


tablets


Oral use




IT - Italy







FIDIA FARMACEUTICI SpA




Via Ponte D/Fabbrica, 3/A - 25031




Abano Terme (PD)






ACIDO ALENDRONICO FIDIA


70 mg


tablets


Oral use




IT - Italy







GERMED PHARMA SpA




Via Cesare Cantù, 11 - 20092




Cinisello Balsamo (MI)






ALENDRONATO GERMED


10 mg


tablets


Oral use




IT - Italy







GERMED PHARMA SpA




Via Cesare Cantù, 11 - 20092




Cinisello Balsamo (MI)






ALENDRONATO GERMED


70 mg


tablets


Oral use




IT - Italy







HEXAL SpA




Via Paracelso, 16 - 20041




Agrate Brianza (MI)






ALENDRONATO HEXAL


70 mg


tablets


Oral use




IT - Italy







ISTITUTO CHIMICO INTERNAZIONALE DR. GIUSEPPE RENDE Srl




Via Salaria, 1240 - 00138




Roma






REALEN


70 mg


tablets


Oral use




IT - Italy







ISTITUTO GENTILI SpA




Via San Giuseppe Cottolengo, 15 - 20143




Milano






GENALEN


10 mg


tablets


Oral use




IT - Italy







ISTITUTO GENTILI SpA




Via San Giuseppe Cottolengo, 15 - 20143




Milano






GENALEN


70 mg


tablets


Oral use




IT - Italy







LABORATORI ALTER Srl




Via Lomellina, 39 - 20124




Milano






ALENDRONATO ALTER


70 mg


tablets


Oral use




IT - Italy







MERCK SHARP & DOHME




Ltd




Hertford Road, Hoddesdon




Hertfordshire EN119BU






FOSAMAX


10 mg


tablets


Oral use




IT - Italy







MERCK SHARP & DOHME




Ltd




Hertford Road, Hoddesdon




Hertfordshire EN119BU






FOSAMAX


70 mg


tablets


Oral use




IT - Italy







MYLAN SpA




Via Vittor Pisani, 20 - 20124




Milano






ALENDRONATO MYLAN GENERICS


70 mg


tablets


Oral use




IT - Italy







NEOPHARMED Srl




Via San Giuseppe Cottolengo, 15 - 20143




Milano






ADRONAT


10 mg


tablets


Oral use




IT - Italy







NEOPHARMED Srl




Via San Giuseppe Cottolengo, 15 - 20143




Milano






ADRONAT


70 mg


tablets


Oral use




IT - Italy







PENSA PHARMA SpA




Via Rossellini Ippolito, 12




20124 – Milano






ALENDRONATO PENSA


70 mg


tablets


Oral use




IT - Italy







PHARMEG Srl




Via dei Giardini, 24 - 85033




Episcopia (PZ)






PORODRON


70 mg


tablets


Oral use




IT - Italy







RANBAXY ITALIA SpA




p.zza Filippo Meda, 3 - 20121 Milano






ALENDRONATO RANBAXY ITALIA


70 mg


tablets


Oral use




IT - Italy







RATIOPHARM GMBH




Graf Arco-strasse, 3




Ulm D-89070






ALENDRONATO RATIOPHARM


70 mg


tablets


Oral use




IT - Italy







S.F.GROUP Srl




Via Beniamino Segre, 59




00134 Roma Italy






NOFRATTIL


70 mg


film coated tablets


Oral use




IT - Italy







SANDOZ SpA




L.go U. Boccioni, 1 - 21040




Origgio (VA)






ALENDRONATO SANDOZ


70 mg


tablets


Oral use




IT - Italy







SEGIX ITALIA Srl




Via Del Mare, 36 - 00040




Pomezia (RM)






DRALENOS


10 mg


tablets


Oral use




IT - Italy







SEGIX ITALIA Srl




Via Del Mare, 36 - 00040




Pomezia (RM)






DRALENOS


70 mg


tablets


Oral use




IT - Italy







SIGMATAU GENERICS SpA




Via Pontina Km30, 400




00040 Pomezia (RM)






ACIDO ALENDRONICO SIGMA TAU GENERICS


70 mg


tablets


Oral use




IT - Italy







SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE SpA




Viale Shakespeare, 47




00144 Roma






DRONAL


10 mg


tablets


Oral use




IT - Italy







SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE SpA




Viale Shakespeare, 47




00144 Roma






DRONAL


70 mg


tablets


Oral use




IT - Italy







SO.SE.PHARM Srl




Via dei Castelli Romani, 22




00040 Pomezia (RM)






LOSS


70 mg


film coated tablets


Oral use




IT - Italy







TEVA ITALIA Srl




Via Messina, 38 - 20154




Milano – Italy






ALENDRONATO TEVA


70 mg


tablets


Oral use




IT - Italy







ACCORD HEALTHCARE LIMITED




Sage House,319




Pinner Road




North Harrow Middlesex






ALENDRONATO AHCL


70 mg


tablets


Oral use




LT - Lithuania


KRKA d.d., Šmarješka Cesta 6 8501 Novo mesto, Slovenia


Lindron


10 mg


Tablet


Oral use




LT - Lithuania


Sandoz d.d., Verovškova 57 SI-1000 Ljubljana Slovenia


Alendon


70 mg


Tablet


Oral use




LT - Lithuania


Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220 Hafnarfjordur, Iceland


Lendrate


70 mg


Tablet


Oral use




LT - Lithuania


Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom


Alendronic acid Accord


70 mg


Tablet


Oral use




LT - Lithuania


Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom


Alendronic acid Accord


10 mg


Tablet


Oral use




LT - Lithuania


Teva Pharma B.V., Computerweg 10 3542 DR Utrecht, The Netherlands


Alenotop


70 mg


Tablet


Oral use




LT - Lithuania


Teva Pharma B.V., Computerweg 10 3542 DR Utrecht, The Netherlands


Tevanate


70 mg


Tablet


Oral use




LT - Lithuania


Mepha Lda., Lagoas Park, Edificio 5-A, Piso 2, 2740-298 Porto Salvo, Portugal


Densidron


70 mg


Tablet


Oral use




LT - Lithuania


Ranbaxy UK Ltd., 20 Balderton Street London W1K 6TL, United Kingdom


Ralenost


70 mg


Tablet


Oral use




LT - Lithuania


Gedeon Richter Plc., 1103 Budapest Gyömrői út 19-21, Hungary


Sedron


70 mg


Film-coated tablet


Oral use




LT - Lithuania


Pharmaceutical Works POLPHARMA SA, 19 Pelplińska Street 83-200 Starogard Gdański, Poland


Ostemax


70 mg


Tablet


Oral use




LT - Lithuania


UAB „Merck Sharp & Dohme“, Kęstučio 59/27, LT-08124 Vilnius, Lithuania


Fosamax


70 mg


Tablet


Oral use




LT - Lithuania


Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland


Alendorion


70 mg


Tablet


Oral use




LU - Luxembourg







Merck Sharp & Dohme




5, Clos du Linx




B-1200 Bruxelles






Fosamax-70 Hebdomadaire


70 mg


tablets


Oral Use




LV - Latvia


Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, united Kingdom


Alendronate sodium Accord


10 mg


tablets


Oral use




LV - Latvia


Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, united Kingdom


Alendronate sodium Accord


70 mg


tablets


Oral use




LV - Latvia


Orion Corporation, Orionintie 1, FI-02200 Espoo Finland


Alendorion


70 mg


tablets


Oral use




LV - Latvia


Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, Netherlands


Alenotop


70 mg


tablets


Oral Use




LV - Latvia


Mepha Lda., Lagoas Park, 2740-298 Porto Salvo, Portugal


Densidron


70 mg


film-coated tablets


Oral Use




LV - Latvia


Gedeon Richter Plc., 1103 Budapest, Gyomroi ut 19-21, Hungary


Sedron


70 mg


film-coated tablets


Oral Use




LV - Latvia


Pharmaceutical Works Polpharma SA., 19 Pelplinska Str., 83-200 Starogard Gdanski, Poland


Ostemax


70 mg


tablets


Oral Use




LV - Latvia


Actavis Group PTC ehf., Reykjavikurvegi 76-78, 220 Hafnarfjordur, Iceland


Lendrate


70 mg


tablets


Oral Use




LV - Latvia


SIA "Merck Sharp & Dohme Latvija", Skanstes iela 13, Riga LV-1013, Latvia


Fosamax


70 mg


tablets


Oral Use




MT - Malta


Mepha - Investigação, Desenvolvimento e Fabricação Farmaceutica, Lda.


Densidron


70 mg


film-coated tablets


Oral Use




MT - Malta


Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, UK


Fosamax


70 mg


tablets


Oral Use




MT - Malta


Arrow Generics Limited, Unit 2, Eastman Way, Stevenage, Hertfordshire SG1 4SZ, United kingdom.


Alendronic Acid 10 mg tablets


10 mg


Tablet


Oral Use




MT - Malta


Arrow Generics Limited, Unit 2, Eastman Way, Stevenage, Hertfordshire SG1 4SZ, United kingdom.


Alendronic Acid 70 mg tablets


70 mg


Tablet


Oral Use




MT - Malta


Aurobindo Pharma (Malta) Ltd, 46/2 South Street, Valletta VLT11, Malta


Alendronic Acid 70 mg tablet


70 mg


Tablet


Oral Use




MT - Malta







Accord Healthcare Limited Sage House




319, Pinner Road




North Harrow




Middlesex HA1 4 HF




United Kingdom






Alendronate Sodium Accord 10 mg Tablets


10 mg


Tablets


Oral Use




MT - Malta







Accord Healthcare Limited Sage House




319, Pinner Road




North Harrow




Middlesex HA1 4 HF




United Kingdom






Alendronate Sodium Accord 70 mg Tablets


70 mg


Tablets


Oral Use




MT - Malta







Actavis Group PTC ehf; Reykjavikurvegi 76-78,




220 Hafnarfjordur




Iceland






Lendrate


70 mg


tablets


Oral Use




NL - Netherlands


acis Arzneimittel GmbH Lil-Dagover-Ring 7 82031 Grünwald, Germany


Osteonorm 70 mg


70 mg


Tablet


Oral Use




NL - Netherlands







ratiopharm Nederland bv




Florapark 4




2012 HK Haarlem Netherlands






Alendroninezuur ratiopharm 70 mg


70 mg


Tablet


Oral Use




NL - Netherlands


Sandoz B.V., Veluwezoom 22 1327 AH Almere Netherlands


Alendroninezuur Sandoz 70 mg


70 mg


Tablet


Oral Use




NL - Netherlands







Iono Limited




65 Delamere Road, Hayes




Middlesex UB4 ONN United Kingdom






Alendroninezuur Iono 70 mg


70 mg


Tablet


Oral Use




NL - Netherlands







Iono Limited




65 Delamere Road, Hayes




Middlesex UB4 ONN United Kingdom






Alendroninezuur Iono 10 mg


10 mg


Tablet


Oral Use




NL - Netherlands







Pharmachemie B.V.




Swensweg 5




2031 GA Haarlem Netherlands






Alendroninezuur 10 PCH


10 mg


Tablet


Oral Use




NL - Netherlands







Pharmachemie B.V.




Swensweg 5




2031 GA Haarlem Netherlands






Alendroninezuur 70 PCH


70 mg


Tablet


Oral Use




NL - Netherlands







Centrafarm Services B.V.




Nieuwe Donk 9




47879 AC Etten-Leur Netherlands






Alendroninezuur CF 70 mg


70 mg


Tablet


Oral Use




NL - Netherlands







Genericon Pharma Gesellschaft m.b.H.




Hafnerstraße 211




8054 Graz Austria






Alendronorm 70 mg


70 mg


Tablet


Oral Use




NL - Netherlands







Bentley Pharmaceuticals Limited,




25/28 North Wall Quay




Dublin 1




Ireland






Alendroninezuur Bentley 70 mg


70 mg


Tablet


Oral Use




NL - Netherlands







Biomedica Foscama Industria Chimico-Farmaceutica S.p.A.




Via Morolense, 87 – 03010 Ferentino






Dronatex 70 mg


70 mg


Tablet


Oral Use




NL - Netherlands


Arrow Generics Limited Unit 2, Eastman Way, Stevenage, Hertfordshire, SG1 4SZ United Kingdom


Alendroninezuur Arrow 70 mg


70 mg


Tablet


Oral Use




NL - Netherlands







Apotex Europe BV




Darwinweg 20




2333 CR Leiden Netherlands






Alendroninezuur Apotex 70 mg


70 mg


Tablet


Oral Use




NL - Netherlands







Ranbaxy Belgium NV




Leuvensestraat 28b




1800 Vilvoorde Belgium






Alendratol 10 mg


10 mg


Tablet


Oral Use




NL - Netherlands







Ranbaxy Belgium NV




Leuvensestraat 28b




1800 Vilvoorde Belgium






Alendratol 70 mg


70 mg


Tablet


Oral Use




NL - Netherlands







Ranbaxy Belgium NV




Leuvensestraat 28b




1800 Vilvoorde Belgium






Randronate 70 mg


70 mg


Tablet


Oral Use




NL - Netherlands


Sandoz B.V., Veluwezoom 22 1327 AH Almere Netherlands


Alendroninezuur Sandoz 10 mg


10 mg


Tablet


Oral Use




NL - Netherlands


Sandoz B.V., Veluwezoom 22 1327 AH Almere Netherlands


Alendroninezuur Sandoz 70 mg


70 mg


Tablet


Oral Use




NL - Netherlands







Mylan BV




Dieselweg 25




3752 LB Bunschoten Netherlands






Alendroninezuur Mylan 10 mg


10 mg


Tablet


Oral Use




NL - Netherlands







Mylan BV




Dieselweg 25




3752 LB Bunschoten Netherlands






Alendroninezuur Mylan 70 mg


70 mg


Tablet


Oral Use




NL - Netherlands







Apothecon B.V.




Nijverheidsweg 3, 3771 ME Barneveld Netherlands






Alendroninezuur 70A


70 mg


Tablet


Oral Use




NL - Netherlands







mibe GmbH Arzneimittel




Münchener Str. 15




06796 Brehna Germany






Ostadil 70 mg


70 mg


Tablet


Oral Use




NL - Netherlands







Actavis Group PTC ehf




Reykjavikurvegur 76-78,220 Hafnarfjordur






Alendroninezuur Actavis 70 mg


70 mg


Tablet


Oral Use




NL - Netherlands







Centrafarm Services B.V.




Nieuwe Donk 9




47879 AC Etten-Leur Netherlands






Alendroninezuur CF 10 mg


10 mg


Tablet


Oral Use




NL - Netherlands


Bluefish Pharmaceuticals AB, Torsgatan 11 111 23 Stockholm Sweden


Akendroninezuur Bluefish 70 mg


70 mg


Tablet


Oral Use




NL - Netherlands







WILL-PHARMA




Wilgenlaan 5




1161 JK Zwanenburg




Netherlands






Bonendro


70 mg / 1 000 mg / 880 IU


Tablet + granulate combination package


Oral Use




NL - Netherlands







Merck Sharp & Dohme BV




Waarderweg 39




2031 BN Haarlem Netherlands






Fosamax 10 mg


10 mg


Tablet


Oral Use




NL - Netherlands







Merck Sharp & Dohme BV




Waarderweg 39




2031 BN Haarlem Netherlands






Fosamax 70 mg


70 mg


Tablet


Oral Use




NL - Netherlands







WILL-PHARMA




Wilgenlaan 5




1161 JK Zwanenburg




Netherlands






Alendronax 70 mg


70 mg


Tablet


Oral Use




NL - Netherlands


Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex HA1 4HF United Kingdom


Alendroninezuur Accord 10 mg


10 mg


Tablet


Oral Use




NL - Netherlands


Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex HA1 4HF United Kingdom


Alendroninezuur Accord 70 mg


70 mg


Tablet


Oral Use




NL - Netherlands







Ranbaxy Belgium NV




Leuvensestraat 28b




1800 Vilvoorde Belgium






Alendroninezuur 70 Ranbaxy


70 mg


Tablet


Oral Use




NO - Norway


Arrow Generics Ltd, 2 Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, united Kingdom


Alendronat Arrrow


10 mg


Tablet


Oral Use




NO - Norway


Arrow Generics Ltd, 2 Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, united Kingdom


Alendronat Arrrow


70 mg


Tablet


Oral Use




NO - Norway


ratiopharm GmbH, Graf-Arco-Strasse 3, D-89070 Ulm Germany


Alendronate ratiopharm


70 mg


Tablet


Oral Use




NO - Norway


Merck Sharp and Dohme B.V., Postbus 581, Waarderweg 39, Haarlem, NL-2003 PC, Netherlands


Fosamax


10 mg


Tablet


Oral Use




NO - Norway


Merck Sharp and Dohme B.V., Postbus 581, Waarderweg 39, Haarlem, NL-2003 PC, Netherlands


Fosamax


70 mg


Tablet


Oral Use




NO - Norway


Bluefish Pharmaceuticals AB Torsgatan 11, SE-11123 Stockholm, Sweden


Alendronat Bluefish


70 mg


tablet


Oral Use




NO - Norway


Mylan AB, Box 23033, 10435 Stockholm, Sweden


Alendronat Mylan


70 mg


Tablet


Oral Use




NO - Norway


Mylan AB, Box 23033, 10435 Stockholm, Sweden


Alendronat Mylan


70 mg


Tablet


Oral Use




NO - Norway


Sandoz A/S, Edvard Thomsens Vej 14, DK-2300 København S, Danmark


Alendronat Sandoz


70 mg


Tablet


Oral Use




NO - Norway


Teva Sweden AB, Box 1070, 25110 Helsingborg, Sweden


Alendronat Teva


10 mg


Tablet


Oral Use




NO - Norway


Teva Sweden AB, Box 1070, 25110 Helsingborg, Sweden


Alendronat Teva


70 mg


Tablet


Oral Use




PL - Poland







Polfarmex S.A.




Józefów st. 9




99-300 Kutno, Poland






Akost


70 mg + 91,37 mg


tablets


Oral Use




PL - Poland







Sandoz GmbH




Biochemiestrasse 10, A-6250 Kundl, Austria






Aldron 70


70 mg


film coated tablets


Oral Use




PL - Poland







ICN Polfa Rezszów S.A.




Przemysłowa 2




35-959 Rzeszów, Poland






Alenato


10 mg


tablets


Oral Use




PL - Poland







Ranbaxy (Poland) Sp. z o.o.




Kubickiego st. 11,




02-954 Warsaw, Poland






Alendran 70


70 mg


tablets


Oral Use




PL - Poland







Orion Corporation




Orionintie 1A, FI-02200 Espoo, Finland






Alendrion


70 mg


tablets


Oral Use




PL - Poland







Generics [UK] Ltd.




Station Close, Potters Bar, Hertfordshire,




EN61TL, United Kingdom






Alendrogen


70 mg


tablets


Oral Use




PL - Poland







Sandoz GmbH




Biochemiestrasse 10, A-6250 Kundl, Austria






AlendroLek 70


70 mg


tablets


Oral Use




PL - Poland







Arrow Generics Ltd




2 Eastman Way, Stevenage,




Hertfordshire, SG1 4SZ, United Kingdom






Alendromax 10 mg tabletki


10 mg


tablets


Oral Use




PL - Poland







Arrow Generics Ltd




2 Eastman Way, Stevenage,




Hertfordshire, SG1 4SZ, United Kingdom






Alendromax 70 mg tabletki


70 mg


tablets


Oral Use




PL - Poland







Bluefish Pharmaceuticals AB




Torsgatan 11




SE-111 23 Stockholm




Sweden






Alendronat Bluefish


70 mg/ tabl.


tablets


Oral Use




PL - Poland







PHARMABILL




Jægersborg Alle 213 2 th




DK-2820 Gentofte




Denmark






Alendronat Pharmabill


70 mg


tablets


Oral Use




PL - Poland







ratiopharm GmbH




Graf-Arco-Strasse 3, Ulm, 89073, Germany






Alendronat-ratiopharm 70


70 mg


tablets


Oral Use




PL - Poland







Arrow Poland S.A.




Al. Jana Pawła II 23




00-854 Warsaw, Poalnd






Alendronate Arrow


10 mg


tablets


Oral Use




PL - Poland







Arrow Poland S.A.




Al. Jana Pawła II 23




00-854 Warsaw, Poalnd






Alendronate Arrow


70 mg


tablets


Oral Use




PL - Poland







Medana Pharma S.A.




10 Władysława Łokietka st., 98-200 Sieradz, Poland






Alendronate Medana


70 mg


tablets


Oral Use




PL - Poland







ACCORD HEALTHCARE LTD.




Reg. Off.: Suite No. 10 & 11 Sage House




319 Pinner Road,




North Harrow, Middlesex HA14HF, UK






Alendronate Sodium Accord


10 mg


tablets


Oral Use




PL - Poland







ACCORD HEALTHCARE LTD.




Reg. Off.: Suite No. 10 & 11 Sage House




319 Pinner Road,




North Harrow, Middlesex HA14HF, UK






Alendronate Sodium Accord


70 mg


tablets


Oral Use




PL - Poland







Teva Pharmaceuticals Polska Sp. z o.o.




53 Emilii Plater St.,




00-113, Warsaw, Poland






Alendronate Teva


70 mg


tablets


Oral Use




PL - Poland







Farmacom Sp. z o.o.




Mogilska 80 st.




31-546, Cracow, Poland






Alendronatum Farmacom


70 mg


tablets


Oral Use




PL - Poland







PLIVA Kraków Zakłady Farmaceutyczne S.A.




ul. Mogilska 80




31-546 Cracow, Poland






Alenotop


10 mg


tablets


Oral Use




PL - Poland







Mepha Lda.




Lagoas Park




Edificio 5-A, Piso 2




2740-298 Porto Salvo




Portugal






Densidron


70 mg


film coated tablets


Oral Use




PL - Poland







MSD Polska Sp. z o.o.




Chlodna st., 51




00-867, Warsaw, Poland






Fosamax 70


70 mg


tablets


Oral Use




PL - Poland







Phargem Sp. z o.o.




Foksal St. 18/210/02




00-372 Warsaw, Poland






Kwas alendronowy 70 mg Tabletka


70 mg


tablets


Oral Use




PL - Poland







Actavis Group PTC ehf.




Reykjavikurvegi 76-78




220 Hafnarfirdi, Iceland






Lendrate


70 mg


tablets


Oral Use




PL - Poland







Zakłady Farmaceutyczne




Polpharma SA




Pelplińska st. 19




83-200 Starogard Gdański, Poland






Ostemax 70 comfort


70 mg


tablets


Oral Use




PL - Poland







Teva Pharmaceuticals Polska Sp. z o.o.




53 Emilii Plater St.,




00-113, Warsaw, Poland






Ostenil


10 mg


tablets


Oral Use




PL - Poland







Teva Pharmaceuticals Polska Sp. z o.o.




53 Emilii Plater St.,




00-113, Warsaw, Poland






Ostenil 70


70 mg


tablets


Oral Use




PL - Poland







Apotex Europe Ltd.




Rowan House, 41 London Street, Reading




Berkshire, RG1 4PS, United Kingdom






Ostodronic


70 mg


tablets


Oral Use




PL - Poland







Przedsiębiorstwo Farmaceutyczne LEK-AM Sp. z o.o.




Al. Jana Pawła II 80




00-175 Warsaw, Poland






Ostolek


10 mg


film coated tablets


Oral Use




PL - Poland







Przedsiębiorstwo Farmaceutyczne LEK-AM Sp. z o.o.




Al. Jana Pawła II 80




00-175 Warsaw, Poland






Ostolek


70 mg


film coated tablets


Oral Use




PL - Poland







Biofarm Sp. z o.o.




Wałbrzyska 13, 60-198,




Poznan, Poalnd






Rekostin 70 mg


70 mg


tablets


Oral Use




PL - Poland







Grodziskie Zakłady Farmaceutyczne "Polfa" Sp. z o.o




Ks. J. Poniatowskiego st. 5




05-825 Grodzisk Mazowiecki, Poland






Sedron 70 mg tabletki powlekane


70 mg


film coated tablets


Oral Use




PT - Portugal


ISUS - Produtos Farmacêuticos e Cosméticos, S.A. Rua António Quadros, 9G - Escritório 3 1600-875 Lisboa Portugal


Ácido Alendrónico Lendral


70 mg


Tablet


Oral Use




PT - Portugal


Mylan, Lda. Rua Doutor António Loureiro Borges, Edíficio Arquiparque 1, R/C Esqo 1499-016 Algés, Portugal


Ácido Alendrónico Mylan


70 mg


Tablet


Oral Use




PT - Portugal


Mylan, Lda. Rua Doutor António Loureiro Borges, Edíficio Arquiparque 1, R/C Esqo 1499-016 Algés, Portugal


Ácido Alendrónico Mylan


10 mg


Tablet


Oral Use




PT - Portugal


Premium Pharma - Sociedade Técnico Medicinal, Lda. Rua da Tapada Grande, n.o 2, Abrunheira, São Pedro de Penaferrim 2714-530 Sintra, Portugal


Ácido Alendrónico Flamisul


70 mg


Film-coated Tablet


Oral Use




PT - Portugal


Teva Pharma - Produtos Farmacêuticos, Lda. Edifício Cyprium, Av. 25 de Abril, 15, 2o F 2795-195 Linda-a-Velha Portugal


Ácido Alendrónico Teva


70 mg


Tablet


Oral use




PT - Portugal


Actavis Group PTC ehf. Reykjavíkurvegi, 76-78 IS-220 Hafnarfjörour, Islândia


Ácido Alendrónico Actavis


70 mg


Tablet


Oral use




PT - Portugal


Actavis Group PTC ehf. Reykjavíkurvegi, 76-78 IS-220 Hafnarfjörour, Islândia


Caldronate


70 mg


Tablet


Oral use




PT - Portugal


Almus, Lda. Rua Engenheiro Ferreira Dias, 772 4149-014 Porto


Ácido Alendrónico Almus


70 mg


Film-coated Tablet


Oral use




PT - Portugal


Alter, S.A. Estrada Marco do Grilo - Zemouto 2830 Coina, Portugal


Ácido Alendrónico Alter


70 mg


Tablet


Oral use




PT - Portugal


Alter, S.A. Estrada Marco do Grilo - Zemouto 2830 Coina, Portugal


Ácido Alendrónico Alter


10 mg


Tablet


Oral use




PT - Portugal


Alter, S.A. Estrada Marco do Grilo - Zemouto 2830 Coina, Portugal


Ácido Alendrónico Bifosal 10 mg Comprimidos


10 mg


Tablet


Oral use




PT - Portugal


Alter, S.A. Estrada Marco do Grilo - Zemouto 2830 Coina, Portugal


Ácido Alendrónico Bifosal 70 mg Comprimidos


70 mg


Tablet


Oral use




PT - Portugal


APceuticals - Farmacêutica, Lda.


Ácido Alendrónico Apceuticals


70 mg


Film-coated Tablet


Oral use




PT - Portugal


Apotex Europe, B.V. Darwinweg 20 2333 CR Leiden Netherland


Ácido Alendrónico Apotex


70 mg


Tablet


Oral use




PT - Portugal


Arrowblue Produtos Farmacêuticos S.A. Av. D. João II, 10 Esqo - Torre Fernão de Magalhães 1998-025 Lisboa, Portugal


Ácido Alendrónico Arrowblue 10 mg Comprimidos


10 mg


Tablet


Oral use




PT - Portugal


Arrowblue Produtos Farmacêuticos S.A. Av. D. João II, 10 Esqo - Torre Fernão de Magalhães 1998-025 Lisboa, Portugal


Ácido Alendrónico Arrowblue 70 mg Comprimidos


70 mg


Tablet


Oral use




PT - Portugal


Arrowblue Produtos Farmacêuticos S.A. Av. D. João II, 10 Esqo - Torre Fernão de Magalhães 1998-025 Lisboa, Portugal


Ácido Alendrónico Winthrop 70 mg Comprimidos


70 mg


Tablet


Oral use




PT - Portugal


Atlantic Pharma - Produções Farmacêuticas, S.A. Zona Industrial da Abrunheira, Rua da Tapada Grande, 2 2710-089 Sintra Portugal


Ácido Alendrónico Blocan


70 mg


Film-coated Tablet


Oral use




PT - Portugal


Aurobindo Pharma (Portugal), Unipessoal Lda. Av. do Forte, no 3 - Parque Suécia, Edifício. IV, 2o 2794-038 Carnaxide, Portugal


Ácido Alendrónico Glob


70 mg


Tablet


Oral use




PT - Portugal


Aurobindo Pharma (Portugal), Unipessoal Lda. Av. do Forte, no 3 - Parque Suécia, Edifício. IV, 2o 2794-038 Carnaxide, Portugal


Ácido Alendrónico Glob


10 mg


Tablet


Oral use




PT - Portugal


Baldacci - Portugal, S.A. Rua Cândido de Figueiredo, 84-B 1549-005 Lisboa, Portugal


Ácido Alendrónico Nozat


70 mg


Film-coated Tablet


Oral use




PT - Portugal


Baldacci - Portugal, S.A. Rua Cândido de Figueiredo, 84-B 1549-005 Lisboa, Portugal


Ácido Alendrónico Baldacci


70 mg


Tablet


Oral use




PT - Portugal


Biara - Produtos Farmacêuticos, Lda. Av. José Malhoa - Edifício Malhoa Plaza no 2, piso-escritório 2.2 1070-325 Lisboa, Portugal


Ácido Alendrónico Prella


70 mg


Tablet


Oral use




PT - Portugal


Bluepharma - Indústria Farmacêutica, S.A. São Martinho do Bispo Apartado 7003 3045-016 Coimbra, Portugal


Ácido Alendrónico Bluepharma


70 mg


Tablet


Oral use




PT - Portugal


Ciclum Farma Unipessoal, Lda. Quinta da Fonte, Rua Vitor Câmara, 2 - Edifício D. Amélia, Piso 1, Ala B 2770-229 Paço de Arcos, Portugal


Ácido Alendrónico Ciclum 10 mg Comprimidos


10 mg


Tablet


Oral use




PT - Portugal


Ciclum Farma Unipessoal, Lda. Quinta da Fonte, Rua Vitor Câmara, 2 - Edifício D. Amélia, Piso 1, Ala B 2770-229 Paço de Arcos, Portugal


Ácido Alendrónico Ciclum 70 mg Comprimidos


70 mg


Tablet


Oral use




PT - Portugal


Cinfa Portugal, Lda. Av. Tomás Ribeiro, 43 - Bloco 1, 4o B - Edifício Neopark 2790-221 Carnaxide, Portugal


Ácido alendrónico Cinfa


70 mg


Tablet


Oral use




PT - Portugal


Daquimed - Comércio de Produtos Farmacêuticos, S.A. Av. Associação Comercial e Industrial de Gondomar, 330 - Zona Industrial da Portelinha 4510-688 Fânzeres, Portugal


Ácido Alendrónico Daquimed


70 mg


Tablet


Oral use




PT - Portugal


Dr. Reddy's Laboratories (UK) Ltd. 6 Riverview Road, Beverley HU17 OLD East Yorkshire, UK


Ácido Alendrónico Dr. Reddy's


70 mg


Tablet


Oral use




PT - Portugal


Faribérica - Produtos Farmacêuticos, S.A. Estrada de Luz, 90 - 9o D/E 1600-160 Lisboa, Portugal


Ácido Alendrónico Faribérica


70 mg


Tablet


Oral use




PT - Portugal


Farmoz - Sociedade Técnico Medicinal, S.A. Rua da Tapada Grande, 2, Abrunheira 2710-089 Sintra, Portugal


Ácido Alendrónico Rinicas


70 mg


Tablet


Oral use




PT - Portugal


Farmoz - Sociedade Técnico Medicinal, S.A. Rua da Tapada Grande, 2, Abrunheira 2710-089 Sintra, Portugal


Ácido Alendrónico Farmoz


70 mg


Film-coated Tablet


Oral use




PT - Portugal


Frosst Portuguesa - Produtos Farmacêuticos, Lda. Quinta da Fonte - Edifício Vasco da Gama, 19 - Porto Salvo Apartado 214 2780-730 Paço D' Arcos, Portugal


Ácido Alendrónico Frosst 70 mg


70 mg


Tablet


Oral use




PT - Portugal


Generis Farmacêutica, S.A. Office Park da Beloura, Edificio 4 - Piso 1, Escritório 8 2710-444 Sintra, Portugal


Ácido Alendrónico Generis 70 mg Comprimidos


70 mg


Tablet


Oral use




PT - Portugal


Germed Farmacêutica, Lda. Rua Alto do Montijo, 13 - 1o Dto - Edifício Monsanto 2790-012 Portela de Carnaxide, Portugal


Ácido Alendrónico Germed


70 mg


Tablet


Oral use




PT - Portugal


Germed Farmacêutica, Lda. Rua Alto do Montijo, 13 - 1o Dto - Edifício Monsanto 2790-012 Portela de Carnaxide, Portugal


Ácido Alendrónico Normon


70 mg


Tablet


Oral use




PT - Portugal


Helm Portugal, Lda. Estrada Nacional n.o 10, Km 140, 260 2695-066 Bobadela - Loures Portugal


Alehelm


70 mg


Tablet


Oral use




PT - Portugal


Helm Portugal, Lda. Estrada Nacional n.o 10, Km 140, 260 2695-066 Bobadela - Loures Portugal


Aleostito


70 mg


Tablet


Oral use




PT - Portugal


ITF Farma - Produtos Farmacêuticos, Lda. Rua Consiglieri Pedroso, 123 - Queluz de Baixo 2730-056 Barcarena, Portugal


Ácido Alendrónico ITF


70 mg


Tablet


Oral use




PT - Portugal


Jaba Recordati, S. A. Lagoas Park, Edificio 5, Torre C, Piso 3 2740-298 Porto Salvo, Portugal


Ácido Alendrónico Jaba 70 mg Comprimidos


70 mg


Tablet


Oral use




PT - Portugal


Labesfal - Laboratórios Almiro, S.A. Zona Industrial do Lagedo 3465-157 Santiago de Besteiros, Portugal


Ácido Alendrónico Labesfal


10 mg


Tablet


Oral use




PT - Portugal


Labesfal - Laboratórios Almiro, S.A. Zona Industrial do Lagedo 3465-157 Santiago de Besteiros, Portugal


Ácido Alendrónico Labesfal


70 mg


Tablet


Oral use




PT - Portugal


Laboratórios Anova - Produtos Farmacêuticos, Lda. Rua Doutor António Loureiro Borges, Edíficio Arquiparque 1, R/C Esqo 1499-016 Algés, Portugal


Ácido Alendrónico Anova


70 mg


Tablet


Oral use




PT - Portugal


Laboratórios Anova - Produtos Farmacêuticos, Lda. Rua Doutor António Loureiro Borges, Edíficio Arquiparque 1, R/C Esqo 1499-016 Algés, Portugal


Ácido Alendrónico Laquifa


70 mg


Tablet


Oral use




PT - Portugal


Laboratórios Azevedos - Indústria Farmacêutica, S.A. Estrada da Quinta, 148-148 A, Manique de Baixo 2645-436 Alcabideche, Portugal


Ácido Alendrónico Azevedos


70 mg


Tablet


Oral use




PT - Portugal


Laboratórios Basi - Indústria Farmacêutica, S.A. Rua do Padrão, 98 3000-312 Coimbra, Portugal


Ácido Alendrónico Basi


70 mg


Tablet


Oral use




PT - Portugal


Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. Lagoas Park, Edifício 5 A - Piso 2 2740-298 Porto Salvo, Portugal


Ácido Alendrónico Mepha 70 mg Comprimidos


70 mg


Tablet


Oral use




PT - Portugal


Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. Lagoas Park, Edifício 5 A - Piso 2 2740-298 Porto Salvo, Portugal


Ácido Alendrónico Stroban


70 mg


Tablet


Oral use




PT - Portugal


Mer Medicamentos, Lda. Office Park da Beloura, Edifício 4 - Piso 1 - Escritório 8, Quinta da Beloura 2710-444 Sintra, Portugal


Ácido Alendrónico Mer


70 mg


Tablet


Oral use




PT - Portugal


Merck Sharp & Dohme, Lda. Quinta da Fonte - Edifício Vasco da Gama, 19 - Porto Salvo Apartado 214 2770-192 Paço d' Arcos, Portugal


Fosamax


10 mg


Tablet


Oral use




PT - Portugal


Merck Sharp & Dohme, Lda. Quinta da Fonte - Edifício Vasco da Gama, 19 - Porto Salvo Apartado 214 2770-192 Paço d' Arcos, Portugal


Fosamax 70 mg


70 mg


Tablet


Oral use




PT - Portugal


Parke-Davis - Produtos Farmacêuticos, Lda. Lagoas Park, Edifício 10 2740-271 Porto Salvo, Portugal


Ácido Alendrónico Parke-Davis


70 mg


Tablet


Oral use




PT - Portugal


Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Edifício Atlas II, Av. José Gomes Ferreira, N.o 11 - 3o, Sala 31 1495-139 Miraflores - Algés, Portugal


Ácido Alendrónico Pharmakern


70 mg


Tablet


Oral use




PT - Portugal


Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Edifício Atlas II, Av. José Gomes Ferreira, N.o 11 - 3o, Sala 31 1495-139 Miraflores - Algés, Portugal


Ácido Alendrónico GIDE


70 mg


Tablet


Oral use




PT - Portugal


Ranbaxy Portugal - Comércio e Desenvol. de Produtos Farmacêuticos, Unip., Lda. Rua do Campo Alegre, 1306, 3o - Sala 301/302 - Edifício Botânico 4150-174 Porto, Portugal


Ácido Alendrónico Ranbaxy


70 mg


Tablet


Oral use




PT - Portugal


Ranbaxy Portugal - Comércio e Desenvol. de Produtos Farmacêuticos, Unip., Lda. Rua do Campo Alegre, 1306, 3o - Sala 301/302 - Edifício Botânico 4150-174 Porto, Portugal


Ácido Alendrónico Alendrol


70 mg


Tablet


Oral use




PT - Portugal


Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda. Rua Quinta do Pinheiro - Edifício Tejo - 6o Piso 2790-143 Carnaxide, Portugal


Ácido Alendrónico ratiopharm 70 mg Comprimidos


70 mg


Tablet


Oral use




PT - Portugal


Sandoz Farmacêutica, Lda. Alameda da Beloura, Edifício 1, 2o - Escritório 15 2710-693 Sintra Portugal


Ácido Alendrónico Sandoz 70 mg Comprimidos


70 mg


Tablet


Oral use




PT - Portugal


Sandoz Farmacêutica, Lda. Alameda da Beloura, Edifício 1, 2o - Escritório 15 2710-693 Sintra Portugal


Ácido Alendrónico 1Apharma


70 mg


Tablet


Oral use




PT - Portugal


Sociedade J. Neves, Lda. Parque Industrial do Seixal 2840-068 Paio Pires, Portugal


Ácido Alendrónico J. Neves 70 mg Comprimidos


70 mg


Tablet


Oral use




PT - Portugal


Tecnifar - Indústria Técnica Farmacêutica, S.A. Rua Tierno Galvan - Amoreiras - Torre 3 - 12o 1099-036 Lisboa, Portugal


Adronat


10 mg


Tablet


Oral use




PT - Portugal


Tecnifar - Indústria Técnica Farmacêutica, S.A. Rua Tierno Galvan - Amoreiras - Torre 3 - 12o 1099-036 Lisboa, Portugal


Adronat 70 mg


70 mg


Tablet


Oral use




PT - Portugal


Tecnimede - Sociedade Técnico-Medicinal, S.A. Rua da Tapada Grande, 2 - Abrunheira 2710-089 Sintra Portugal


Ácido Alendrónico Ecosis 70 mg Comprimidos


70 mg


Film-coated Tablet


Oral use




PT - Portugal


Tetrafarma - Produtos Farmacêuticos, Lda. Rua Helena Aragão, 20 R/C Frente - Massamá 2745-879 Queluz, Portugal


Ácido Alendrónico Tetrafarma


70 mg


Film-coated Tablet


Oral use




PT - Portugal


ToLife - Produtos Farmacêuticos, S.A. Avenida do Forte, 3 - Edificio Suécia III, Piso 1 2794-093 Carnaxide, Portugal


Ácido Alendrónico ToLife 70 mg Comprimidos


70 mg


Film-coated Tablet


Oral use




PT - Portugal


Verum Pharma - Produtos Farmacêuticos - Unipessoal, Lda Av. Sidónio Pais, n.o 24, rés-do-chão esq, São Sebastião da Pedreira 1000 Lisboa, Portugal


Ácido Alendrónico Flazium


70 mg


Film-coated Tablet


Oral Use




RO - Romania


MERCK SHARP & DOHME ROMÂNIA S.R.L.Bucharest Business ParkȘos. București-Ploiești, Nr. 1A, Clădirea C1, Etaj 3,Sector 1, București, România


FOSAMAX 5 mg


5 mg


Tablet


Oral Use




RO - Romania


MERCK SHARP & DOHME ROMÂNIA S.R.L.Bucharest Business ParkȘos. București-Ploiești, Nr. 1A, Clădirea C1, Etaj 3,Sector 1, București, România


FOSAMAX 10 mg


10 mg


Tablet


Oral Use




RO - Romania


MERCK SHARP & DOHME ROMÂNIA S.R.L.Bucharest Business ParkȘos. București-Ploiești, Nr. 1A, Clădirea C1, Etaj 3,Sector 1, București, România


FOSAMAX 70 mg


70 mg


Tablet


Oral Use




RO - Romania


S.C. TEVA PHARMACEUTICALS S.R.L.,Str. Domnița Ruxandra nr. 12, Parter, Sectorul 2, București, România


TEVANAT 10 mg


10 mg


Tablet


Oral Use




RO - Romania


S.C. TEVA PHARMACEUTICALS S.R.L.,Str. Domnița Ruxandra nr. 12, Parter, Sectorul 2, București, România


TEVANAT 70 mg


70 mg


Tablet


Oral Use




RO - Romania


SANDOZ S.R.L., Str. Livezeni nr. 7A, Târgu Mureș, România


ALENDRONAT SANDOZ


70 mg


film coatet tablet


Oral Use




RO - Romania


GEDEON RICHTER ROMÂNIA S.A., România


SEDRON


70 mg


film coatet tablet


Oral Use




RO - Romania


ACCORD HEALTHCARE LIMITED, Sage house, 319 Pinner road, North Harrow HA1 4 HF, Middlesex, Marea Britanie


ACID ALENDRONIC ACCORD 10 mg


10 mg


Tablet


Oral Use




RO - Romania


ACCORD HEALTHCARE LIMITED, Sage house, 319 Pinner road, North Harrow HA1 4 HF, Middlesex, Marea Britanie


ACID ALENDRONIC ACCORD 70 mg


70 mg


Tablet


Oral Use




RO - Romania


TERAPIA SA, Str. Fabricii nr. 124, Cluj Napoca, România


RANOS 10 mg


10 mg


Tablet


Oral Use




RO - Romania


TERAPIA SA, Str. Fabricii nr. 124, Cluj Napoca, România


RANOS 70 mg


70 mg


Tablet


Oral Use




RO - Romania


LABORATOARELE PROF. Dr. MORAIT, Str. Sperantei nr.29, Bucuresti sector 2, Romania


ANDRONIK


70 mg


film coatet tablet


Oral Use




RO - Romania


BLUEFISH PHARMACEUTICALS AB, Torsgatan 11, 111 23 Stockholm, Sweden


ACID ALENDRONIC BLUEFISH


70 mg


Tablet


Oral Use




RO - Romania


PHARMACEUTICAL WORKS POLPHARMA SA,19 Pelplińska Street, 83-200 Starogard Gdański, Polonia


OSTEMAX


70 mg


Tablet


Oral Use




RO - Romania


Dr. REDDY'S LABORATORIES, Str. Av. Petre Crețu nr. 74, et. 1, ap. 2, sect. 1, București, România


INSTREL


70 mg


Tablet


Oral Use




RO - Romania







Teva Pharmaceuticals S.R.L,




Str Domnita Ruxandra nr. 12, parter, sector 2, 020562, Bucuresti




Romania






Teva nat, 70 mg comprimate


70 mg


Tablet


Oral Use




SE - Sweden


Merck Sharp & Dohme BV, PO Box 581, NL-2003 PC Harlem, Netherlands (NLD)


Fosamax


10 mg


tablet


Oral Use




SE - Sweden


Merck Sharp & Dohme BV, PO Box 581, NL-2003 PC Harlem, Netherlands (NLD)


Fosamax veckotablett


70 mg


tablet


Oral Use




SE - Sweden


Arrow Generics Ltd, Unit 2 Eastman Way, Stevenage, Hertfordshire SGI 4SZ, United Kingdom and Northern Ireland (GBR)


Alendronate Arrow


10 mg


tablet


Oral Use




SE - Sweden


Arrow Generics Ltd, Unit 2 Eastman Way, Stevenage, Hertfordshire SGI 4SZ, United Kingdom and Northern Ireland (GBR)


Alendronate Arrow veckotablett


70 mg


tablet


Oral Use




SE - Sweden


Arrow Generics Ltd, Unit 2 Eastman Way, Stevenage, Hertfordshire SGI 4SZ, United Kingdom and Northern Ireland (GBR)


Alenat


10 mg


tablet


Oral Use




SE - Sweden


Arrow Generics Ltd, Unit 2 Eastman Way, Stevenage, Hertfordshire SGI 4SZ, United Kingdom and Northern Ireland (GBR)


Alenat veckotablett


70 mg


tablet


Oral Use




SE - Sweden


Arrow Generics Ltd, Unit 2 Eastman Way, Stevenage, Hertfordshire SGI 4SZ, United Kingdom and Northern Ireland (GBR)


Medarin


10 mg


tablet


Oral Use




SE - Sweden


Arrow Generics Ltd, Unit 2 Eastman Way, Stevenage, Hertfordshire SGI 4SZ, United Kingdom and Northern Ireland (GBR)


Medarin veckotablett


70 mg


tablet


Oral Use




SE - Sweden


ratiopharm GmbH, Graf-Arco-Strasse 3, DE-89079 Ulm, Germany


Dedarin veckotablett


70 mg


tablet


Oral Use




SE - Sweden


CT Arzneimittel GmbH, Lengeder Strasse 42 a, DE-13407 Berlin, Germany


Gendarin veckotablett


70 mg


tablet


Oral Use




SE - Sweden


PLIVA Pharma Ltd, Vision House, Bedford Road, Petersfield Hampshire, GU32 3QB, United Kingdom and Northern Ireland


Kendarin


10 mg


tablet


Oral Use




SE - Sweden


PLIVA Pharma Ltd, Vision House, Bedford Road, Petersfield Hampshire, GU32 3QB, United Kingdom and Northern Ireland


Kendarin veckotablett


70 mg


tablet


Oral Use




SE - Sweden


Arrow Generics Ltd, Unit 2 Eastman Way, Stevenage, Hertfordshire SGI 4SZ, United Kingdom and Northern Ireland (GBR)


Alendroarrow


10 mg


tablet


Oral Use




SE - Sweden


Arrow Generics Ltd, Unit 2 Eastman Way, Stevenage, Hertfordshire SGI 4SZ, United Kingdom and Northern Ireland (GBR)


Alendroarrow veckotablett


70 mg


tablet


Oral Use




SE - Sweden


ratiopharm GmbH, Graf-Arco-Strasse 3, DE-89079 Ulm, Germany


Alendronat ratiopharm veckotablett


70 mg


tablet


Oral Use




SE - Sweden


STADA Arzneimittel AG, Stadastrasse 2-18, DE-61118 Bad Vilbel, Germany (DEU)


Alendrostad


10 mg


tablet


Oral Use




SE - Sweden


STADA Arzneimittel AG, Stadastrasse 2-18, DE-61118 Bad Vilbel, Germany (DEU)


Alendrostad veckotablett


70 mg


tablet


Oral Use




SE - Sweden


STADA Arzneimittel AG, Stadastrasse 2-18, DE-61118 Bad Vilbel, Germany (DEU)


Alendronat STADA


10 mg


tablet


Oral Use




SE - Sweden


STADA Arzneimittel AG, Stadastrasse 2-18, DE-61118 Bad Vilbel, Germany (DEU)


Alendronat STADA veckotablett


70 mg


tablet


Oral Use




SE - Sweden


Interpharm ProduktionsgmbH, Effingerstrasse 21, AT-1160 Wien, Austria (AUT)


Alendronat Interpharm


10 mg


tablet


Oral Use




SE - Sweden


Interpharm ProduktionsgmbH, Effingerstrasse 21, AT-1160 Wien, Austria (AUT)


Alendronat Interpharm veckotablett


70 mg


tablet


Oral Use




SE - Sweden


Hexal A/S Kanalholmen 8-12 DK-2650 Hvidovre Denmark


Alendronat Hexal


10 mg


tablet


Oral Use




SE - Sweden


Hexal A/S Kanalholmen 8-12 DK-2650 Hvidovre Denmark


Alendronat Hexal Veckotablett


70 mg


tablet


Oral Use




SE - Sweden


Arrow Generics Ltd, Unit 2 Eastman Way, Stevenage, Hertfordshire SGI 4SZ, United Kingdom and Northern Ireland (GBR)


AlendroLich


10 mg


tablet


Oral Use




SE - Sweden


Arrow Generics Ltd, Unit 2 Eastman Way, Stevenage, Hertfordshire SGI 4SZ, United Kingdom and Northern Ireland (GBR)


AlendroLich Veckotablett


70 mg


tablet


Oral Use




SE - Sweden


Orifarm Generics A/S Energivej 15 POB 69 DK-5260 Odense S Denmark


Alendronat Orifarm Veckotablett


70 mg


tablet


Oral Use




SE - Sweden


Mylan AB Box 23033 104 35 Stockholm Sweden


Alendronat Mylan Veckotablett


70 mg


tablet


Oral Use




SE - Sweden


Pharmaceutical Works Polpharma S.A. 19 Pelplinska Str. PL-83-200 Starogard Gdanski Poland


Alendropol Veckotablett


70 mg


tablet


Oral Use




SE - Sweden


Pharmaceutical Works Polpharma S.A. 19 Pelplinska Str. PL-83-200 Starogard Gdanski Poland


Alendrixen Veckotablett


70 mg


tablet


Oral Use




SE - Sweden


Pharmaceutical Works Polpharma S.A. 19 Pelplinska Str. PL-83-200 Starogard Gdanski Poland


Polerixen Veckotablett


70 mg


tablet


Oral Use




SE - Sweden


HELP S.A. Pharmaceuticals 10, Valaoritou Str. Metamorphosis 144 52 Athen Greece


Terixen Veckotablett


70 mg


tablet


Oral Use




SE - Sweden


Pharmaceutical Works Polpharma S.A. 19 Pelplinska Str. PL-83-200 Starogard Gdanski Poland


Alenpol Veckotablett


70 mg


tablet


Oral Use




SE - Sweden


Pharmaceutical Works Polpharma S.A. 19 Pelplinska Str. PL-83-200 Starogard Gdanski Poland


Alendronat Polpharma Veckotablett


70 mg


tablet


Oral Use




SE - Sweden


Ranbaxy (UK) Ltd 20 Baldertoon Street London W1K 6TL United Kingdom


Alendronat Ranbaxy Veckotablett


70 mg


tablet


Oral Use




SE - Sweden


Mylan AB Box 23033 104 35 Stockholm Sweden


Alendronat Mylan


10 mg


tablet


Oral Use




SE - Sweden


Sandoz A/S C.F. Tietgens Boulevard 40 DK-5220 Odense SØ Denmark


Alendronat Sandoz Veckotablett


70 mg


film-coated tablet


Oral Use




SE - Sweden


Hexal A/S Kanalholmen 8-12 DK-2650 Hvidovre Denmark


Alendronat Hexal Veckotablett


70 mg


film-coated tablet


Oral Use




SE - Sweden


1A Farma A/S Herstedøstervej 27-29 DK-2620 Albertslund Denmark


Alendronat 1A Farma Veckotablett


70 mg


film-coated tablet


Oral Use




SE - Sweden


Accord Healthcare Limited Sage House 319 Pinner Road North Harrow, Middlesex HA1 4HF United Kingdom


Alendronat Accord


10 mg


tablet


Oral Use




SE - Sweden


Accord Healthcare Limited Sage House 319 Pinner Road North Harrow, Middlesex HA1 4HF United Kingdom


Alendronat Accord Veckotablett


70 mg


tablet


Oral Use




SE - Sweden


Bluefish Pharmaceuticals AB Torsgatan 11 111 23 Stockholm Sweden


Alendronat Bluefish Veckotablett


70 mg


tablet


Oral Use




SE - Sweden


Actavis Group PTC ehf. Reykjavikurvegur 76-78 IS-220 Hafnarfjördur Island


Alendronat Actavis Veckotablett


70 mg


tablet


Oral Use




SE - Sweden


Orion Corporation, Orion Pharma PO Box 65 FI-02101 Espoo Finland


Alendronat Orion Veckotablett


70 mg


tablet


Oral Use




SI - Slovenia


Generics UK Ltd., Station Close, Potters Bar, Hertford Shire EN6 1AG, UK


Alenax 70 mg tablete


70 mg


tablet


Oral Use




SI - Slovenia


Pliva Ljubljana d.o.o., pot k sejmišču 35, SI-1231 Ljubljana- Črnuče, Slovenia


Alendor 70 mg tablete


70 mg


tablet


Oral Use




SI - Slovenia


Arrow Generics Limited, 2 Eastman Way, Stevenage, Hertfordshire, UK


Alendronat Arrow 10 mg


10 mg


tablet


Oral Use




SI - Slovenia


Arrow Generics Limited, 2 Eastman Way, Stevenage, Hertfordshire, UK


Alendronat Arrow 70 mg


70 mg


tablet


Oral Use




SI - Slovenia


Lek farmacevtska družba, d.d., Verovškova 57, SI-1000 Ljubljana, Slovenia


Alendronat Lek 70 mg filmsko obložene tablete


70 mg


film-coated tablet


Oral Use




SI - Slovenia


Kemofarmacija d.d., cesta na Brdo 100, SI-1000 Ljubljana Slovenia


Forosa 70 mg filmsko obložene tablete


70 mg


film-coated tablet


Oral Use




SI - Slovenia


Merck Sharp& Dohme, inovativna zdravila d.o.o., Šmartinska cesta 140, SI-1000 Ljubljana


Fosamax enkrat tedensko 70 mg tablete


70 mg


tablet


Oral Use




SI - Slovenia


Krka, tovarna zdravil, d.d., Šmarješka cesta 6, SI-8501 Novo mesto, Slovenia


Lindron 10 mg tablete


10 mg


tablet


Oral Use




SI - Slovenia


Actavis Group PTC ehf., Reykjavikurvegi 78, 220 Hafnarfjordur, Iceland


Natrijev alendronat Actavis 70 mg tablete


70 mg


tablet


Oral Use




SI - Slovenia


Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, NL


Tevanate 70 mg tablete


70 mg


tablet


Oral Use




SK - Slovakia


Merck Sharp & Dohme B.V. Waarderweg 39 P.O. Box 581, Haarlem, 2031 BN Netherlands


FOSAMAX 70 mg 1 x týždenne


70 mg


Tablet


Oral Use




SK - Slovakia


Bentley Pharmaceuticals Ireland Limited North Wall Quay 25 - 28 Dublin 1 Ireland


Gendron 70 Tablety


70 mg


Tablet


Oral Use




SK - Slovakia


Teva Pharmaceuticals CR, s.r.o. Radlická 3185/1c 150 00 Praha 5 Czech Republic


Tevalen 70 mg


70 mg


Tablet


Oral Use




SK - Slovakia


Gedeon Richter Plc. Gyômrôi út 19-21 1103, Budapest Hungary


Siranin 70 mg filmom obalené tablety


70 mg


Film coated tablet


Oral Use




SK - Slovakia


Generics (UK) Ltd. Station Close, Hertfordshire Potters Bar, EN6 1TL United Kingdom


Alendrogen 70 mg


70 mg


Tablet


Oral Use




SK - Slovakia







Arrow Generics Limited Unit 2, Eastman Way, Stevenage, Hertfordshire, SG14SZ




United Kingdom






Alendromax 70 mg tablety


70 mg


Tablet


Oral Use




SK - Slovakia


ratiopharm GmbH Graf-Arco-Strasse 3 Ulm, 89079 Germany


Alendronat-ratiopharm 70 mg


70 mg


Tablet


Oral Use




SK - Slovakia







Sandoz Pharmaceuticals d.d. Verovškova 57, Ľubľana 1000




Slovenia






Alendronát Sandoz 70 mg 1 x týždenne tablety


70 mg


Tablet


Oral Use




SK - Slovakia







Xeolas Pharmaceuticals Limited 97 Furry Park Road Killester, Dublin 5




Ireland






Bonasol 70 mg perorálny roztok


70 mg


Oral Solution


Oral Use




SK - Slovakia







Actavis Group PTC ehf; Reykjavikurvegi 76-78,




220 Hafnarfjordur




Iceland






Alendronat Actavis


70 mg


tablets


Oral Use




UK - United Kingdom


MERCK SHARP & DOHME LIMITED Hertford Road, Hoddesdon, Hertfordshire EN11 UK


Fosamax


10 mg


Tablet


Oral Use




UK - United Kingdom


MERCK SHARP & DOHME LIMITED Hertford Road, Hoddesdon, Hertfordshire EN11 UK


Fosamax Once weekly


70 mg


Tablet


Oral Use




UK - United Kingdom


MERCK SHARP & DOHME LIMITED Hertford Road, Hoddesdon, Hertfordshire EN11 UK


Adronat Once weekly


70 mg


Tablet


Oral Use




UK - United Kingdom


MERCK SHARP & DOHME LIMITED Hertford Road, Hoddesdon, Hertfordshire EN11 UK


Alegen Once weekly


70 mg


Tablet


Oral Use




UK - United Kingdom


MERCK SHARP & DOHME LIMITED Hertford Road, Hoddesdon, Hertfordshire EN11 UK


Alendros Once Weekly


70 mg


Tablet


Oral Use




UK - United Kingdom


MERCK SHARP & DOHME LIMITED Hertford Road, Hoddesdon, Hertfordshire EN11 UK


Once weekly


70 mg


Tablet


Oral Use




UK - United Kingdom


MERCK SHARP & DOHME LIMITED Hertford Road, Hoddesdon, Hertfordshire EN11 UK


Fosatrol Once weekly


70 mg


Tablet


Oral Use




UK - United Kingdom


Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG


alendronic acid


10 mg


Tablet


Oral Use




UK - United Kingdom


Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG


alendronic acid


70 mg


Tablet


Oral Use




UK - United Kingdom


Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG


alendronic acid


70 mg


Tablet


Oral Use




UK - United Kingdom


Sandoz Limited, 37 Woolmer Way, Bordon, Hampshire GU35 9QE


alendronic acid


70 mg


Film-coated tablet


Oral Use




UK - United Kingdom


Generics (UK) Limited, Station Close, Potters Bar, Hertfordshire EN6 1TL


alendronic acid


10 mg


Tablet


Oral Use




UK - United Kingdom


Generics (UK) Limited, Station Close, Potters Bar, Hertfordshire EN6 1TL


alendronic acid


70 mg


Tablet


Oral Use




UK - United Kingdom


Gideon Richter Plc, Gyomrui Utca 19-21, Budapest H-1103, Hungary


alendronic acid


70 mg


Film-coated tablet


Oral Use




UK - United Kingdom


Gideon Richter Plc, Gyomrui Utca 19-21, Budapest H-1103, Hungary


alendronic acid


70 mg


Film-coated tablet


Oral Use




UK - United Kingdom


Dr Reddy's Laboratories (UK) Limited, 6 Riverview Road, Beverley, East Yorkshire HU17 0LD, United Kingdom


alendronic acid


70 mg


Tablet


Oral Use




UK - United Kingdom


Pliva Pharma Limited, Vision House, Bedford Road, Petersfield, Hampshire GU23 3QB, United Kingdom


alendronic acid


10 mg


Tablet


Oral Use




UK - United Kingdom


Pliva Pharma Limited, Vision House, Bedford Road, Petersfield, Hampshire GU23 3QB, United Kingdom


alendronic acid once-weekly


70 mg


Tablet


Oral Use




UK - United Kingdom


Ranbaxy (UK) Limited, 95 Park Lane, Mayfair. London W1K 7TE, United Kingdom


alendronic acid


70 mg


Tablet


Oral Use




UK - United Kingdom


Strandhaven Limited, 600 High Road, Seven Kings, Ilford, Essex IG3 8BS, United Kingdom


alendronic acid


70 mg


Tablet


Oral Use




UK - United Kingdom


Ratiopharm GmbH, 5 Jackson Close, Grove Road, Cosham, Portsmouth, Hampshire, PO6 1UP


alendronic acid


70 mg


Tablet


Oral Use




UK - United Kingdom


Prostrakan Limited, 3 Galabank Business Park, Queen Street, Galashiels, TD1 1QH, United Kingdom


Ostalis


70 mg


Film-coated tablet


Oral Use




UK - United Kingdom


Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS, United Kingdom


alendronic acid


10 mg


Tablet


Oral Use




UK - United Kingdom


Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS, United Kingdom


alendronic acid


70 mg


Tablet


Oral Use




UK - United Kingdom


Arrow Generics Limited, Unit 2 Eastman Way, Stevenage, Hertfordshire SG1 4SZ, United Kingdom


alendronic acid


10 mg


Tablet


Oral Use




UK - United Kingdom


Arrow Generics Limited, Unit 2 Eastman Way, Stevenage, Hertfordshire SG1 4SZ, United Kingdom


alendronic acid


70 mg


Tablet


Oral Use




UK - United Kingdom


Accord Healthcare Limited, Sage House, 319 Pinner Road, Harrow, Middlesex HA1 4HF, United Kingdom


alendronic acid


10 mg


Tablet


Oral Use




UK - United Kingdom


Accord Healthcare Limited, Sage House, 319 Pinner Road, Harrow, Middlesex HA1 4HF, United Kingdom


alendronic acid once weekly


70 mg


Tablet


Oral Use




UK - United Kingdom


Accord Healthcare Limited, Sage House, 319 Pinner Road, Harrow, Middlesex HA1 4HF, United Kingdom


alendronic acid


70 mg


Tablet


Oral Use




UK - United Kingdom


Relonchem Limited, 27 Old Gloucester Street, London WC1 3XX, United Kingdom


alendronic acid


70 mg


Tablet


Oral Use




UK - United Kingdom


Resource Medical (UK) Limited, 2 Carlton Avenue, Batley, West Yorkshire WF17 7AQ, United Kingdom


alendronic acid


70 mg


Tablet


Oral Use




UK - United Kingdom


Laboratorios Davur S.L., Calle Teide 4. Parque Empresarial La Marina, 28700 San Sebastian De Los Reyes, Madrid E-28700 Spain


alendronic acid


70 mg


Tablet


Oral Use




UK - United Kingdom


Apotex Europe BV, Darwinweg 20, Leiden, NL 2333 CR, Netherlands


alendronic acid


70 mg


Tablet


Oral Use




UK - United Kingdom


Wockhardt UK Limited, Ash Road North, Wrexham Industrial Estate, Wrexham LL13 9UF, UK


alendronic acid


70 mg


Tablet


Oral Use




UK - United Kingdom


Actavis Group PTC EHF, Reykjavikurvegi 76-78, Hafnarfirdi IS-220 Iceland


alendronic acid


70 mg


Tablet


Oral Use








Clodronic acid containing medicinal products with Marketing Authorisation in the European Union











Member State EU/EEA


Marketing authorisation holder


(Invented) Name


Strength


Pharmaceutical form


Route of administration




AT - Austria







Bayer Austria Ges.m.b.H.




Herbststraße 6 – 10




A-1160 Wien, Austria






Bonefos 800 mg - Filmtabletten


800 mg (Clodronate Disodium)


film-coated tablet


Oral use




AT - Austria







Bayer Austria Ges.m.b.H.




Herbststraße 6 – 10




A-1160 Wien, Austria






Bonefos 300 mg - Konzentrat zur Infusionsbereitung


300 mg/5 ml (Clodronate Disodium)


concentrate for solution for infusion


Intravenous




AT - Austria


Roche Austria GmbH, Engelhorngasse 3, A-1211 Wien, Austria


Lodronat 520 mg - Filmtabletten


520 mg (Clodronate Disodium)


film-coated tablet


Oral use




BE - Belgium







Bayer SA.NV.




J.E. Mommaertslaan 14




1831 Diegem-Machelen




Belgium






Bonefos


300 mg/5 ml


Concentrate for solution for infusion


Intravenous




BE - Belgium







Bayer SA.NV.




J.E. Mommaertslaan 14




1831 Diegem-Machelen




Belgium






Bonefos


800 mg


Film-coated tablets


Oral use




BG - Bulgaria







Atavis EAD




1407 Sofia




29 Atanas Dukov Str.




Bulgaria






Sindronat


400 mg


capsules, hard


Oral use




CZ - Czech Republic







Bayer Schering Pharma Oy




PO Box 415, FI-20101 Turku, Finland






Bonefos


60 mg/1 ml


Concentrate for solution for infusion


Infusion




CZ - Czech Republic







Bayer Schering Pharma Oy




PO Box 415, FI-20101 Turku, Finland






Bonefos 400 mg


400 mg


Capsule, hard


Oral use




CZ - Czech Republic







Bayer Schering Pharma Oy




PO Box 415, FI-20101 Turku, Finland






Bonefos 800 mg


800 mg


Film-coated tablet


Oral use




CZ - Czech Republic


Roche s.r.o., Dukelských hrdinů 567/52, 170 00 Praha-Holešovice, Czech Republic


Lodronat 520


520 mg


Film-coated tablet


Oral use




DE - Germany







1 A Pharma GmbH




Keltenring 1 + 3




D-82041 Oberhaching






Clodron 800-1 A Pharma


1 000 mg


Film-coated tablet


Oral use




DE - Germany







1 A Pharma GmbH




Keltenring 1 + 3




D-82041 Oberhaching






Clodron 400-1 A Pharma


500 mg


Film-coated tablet


Oral use




DE - Germany







Bayer Vital GmbH




Kaiser-Wilhelm-Allee




D-51373 Leverkusen






Bonefos pro infusione


75 mg


Concentrate for solution for infusion


Intravenous




DE - Germany







Bayer Vital GmbH




Kaiser-Wilhelm-Allee




D-51373 Leverkusen






Bonefos


500 mg


Capsule, hard


Oral use




DE - Germany







Bayer Vital GmbH




Kaiser-Wilhelm-Allee




D-51373 Leverkusen






BONEFOS FILMTABLETTEN 800 mg


1 000 mg


Film-coated tablet


Oral use




DE - Germany







betapharm Arzneimittel GmbH




Kobelweg 95




D-86156 Augsburg






Clodron beta 800 mg


1 000 mg


Film-coated tablet


Oral use




DE - Germany







HEXAL AG




Industriestr. 25




D-83607 Holzkirchen






Clodron HEXAL PI


374,9 mg


Concentrate for solution for infusion


Intravenous




DE - Germany







HEXAL AG




Industriestr. 25




D-83607 Holzkirchen






Clodron 800 mg HEXAL Filmtabletten


1 000 mg


Film-coated tablet


Oral use




DE - Germany







HEXAL AG




Industriestr. 25




D-83607 Holzkirchen






Clodron 800 mg HEXAL Filmtabletten


500 mg


Film-coated tablet


Oral use




DE - Germany







Roche Pharma AG




Emil-Barell-Str. 1




D-79639 Grenzach-Wyhlen






Ostac


649,73 mg


Film-coated tablet


Oral use




DE - Germany







Sandoz Pharmaceuticals GmbH




Raiffeisenstr. 11




D-83607 Holzkirchen






Clodron Sandoz 300 mg Konzentrat zur Herstellung einer Infusionslösung


300 mg


Concentrate for solution for infusion


Intravenous




DK - Denmark


Bayer AB, Postbox 606, Gustav III:s Boulevard 56, SE-16926 Solna


Bonefos


800 mg


film-coated tablets


Oral use




ES - Spain


QUIMICA FARMACEUTICA BAYER, S.L.Av. Baix Llobregat, 3-5 08970 Sant Joan Despi


BONEFOS 400 mg cápsulas


400 mg


capsules


Oral use




ET - Estonia







Bayer Schering Pharma OY Pansiontie 47




20210 Turku FINLAND






BONEFOS


800 mg


Film-coated tablet


Oral use




ET - Estonia







Bayer Schering Pharma OY Pansiontie 47




20210 Turku FINLAND






BONEFOS


400 mg


Capsule, hard


Oral use




ET - Estonia







Bayer Schering Pharma OY Pansiontie 47




20210 Turku FINLAND






BONEFOS


60 mg 1 ml


Concentrate for solution for infusion


Intravenous




FI - Finland


Bayer Schering Pharma Oy, Pansiontie 47, PL 415, 20210 Turku, Finland


Bonefos


60 mg/ml


Concentrate for solution for infusion


Intravenous




FI - Finland


Bayer Schering Pharma Oy, Pansiontie 47, PL 415, 20210 Turku, Finland


Bonefos


400 mg


capsule, hard


Oral use




FI - Finland


Bayer Schering Pharma Oy, Pansiontie 47, PL 415, 20210 Turku, Finland


Bonefos


800 mg


film-coated tablet


Oral use




FI - Finland


Bayer Schering Pharma Oy, Pansiontie 47, PL 415, 20210 Turku, Finland


Clodrobon


400 mg


capsule, hard


Oral use




FI - Finland


Bayer Schering Pharma Oy, Pansiontie 47, PL 415, 20210 Turku, Finland


Clodrobon


800 mg


film-coated tablet


Oral use




FR - France







BAYER SANTE




220, avenue de la Recherche




59120 Loos




FRANCE






CLASTOBAN 300 mg/5 ml, solution injectable pour perfusion en ampoule


300 mg/5 ml


solution


Intravenous




FR - France







BAYER SANTE




220, avenue de la Recherche




59120 Loos




FRANCE






CLASTOBAN 400 mg, gélule


400 mg


capsule


Oral use




FR - France







BAYER SANTE




220, avenue de la Recherche




59120 Loos




FRANCE






CLASTOBAN 800 mg, gélule


800 mg


tablet


Oral use




FR - France







SANDOZ




49, avenue Georges Pompidou




92300 Levallois-Perret




France






CLODRONATE DE SODIUM G GAM 400 mg, comprimé enrobé


400 mg


tablet


Oral use




FR - France







SANDOZ




49, avenue Georges Pompidou




92300 Levallois-Perret




France






CLODRONATE DE SODIUM G GAM 800 mg, comprimé pelliculé


800 mg


tablet


Oral use




FR - France







ROCHE




52, boulevard du Parc




92521 Neuilly-sur-Seine Cedex




FRANCE






LYTOS 520 mg, comprimé pelliculé


520 mg


tablet


Oral use




HU - Hungary







Bayer Schering Pharma Oy




Pansiontie 47.




20210 Turku




Finland






BONEFOS 800 mg tabletta


800 mg Disodium clodronate anhydrous
(in the form of 1 000 mg
Disodium clodronate tetrahydrate


tablet


Oral use




HU - Hungary







Bayer Schering Pharma Oy




Pansiontie 47.




20210 Turku




Finland






BONEFOS 400 mg kemény kapszula


400 mg Disodium clodronate anhydrous
(in the form of 500 mg
Disodium clodronate tetrahydrate


hard capsules


Oral use




HU - Hungary







Bayer Schering Pharma Oy




Pansiontie 47.




20210 Turku




Finland






BONEFOS 60 mg/ml koncentrátum oldatos infúzióhoz


60 mg/ml Disodium clodronate anhydrous
(in the form
Disodium clodronate tetrahydrate


concentrate for solution for infusion


Parenteral




IE - Ireland







Bayer Limited




The Atrium




Blackthorn Road




Dublin 18






Bonefos 800 mg film-coated tablets.


800 mg


Film-coated tablets


Oral use




IS - Iceland


Bayer Ab, Box 606, Solna, Sweden


Bonefos


800 mg


Tablet


Oral use




IT - Italy







ABIOGEN PHARMA SpA




Via Meucci, 36 - 56014




Ospedaletto (PI)






CLASTEON


100 mg/3,3 ml


Solution for injection


Intramuscolar




IT - Italy







FIDIA FARMACEUTICI SpA




Via Ponte Della Fabbrica, 3/A - 35031




Abano Terme (PD)






CLODRON


100 mg/3,3 ml


Solution for injection


Intramuscular




IT - Italy







PROMEDICA Srl




Via Palermo, 26/A - 43100




Parma






CLODY


100 mg/3,3 ml


Solution for injection


Intramuscular




IT - Italy







SPA - SOCIETA' PRODOTTI ANTIBIOTICI SpA




Via Biella, 8




20143 Milano






DIFOSFONAL


100 mg/3,3 ml


Solution for injection


Intramuscular




IT - Italy







ISTITUTO BIOCHIMICO NAZIONALE SAVIO SRL




Via E. Bazzano, 14 16019 Ronco Scrivia - Genova (Italy)






NIKLOD


100 mg/3,3 ml


Solution for injection


Intramuscular




IT - Italy







ABC FARMACEUTICI SpA




Corso Vittorio Emanuele II, 72 10121 Torino






CLODRONATO ABC


100 mg/3,3 ml


Solution for injection


Intramuscular, Intravenous




IT - Italy







ABC FARMACEUTICI SpA




Corso Vittorio Emanuele II, 72 10121 Torino






CLODRONATO ABC


300 mg/10 ml


Solution for infusion


Intravenous




IT - Italy







ABIOGEN PHARMA SpA




Via Meucci, 36 - 56014




Ospedaletto (PI)






CLASTEON


300 mg


Concentrate for solution for infusion


Intravenous




IT - Italy







ABIOGEN PHARMA SpA




Via Meucci, 36 - 56014




Ospedaletto (PI)






CLASTEON


400 mg


Capsule, hard


Oral Use




IT - Italy







EG SpA




Via Pavia, 6 - 20136




Milano - Italy






ACIDO CLODRONICO EG


100 mg/3,3 ml


Solution for injection


Intramuscular, Intravenous




IT - Italy







FARMACEUTICI CABER SpA




Viale Città d' Europa, 681




00144 Roma






OSTEONORM


100 mg


Solution for injection


Intramuscular, Intravenous




IT - Italy







FIDIA FARMACEUTICI SpA




Via Ponte Della Fabbrica, 3/A - 35031




Abano Terme (PD)






CLODRON


300 mg/10 ml


Solution for injection


Intravenous




IT - Italy







FIDIA FARMACEUTICI SpA




Via Ponte Della Fabbrica, 3/A - 35031




Abano Terme (PD)






CLODRON


400 mg


Capsule


Oral Use




IT - Italy







ISTITUTO BIOCHIMICO NAZIONALE SAVIO SRL




Via E. Bazzano, 14 16019 Ronco Scrivia - Genova (Italy)






NIKLOD


300 mg/10 ml


Concentrate for solution for infusion


Intravenous




IT - Italy







LABORATORI ALTER Srl




Via Lomellina, 39 - 20124




Milano






DISODIO CLODRONATO ALTER


100 mg/3,3 ml


Solution for injection


Intramuscular, Intravenous




IT - Italy







LABORATORI ALTER Srl




Via Lomellina, 39 - 20124




Milano






DISODIO CLODRONATO ALTER


300 mg/10 ml


Solution for infusion


Intravenous




IT - Italy







LISAPHARMA SpA




Via Licinio, 11




22036 Erba (CO)






MOTICLOD


300 mg/10 ml


Solution for infusion


Intravenous




IT - Italy







LISAPHARMA SpA




Via Licinio, 11




22036 Erba (CO)






MOTICLOD


100 mg/3,3 ml


Solution for injection


Intramuscular, Intravenous




IT - Italy







MASTELLI Srl




Via Bussana Vecchia, 32




18032 San Remo (IM)






CLIMACLOD


300 mg/10 ml


Solution for infusion


Intravenous




IT - Italy







MASTELLI Srl




Via Bussana Vecchia, 32




18032 San Remo (IM)






CLIMACLOD


100 mg/3,3 ml


Solution for injection


Intramuscular




IT - Italy







MYLAN SpA




Via Aquileia, 35 - 20092




Cinisello Balsamo




Milano






ACIDO CLODRONICO MYLAN GENERICS


100 mg/3,3 ml


Solution for injection


Intramuscular, Intravenous




IT - Italy







MYLAN SpA




Via Vittor Pisani, 20 - 20124




Milano






ACIDO CLODRONICO MYLAN GENERICS


300 mg/10 ml


Solution for infusion


Intravenous




IT - Italy







PROMEDICA Srl




Via Palermo, 26/A - 43100




Parma






CLODY


300 mg/10 ml


Concentrate for solution for infusion


Intravenous




IT - Italy







ROTTAPHARM SpA




Via Galleria Unione,5




20122 Milano (MI)






OSTEOTAB


100 mg/3,3 ml


Solution for injection


Intramuscular, Intravenous




IT - Italy







ROTTAPHARM SpA




Via Galleria Unione,5




20122 Milano (MI)






OSTEOTAB


300 mg/10 ml


Solution for infusion


Intravenous




IT - Italy







SANDOZ SpA




L.go U. Boccioni, 1 - 21040




Origgio (VA)






ACIDO CLODRONICO


100 mg/3,3 ml


Solution for injection


Intramuscular, Intravenous




IT - Italy







SANDOZ SpA




L.go U. Boccioni, 1 - 21040




Origgio (VA)






ACIDO CLODRONICO


300 mg/10 ml


Solution for infusion


Intravenous




IT - Italy







SPA - SOCIETA' PRODOTTI ANTIBIOTICI SpA




Via Biella, 8




20143 Milano






DIFOSFONAL


300 mg/10 ml


Concentrate for solution for infusion


Intravenous




IT - Italy







SPA - SOCIETA' PRODOTTI ANTIBIOTICI SpA




Via Biella, 8




20143 Milano






DIFOSFONAL


400 mg


Capsule


Oral Use




IT - Italy







TEVA ITALIA Srl




Via Messina, 38 - 20154




Milano – Italy






CLODRONATO TEVA


100 mg/3,3 ml


Solution for injection


Intramuscular, Intravenous




IT - Italy







TEVA ITALIA Srl




Via Messina, 38 - 20154




Milano






CLODRONATO TEVA


300 mg/10 ml


Solution for infusion


Intravenous




IT - Italy







LABORATORIO PRODOTTI FARMACEUTICI BONISCONTRO & GAZZONE Srl




Via Pavia, 6 - 20136




Milano – Italy






CLODEOSTEN


100 mg/3,3 ml


Soluction for injection


Intravenous




IT - Italy


ATHENA PHARMA ITALIA SRL Viale Citta D'Europa, 681 00144 Roma


TRAXOVICAL


100 mg/3,3 ml


Soluction for injection


Intravenous




IT - Italy


ATHENA PHARMA ITALIA SRL Viale Citta D'Europa, 681 00144 Roma


TRAXOVICAL


300 mg/10 ml


Soluction for infusion


Intravenous




LU - Luxembourg







Bayer s.a.




14, J.E. Mommaertslaan




B-1831 Diegem






Bonefos


300 mg/5 ml


solution for infusion


Intraveinous




LV - Latvia


Bayer Schering Pharma Oy, Pansiontie 47, FIN-20210 Turku, Finland


Bonefos


60 mg/ml


concentrate for solution for infusion


Intravenous




LV - Latvia


Bayer Schering Pharma Oy, Pansiontie 47, FIN-20210 Turku, Finland


Bonefos


400 mg


capsules


Oral use




MT - Malta







Bayer plc




Consumer Care Division




Bayer House




Strawberry Hill




Newbury




Berkshire




RG14 1JA




United Kingdom






Bonefos


400 mg


Capsules


Oral use




NL - Netherlands







Roche Nederland B.V.




Beneluxlaan 2a




3446 GR Woerden Netherlands






Ostac, concentration for solution for infusion 30 mg/ml


30 mg/ml


concentration for solution for infusion


Intravenous




NL - Netherlands







Roche Nederland B.V.




Beneluxlaan 2a




3446 GR Woerden Netherlands






Ostac® 520, filmcaoted tablets 520 mg


520 mg


filmcoated tablets


Oral use




NL - Netherlands


Bayer B.V. Energieweg 1 3641 RT Mijdrecht


Bonefos


60 mg/ml


concentration for solution for infusion


Intravenous




NL - Netherlands


Bayer B.V. Energieweg 1 3641 RT Mijdrecht


Bonefos capsules 400 mg


400 mg


hard capsules


Oral use




NL - Netherlands


Bayer B.V. Energieweg 1 3641 RT Mijdrecht


Bonefos tablets 800 mg


800 mg


filmcoated tablets


Oral use




NO - Norway


Bayer AB Box 606 169 26 Solna Sweden


Bonefos


800 mg


film-coated tablet


Oral use




PL - Poland







Bayer Schering Pharma AG




Berlin, D-13342, Germany






Bonefos


400 mg


capsules, hard


Oral use




PL - Poland







Bayer Schering Pharma AG




Berlin, D-13342, Germany






Bonefos


60 mg/ml


concentrate for solution for infusion


Intravenous




PL - Poland







Bayer Schering Pharma AG




Berlin, D-13342, Germany






Bonefos


800 mg


film coated tablets


Oral use




PL - Poland







Actavis Group PTC ehf.




Reykjavikurvegi 76-78




220 Hafnarfirdi, Iceland






Sindronat


400 mg


capsules, hard


Oral use




PT - Portugal


Roche Farmacêutica Química, Lda. Estrada Nacional 249, 1, 2720-413 Amadora Portugal


Ostac


520 mg


Coated tablet


Oral use




PT - Portugal


Lusalfarma - Especialidades Farmacêuticas, Lda. Rua Quinta Pinheiro, 5, Outurela 2794-003 Carnaxide Portugal


Bonefos


800 mg


Film-coated tablet


Oral use




RO - Romania


BAYER SCHERING PHARMA OY, Pansiontie 47, 20210 Turku, Finland


BONEFOS 400 mg, capsules


400 mg


capsules


Oral use




RO - Romania


BAYER SCHERING PHARMA OY, Pansiontie 47, 20210 Turku, Finland


BONEFOS 800 mg, capsules


800 mg


capsules


Oral use




RO - Romania


BAYER SCHERING PHARMA OY, Pansiontie 47, 20210 Turku, Finland


BONEFOS 60 mg/ml concentrate for solution for infusion


60 mg/ml


concentrate for solution for infusion


Parenteral




RO - Romania


ACTAVIS S.R.L. B-dul Ion Mihalache, nr. 11 Sector 1, Cod 011171, București, Romania


SINDRONAT 300 mg/5 ml concentrate for solution for infusion


300 mg/5 ml


concentrate for solution for infusion


Prenteral




SE - Sweden


Bayer AB Box 606 169 26 Solna Sweden


Bonefos


60 mg/ml


concentrate for solution for infusion


For infusion




SE - Sweden


Bayer AB Box 606 169 26 Solna Sweden


Bonefos


800 mg


film-coated tablet


Oral use




SI - Slovenia


Bayer Schering Pharma Oy, Pansiontie 47, 20210 Turku, Finland


Bonefos 60 mg/ml koncentrat za raztopine za infundiranje


60 mg/ml


concentrate for solution for infusion


Intravenous




SI - Slovenia


Bayer Schering Pharma Oy, Pansiontie 47, 20210 Turku, Finland


Bonefos 800 mg filmsko obložene tablete


800 mg


film-coated tablet


Oral use




SK - Slovak Republic


Bayer Schering Pharma Oy, Pansiontie 47, PL 415, 20210 Turku, Finland


Bonefos


60 mg/ml


Concentrate for solution for infusion


Intravenous




SK - Slovak Republic


Bayer Schering Pharma Oy, Pansiontie 47, PL 415, 20210 Turku, Finland


Bonefos


400 mg


capsule, hard


Oral use




SK - Slovak Republic


Bayer Schering Pharma Oy, Pansiontie 47, PL 415, 20210 Turku, Finland


Bonefos


800 mg


film-coated tablet


Oral use




UK - United Kingdom


Bayer Plc, bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA, UK


Bonefos


400 mg


Capsules


Oral use




UK - United Kingdom


Bayer Plc, bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA, UK


Bonefos


800 mg


coated Tablets


Oral use




UK - United Kingdom


Roche Products Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, UK


Loron 540


 


film coated tablets


Oral use




UK - United Kingdom


Beacon Pharmaceuticals Limited, 85, High strret, Tunbridge Wells, TN1 1YG, UK


Clasteon


400 mg


Capsules


Oral use




UK - United Kingdom


Beacon Pharmaceuticals Limited, 85, High strret, Tunbridge Wells, TN1 1YG, UK


Sodium clodronate


400 mg


Capsules


Oral use




UK - United Kingdom


Caduceus Pharma Limited, 6th floor, 94 Wigmore Street, London W1U 3RF, UK


Disodium Clodronate


60 mg/ml


solution for Injection


Intravenous








Etidronic acid containing medicinal products with Marketing Authorisation in the European Union











Member State EU/EEA


Marketing authorisation holder


(Invented) Name


Strength


Pharmaceutical form


Route of administration




BE - Belgium







Procter & Gamble Pharmaceuticals SA.NV.




Temselaan 100






Didronel


200 mg


Tablets


Oral use




BE - Belgium







Warner Chilcott Pharmaceuticals BVBA




Pegasuslaan 5




1831 Diegem,




Belgium






Osteodidronel


400 mg


Tablets


Oral use




DE - Germany







mibe GmbH Arznzemittel




Münchener Str. 15




D-06796 Brehna






Etidronat 200 mg Jenapharm


200 mg


Tablet


Oral use




DE - Germany







C.H.R. Heim Arzneimittel GmbH




Elisabethenstr. 34




D-64283 Darmstadt






Etical


400 mg
1 250 mg


Tablet


Oral use




DE - Germany







HEXAL AG




Industriestr. 25




D-83607 Holzkirchen






Etidron HEXAL Kombi


400 mg
1 250 mg


Tablet and effervescent tablet


Oral use




DE - Germany







Warner Chilcott Deutschland GmbH




Dr.-Otto-Röhm-Str. 2 - 4




D-64331 Weiterstadt






Didronel-Kit


400 mg
1 250 mg


Tablet


Oral use




DK - Denmark


Procter & Gamble Pharmaceuticals UK Ltd., Rusham Park Technical Centre, Whitehall Lane, GB-TW20 9 NW Egham, Surrey, England


Didronate


200 mg


Tablets


Oral use




DK - Denmark


Procter & Gamble Pharmaceuticals UK Ltd., Rusham Park Technical Centre, Whitehall Lane, GB-TW20 9 NW Egham, Surrey, England


Didronate/Calcium "Procter & Gamble"


400 mg + 500 mg calcium


Tablets


Oral use




EL - Greece







UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES




14KM OF NATIONAL HIGHWAY ATHENS-LAMIA




KIFISSIA 14564






OSTOPOR


200 MG/CAP


HARD CAPSULE


Oral use




EL - Greece







UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES




14KM OF NATIONAL HIGHWAY ATHENS-LAMIA




KIFISSIA 14565






OSTOPOR


300 MG/CAP


HARD CAPSULE


Oral use




EL - Greece







UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES




14KM OF NATIONAL HIGHWAY ATHENS-LAMIA




KIFISSIA 14566






OSTOPOR


400 MG/CAP


HARD CAPSULE


Oral use




EL - Greece


PHARMACEUTICAL INDUSTRY PROEL EPAMEINONDAS G. KORONIS S.A.


ANFOZAN


400 MG/CAP


HARD CAPSULE


Oral use




ES - Spain


LABORATORIOS VIÑAS, S.A. Provenza, 386 08025 Barcelona


OSTEUM


200 mg


tablets


Oral use




FR - France







Warner Chilcott France




Immeuble "Le Jean Monnet"




11, Place des Vosges




92061 Paris La Défense Cedex




France






DIDRONEL 200 mg, comprimé


200 mg


tablet


Oral use




FR - France







Warner Chilcott France




Immeuble "Le Jean Monnet"




11, Place des Vosges




92061 Paris La Défense Cedex




France






DIDRONEL 400 mg, comprimé


400 mg


tablet


Oral use




FR - France







Warner Chilcott France




Immeuble "Le Jean Monnet"




11, Place des Vosges




92061 Paris La Défense Cedex




France






DIPOROS 400 mg, comprimé


400 mg


tablet


Oral use




FR - France







Warner Chilcott France




Immeuble "Le Jean Monnet"




11, Place des Vosges




92061 Paris La Défense Cedex




France






ETIDRONATE DISODIQUE PROCTER & GAMBLE PHARMACEUTICALS 200 mg, comprimé


200 mg


tablet


Oral use




FR - France







MYLAN SAS




117, allée des Parcs




69800 Saint-Priest




FRANCE






ETIDRONATE MYLAN 200 mg, comprimé


200 mg


tablet


Oral use




FR - France







MYLAN SAS




117, allée des Parcs




69800 Saint-Priest




FRANCE






ETIDRONATE MYLAN 400 mg, comprimé


400 mg


tablet


Oral use




FR - France







SANDOZ




49, avenue Georges Pompidou




92300 Levallois-Perret




France






ETIDRONATE SANDOZ 400 mg, comprimé


400 mg


tablet


Oral use




IT - Italy







ABIOGEN PHARMA SpA




Via Meucci, 36 - 56014




Ospedaletto (PI)






ETIDRON


300 mg


Capsule


Oral use




NL - Netherlands


Procter & Gamble Pharmaceuticals Nederland B.V. Postbus 2507 3000 CM Rotterdam Netherlands


Didronel 400


400 mg


Tablet


Oral use




NL - Netherlands







Warner Chilcott Nederland B.V.




Lichtenauerlaan 102-120




3062 ME Rotterdam Netherlands






Didrokit, combinatieverpakking


400 mg + 1 250 mg


Tablet + Effervescent tablets


Oral use




NO - Norway


Warner Chilcott UK Ltd.; Old Belfast Rd, Larne BT40 2SH, UK


Didronate + Calsium Kombinasjonspakning


400 mg/500 mg


tablet


Oral use




SE - Sweden


Warner Chilcott UK Limited Old Belfast Road Millbrook Larne County Antrim BT40 2SH, United Kingdom


Didronate


200 mg


tablet


Oral use




SE - Sweden


Warner Chilcott UK Limited Old Belfast Road Millbrook Larne County Antrim BT40 2SH, United Kingdom


Didronate 400 mg + Calcium 500 mg


Didronate 400 mg + Calcium 500 mg


tablet


Oral use




UK - United Kingdom


Generics (UK) Limited, Station Close, Potters Bar, Hertfordshire EN6 1TL


ETIDRONATE DISODIUM


200 mg


Tablets


Oral use




UK - United Kingdom


Warner Chilcott UK Limted, Old Belfast Road, Millbrook, Larne, Co. Antrim BT40 2SH, UK


DIDRONEL


200 mg


Tablets


Oral use




UK - United Kingdom


Warner Chilcott UK Limted, Old Belfast Road, Millbrook, Larne, Co. Antrim BT40 2SH, UK


DIDRONEL PMO


400 mg


Tablets


Oral use




UK - United Kingdom


Tillomed Laboratories Limited, 3 Howard Road, Eaton Socon, St. Neots, Cambridgeshire, PE19 8ET, UK


TILOETCA COMBI


400 mg


Tablets


Oral use




UK - United Kingdom


Arrow Generics Limited, Unit 2 Eastman Way, Stevenage, Hertfordshire SG1 4SZ, United Kingdom


DISODIUM ETIDRONATE


200 mg


Tablets


Oral use




UK - United Kingdom


Arrow Generics Limited, Unit 2 Eastman Way, Stevenage, Hertfordshire SG1 4SZ, United Kingdom


DISODIUM ETIDRONATE


400 mg


Tablets


Oral use








Neridronic acid containing medicinal products with Marketing Authorisation in the European Union











Member State EU/EEA


Marketing authorisation holder


(Invented) Name


Strength


Pharmaceutical form


Route of administration




IT - Italy







ABIOGEN PHARMA SpA




Via Meucci, 36 - 56014




Ospedaletto (PI)






NERIXIA


25 mg


Solution for injection


Intramuscular, Intravenous




IT - Italy







ABIOGEN PHARMA SpA




Via Meucci, 36 - 56014




Ospedaletto (PI)






NERIXIA


100 mg


Concentrate for solution for infusion


Intravenous








Pamidronic acid containing medicinal products with Marketing Authorisation in the European Union











Member State EU/EEA


Marketing authorisation holder


(Invented) Name


Strength


Pharmaceutical form


Route of administration




AT - Austria


Novartis Pharma GmbH, Stella-Klein-Löw-Weg 17, A-1020 Wien, Austria


Aredia 15 mg - Trockensubstanz zur Infusionsbereitung mit Lösungsmittel


15 mg/5 ml (Pamidronate Disodium)


Powder and solvent for solution for infusion


Intravenous




AT - Austria


Novartis Pharma GmbH, Stella-Klein-Löw-Weg 17, A-1020 Wien, Austria


Aredia 30 mg - Trockensubstanz zur Infusionsbereitung mit Lösungsmittel


30 mg/10 ml (Pamidronate Disodium)


Powder and solvent for solution for infusion


Intravenous




AT - Austria


Novartis Pharma GmbH, Stella-Klein-Löw-Weg 17, A-1020 Wien, Austria


Aredia 90 mg - Trockensubstanz zur Infusionsbereitung mit Lösungmittel


90 mg/10 ml (Pamidronate Disodium)


Powder and solvent for solution for infusion


Intravenous




AT - Austria







Medac




Gesellschaft für klinische Spezialpräparate mbH




Fehlandtstraße 3




D-20354 Hamburg, Germany






Ebedronat 3 mg/ml Konzentrat zur Herstellung einer Infusionslösung


3 mg/ml (Pamidronate Disodium)


concentrate for solution for infusion


Intravenous




AT - Austria







Hospira Deutschland GmbH




Rablstraße 24




81669 München, Germany






Pamidronat Dinatrium Hospira 3 mg/ml, Konzentrat zur Herstellung einer Infusionslösung


3 mg/ml (Pamidronate Disodium)


concentrate for solution for infusion


Intravenous




AT - Austria







Hospira Deutschland GmbH




Rablstraße 24




81669 München, Germany






Pamidronat Dinatrium Hospira 6 mg/ml, Konzentrat zur Herstellung einer Infusionslösung


6 mg/ml (Pamidronate Disodium)


concentrate for solution for infusion


Intravenous




AT - Austria







Hospira Deutschland GmbH




Rablstraße 24




81669 München, Germany






Pamidronat Dinatrium Hospira 9 mg/ml, Konzentrat zur Herstellung einer Infusionslösung


9 mg/ml (Pamidronate Disodium)


concentrate for solution for infusion


Intravenous




AT - Austria


Stada Arzneimittel GmbH, Muthgasse 36, A-1190 Wien, Austria


Pamidronat STADA 3 mg/ml Konzentrat zur Herstellung einer Infusionslösung


3 mg/ml (Pamidronate Disodium)


concentrate for solution for infusion


Intravenous




AT - Austria







Torrex Chiesi Pharma GmbH




Gonzagagasse 16/16, A- 1010 Wien, Austria






Pamitor 15 mg/ml - Konzentrat zur Herstellung einer Infusionslösung


15 mg/ml (Pamidronate Disodium)


concentrate for solution for infusion


Intravenous




BE - Belgium







Novartis Pharma N.V.




Medialaan 40




1800 Vilvoorde




Belgium






Aredia


15 mg/5 ml


Powder for Solution for infusion


Intravenous




BE - Belgium







Novartis Pharma N.V.




Medialaan 40




1800 Vilvoorde




Belgium






Aredia


90 mg/10 ml


Powder for Solution for infusion


Intravenous




BE - Belgium







Teva Pharma Belgium N.V.




Laarstraat 16




2610 Wilrijk




Belgium






Pamidrin


3 mg/ml


Concentrate for solution for infusion


Intravenous




BE - Belgium







Actavis Group PTC EHF




Reykjavikuregur 76-78




220 Hafnarfjordur




Iceland






Pamidronaat Actavis


3 mg/ml


Concentrate for solution for infusion


Intravenous




BE - Belgium







Actavis Group PTC EHF




Reykjavikuregur 76-78




220 Hafnarfjordur




Iceland






Pamidronaat Actavis


6 mg/ml


Concentrate for solution for infusion


Intravenous




BE - Belgium







Actavis Group PTC EHF




Reykjavikuregur 76-78




220 Hafnarfjordur




Iceland






Pamidronaat Actavis


9 mg/ml


Concentrate for solution for infusion


Intravenous




BE - Belgium







Hospira Benelux BVBA




Stallestraat 63




1180 Brussels




Belgium






Pamidronaatdinatrium Hospira


3 mg/ml


Concentrate for solution for infusion


Intravenous




BE - Belgium







Hospira Benelux BVBA




Stallestraat 63




1180 Brussels




Belgium






Pamidronaatdinatrium Hospira


6 mg/ml


Concentrate for solution for infusion


Intravenous




BE - Belgium







Hospira Benelux BVBA




Stallestraat 63




1180 Brussels




Belgium






Pamidronaatdinatrium Hospira


9 mg/ml


Concentrate for solution for infusion


Intravenous




BE - Belgium







Eurogenerics N.V.




Heizel Esplanade b22




1020 Brussels




Belgium






Pamidronate EG


3 mg/ml


Concentrate for solution for infusion


Intravenous




BE - Belgium







Mylan BVBA/SPRL




Terhulpsesteenweg 6A




1560 Hoeilaart




Belgium






Pamidronate Mylan


15 mg/ml


Concentrate for solution for infusion


Intravenous




BG - Bulgaria


Tchaikapharma High Quality Medicines, 1, G.M. Dimitorv Blvd, 1172 Sofia, Bulgaria


Pamitor


15 mg/ml


Concentrate for solution for infusion


Intravenous




BG - Bulgaria


Novartis Pharma GmbH, Roonstrasse 25, D-90429 Nuernberg, Germany


Aredia


30 mg


powder and solvent for solution for infusion


Intravenous




BG - Bulgaria


Actavis Group PTC ehf, Iceland Reykjavikurvegur 76-78, IS-220, Hafnarfjordur


Clastodron


3 mg/ml,


concentrate for solution for infusion, 5 ml


Intravenous




BG - Bulgaria


Actavis Group PTC ehf, Iceland Reykjavikurvegur 76-78, IS-220, Hafnarfjordur


Clastodron


6 mg/ml


concentrate for solution for infusion - 10 ml


Intravenous




BG - Bulgaria


Actavis Group PTC ehf, Iceland Reykjavikurvegur 76-78, IS-220, Hafnarfjordur


Clastodron


9 mg/ml


concentrate for solution for infusion - 10 ml


Intravenous




CY - Cyprus


PHARMACEUTICAL TRADING CO LTD, 18 THOUKIDIDOU STR, P O BOX 40628, 6306 LARNACA, CYPRUS


PAMIDRONATE DISODIUM CONCENTRATE FOR SOLUTION FOR INFUSION 9 mg/ml


9 mg/ml, 10 ml


SOLUTION FOR INFUSION


Intravenous




CZ - Czech Republic







Novartis s.r.o., U nákladového nádraží 3265/10, 130 00 Praha-Strašnice




(Nagano III.), Czech Republic






Aredia 15 mg


1,5 mg/ml


Powder and solvent for solution for infusion


Infusion




CZ - Czech Republic







Novartis s.r.o., U nákladového nádraží 3265/10, 130 00 Praha-Strašnice




(Nagano III.), Czech Republic






Aredia 30 mg


3 mg/ml


Powder and solvent for solution for infusion


Infusion




CZ - Czech Republic


Medac Gesellschaft für klinische Spezialpräparate mbH, Fehlandtstraße 3, D-20354 Hamburg, Germany


Pamidronate Medac 3 mg/ml


3 mg/ml


Concentrate for solution for infusion


Infusion




CZ - Czech Republic







Teva Pharmaceuticals CR, s.r.o., Radlická 3185/1c




150 00 Praha 5




Cezch Republic






Pamidronate-Teva 3 mg/ml


3 mg/ml


Concentrate for solution for infusion


Infusion




CZ - Czech Republic


Torrex Chiesi CZ, s.r.o., Na květnici 878/33, 140 00 Praha-Nusle, Czech Republic


Pamitor 15 mg/ml


15 mg/ml


Concentrate for solution for infusion


Infusion




DE - Germany







axios Pharma GmbH




Hauptstr. 198




D-33647 Bielefeld






axidronat 3 mg/ml Konzentrat zur Herstellung einer Infusionslösung


3 mg


Concentrate for solution for infusion


Intravenous




DE - Germany







Cancernova GmbH onkologische Arzneimittel




Lil-Dagover-Ring 7




D-82031 Grünwald






NOVAPAM 15 mg Pulver zur Herstellung einer Infusionslösung


15 mg


Powder for solution for infusion


Intravenous




DE - Germany







Cancernova GmbH onkologische Arzneimittel




Lil-Dagover-Ring 7




D-82031 Grünwald






NOVAPAM 30 mg Pulver zur Herstellung einer Infusionslösung


30 mg


Powder for solution for infusion


Intravenous




DE - Germany







Cancernova GmbH onkologische Arzneimittel




Lil-Dagover-Ring 7




D-82031 Grünwald






NOVAPAM 60 mg Pulver zur Herstellung einer Infusionslösung


60 mg


Powder for solution for infusion


Intravenous




DE - Germany







Cancernova GmbH onkologische Arzneimittel




Lil-Dagover-Ring 7




D-82031 Grünwald






NOVAPAM 60 mg Pulver zur Herstellung einer Infusionslösung


60 mg


Powder for solution for infusion


Intravenous




DE - Germany







cell Pharm GmbH




Theodor-Heuss-Str. 52




D-61118 Bad Vilbel






PAMIDRO-cell 3 mg/ml Konzentrat zur Herstellung einer Infsionslösung


3 mg


Concentrate for solution for infusion


Intravenous




DE - Germany







TEVA Deutschland GmbH




Wasastr. 50




D-01445 Radebeul






Pamidronat-GRY 3 mg/ml Konzentrat zur Herstellung einer Infsionslösung


3 mg


Concentrate for solution for infusion


Intravenous




DE - Germany







HEXAL AG




Industriestr. 25




D-83607 Holzkirchen






Pamidron HEXAL 15 mg/ml Konzentrat zur Herstellung einer Infsionslösung


15 mg


Concentrate for solution for infusion


Intravenous




DE - Germany







HIKMA Farmaceutica (Portugal) S.A.




Estrada do Rio da Mo, 8,8 A e 8 B - Fervenca




P-2705-906 TERRUGem SNT






Ribodronat 3 mg/ ml Konzentrat zur Herstellung einer Infsionslösung


3 mg


Concentrate for solution for infusion


Intravenous




DE - Germany







Hospira Deutschland GmbH




Rablstr. 24




D-81669 München






Pamidronat Hospira 3 mg/ml Konzentrat zur Herstellung einer Infsionslösung


3 mg


Concentrate for solution for infusion


Intravenous




DE - Germany







Hospira Deutschland GmbH




Rablstr. 24




D-81669 München






Pamidronat Hospira 6 mg/ml Konzentrat zur Herstellung einer Infsionslösung


6 mg


Concentrate for solution for infusion


Intravenous




DE - Germany







Hospira Deutschland GmbH




Rablstr. 24




D-81669 München






Pamidronat Hospira 9 mg/ml Konzentrat zur Herstellung einer Infsionslösung


9 mg


Concentrate for solution for infusion


Intravenous




DE - Germany







medac Gesellschaft für klinische Spezialpräparate mbH




Fehlandtstr. 3




D-20354 Hamburg






Pamifos 3 mg/ml Konzentrat zur Herstellung eriner Infusionslösung


3 mg


Concentrate for solution for infusion


Intravenous




DE - Germany







Novartis Pharma GmbH




Roonstr. 25




D-90429 Nürnberg






Aredia 15 mg


15 mg


Dry substanced and solvent


Intravenous




DE - Germany







Novartis Pharma GmbH




Roonstr. 25




D-90429 Nürnberg






Aredia 30 mg


30 mg


Dry substanced and solvent


Intravenous




DE - Germany







Novartis Pharma GmbH




Roonstr. 25




D-90429 Nürnberg






Aredia 90 mg


90 mg


Dry substanced and solvent


Intravenous




DE - Germany







Novartis Pharma GmbH




Roonstr. 25




D-90429 Nürnberg






Aredia 60 mg


60 mg


Dry substanced and solvent


Intravenous




DE - Germany







Onkovis GmbH




Grube 45




D-82377 Penzberg






Pamidronat Onkovis 3 mg/ml Konzentrat zur Herstellung einer Infusionslösung


3 mg


Concentrate for solution for infusion


Intravenous




DK - Denmark


Helm AG, Nordkanalstrasse 28D, DE-20097 Hamburg, Germany


Epsilonat


15 mg/ml


Concentrat for infusion, solution


Intravenous




DK - Denmark


Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118 Bad Vilbel, Germany


Pamidrocell


3 mg/ml


Concentrat for infusion, solution


Intravenous




DK - Denmark


Hexal AG, Industriestrasse 25, DE-83607 Holzkirchen, Germany


Pamidronat "Hexal"


15 mg/ml


Concentrat for infusion, solution


Intravenous




DK - Denmark


Meda AS, Solvang 8, DK-3450 Allerød, Denmark


Pamidronat "Meda"


15 mg/ml


Concentrat for infusion, solution


Intravenous




DK - Denmark


BMM Pharma AB, Blasieholmsgatan 2, SE-11148 Stockholm, Sweden


Pamidronatdinatrium "BMM Pharma"


3 mg/ml


Concentrat for infusion, solution


Intravenous




DK - Denmark


BMM Pharma AB, Blasieholmsgatan 2, SE-11148 Stockholm, Sweden


Pamidronatdinatrium "BMM Pharma"


6 mg/ml


Concentrat for infusion, solution


Intravenous




DK - Denmark


BMM Pharma AB, Blasieholmsgatan 2, SE-11148 Stockholm, Sweden


Pamidronatdinatrium "BMM Pharma"


9 mg/ml


Concentrat for infusion, solution


Intravenous




DK - Denmark


Hospira UK Limited, Queensway, Royal Leamington Spa, GB-CV31 3RW Warwickshire, England


Pamidronatdinatrium "Hospira"


3 mg/ml


Concentrat for infusion, solution


Intravenous




DK - Denmark


Hospira UK Limited, Queensway, Royal Leamington Spa, GB-CV31 3RW Warwickshire, England


Pamidronatdinatrium "Hospira"


6 mg/ml


Concentrat for infusion, solution


Intravenous




DK - Denmark


Hospira UK Limited, Queensway, Royal Leamington Spa, GB-CV31 3RW Warwickshire, England


Pamidronatdinatrium "Hospira"


9 mg/ml


Concentrat for infusion, solution


Intravenous




DK - Denmark


Teva Denmark A/S, Parallelvej 10-12, DK-2800 Kongens Lyngby, Denmark


Pamidronatdinatrium "Teva"


3 mg/ml


Concentrat for infusion, solution


Intravenous




DK - Denmark


medac, Gesellschaft fur klinisch, Spezialpraeparate mbH, Fehlandstrasse 3, DE-20354 Hamburg, Germany


Pamifos


3 mg/ml


Concentrat for infusion, solution


Intravenous




EL - Greece







HOSPIRA UK LIMITED, U.K.




Queensway, Royal Leamington Spa




Warwickshire




CV31 3RW




United Kingdom






PAMIDRONATE DISODIUM / HOSPIRA


6 MG/1 ML


CONCENTRATE FOR SOLUTION FOR INFUSION


Intravenous




EL - Greece







MEDICUS S.A.




VALAORITOU 10




METAMORFOSI ATTIKIS 14452






PAMIDRONE


60 MG/VIAL


POWDER AND SOLUTION FOR INFUSION


Intravenous




EL - Greece







MEDICUS S.A.




VALAORITOU 10




METAMORFOSI ATTIKIS 14453






PAMIDRONE


90 MG/VIAL


POWDER AND SOLUTION FOR INFUSION


Intravenous




EL - Greece







HOSPIRA UK LIMITED, U.K.




Queensway, Royal Leamington Spa




Warwickshire




CV31 3RW




United Kingdom






PAMIDRONATE DISODIUM / HOSPIRA


3 MG/1 ML


CONCENTRATE FOR SOLUTION FOR INFUSION


Intravenous




EL - Greece







HOSPIRA UK LIMITED, U.K.




Queensway, Royal Leamington Spa




Warwickshire




CV31 3RW




United Kingdom






PAMIDRONATE DISODIUM / HOSPIRA


6 MG/1 ML


CONCENTRATE FOR SOLUTION FOR INFUSION


Intravenous




EL - Greece







HOSPIRA UK LIMITED, U.K.




Queensway, Royal Leamington Spa




Warwickshire




CV31 3RW




United Kingdom






PAMIDRONATE DISODIUM / HOSPIRA


9 MG/1 ML


CONCENTRATE FOR SOLUTION FOR INFUSION


Intravenous




EL - Greece







ALAPIS ABEE




AUTOKRATOROS NIKOLAOU 2




ATHENS 17671






PAMERIT


15 MG/1 ML


CONCENTRATE FOR SOLUTION FOR INFUSION


Intravenous




ES - Spain


HOSPIRA UK LIMITED Queensway. Royal Leadmington Spa Warwickshire CV31 3RW Reino Unido


PAMIDRONATO HOSPIRA 3 mg/ml concentrado para solución para perfusión


3 mg/ml


Concentrate for solution for infusion


Intravenous




ES - Spain


HOSPIRA UK LIMITED Queensway. Royal Leadmington Spa Warwickshire CV31 3RW Reino Unido


PAMIDRONATO HOSPIRA 6 mg/ml concentrado para solución para perfusión


6 mg/ml


Concentrate for solution for infusion


Intravenous




ES - Spain


HOSPIRA UK LIMITED Queensway. Royal Leadmington Spa Warwickshire CV31 3RW Reino Unido


PAMIDRONATO HOSPIRA 9 mg/ml concentrado para solución para perfusión


9 mg/ml


Concentrate for solution for infusion


Intravenous




ES - Spain


NOVARTIS FARMACEUTICA, S.A.Gran Via de les Corts Catalanes, 764 08013 Barcelona


AREDIA 15 mg polvo y disolvente para solución para perfusión


15 mg polvo


solution for infusion


Intravenous




ES - Spain


NOVARTIS FARMACEUTICA, S.A.Gran Via de les Corts Catalanes, 764 08013 Barcelona


AREDIA 30 mg polvo y disolvente para solución para perfusión


30 mg


solution for infusion


Intravenous




ES - Spain


NOVARTIS FARMACEUTICA, S.A.Gran Via de les Corts Catalanes, 764 08013 Barcelona


AREDIA 90 mg polvo y disolvente para solución para perfusión


90 mg


solution for infusion


Intravenous




ES - Spain


GENERIS FARMACÉUTICA, S.A.MOIÁ, 1, 2o 08006 BARCELONA


PAMIDRONATO GENERIS 15 mg/ml concentrado para solución para perfusión


15 mg/ml


Concentrate for solution for infusion


Intravenous




ES - Spain


LABORATORIO STADA, S.L. Frederic Mompou, 5 08960 Sant Just Desvern


PAMIDRONATO STADA 3 mg/ml concentrado para solución para perfusión


3 mg /ml


Concentrate for solution for infusion


Intravenous




ES - Spain


MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH Fehlandtstrasse 3 Hamburgo D-20354


PAMIFOS 3 mg/ml concentrado para solución para perfusión


3 mg /ml


Concentrate for solution for infusion


Intravenous




ES - Spain


LABORATORIO STADA, S.L. Frederic Mompou, 5 08960 Sant Just Desvern


PAMIDRONATO TEVA 3 mg/ml, concentrado para solución para perfusión


3 mg /ml


Concentrate for solution for infusion


Intravenous




ES - Spain


COMBINO PHARM, S.L.Fructuos Gelabert, 6-8 08970 Sant Joan Despi


PAMIDRONATO DISODICO COMBINO PHARM 15 mg polvo para solución para perfusión


15 mg


solution for infusion


Intravenous




ES - Spain


COMBINO PHARM, S.L.Fructuos Gelabert, 6-8 08970 Sant Joan Despi


PAMIDRONATO DISODICO COMBINO PHARM 30 mg polvo para solución para perfusión


30 mg


solution for infusion


Intravenous




ES - Spain


COMBINO PHARM, S.L.Fructuos Gelabert, 6-8 08970 Sant Joan Despi


PAMIDRONATO DISODICO COMBINO PHARM 60 mg polvo para solución para perfusión


60 mg


solution for infusion


Intravenous




ES - Spain


COMBINO PHARM, S.L.Fructuos Gelabert, 6-8 08970 Sant Joan Despi


PAMIDRONATO DISODICO COMBINO PHARM 90 mg polvo para solución para perfusión


90 mg


solution for infusion


Intravenous




ET - Estonia







Novartis Finland OY Metsänneidonkuja 10




FIN-02130 Espoo FINLAND






AREDIA


15 mg


Powder and solvent for solution for infusion


Intravenous




ET - Estonia


Torrex Chiesi Pharma GmbH Gonzagagasse 16/16, 1010 Vienna AUSTRIA


PAMITOR 15 MG/ML


15 mg 1 ml


Concentrate for solution for infusion


Intravenous




FI - Finland


medac Gesellschaft für klinische Spezialpräparate mbH, Fehlandtstrasse 3, 20354 Hamburg, Germany


Pamifos


3 mg/ml


Concentrate for solution for infusion


Intravenous




FI - Finland


Stada Arzneimittel AG, Stadastrasse 2 - 18, 61118 BAD VILBEL, Germany


Paminject


3 mg/ml


Concentrate for solution for infusion


Intravenous




FI - Finland


Meda Oy, Vaisalantie 4, 02130 Espoo, Finland


Pamidronat Meda


15 mg/ml


Concentrate for solution for infusion


Intravenous




FI - Finland


Hospira UK Limited, Queensway, Royal Leamington Spa, WARWICKSHIRE CV313RW, United Kingdom


Pamidronatdinatrium Hospira


3 mg/ml


Concentrate for solution for infusion


Intravenous




FI - Finland


Hospira UK Limited, Queensway, Royal Leamington Spa, WARWICKSHIRE CV313RW, United Kingdom


Pamidronatdinatrium Hospira


6 mg/ml


Concentrate for solution for infusion


Intravenous




FI - Finland


Hospira UK Limited, Queensway, Royal Leamington Spa, WARWICKSHIRE CV313RW, United Kingdom


Pamidronatdinatrium Hospira


9 mg/ml


Concentrate for solution for infusion


Intravenous




FI - Finland


BMM Pharma AB, Blasieholmsgatan 2, 11148 Stockholm, Sweden


Pamidronate BMM Pharma


3 mg/ml


Concentrate for solution for infusion


Intravenous




FI - Finland


BMM Pharma AB, Blasieholmsgatan 2, 11148 Stockholm, Sweden


Pamidronate BMM Pharma


6 mg/ml


Concentrate for solution for infusion


Intravenous




FI - Finland


BMM Pharma AB, Blasieholmsgatan 2, 11148 Stockholm, Sweden


Pamidronate BMM Pharma


9 mg/ml


Concentrate for solution for infusion


Intravenous




FR - France







NOVARTIS PHARMA




2-4, rue Lionel Terray




92500 Rueil-Malmaison




FRANCE






AREDIA 15 mg/5 ml, poudre et solvant pour solution pour perfusion


15 mg/5 ml


powder and solvent


Intravenous




FR - France







NOVARTIS PHARMA




2-4, rue Lionel Terray




92500 Rueil-Malmaison




FRANCE






AREDIA 60 mg/10 ml, poudre et solvant pour solution pour perfusion


60 mg/10 ml


powder and solvent


Intravenous




FR - France







NOVARTIS PHARMA




2-4, rue Lionel Terray




92500 Rueil-Malmaison




FRANCE






AREDIA 90 mg/10 ml, poudre et solvant pour solution pour perfusion


90 mg/10 ml


powder and solvent


Intravenous




FR - France







NORDIC PHARMA




216, boulevard Saint Germain




75007 Paris




FRANCE






OSTEPAM 15 mg/ml, solution à diluer pour perfusion


15 mg/ml


solution


Intravenous




FR - France







AGUETTANT




1, rue Alexander Fleming




69007 Lyon




FRANCE






PAMIDRONATE DE SODIUM AGUETTANT 15 mg/5 ml, poudre et solvant pour solution pour perfusion


15 mg/5 ml


powder and solvent


Intravenous




FR - France







AGUETTANT




1, rue Alexander Fleming




69007 Lyon




FRANCE






PAMIDRONATE DE SODIUM AGUETTANT 60 mg/10 ml, poudre et solvant pour solution pour perfusion


60 mg/10 ml


powder and solvent


Intravenous




FR - France







AGUETTANT




1, rue Alexander Fleming




69007 Lyon




FRANCE






PAMIDRONATE DE SODIUM AGUETTANT 90 mg/10 ml, poudre et solvant pour solution pour perfusion


90 mg/10 ml


powder and solvent


Intravenous




FR - France







HOSPIRA FRANCE




17-19, rue Jeanne Braconnier




Immeuble Volta




92360 Meudon La Forêt




FRANCE






PAMIDRONATE DE SODIUM HOSPIRA 3 mg/ml, solution à diluer pour perfusion


3 mg/ml


solution


Intravenous




FR - France







HOSPIRA FRANCE




17-19, rue Jeanne Braconnier




Immeuble Volta




92360 Meudon La Forêt




FRANCE






PAMIDRONATE DE SODIUM HOSPIRA 6 mg/ml, solution à diluer pour perfusion


6 mg/ml,


solution


Intravenous




FR - France







HOSPIRA FRANCE




17-19, rue Jeanne Braconnier




Immeuble Volta




92360 Meudon La Forêt




FRANCE






PAMIDRONATE DE SODIUM HOSPIRA 9 mg/ml, solution à diluer pour perfusion


9 mg/ml


solution


Intravenous




FR - France







MYLAN SAS




117, allée des Parcs




69800 Saint-Priest




FRANCE






PAMIDRONATE DE SODIUM MYLAN 3 mg/ml, solution à diluer pour perfusion


3 mg/ml


solution


Intravenous




FR - France







NOVARTIS PHARMA




2-4, rue Lionel Terray




92500 Rueil-Malmaison




FRANCE






PAMIDRONATE DE SODIUM NOVARTIS PHARMA 15 mg/5 ml, poudre et solvant pour solution pour perfusion


15 mg/5 ml


powder and solvent


Intravenous




FR - France







NOVARTIS PHARMA




2-4, rue Lionel Terray




92500 Rueil-Malmaison




FRANCE






PAMIDRONATE DE SODIUM NOVARTIS PHARMA 60 mg/10 ml, poudre et solvant pour solution pour perfusion


60 mg/10 ml


powder and solvent


Intravenous




FR - France







NOVARTIS PHARMA




2-4, rue Lionel Terray




92500 Rueil-Malmaison




FRANCE






PAMIDRONATE DE SODIUM NOVARTIS PHARMA 90 mg/10 ml, poudre et solvant pour solution pour perfusion


90 mg/10 ml


powder and solvent


Intravenous




FR - France







RATIOPHARM (ALLEMAGNE)




Graf Arco Strasse 3




89079 Ulm




ALLEMAGNE






PAMIDRONATE DE SODIUM RATIOPHARM 3 mg/ml, solution à diluer pour perfusion


3 mg/ml


solution


Intravenous




FR - France







TEVA SANTE




Le Palatin 1




1 cours du Triangle




92936 Paris la Défense Cedex




FRANCE






PAMIDRONATE DE SODIUM TEVA 3 mg/ml, solution à diluer pour perfusion


3 mg/ml


solution


Intravenous




FR - France







PHARMAKI GENERICS (ROYAUME-UNI)




5 Bourlet Close




W1W 7BL London




ROYAUME-UNI






PAMIDRONATE PHARMAKI GENERICS 3 mg/ml, solution à diluer pour perfusion


3 mg/ml


solution


Intravenous




FR - France







PHARMAKI GENERICS (ROYAUME-UNI)




5 Bourlet Close




W1W 7BL London




ROYAUME-UNI






PAMIDRONATE PHARMAKI GENERICS 6 mg/ml, solution à diluer pour perfusion


6 mg/ml


solution


Intravenous




FR - France







PHARMAKI GENERICS (ROYAUME-UNI)




5 Bourlet Close




W1W 7BL London




ROYAUME-UNI






PAMIDRONATE PHARMAKI GENERICS 9 mg/ml, solution à diluer pour perfusion


9 mg/ml


solution


Intravenous




FR - France







EG LABO - LABORATOIRES EUROGENERICS




"Le Quintet" - bâtiment A




12, rue Danjou




92517 Boulogne Billancourt Cedex




FRANCE






PAMINJECT 3 mg/ml, solution à diluer pour perfusion


3 mg/ml


solution


Intravenous




HU - Hungary







Novartis Hungária Kft. Pharma részlege




Bartók Béla út 43-47. Bartók-Ház, V. em.




1114 Budapest




Hungary






AREDIA 30 mg por és oldószer oldatos infúzióhoz


30,0 mg Disodium pamidronate, anhydrous [from Disodium pamidronate pentahydrate


powder and solvent for solution for infusion


Parenteral




HU - Hungary







Hospira UK Limited




Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, UK






PAMIDRONATE HOSPIRA 3 mg/ml koncentrátum oldatos infúzióhoz, 5 ml


3 mg/ml Pamidronic acid (equal to pamidronate disodium)


concentrate for solution for infusion


Parenteral




HU - Hungary







Hospira UK Limited




Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, UK






PAMIDRONATE HOSPIRA 3 mg/ml koncentrátum oldatos infúzióhoz, 10 ml


3 mg/ml Pamidronic acid (equal to pamidronate disodium)


concentrate for solution for infusion


Parenteral




HU - Hungary







Hospira UK Limited




Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, UK






PAMIDRONATE HOSPIRA 6 mg/ml koncentrátum oldatos infúzióhoz


6 mg/ml Pamidronic acid (equal to pamidronate disodium)


concentrate for solution for infusion


Parenteral




HU - Hungary







Hospira UK Limited




Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, UK






PAMIDRONATE HOSPIRA 9 mg/ml koncentrátum oldatos infúzióhoz


9 mg/ml Pamidronic acid (equal to pamidronate disodium)


concentrate for solution for infusion


Parenteral




HU - Hungary







Medac GmbH




Fehlandstrasse 3.




20354 Hamburg




Germany






PAMIFOS 3 mg/ml koncentrátum oldatos infúzióhoz


3 mg/ml Disodium pamidronate (equal to Pamidronic acid)


concentrate for solution for infusion


Parenteral




HU - Hungary







Torrex Chiesi Pharma GmbH




Gonzagagasse 16/16.




1010 Vienna




Austria






PAMITOR 15 mg/ml koncentrátum oldatos infúzióhoz


15 mg/ ml Disodium pamidronate (equal to 12,6 mg pamidronic acid)


concentrate for solution for infusion


Parenteral




IE - Ireland


Novartis Pharmaceuticals UK Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK


Aredia


30 mg


Powder and solvent for concentrate for solution for infusion


Slow intravenous infusion




IE - Ireland


Novartis Pharmaceuticals UK Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK


Aredia


90 mg


Powder and solvent for concentrate for solution for infusion


Slow intravenous infusion




IS - Iceland


Hospira UK Limited, Queensway Royale Leamington Spa, Warwickshire CV31 3RW United Kingdom


Pamidronatdinatrium Hospira 3 mg/ml


3 mg/ml


Concentrate for solution for infusion


Intravenous




IS - Iceland


Hospira UK Limited, Queensway Royale Leamington Spa, Warwickshire CV31 3RW United Kingdom


Pamidronatdinatrium Hospira 6 mg/ml


6 mg/ml


Concentrate for solution for infusion


Intravenous




IS - Iceland


Hospira UK Limited, Queensway Royale Leamington Spa, Warwickshire CV31 3RW United Kingdom


Pamidronatdinatrium Hospira 9 mg/ml


9 mg/ml


Concentrate for solution for infusion


Intravenous




IT - Italy







BIOINDUSTRIA L.I.M. SpA




Via de Ambrosiis, 2




15067 Novi Ligure (AL)






PAMIDRONATO BIOINDUSTRIA LIM


15 mg/5 ml


Powder and solvent for concentrate for solution for infusion


Intravenous




IT - Italy







BIOINDUSTRIA L.I.M. SpA




Via de Ambrosiis, 2




15067 Novi Ligure (AL)






PAMIDRONATO BIOINDUSTRIA LIM


30 mg/10 ml


Powder and solvent for concentrate for solution for infusion


Intravenous




IT - Italy







BIOINDUSTRIA L.I.M. SpA




Via de Ambrosiis, 2




15067 Novi Ligure (AL)






PAMIDRONATO BIOINDUSTRIA LIM


60 mg/10 ml


Powder and solvent for concentrate for solution for infusion


Intravenous




IT - Italy







BIOINDUSTRIA L.I.M. SpA




Via de Ambrosiis, 2




15067 Novi Ligure (AL)






PAMIDRONATO BIOINDUSTRIA LIM


90 mg/10 ml


Powder and solvent for concentrate for solution for infusion


Intravenous




IT - Italy







HIKMA ITALIA SpA




Viale Certosa, 10




27100 Pavia






PAMIDRONATO DISODICO HIKMA


15 mg/5 ml


Solution for infusion


Intravenous




IT - Italy







HIKMA ITALIA SpA




Viale Certosa, 10




27100 Pavia






PAMIDRONATO DISODICO HIKMA


30 mg/10 ml


Solution for infusion


Intravenous




IT - Italy







HIKMA ITALIA SpA




Viale Certosa, 10




27100 Pavia






PAMIDRONATO DISODICO HIKMA


60 mg/10 ml


Solution for infusion


Intravenous




IT - Italy







HIKMA ITALIA SpA




Viale Certosa, 10




27100 Pavia






PAMIDRONATO DISODICO HIKMA


90 mg/10 ml


Solution for infusion


Intravenous




IT - Italy







HOSPIRA ITALIA Srl




Via Orazio, 20/22




80122 Napoli






PAMIDRONATO DISODICO HIKMA Attenzione: E' Hospira


15 mg


Solution for injection


Intravenous




IT - Italy







HOSPIRA ITALIA Srl




Via Orazio, 20/22




80122 Napoli






PAMIDRONATO DISODICO HOSPIRA


3 mg/ml


concentrate for solution for infusion


Intravenous




IT - Italy







HOSPIRA ITALIA Srl




Via Orazio, 20/22




80122 Napoli






PAMIDRONATO DISODICO HOSPIRA


6 mg/ml


concentrate for solution for infusion


Intravenous




IT - Italy







HOSPIRA ITALIA Srl




Via Orazio, 20/22




80122 Napoli






PAMIDRONATO DISODICO HOSPIRA


9 mg/ml


concentrate for solution for infusion


Intravenous




IT - Italy







NOVARTIS FARMA SpA




Largo Umberto Boccioni, 2




21040 Origgio (VA)






AREDIA


15 mg/5 ml


Powder and solvent for solution for infusion


Intravenous




IT - Italy







NOVARTIS FARMA SpA




Largo Umberto Boccioni, 2




21040 Origgio (VA)






AREDIA


30 mg/10 ml


Powder and solvent for solution for infusion


Intravenous




IT - Italy







NOVARTIS FARMA SpA




Largo Umberto Boccioni, 2




21040 Origgio (VA)






AREDIA


60 mg/10 ml


Powder and solvent for solution for infusion


Intravenous




IT - Italy







NOVARTIS FARMA SpA




Largo Umberto Boccioni, 2




21040 Origgio (VA)






AREDIA


90 mg/10 ml


Powder and solvent for solution for infusion


Intravenous




IT - Italy







PHARMATEX ITALIA Srl




Via Appiani, 22




20121 Milano






TEXPAMI


15 mg/5 ml


Solution for infusion


Intravenous




IT - Italy







PHARMATEX ITALIA Srl




Via Appiani, 22




20121 Milano






TEXPAMI


30 mg/10 ml


Solution for infusion


Intravenous




IT - Italy







PHARMATEX ITALIA Srl




Via Appiani, 22




20121 Milano






TEXPAMI


60 mg/10 ml


Solution for infusion


Intravenous




IT - Italy







PHARMATEX ITALIA Srl




Via Appiani, 22




20121 Milano






TEXPAMI


90 mg/10 ml


Solution for infusion


Intravenous




IT - Italy







RATIOPHARM GMBH




Graf Arco-strasse, 3




Ulm D-89070






PAMIDRONATO RATIOPHARM


3 mg/ml


concentrate for solution for infusion


Intravenous




IT - Italy







TEVA ITALIA Srl




Via Messina, 38 - 20154




Milano






PAMIDRONATO TEVA


3 mg/ml


concentrate for solution for infusion


Intravenous




IT - Italy







CRINOS SpA




Via Pavia, 6




20136 Milano






AMIDROX


3 mg/ml


concentrate for solution for infusion


Intravenous




IT - Italy







Actavis Itlay S.p.A.




Via Luigi Pasteur, 10




20014 Nerviano (MI) Italy






PAMIDRONATO ACTAVIS


3 mg/ml


concentrate for solution for infusion


Intravenous




IT - Italy







Actavis Itlay S.p.A.




Via Luigi Pasteur, 10




20014 Nerviano (MI) Italy






PAMIDRONATO ACTAVIS


6 mg/ml


concentrate for solution for infusion


Intravenous




IT - Italy







Actavis Itlay S.p.A.




Via Luigi Pasteur, 10




20014 Nerviano (MI) Italy






PAMIDRONATO ACTAVIS


9 mg/ml


concentrate for solution for infusion


Intravenous




LT - Lithuania


Torrex Chiesi -Pharma GmbH, Gonzagagasse 16/16, 1010 Viena, Austria


Pamitor


60 mg/4 ml


Concentrate for solution for infusion


Intravenous




LT - Lithuania


Torrex Chiesi -Pharma GmbH, Gonzagagasse 16/16, 1010 Viena, Austria


Pamitor


90 mg/6 ml


Concentrate for solution for infusion


Intravenous




LT - Lithuania


Torrex Chiesi -Pharma GmbH, Gonzagagasse 16/16, 1010 Viena, Austria


Pamitor


30 mg/2 ml


Concentrate for solution for infusion


Intravenous




LT - Lithuania


Torrex Chiesi -Pharma GmbH, Gonzagagasse 16/16, 1010 Viena, Austria


Pamitor


15 mg/ml


Concentrate for solution for infusion


Intravenous




LT - Lithuania


Hospira UK Limited, Queensway Royal Leamington Spa Warwickshire CV 31 3RW, United Kingdom


Pamidronate disodium Hospira


9 mg/ ml


Concentrate for solution for infusion


Intravenous




LT - Lithuania


Hospira UK Limited, Queensway Royal Leamington Spa Warwickshire CV 31 3RW, United Kingdom


Pamidronate disodium Hospira


6 mg/ ml


Concentrate for solution for infusion


Intravenous




LT - Lithuania


Hospira UK Limited, Queensway Royal Leamington Spa Warwickshire CV 31 3RW, United Kingdom


Pamidronate disodium Hospira


3 mg/ml


Concentrate for solution for infusion


Intravenous




LU - Luxembourg







NOVARTIS PHARMA GMBH




25, ROONSTRASSE




D 90429 NUERNBERG






Aredia


15 mg


powder for infusion


Intravenous




LU - Luxembourg







EUROGENERICS S.A




ESPLANADE HEYSEL, B.22




B 1020 BRUXELLES






Paminject


3 mg/ml


solution for infusion


Intravenous




LU - Luxembourg







HOSPIRA BENELUX SPRL




63, RUE DE STALLE




B 1180 BRUXELLES






Pamidronate Disodique Hospira


3 mg/ml


solution for infusion


Intravenous




LU - Luxembourg







HOSPIRA BENELUX SPRL




63, RUE DE STALLE




B 1180 BRUXELLES






Pamidronate Disodique Hospira


6 mg/ml


solution for infusion


Intravenous




LU - Luxembourg







TEVA PHARMA BELGIUM S.A.




16, LAARSTRAAT




B 2610 WILRIJK






Pamidrin


3 mg/ml


solution for infusion


Intravenous




LV - Latvia


Torrex Chiesi Pharma GmbH, Gonzagagasse 16/16, 1010 Vienna, Austria


PAMITOR


15 mg/ml


Concentrate for solution for infusion


Intravenous




LV - Latvia


Torrex Chiesi Pharma GmbH, Gonzagagasse 16/16, 1010 Vienna, Austria


PAMITOR


30 mg/2 ml


Concentrate for solution for infusion


Intravenous




LV - Latvia


Torrex Chiesi Pharma GmbH, Gonzagagasse 16/16, 1010 Vienna, Austria


PAMITOR


60 mg/4 ml


Concentrate for solution for infusion


Intravenous




LV - Latvia


Torrex Chiesi Pharma GmbH, Gonzagagasse 16/16, 1010 Vienna, Austria


PAMITOR


90 mg/6 ml


Concentrate for solution for infusion


Intravenous




MT - Malta







Novartis Pharmaceuticals UK Limited




Frimley Business Park, Frimley,




Camberley, Surrey GU16 7SR




England






Aredia


15 mg


powder and solvent for solution for infusion


Intravenous




MT - Malta







Novartis Pharmaceuticals UK Limited




Frimley Business Park, Frimley,




Camberley, Surrey GU16 7SR




England






Aredia


30 mg


powder and solvent for solution for infusion


Intravenous




MT - Malta







Novartis Pharmaceuticals UK Limited




Frimley Business Park, Frimley,




Camberley, Surrey GU16 7SR




England






Aredia


60 mg


powder and solvent for solution for infusion


Intravenous




MT - Malta







Novartis Pharmaceuticals UK Limited




Frimley Business Park, Frimley,




Camberley, Surrey GU16 7SR




England






Aredia


90 mg


powder and solvent for solution for infusion


Intravenous




NL - Netherlands







Nordic Pharma B.V.




Tolweg 15




3741 LM Baarn Netherlands






Pamidronaat dinatrium 15 mg


15 mg


Powder for solution for infusion


Intravenous




NL - Netherlands







Nordic Pharma B.V.




Tolweg 15




3741 LM Baarn Netherlands






Pamidronaat dinatrium 30 mg


30 mg


Powder for solution for infusion


Intravenous




NL - Netherlands







Nordic Pharma B.V.




Tolweg 15




3741 LM Baarn Netherlands






Pamidronaat dinatrium 60 mg


60 mg


Powder for solution for infusion


Intravenous




NL - Netherlands







Nordic Pharma B.V.




Tolweg 15




3741 LM Baarn Netherlands






Pamidronaat dinatrium 90 mg


90 mg


Powder for solution for infusion


Intravenous




NL - Netherlands







Pharmachemie B.V.




Swensweg 5




2031 GA Haarlem Netherlands






Pamidronaatdinatrium 3 mg/ml PCH


3 mg/ml


Concentrate for solution for infusion


Intravenous




NL - Netherlands


All-gen Pharmaceuticals & Generics B.V. Rouboslaan 32 2252 TR Voorschoten Netherlands


Pamidronaatdinatrium Allgen 3 mg/ml


3 mg/ml


Concentrate for solution for infusion


Intravenous




NL - Netherlands


All-gen Pharmaceuticals & Generics B.V. Rouboslaan 32 2252 TR Voorschoten Netherlands


Pamidronaatdinatrium Allgen 6 mg/ml


6 mg/ml


Concentrate for solution for infusion


Intravenous




NL - Netherlands


All-gen Pharmaceuticals & Generics B.V. Rouboslaan 32 2252 TR Voorschoten Netherlands


Pamidronaatdinatrium Allgen 9 mg/ml


9 mg/ml


Concentrate for solution for infusion


Intravenous




NL - Netherlands


Hospira Benelux BVBA, Stallestraat 63 1180 Brussel Belgium


Pamidronaatdinatrium Hospira 3 mg/ml


3 mg/ml


Concentrate for solution for infusion


Intravenous




NL - Netherlands


Hospira Benelux BVBA, Stallestraat 63 1180 Brussel Belgium


Pamidronaatdinatrium Hospira 6 mg/ml


6 mg/ml


Concentrate for solution for infusion


Intravenous




NL - Netherlands


Hospira Benelux BVBA, Stallestraat 63 1180 Brussel Belgium


Pamidronaatdinatrium Hospira 9 mg/ml


9 mg/ml


Concentrate for solution for infusion


Intravenous




NL - Netherlands


Medac Gesellschaft für klinische Spezialpreparate mbH Fehlandtstr. 3 20354 Hamburg Germany


Pamipro 3 mg/ml


3 mg/ml


Concentrate for solution for infusion


Intravenous




NO - Norway


Meda, postboks 194, 1371 Asker Norawy


Pamidronat Meda


15 mg/ml


Concentrate for solution for infusion


Intravenous




NO - Norway


Hospira UK Limited, Queensway, Royal Leamington Spa, CV31 3RW Warwickshire, Great Britain


Pamidronatdinatrium Hospira


3 mg/ml


Concentrate for solution for infusion


Intravenous




NO - Norway


Hospira UK Limited, Queensway, Royal Leamington Spa, CV31 3RW Warwickshire, Great Britain


Pamidronatdinatrium Hospira


6 mg/ml


Concentrate for solution for infusion


Intravenous




NO - Norway


Hospira UK Limited, Queensway, Royal Leamington Spa, CV31 3RW Warwickshire, Great Britain


Pamidronatdinatrium Hospira


9 mg/ml


Concentrate for solution for infusion


Intravenous




PL - Poland







Hospira UK Limited




Queensway,




CV31 3RW, Royal Leamington Spa, Warwickshire, United Kingdom






Pamisol 3 mg/ml


3 mg/ml


concentrate for solution for infusion


Intravenous




PL - Poland







Hospira UK Limited




Queensway,




CV31 3RW, Royal Leamington Spa, Warwickshire, United Kingdom






Pamisol 6 mg/ml


6 mg/ml


concentrate for solution for infusion


Intravenous




PL - Poland







Farmacom Sp. z o.o.




Mogilska 80 st.




31-546, Cracow, Poland






Pamidia


3 mg


concentrate for solution for infusion


Intravenous




PL - Poland







Farmacom Sp. z o.o.




Mogilska 80 st.




31-546, Cracow, Poland






Pamidia


6 mg


concentrate for solution for infusion


Intravenous




PL - Poland







Farmacom Sp. z o.o.




Mogilska 80 st.




31-546, Cracow, Poland






Pamidia


9 mg


concentrate for solution for infusion


Intravenous




PL - Poland







medac Gesellschaft fur klinische Specialpraparate mbH




Theaterstrasse 6




22880 Wedel / Germany






Pamidronat medac 3 mg / ml


3 mg/ml


concentrate for solution for infusion


Intravenous




PL - Poland







ratiopharm GmbH




Graf-Arco-Strasse 3, Ulm, 89073, Germany






Pamidronat-ratiopharm


3 mg/ml


concentrate for solution for infusion


Intravenous




PL - Poland







VIPHARM S.A.




Przewoźników st. 11




03-691 Warsaw, Poland






Pamifos-15


15 mg


powder and solvent for solution for infusion


Intravenous




PL - Poland







VIPHARM S.A.




Przewoźników st. 11




03-691 Warsaw, Poland






Pamifos-30


30 mg


powder and solvent for solution for infusion


Intravenous




PL - Poland







VIPHARM S.A.




Przewoźników st. 11




03-691 Warsaw, Poland






Pamifos-60


60 mg


powder and solvent for solution for infusion


Intravenous




PL - Poland







VIPHARM S.A.




Przewoźników st. 11




03-691 Warsaw, Poland






Pamifos-90


90 mg


powder and solvent for solution for infusion


Intravenous




PL - Poland







STADA Arzneimittel AG




Stadastraße 2-18




61118 Bad Vilbel, Germany






Pamistad


3 mg/ml


concentrate for solution for infusion


Intravenous




PL - Poland







Torrex Chiesi Pharma GmbH




Gonzagagasse 16/16,




A-1010 Vienna, Austria






Pamitor


15 mg/ml


concentrate for solution for infusion


Intravenous




PL - Poland







Novartis Pharma GmbH




Roonstraße 25




D-90429 Nürnberg, Germany






Aredia


60 mg


powder and solvent for solution for infusion


Intravenous




PL - Poland







Novartis Pharma GmbH




Roonstraße 25




D-90429 Nürnberg, Germany






Aredia


90 mg


powder and solvent for solution for infusion


Intravenous




PT - Portugal


Hospira Portugal, Lda. Rua Amália Rodrigues, n.o 240, 2750-228 Cascais Portugal


Pamidran


3 mg/ml


Concentrate for solution for infusion


Intravenous




PT - Portugal


Hospira Portugal, Lda. Rua Amália Rodrigues, n.o 240, 2750-228 Cascais Portugal


Pamidran


6 mg/ml


Concentrate for solution for infusion


Intravenous




PT - Portugal


Hospira Portugal, Lda. Rua Amália Rodrigues, n.o 240, 2750-228 Cascais Portugal


Pamidran


9 mg/ml


Concentrate for solution for infusion


Intravenous




PT - Portugal


Generis Farmacêutica, S.A. Office Park da Beloura, Edificio 4 - Piso 1, Escrit. 8, 2710-444 Sintra Portugal


Pamidronato APS


15 mg/ml


Concentrate for solution for infusion


Intravenous




PT - Portugal


Laboratórios Azevedos - Indústria Farmacêutica, S.A. Estrada da Quinta, 148-148 A, Manique de Baixo 2645-436 Alcabideche Portugal


Pamidronato Azevedos 15 mg Pó para perfusão


15 mg


Powder for solution for infusion


Intravenous




PT - Portugal


Laboratórios Azevedos - Indústria Farmacêutica, S.A. Estrada da Quinta, 148-148 A, Manique de Baixo 2645-436 Alcabideche Portugal


Pamidronato Azevedos 30 mg Pó para perfusão


30 mg


Powder for solution for infusion


Intravenous




PT - Portugal


Laboratórios Azevedos - Indústria Farmacêutica, S.A. Estrada da Quinta, 148-148 A, Manique de Baixo 2645-436 Alcabideche Portugal


Pamidronato Azevedos 90 mg Pó para perfusão


90 mg


Powder for solution for infusion


Intravenous




PT - Portugal


Laboratórios Azevedos - Indústria Farmacêutica, S.A. Estrada da Quinta, 148-148 A, Manique de Baixo 2645-436 Alcabideche Portugal


Pamidronato Azevedos 60 mg Pó para perfusão


60 mg


Powder for solution for infusion


Intravenous




PT - Portugal


Teva Pharma - Produtos Farmacêuticos, Lda. Edifício Cyprium, Av. 25 de Abril, 15, 2o F, 2795-195 Linda-a-Velha Portugal


Pamidronato Teva


3 mg/ml


Concentrate for solution for infusion


Intravenous




PT - Portugal


Hikma Farmacêutica (Portugal), S.A. Estrada do Rio da Mó, 8 - 8 A/B - Fervença, 2705-906 Terrugem (SNT) Portugal


Pamidronato Hikma


3 mg/ml


Concentrate for solution for infusion


Intravenous




PT - Portugal


Hikma Farmacêutica (Portugal), S.A. Estrada do Rio da Mó, 8 - 8 A/B - Fervença, 2705-906 Terrugem (SNT) Portugal


Pamidronato Hikma


6 mg/ml


Concentrate for solution for infusion


Intravenous




PT - Portugal


Hikma Farmacêutica (Portugal), S.A. Estrada do Rio da Mó, 8 - 8 A/B - Fervença, 2705-906 Terrugem (SNT) Portugal


Pamidronato Hikma


9 mg/ml


Concentrate for solution for infusion


Intravenous




PT - Portugal


Hospira Portugal, Lda. Rua Amália Rodrigues, n.o 240, 2750-228 Cascais Portugal


Pamidran


3 mg/ml


Concentrate for solution for infusion


Intravenous




PT - Portugal


Hospira Portugal, Lda. Rua Amália Rodrigues, n.o 240, 2750-228 Cascais Portugal


Pamidran


6 mg/ml


Concentrate for solution for infusion


Intravenous




PT - Portugal


Hospira Portugal, Lda. Rua Amália Rodrigues, n.o 240, 2750-228 Cascais Portugal


Pamidran


9 mg/ml


Concentrate for solution for infusion


Intravenous




PT - Portugal


Generis Farmacêutica, S.A. Office Park da Beloura, Edificio 4 - Piso 1, Escrit. 8, 2710-444 Sintra Portugal


Pamidronato APS


15 mg/ml


Concentrate for solution for infusion


Intravenous




PT - Portugal


Laboratórios Azevedos - Indústria Farmacêutica, S.A. Estrada da Quinta, 148-148 A, Manique de Baixo 2645-436 Alcabideche Portugal


Pamidronato Azevedos 15 mg Pó para perfusão


15 mg


Powder for solution for infusion


Intravenous




PT - Portugal


Laboratórios Azevedos - Indústria Farmacêutica, S.A. Estrada da Quinta, 148-148 A, Manique de Baixo 2645-436 Alcabideche Portugal


Pamidronato Azevedos 30 mg Pó para perfusão


30 mg


Powder for solution for infusion


Intravenous




PT - Portugal


Laboratórios Azevedos - Indústria Farmacêutica, S.A. Estrada da Quinta, 148-148 A, Manique de Baixo 2645-436 Alcabideche Portugal


Pamidronato Azevedos 90 mg Pó para perfusão


90 mg


Powder for solution for infusion


Intravenous




PT - Portugal


Laboratórios Azevedos - Indústria Farmacêutica, S.A. Estrada da Quinta, 148-148 A, Manique de Baixo 2645-436 Alcabideche Portugal


Pamidronato Azevedos 60 mg Pó para perfusão


60 mg


Powder for solution for infusion


Intravenous




PT - Portugal


Teva Pharma - Produtos Farmacêuticos, Lda. Edifício Cyprium, Av. 25 de Abril, 15, 2o F, 2795-195 Linda-a-Velha Portugal


Pamidronato Teva


3 mg/ml


Concentrate for solution for infusion


Intravenous




PT - Portugal


Hikma Farmacêutica (Portugal), S.A. Estrada do Rio da Mó, 8 - 8 A/B - Fervença, 2705-906 Terrugem (SNT) Portugal


Pamidronato Hikma


3 mg/ml


Concentrate for solution for infusion


Intravenous




PT - Portugal


Hikma Farmacêutica (Portugal), S.A. Estrada do Rio da Mó, 8 - 8 A/B - Fervença, 2705-906 Terrugem (SNT) Portugal


Pamidronato Hikma


6 mg/ml


Concentrate for solution for infusion


Intravenous




PT - Portugal


Hikma Farmacêutica (Portugal), S.A. Estrada do Rio da Mó, 8 - 8 A/B - Fervença, 2705-906 Terrugem (SNT) Portugal


Pamidronato Hikma


9 mg/ml


Concentrate for solution for infusion


Intravenous




RO - Romania


NOVARTIS PHARMA GmbH Roonstrasse 25 D-90429 Nürnberg, Germany


AREDIA 15 mg/ml powder and solvent for solution for infusion


15 mg/ml


powder and solvent for solution for infusion


Parenteral




RO - Romania


TORREX CHIESI PHARMA GmbH Gonzagagasse 16/16, A-1010, Viena, Austria


PAMIDRONAT TORREX 15 mg/ml powder for solution for infusion


15 mg/ml


powder for solution for infusion


Parenteral




RO - Romania


DR. REDDY'S LABORATORIES Str. Av. Petre Crețu, nr. 74, Sector 1, București, Romania


PAMIRED 60 powder for solution for infusion


60 mg


powder for solution for infusion


Parenteral




RO - Romania


DR. REDDY'S LABORATORIES Str. Av. Petre Crețu, nr. 74, Sector 1, București, Romania


PAMIRED 30 powder for solution for infusion


30 mg


powder for solution for infusion


Parenteral




SE - Sweden


Hospira UK Limited Queensway Royal Leamington Spa Warwickshire, CV31 3RW United Kingdom


Pamidronatdinatrium Hospira


3 mg/ml


concentrate for solution for infusion


For infusion




SE - Sweden


Hospira UK Limited Queensway Royal Leamington Spa Warwickshire, CV31 3RW United Kingdom


Pamidronatdinatrium Hospira


6 mg/ml


concentrate for solution for infusion


For infusion




SE - Sweden


Hospira UK Limited Queensway Royal Leamington Spa Warwickshire, CV31 3RW United Kingdom


Pamidronatdinatrium Hospira


9 mg/ml


concentrate for solution for infusion


For infusion




SE - Sweden


Meda AB 170 09 Solna Sweden


Pamidronat Meda


15 mg/ml


concentrate for solution for infusion


For infusion




SE - Sweden


Teva Sweden AB Box 1070 251 10 Helsingborg Sweden


Pamidronat Teva


3 mg/ml


concentrate for solution for infusion


For infusion




SE - Sweden


STADA Arzneimittel AG Stadastrasse 2-18 DE-61118 Bad Vilbel Germany


Pamidrocell


3 mg/ml


concentrate for solution for infusion


For infusion




SE - Sweden


BMM Pharma AB Blasieholmsgatan 2 111 48 Stockholm Sweden


Pamidronate BMM Pharma


3 mg/ml


concentrate for solution for infusion


For infusion




SE - Sweden


BMM Pharma AB Blasieholmsgatan 2 111 48 Stockholm Sweden


Pamidronate BMM Pharma


6 mg/ml


concentrate for solution for infusion


For infusion




SE - Sweden


BMM Pharma AB Blasieholmsgatan 2 111 48 Stockholm Sweden


Pamidronate BMM Pharma


9 mg/ml


concentrate for solution for infusion


For infusion




SI - Slovenia


Novartis Pharma GmbH, Roonstrasse 25, Nuernberg D-90429, Germany


Aredia 15 mg prašek in vehikel za koncentrat za raztopino za infundiranje


15 mg


powder and solvent for solution for injection


Intravenous




SI - Slovenia


Novartis Pharma GmbH, Roonstrasse 25, Nuernberg D-90429, Germany


Aredia 30 mg prašek in vehikel za koncentrat za raztopino za infundiranje


30 mg


powder and solvent for solution for injection


Intravenous




SI - Slovenia


Torrex Chiesi Slovenija d.o.o., Trdinova 4, SI-1000 Ljubljana, Slovenia


Pamitor 30 mg koncentrat za raztopino za infundiranje


12,6 mg/ ml


powder and solvent for solution for injection


Intravenous




SI - Slovenia


Torrex Chiesi Slovenija d.o.o., Trdinova 4, SI-1000 Ljubljana, Slovenia


Pamitor 60 mg koncentrat za raztopino za infundiranje


12,6 mg/ ml


powder and solvent for solution for injection


Intravenous




SI - Slovenia


Torrex Chiesi Slovenija d.o.o., Trdinova 4, SI-1000 Ljubljana, Slovenia


Pamitor 90 mg koncentrat za raztopino za infundiranje


12,6 mg/ ml


powder and solvent for solution for injection


Intravenous




SK - Slovakia


Torrex Chiesi -Pharma GmbH, Gonzagagasse 16/16, 1010 Viena, Austria


Pamitor 15 mg/ml


15 mg/ml


concentrate for solution for infusion


Intravenous




SK - Slovakia







medac GmbH Theaterstraße 6




D-22880 Wedel Germany






PAMIFOS


3 mg/ml


Concentrate for infusion


Intravenous




UK - United Kingdom


Novartis Pharmaceuticals UK Limited, Frimly Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK


AREDIA DRY POWDER


15 mg


Powder for Injection


Intravenous




UK - United Kingdom


Novartis Pharmaceuticals UK Limited, Frimly Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK


AREDIA DRY POWDER


30 mg


Powder for Injection


Intravenous




UK - United Kingdom


Novartis Pharmaceuticals UK Limited, Frimly Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK


AREDIA DRY POWDER


90 mg


Powder for Injection


Intravenous




UK - United Kingdom


Actavis Group PTC EHF, Reykjavikurvegi 76-78, Hafnarfirdi IS-220 Iceland


PAMIDRONATE DISODIUM


3 MG/ML


CONCENTRATE FOR SOLUTION FOR INFUSION


Intravenous




UK - United Kingdom


Actavis Group PTC EHF, Reykjavikurvegi 76-78, Hafnarfirdi IS-220 Iceland


PAMIDRONATE DISODIUM


6 MG/ML


CONCENTRATE FOR SOLUTION FOR INFUSION


Intravenous




UK - United Kingdom


Actavis Group PTC EHF, Reykjavikurvegi 76-78, Hafnarfirdi IS-220 Iceland


PAMIDRONATE DISODIUM


9 MG/ML


CONCENTRATE FOR SOLUTION FOR INFUSION


Intravenous




UK - United Kingdom


Apsala Limited, bayview House, 49 Northstrand Road, Dublin 3, Ireland


DISODIUM PAMIDRONATE


3 MG/ML


CONCENTRATE FOR SOLUTION FOR INFUSION


Intravenous




UK - United Kingdom


Apsala Limited, bayview House, 49 Northstrand Road, Dublin 3, Ireland


DISODIUM PAMIDRONATE


6 MG/ML


CONCENTRATE FOR SOLUTION FOR INFUSION


Intravenous




UK - United Kingdom


Apsala Limited, bayview House, 49 Northstrand Road, Dublin 3, Ireland


DISODIUM PAMIDRONATE


9 MG/ML


CONCENTRATE FOR SOLUTION FOR INFUSION


Intravenous








Risedronic acid containing medicinal products with Marketing Authorisation in the European Union











Member State EU/EEA


Marketing authorisation holder


(Invented) Name


Strength


Pharmaceutical form


Route of administration




AT - Austria







sanofi-aventis GmbH ÖSTERREICH




SATURN Tower, Leonard-Bernstein-Straße 10




A-1220 Wien, Austria






Actonel Combi Filmtabletten


35 mg (risedronate sodium) + 500 mg/400 UI


film-coated tablets


Oral use




AT - Austria







sanofi-aventis GmbH




SATURN Tower, Leonard-Bernstein-Straße 10




A-1220 Wien, Austria






Actonel einmal wöchentlich 35 mg Filmtabletten


35 mg (risedronate sodium)


film-coated tablets


Oral use




AT - Austria







sanofi-aventis GmbH




SATURN Tower, Leonard-Bernstein-Straße 10




A-1220 Wien, Austria






Actonel 30 mg Filmtabletten


30 mg (risedronate sodium)


film-coated tablets


Oral use




AT - Austria







sanofi-aventis GmbH




SATURN Tower, Leonard-Bernstein-Straße 10




A-1220 Wien, Austria






Actonel 5 mg Filmtabletten


5 mg (risedronate sodium)


film-coated tablets


Oral use




AT - Austria







sanofi-aventis GmbH




SATURN Tower, Leonard-Bernstein-Straße 10




A-1220 Wien, Austria






Actonel 75 mg Filmtabletten


75 mg (risedronate sodium)


film-coated tablets


Oral use




AT - Austria







Arcana Arzneimittel GmbH,




Hütteldorfer Straße 299,




A-1140 Wien,




Austria






Risedronat Arcana einmal wöchentlich 35 mg - Filmtabletten


35 mg (risedronate sodium)


film-coated tablets


Oral use




AT - Austria


Hexal Pharma GmbH, Stella-Klein-Löw-Weg 17, A-1020 Wien, Austria


Risedronat Hexal einmal wöchentlich 35 mg Filmtabletten


35 mg (risedronate sodium)


film-coated tablets


Oral use




AT - Austria


1A Pharma GmbH, Stella-Klein-Löw-Weg 17, A-1020 Wien, Austria


Risedronat 1A Pharma einmal wöchentlich 35 mg Filmtabletten


35 mg (risedronate sodium)


film-coated tablets


Oral use




AT - Austria







Ratiopharm Arzneimittel Vertriebs-GmbH




Albert-Schweitzer Gasse 3




A-1140 Wien




Austria






Risedronat-ratiopharm einmal wöchentlich 35 mg Filmtabletten


35 mg (risedronate sodium)


film-coated tablets


Oral use




AT - Austria


Sandoz GmbH, Biochemiestraße 10 A-6250 Kundl, Austria


Risedronat Sandoz einmal wöchentlich 35 mg Filmtabletten


35 mg (risedronate sodium)


film-coated tablets


Oral use




AT - Austria







Stada Arzneimittel GmbH




Muthgasse 36




A-1190 Wien




Austria






Risedronat STADA einmal wöchentlich 35 mg Filmtabletten


35 mg (risedronate sodium)


film-coated tablets


Oral use




AT - Austria







TEVA Pharma B.V.




Computerweg 10




3542 DR Utrecht




Netherlands






Risedronat Teva 35 mg Filmtabletten


35 mg (risedronate sodium)


film-coated tablets


Oral use




BE - Belgium







Warner Chilcott Pharmaceuticals BVBA




Pegasuslaan 5




1831 Diegem,




Belgium






Actonel


5 mg


Film-Coated Tablets


Oral Use




BE - Belgium







Warner Chilcott Pharmaceuticals BVBA




Pegasuslaan 5




1831 Diegem,




Belgium






Actonel


30 mg


Film-Coated Tablets


Oral Use




BE - Belgium







Warner Chilcott Pharmaceuticals BVBA




Pegasuslaan 5




1831 Diegem,




Belgium






Actonel


35 mg


Film-Coated Tablets


Oral Use




BE - Belgium







Warner Chilcott Pharmaceuticals BVBA




Pegasuslaan 5




1831 Diegem,




Belgium






Actonel


75 mg


Film-Coated Tablets


Oral Use




BE - Belgium







Warner Chilcott Pharmaceuticals BVBA




Pegasuslaan 5




1831 Diegem,




Belgium






Actonel Combi


35 mg + 1 250 mg calcium


Film-Coated Tablets


Oral Use




BE - Belgium







Warner Chilcott Pharmaceuticals BVBA




Pegasuslaan 5




1831 Diegem,




Belgium






Actonel Combi D


35 mg + 1 000 mg / 880 IU


Film-Coated Tablets and effervescent granules


Oral Use




BE - Belgium







Warner Chilcott Pharmaceuticals BVBA




Pegasuslaan 5




1831 Diegem,




Belgium






Actonel Plus calcium D


35 mg + 500 mg / 400 UI


Film-Coated Tablets


Oral use




BE - Belgium







TEVA Pharma Belgium N.V,




Laarstraat 16,




B-2610 Wilrijk,




Belgium






Risedronate Teva 35 mg filmomhulde tabletten


35 mg


film-coated tablets


Oral use




BG - Bulgaria


LABORMED-PHARMA S.A., Theodor Pallady Boulevard 44B, Sector 3, RO-032266 Bucharest, Romania


Juverital


5 mg


Film-coated tablets


Oral use




BG - Bulgaria


LABORMED-PHARMA S.A., Theodor Pallady Boulevard 44B, Sector 3, RO-032266 Bucharest, Romania


Juverital


35 mg


Film-coated tablets


Oral use




BG - Bulgaria







Sanofi-Aventis Bulgaria EOOD




103, blvd Al. Stamboliyski




Office Building Sofia Tower




Level 8, 1303 Sofia




Bulgaria






ACTONEL 5 MG FILM-COATED TABLETS


5 mg


Film-Coated Tablets


Oral use




BG - Bulgaria







Sanofi-Aventis Bulgaria EOOD




103, blvd Al. Stamboliyski




Office Building Sofia Tower




Level 8, 1303 Sofia




Bulgaria






ACTONEL 30 MG FILM-COATED TABLETS


30 mg


Film-Coated Tablets


Oral use




BG - Bulgaria







Sanofi-Aventis Bulgaria EOOD




103, blvd Al. Stamboliyski




Office Building Sofia Tower




Level 8, 1303 Sofia




Bulgaria






ACTONEL ONCE A WEEK 35 MG FILM-COATED TABLETS


35 mg


Film-Coated Tablets


Oral use




BG - Bulgaria







Sanofi-Aventis Bulgaria EOOD




103, blvd Al. Stamboliyski




Office Building Sofia Tower




Level 8, 1303 Sofia




Bulgaria






ACTONEL 75 MG FILM-COATED TABLETS


75 mg


Film-Coated Tablets


Oral use




BG - Bulgaria


ZENTIVA, k.s. U kabelovny 130, Dolní Měcholupy 102 37 Praga 10, Czech Republic


RISENDROS 35 mg


35 mg


film-coated tablets


Oral use




BG - Bulgaria


ratiopharm GmbH, Graf-Arco-Strasse 3, 89079 Ulm, Germany


Risedronat-ratiopharm


35 mg


film - coated tablets


Oral use




BG - Bulgaria


Vale Pharmaceuticals Ltd 1B Gurtnafleur Business Park, Gurtnafleur, clonmel, Co. Tipperary IRELAND


RIGAT


35 mg


film - coated tablets


Oral use




BG - Bulgaria


Stada Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany


Zilar


5 mg


film - coated tablets


Oral use




BG - Bulgaria







Teva Pharmaceuticals




N.V.Gogol 15




ЕООД




Sofia




Bulgaria






Rizida


35 mg


film - coated tablets


Oral use




BG - Bulgaria


Genericon Pharma Gesellschaft m.b.H, Hafnerstabe 211, 8054 Graz, Austria


Risedronat Genericon


5 mg


film - coated tablets


Oral use




BG - Bulgaria


Genericon Pharma Gesellschaft m.b.H, Hafnerstabe 211, 8054 Graz, Austria


Risedronat Genericon


30 mg


film - coated tablets


Oral use




BG - Bulgaria


Genericon Pharma Gesellschaft m.b.H, Hafnerstabe 211, 8054 Graz, Austria


Risedronat Genericon


35 mg


film - coated tablets


Oral use




BG - Bulgaria


Actavis Group PTC ehf, Reykjavikurvegur 76-78, 220 Hafnarjordur, Iceland


Risadis


5 mg


film - coated tablets


Oral use




BG - Bulgaria


Actavis Group PTC ehf, Reykjavikurvegur 76-78, 220 Hafnarjordur, Iceland


Risadis


35 mg


film - coated tablets


Oral use




CY - Cyprus


SANOFI AVENTIS CYPRUS LTD, CHARALAMBOU MOUSKOU 14, 2015 STROVOLOS, CYPRUS


ACTONEL TABLET 5 MG


5 MG


TABLET


Oral use




CY - Cyprus


SANOFI AVENTIS CYPRUS LTD, CHARALAMBOU MOUSKOU 14, 2015 STROVOLOS, CYPRUS


ACTONEL OAW/"ONCE A WEEK" TABLETS 35 MG


35 MG


TABLET


Oral use




CY - Cyprus


SANOFI AVENTIS CYPRUS LTD, CHARALAMBOU MOUSKOU 14, 2015 STROVOLOS, CYPRUS


ACTONEL (2 CONSEQUENTIAL DAYS PER MONTH)


75 MG


TABLET


Oral use




CY - Cyprus


ACTAVIS GROUP PTC ehf., REYKJAVIKURVEGUR 76-78, 220 HAFNAFJORDUR, ICELAND


BIFODRON TABLETS 5 MG


5 MG


TABLET


Oral use




CY - Cyprus


ACTAVIS GROUP PTC ehf., REYKJAVIKURVEGUR 76-78, 220 HAFNAFJORDUR, ICELAND


BIFODRON TABLETS 30 MG


30 MG


TABLET


Oral use




CY - Cyprus


ACTAVIS GROUP PTC ehf., REYKJAVIKURVEGUR 76-78, 220 HAFNAFJORDUR, ICELAND


BIFODRON TABLETS 35 MG


35 MG


TABLET


Oral use




CY - Cyprus


BEACON PHARMACEUTICAL LIMITED, 85 HIGH STREET, TUNBIDGE WELLS TN1 1YG, UK


RISEDRONATE SODIUM TABLET 5 MG


5 MG


TABLET


Oral use




CY - Cyprus


BEACON PHARMACEUTICAL LIMITED, 85 HIGH STREET, TUNBIDGE WELLS TN1 1YG, UK


RISEDRONATE SODIUM TABLET 30 MG


30 MG


TABLET


Oral use




CY - Cyprus


BEACON PHARMACEUTICAL LIMITED, 85 HIGH STREET, TUNBIDGE WELLS TN1 1YG, UK


RISEDRONATE SODIUM TABLET 35 MG


35 MG


TABLET


Oral use




CY - Cyprus


P T HADJIGEORGIOU CO LTD, 31 YILDIZ, P O BOX 53158, 3301 LEMESOS, CYPRUS


ATRONATE "ONCE A WEEK" TABLETS 35 MG


35 MG


TABLET


Oral use




CY - Cyprus


PHARMATHEN SA, DERVENAKION 6, 15351 PALLINI ATTIKI, GREECE


RISEPALLIN TABLETS 5 MG


5 MG


TABLET


Oral use




CY - Cyprus


PHARMATHEN SA, DERVENAKION 6, 15351 PALLINI ATTIKI, GREECE


RISEPALLIN TABLETS 30 MG


30 MG


TABLET


Oral use




CY - Cyprus


PHARMATHEN SA, DERVENAKION 6, 15351 PALLINI ATTIKI, GREECE


RISEPALLIN TABLETS 35 MG


35 MG


TABLET


Oral use




CY - Cyprus


Arrow Generics Limited, Unit 2 Eastman Way, Hertfordshire, SG1 4SZ, Stevenage, UK


RISEDRONATE ARROW TABLETS 35 MG


35 MG


TABLET


Oral use




CZ - Czech Republic


Sanofi-Aventis s.r.o., Evropská 846/176a, 160 00 Praha-Dejvice, Czech Republic


Actonel 30 mg


30 mg


Film-coated tablet


Oral use




CZ - Czech Republic


Sanofi-Aventis s.r.o., Evropská 846/176a, 160 00 Praha-Dejvice, Czech Republic


Actonel 35 mg


35 mg


Film-coated tablet


Oral use




CZ - Czech Republic


Sanofi-Aventis s.r.o., Evropská 846/176a, 160 00 Praha-Dejvice, Czech Republic


Actonel 5 mg


5 mg


Film-coated tablet


Oral use




CZ - Czech Republic


S.C. LaborMed Pharma S.A., Bd. Theodor Pallady nr. 44B, sector 3, Bucharest, Romania


Juverital 35 mg potahované tablety


35 mg


Film-coated tablet


Oral use




CZ - Czech Republic


S.C. LaborMed Pharma S.A., Bd. Theodor Pallady nr. 44B, sector 3, Bucharest, Romania


Juverital 5 mg potahované tablety


5 mg


Film-coated tablet


Oral use




CZ - Czech Republic


Sanofi-Aventis s.r.o., Evropská 846/176a, 160 00 Praha-Dejvice, Czech Republic


Norsed 35 mg


35 mg


Film-coated tablet


Oral use




CZ - Czech Republic


Galex d.d., Tišinska ul. 29g, 9000 Murska Sobota, Slovenia


Risedronat Galex 35 mg


35 mg


Film-coated tablet


Oral use




CZ - Czech Republic


Galex d.d., Tišinska ul. 29g, 9000 Murska Sobota, Slovenia


Risedronat Galex 5 mg


5 mg


Film-coated tablet


Oral use




CZ - Czech Republic







Generics Ltd., Mylan




Albany Gate, Darkes Lane,




Potters Bar




Hertfordshire




EN6 1AG




United Kingdom






Risedronat Mylan 35 mg


5 mg


Film-coated tablet


Oral use




CZ - Czech Republic







Teva Pharmaceuticals CR, s.r.o., Radlická 3185/1c




150 00 Praha 5




Cezch Republic






Risedronat Teva 35 mg


5 mg


Film-coated tablet


Oral use




CZ - Czech Republic







Ratiopharm GmbH, Graf-Arco-Straße 3




89079 Ulm, Germany






Risedronat-Ratiopharm 35 mg


35 mg


Film-coated tablet


Oral use




CZ - Czech Republic







ZENTIVA, k.s.




U kabelovny 130, Dolní Měcholupy 102 37 Praga 10, Czech Republic






Risendros 35 mg


35 mg


Film-coated tablet


Oral use




CZ - Czech Republic


Ingers Industrial Solutions, s.r.o., Slunná 271/16, 617 00 Brno-Komárov, Czech Republic


Tevanel 35 mg


35 mg


Film-coated tablet


Oral use




CZ - Czech Republic


Zaklad Farmaceutyczny Adamed Pharma S.A., Szkolna Street 33, 95-054 Ksawerow, Poland


NORIFAZ 35 MG POTAHOVANÉ TABLETY


35 mg


Film-coated tablet


Oral use




DE - Germany







ALIUD PHARMA GmbH




Gottlieb-Daimler-Str. 19




D-89150 Laichingen






Risedronat AL 35 mg Filmtabletten


35 mg


Film-coated tablet


Oral use




DE - Germany







Stadapharm GmbH




Stadastr. 2 - 18




D-61118 Bad Vilbel






Risedronat STADA 35 mg Filmtabletten


35 mg


Film-coated tablet


Oral use




DE - Germany







Warner Chilcott Deutschland GmbH




Dr.-Otto-Röhm-Str. 2 - 4




D-64331 Weiterstadt






Actonel 5 mg Filmtabletten


5 mg


Film-coated tablet


Oral use




DE - Germany







Warner Chilcott Deutschland GmbH




Dr.-Otto-Röhm-Str. 2 - 4




D-64331 Weiterstadt






Actonel 30 mg Filmtabletten


30 mg


Film-coated tablet


Oral use




DE - Germany







Warner Chilcott Deutschland GmbH




Dr.-Otto-Röhm-Str. 2 - 4




D-64331 Weiterstadt






Actonel 75 mg Filmtabletten


75 mg


Film-coated tablet


Oral use




DE - Germany







Warner Chilcott Deutschland GmbH




Dr.-Otto-Röhm-Str. 2 - 4




D-64331 Weiterstadt






Actonel einmal wöchentlich 35 mg Filmtabletten


35 mg


Film-coated tablet


Oral use




DE - Germany







Warner Chilcott Deutschland GmbH




Dr.-Otto-Röhm-Str. 2 - 4




D-64331 Weiterstadt






Norsed einmal wöchentlich 35 mg Filmtabletten


35 mg


Film-coated tablet


Oral use




DE - Germany







Warner Chilcott Deutschland GmbH




Dr.-Otto-Röhm-Str. 2 - 4




D-64331 Weiterstadt






Actonel 35 mg plus Calcium Filmtabletten


35 mg + 1 250 mg calcium


Film-coated tablet


Oral use




DE - Germany







Warner Chilcott Deutschland GmbH




Dr.-Otto-Röhm-Str. 2 - 4




D-64331 Weiterstadt






Actonel plus Calcium D 35 mg + 1 000 mg/880 I.E. Filmtabletten + Brausegranulat


35 mg + 1 000 mg / 800 IU


Film-coated tablet and Effervescent granules


Oral use




DE - Germany







Warner Chilcott Deutschland GmbH




Dr.-Otto-Röhm-Str. 2 - 4




D-64331 Weiterstadt






Norsed plus Calcium D 35 mg + 1 000 mg/880 I.E. Filmtabletten + Brausegranulat


35 mg + 1 000 mg / 800 IU


Film-coated tablet and Effervescent granules


Oral use




DE - Germany







Warner Chilcott Deutschland GmbH




Dr.-Otto-Röhm-Str. 2 - 4




D-64331 Weiterstadt






Actonel plus Calcium D 35 mg + 500 mg/400 I.E. Filmtabletten


35 mg + 500 mg / 400 IU


Film-coated tablet and


Oral use




DE - Germany







Heumann Pharma GmbH & Co. Generica KG




Südwestpark 50




D-90449 Nürnberg






Risedronat Heumann 35 mg Filmtabletten


40,17 mg


Film-coated tablet


Oral use




DK - Denmark


Ratiopharm GmbH, Graf-Arco-Strasse 3, DE-89079 Ulm, Germany


Risostad


5 mg


Film-coated tablets


Oral use




DK - Denmark


Ratiopharm GmbH, Graf-Arco-Strasse 3, DE-89079 Ulm, Germany


Risostad


35 mg


Film-coated tablets


Oral use




DK - Denmark


Mylan AB, P.O.box 23033, Ynglingagatan 14, SE-104 35 Stockholm; Sweden


Vionate


5 mg


Film-coated tablets


Oral use




DK - Denmark


Mylan AB, P.O.box 23033, Ynglingagatan 14, SE-104 35 Stockholm; Sweden


Vionate


35 mg


Film-coated tablets


Oral use




DK - Denmark


Pharmathen S.A., Dervenakion str. 6, GR-15351 Pallini Attiki, Greece


Dimidronat


5 mg


Film-coated tablets


Oral use




DK - Denmark


Pharmathen S.A., Dervenakion str. 6, GR-15351 Pallini Attiki, Greece


Dimidronat


30 mg


Film-coated tablets


Oral use




DK - Denmark


Pharmathen S.A., Dervenakion str. 6, GR-15351 Pallini Attiki, Greece


Dimidronat


35 mg


Film-coated tablets


Oral use




DK - Denmark


Pharmathen S.A., Dervenakion str. 6, GR-15351 Pallini Attiki, Greece


Ellidronat


35 mg


Film-coated tablets


Oral use




DK - Denmark


LABORMED-PHARMA S.A., Theodor Pallady Boulevard 44B, Sector 3, RO-032266 Bucharest, Romania


Juverital


5 mg


Film-coated tablets


Oral use




DK - Denmark


LABORMED-PHARMA S.A., Theodor Pallady Boulevard 44B, Sector 3, RO-032266 Bucharest, Romania


Juverital


35 mg


Film-coated tablets


Oral use




DK - Denmark


Pharmathen S.A., Dervenakion str. 6, GR-15351 Pallini Attiki, Greece


Karadronat


5 mg


Film-coated tablets


Oral use




DK - Denmark


Pharmathen S.A., Dervenakion str. 6, GR-15351 Pallini Attiki, Greece


Karadronat


30 mg


Film-coated tablets


Oral use




DK - Denmark


Pharmathen S.A., Dervenakion str. 6, GR-15351 Pallini Attiki, Greece


Karadronat


35 mg


Film-coated tablets


Oral use




DK - Denmark


ZaKlad Farmaceutyczny, Adamed Phama S.a, 33 Szkolna Street, PL-95054 Ksawerów; Poland


Norifaz


35 mg


Film-coated tablets


Oral use




DK - Denmark


Sanofi-Aventis Denmark A/S, Slotsmarken 13, DK-3970 Hørsholm, Denmark


Optinate


5 mg


Film-coated tablets


Oral use




DK - Denmark


Sanofi-Aventis Denmark A/S, Slotsmarken 13, DK-3970 Hørsholm, Denmark


Optinate


30 mg


Film-coated tablets


Oral use




DK - Denmark


Sanofi-Aventis Denmark A/S, Slotsmarken 13, DK-3970 Hørsholm, Denmark


Optinate


75 mg


Film-coated tablets


Oral use




DK - Denmark


Sanofi-Aventis Denmark A/S, Slotsmarken 13, DK-3970 Hørsholm, Denmark


Optinate Combi


35 mg + 1 250 mg calcium


Film-coated tablets


Oral use




DK - Denmark


Sanofi-Aventis Denmark A/S, Slotsmarken 13, DK-3970 Hørsholm, Denmark


Optinate Septimum


35 mg


Film-coated tablets


Oral use




DK - Denmark


CT Arzneimittel GmbH, Lengeder Str. 42A, DE-13407 Berlin, Germany


Racidrix


35 mg


Film-coated tablets


Oral use




DK - Denmark


ratiopharm GmbH, Graf-Arco-Strasse 3, DE-89079 Ulm, Germany


Ridracid


35 mg


Film-coated tablets


Oral use




DK - Denmark


Ratiopharm GmbH, Graf-Arco-Strasse 3, DE-89079 Ulm, Germany


Rinon


35 mg


Film-coated tablets


Oral use




DK - Denmark


Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118 Bad Vilbel, Germany


Risdronostad


5 mg


Film-coated tablets


Oral use




DK - Denmark


Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118 Bad Vilbel, Germany


Risdronostad


30 mg


Film-coated tablets


Oral use




DK - Denmark


Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118 Bad Vilbel, Germany


Risdronostad


35 mg


Film-coated tablets


Oral use




DK - Denmark


Actavis Group PTC ehf., PO Box 425, Reykjavikurvegi 76-78, IS-220 Hafnarfjördur, Iceland


Risedronatnatrium "Actavis"


35 mg


Film-coated tablets


Oral use




DK - Denmark


Orifarm Generics A/S, Energivej 15, DK-5260 Odense S., Denmark


Risedronatnatrium "Orifarm"


5 mg


Film-coated tablets


Oral use




DK - Denmark


Orifarm Generics A/S, Energivej 15, DK-5260 Odense S., Denmark


Risedronatnatrium "Orifarm"


30 mg


Film-coated tablets


Oral use




DK - Denmark


Orifarm Generics A/S, Energivej 15, DK-5260 Odense S., Denmark


Risedronatnatrium "Orifarm"


35 mg


Film-coated tablets


Oral use




DK - Denmark


Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118 Bad Vilbel, Germany


Risedronatnatrium "Stada"


5 mg


Film-coated tablets


Oral use




DK - Denmark


Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118 Bad Vilbel, Germany


Risedronatnatrium "Stada"


30 mg


Film-coated tablets


Oral use




DK - Denmark


Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118 Bad Vilbel, Germany


Risedronatnatrium "Stada"


35 mg


Film-coated tablets


Oral use




DK - Denmark


Teva Denmark A/S, Parallelvej 10-12, DK-2800 Kongens Lyngby, Denmark


Risedronatnatrium "Teva"


35 mg


Film-coated tablets


Oral use




DK - Denmark


Pharmathen S.A., Dervenakion str. 6, GR-15351 Pallini Attiki, Greece


Risepallin


5 mg


Film-coated tablets


Oral use




DK - Denmark


Pharmathen S.A., Dervenakion str. 6, GR-15351 Pallini Attiki, Greece


Risepallin


30 mg


Film-coated tablets


Oral use




DK - Denmark


Pharmathen S.A., Dervenakion str. 6, GR-15351 Pallini Attiki, Greece


Risepallin


35 mg


Film-coated tablets


Oral use




DK - Denmark


ratiopharm GmbH, Graf-Arco-Strasse 3, DE-89079 Ulm, Germany


Riseratio


35 mg


Film-coated tablets


Oral use




DK - Denmark


ratiopharm GmbH, Graf-Arco-Strasse 3, DE-89079 Ulm, Germany


Risonat


35 mg


Film-coated tablets


Oral use




EL - Greece







SANOFI-AVENTIS AEBE




SYNGROU AVENUE 348 BUILDING A




KALITHEA 17674






ACTONEL


5 MG/TAB


FILM COATED TABLET


Oral use




EL - Greece







SANOFI-AVENTIS AEBE




SYNGROU AVENUE 348 BUILDING A




KALITHEA 17675






ACTONEL


30 MG/TAB


FILM COATED TABLET


Oral use




EL - Greece







SANOFI-AVENTIS AEBE




SYNGROU AVENUE 348 BUILDING A




KALITHEA 17676






ACTONEL OAW


35 MG/TAB


FILM COATED TABLET


Oral use




EL - Greece







SANOFI-AVENTIS AEBE




SYNGROU AVENUE 348 BUILDING A




KALITHEA 17677






ACTONEL 2 CONSECUTIVE DAYS PER MONTH


75 MG/TAB


FILM COATED TABLET


Oral use




EL - Greece







SANOFI-AVENTIS AEBE




SYNGROU AVENUE 348 BUILDING A




KALITHEA 17678






RISEDRONATE / WINTHROP


35 MG/TAB


FILM COATED TABLET


Oral use




EL - Greece







ACTAVIS GROUP PTC EHF., ICELAND




Reykjavikurvegur 76-78,




220, Hafnarfjordur




Iceland






RISEDRONATE SODIUM / ACTAVIS


35 MG/TAB


FILM COATED TABLET


Oral use




EL - Greece







PNG GEROLYMATOS MEDICAL S.A.




ASKLIPIOU 13




KRYONERI ATTIKIS 14568






MOTIVUS


35 MG/TAB


FILM COATED TABLET


Oral use




EL - Greece







DELEGANT HOLDINGS LTD, CYPRUS




AGIAS ELENIS 36




COMMERCIAL CENTRE GALAXY 401




NICOSIA 1061




CYPRUS






RISELIB


35 MG/TAB


FILM COATED TABLET


Oral use




EL - Greece







S.J.A. PHARM Ltd




ARKOLEON 11




10445 PATISSIA






DIFOSFON-S


35 MG/TAB


FILM COATED TABLET


Oral use




EL - Greece







ELPEN S.A. PHARMACEUTICAL INDUSTRY




MARATHONOS AVENUE 95




PIKERMI 190 09






BONDAPEN


35 MG/TAB


FILM COATED TABLET


Oral use




EL - Greece







AURORA PHARMACEUTICALS A.E.




EVROU 4 & MESSINIAS 2




GERAKAS 15344






BONMATE


35 MG/TAB


FILM COATED TABLET


Oral use




EL - Greece







GENERICS (U.K.) LTD - ENGLAND




STATION CLOSE POTTERS BAR HERTS EN6 1TL




ENGLAND






RISEDRONATE / GENERICS


35 MG/TAB


FILM COATED TABLET


Oral use




EL - Greece







TEVA PHARMA B.V., UTRECHT, THE NETHERLANDS




Computerweg 10,




3542 DR, Utrecht,




The Netherlands






RISEDRONATE / TEVA


35 MG/TAB


FILM COATED TABLET


Oral use




ES - Spain


SANOFI AVENTIS, S.A.Josep Plá, 2 08019 Barcelona


ACTONEL 30 mg comprimidos recubiertos


30 mg


film coated tablets


Oral use




ES - Spain


SANOFI AVENTIS, S.A.Josep Plá, 2 08019 Barcelona


ACTONEL 5 mg comprimidos recubiertos


5 mg


film coated tablets


Oral use




ES - Spain







Warner Chilcott Iberia, S.L.




WTC Almeda Park, Ed. 1, 2a pl.




Plaça de la Pau s/n




08940 Cornellà de Llobregat (Barcelona)




Spain






ACREL 5 mg comprimidos recubiertos con película


5 mg


film coated tablets


Oral use




ES - Spain







Warner Chilcott Iberia, S.L.




WTC Almeda Park, Ed. 1, 2a pl.




Plaça de la Pau s/n




08940 Cornellà de Llobregat (Barcelona)




Spain






ACREL SEMANAL 35 mg comprimidos recubiertos con película


35 mg


film coated tablets


Oral use




ES - Spain


SANOFI AVENTIS, S.A.Josep Plá, 2 08019 Barcelona


ACTONEL SEMANAL 35 mg comprimidos recubiertos con película


35 mg


film coated tablets


Oral use




ES - Spain


SANOFI AVENTIS, S.A.Josep Plá, 2 08019 Barcelona


ACTONEL 75 mg comprimidos recubiertos con película


75 mg


film coated tablets


Oral use




ES - Spain


SANOFI AVENTIS, S.A.Josep Plá, 2 08019 Barcelona


LOSENTRA SEMANAL 35 mg comprimidos recubiertos con película


35 mg


film coated tablets


Oral use




ES - Spain







Warner Chilcott Iberia, S.L.




WTC Almeda Park, Ed. 1, 2a pl.




Plaça de la Pau s/n




08940 Cornellà de Llobregat (Barcelona)




Spain






ACREL 75 mg comprimidos recubiertos con película


75 mg


film coated tablets


Oral use




ES - Spain


SANOFI AVENTIS, S.A.Josep Plá, 2 08019 Barcelona


ACTONEL COMBI 35 mg comprimidos recubiertos con película + 1 000 mg/880 UI granulado efervescente


35 mg + 1 000 mg / 880 IU


film coated tablets


Oral use




ES - Spain







Warner Chilcott Iberia, S.L.




WTC Almeda Park, Ed. 1, 2a pl.




Plaça de la Pau s/n




08940 Cornellà de Llobregat (Barcelona)




Spain






ACRELCOMBI 35 mg comprimidos recubiertos con pelicula + 1 000 mg/880UI granulado efervescente


35 mg + 1 000 mg / 880 IU


film coated tablets and efervescent granules


Oral use




ES - Spain







Warner Chilcott Iberia, S.L.




WTC Almeda Park, Ed. 1, 2a pl.




Plaça de la Pau s/n




08940 Cornellà de Llobregat (Barcelona)




Spain






ACREL COMBI 35 mg + 500 mg/400 UI comprimidos recubiertos con película


35 mg + 500 mg/400 UI


film coated tablets and efervescent granules


Oral use




ES - Spain


SANOFI AVENTIS, S.A.Josep Plá, 2 08019 Barcelona


ACTONEL COMBI 35 mg + 500 mg/400 UI comprimidos recubiertos con película


35 mg + 500 mg/400 UI


film coated tablets


Oral use




ES - Spain


QUALIGEN, S.L.Avda. Barcelona, 69 08970 Sant Joan Despi, Spain


RISEDRONATO SEMANAL QUALIGEN 35 mg comprimidos recubiertos con película


 


film coated tablets


Oral use




ES - Spain


RATIOPHARM ESPAÑA, S.A.Avda. de Burgos, 16 D - 5a Planta 28036 Madrid


RISEDRONATO SEMANAL RATIOPHARM 35 mg comprimidos recubiertos con película


 


film coated tablets


Oral use




ES - Spain


MYLAN PHARMACEUTICALS, S.L. Plom 2-4, 5o Planta 08038 Barcelona


RISEMYL SEMANAL 35 mg comprimidos recubiertos con película


 


film coated tablets


Oral use




ES - Spain


TEVA GENERICOS ESPAÑOLA, S.L. Guzmán el Bueno 133, Edificio Britania 4oIzq 28003 Madrid


MIOSEN SEMANAL 35 mg comprimidos recubiertos con película


 


film coated tablets


Oral use




ES - Spain


HEXAL PHARMA GMBH Carlberger Gasse, 44 A-1235 Viena


RISEDRONATO SEMANAL HEXAL 35 mg comprimidos recubiertos con película


 


film coated tablets


Oral use




ES - Spain


SANDOZ FARMACEUTICA, S.A. Avda. Osa Mayor, 4 28023 Aravaca (Madrid)


RISEDRONATO SEMANAL SANDOZ 35 mg comprimidos recubiertos con pelicula


 


film coated tablets


Oral use




ES - Spain


1A PHARMA GMBH Eduard Kittenberger Gasse, 56 A-1235 Viena


RISEDRONATO SEMANAL SALUTAS 35 mg comprimidos recubiertos con película


 


film coated tablets


Oral use




ES - Spain


LABORATORIO STADA, S.L. Frederic Mompou, 5 08960 Sant Just Desvern


RISEDRONATO SEMANAL STADA 35 mg comprimidos recubiertos con película


 


film coated tablets


Oral use




ES - Spain


KERN PHARMA, S.L. Venus, 72. Poligono Industrial Colon II. 08228 Tarrasa


RISEDRONATO SEMANAL KERN PHARMA 35 mg comprimidos recubiertos con película


 


film coated tablets


Oral use




ES - Spain


LABORATORIOS RANBAXY, S.L. Passeig de Gracia, 9 08007 Barcelona


RISEDRONATO SEMANAL RANBAXY 35 mg comprimidos recubiertos con película


 


film coated tablets


Oral use




ES - Spain


ZAKLAD FARMACEUTYCZNY ADAMED PHARMA, S.A. ul. Szkolna, 33 95-054 Ksawerow/Lodz


NORIFAZ 35 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA


 


film coated tablets


Oral use




ET - Estonia


Portfarma ehf Kollunarklettsvegur 2, 104 Reykjavik ICELAND


OSSINAT


5 mg


Film-coated tablet


Oral use




ET - Estonia


Portfarma ehf Kollunarklettsvegur 2, 104 Reykjavik ICELAND


OSSINAT


35 mg


Film-coated tablet


Oral use




ET - Estonia







Sanofi-Aventis Estonia OÜ Pärnu mnt 139E/2




11317 Tallinn ESTONIA






ACTONEL 35 MG OAW


35 mg


Film-coated tablet


Oral use




ET - Estonia







Zentiva, k.s. UKabelovny 130




Dolni Mecholupy




102 37 Prague 10 CZECH REPUBLIC






RISENDROS 35 MG


35 mg


Film-coated tablet


Oral use




ET - Estonia







Actavis Group PTC ehf Reykjavikurvegi 76-78




220 Hafnarfjördur ICELAND






RISEDRONATE SODIUM ACTAVIS


35 mg


Film-coated tablet


Oral use




ET - Estonia







ratiopharm GmbH Graf-Arco-Strasse 3




D-89079 Ulm GERMANY






RIBIDRON


35 mg


Film-coated tablet


Oral use




ET - Estonia







Sanofi-Aventis Estonia OÜ Pärnu mnt 139E/2




11317 Tallinn ESTONIA






ACTONEL


75 mg


Film-coated tablet


Oral use




ET - Estonia


Zaklad Farmaceutyczny Adamed Pharma S.A. 33 Szkolna Street, 95-054 Ksawerow POLAND


NORIFAZ


35 mg


Film-coated tablet


Oral use




ET - Estonia







Teva Pharma B.V. Computerweg 10




3542 DR Utrecht THE NETHERLANDS






RISONATE


35 mg


Film-coated tablet


Oral use




ET - Estonia


Vale Pharmaceuticals Ltd 1B Gurtnafleur Business Park, Gurtnafleur, clonmel, Co. Tipperary IRELAND


RIGAT


35 mg


Film-coated tablet


Oral use




FI - Finland


sanofi-Aventis Oy, Huopalahdentie 24, PL 22, 00350 Helsinki, Finland


Optinate


30 mg


film-coated tablet


Oral use




FI - Finland


sanofi-Aventis Oy, Huopalahdentie 24, PL 22, 00350 Helsinki, Finland


Optinate


5 mg


film-coated tablet


Oral use




FI - Finland


sanofi-Aventis Oy, Huopalahdentie 24, PL 22, 00350 Helsinki, Finland


Optinate Combi D


35 mg + 1 000 mg / 880 IU


film-coated tablet and effervescent granules


Oral use




FI - Finland


sanofi-Aventis Oy, Huopalahdentie 24, PL 22, 00350 Helsinki, Finland


Optinate Septimum


35 mg


film-coated tablet


Oral use




FI - Finland


Ranbaxy (UK) Limited, Building 4, Chiswick Park, 566 Chiswick High Road, LONDON W4 5YE, United Kingdom


Risedronat Ranbaxy


35 mg


film-coated tablet


Oral use




FI - Finland


sanofi-Aventis Oy, Huopalahdentie 24, PL 22, 00350 Helsinki, Finland


Optinate


75 mg


film-coated tablet


Oral use




FI - Finland


Oy Leiras Finland Ab, PL 1406, 00101 Helsinki, Finland


Riseos


35 mg


film-coated tablet


Oral use




FI - Finland


ratiopharm GmbH, Graf-Arco-Strasse 3, 89079 Ulm, Germany


Riseratio


35 mg


film-coated tablet


Oral use




FI - Finland


Mylan AB, BOX 23033, 10435 STOCKHOLM, Sweden


Vionate


35 mg


film-coated tablet


Oral use




FI - Finland


Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220 HAFNARFJORDUR, Iceland


Risedronat Actavis


35 mg


film-coated tablet


Oral use




FI - Finland


Orifarm Generics A/S, Energivej 15, 5260 ODENSE S, Denmark


Risedronat Orifarm


30 mg


film-coated tablet


Oral use




FI - Finland


Orifarm Generics A/S, Energivej 15, 5260 ODENSE S, Denmark


Risedronat Orifarm


35 mg


film-coated tablet


Oral use




FI - Finland


Orifarm Generics A/S, Energivej 15, 5260 ODENSE S, Denmark


Risedronat Orifarm


5 mg


film-coated tablet


Oral use




FI - Finland


Sandoz A/S, C. F. Tietgens Boulevard 40, 5220 ODENSE SØ, Denmark


Risedronat Sandoz


35 mg


film-coated tablet


Oral use




FI - Finland


Stada Arzneimittel AG, Stadastrasse 2 - 18, 61118 BAD VILBEL, Germany


Risedronat Stada


35 mg


film-coated tablet


Oral use




FI - Finland


Stada Arzneimittel AG, Stadastrasse 2 - 18, 61118 BAD VILBEL, Germany


Risedronat Stada


5 mg


film-coated tablet


Oral use




FI - Finland


TEVA Sweden AB, Järnvägsgatan 11, BOX 1070, 25110 HELSINGBORG, Sweden


Risedronat Teva


35 mg


film-coated tablet


Oral use




FR - France







BIOGARAN




15, boulevard Charles de Gaulle




92700 Colombes




FRANCE






RISEDRONATE ALMUS 35 mg, comprimé pelliculé


35 mg


tablet


Oral use




FR - France







BIOGARAN




15, boulevard Charles de Gaulle




92700 Colombes




FRANCE






RISEDRONATE BGR 35 mg, comprimé pelliculé


35 mg


tablet


Oral use




FR - France







RANBAXY PHARMACIE GENERIQUES




11-15 Quai Dion Bouton




92800 Puteaux




FRANCE






RISEDRONATE RANBAXY 35 mg, comprimé pelliculé


35 mg


tablet


Oral use




FR - France







SANOFI AVENTIS FRANCE




1-13, boulevard Romain Rolland




75014 Paris




FRANCE






RISEDRONATE WINTHROP 35 mg, comprimé pelliculé


35 mg


film-coated tablet


Oral use




FR - France







SANOFI AVENTIS FRANCE




1-13, boulevard Romain Rolland




75014 Paris




FRANCE






RISEDRONATE WINTHROP 75 mg, comprimé pelliculé


75 mg


film-coated tablet


Oral use




FR - France







Warner Chilcott France




Immeuble "Le Jean Monnet"




11, Place des Vosges




92061 Paris La Défense Cedex




France






ACTONEL 30 mg, comprimé pelliculé


30 mg


film-coated tablet


Oral use




FR - France







Warner Chilcott France




Immeuble "Le Jean Monnet"




11, Place des Vosges




92061 Paris La Défense Cedex




France






ACTONEL 35 mg, comprimé pelliculé


35 mg


film-coated tablet


Oral use




FR - France







Warner Chilcott France




Immeuble "Le Jean Monnet"




11, Place des Vosges




92061 Paris La Défense Cedex




France






ACTONEL 5 mg, comprimé pelliculé


5 mg


film-coated tablet


Oral use




FR - France







Warner Chilcott France




Immeuble "Le Jean Monnet"




11, Place des Vosges




92061 Paris La Défense Cedex




France






ACTONELCOMBI 35 mg + 1 000 mg/880 UI, comprimé pelliculé et granulés effervescents


35 mg + 1 000 mg/800 UI


film-coated tablet and effervescent granules


Oral use




FR - France







Warner Chilcott France




Immeuble "Le Jean Monnet"




11, Place des Vosges




92061 Paris La Défense Cedex




France






ACTONEL 75 mg, comprimé pelliculé


75 mg


tablet


Oral use




FR - France







Warner Chilcott France




Immeuble "Le Jean Monnet"




11, Place des Vosges




92061 Paris La Défense Cedex




France






ACTONELCOMBI 35 mg + 500 mg/400 UI, comprimé pelliculé


35 mg + 500 mg/400 UI


tablet


Oral use




HU - Hungary







Sanofi-aventis zrt.




Tó u. 1-5.




1045 Budapest




Hungary






ACTONEL 5 mg filmtabletta


5,00 mg Risedronate sodium
(equivalent to 4,64 mg Risendronic acid)


film-coated tablet


Oral use




HU - Hungary







Sanofi-aventis zrt.




Tó u. 1-5.




1045 Budapest




Hungary






ACTONEL 35 mg filmtabletta


35,00 mg Risedronate sodium
(equivalent to 32,5 mg Risendronic acid)


film-coated tablet


Oral use




HU - Hungary







Sanofi-aventis zrt.




Tó u. 1-5.




1045 Budapest




Hungary






ACTONEL TRIO 35 mg film- és rágótabletta


35,00 mg Risedronate sodium
(equivalent to 69,6 mg Risendronic acid)


film-coated tablet and chewing tablet


Oral use




HU - Hungary







Sanofi-aventis zrt.




Tó u. 1-5.




1045 Budapest




Hungary






ACTONEL TRIO 75 mg film- és rágótabletta


75,00 mg Risedronate sodium
(as Risendronic acid)


film-coated tablet and chewing tablet


Oral use




HU - Hungary







Vera Pharma Kft.




Rákos köz 22.




1028 Budapest




Hungary






BONEACT 35 mg filmtabletta


35,00 mg Risedronate sodium
(as Risendronic acid)


film-coated tablet


Oral use




HU - Hungary







Vera Pharma Kft.




Rákos köz 22.




1028 Budapest




Hungary






BONEACT 755 mg filmtabletta


75,00 mg Risedronate sodium
(as Risendronic acid)


film-coated tablet


Oral use




HU - Hungary







Aramis Pharma Kft.




Mester u. 28. III/5.




1095 Budapest




Hungary






NORIFAZ Trio 35 mg film- és rágótabletta


35,0 mg Risedronate sodium
(equivalent to 40,17 mg Risedronate
sodium hemipentahydrate


film-coated tablet and chewing tablet


Oral use




HU - Hungary







Zentiva k.s.




Dolny Mecholupy, U kabelovny 130.




10237 Prague 10.




Czech Republic






RISENDROS 35 mg filmtabletta


35,0 mg Risedronate sodium


film-coated tablet


Oral use




HU - Hungary







Vera Pharma Kft.




Rákos köz 22.




1028 Budapest




Hungary






RISETACT 35 mg filmtabletta


35,0 mg Risedronate sodium


film-coated tablet


Oral use




HU - Hungary







Sanofi-aventis zrt.




Tó u. 1-5.




1045 Budapest




Hungary






ACTONEL 75 mg filmtabletta


75,00 mg Risedronate sodium
(equal to Risendronic acid)


film-coated tablet


Oral use




HU - Hungary







Ozone Laboratories BV




2 Martinus Nijhofflaan




2624 ES Delft




Holland






JUVERITAL 5 mg filmtabletta


5,0 mg Risedronate sodium
(equivalent to 5,74 mg Risedronate
sodium hemipentahydrate


film-coated tablet


Oral use




HU - Hungary







Ozone Laboratories BV




2 Martinus Nijhofflaan




2624 ES Delft




Holland






JUVERITAL 35 mg filmtabletta


35,0 mg Risedronate sodium
(equivalent to 40,17 mg Risedronate
sodium hemipentahydrate


film-coated tablet


Oral use




HU - Hungary







Aramis Pharma Kft.




Mester u. 28. III/5.




1095 Budapest




Hungary






NORIFAZ 35 mg filmtabletta


35,0 mg Risedronate sodium
(equivalent to 40,17 mg Risedronate
sodium hemipentahydrate


film-coated tablet


Oral use




HU - Hungary







GALEX d.d.




Tisinška ulica 29g




9000 Murska Sobota




Slovenia






RISEDRONAT GALEX 35 mg filmtabletta


35,0 mg Risedronate sodium
(equivalent to 40,17 mg Risedronate
sodium hemipentahydrate


film-coated tablet


Oral use




HU - Hungary







Actavis Group PTC ehf.




Reykjavikurvegur 76-78.




220 Hafnarfjordur




Iceland






RISEDRONATE ACTAVIS 35 mg filmtabletta


35,0 mg Risedronate sodium
(equivalent to 40,17 mg Risedronate
sodium hemipentahydrate


film-coated tablet


Oral use




HU - Hungary







Generics (UK) Ltd.




Albany Gate, Darkes Lane, Potters bar




EN61AG Hertfordshire




UK






RISEDRONATE GENERICS (UK) 5 mg filmtabletta


5,0 mg Risedronate sodium
(equivalent to 5,74 mg Risedronate
sodium hemipentahydrate


film-coated tablet


Oral use




HU - Hungary







Generics (UK) Ltd.




Albany Gate, Darkes Lane, Potters bar




EN61AG Hertfordshire




UK






RISEDRONATE GENERICS (UK) 35 mg filmtabletta


35,0 mg Risedronate sodium
(equivalent to 40,17 mg Risedronate
sodium hemipentahydrate


film-coated tablet


Oral use




HU - Hungary


LABORMED-PHARMA S.A., Theodor Pallady Boulevard 44B, Sector 3, RO-032266 Bucharest, Romania


Juverital


5 mg


Film-coated tablets


Oral use




HU - Hungary


LABORMED-PHARMA S.A., Theodor Pallady Boulevard 44B, Sector 3, RO-032266 Bucharest, Romania


Juverital


35 mg


Film-coated tablets


Oral use




IE - Ireland







Rowex Ltd




Bantry




Co. Cork






Ridate Once a Week 35 mg film-coated tablets


35 mg


film-coated tablets


Oral use




IE - Ireland







TEVA Pharma B.V.




Computerweg 10




3542 DR Utrecht




The Netherlands






Risonate Once Weekly 35 mg Film-Coated Tablets.


35 mg


film-coated tablets


Oral use




IE - Ireland







Warner Chilcott UK Limited




Old Belfast Road




Millbrook




Larne




County Antrim




BT40 2SH




United Kingdom






Actonel 5 mg film coated tablets


5 mg


film-coated tablets


Oral use




IE - Ireland







Warner Chilcott UK Limited




Old Belfast Road




Millbrook




Larne




County Antrim




BT40 2SH




United Kingdom






Actonel 30 mg film coated tablets


30 mg


film-coated tablets


Oral use




IE - Ireland







Warner Chilcott UK Limited




Old Belfast Road




Millbrook




Larne




County Antrim




BT40 2SH




United Kingdom






Actonel Once A Week 35 mg film-coated tablets


35 mg


film-coated tablets


Oral use




IE - Ireland







Warner Chilcott UK Limited




Old Belfast Road




Millbrook




Larne




County Antrim




BT40 2SH




United Kingdom






Actonel 75 Milligram Film Coated Tablets


75 mg


film-coated tablets


Oral use




IE - Ireland







Warner Chilcott UK Limited




Old Belfast Road




Millbrook




Larne




County Antrim




BT40 2SH




United Kingdom






Actonel Combi 35 mg + 500 mg film-coated tablets


35 mg + 1 250 mg calcium


film-coated tablets


Oral use




IE - Ireland







Warner Chilcott UK Limited




Old Belfast Road




Millbrook




Larne




County Antrim




BT40 2SH




United Kingdom






Actonel Plus Ca & D 35 mg film-coated tablet + 1 000 mg/800 IU Effervescent Granules


35 mg + 1 000 mg/880 IU


film-coated tablets + effervescent granules


Oral use




IE - Ireland







Warner Chilcott UK Limited




Old Belfast Road




Millbrook




Larne




County Antrim




BT40 2SH




United Kingdom






Actonel Plus Ca & D Tablet 35 mg and 500 mg/400 IU Film-Coated Tablets.


35 mg + (risedronate sodium) + 500 mg/400 UI


film-coated tablets


Oral use




IE - Ireland







Warner Chilcott UK Limited




Old Belfast Road




Millbrook




Larne




County Antrim




BT40 2SH




United Kingdom






Optinate Once a Week 35 mg Film-coated Tablets


35 mg


film-coated tablets


Oral use




IE - Ireland







Warner Chilcott UK Limited




Old Belfast Road




Millbrook




Larne




County Antrim




BT40 2SH




United Kingdom






Optinate 75 mg Film-coated Tablets


75 mg


film-coated tablets


Oral use




IE - Ireland







Ranbaxy Ireland Ltd. Spafield, Cork Road, Cashel, Co. Tipperary




Ranbaxy Ireland Ltd






Risedronate Sodium 35 mg Once A Week Film-Coated Tablets


35 mg


film-coated tablets


Oral use




IE - Ireland







Clonmel Healthcare Limited




Waterford Road




Clonmel




Co. Tipperary




Ireland






Risontel Once a week 35 mg film-coated tablets


35 mg


film-coated tablets


Oral use




IE - Ireland







Actavis Group PTC ehf Reykjavíkurvegi 76-78, 220 Hafnarfjordur, Iceland




Actavis Group PTC ehf






Risedronate Sodium Actavis 5 mg film-coated tablets


5 mg


film-coated tablets


Oral use




IE - Ireland







Actavis Group PTC ehf Reykjavíkurvegi 76-78, 220 Hafnarfjordur, Iceland




Actavis Group PTC ehf






Risedronate Sodium Actavis 30 mg film-coated tablets


30 mg


film-coated tablets


Oral use




IE - Ireland







Actavis Group PTC ehf Reykjavíkurvegi 76-78, 220 Hafnarfjordur, Iceland




Actavis Group PTC ehf






Risedronate Sodium Actavis 35 mg film-coated tablets


35 mg


film-coated tablets


Oral use




IS - Iceland


Sanofi-aventis Norge AS, Strandveien 15 Box 133, 1325 Lysaker, Norway


Optinate


5 mg


Film-coated tablet


Oral use




IS - Iceland


Sanofi-aventis Norge AS, Strandveien 15 Box 133, 1325 Lysaker, Norway


Optinate


30 mg


Film-coated tablet


Oral use




IS - Iceland


Sanofi-aventis Norge AS, Strandveien 15 Box 133, 1325 Lysaker, Norway


Optinate


75 mg


Film-coated tablet


Oral use




IS - Iceland


Sanofi-aventis Norge AS, Strandveien 15 Box 133, 1325 Lysaker, Norway


Optinate Combi


35 mg + 1 250 mg calcium


film-coated tablets


Oral use




IS - Iceland


Sanofi-aventis Norge AS, Strandveien 15 Box 133, 1325 Lysaker, Norway


Optinate Combi D


35 mg and 1 000 mg/880 IU


film-coated tablet and effervescent granules


Oral use




IS - Iceland


Sanofi-aventis Norge AS, Strandveien 15 Box 133, 1325 Lysaker, Norway


Optinate Septimum


35 mg


film-coated tablet


Oral use




IS - Iceland


Portfarma ehf., Borgartúni 26, 105 Reykjavík, Iceland


Risedronat Sodium Portfarma


5 mg


Film-coated tablet


Oral use




IS - Iceland


Qualigen S.L., Avda. Barcelona 69 08970, Sant Joan Despi, (Barcelona) Spain


Risedronat Qualigen


35 mg


Film-coated tablet


Oral use




IT - Italy







GRUPPO LEPETIT Srl




VIALE LUIGI BODIO, 37/B




20158 Milano – Italy






OPTINATE


5 mg


film-coated tablets


Oral use




IT - Italy







GRUPPO LEPETIT Srl




VIALE LUIGI BODIO, 37/B




20158 Milano – Italy






OPTINATE


30 mg


film-coated tablets


Oral use




IT - Italy







GRUPPO LEPETIT Srl




VIALE LUIGI BODIO, 37/B




20158 Milano – Italy






OPTINATE


35 mg


film-coated tablets


Oral use




IT - Italy







GRUPPO LEPETIT Srl




VIALE LUIGI BODIO, 37/B




20158 Milano – Italy






OPTINATE


75 mg


film-coated tablets


Oral use




IT - Italy







SANOFI-AVENTIS SpA




Viale L. Bodio, 37/B




20158 Milano






Risedronato Winthrop 5 mg compresse rivestite con film


5 mg


film-coated tablets


Oral use




IT - Italy







SANOFI-AVENTIS SpA




Viale L. Bodio, 37/B




20158 Milano






Risedronato Winthrop 30 mg compresse rivestite con film


30 mg


film-coated tablets


Oral use




IT - Italy







SANOFI-AVENTIS SpA




Viale L. Bodio, 37/B




20158 Milano






Risedronato Winthrop 35 mg compresse rivestite con film


35 mg


film-coated tablets


Oral use




IT - Italy







SANOFI-AVENTIS SpA




Viale L. Bodio, 37/B




20158 Milano






Risedronato Winthrop 75 mg compresse rivestite con film


75 mg


film-coated tablets


Oral use




IT - Italy







WARNER CHILCOTT ITALY Srl




Viale Giorgio Ribotta, 11




00144 Roma






ACTONEL


5 mg


film-coated tablets


Oral use




IT - Italy







WARNER CHILCOTT ITALY Srl




Viale Giorgio Ribotta, 11




00144 Roma






ACTONEL


30 mg


film-coated tablets


Oral use




IT - Italy







WARNER CHILCOTT ITALY Srl




Viale Giorgio Ribotta, 11




00144 Roma






ACTONEL


35 mg


film-coated tablets


Oral use




IT - Italy







WARNER CHILCOTT ITALY Srl




Viale Giorgio Ribotta, 11




00144 Roma






ACTONEL


75 mg


film-coated tablets


Oral use




IT - Italy







WARNER CHILCOTT ITALY Srl




Viale Giorgio Ribotta, 11




00144 Roma






ACTOCALCIO D3


35 mg + 1 000 mg/880 IU


film-coated tablets + effervescent granules


Oral use




IT - Italy







SANOFI-AVENTIS SpA




Viale L. Bodio, 37/B




20158 Milano






OPTICALCIO D3


35 mg + 1 000 mg/880 IU


film-coated tablets + effervescent granules


Oral use




LT - Lithuania


ZENTIVA, k.s., Ukabelovny 130 Dolní Měcholupy 102 37, Praha 10, Czechia


Risendros


35 mg


Film-coated tablet


Oral use




LT - Lithuania


UAB “SANOFI-AVENTIS LIETUVA”, A.Juozapavičiaus g. 6/2 LT-09310 Vilnius, Lithuania


Actonel


35 mg


Film-coated tablet


Oral use




LT - Lithuania


UAB “SANOFI-AVENTIS LIETUVA”, A.Juozapavičiaus g. 6/2 LT-09310 Vilnius, Lithuania


Actonel


5 mg


Film-coated tablet


Oral use




LT - Lithuania


Teva Pharma B.V., Computerweg 10 3542 DR Utrecht, The Netherlands


Risonate


35 mg


Film-coated tablet


Oral use




LT - Lithuania


Zakład Farmaceutyczny Adamed Pharma S.A, Ul. Szkolna 33, 95-054 Ksawerów, Poland


Norifaz


35 mg


Film-coated tablet


Oral use




LT - Lithuania


Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220 Hafnarfjordur, Islandia


Risedronate sodium Actavis


35 mg


Film-coated tablet


Oral use




LT - Lithuania


UAB “SANOFI-AVENTIS LIETUVA”, A.Juozapavičiaus g. 6/2 LT-09310 Vilnius, Lithuania


Actonel


75 mg


Film-coated tablet


Oral use




LT - Lithuania


UAB “SANOFI-AVENTIS LIETUVA”, A.Juozapavičiaus g. 6/2 LT-09310 Vilnius, Lithuania


Actonel


35 mg + 1 000 mg/880 IU


film-coated tablets + effervescent granules


Oral use




LT - Lithuania


ratiopharm GmbH, Graf-Arco-Strasse 3, Ulm D-89079, Germany


Ribidron


35 mg


Film-coated tablet


Oral use




LU - Luxembourg







Warner Chilcott Pharmaceuticals BVBA




Pegasuslaan 5




1831 Diegem,




Belgium






Actonel


5 mg


Film-coated tablets


oral use




LU - Luxembourg







Warner Chilcott Pharmaceuticals BVBA




Pegasuslaan 5




1831 Diegem,




Belgium






Actonel


30 mg


film-coated tablets


oral use




LU - Luxembourg







Warner Chilcott Pharmaceuticals BVBA




Pegasuslaan 5




1831 Diegem,




Belgium






Actonel


75 mg


film-coated tablets


Oral use




LU - Luxembourg







Warner Chilcott Pharmaceuticals BVBA




Pegasuslaan 5




1831 Diegem,




Belgium






Actonel Combi D


35 mg + 1 000 mg/880 IU


film-coated tablets + effervescent granules


Oral use




LU - Luxembourg







Warner Chilcott Pharmaceuticals BVBA




Pegasuslaan 5




1831 Diegem,




Belgium






Actonel Combi


35 mg + 1 250 mg calcium


film-coated tablets


Oral use




LU - Luxembourg







Warner Chilcott Pharmaceuticals BVBA




Pegasuslaan 5




1831 Diegem,




Belgium






Actonel hebdomadaire


35 mg


film-coated tablets


Oral use




LV - Latvia


Portfarma ehf, Köllunarklettsvegi 2, 104 Reykjavík, Iceland


Risedronate sodium Portfarma


5 mg


film-coated tablets


Oral use




LV - Latvia


Portfarma ehf, Köllunarklettsvegi 2, 104 Reykjavík, Iceland


Risedronate sodium Portfarma


35 mg


film-coated tablets


Oral use




LV - Latvia


Zentiva k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Praha 10, Czech Republic


Risendros


35 mg


film-coated tablets


Oral use




LV - Latvia


sanofi-aventis Latvia SIA, Kr. Valdemara iela 33-8, Riga LV 1010, Latvia


Actonel Combi


35 mg + 1 000 mg/880 IU


Film-coated tablets + effervescent granules


Oral use




LV - Latvia


sanofi-aventis Latvia SIA, Kr. Valdemara iela 33-8, Riga LV 1010, Latvia


Actonel OAW


35 mg


film-coated tablets


Oral use




LV - Latvia


Vale Pharmaceuticals Ltd., 1B Gurtnafleur Business Park, Gurtnafleur, Clonmel, Co. Tipperary, Ireland


Rigat


35 mg


film-coated tablets


Oral use




LV - Latvia


ratiopharm GmbH, Graf-Arco-Str. 3, 89079 Ulm, Germany


Ribidron


35 mg


film-coated tablets


Oral use




LV - Latvia


Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, Netherlands


Risonate


35 mg


film-coated tablets


Oral use




LV - Latvia


Zakład Farmaceutyczny Adamed Pharma S.A., ul. Szkolna 33, 95-054 Ksawerow, Poland


Norifaz


35 mg


film-coated tablets


Oral use




LV - Latvia


Actavis Group PTC ehf., Reykjavikurvegi 76-78, 220 Hafnarfjordur, Iceland


Risedronate Sodium Actavis


35 mg


film-coated tablets


Oral use




LV - Latvia


sanofi-aventis Latvia SIA, Kr. Valdemara iela 33-8, Riga LV 1010, Latvia


Actonel


75 mg


film-coated tablets


Oral use




MT - Malta


Sanofi-Aventis Malta Ltd, Triq Kan. K. Pirotta, Birkirkara, BKR 1114, Malta


Actonel


5 mg


film-coated tablet


Oral use




MT - Malta


Sanofi-Aventis Malta Ltd, Triq Kan. K. Pirotta, Birkirkara, BKR 1114, Malta


Actonel


30 mg


film-coated tablet


Oral use




MT - Malta


Sanofi-Aventis Malta Ltd, Triq Kan. K. Pirotta, Birkirkara, BKR 1114, Malta


Actonel Once a Week


35 mg


film-coated tablet


Oral use




MT - Malta







Beacon Pharmaceuticals Ltd




85 High Street




Tunbridge Wells




TN1 1YG




United Kingdom






Risedronate 5 mg film coated tablets


5 mg


Tablets


Oral use




MT - Malta







Beacon Pharmaceuticals Ltd




85 High Street




Tunbridge Wells




TN1 1YG




United Kingdom






Risedronate 30 mg film coated tablets


30 mg


Tablets


Oral use




MT - Malta







Beacon Pharmaceuticals Ltd




85 High Street




Tunbridge Wells




TN1 1YG




United Kingdom






Risedronate 35 mg film coated tablets


35 mg


Tablets


Oral use




MT - Malta


Sanofi-Aventis Malta Ltd, Triq Kan. K. Pirotta, Birkirkara, BKR 1114, Malta


Actonel


75 mg


film-coated tablet


Oral use




MT - Malta


Sanofi-Aventis Malta Ltd, Triq Kan. K. Pirotta, Birkirkara, BKR 1114, Malta


Actonel Plus Ca & D


35 mg + 1 000 mg/880 IU


film-coated tablet/effervescent granules


Oral use




NL - Netherlands







Warner Chilcott Nederland BV




Lichtenauerlaan 102-120




3062 ME Rotterdam Netherlands






Actokit D, combinatieverpakking


35 mg + 1 000 mg/880 IE


filmcoated tablets + effervescent granules


Oral use




NL - Netherlands







Warner Chilcott Nederland BV




Lichtenauerlaan 102-120




3062 ME Rotterdam Netherlands






Actonel® 30 mg, filmomhulde tabletten


30 mg


filmcoated tablets


Oral use




NL - Netherlands







Warner Chilcott Nederland BV




Lichtenauerlaan 102-120




3062 ME Rotterdam Netherlands






Actonel® 5 mg, filmomhulde tabletten


5 mg


filmcoated tablets


Oral use




NL - Netherlands







Warner Chilcott Nederland BV




Lichtenauerlaan 102-120




3062 ME Rotterdam Netherlands






Actonel® Wekelijks 35 mg, filmomhulde tabletten


35 mg


filmcoated tablets


Oral use




NL - Netherlands







Warner Chilcott Nederland BV




Lichtenauerlaan 102-120




3062 ME Rotterdam Netherlands






Actokit


35 mg + 1 250 mg calcium


Film-coated tablets


Oral use




NL - Netherlands







Ranbaxy Belgium NV




Leuvensestraat 28b




1800 Vilvoorde Belgium






Natriumrisedronaat 35 mg Ranbaxy


35 mg


filmcoated tablets


Oral use




NL - Netherlands







Ceft Limited




65 Delamere Road, Hayes




Middlesex UB4 0NN Belgium






Natriumrisedronaat Ceft 30 mg


30 mg


filmcoated tablets


Oral use




NL - Netherlands







Ceft Limited




65 Delamere Road, Hayes




Middlesex UB4 0NN Belgium






Natriumrisedronaat Ceft 35 mg


35 mg


filmcoated tablets


Oral use




NL - Netherlands







Ceft Limited




65 Delamere Road, Hayes




Middlesex UB4 0NN Belgium






Natriumrisedronaat Ceft 5 mg


5 mg


filmcoated tablets


Oral use




NL - Netherlands


Sandoz B.V., Veluwezoom 22 1327 AH Almere Netherlands


Natriumrisedronaat Sandoz® wekelijks 35 mg


35 mg


filmcoated tablets


Oral use




NL - Netherlands







Centrafarm Services B.V.




Nieuwe Donk 9




47879 AC Etten-Leur Netherlands






Risedronaatnatrium CF 30 mg


30 mg


filmcoated tablets


Oral use




NL - Netherlands







Centrafarm Services B.V.




Nieuwe Donk 9




47879 AC Etten-Leur Netherlands






Risedronaatnatrium CF wekelijks 35 mg


35 mg


filmcoated tablets


Oral use




NL - Netherlands







Centrafarm Services B.V.




Nieuwe Donk 9




47879 AC Etten-Leur Netherlands






Risedronaatnatrium CF 5 mg


5 mg


filmcoated tablets


Oral use




NL - Netherlands







Mylan B.V.




Dieselweg 25




3752 LB Bunschoten Netherlands






Risedronaatnatrium Mylan 5 mg


5 mg


filmcoated tablets


Oral use




NL - Netherlands







Mylan B.V.




Dieselweg 25




3752 LB Bunschoten Netherlands






Risedronaatnatrium Mylan Wekelijks 35 mg


35 mg


filmcoated tablets


Oral use




NL - Netherlands







Pharmachemie B.V.




Swensweg 5




2031 GA Haarlem Netherlands






Risedronaatnatrium Wekelijks 35 mg PCH


35 mg


filmcoated tablets


Oral use




NL - Netherlands







Warner Chilcott Nederland BV




Lichtenauerlaan 102-120




3062 ME Rotterdam Netherlands






ActoCalD tabletten 35 mg + 500 mg / 400 IE filmomhulde tabletten, combinatieverpakking


35 mg + 500 mg / 400 IE


filmcoated tablets


Oral use




NL - Netherlands







Warner Chilcott Nederland BV




Lichtenauerlaan 102-120




3062 ME Rotterdam Netherlands






Actonel® 75 mg, filmomhulde tabletten


75 mg


filmcoated tablets


Oral use




NO - Norway


Sanofi-aventis, Strandveien 15, 1366 Lysaker Norway


Optinate


5 mg


Film-coated tablet


Oral use




NO - Norway


Sanofi-aventis, Strandveien 15, 1366 Lysaker Norway


Optinate


30 mg


Film-coated tablet


Oral use




NO - Norway


Sanofi-aventis, Strandveien 15, 1366 Lysaker Norway


Optinate Septimum


35 mg


Film-coated tablet


Oral use




NO - Norway


Orifarm Energivej 15, POB 69, DK-5260 Odense S Danmark


Risedronat Orifarm


5 mg


Film-coated tablet


Oral use




NO - Norway


Orifarm Energivej 15, POB 69, DK-5260 Odense S Danmark


Risedronat Orifarm


30 mg


Film-coated tablet


Oral use




NO - Norway


Orifarm Energivej 15, POB 69, DK-5260 Odense S Danmark


Risedronat Orifarm


35 mg


Film-coated tablet


Oral use




NO - Norway


Zaklad Farmaceutyczny Adamed Pharma S.A., Szkolna Street 33, 95-054 Ksawerow, Poland


Norifaz


35 mg


Film-coated tablet


Oral use




NO - Norway


Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220 Hafnarfjordur, Iceland


Risedronat Actavis


35 mg


Film-coated tablet


Oral use




NO - Norway


Teva Sweden AB, Box 1070, 25110 Helsingborg, Sweden


Risedronat Teva


35 mg


Film-coated tablet


Oral use




NO - Norway


Mylan AB, Box 23033, 10435 Stockholm, Sweden


Vionate


35 mg


Film-coated tablet


Oral use




PL - Poland







Sanofi-Aventis AB




Gustavslundsvägen 139




Box 14142




167 14 BROMMA, Sweden






Actonel


5 mg


film coated tablets


Oral use




PL - Poland







Ranbaxy (Poland) Sp. z o.o.




Kubickiego st. 11,




02-954 Warsaw, Poland






Resorpate


35 mg


film coated tablets


Oral use




PL - Poland







Sanofi-Aventis AB




Gustavslundsvägen 139




Box 14142




167 14 BROMMA, Sweden






Actonel


30 mg


film coated tablets


Oral use




PL - Poland







Sanofi-Aventis AB




Gustavslundsvägen 139




Box 14142




167 14 BROMMA, Sweden






Actonel


35 mg


film coated tablets


Oral use




PL - Poland







ZENTIVA, k.s.




U kabelovny 130, Dolní Měcholupy 102 37 Praga 10, Czech Republic






Risendros 35


35 mg


film coated tablets


Oral use




PL - Poland







Actavis Group PTC ehf.




Reykjavikurvegi 76-78




220 Hafnarfirdi, Iceland






Bifodron


35 mg


film coated tablets


Oral use




PL - Poland







Teva Pharmaceuticals Polska Sp. z o.o.




53 Emilii Plater St.,




00-113, Warsaw, Poland






Nofemix


35 mg


film coated tablets


Oral use




PL - Poland







Zakład Farmaceutyczny Adamed Pharma S.A.




Szkolna st. 33,




95-054 Ksawerów, Poland






Norifaz


35 mg


film coated tablets


Oral use




PL - Poland







Vale Pharmaceuticals Ltd




1G Gurtnafleur Business Park,




Gurtnafleur, Clonmel, Co. Tipperary, Ireland






Rigat


35 mg


film coated tablets


Oral use




PL - Poland







ratiopharm GmbH




Graf-Arco-Strasse 3, Ulm, 89073, Germany






Risedronat-ratiopharm


35 mg


film coated tablets


Oral use




PL - Poland







Labormed Pharma S.A.




Bd. Theodor Pallady nr. 44B, sector 3, Bucharest, Romania






Juverital


5 mg


film coated tablets


Oral use




PL - Poland







Labormed Pharma S.A.




Bd. Theodor Pallady nr. 44B, sector 3, Bucharest, Romania






Juverital


35 mg


film coated tablets


Oral use




PL - Poland







Galex d.d.




Tišinska ul. 29g,




9000 Murska Sobota, Slovenia






Risedrolex 35 mg


35 mg


film coated tablets


Oral use




PT - Portugal


Sanofi-Aventis - Produtos Farmacêuticos, S.A. Empreendimento Lagoas Park, Edifício 7 - 3o, 2740-244 Porto Salvo Portugal


Actonel


5 mg


Film-coated tablet


Oral use




PT - Portugal


Sanofi-Aventis - Produtos Farmacêuticos, S.A. Empreendimento Lagoas Park, Edifício 7 - 3o, 2740-244 Porto Salvo Portugal


Actonel


30 mg


Film-coated tablet


Oral use




PT - Portugal


Sanofi-Aventis - Produtos Farmacêuticos, S.A. Empreendimento Lagoas Park, Edifício 7 - 3o, 2740-244 Porto Salvo Portugal


Actonel 35 mg


35 mg


Film-coated tablet


Oral use




PT - Portugal


Sanofi-Aventis - Produtos Farmacêuticos, S.A. Empreendimento Lagoas Park, Edifício 7 - 3o, 2740-244 Porto Salvo Portugal


Norsed


35 mg


Film-coated tablet


Oral use




PT - Portugal


Generis Farmacêutica, S.A. Office Park da Beloura, Edificio 4 - Piso 1, Escrit. 8, 2710-444 Sintra Portugal


Risedronato de sódio Generis


5 mg


Film-coated tablet


Oral use




PT - Portugal


Generis Farmacêutica, S.A. Office Park da Beloura, Edificio 4 - Piso 1, Escrit. 8, 2710-444 Sintra Portugal


Risedronato de sódio Generis


30 mg


Film-coated tablet


Oral use




PT - Portugal


Generis Farmacêutica, S.A. Office Park da Beloura, Edificio 4 - Piso 1, Escrit. 8, 2710-444 Sintra Portugal


Risedronato de sódio Generis


35 mg


Film-coated tablet


Oral use




PT - Portugal


Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. Lagoas Park, Edifício 5 A - Piso 2, 2740-298 Porto Salvo Portugal


Risedronato de sódio Mepha


35 mg


Film-coated tablet


Oral use




PT - Portugal


Bluepharma Genéricos - Comércio de Medicamentos, S.A. São Martinho do Bispo, 3045-016 Coimbra Portugal


Risedronato de sódio Bluepharma


35 mg


Film-coated tablet


Oral use




PT - Portugal


Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Edifício Atlas II, Av. José Gomes Ferreira, N.o 11 - 3o, Sala 31, 1495-139 Miraflores - Algés Portugal


Risedronato de sódio Pharmakern


35 mg


Coated tablet


Oral use




PT - Portugal


GP - Genéricos Portugueses, Lda. Rua Henrique Paiva Couceiro, 29 - Venda Nova, 2700-451 Amadora Portugal


Risedronato de sódio GP


35 mg


Film-coated tablet


Oral use




PT - Portugal


Farmoz - Sociedade Técnico Medicinal, S.A. Rua da Tapada Grande, 2, Abrunheira, 2710-089 Sintra Portugal


Risedronato de sódio Farmoz


35 mg


Film-coated tablet


Oral use




PT - Portugal


Alter, S.A. Estrada Marco do Grilo - Zemouto, 2830 Coina Portugal


Risedronato de sódio Alter


5 mg


Film-coated tablet


Oral use




PT - Portugal


Alter, S.A. Estrada Marco do Grilo - Zemouto, 2830 Coina Portugal


Risedronato de sódio Alter


30 mg


Film-coated tablet


Oral use




PT - Portugal


Alter, S.A. Estrada Marco do Grilo - Zemouto, 2830 Coina Portugal


Risedronato de sódio Alter


35 mg


Film-coated tablet


Oral use




PT - Portugal


Ranbaxy Portugal - Comércio e Desenvol. de Produtos Farmacêuticos, Unip., Lda. Rua do Campo Alegre, 1306, 3o - Sala 301/302 - Edifício Botânico, 4150-174 Porto Portugal


Risedronato de sódio Ranbaxy


35 mg


Film-coated tablet


Oral use




PT - Portugal


Solufarma - Produtos Farmacêuticos Unipessoal, Lda. Av. dos Bombeiros Voluntários, no 146 - 1o, 2765-201 Estoril Portugal


Risedronato de sódio Riseflore


35 mg


Film-coated tablet


Oral use




PT - Portugal


Baldacci - Portugal, S.A. Rua Cândido de Figueiredo, 84-B, 1549-005 Lisboa Portugal


Risedronato de sódio Medilusa


35 mg


Film-coated tablet


Oral use




PT - Portugal


ISUS - Produtos Farmacêuticos e Cosméticos, S.A. Rua António Quadros, 9G - Escritório 3, 1600-875 Lisboa Portugal


Risedronato de sódio Rizat


35 mg


Film-coated tablet


Oral use




PT - Portugal


Labesfal - Laboratórios Almiro, S.A. Zona Industrial do Lagedo, 3465-157 Santiago de Besteiros Portugal


Risedronato de sódio Labesfal


35 mg


Film-coated tablet


Oral use




PT - Portugal


Cinfa Portugal, Lda. Av. Tomás Ribeiro, 43 - Bloco 1, 4o B - Edifício Neopark, 2790-221 Carnaxide Portugal


Risedronato de sódio Cinfa


35 mg


Film-coated tablet


Oral use




PT - Portugal


Laboratórios Atral, S.A. Rua da Estação, 42 - Vala do Carregado, 2600-726 Castanheira do Ribatejo Portugal


Risedronato de sódio Atral


5 mg


Film-coated tablet


Oral use




PT - Portugal


Laboratórios Atral, S.A. Rua da Estação, 42 - Vala do Carregado, 2600-726 Castanheira do Ribatejo Portugal


Risedronato de sódio Atral


30 mg


Film-coated tablet


Oral use




PT - Portugal


Laboratórios Atral, S.A. Rua da Estação, 42 - Vala do Carregado, 2600-726 Castanheira do Ribatejo Portugal


Risedronato de sódio Atral


35 mg


Film-coated tablet


Oral use




PT - Portugal


Vida - Produtos Farmacêuticos, S.A. Rua da Estação, 42 - Vala do Carregado, 2600-726 Castanheira do Ribatejo Portugal


Risedronato de sódio Vida


5 mg


Film-coated tablet


Oral use




PT - Portugal


Vida - Produtos Farmacêuticos, S.A. Rua da Estação, 42 - Vala do Carregado, 2600-726 Castanheira do Ribatejo Portugal


Risedronato de sódio Vida


30 mg


Film-coated tablet


Oral use




PT - Portugal


Vida - Produtos Farmacêuticos, S.A. Rua da Estação, 42 - Vala do Carregado, 2600-726 Castanheira do Ribatejo Portugal


Risedronato de sódio Vida


35 mg


Film-coated tablet


Oral use




PT - Portugal


Decomed Farmacêutica, S.A. Rua Sebastião e Silva, 56, 2745-838 Massamá Portugal


Zectoel


5 mg


Film-coated tablet


Oral use




PT - Portugal


Decomed Farmacêutica, S.A. Rua Sebastião e Silva, 56, 2745-838 Massamá Portugal


Zectoel


30 mg


Film-coated tablet


Oral use




PT - Portugal


Decomed Farmacêutica, S.A. Rua Sebastião e Silva, 56, 2745-838 Massamá Portugal


Zectoel


35 mg


Film-coated tablet


Oral use




PT - Portugal


Germed Farmacêutica, Lda. Rua Alto do Montijo, 13 - 1o Dto - Edifício Monsanto 2790-012 Portela de Carnaxide Portugal


Risedronato de sódio Germed


5 mg


Film-coated tablet


Oral use




PT - Portugal


Germed Farmacêutica, Lda. Rua Alto do Montijo, 13 - 1o Dto - Edifício Monsanto 2790-012 Portela de Carnaxide Portugal


Risedronato de sódio Germed


30 mg


Film-coated tablet


Oral use




PT - Portugal


Germed Farmacêutica, Lda. Rua Alto do Montijo, 13 - 1o Dto - Edifício Monsanto 2790-012 Portela de Carnaxide Portugal


Risedronato de sódio Germed


35 mg


Film-coated tablet


Oral use




PT - Portugal


Sanofi-Aventis - Produtos Farmacêuticos, S.A. Empreendimento Lagoas Park, Edifício 7 - 3o, 2740-244 Porto Salvo Portugal


Actonel


75 mg


Film-coated tablet


Oral use




PT - Portugal


Actavis Group PTC ehf. Reykjavíkurvegi, 76-78, IS-220 Hafnarfjörour Islândia


Risedronato de sódio Actavis


35 mg


Film-coated tablet


Oral use




PT - Portugal


Laboratórios Azevedos - Indústria Farmacêutica, S.A. Estrada da Quinta, 148-148 A, Manique de Baixo 2645-436 Alcabideche Portugal


Norifaz


35 mg


Film-coated tablet


Oral use




PT - Portugal


Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda. Rua Quinta do Pinheiro - Edifício Tejo - 6o Piso, 2790-143 Carnaxide Portugal


Risedronato de sódio Ratiopharm


35 mg


Film-coated tablet


Oral use




PT - Portugal


Mylan, Lda. Rua Doutor António Loureiro Borges, Edíficio Arquiparque 1, R/C Esqo, 1499-016 Algés Portugal


Risedronato de sódio Mylan


5 mg


Film-coated tablet


Oral use




PT - Portugal


Mylan, Lda. Rua Doutor António Loureiro Borges, Edíficio Arquiparque 1, R/C Esqo, 1499-016 Algés Portugal


Risedronato de sódio Mylan


35 mg


Film-coated tablet


Oral use




PT - Portugal


Qualigen, S.L. Avenida Barcelona, 69, Sant Joan Despí, 08970 Barcelona Espanha


Risedronato de sódio Qualigen


35 mg


Film-coated tablet


Oral use




PT - Portugal


Teva Pharma - Produtos Farmacêuticos, Lda. Edifício Cyprium, Av. 25 de Abril, 15, 2o F, 2795-195 Linda-a-Velha Portugal


Risedronato de sódio Teva


35 mg


Film-coated tablet


Oral use




PT - Portugal


Sandoz Farmacêutica, Lda. Alameda da Beloura, Edifício 1, 2o - Escritório 15, 2710-693 Sintra Portugal


Risedronato de sódio Sandoz


35 mg


Film-coated tablet


Oral use




PT - Portugal


Sandoz Farmacêutica, Lda. Alameda da Beloura, Edifício 1, 2o - Escritório 15, 2710-693 Sintra Portugal


Risedronato de sódio 1APharma


35 mg


Film-coated tablet


Oral use




PT - Portugal


Ciclum Farma Unipessoal, Lda. Quinta da Fonte, Rua Vitor Câmara, 2 - Edifício D. Amélia, Piso 1, Ala B, 2770-229 Paço de Arcos Portugal


Risedronato de sódio Ciclum


35 mg


Film-coated tablet


Oral use




PT - Portugal


Ciclum Farma Unipessoal, Lda. Quinta da Fonte, Rua Vitor Câmara, 2 - Edifício D. Amélia, Piso 1, Ala B, 2770-229 Paço de Arcos Portugal


Risedronato de sódio Ciclum


5 mg


Film-coated tablet


Oral use




PT - Portugal


Actavis Group PTC ehf. Reykjavíkurvegi, 76-78, IS-220 Hafnarfjörour Islândia


Claronate


5 mg


Film-coated tablet


Oral use




PT - Portugal


Actavis Group PTC ehf. Reykjavíkurvegi, 76-78, IS-220 Hafnarfjörour Islândia


Claronate


30 mg


Film-coated tablet


Oral use




PT - Portugal


Actavis Group PTC ehf. Reykjavíkurvegi, 76-78, IS-220 Hafnarfjörour Islândia


Claronate


35 mg


Film-coated tablet


Oral use




PT - Portugal


Arrow Generics, Ltd. Unit 2 - Eastman Way, SG1 4SZ Stevenage - Hertfordshire Reino Unido


Risedronato de sódio Arrow


35 mg


Tablet


Oral use




PT - Portugal


Zaklad Farmaceutyczny Adamed Pharma S.A., Szkolna Street 33, 95-054 Ksawerow, Poland


Norifaz, 35 mg, comprimidos revestidos por pelicula


35 mg


film coated tablets


Oral use




RO - Romania


AVENTIS PHARMA AB Bryggvagen 16-18, 11768 Stockholm, Sweden


ACTONEL 5 mg film coated tablets


5 mg


film coated tablets


Oral use




RO - Romania







SANOFI-AVENTIS ROMÂNIA S.R.L.




Str. Izvor, nr 80, etajele 6-11, sector 5 Bucharest, Romania






ACTONEL SAPTAMANAL 35 mg film coated tablets


35 mg


film coated tablets


Oral use




RO - Romania







SANOFI-AVENTIS ROMÂNIA S.R.L.




Str. Izvor, nr 80, etajele 6-11, sector 5 Bucharest, Romania






ACTONEL 75 mg film coated tablets


75 mg


film coated tablets


Oral use




RO - Romania


TERAPIA SA Str. Fabricii nr. 124, Cluj-Napoca, Romania


OSODENS 35 mg film coated tablets


35 mg


film coated tablets


Oral use




RO - Romania







ZENTIVA, k.s.




U kabelovny 130, Dolní Měcholupy 102 37 Praga 10, Czech Republic






RISENDROS 35 mg film coated tablets


35 mg


film coated tablets


Oral use




RO - Romania


Actavis Group PTC ehf Reykjavikurvegi 76-78, 220 Hafnarfjordur, Island


OSTEORON 35 mg film coated tablets


35 mg


film coated tablets


Oral use




RO - Romania


Antibiotice S.A. Valea Lupului nr. 1, 707410 Iași, Romania


LORINE 35 mg film coated tablets


35 mg


film coated tablets


Oral use




RO - Romania


TEVA PHARMACEUTICALS S.R.L. Str. Domnița Ruxandra, nr. 12 parter, sector 2București, Romania


RISEDRONAT TEVA 35 mg film coated tablets


35 mg


film coated tablets


Oral use




RO - Romania


STADA Hemofarm SRL Zugrav Nedelcu nr. 3, Timișoara, Romania


RISEDRONAT SODIC HF 35 mg, film coated tablets


35 mg


film coated tablets


Oral use




RO - Romania







LABORMED PHARMA S.A.




Theodor Pallady Boulevard 44B, Sector 3, RO-032266 Bucharest, Romania






JUVERITAL 5 mg film coated tablets


5 mg


film coated tablets


Oral use




RO - Romania







LABORMED PHARMA S.A.




Theodor Pallady Boulevard 44B, Sector 3, RO-032266 Bucharest, Romania






JUVERITAL 35 mg film coated tablets


35 mg


film coated tablets


Oral use




RO - Romania


Sanofi-aventis AB Gustavslundsvägen 139, Box 141 42, 167 14 Bromma, Sweden


ACTONEL COMBI D 35 mg + 500 mg/400 UI film coated tablets


35 mg + 500 mg/400 UI


film coated tablets


Oral use




SE - Sweden


Warner Chilcott UK Limited Old Belfast Road Millbrook Larne County Antrim BT40 2SH, United Kingdom


Fortipan


5 mg


film-coated tablet


Oral use




SE - Sweden


Warner Chilcott UK Limited Old Belfast Road Millbrook Larne County Antrim BT40 2SH, United Kingdom


Fortipan


30 mg


film-coated tablet


Oral use




SE - Sweden


Sanofi-aventis AB Box 14142 167 14 Bromma Sweden


Optinate


5 mg


film-coated tablet


Oral use




SE - Sweden


Sanofi-aventis AB Box 14142 167 14 Bromma Sweden


Optinate


30 mg


film-coated tablet


Oral use




SE - Sweden


Gruppo LePetit S.r.l. Viale Luigi Bodio 37/b IT-20158 Milano Italy


Avestra


5 mg


film-coated tablet


Oral use




SE - Sweden


Gruppo LePetit S.r.l. Viale Luigi Bodio 37/b IT-20158 Milano Italy


Avestra


30 mg


film-coated tablet


Oral use




SE - Sweden


Sanofi-aventis S.p.A. Viale Luigi Bodio 37/b IT-20158 Milano Italy


Norsed


5 mg


film-coated tablet


Oral use




SE - Sweden


Sanofi-aventis S.p.A. Viale Luigi Bodio 37/b IT-20158 Milano Italy


Norsed


30 mg


film-coated tablet


Oral use




SE - Sweden


Sanofi-aventis AB Box 14142 167 14 Bromma Sweden


Optinate Septimum


35 mg


film-coated tablet


Oral use




SE - Sweden


Warner Chilcott UK Limited Old Belfast Road Millbrook Larne County Antrim BT40 2SH, United Kingdom


Fortipan Septimum


35 mg


film-coated tablet


Oral use




SE - Sweden


Gruppo LePetit S.r.l. Viale Luigi Bodio 37/b IT-20158 Milano Italy


Avestra Septimum


35 mg


film-coated tablet


Oral use




SE - Sweden


Sanofi-aventis S.p.A. Viale Luigi Bodio 37/b IT-20158 Milano Italy


Norsed Septimum


35 mg


film-coated tablet


Oral use




SE - Sweden


Sanofi-aventis AB Box 14142 167 14 Bromma Sweden


Optinate Combi


35 mg + 1 250 mg calcium


film-coated tablet


Oral use




SE - Sweden


Gruppo LePetit S.r.l. Viale Luigi Bodio 37/b IT-20158 Milano Italy


Avestra Combi


35 mg + 1 250 mg calcium


film-coated tablet


Oral use




SE - Sweden


Sanofi-aventis S.p.A. Viale Luigi Bodio 37/b IT-20158 Milano Italy


Norsed Combi


35 mg + 1 250 mg calcium


film-coated tablet


Oral use




SE - Sweden


Warner Chilcott UK Limited Old Belfast Road Millbrook Larne County Antrim BT40 2SH, United Kingdom


Fortipan Combi


35 mg + 1 250 mg calcium


film-coated tablet


Oral use




SE - Sweden


Sanofi-aventis AB Box 14142 167 14 Bromma Sweden


Optinate Combi D


35 mg + 1 000 mg/880 IE


film-coated tablet and effervescent granules


Oral use




SE - Sweden


Warner Chilcott UK Limited Old Belfast Road Millbrook Larne County Antrim BT40 2SH, United Kingdom


Fortipan Combi D


35 mg + 1 000 mg/880 IE


film-coated tablet and effervescent granules


Oral use




SE - Sweden


Gruppo LePetit S.r.l. Viale Luigi Bodio 37/b IT-20158 Milano Italy


Avestra Combi D


35 mg + 1 000 mg/880 IE


film-coated tablet and effervescent granules


Oral use




SE - Sweden


Sanofi-aventis S.p.A. Viale Luigi Bodio 37/b IT-20158 Milano Italy


Norsed Combi D


35 mg + 1 000 mg/880 IE


film-coated tablet and effervescent granules


Oral use




SE - Sweden


Sanofi-aventis AB Box 14142 167 14 Bromma Sweden


Optinate


75 mg


film-coated tablet


Oral use




SE - Sweden


Sanofi-aventis S.p.A. Viale Luigi Bodio 37/b IT-20158 Milano Italy


Norsed


75 mg


film-coated tablet


Oral use




SE - Sweden


Sanofi-aventis S.p.A. Viale Luigi Bodio 37/b IT-20158 Milano Italy


Norsed Combi D


35 mg + 500 mg/400 IE


film-coated tablet


Oral use




SE - Sweden


Gruppo LePetit S.r.l. Viale Luigi Bodio 37/b IT-20158 Milano Italy


Avestra Combi D


35 mg + 500 mg/400 IE


film-coated tablet


Oral use




SE - Sweden


Ranbaxy (UK) Ltd 3rd floor, CP house 97-107, Uxbridge Road Ealing, London W5 5TL United Kngdom


Risedronate Ranbaxy


35 mg


film-coated tablet


Oral use




SE - Sweden


Sandoz A/S Edvard Thomsens Vej 14 DK-2300 Köpenhamn S Danmark


Risedronat Sandoz


35 mg


film-coated tablet


Oral use




SE - Sweden


Orifarm Generics A/S Energivej 15 POB 69 DK-5260 Odense S Denmark


Risedronat Orifarm


5 mg


film-coated tablet


Oral use




SE - Sweden


Orifarm Generics A/S Energivej 15 POB 69 DK-5260 Odense S Denmark


Risedronat Orifarm


30 mg


film-coated tablet


Oral use




SE - Sweden


Orifarm Generics A/S Energivej 15 POB 69 DK-5260 Odense S Denmark


Risedronat Orifarm


35 mg


film-coated tablet


Oral use




SE - Sweden


Ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Germany


Riseratio


35 mg


film-coated tablet


Oral use




SE - Sweden


Teva Sweden AB Box 1070 251 10 Helsingborg Sweden


Risedronat Teva


35 mg


film-coated tablet


Oral use




SE - Sweden


Warner Chilcott UK Limited Old Belfast Road Millbrook Larne County Antrim BT40 2SH, United Kingdom


Fortipan


75 mg


film-coated tablet


Oral use




SE - Sweden


Gruppo LePetit S.r.l. Viale Luigi Bodio 37/b IT-20158 Milano Italy


Avestra


75 mg


film-coated tablet


Oral use




SE - Sweden


sanofi-aventis AB Box 14142 167 14 Bromma Sweden


Optinate Combi D


35 mg + 500 mg/400 IE


film-coated tablet


Oral use




SE - Sweden


Warner Chilcott UK Limited Old Belfast Road Millbrook Larne County Antrim BT40 2SH, United Kingdom


Fortipan Combi D


35 mg + 500 mg/400 IE


film-coated tablet


Oral use




SE - Sweden


Zaklad Farmaceutyczny Adamed Pharma S.A., ul. Szkolna 33 95-054 Ksawerow, Polen


Risedronat Adamed Pharma


35 mg


film-coated tablet


Oral use




SI - Slovenia


Sanofi-aventis d.o.o., Dunajska cesta 151, SI-1000 Ljubljana


Actonel 30 mg filmsko obložene tablete


30 mg


film-coated tablet


Oral use




SI - Slovenia


Sanofi-aventis d.o.o., Dunajska cesta 151, SI-1000 Ljubljana


Actonel 5 mg filmsko obložene tablete


5 mg


film-coated tablet


Oral use




SI - Slovenia


Sanofi-aventis d.o.o., Dunajska cesta 151, SI-1000 Ljubljana


Actonel 75 mg filmsko obložene tablete


75 mg


film-coated tablet


Oral use




SI - Slovenia


Sanofi-aventis d.o.o., Dunajska cesta 151, SI-1000 Ljubljana


Actonel enkrat tedensko 35 mg filmsko obložene tablete


35 mg


film-coated tablet


Oral use




SI - Slovenia


Sanofi-aventis d.o.o., Dunajska cesta 151, SI-1000 Ljubljana


Actonel Combi D


35 mg + 1 000 mg/880 IE


film-coated tablet and effervescent granules


Oral use




SI - Slovenia


Galex, d.d., Tišinska ulica 29g, Murska Sobota, Slovenia


Riserdonat Galex 35 mg filmsko obložene tablete


35 mg


film-coated tablet


Oral use




SK - Slovakia


STADA Arzneimittel AG Stadastrasse 2-18 Bad Vilbel, 61118 Germany


Risedronat STADA 35 mg


35 mg


Film coated tablet


Oral use




SK - Slovakia


Actavis Group PTC ehf Dalshraun 1 220 Hafnarfjordur Iceland


Bifodron 35 mg


35 mg


Film coated tablet


Oral use




SK - Slovakia


Zaklad Farmaceutyczny Adamed Pharma SA 33 Szkolna Street Ksawerów, 95-054 Poland


Norifaz 35 mg


35 mg


Film coated tablet


Oral use




SK - Slovakia


Gedeon Richter Plc. Gyômrôi út 19-21 1103, Budapest Hungary


Nurrid 35 mg


35 mg


Film coated tablet


Oral use




SK - Slovakia


ZENTIVA, k.s. U kabelovny 130, Dolní Měcholupy 102 37 Praga 10, Czech Republic


RISENDROS 35 mg - TBL FLM


35 mg


film-coated tablets


Oral use




SK - Slovakia


LABORMED-PHARMA S.A., Theodor Pallady Boulevard 44B, Sector 3, RO-032266 Bucharest, Romania


Juverital


5 mg


Film-coated tablets


Oral use




SK - Slovakia


LABORMED-PHARMA S.A., Theodor Pallady Boulevard 44B, Sector 3, RO-032266 Bucharest, Romania


Juverital


35 mg


Film-coated tablets


Oral use




SK - Slovakia







Sanofi-aventis Slovakia s.r.o.




Einsteinova 24




SK – 851 01 BRATISLAVA






ACTONEL 5 MG


5 mg


Film coated tablet


Oral use




SK - Slovakia







Sanofi-aventis Slovakia s.r.o.




Einsteinova 24




SK – 851 01 BRATISLAVA






ACTONEL 75 MG


75 mg


Film coated tablet


Oral use




SK - Slovakia







Sanofi-aventis Slovakia s.r.o.




Einsteinova 24




SK – 851 01 BRATISLAVA






ACTONEL COMBI


35 mg + 500 mg/400 UI


film coated tablets


Oral use




SK - Slovakia







TEVA Pharmaceuticals Slovakia s.r.o.,




Teslova 26,




82102 Bratislava,




Slovak Republic






Risedronat Teva 35 mg filmom obalené tablety


35 mg


Film coated tablet


Oral use




UK - United Kingdom


Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG


Risedronate sodium 35 mg tablets


35 mg


film-coated tablet


Oral use




UK - United Kingdom


Sandoz Limited, 37 Woolmer Way, Bordon, Hampshire GU35 9QE


Risedronate sodium 35 mg tablets


35 mg


film-coated tablet


Oral use




UK - United Kingdom


Generics (UK) Limited, Station Close, Potters Bar, Hertfordshire EN6 1TL


Risedronate sodium 5 mg tablets


5 mg


film-coated tablet


Oral use




UK - United Kingdom


Generics (UK) Limited, Station Close, Potters Bar, Hertfordshire EN6 1TL


Risedronate sodium 35 mg tablets


35 mg


film-coated tablet


Oral use




UK - United Kingdom


Warner Chilcott UK Limted, Old Belfast Road, Millbrook, Larne, Co. Antrim BT40 2SH, UK


Actonel 5 mg Tablets


5 mg


film-coated tablet


Oral use




UK - United Kingdom


Warner Chilcott UK Limted, Old Belfast Road, Millbrook, Larne, Co. Antrim BT40 2SH, UK


Actonel 30 mg Tablets


30 mg


film-coated tablet


Oral use




UK - United Kingdom


Warner Chilcott UK Limted, Old Belfast Road, Millbrook, Larne, Co. Antrim BT40 2SH, UK


Actonel Once a Week 35 mg Tablet


35 mg


film-coated tablet


Oral use




UK - United Kingdom


Warner Chilcott UK Limted, Old Belfast Road, Millbrook, Larne, Co. Antrim BT40 2SH, UK


Actonel Combi 35 mg film-coated tablets + 1 000 mg / 880 IU effervescent granules


35 mg + 1 000 mg/880 IE


film-coated tablet and effervescent granules


Oral use




UK - United Kingdom


Warner Chilcott UK Limted, Old Belfast Road, Millbrook, Larne, Co. Antrim BT40 2SH, UK


Actonel 75 mg tablet


75 mg


film-coated tablet


Oral use




UK - United Kingdom


Warner Chilcott UK Limted, Old Belfast Road, Millbrook, Larne, Co. Antrim BT40 2SH, UK


Actonel Combi 35 mg + 500 mg / 400 IU film-coated tablets


35 mg + 500 mg/400 UI


film-coated tablet


Oral use




UK - United Kingdom


Winthrop Pharmaceuticals UK Ltd, One Onslow Street, Guildford, Surrey, GU1 4YS, UK


Norsed Once a Week


35 mg


film-coated tablet


Oral use




UK - United Kingdom


Ranbaxy (UK) Limited, 95 Park Lane, Mayfair. London W1K 7TE, United Kingdom


Risedronate sodium 35 mg tablets


35 mg


film-coated tablet


Oral use




UK - United Kingdom


Ratiopharm GmbH, 5 Jackson Close, Grove Road, Cosham, Portsmouth, Hampshire, PO6 1UP


Risedronate sodium 35 mg tablets


35 mg


film-coated tablet


Oral use




UK - United Kingdom


Pharmathen SA, 6 Dervenakion Street, Pallini, Athens, GR-153 51, Greece


Risedronate sodium 5 mg tablets


5 mg


film-coated tablet


Oral use




UK - United Kingdom


Pharmathen SA, 6 Dervenakion Street, Pallini, Athens, GR-153 51, Greece


Risedronate sodium 30 mg tablets


30 mg


film-coated tablet


Oral use




UK - United Kingdom


Pharmathen SA, 6 Dervenakion Street, Pallini, Athens, GR-153 51, Greece


Risedronate sodium 35 mg tablets


35 mg


film-coated tablet


Oral use




UK - United Kingdom


Beacon Pharmaceuticals Ltd, 85 High Street, Tunbridge Wells, Kent TN1 1YG, UK


Risedronate sodium 5 mg tablets


5 mg


film-coated tablet


Oral use




UK - United Kingdom


Beacon Pharmaceuticals Ltd, 85 High Street, Tunbridge Wells, Kent TN1 1YG, UK


Risedronate sodium 30 mg tablets


30 mg


film-coated tablet


Oral use




UK - United Kingdom


Beacon Pharmaceuticals Ltd, 85 High Street, Tunbridge Wells, Kent TN1 1YG, UK


Risedronate sodium 35 mg tablets


35 mg


film-coated tablet


Oral use




UK - United Kingdom


Zaklad Farmaceutyczny Adamed Pharma SA, ul. Szkolna 33, 95-054 Ksawerow, Poland


Norifaz 35 mg tablet


35 mg


film-coated tablet


Oral use




UK - United Kingdom


Apotex Europe BV, Darwinweg 20, 2333 C R Leiden, The Netherlands


Risedronate sodium 35 mg tablets


35 mg


film-coated tablet


Oral use








Tiludronic acid containing medicinal products with Marketing Authorisation in the European Union











Member State EU/EEA


Marketing authorisation holder


(Invented) Name


Strength


Pharmaceutical form


Route of administration




BE - Belgium







Sanofi-Aventis Belgium NV




Culliganlaan 1C




1831 Diegem




Belgium






Skelid


200 mg


Tablets


Oral use




ES - Spain


SANOFI AVENTIS, S.A.Josep Plá, 2 08019 Barcelona


SKELID 200 mg comprimidos


200 mg


tablets


Oral use




FR - France







SANOFI AVENTIS FRANCE




1-13, boulevard Romain Rolland




75014 Paris




FRANCE






ACIDE TILUDRONIQUE SANOFI PHARMA 200 mg, comprimé


200 mg


tablet


Oral use




FR - France







SANOFI AVENTIS FRANCE




1-13, boulevard Romain Rolland




75014 Paris




FRANCE






SKELID 200 mg, comprimé


200 mg


tablet


Oral use




LU - Luxembourg







Sanofi-Aventis Belgium NV




Culliganlaan 1C




1831 Diegem




Belgium






Skelid


200 mg


Tablets


Oral use




UK - United Kingdom


Sanofi-Synthelabo Limited, One Onslow Street, Guildford, Surry GU1 4YS, UK


Skelid


200 mg


tablet


Oral use








Ibandronic acid containing medicinal products with Marketing Authorisation in the European Union











Member State EU/EEA


Marketing authorisation holder


(Invented) Name


Strength


Pharmaceutical form


Route of administration




DE - Germany







Mylan dura GmbH




Wittichstr. 6




D-64295 Darmstadt






Ibandronsäure dura 150 mg Filmtabletten


169,32 mg


Film-coated tablet


Oral use




DE - Germany







Orifarm Generixs A/S




Energivej 15




DK-7260ODENSE S




Denmark






Ibandronat Orifarm 50 mg Filmtabletten


65,4 mg


Film-coated tablet


Oral use




DK - Denmark


Pharmathen S.A., 6, Dervenakion str., GR-15351 Pallini Attiki, Greece


Baxogar


150 mg


Filmcoated-tablets


Oral use




DK - Denmark


Gedeon Richter Plc., Gyömröí út 19-21, HU-1103 Budapest, Hungary


Etanorden


50 mg


Filmcoated-tablets


Oral use




DK - Denmark


Gedeon Richter Plc., Gyömröí út 19-21, HU-1103 Budapest, Hungary


Etanorden


150 mg


Filmcoated-tablets


Oral use




DK - Denmark


Mylan AB, Postbox 230 33, Ynglingagatan 14, Se-104 35 Stockholm, Sweden


Ibamyl


150 mg


Filmcoated-tablets


Oral use




DK - Denmark


Actavis Group PTC ehf., Postbox 425, Reykjavikurvegi 76-78, IS-220 Hafnarfjördur, Iceland


Ibandronat "Actavis"


50 mg


Filmcoated-tablets


Oral use




DK - Denmark


Actavis Group PTC ehf., Postbox 425, Reykjavikurvegi 76-78, IS-220 Hafnarfjördur, Iceland


Ibandronat "Actavis"


150 mg


Filmcoated-tablets


Oral use




DK - Denmark


Arrow ApS, Hovedgaden 41, 2, DK-2970 Hørsholm, Denmark


Ibandronate "Arrow"


150 mg


Tablets


Oral use




DK - Denmark


Orifarm Generics A/S, Postbox 69, Energivej 15, DK-5260 Odense S, Denmark


Ibandronate "Orifarm"


50 mg


Filmcoated-tablets


Oral use




DK - Denmark


ratiopharm GmbH, Graf-Arco-Strasse 3, DE-89079 Ulm, Germany


Ibandronate "ratiopharm"


50 mg


Filmcoated-tablets


Oral use




DK - Denmark


ratiopharm GmbH, Graf-Arco-Strasse 3, DE-89079 Ulm, Germany


Ibandronate "ratiopharm"


150 mg


Filmcoated-tablets


Oral use




DK - Denmark


Pharmathen S.A., 6, Dervenakion str., GR-15351 Pallini Attiki, Greece


Quodixor


150 mg


Filmcoated-tablets


Oral use




DK - Denmark


Orifarm Generics A/S, Postbox 69, Energivej 15, DK-5260 Odense S, Denmark


Ibandronate "Orifarm"


50 mg


Filmcoated-tablets


Oral use




FI - Finland


Arrow Pharma ApS, Hovedgaden 41. 2. sal, 2970 HØRSHOLM, Denmark


Ibandronate Arrow


150 mg


tablet


Oral use




FI - Finland


Orifarm Generics A/S, Energivej 15, 5260 ODENSE S, Denmark


Ibandronate Orifarm


50 mg


film-coated tablet


Oral use




FI - Finland


Ratiopharm GmbH, Graf-Arco-Strasse 3, 89079 Ulm, Germany


Ibandronate ratiopharm


150 mg


film-coated tablet


Oral use




FI - Finland


Ratiopharm GmbH, Graf-Arco-Strasse 3, 89079 Ulm, Germany


Ibandronate ratiopharm


50 mg


film-coated tablet


Oral use




FI - Finland


Gedeon Richter Plc, Gyömrõi út 19-21, 1103 Budabest, Hungary


Etanorden


150 mg


film-coated tablet


Oral use




FI - Finland


Mylan AB, BOX 23033, 10435 STOCKHOLM, Sweden


Ibamyl


150 mg


film-coated tablet


Oral use




FR - France







GEDEON RICHTER




Gyömroi ut 19-21




1103 Budapest X




HONGRIE






KALOSSO 50 mg, comprimé pelliculé


50 mg


tablet


Oral use




FR - France







MYLAN SAS




117, allée des Parcs




69800 Saint-Priest




FRANCE






ACIDE IBANDRONIQUE MYLAN 150 mg, comprimé pelliculé


150 mg


tablet


Oral use




FR - France







GEDEON RICHTER




Gyömroi ut 19-21




1103 Budapest X




HONGRIE






ETANORDEN 150 mg, comprimé pelliculé


150 mg


tablet


Oral use




FR - France







MYLAN SAS




117, allée des Parcs




69800 Saint-Priest




FRANCE






IBANDROMYLAN 150 mg, comprimé pelliculé


150 mg


tablet


Oral use




FR - France







GEDEON RICHTER




Gyömroi ut 19-21




1103 Budapest X




HONGRIE






KALOSSO 150 mg, comprimé pelliculé


150 mg


tablet


Oral use




IS - Iceland


Portfarma ehf., Borgartúni 26, 105 Reykjavík, Iceland


Ziveteno


150 mg


Film-coated tablet


Oral use




LT - Lithuania


Gedeon Richter Plc., 1103 Budapest Gyömrői út 19-21, Hungary


Etanorden


150 mg


Film-coated tablet


Oral use




PT - Portugal


Generis Farmacêutica, S.A. Office Park da Beloura, Edificio 4 - Piso 1, Escrit. 8, 2710-444 Sintra Portugal


Ácido Ibandrónico Generis


150 mg


Film-coated tablets


Oral use




PT - Portugal


Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. Lagoas Park, Edifício 5 A - Piso 2, 2740-298 Porto Salvo Portugal


Ácido ibandrónico Ombene


150 mg


Film-coated tablets


Oral use




PT - Portugal


Optimal Regulatory Solutions, S.L. Via Augusta, 59, 08006 Barcelona Espanha


Ácido ibandrónico Orsfelt


150 mg


Film-coated tablets


Oral use




PT - Portugal


Ciclum Farma Unipessoal, Lda. Quinta da Fonte, Rua Vitor Câmara, 2 - Edifício D. Amélia, Piso 1, Ala B, 2770-229 Paço de Arcos Portugal


Ácido ibandrónico Ciclum


150 mg


Film-coated tablets


Oral use




PT - Portugal


Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Edifício Atlas II, Av. José Gomes Ferreira, N.o 11 - 3o, Sala 31, 1495-139 Miraflores - Algés Portugal


Ácido Ibandrónico Pharmakern


150 mg


Film-coated tablets


Oral use




PT - Portugal


Gedeon Richter, Plc. Gyömröi út, 19-21, H-1103 Budapest Hungria


Etanorden


150 mg


Film-coated tablets


Oral use




PT - Portugal


Mylan, Lda. Rua Doutor António Loureiro Borges, Edíficio Arquiparque 1, R/C Esqo, 1499-016 Álges Portugal


Ácido Ibandrónico Mylan


150 mg


Film-coated tablets


Oral use




PT - Portugal


Arrow ApS Hovedgaden 41, 2, 2970 Horsholm Dinamarca


Ácido Ibandrónico Arrow


150 mg


Tablets


Oral use




PT - Portugal


Sandoz Farmacêutica, Lda. Alameda da Beloura, Edifício 1, 2o - Escritório 15, 2710-693 Sintra Portugal


Ácido Ibandrónico Sandoz


150 mg


Film-coated tablets


Oral use




PT - Portugal


Pharmathen - Pharmaceutical Industry, S.A. 6, Dervenakion Street, GR-15351 Pallini Attiki Grécia


Quodixor


150 mg


Film-coated tablets


Oral use




SE - Sweden


Orifarm Generics A/S Energivej 15 POB 69 DK-5260 Odense S Denmark


Ibandronate Orifarm


50 mg


film-coated tablet


Oral use




SI - Slovenia


Generics UK Ltd., Station Close, Potters Bar, Hertford Shire EN6 1AG, UK


Ibandronska kislina Mylan 150 mg filmsko obložene tablete


150 mg


film-coated tablet


Oral use







ANNEX VI

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES











Member State


Marketing authorisation holder


Product name


Strength


Pharmaceutical form


Route of administration




Austria


Baxter Healthcare GmbH, Stella-Klein-Löw-Weg 15, A-1020 Wien, Austria


Dianeal PD4 Glucose 1,36 % w/v/13,6 mg/ml - Peritonealdialyselösung


Anhydrous glucose 13,6 g/L, sodium chloride 5,38 g/L, sodium-L(+) lactate 4,48 g/L, calcium chloride dihydrate 0,184 g/L, magnesium chloride hexahydrate 0,051 g/L


Solution for peritoneal dialysis


Intraperitoneal use




Austria


Baxter Healthcare GmbH, Stella-Klein-Löw-Weg 15, A-1020 Wien, Austria


Dianeal PD4 Glucose 2,27 % w/v/22,7 mg/ml - Peritonealdialyselösung


Anhydrous glucose 22,7 g/L, sodium chloride 5,38 g/L, sodium-L(+) lactate 4,48 g/L, calcium chloride dihydrate 0,184 g/L, magnesium chloride hexahydrate 0,051 g/L


Solution for peritoneal dialysis


Intraperitoneal use




Austria


Baxter Healthcare GmbH, Stella-Klein-Löw-Weg 15, A-1020 Wien, Austria


Dianeal PD4 Glucose 3,86 % w/v/38,6 mg/ml - Peritonealdialyselösung


Anhydrous glucose 38,6 g/L, sodium chloride 5,38 g/L, sodium-L(+) lactate 4,48 g/L, calcium chloride dihydrate 0,184 g/L, magnesium chloride hexahydrate 0,051 g/L


Solution for peritoneal dialysis


Intraperitoneal use




Austria


Baxter Healthcare GmbH, Stella-Klein-Löw-Weg 15, A-1020 Wien, Austria


EXTRANEAL - Peritonealdialyselösung


75 g/L


Solution for peritoneal dialysis


Intraperitoneal use




Belgium







Baxter SA




Bld R Branquart 80




7860 Lessines




Belgium






Dianeal PD4 Glucose 1,36 % (13,6 mg/ml), solution pour dialyse péritonéale.


13,6 g/l glucose anhydrate


Solution for peritoneal dialysis


Intraperitoneal use




Belgium







Baxter SA




Bld R Branquart 80




7860 Lessines




Belgium






Dianeal PD4 Glucose 2,27 % (22,7 mg/ml), solution pour dialyse péritonéale.


22,7 g/l glucose anhydrate


Solution for peritoneal dialysis


Intraperitoneal use




Belgium







Baxter SA




Bld R Branquart 80




7860 Lessines




Belgium






Dianeal PD4 Glucose 3,86 % (38,6 mg/ml), solution pour dialyse péritonéale.


38,6 g/l glucose anhydrate


Solution for peritoneal dialysis


Intraperitoneal use




Belgium







Baxter SA




Bld R Branquart 80




7860 Lessines




Belgium






EXTRANEAL 7,5 %, solution pour dialyse péritonéale


75,00 g/l Icodextrine


Solution for peritoneal dialysis


Intraperitoneal use




Bulgaria


BAXTER d.o.o., Zelezna cesta 18, 1000 Ljubljana, Slovenia


Dianeal PD4 Glucose


2,27 % w/v/22,7 mg/ml


Solution for peritoneal dialysis


Intraperitoneal use




Bulgaria


BAXTER d.o.o., Zelezna cesta 18, 1000 Ljubljana, Slovenia


Dianeal PD4 Glucose


3,86 % w/v/38,6 mg/ml


Solution for peritoneal dialysis


Intraperitoneal use




Bulgaria


BAXTER d.o.o., Zelezna cesta 18, 1000 Ljubljana, Slovenia


Dianeal PD4 Glucose 1,36 % w/v/13,6 mg/ml


1,36 % w/v/13,6 mg/ml


Solution for peritoneal dialysis


Intraperitoneal use




Bulgaria


BAXTER d.o.o., Zelezna cesta 18, 1000 Ljubljana, Slovenia


Extraneal


7,50 %


Solution for peritoneal dialysis


Intraperitoneal use




Czech Republic


Baxter Healthcare S.A. Moneen Road Castlebar, Co. Mayo Ireland


Dianeal PD4 Glucose 1,36 % w/v/13,6 mg/ml


1,36 % w/v/13,6 mg/ml


Solution for peritoneal dialysis


Intraperitoneal use




Czech Republic


Baxter Healthcare S.A. Moneen Road Castlebar, Co. Mayo Ireland


Dianeal PD4 Glucose 2,27 % w/v/22,7 mg/ml


2,27 % w/v/22,6 mg/ml


Solution for peritoneal dialysis


Intraperitoneal use




Czech Republic


Baxter Healthcare S.A. Moneen Road Castlebar, Co. Mayo Ireland


Dianeal PD4 Glucose 3,86 % w/v/38,6 mg/ml


3,86 % w/v/38,6 mg/ml


Solution for peritoneal dialysis


Intraperitoneal use




Czech Republic


Baxter Healthcare S.A. Moneen Road Castlebar, Co. Mayo Ireland


EXTRANEAL


7,5 % 75 g/1 000 ml


Solution for peritoneal dialysis


Intraperitoneal use




Denmark


Baxter A/S, Gydevang 43, DK-3450 Allerød, Denmark


Dianeal PD4 med Glucos


13,6 mg/ml


Solution for peritoneal dialysis


Intraperitoneal use




Denmark


Baxter A/S, Gydevang 43, DK-3450 Allerød, Denmark


Dianeal PD4 med Glucos


22,7 mg/ml


Solution for peritoneal dialysis


Intraperitoneal use




Denmark


Baxter A/S, Gydevang 43, DK-3450 Allerød, Denmark


Dianeal PD4 med Glucos


38,6 mg/ml


Solution for peritoneal dialysis


Intraperitoneal use




Denmark


Baxter A/S, Gydevang 43, DK-3450 Allerød, Denmark


Extraneal


75 mg/ml


Solution for peritoneal dialysis


Intraperitoneal use




Estonia


Baxter OY P.O box 270, Valimotie 15A, Helsinki 00381 Finland


EXTRANEAL


7,50 %


Solution for peritoneal dialysis


Intraperitoneal use




Finland


Baxter Healthcare S.A. Moneen Road, Castlebar County Mayo Ireland


Dianeal PD4 Glucose


13,6 mg/ml


Solution for peritoneal dialysis


Intraperitoneal use




Finland


Baxter Healthcare S.A. Moneen Road, Castlebar County Mayo Ireland


Dianeal PD4 Glucose


22,7 mg/ml


Solution for peritoneal dialysis


Intraperitoneal use




Finland


Baxter Healthcare S.A. Moneen Road, Castlebar County Mayo Ireland


Dianeal PD4 Glucose


38,6 mg/ml


Solution for peritoneal dialysis


Intraperitoneal use




Finland


Baxter Oy Valimotie 15 A 00380 Helsinki Finland


Extraneal


7,5 %


Solution for peritoneal dialysis


Intraperitoneal use




France







Baxter SAS




Avenue louis Pasteur




ZA de Coignères Maurepas




78310 Maurepas




France






DIANEAL PD4 GLUCOSE 1,36 %, solution pour dialyse péritonéale en poche


1,36 %


Solution for peritoneal dialysis


Intraperitoneal use




France







Baxter SAS




Avenue louis Pasteur




ZA de Coignères Maurepas




78310 Maurepas




France






DIANEAL PD4 GLUCOSE 2,27 %, solution pour dialyse péritonéale en poche


2,27 %


Solution for peritoneal dialysis


Intraperitoneal use




France







Baxter SAS




Avenue louis Pasteur




ZA de Coignères Maurepas




78310 Maurepas




France






DIANEAL PD4 GLUCOSE 3,86 %, solution pour dialyse péritonéale en poche


3,86 %


Solution for peritoneal dialysis


Intraperitoneal use




France







Baxter SAS




Avenue louis Pasteur




ZA de Coignères Maurepas




78310 Maurepas




France






EXTRANEAL, solution pour dialyse péritonéale


7,50 %


Solution for peritoneal dialysis


Intraperitoneal use




Germany







Baxter Deutschland GmbH




Edisonstr. 4




D-85716 Unterschleißheim




Germany






Dianeal PD4 Glucose 1,36 % w/v


13,6 g/l
5,4 g/l
4,5 g/l
0,184 g/l
0,051 g/l


Solution for peritoneal dialysis


Intraperitoneal use




Germany







Baxter Deutschland GmbH




Edisonstr. 4




D-85716 Unterschleißheim




Germany






Dianeal PD4 Glucose 2,27 % w/v


22,7 g/l
5,4 g/l
4,5 g/l
0,184 g/l
0,051 g/l


Solution for peritoneal dialysis


Intraperitoneal use




Germany







Baxter Deutschland GmbH




Edisonstr. 4




D-85716 Unterschleißheim




Germany






Dianeal PD4 Glucose 3,86 % w/v


38,6 g/l
5,4 g/l
4,5 g/l
0,184 g/l
0,051 g/l


Solution for peritoneal dialysis


Intraperitoneal use




Germany







Baxter Deutschland GmbH




Edisonstr. 4




D-85716 Unterschleißheim




Germany






Dianeal PDG4 1,36 %


13,6 g/l
5,38 g/l
4,48 g/l
0,184 g/l
0,051 g/l


Solution for peritoneal dialysis


Intraperitoneal use




Germany







Baxter Deutschland GmbH




Edisonstr. 4




D-85716 Unterschleißheim




Germany






Dianeal PDG4 2,27 %


22,7 g/l
5,38 g/l
4,48 g/l
0,184 g/l
0,051 g/l


Solution for peritoneal dialysis


Intraperitoneal use




Germany







Baxter Deutschland GmbH




Edisonstr. 4




D-85716 Unterschleißheim




Germany






Dianeal PD4 Glucose 3,86 % w/v


38,6 g/l
5,38 g/l
4,48 g/l
0,184 g/l
0,051 g/l


Solution for peritoneal dialysis


Intraperitoneal use




Germany







Baxter Deutschland GmbH




Edisonstr. 4




D-85716 Unterschleißheim




Germany






Extraneal


75 g/l
5,4 g/l
4,5 g/l
0,257 g/l
0,051 g/l


Solution for peritoneal dialysis


Intraperitoneal use




Greece







DIOPHAR S.A.




Kifissias Avenue 368,




Halandri, 152 33




Greece






DIANEAL PD4


1,36 %


Solution for peritoneal dialysis


Intraperitoneal use




Greece







DIOPHAR S.A.




Kifissias Avenue 368,




Halandri, 152 33




Greece






EXTRANEAL


(7,5 + 0,54 + 0,45 + 0,0257 + 0,0051) % w/v


Solution for peritoneal dialysis


Intraperitoneal use




Hungary







Baxter Hungary Kft.




Népfürdő u. 22.




1138, Budapest




Hungary






DIANEAL PD 4 Glucose 1,36 % peritoneális dializáló oldat


1,36 %


Solution for peritoneal dialysis


Intraperitoneal use




Hungary







Baxter Hungary Kft.




Népfürdő u. 22.




1138, Budapest




Hungary






DIANEAL PD 4 Glucose 2,27 % peritoneális dializáló oldat


2,27 %


Solution for peritoneal dialysis


Intraperitoneal use




Hungary







Baxter Hungary Kft.




Népfürdő u. 22.




1138, Budapest




Hungary






DIANEAL PD 4 Glucose 3,86 % peritoneális dializáló oldat


3,86 %


Solution for peritoneal dialysis


Intraperitoneal use




Hungary







Baxter Hungary Kft.




Népfürdő u. 22.




1138, Budapest




Hungary






EXTRANEAL peritoneális dializáló oldat


7,5 % (icodextrin)


Solution for peritoneal dialysis


Intraperitoneal use




Iceland


Baxter Healthare SA Moneen Road Castlebar County Mayo Irland


Dianeal PD4 Glucose


13,6 mg/ml


Solution for peritoneal dialysis


Intraperitoneal use




Iceland


Baxter Healthare SA Moneen Road Castlebar County Mayo Irland


Dianeal PD4 Glucose


22,7 mg/ml


Solution for peritoneal dialysis


Intraperitoneal use




Iceland


Baxter Healthare SA Moneen Road Castlebar County Mayo Irland


Dianeal PD4 Glucose


38,6 mg/ml


Solution for peritoneal dialysis


Intraperitoneal use




Ireland


Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom


Dianeal PD4 Glucose 1,36 % w/v (13,6 mg/ml) Solution for peritoneal dialysis


1,36 % w/v (13,6 mg/ml)


Solution for peritoneal dialysis


Intraperitoneal use




Ireland


Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom


Dianeal PD4 Glucose 2,27 % w/v (22,7 mg/ml) Solution for peritoneal dialysis


2,27 % w/v (22,7 mg/ml)


Solution for peritoneal dialysis


Intraperitoneal use




Ireland


Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom


Dianeal PD4 Glucose 3,86 % w/v (38,6 mg/ml) Solution for peritoneal dialysis


3,86 % w/v (38,6 mg/ml)


Solution for peritoneal dialysis


Intraperitoneal use




Ireland


Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom


EXTRANEAL Solution for peritoneal dialysis


 


Solution for peritoneal dialysis


Intraperitoneal use




Italy







Baxter SPA piazzale dell' industria 20 - 00144-Roma




Italy






EXTRANEAL


7,5 %


Solution for dialysis peritoneal


Intraperitoneal use




Italy







Baxter SPA piazzale dell' industria 20 - 00144-Roma




Italy






SOLUZIONI PER DIALISI PERITONEALE BAXTER


4,95 g/l - 49,54 g/l;


Solution for dialysis peritoneal


Intraperitoneal use




Latvia







Baxter Healthcare S.A. Moneen Road




Castlebar




County Mayo




IRELAND






Dianeal PD4 Glucose 1,36 % w/v/13,6 mg/ml solution for peritoneal dialysis


1,36 % w/v 0,538 % w/v 0,448 % w/v 0,0184 % w/v 0,0051 % w/v


Solution for peritoneal dialysis


Intraperitoneal use




Latvia







Baxter Healthcare S.A. Moneen Road




Castlebar




County Mayo




IRELAND






Dianeal PD4 Glucose 2,27 % w/v/22,7 mg/ml solution for peritoneal dialysis


2,27 % w/v
0,538 % w/v 0,448 % w/v
0,0184 % w/v 0,0051 % w/v


Solution for peritoneal dialysis


Intraperitoneal use




Latvia







Baxter Healthcare S.A. Moneen Road




Castlebar




County Mayo




IRELAND






Dianeal PD4 Glucose 3,86 % w/v/38,6 mg/ml solution for peritoneal dialysis


3,86 % w/v 0,538 % w/v 0,448 % w/v 0,0184 % w/v 0,0051 % w/v


Solution for peritoneal dialysis


Intraperitoneal use




Latvia







Baxter Oy Valimotie 15 A 00380 Helsinki Finland




FINLAND






Extraneal solution for peritoneal dialysis


75 g/L 5,4 g/L 4,5 g/L 0,257 g/L 0,051 g/L


Solution for peritoneal dialysis


Intraperitoneal use




Lithuania


Baxter Healthcare S.A., Moneen Road, Castlebar County Mayo, Ireland


Dianeal PD4 Glucose


13,6 g + 5,38 g + 4,48 g + 0,184 g + 0,051 g/l


Solution for peritoneal dialysis


Intraperitoneal use




Lithuania


Baxter Healthcare S.A., Moneen Road, Castlebar County Mayo, Ireland


Dianeal PD4 Glucose


22,7 g + 5,38 g + 4,48 g + 0,184 g + 0,051 g/l


Solution for peritoneal dialysis


Intraperitoneal use




Lithuania


Baxter Healthcare S.A., Moneen Road, Castlebar County Mayo, Ireland


Dianeal PD4 Glucose


38,6 g + 5,38 g + 4,48 g + 0,184 g + 0,051 g/l


Solution for peritoneal dialysis


Intraperitoneal use




Lithuania


Baxter Oy, P.O. Box 270 Valimotie 15A 00381 Helsinki, Finland


EXTRANEAL


75 g + 5,4 g + 4,5 g + 0,257 g + 0,051 g/1 000 ml


Solution for peritoneal dialysis


Intraperitoneal use




Luxembourg







Baxter SA,




Bd René Branquart 80,




B-7860 Lessines




Belgium






Dianeal PD4 Glucose


1,36 %/2,27 %/3,86 % dextrose anydre


Solution for peritoneal dialysis


Intraperitoneal use




Luxembourg







Baxter SA,




Bd René Branquart 80,




B-7860 Lessines




Belgium






Extraneal


75,00 g/l Icodextrine


Solution for peritoneal dialysis


Intraperitoneal use




Malta







Baxter Healthcare Ltd.,




Caxton Way,




Thetford,




Norfolk,




IP24 3SE




United Kingdom






Dianeal PD4 Glucose 1,36 % w/v 13,6 mg/ml


Anhydrous Glucose Ph.Eur. 1,36 % w/v
or Glucose Monohydrate Ph.Eur. 1,50 % w/v
Sodium Chloride Ph.Eur. 0,538 % w/v
Sodium Lactate Ph.Eur. 0,448 % w/v
Calcium Chloride Ph.Eur. 0,0184 % w/v
Magnesium Chloride Ph.Eur. 0,0051 % w/v


Solution for peritoneal dialysis


Intraperitoneal use




Malta







Baxter Healthcare Ltd.,




Caxton Way,




Thetford,




Norfolk,




IP24 3SE




United Kingdom






Dianeal PD4 Glucose 2,27 % w/v 22,7 mg/ml


Anhydrous Glucose Ph.Eur. 2,27 % w/v
or Glucose Monohydrate Ph.Eur. 2,50 % w/v
Sodium Chloride Ph.Eur. 0,538 % w/v
Sodium Lactate Ph.Eur. 0,448 % w/v
Calcium Chloride Ph.Eur. 0,0184 % w/v
Magnesium Chloride Ph.Eur. 0,0051 % w/v


Solution for peritoneal dialysis


Intraperitoneal use




Malta







Baxter Healthcare Ltd.,




Caxton Way,




Thetford,




Norfolk,




IP24 3SE




United Kingdom






Dianeal PD4 Glucose 3,86 % w/v 38,6 mg/ml


Anhydrous Glucose Ph.Eur. 3,86 % w/v
or Glucose Monohydrate Ph.Eur. 4,25 % w/v
Sodium Chloride Ph.Eur. 0,538 % w/v
Sodium Lactate Ph.Eur. 0,448 % w/v
Calcium Chloride Ph.Eur. 0,0184 % w/v
Magnesium Chloride Ph.Eur. 0,0051 % w/v


Solution for peritoneal dialysis


Intraperitoneal use




Malta







Baxter Healthcare Ltd.,




Caxton Way,




Thetford,




Norfolk,




IP24 3SE




United Kingdom






Extraneal (Icodextrin 7,5 %)


Icodextrin (75 g/l), Sodium chloride (5,4 g/l),
Calcium chloride (0,257 g/l), Magnesium chloride
(0,051 g/l), Sodium lactate solution (4,5 g/l)


Solution for peritoneal dialysis


Intraperitoneal use




Norway







Baxter AS




Gjerdrumsvei 11




0484 Oslo, Norway






Extraneal


75 mg/ml


Solution for peritoneal dialysis


Intraperitoneal use




Poland







Baxter Polska SP. z o.o.




Kruczkowskiego 8 st.,




00-380 Warsawa, Poland






Dianeal PD4 (glukoza 1,36 %). Zestaw do dializy otrzewnowej


 


Solution for peritoneal dialysis


Intraperitoneal use




Poland







Baxter Polska SP. z o.o.




Kruczkowskiego 8 st.,




00-380 Warsawa, Poland






Dianeal PD4 (glukoza 2,27 %). Zestaw do dializy otrzewnowej


 


Solution for peritoneal dialysis


Intraperitoneal use




Poland







Baxter Polska SP. z o.o.




Kruczkowskiego 8 st.,




00-380 Warsawa, Poland






Dianeal PD4 (glukoza 3,86 %). Zestaw do dializy otrzewnowej


 


Solution for peritoneal dialysis


Intraperitoneal use




Poland







Baxter Polska SP. z o.o.




Kruczkowskiego 8 st.,




00-380 Warsawa, Poland






Extraneal Zestaw do dializy otrzewnowej


 


Solution for peritoneal dialysis


Intraperitoneal use




Poland







Baxter Polska SP. z o.o.




Kruczkowskiego 8 st.,




00-380 Warsawa, Poland






Extraneal Zestaw do dializy otrzewnowej


 


Solution for peritoneal dialysis


Intraperitoneal use




Portugal


Baxter Médico-Farmacêutica, Lda. Zona Industrial da Abrunheira - Edifício 10 - Sintra Business Park, 2710-089 Sintra Portugal


Dianeal Pd4


42,5 mg/ml Glucose Monohydrate; 5,38 mg/ml Sodium Chloride; 0,184 mg/ml Calcium Chloride Dihydrate; 0,051 mg/ml Magnesium Chloride Hexahydrate; 4,48 mg/ml Sodium Lactate.


Solution for peritoneal dialysis


Intraperitoneal use




Portugal


Baxter Médico-Farmacêutica, Lda. Zona Industrial da Abrunheira - Edifício 10 - Sintra Business Park, 2710-089 Sintra Portugal


Dianeal Pd4


25 mg/ml Glucose Monohydrate; 5,38 mg/ml Sodium Chloride; 0,184 mg/ml Calcium Chloride Dihydrate; 0,051 mg/ml Magnesium Chloride Hexahydrate; 4,48 mg/ml Sodium Lactate.


Solution for peritoneal dialysis


Intraperitoneal use




Portugal


Baxter Médico-Farmacêutica, Lda. Zona Industrial da Abrunheira - Edifício 10 - Sintra Business Park, 2710-089 Sintra Portugal


Dianeal Pd4


15 mg/ml Glucose Monohydrate; 5,38 mg/ml Sodium Chloride; 0,184 mg/ml Calcium Chloride Dihydrate; 0,051 mg/ml Magnesium Chloride Hexahydrate; 4,48 mg/ml Sodium Lactate.


Solution for peritoneal dialysis


Intraperitoneal use




Portugal


Baxter Médico-Farmacêutica, Lda. Zona Industrial da Abrunheira - Edifício 10 - Sintra Business Park, 2710-089 Sintra Portugal


Extraneal


75 mg/ml Icodextrin; 5,4 mg/ml Sodium Chloride; 4,5 mg/ml Sodium (S) - lactate solution; 0,051 mg/ml Magnesium Chloride; 0,257 mg/ml Calcium Chloride.


Solution for peritoneal dialysis


Intraperitoneal use




Romania







BAXTER HEALTHCARE S.A.




Moneen Road, Castelbar, County Mayo, Ireland






DIANEAL PD4 GLUCOSE 1,36 % m/v (13,6 mg/ml),


13,6 mg/ml


Solution for peritoneal dialysis


Intraperitoneal use




Romania







BAXTER HEALTHCARE S.A.




Moneen Road, Castelbar, County Mayo, Ireland






DIANEAL PD4 GLUCOSE 2,27 % m/v (22,7 mg/ml)


22,7 mg/ml


Solution for peritoneal dialysis


Intraperitoneal use




Romania







BAXTER HEALTHCARE S.A.




Moneen Road, Castelbar, County Mayo, Ireland






DIANEAL PD4 GLUCOSE 3,86 % m/v (38,6 mg/ml)


38,6 mg/ml


Solution for peritoneal dialysis


Intraperitoneal use




Romania







BAXTER HEALTHCARE Ltd.,




Caxton Way, Thetford, Norfolk, 1P24 3SE, Thetford,




United Kingdom






EXTRANEAL


75 mg/ml


Solution for peritoneal dialysis


Intraperitoneal use




Slovak Republic







Baxter Healthcare SA Moneen Rd




Castlebar, Co. Mayo Ireland






DIANEAL PD4 glucose 1,36 % w/v/13,6 mg/ml


13,6 mg/1 ml


Solution for peritoneal dialysis


Intraperitoneal use




Slovak Republic







Baxter Healthcare SA Moneen Rd




Castlebar, Co. Mayo Ireland






DIANEAL PD4 glucose 2,27 % w/v/22,7 mg/ml


22,7 mg/1 ml


Solution for peritoneal dialysis


Intraperitoneal use




Slovak Republic







Baxter Healthcare SA Moneen Rd




Castlebar, Co. Mayo Ireland






DIANEAL PD4 glucose 3,86 % w/v/38,6 mg/ml


38,6 mg/1 ml


Solution for peritoneal dialysis


Intraperitoneal use




Slovak Republic







Baxter Healthcare Ltd.Caxton Way Thetford Norfolk IP24 3SE




United Kingdom






EXTRANEAL


7,5 %


Solution for peritoneal dialysis


Intraperitoneal use




Slovenia


Baxter d.o.o., Zelezna cesta 18, Ljubljana, SI-1000, Slovenia


Dianeal PD4 13,6 mg/ml glukoze raztopina za peritonelano dializo


13,6 mg/ml


Solution for peritoneal dialysis


Intraperitoneal use




Slovenia


Baxter d.o.o., Zelezna cesta 18, Ljubljana, SI-1000, Slovenia


Dianeal PD4 22,7 mg/ml glukoze raztopina za peritonelano dializo


22,7 mg/ml


Solution for peritoneal dialysis


Intraperitoneal use




Slovenia


Baxter d.o.o., Zelezna cesta 18, Ljubljana, SI-1000, Slovenia


Dianeal PD4 38,6 mg/ml glukoze raztopina za peritonelano dializo


38,6 mg/ml


Solution for peritoneal dialysis


Intraperitoneal use




Slovenia


Baxter d.o.o., Zelezna cesta 18, Ljubljana, SI-1000, Slovenia


Extraneal 75 mg/ml ikodekstrina raztopina za peritonealno dializo


75 mg/ml


Solution for peritoneal dialysis


Intraperitoneal use




Spain







BAXTER S.L.




Pouet de Camilo 2




Ribarroja del Turia (Valencia)




46394




Spain






Dianeal PD4 Glucosa 1,36 %


15,0 g/l; 5,38 g/l; 4,48 g/l; 0,184 g/l; 0,051 g/l


Solution for peritoneal dialysis


Intraperitoneal use




Spain







BAXTER S.L.




Pouet de Camilo 2




Ribarroja del Turia (Valencia)




46394




Spain






Dianeal PD4 Glucosa 1,36 % con sistema de desconexión integrado


15,0 g/l; 5,38 g/l; 4,48 g/l; 0,184 g/l; 0,051 g/l


Solution for peritoneal dialysis


Intraperitoneal use




Spain







BAXTER S.L.




Pouet de Camilo 2




Ribarroja del Turia (Valencia)




46394




Spain






Dianeal PD4 Glucosa 2,27 %


25,0 g/l; 5,38 g/l; 4,48 g/l; 0,184 g/l; 0,051 g/l


Solution for peritoneal dialysis


Intraperitoneal use




Spain







BAXTER S.L.




Pouet de Camilo 2




Ribarroja del Turia (Valencia)




46394




Spain






Dianeal PD4 Glucosa 2,27 % con sistema de desconexión integrado


25,0 g/l; 5,38 g/l; 4,48 g/l; 0,184 g/l; 0,051 g/l


Solution for peritoneal dialysis


Intraperitoneal use




Spain







BAXTER S.L.




Pouet de Camilo 2




Ribarroja del Turia (Valencia)




46394




Spain






Dianeal PD4 Glucosa 3,86 %


42,50 g/l; 5,38 g/l; 4,48 g/l; 0,184 g/l; 0,051 g/l


Solution for peritoneal dialysis


Intraperitoneal use




Spain







BAXTER S.L.




Pouet de Camilo 2




Ribarroja del Turia (Valencia)




46394




Spain






Dianeal PD4 Glucosa 3,86 % con sistema de desconexión integrado


42,50 g/l; 5,38 g/l; 4,48 g/l; 0,184 g/l; 0,051 g/l


Solution for peritoneal dialysis


Intraperitoneal use




Spain







BAXTER S.L.




Pouet de Camilo 2




46394 Ribarroja del Turia (Valencia)




Spain






EXTRANEAL
Solución para diálisis peritoneal


75 g/l; 5,4 g/l; 4,5 g/l; 0,257 g/l; 0,051 g/l


Solution for peritoneal dialysis


Intraperitoneal use




Sweden


Baxter Healthare SA Moneen Road Castlebar County Mayo Irland


Dianeal PD4 med glucos 13,6 mg/ml


13,6 mg/ml


Solution for peritoneal dialysis


Intraperitoneal use




Sweden


Baxter Healthare SA Moneen Road Castlebar County Mayo Irland


Dianeal PD4 med glucos 22,7 mg/ml


22,7 mg/ml


Solution for peritoneal dialysis


Intraperitoneal use




Sweden


Baxter Healthare SA Moneen Road Castlebar County Mayo Irland


Dianeal PD4 med glucos 38,6 mg/ml


38,6 mg/ml


Solution for peritoneal dialysis


Intraperitoneal use




Sweden







Baxter Medical AB Box 6316494 Kista Sverige




Sweden






Extraneal


7,5 %


Solution for peritoneal dialysis


Intraperitoneal use




The Netherlands


Baxter B.V., Kobaltweg 49, 3542 CE Utrecht, the Netherlands


Dianeal PD4 Glucose 1,36 %/13,6 mg/ml, peritoneaaldialysevloeistof


13,6 g/l glucose anhydrate


Solution for peritoneal dialysis


Intraperitoneal use




The Netherlands


Baxter B.V., Kobaltweg 49, 3542 CE Utrecht, the Netherlands


Dianeal PD4 Glucose 2,27 %/22,7 mg/ml, peritoneaaldialysevloeistof


22,7 g/l glucose anhydrate


Solution for peritoneal dialysis


Intraperitoneal use




The Netherlands


Baxter B.V., Kobaltweg 49, 3542 CE Utrecht, the Netherlands


Dianeal PD4 Glucose 3,86 %/38,6 mg/ml, peritoneaaldialysevloeistof


38,6 g/l glucose anhydrate


Solution for peritoneal dialysis


Intraperitoneal use




The Netherlands


Baxter B.V., Kobaltweg 49, 3542 CE Utrecht, the Netherlands


EXTRANEAL 7,5 %, oplossing voor peritoneale dialyse


75 g/l icodextrine


Solution for peritoneal dialysis


Intraperitoneal use




United Kingdom


Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24 3SE, United Kingdom


Dianeal PD4 Glucose 1,36 % w/v/13,6 mg/ml


magnseium chloride 0,005 % w/v; glucose 1,36 % w/v; sodium lactate 0,45 % w/v; calcium chloride 0,018 % w/v; sodium chloride 0,54 % w/v


Solution for peritoneal dialysis


Intraperitoneal use




United Kingdom


Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24 3SE, United Kingdom


Dianeal PD4 Glucose 2,27 % w/v/22,7 mg/ml


magnseium chloride 0,005 % w/v; glucose 2,27 % w/v; sodium lactate 0,45 % w/v; calcium chloride 0,018 % w/v; sodium chloride 0,54 % w/v


Solution for peritoneal dialysis


Intraperitoneal use




United Kingdom


Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24 3SE, United Kingdom


Dianeal PD4 Glucose 3,86 % w/v/38,6 mg/ml


magnseium chloride 0,005 % w/v; glucose 3,86 % w/v; sodium lactate 0,45 % w/v; calcium chloride 0,018 % w/v; sodium chloride 0,54 % w/v


Solution for peritoneal dialysis


Intraperitoneal use




United Kingdom


Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24 3SE, United Kingdom


Extraneal (Icodextrin 7,5 %) Solution for peritoneal dialysis


icodextrin 75 g/l; sodium chloride 5,4 g/l; calcium chloride 0,257 g/l; magnesium chloride 0,051 g/l; sodium s-lactate 4,5 g/l


Solution for peritoneal dialysis


Intraperitoneal use







ANNEX VII

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND APPLICANT IN THE MEMBER STATES












Member State EU/EEA


Applicant


(Invented) Name


Strength


Pharmaceutical form


Route of administration


Content
(concentration)




Austria







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics 20 mg Pulver und Lösungsmittel für ein Konzentrat zur Herstellung einer Infusionslösung


20 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


20 mg




Austria







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics 80 mg Pulver und Lösungsmittel für ein Konzentrat zur Herstellung einer Infusionslösung


80 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


80 mg




Belgium







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics


20 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


20 mg




Belgium







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics


80 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


80 mg




Bulgaria







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Доцетаксел Тева Генерикс


20 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


20 mg




Bulgaria







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Доцетаксел Тева Генерикс


80 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


80 mg




Cyprus







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics


20 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


20 mg




Cyprus







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics


80 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


80 mg




Czech Republic







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Tevadoxel


20 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


20 mg




Czech Republic







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Tevadoxel


80 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


80 mg




Denmark







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics


20 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


20 mg




Denmark







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics


80 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


80 mg




Estonia







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics


20 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


20 mg




Estonia







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics


80 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


80 mg




Finland







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics


20 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


20 mg




Finland







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics


80 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


80 mg




France







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics


20 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


20 mg




France







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics


80 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


80 mg




Germany







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics


20 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


20 mg




Germany







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics


80 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


80 mg




Greece







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics


20 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


20 mg




Greece







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics


80 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


80 mg




Hungary







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics


20 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


20 mg




Hungary







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics


80 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


80 mg




Ireland







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics


20 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


20 mg




Ireland







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics


80 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


80 mg




Italy







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics


20 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


20 mg




Italy







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics


80 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


80 mg




Latvia







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics


20 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


20 mg




Latvia







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics


80 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


80 mg




Lithuania







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics


20 mg


Powder and solvent for solution for infusion


Intravenous use


20 mg




Lithuania







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics


80 mg


Powder and solvent for solution for infusion


Intravenous use


80 mg




Luxembourg







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics


20 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


20 mg




Luxembourg







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics


80 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


80 mg




Malta







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics


20 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


20 mg




Malta







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics


80 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


80 mg




Netherlands







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics


20 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


20 mg




Netherlands







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics


80 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


80 mg




Norway







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics


20 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


20 mg




Norway







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics


80 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


80 mg




Poland







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics


20 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


20 mg




Poland







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics


80 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


80 mg




Romania







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics


20 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


20 mg




Romania







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics


80 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


80 mg




Slovak Republic







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics


20 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


20 mg




Slovak Republic







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics


80 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


80 mg




Slovenia







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics 20 mg prašek in vehikel za koncentrat za raztopino za infundiranje


20 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


20 mg




Slovenia







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics 80 mg prašek in vehikel za koncentrat za raztopino za infundiranje


80 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


80 mg




Spain







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics


20 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


20 mg




Spain







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics


80 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


80 mg




Sweden







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics


20 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


20 mg




Sweden







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics


80 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


80 mg




United Kingdom







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics


20 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


20 mg




United Kingdom







Teva Generics B.V.




Computerweg 10, 3542 DR Utrecht




The Netherlands






Docetaxel Teva Generics


80 mg


Powder and solvent for concentrate for solution for infusion


Intravenous use


80 mg







ANNEX VIII

LIST OF THE NAME, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, WITHDRAWAL PERIODS, APPLICANT, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES













Member State EU/EEA


Applicant/Marketing Authorisation Holder


Invented Name


Pharmaceutical form


Strengths


Animal species


Recommended dose, frequency and route of administration


Withdrawal period
(meat and milk)




Ireland







Norbrook Laboratories Limited




Station Works,




Newry,




Co. Down, BT35 6JP




Northern Ireland






Noroclav Lactating Cow Intramammary Suspension


Intramammary suspension


Amoxicillin 200 mg
Clavulanic acid 50 mg
Prednisolone 10 mg


Lactating cattle


Intramammary administration to lactating cattle at a dose rate of 3 syringes per affected quarter administered singly at 12 hour intervals


Not established




United Kingdom







Norbrook Laboratories Limited




Station Works,




Newry,




Co. Down, BT35 6JP




Northern Ireland






Combimox Lactating Cow Intramammary Suspension


Intramammary suspension


Amoxicillin 200 mg
Clavulanic acid 50 mg
Prednisolone 10 mg


Lactating cattle


Intramammary administration to lactating cattle at a dose rate of 3 syringes per affected quarter administered singly at 12 hour intervals


Meat: 7 days
Milk: 60 hours







ANNEX IX

LIST OF THE NAME, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, WITHDRAWAL PERIODS, APPLICANT, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES













Member State EU/EEA


Applicant/Marketing Authorisation Holder


Invented Name


Pharmaceutical form


Strengths


Animal species


Recommended dose, frequency and route of administration


Withdrawal period
(meat and milk)




Austria







Norbrook Laboratories Limited




Station Works,




Newry,




Co. Down, BT35 6JP




Northern Ireland






Combisyn Lactating Cow Intramammary Suspension


Intramammary suspension


Amoxicillin 200 mg
Clavulanic acid 50 mg
Prednisolone 10 mg


Lactating cattle


Intramammary administration to lactating cattle at a dose rate of 3 syringes per affected quarter administered singly at 12 hour intervals


Not established




Belgium







Norbrook Laboratories Limited




Station Works,




Newry,




Co. Down, BT35 6JP




Northern Ireland






Combisyn Lactating Cow Intramammary Suspension


Intramammary suspension


Amoxicillin 200 mg
Clavulanic acid 50 mg
Prednisolone 10 mg


Lactating cattle


Intramammary administration to lactating cattle at a dose rate of 3 syringes per affected quarter administered singly at 12 hour intervals


Not established




Denmark







Norbrook Laboratories Limited




Station Works,




Newry,




Co. Down, BT35 6JP




Northern Ireland






Combisyn Lactating Cow Intramammary Suspension


Intramammary suspension


Amoxicillin 200 mg
Clavulanic acid 50 mg
Prednisolone 10 mg


Lactating cattle


Intramammary administration to lactating cattle at a dose rate of 3 syringes per affected quarter administered singly at 12 hour intervals


Not established




Finland







Norbrook Laboratories Limited




Station Works,




Newry,




Co. Down, BT35 6JP




Northern Ireland






Combisyn Lactating Cow Intramammary Suspension


Intramammary suspension


Amoxicillin 200 mg
Clavulanic acid 50 mg
Prednisolone 10 mg


Lactating cattle


Intramammary administration to lactating cattle at a dose rate of 3 syringes per affected quarter administered singly at 12 hour intervals


Not established




France







Norbrook Laboratories Limited




Station Works,




Newry,




Co. Down, BT35 6JP




Northern Ireland






Combisyn Lactating Cow Intramammary Suspension


Intramammary suspension


Amoxicillin 200 mg
Clavulanic acid 50 mg
Prednisolone 10 mg


Lactating cattle


Intramammary administration to lactating cattle at a dose rate of 3 syringes per affected quarter administered singly at 12 hour intervals


Not established




Portugal







Norbrook Laboratories Limited




Station Works,




Newry,




Co. Down, BT35 6JP




Northern Ireland






Combisyn Lactating Cow Intramammary Suspension


Intramammary suspension


Amoxicillin 200 mg
Clavulanic acid 50 mg
Prednisolone 10 mg


Lactating cattle


Intramammary administration to lactating cattle at a dose rate of 3 syringes per affected quarter administered singly at 12 hour intervals


Not established




Spain







Norbrook Laboratories Limited




Station Works,




Newry,




Co. Down, BT35 6JP




Northern Ireland






Combisyn Lactating Cow Intramammary Suspension


Intramammary suspension


Amoxicillin 200 mg
Clavulanic acid 50 mg
Prednisolone 10 mg


Lactating cattle


Intramammary administration to lactating cattle at a dose rate of 3 syringes per affected quarter administered singly at 12 hour intervals


Not established




United Kingdom







Norbrook Laboratories Limited




Station Works,




Newry,




Co. Down, BT35 6JP




Northern Ireland






Combisyn Lactating Cow Intramammary Suspension


Intramammary suspension


Amoxicillin 200 mg
Clavulanic acid 50 mg
Prednisolone 10 mg


Lactating cattle


Intramammary administration to lactating cattle at a dose rate of 3 syringes per affected quarter administered singly at 12 hour intervals


Meat: 7 days
Milk: 60 hours







ANNEX X

LIST OF THE NAME, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, WITHDRAWAL PERIODS, APPLICANT, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES













Member State EU/EEA


Applicant/Marketing Authorisation Holder


Invented Name


Pharmaceutical form


Strengths


Animal species


Recommended dose, frequency and route of administration


Withdrawal period
(meat and milk)




The Netherlands







Norbrook Laboratories Limited




Station Works,




Newry,




Co. Down




BT35 6JP




Northern Ireland






Nisamox Lactating Cow Intramammary Suspension


Intramammary suspension


Amoxicillin 200 mg
Clavulanic acid 50 mg
Prednisolone 10 mg


Lactating cattle


Intramammary administration to lactating cattle at a dose rate of 3 syringes per affected quarter administered singly at 12 hour intervals


Not established




United Kingdom







Norbrook Laboratories Limited




Station Works,




Newry,




Co. Down




BT35 6JP




Northern Ireland






Nisamox Lactating Cow Intramammary Suspension


Intramammary suspension


Amoxicillin 200 mg
Clavulanic acid 50 mg
Prednisolone 10 mg


Lactating cattle


Intramammary administration to lactating cattle at a dose rate of 3 syringes per affected quarter administered singly at 12 hour intervals


Meat: 7 days
Milk: 60 hours