Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2011 to 28 February 2011 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC )
Date: 2011-04-29
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product, pharmaceutical industry, pharmaceutical legislation








C_2011128EN.01001901.xml










29.4.2011   


EN


Official Journal of the European Union


C 128/19





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2011 to 28 February 2011

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

2011/C 128/02
—   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




21.2.2011


Tazocin


See Annex I


See Annex I


23.2.2011




13.1.2011


Fortum and associated names


See Annex II


See Annex II


17.1.2011




21.1.2011


Vascace plus and associated names


See Annex III


See Annex III


24.1.2011




28.2.2011


fenofibrate, bezafibrate, ciprofibrate, gemfibrozil


See Annex IV


See Annex IV


1.3.2011




27.1.2011


Modafinil containing medicinal products


See Annex V


See Annex V


31.1.2011




6.1.2011


Lucentis


Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


These Decisions are addressed to the Member States


10.1.2011




28.2.2011


Xiapex


Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom


These Decisions are addressed to the Member States


1.3.2011




21.1.2011


Revatio


Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom


These Decisions are addressed to the Member States


25.1.2011




28.2.2011


Daliresp


Nycomed GmbH, Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland


These Decisions are addressed to the Member States


1.3.2011




28.2.2011


Esbriet


InterMune Europe Ltd, Wellesley House, Duke of Wellington Avenue, Royal Arsenal, London SE18 6SS, United Kingdom


These Decisions are addressed to the Member States


1.3.2011




28.2.2011


Libertek


Nycomed GmbH, Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland


These Decisions are addressed to the Member States


1.3.2011




28.1.2011


Siklos


ADDMEDICA, 101, rue Saint Lazare, Paris 75009, France


These Decisions are addressed to the Member States


4.3.2011







—   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




21.2.2011


Galantamine STADA and ass. names


See Annex VI


See Annex VI


24.2.2011






(1)  OJ L 311, 28.11.01, p. 67.

(2)  OJ L 311, 28.11.01, p. 1.


ANNEX I

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE 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







Pfizer Corporation Austria Ges.m.b.H




Floridsdorfer




Hauptstraße 1,




A-1210 Wien




Austria






Tazonam 4,0 g/0,5 g - Trockenstechampullen


4,0 g/0,5 g


Lyophilisate for solution for injection or infusion


Intravenous


1 injection vial contains piperacillin sodium equivalent to 4,0 g of piperacillin and tazobactam sodium equivalent to 0,5g of tazobactam.




Belgium







Pfizer S.A.




Boulevard de la Plaine 17




1050 Brussels




Belgium






Tazocin 2 g/250 mg
poudre pour solution injectable


2 g/250 mg


Powder for solution for injection


Intravenous


2,085 g sodium piperacillin + 268,30 mg sodium tazobactam




Belgium







Pfizer S.A.




Boulevard de la Plaine 17




1050 Brussels




Belgium






Tazocin 4g/500 mg
poudre pour solution injectable


4 g/500 mg


Powder for solution for injection


Intravenous


4,170 g sodium piperacillin + 536,60 mg sodium tazobactam




Bulgaria







Pfizer Europe MA EEIG




Ramsgate Road, Sandwich,




Kent,




CT13 9NJ,




United Kingdom






(TAZOCIN 4 g/0,5 g
powder for solution for injection/infusion Piperacillin/Tazobactam)


4 g/0,5 g


powder for solution for injection/infusion


Intravenous


4,170 g piperacillin sodium equivalent to 4 g piperacillin and 0,5366 g tazobactam sodium equivalent to 500 milligrams tazobactam.




Cyprus







Pfizer Hellas A.E.




243 Messoghion Avenue 154 51




Neo Psychico




Greece






TAZOCIN® EF


2,25 G/VIAL


Powder for solution for injection


Intravenous use


2,085 g sodium piperacillin equivalent to 2 g piperacillin and 0,2683 g sodium tazobactam equivalent to 0,250 g tazobactam.




Cyprus







Pfizer Hellas A.E.




243 Messoghion Avenue 154 51




Neo Psychico




Greece






TAZOCIN® EF


4,5 G/VIAL


Powder for solution for injection


Intravenous use


4,17 g sodium piperacillin equivalent to 4 g piperacillin and 0,5366 g sodium tazobactam equivalent to 0,5 g tazobactam.




Czech Republic







Pfizer spol. s r.o.




Stroupežnického 3191/17,




150 00 Praha Smíchov,




Czech Republic






Tazocin 2,25 g


2,25 g


Powder for solution for injection


Intravenous use


2 g piperacillinum/0,25 g tazobactamum




Czech Republic







Pfizer spol. s r.o.




Stroupežnického 3191/17,




150 00 Praha Smíchov




Czech Republic






Tazocin 4,5 g


4,5 g


Powder for solution for injection


Intravenous use


4 g piperacillinum/0,5 g tazobactamum




Denmark







Pfizer ApS




Lautrupvang 8




2750 Ballerup




Denmark






Tazocin


2 g/0,25 g


Powder for solution for injection/infusion


Intravenous


Piperacillin sodium corresponding to piperacillin 2 g, tazobactam sodium corresponding to tazobactam 0,25 g.




Denmark







Pfizer ApS




Lautrupvang 8




2750 Ballerup




Denmark






Tazocin


4 g/0,5 g


Powder for solution for injection/infusion


Intravenous


Piperacillin sodium corresponding to piperacillin 4 g, tazobactam sodium corresponding to tazobactam 0,5 g




Estonia







Pfizer Europe MA EEIG




Ramsgate Road, Sandwich, Kent,




CT13 9NJ,




United Kingdom






TAZOCIN 4,5G


4 000 m g+500 mg g


Powder for solution for injection or infusion


Intravenous


4,170 g piperacillin sodium equivalent to 4 000 mg of piperacillin and 0,5366 g tazobactam sodium equivalent to 500 mg of tazobactam.




Finland







Pfizer Oy




Tietokuja 4,00330 Helsinki,




Finland






Tazocin


2 g/0,25 g


Powder for solution for injection/infusion


Intravenous


Piperacillin. sodium 2,085 g
Tazobactam.sodium 0,2683 g




Finland







Pfizer Oy




Tietokuja 4,00330 Helsinki,




Finland






Tazocin


4 g/0,5 g


Powder for solution for injection/infusion


Intravenous


Piperacillin. sodium 4,170 g
Tazobactam.sodium 0,5366 g




France







Pfizer, Coeur Défense - Tour A – La Défense 4




92931 PARIS LA DEFENSE Cedex




France






TAZOCILLINE 2 g/250 mg,
poudre pour solution pour perfusion


2 g/250 mg


Powder for solution for infusion


Infusion


Sodium piperacillin 2,085 g
sodium tazobactam 268,300 mg




France







Pfizer, Coeur Défense - Tour A – La Défense 4




92931 PARIS LA DEFENSE Cedex




France






TAZOCILLINE 4 g/500 mg,
poudre pour solution pour perfusion


4 g/500 mg


Powder for solution for infusion


Infusion


Sodium piperacillin 4,170 g
sodium tazobactam 536,600 mg




Germany







Pfizer Pharma GmbH




Linkstr. 10




10785 Berlin




Germany






Tazobac EF 4 g/0,5 g


4 g/0,5 g


Lyophilisate for injection or infusion


Intravenous (Infusion, Injection)


4 g piperacillin equivalent to 4,17 g piperacillin sodium
0,5 g tazobactam equivalent to 0,5366 g tazobactam sodium




Greece







Pfizer Hellas A.E.




243 Messoghion Avenue 154 51




Neo Psychico




Greece






TAZOCIN® EF


2 + 0,250 G/VIAL


Powder for solution for injection


Intravenous use


2,085 g sodium piperacillin equivalent to 2 g piperacillin and 0,2683 g sodium tazobactam equivalent to 0,250 g tazobactam.




Greece







Pfizer Hellas A.E.




243 Messoghion Avenue 154 51




Neo Psychico




Greece






TAZOCIN® EF


4 + 0,500 G/VIAL


Powder for solution for injection


Intravenous use


4,17 g sodium piperacillin equivalent to 4 g piperacillin and 0,5366 g sodium tazobactam equivalent to 0,5 g tazobactam.




Hungary







Wyeth Whitehall Export GmbH




Storchengasse 1 A-1150 Vienna




Austria






Tazocin 4,5 g injekció


4,5 g


Powder for solution for injection or infusion


Intravenous


0,5366 g tazobactam sodium equivalent to 0,500 g tazobactam and 4,170 g piperacillin sodium equivalent to 4,00 g piperacillin




Ireland







John Wyeth & Brother Limited




(trading as Wyeth Pharmaceuticals)




Huntercombe Lane South




Taplow, Maidenhead,




Berks, SL6 0PH




United Kingdom






Tazocin2 g/0,25 g
Powder for Solution for Injection or Infusion


2 g/0,25 g


Powder for Solution for Injection or Infusion


Intravenous


2 g piperacillin and 0,25 g tazobactam (both present as sodium salts).




Ireland







John Wyeth & Brother Limited




(trading as Wyeth Pharmaceuticals)




Huntercombe Lane South




Taplow, Maidenhead,




Berks, SL6 0PH




United Kingdom






Tazocin4 g/0,5 g
Powder for Solution for Injection or Infusion


4 g/0,5 g


Powder for Solution for Injection or Infusion


Intravenous


4 g piperacillin and 0,5 g tazobactam (both present as sodium salts).




Italy







Wyeth Lederle S.p.A.




Via Nettunense, 90




Aprilia (LT), 04011,




Italy






TAZOCIN


2 g + 0,250 g


Powder for solution for infusion


Intravenous use


Piperacillin sodium (equiv. to piperacillin 2 g) 2 085 mg
Tazobactam sodium (equiv. to tazobactam 250 mg) 268,3 mg




Italy







Wyeth Lederle S.p.A.




Via Nettunense, 90




Aprilia (LT), 04011,




Italy






TAZOCIN


4 g + 0,500 g


Powder for solution for infusion


Intravenous use


Piperacillin sodium (equiv. to piperacillin 4 g) 4 170 mg
Tazobactam sodium (equiv. to tazobactam 500 mg) 536,6 mg




Latvia







Pfizer Europe MA EEIG




Ramsgate Road, Sandwich, Kent,




CT13 9NJ,




United Kingdom






TAZOCIN 4,0 g/0,5 g
pulveris injekciju vai infūziju šķīduma pagatavošanai


4,0 g/0,500 mg


Powder for solution for injection or infusion


Intravenous


4,170 g piperacillin sodium equivalent to 4 g piperacillin and 0,5366 g tazobactam sodium equivalent to 500 milligrams tazobactam




Lithuania







Pfizer Europe MA EEIG




Ramsgate Road, Sandwich, Kent,




CT13 9NJ,




United Kingdom






TAZOCIN


4,0 g/0,5 g


Powder for solution for injection or infusion


Intravenous


4,170 g piperacillin sodium equivalent to 4 g piperacillin and 0,5366 g tazobactam sodium equivalent to 500 milligrams tazobactam




Luxembourg







Pfizer S.A.




Boulevard de la Plaine 17




1050 Brussels




Belgium






Tazocin 2 g/250 mg
poudre pour solution injectable


2 g/250 mg


Powder for Solution for Injection or Infusion


Intravenous


2,085 g sodium piperacillin + 268,30 mg sodium tazobactam




Luxembourg







Pfizer S.A.




Boulevard de la Plaine 17




1050 Brussels




Belgium






Tazocin 4g/500 mg
poudre pour solution injectable


4g/500 mg


Powder for Solution for Injection or Infusion


Intravenous


4,170 g sodium piperacillin + 536,60 mg sodium tazobactam




Malta







John Wyeth & Brother Limited




(trading as Wyeth Pharmaceuticals)




Huntercombe Lane South




Taplow




Maidenhead




Berkshire SL6 0PH




United Kingdom






Tazocin 2 g/0,25 g
Powder for Solution for Injection or Infusion


2 g/0,25 g


Powder for Solution for Injection or Infusion


Intravenous


TAZOCIN 2 g/0,25 g contains 2 active ingredients; piperacillin 2 g and tazobactam 0,25 g both present as sodium salts.




Malta







John Wyeth & Brother Limited




(trading as Wyeth Pharmaceuticals)




Huntercombe Lane South




Taplow




Maidenhead




Berkshire SL6 0PH




United Kingdom






TAZOCIN 4 g/0,5 g
Powder for Solution for Injection or Infusion


4 g/0,5 g


Powder for Solution for Injection or Infusion


Intravenous


TAZOCIN 4 g/0,5 g contains 2 active ingredients; piperacillin 4 g and tazobactam 0,5 g both present as sodium salts.




Netherlands







Pfizer B.V.




Rivium westlaan 142 2909 LD Capelle a/d Ijssel




The Netherlands






Tazocin® 2 g/250 mg


2 g/250 mg


Powder for solution for injection


Intravenous


Sodium piperacillin and sodium tazobactam, equivalent to 2 g piperacillin and 250 mg tazobactam.




Netherlands







Pfizer B.V.




Rivium westlaan 142 2909 LD Capelle a/d Ijssel




The Netherlands






Tazocin® 4 g/500 mg


4 g/500 mg


Powder for solution for injection


Intravenous


Sodium piperacillin and sodium tazobactam, equivalent to 4 g piperacillin and 500 mg tazobactam




Norway







Pfizer AS




Postboks 3




1324 Lysaker




Norway






Tazocin


2 g/0,25 g


Powder for solution for injection/infusion


Intravenous


Piperacillin sodium corresponding to piperacillin 2 g, tazobactam sodium corresponding to tazobactam. 0,25 g




Norway







Pfizer AS




Postboks 3




1324 Lysaker




Norway






Tazocin


4 g/0,5 g


Powder for solution for injection/infusion


Intravenous


Piperacillin sodium corresponding to piperacillin 4 g, tazobactam sodium corresponding to tazobactam 0,5 g.




Poland







Pfizer Europe MA EEIG




Ramsgate Road, Sandwich, Kent,




CT13 9NJ,




United Kingdom






Tazocin


2 g + 0,25 g


Powder for solution for injection or infusion


Intravenous


2 g piperacillin (in form of piperacillin sodium) and 0,25 g tazobactam (in form of tazobactam sodium).




Poland







Pfizer Europe MA EEIG




Ramsgate Road, Sandwich, Kent,




CT13 9NJ,




United Kingdom






Tazocin


4 g + 0,5 g


Powder for solution for injection or infusion


Intravenous


4 g piperacillin (in form of piperacillin sodium) and 0,5 g tazobactam (in form of tazobactam sodium).




Portugal







Instituto Pasteur de Lisboa, S.A.




Rua Dr. António Loureiro Borges, 2




Arquiparque - Miraflores




1495-131 ALGÉS




Portugal






Tazobac


2 000 mg + 250 mg


Powder for solution for injection


Intravenous use


2,085 g of piperacillin sodium equivalent to 2 g of piperacillin and 0,2683 g of tazobactam sodium equivalent to 250 mg of tazobactam




Portugal







Instituto Pasteur de Lisboa, S.A.




Rua Dr. António Loureiro Borges, 2




Arquiparque - Miraflores




1495-131 ALGÉS




Portugal






Tazobac


4 000 mg + 500 mg


Powder for solution for injection


Intravenous use


4,170 g of piperacillin sodium equivalent to 4 g of piperacillin and 0,5366 g of tazobactam sodium equivalent to 500 mg of tazobactam




Romania







Pfizer Europe MA EEIG




Ramsgate Road, Sandwich, Kent,




CT13 9NJ,




United Kingdom






Tazocin 2,25 g,
liofilizat pentru soluție injectabilă/perfuzabilă


2,00/0,25 g


Lyophilised powder for solution for injection or infusion


Intravenous


Piperacillin 2,00 g as piperacillin sodium and tazobactam 0,25 g as tazobactam sodium.




Romania







Pfizer Europe MA EEIG




Ramsgate Road, Sandwich, Kent,




CT13 9NJ,




United Kingdom






Tazocin 4,5 g,
liofilizat pentru soluție injectabilă/perfuzabilă


4,00/0,5 g


Lyophilised powder for solution for injection or infusion


Intravenous


Piperacillin 4,00 g as piperacillin sodium and tazobactam 0,5 g as tazobactam sodium.




Slovak Republic







Pfizer Europe MA EEIG




Ramsgate Road, Sandwich, Kent,




CT13 9NJ,




United Kingdom






Tazocin 2,25 g


2,25 g


Powder for solution for injection and infusion


Intravenous


contains 2,085 g piperacillin sodium equivalent to 2 g piperacillin and 0,2683 g tazobactam sodium equivalent to 250 milligrams tazobactam




Slovak Republic







Pfizer Europe MA EEIG




Ramsgate Road, Sandwich, Kent,




CT13 9NJ,




United Kingdom






Tazocin 4,5 g


4,5 g


Powder for solution for injection and infusion


Intravenous


contains 4,170 g piperacillin sodium equivalent to 4 g piperacillin and 0,5366 g tazobactam sodium equivalent to 500 milligrams tazobactam




Slovenia







Pfizer Europe MA EEIG




Ramsgate Road, Sandwich, Kent,




CT13 9NJ,




United Kingdom






TAZOCIN 4,5 g
prašek za raztopino za injiciranje ali infundiranje


4,0 g/0,5 g


Powder for solution for injection or infusion.


Intravenous


4,170 g piperacillin sodium equivalent to 4 g piperacillin and 0,5366 g tazobactam sodium equivalent to 500 mg tazobactam.




Spain







Wyeth Farma S.A.




Ctra. Burgos, Km 23 - Desvío Algete Km 1




28700 San Sebastián de los Reyes (Madrid)




Spain






Tazocel 2/0,25 g
Polvo para solución inyectable


2/0,25 g


Powder for injectable solution


Intravenous


Piperacillin (in the form of piperacillin sodium) 2 g
Tazobactam (in the form of tazobactam sodium) 0,25 g




Spain







Wyeth Farma S.A.




Ctra. Burgos, Km 23 - Desvío Algete Km 1




28700 San Sebastián de los Reyes (Madrid),




Spain






Tazocel 4/0,5 g
Polvo para solución inyectable


4/0,5 g


Powder for injectable solution


Intravenous


Piperacillin (in the form of piperacillin sodium) 4 g
Tazobactam (in the form of tazobactam sodium) 0,50 g




Sweden







Pfizer AB




Vetenskapsvägen 10




191 90 Sollentuna,




Sweden






Tazocin


2 g/0,25 g


Powder for solution for injection/infusion


Intravenous


Piperacillin sodium corresponding to piperacillin 2 g and tazobactam sodium corresponding to tazobactam 0,25 g




Sweden







Pfizer AB




Vetenskapsvägen 10




191 90 Sollentuna,




Sweden






Tazocin


4 g/0,5 g


Powder for solution for injection/infusion


Intravenous


Piperacillin sodium corresponding to piperacillin 4 g and tazobactam sodium corresponding to tazobactam 0,5 g




United Kingdom







John Wyeth & Brother Limited




(trading as Wyeth Pharmaceuticals)




Huntercombe Lane South




Taplow




Maidenhead




Berkshire SL6 0PH




United Kingdom






TAZOCIN 2 g/0,25 g
Powder for Solution for Injection or Infusion


2,25 g


Powder for Solution for Injection or Infusion


Intravenous


Piperacillin 2 g and tazobactam 250 mg both present as sodium salts.




United Kingdom







John Wyeth & Brother Limited




(trading as Wyeth Pharmaceuticals)




Huntercombe Lane South




Taplow




Maidenhead




Berkshire SL6 0PH




United Kingdom






TAZOCIN 4 g/0,5 g
Powder for Solution for Injection or Infusion


4,5 g


Powder for Solution for Injection or Infusion


Intravenous


Piperacillin 4 g and tazobactam 500 mg both present as sodium salts.







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







GlaxoSmithKline Pharma GmbH,




Albert Schweitzer-Gasse 6,




A-1140 Wien






Fortum 0,5 g - Trockenstechampullen


500mg


Powder for injection


Intravenous or intramuscular use


 




Fortum 1 g - Trockenstechampullen


1g


Powder for injection


Intravenous or intramuscular use


 




Fortum 2 g - Trockenstechampullen


2 g


Powder for injection/infusion


Intravenous use


 




Belgium







GlaxoSmithKline s.a. / n.v.




Rue du Tilleul 13




1332 Genval




Belgium






Glazidim


500 mg


Powder for solution for Injection


For Intravenous or Intramuscular use


 




Glazidim


1 g


Powder for solution for Infusion


For intravenous use


 




Glazidim


1 g


Powder for solution for Injection


For Intravenous or Intramuscular use


 




Glazidim


2 g


Powder for solution for infusion


For intravenous use


 




Glazidim


2 g


Powder for solution for injection


For intravenous use


 




Bulgaria







Glaxo Group Ltd.




Glaxo Wellcome House,




Berkeley avenue, Greenford,




Middlesex UB6 0NN,




England






Fortum


1 g


Powder for solution for Injection


For intravenous or intramuscular use


 




Cyprus







Glaxo Group Limited




Berkeley Avenue




Greenford




Middlex UB6 0NN




United Kingdom






Fortum


1 g


Powder for Injection


For intravenous use


Vials contain 1g ceftazidime (as pentahydrate)




Czech Republic







Glaxo Group Ltd.,




Glaxo Welcome House,




Berkeley avenue, Greenford,




Middlesex UB6 0NN




United Kingdom






Fortum 500mg


500 mg


Powder for solution for injection


For intravenous use


 




Fortum 1g


1 g


Powder for solution for injection


For intravenous use


 




Fortum 2g


2 g


Powder for solution for injection


For intravenous use


 




Denmark







GlaxoSmithKline Pharma A/S




Nykaer 68, 2605 Broendby




Denmark






Fortum


500 mg


Powder for Injection


For intravenous use


 




Fortum


1 g


Powder for Injection


For intravenous use


 




Fortum


2 g


Powder for Injection


For intravenous use


 




Estonia







Glaxo Wellcome Operations,




Glaxo Wellcome House,




Berkeley Avenue, Greenford,




Middlesex, UB6 0NN




United Kingdom






Fortum


1 g


Powder for solution for injection /infusion


For intramuscular or intravenous use


1g




Finland







Glaxo Operations UK Ltd, Glaxo Wellcome House,




Berkeley Avenue, Greenford,




Middlesex UB6 0NN




England






Glazidim


500 mg


Powder for solution for Injection


For intramuscular or intravenous use


Vials contain 500 mg ceftazidime (as pentahydrate)









Glaxo Operations UK Ltd, Glaxo Wellcome House,




Berkeley Avenue, Greenford,




Middlesex UB6 0NN




United Kingdom






Glazidim


1 g


Powder for solution for injection


For intramuscular or intravenous use


Vials contain 1 g ceftazidime (as pentahydrate)









GlaxoSmithKline Oy,




PB 24, 02231 Espoo






Glazidim


1 g


Powder for solution for injection/infusion


For intramuscular or intravenous use


Vials contain 1 g ceftazidime (as pentahydrate)









GlaxoSmithKline Oy,




PB 24, 02231 Espoo




Finland






Glazidim


2 g


Powder for solution for injection/infusion


For intramuscular or intravenous use


Vials contain 2 g ceftazidime (as pentahydrate)









GlaxoSmithKline Oy,




PB 24, 02231 Espoo




Finland






Glazidim


3 g


Powder for solution for injection/infusion


For intramuscular or intravenous use


Vials contain 3 g ceftazidime (as pentahydrate)




France







Laboratoire GlaxoSmithKline




100, route de Versailles – 78163 Marly-le-Roi Cedex




France






Fortum enfants et nourrisons


250 mg


Powder for solution for injection


For intravenous or intramuscular use


295 mg




Fortum enfants et nourrisons


500 mg


Powder for solution for injection


For intravenous or intramuscular use


591 mg




Fortumset


1 g


Powder for solution for infusion (IV)


For intravenous use


1 182 mg




Fortum


1 g


Powder for solution for Injection


For intravenous or intramuscular use


1 182mg




Fortumset


2 g


Powder for solution for infusion (IV)


For intravenous use


2 364 mg




Fortum


2 g


Powder for solution for injection (IV)


For intravenous use


2 364 mg




Germany







GlaxoSmithKline GmbH & Co. KG




Theresienhöhe 11




80339 München




Germany






Fortum


500 mg


Powder for solution for injection or infusion


For intravenous and intramuscular use


 




Fortum


1 g


Powder for solution for injection or infusion


For intravenous and intramuscular use


 




Fortum


2 g


Powder for solution for injection or infusion


For intravenous use


 




Greece







GlaxoSmithKline a.e.b.e, Leof.




Kifissias 266,




152 32 Halandri, Athens




Greece






Solvetan


1 g


Powder for injection


For intramuscular or intravenous use


 




Solvetan


2 g


Powder for injection


For intravenous use


 




Hungary







GlaxoSmithKline Kft.




1124 Bp, Csörsz u. 43.




Hungary






Fortum


500 mg


Powder for injection


For intravenous use


 




Fortum


1 g


Powder for injection


For intravenous use


 




Fortum


2 g


Powder for infusion


For intravenous use


 




Iceland







GlaxoSmithKline ehf.




Thverholt 14




105 Reykjavík




Iceland






Fortum


1 g


Powder for solution for injection


For intravenous or intramuscular use


 




Fortum


2 g


Powder for solution for infusion


For intravenous use


 




Ireland







GlaxoSmithKline (Ireland) Limited




Stonemasons Way,




Rathfarnham,




Dublin 16




Ireland






Fortum


500 mg


Powder for solution for injection


For intravenous or intramuscular injection


Reconstituted solution contains 500mg ceftazidime




Fortum


1 g


Powder for solution for injection or infusion, vial


For intravenous or intramuscular injection or infusion


Reconstituted solution contains 1g ceftazidime




Fortum


1 g


Powder for infusion, monovial


For infusion


Reconstituted solution contains 1g ceftazidime




Fortum


2 g


Powder for solution for injection or infusion, vial


For intravenous or intramuscular injection or infusion


Reconstituted solution contains 2g ceftazidime




Fortum


2 g


Powder for infusion, monovial


For infusion


Reconstituted solution contains 2g ceftazidime




Italy







GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –




37135 Verona




Italy






Glazidim


250 mg/ml


Powder and solvent for solution for injection


For intramuscular use


 




Glazidim


500 mg/1,5 ml


Powder and solvent for solution for injection


For intramuscular use


 




Glazidim


1 g/3 ml


Powder and solvent for solution for injection


For intramuscular use


 




Glazidim


1 g/10 ml


Powder and solvent for solution for injection


For intravenous use


 




Glazidim


2 g


Powder for solution for infusion


For intravenous use


 




Glazidim


1 g/100 ml


Powder and solvent for solution for infusion (Monovial)


For intravenous use


 




Glazidim


2 g/100 ml


Powder and solvent for solution for infusion (Monovial)


For intravenous use


 




Glazidim


1 g


Powder for solution for infusion (Monovial)


For intravenous use


 




Glazidim


2 g


Powder for solution for infusion (Monovial)


For intravenous use


 









Glaxo Allen S.p.A




Via Fleming, 2




Verona




Italy






Panzid


1 g/3 ml


Powder and solvent for solution for injection


For intramuscular use


 




Latvia







GlaxoSmithKline Latvia SIA




Bruninieku 5, Riga, LV-1001,




Latvia






Fortum 1 g powder for solution for injection or infusion


1 g


Powder for solution for injection or infusion


For intravenous use or intramuscular use


1 g ceftazidime (as ceftazidime pentahydrate)




Lithuania







UAB „GlaxoSmithKline Lietuva“,




A. Goštauto g. 40A,




LT-01112 Vilnius, Lithuania






Fortum


500 mg


Powder and solvent for solution for injection


Intravenous use or intramuscular use


 




Fortum


1 g


Powder and solvent for solution for injection


Intravenous use or intramuscular use


 




Fortum


2 g


Powder for solution for injection or infusion


Intravenous use


 




Fortum


3 g


Powder for solution for injection or infusion


Intravenous use


 




Luxembourg







GlaxoSmithKline s.a. / n.v.




Rue du Tilleul 13




1332 Genval




Belgium






Glazidim


500 mg


Powder for solution for injection


For Intravenous or Intramuscular use


 




Glazidim


1 g


Powder for solution for infusion


For intravenous use


 




Glazidim


1 g


Powder for solution for injection


For Intravenous or Intramuscular use


 




Glazidim


2 g


Powder for solution for infusion


For intravenous use


 




Glazidim


2 g


Powder for solution for injection


For intravenous use


 




Malta







Glaxo Operations UK Limited




Glaxo Wellcome House




Berkeley Avenue




Greenford




Middlesex UB6 0NN




United Kingdom






Fortum


1g per vial


Powder for solution for injection


For intravenous or Intramuscular use


 




Netherlands







Glaxo Smith Kline B.V.




Huis ter Heideweg 62




3705 LZ ZEIST




THE NETHERLANDS






Fortum


500 mg


Powder for solution for injection


For intravenous or intramuscular use


 




Fortum


1 g


Powder for solution for injection


For intravenous or intramuscular use


 




Fortum


2 g


Powder for solution for injection


For intravenous use


 




Norway







GlaxoSmithKline AS




Forskningsveien 2A




Postboks 180 Vinderen




0319 Oslo




Norway






Fortum


500 mg


Powder for infusion/injection


For intravenous or intramuscular use


 




Fortum


1 g


Powder for infusion/injection


For intravenous or intramuscular use


 




Fortum


2 g


Powder for infusion/injection


For intravenous use


 




Poland







GlaxoSmithKline Export Ltd




980 Great West Road




Brentford, Middlesex, TW8 9GS




United Kingdom






Fortum


250 mg


Powder for solution for injection


For intramuscular or intravenous use


 




Fortum


500 mg


Powder for solution for injection


For intramuscular or intravenous use


 




Fortum


1 g


Powder for solution for injection and infusion


For intramuscular or intravenous use


 




Fortum


2 g


Powder solution for injection and infusion


For intravenous use


 




Portugal







Glaxo Wellcome Farmacêutica, Lda.




Rua Dr. António Loureiro Borges, 3




Aquiparque – Miraflores




1495 – 131 Algés




Portugal






Cefortam


500 mg/1,5 ml


Powder and solvent for solution for injection


For intravenous or intramuscular use


 




Cefortam


1 g/3 ml


Powder and solvent for solution for injection


For intravenous or intramuscular use


 




Cefortam


2 g


Powder for solution for injection


For intravenous use


 




Romania







Glaxo Wellcome UK Limited, Glaxo Wellcome House,




Berkeley Avenue, Greenford,




Middlesex, UB6 0NN




United Kingdom






Fortum


500 mg


Powder for injection


For intravenous or intramuscular use


 




Fortum


1 g


Powder for injection


For intravenous or intramuscular use


 




Fortum


1 g


Powder for injection


For intravenous or intramuscular use


 




Fortum


1 g


Powder for injection


For intravenous or intramuscular use


 




Fortum


2 g


Powder for injection or infusion


For intravenous or intramuscular use


 




Slovak Republic







GlaxoSmithKline Slovakia sro.,




Galvaniho7/A, 82104 Bratislava,




Slovakia.






Fortum


500 mg


Powder for injection


For intravenous use


 




Fortum


1 g


Powder for infusion


For intravenous use


 




Fortum


2 g


Powder for infusion


For intravenous use


 




Slovenia







GSK d.o.o., Ljubljana




Knezov štradon 90




SI-1000 Ljubljana




Slovenija






Fortum


1 g


Powder for injection or infusion


For intravenous use


 




Fortum Monovial


1 g


Powder for infusion


For intravenous use


 




Spain







GlaxoSmithKline, S.A.




P.T.M.- C/Severo Ochoa, 2




28760 Tres Cantos (Madrid)




Spain






Fortam IM/IV


500 mg


Powder for injection


For intravenous use/IM


 




Fortam IV


1 g


Powder for injection


For intravenous use


 




Fortam 1 g


1 g


Powder for injection


For intravenous use/IM


 




Fortam IV


2 g


Powder for infusion


For intravenous use


 




Sweden







GlaxoSmithKline AB




Box 516




169 29 Solna




Sweden






Fortum


250 mg


Powder for solution for injection


For intramuscular or intravenous use


250 mg ceftazidime (as pentahydrate)




Fortum


500 mg


Powder for solution for injection


For intramuscular or intravenous use


500 mg ceftazidime (as pentahydrate)




Fortum


1 g


Powder for solution for injection


For intramuscular or intravenous use


1 g ceftazidime (as pentahydrate)




Fortum


1 g


Powder for solution for infusion


For intravenous use


1 g ceftazidime (as pentahydrate)




Fortum


1 g Monovial


Powder for solution for infusion


For intravenous use


1 g ceftazidime (as pentahydrate)




Fortum


2 g Monovial


Powder for solution for infusion


For intravenous use


2 g ceftazidime (as pentahydrate)




Fortum


2 g


Powder for solution for injection/infusion


For intravenous use


2 g ceftazidime (as pentahydrate)




United Kingdom







Glaxo Operations UK Ltd,




Glaxo Wellcome House,




Berkeley Avenue, Greenford Road,




Middlesex, UB6 0NN




United Kingdom






Fortum


250 mg


Powder for injection


intravenous use and intramuscular use


118 mg per gram of ceftazidime




Fortum


500 mg


Powder for injection


intravenous use and intramuscular use


118 mg per gram of ceftazidime




Fortum


1 g


Powder for injection


intravenous use and intramuscular use


118 mg per gram of ceftazidime




Fortum


2 g and 3 g + 2 g Monovial


Powder for infusion


intravenous use and intramuscular use


118 mg per gram of ceftazidime







ANNEX III

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




Austria







Roche Austria GmbH,




Engelhorngasse 3,




A - 1211 Vienna




Austria






Inhibace plus «Roche» - Filmtabletten


5 mg/12,5 mg


Film-coated tablets


Oral use




Belgium







N.V. Roche S.A.




Rue Dante 75




1070 Bruxelles




Belgium






Co-Inhibace


5 mg/12,5 mg


Film-coated tablets


Oral use




Czech Republic







Roche s.r.o.




Dukelskych hrdinu 567/52




170 00 / Praha 7




Czech Republic






Inhibace Plus


5 mg/12,5 mg


Film-coated tablets


Oral use




Germany







Roche Pharma AG




Emil-Barell-Strasse 1




79639/Grenzach




Germany






Dynorm Plus


5 mg/12,5 mg


Film-coated tablets


Oral use




Greece







Roche (Hellas) SA




4, Alamanas & Delfon Str.




Maroussi 15125




Attiki




Greece






Vascace Plus


5 mg/12,5 mg


Film-coated tablets


Oral use




Hungary







Roche Hungary Ltd




Edison ut 1




2040 / Budaörs




Hungary






Inhibace Plus


5 mg/12,5 mg


Film-coated tablets


Oral use




Italy







Roche S.p.A




Via G.B Stucchi 110




20052/Monza




Italy






Inibace Plus


5 mg/12,5 mg


Film-coated tablets


Oral use




Luxembourg







N.V. Roche S.A.




Rue Dante 75




1070 Bruxelles




Belgium






Co-Inhibace


5 mg/12,5 mg


Film-coated tablets


Oral use




Poland







Roche Polska Sp.z.o.o.




Ul. Domaniewska 39B




02-672 / Warsaw




Poland






Inhibace Plus


5 mg/12,5 mg


Film-coated tablets


Oral use




Portugal







Roche Farmacêutica Química, Lda




Estrada Nacional 249-1




2720-413 / Amadora




Portugal






Inibace Plus


5 mg/12,5 mg


Film-coated tablets


Oral use




Spain







Roche Farma S.A.




Eucalipto no 33




28016 / Madrid




Spain






Inhibace Plus


5 mg/12,5 mg


Film-coated tablets


Oral use







ANNEX IV

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


Fenofibrate 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







Solvay Pharma GmbH




Dresdner Straße 91/C2/Top 12




A- 1200 Wien




Austria






Apteor 160 mg - Filmtabletten


160 mg


film-coated tablet


oral




AT - Austria







G.L. Pharma GmbH




Schlossplatz 1




A-8502 Lannach




Austria






Fenolip retard 250 mg - Kapseln


250 mg


prolonged release capsule, hard


oral




AT - Austria







Solvay Pharma GmbH




Dresdner Straße 91/C2/Top 12




A- 1200 Wien




Austria






Lipanthyl Nanopartikel 145 mg - Filmtabletten


145 mg


film-coated tablet


oral




AT - Austria







Solvay Pharma GmbH




Dresdner Straße 91/C2/Top 12




A- 1200 Wien




Austria






Lipanthyl supra 160 mg - Filmtabletten


160 mg


film-coated tablet


oral




AT - Austria







Solvay Pharma GmbH




Dresdner Straße 91/C2/Top 12




A- 1200 Wien




Austria






Lipcor 200 mg - Kapseln


200 mg


capsule, hard


oral




AT - Austria







Solvay Pharma GmbH




Dresdner Straße 91/C2/Top 12




A- 1200 Wien




Austria






Lipsin 100 mg - Kapseln


100 mg


capsule, hard


oral




AT - Austria







Solvay Pharma GmbH




Dresdner Straße 91/C2/Top 12




A- 1200 Wien




Austria






Lipsin retard 250 mg - Kapseln


250 mg


prolonged release capsule, hard


oral




BE - Belgium







DOCPHARMA N.V.




Ambachtenlaan 13H




3001 Leuven




Belgium






DOCFENOFI 200


200 mg


CAPSULES


oral




BE - Belgium







EUROGENERICS N.V. AFGEKORT „E.G.”




Heizel Esplanade b22




1020 Laeken




Belgium






FENOFIBRAAT EG 200 MG


200 mg


CAPSULES


oral




BE - Belgium







EUROGENERICS N.V. AFGEKORT „E.G.”




Heizel Esplanade b22




1020 Laeken




Belgium






FENOFIBRAAT EG 100 MG


100 mg


CAPSULES


oral




BE - Belgium







EUROGENERICS N.V. AFGEKORT „E.G.”




Heizel Esplanade b22




1020 Laeken




Belgium






FENOFIBRAAT EG 200 MG


200 mg


CAPSULES


oral




BE - Belgium







JUBILANT PHARMACEUTICALS NV




Axxes Business Park




Guldensporenpark 22 - Block C




9820 Merelbeke




Belgium






FENOFIBRAAT JUBILANT 200 MG CAPSULES


200 mg


CAPSULES


oral




BE - Belgium







APOTEX NV




Av. du Bourg.




Etienne Demunter 5 box 8




1090 Jette




Belgium






FENOFIBRATE APOTEX 200 MG


200 mg


CAPSULES


oral




BE - Belgium







MYLAN BVBA/SPRL




Terhulpsesteenweg 6A




1560 Hoeilaart




Belgium






FENOFIBRATE MYLAN 200 MG MICRONISED


200 mg


Capsule, hard


oral




BE - Belgium







SANDOZ N.V.




Telecom Gardens




Medialaan 40




1800 Vilvoorde




Belgium






FENOFIBRATE SANDOZ 200 MG


200 mg


CAPSULES


oral




BE - Belgium







LABORATOIRES S.M.B. S.A.




Rue De La Pastorale 26-28




1080 Bruxelles




Belgium






FENOGAL 200 LIDOSE


200 mg


capsule, hard


oral




BE - Belgium







LABORATOIRES S.M.B. S.A.




Rue De La Pastorale 26-28




1080 Bruxelles




Belgium






FENOGAL 267 MG LIDOSE


267 mg


capsule hard


oral




BE - Belgium







S.M.B. TECHNOLOGY S.A.




Rue du Parc Industriel 39




6900 Marche-en-Famenne




Belgium






FENOSUP LIDOSE 160 MG


160 mg


capsule hard


oral




BE - Belgium







SOLVAY PHARMA S.A.-N.V.




Blue Planet Building




Av. Brg. E. Demunterlaan 3




1090 Bruxelles




Belgium






LIPANTHYL 200 MICRONISED


200 mg


capsule, hard


oral




BE - Belgium







SOLVAY PHARMA S.A.-N.V.




Blue Planet Building




Av. Brg. E. Demunterlaan 3




1090 Bruxelles




Belgium






LIPANTHYL 267 MICRONISED


267 mg


capsule, hard


oral




BE - Belgium







SOLVAY PHARMA S.A.-N.V.




Blue Planet Building




Av. Brg. E. Demunterlaan 3




1090 Bruxelles




Belgium






LIPANTHYL 67 MICRONISED


67 mg


capsule, hard


oral




BE - Belgium







SOLVAY PHARMA S.A.-N.V.




Blue Planet Building




Av. Brg. E. Demunterlaan 3




1090 Bruxelles




Belgium






LIPANTHYL SUPRA 215MG


215 mg


film-coated tablet


oral




BE - Belgium







SOLVAY PHARMA S.A.-N.V.




Blue Planet Building




Av. Brg. E. Demunterlaan 3




1090 Bruxelles




Belgium






LIPANTHYL SUPRA 160 MG


160 mg


film-coated tablet


oral




BE - Belgium







SOLVAY PHARMA S.A.-N.V.




Blue Planet Building




Av. Brg. E. Demunterlaan 3




1090 Bruxelles




Belgium






LIPANTHYLNANO 145MG


145 mg


film-coated tablet


oral




BE - Belgium







SOLVAY PHARMA S.A.-N.V.




Blue Planet Building




Av. Brg. E. Demunterlaan 3




1090 Bruxelles




Belgium






LIPERIAL 145MG


145 mg


film-coated tablet


oral




BG - Bulgaria







Laboratoires Fournier SA




28 Boulevard Clemenceau




21000 Dijon




France






Lipanthyl Supra


160 mg


Modified-release tablet


Oral use




BG - Bulgaria







Laboratoires Fournier SA




28 Boulevard Clemenceau




21000 Dijon




France






Lipanthyl 200 M


200 mg


Capsule, hard


Oral use




BG - Bulgaria







Laboratoires Fournier SA




28 Boulevard Clemenceau




21000 Dijon




France






Lipanthyl 267 M


267 mg


Capsule, hard


Oral use




CY - Cyprus







Varnavas Hadjipanayis Ltd




7 Androcleous street




P.O.Box 21229




1504 Lefkosia




Cyprus






LIPIDIL MICRONISED HARD CAPSULES 267mg


267 mg


capsules


oral




CY - Cyprus







Varnavas Hadjipanayis Ltd,




7 Androcleous street




P.O.Box 21229




1504 Lefkosia




Cyprus






LIPIDIL MICRONISED HARD CAPSULES 200mg


200 mg


capsules


oral




CZ - Czech Republic







Laboratoires Fournier S.A.




28Bd Clemenceau




21 000 Dijon




France






LIPANTHYL 267 M


267 mg


capsule, hard


oral use




CZ - Czech Republic







Laboratoires Fournier S.A.




28Bd Clemenceau




21 000 Dijon




France






LIPANTHYL NT 145 MG


145 MG


Film-coated tablet


oral use




CZ - Czech Republic







Laboratoires Fournier S.A.




28Bd Clemenceau




21 000 Dijon




France






LIPANTHYL SUPRA 160 MG


160 MG


Modified-release tablet


oral use




CZ - Czech Republic







Laboratoires Fournier S.A.




28Bd Clemenceau




21 000 Dijon




France






LIPANTHYL 200 M


200 MG


capsule, hard


oral use




CZ - Czech Republic







Laboratoires Fournier S.A.




28Bd Clemenceau




21 000 Dijon




France






LIPANTHYL S 215 MG


215 MG


Film-coated tablet


oral use




CZ - Czech Republic







HEXAL AG




Industriestraße 25




83607 Holzkirchen




Germany






LIPOHEXAL 250 RETARD


250 MG


Modified-release capsule,hard


oral use




CZ - Czech Republic







Ingers Industrial Solutions s.r.o.




Slunná 16




617 00 Brno




Czech Republic






FENOFIX 267 MG


267 MG


capsule, hard


oral use




CZ - Czech Republic







Ingers Industrial Solutions s.r.o.




Slunná 16




617 00 Brno




Czech Republic






FENOFIX 200 MG


200 MG


capsule, hard


oral use




CZ - Czech Republic







Zentiva a.s.




Nitrianska 100




920 27 Hlohovec




Slovac Republic






FEBIRA 200


200 MG


capsule, hard


oral use




CZ - Czech Republic







sanofi-aventis s.r.o.




Evropská 846/176a




160 00 Praha 6




Czech Republic






LIPIREX 267 MG


267 MG


capsule, hard


oral use




CZ - Czech Republic







sanofi-aventis s.r.o.




Evropská 846/176a




160 00 Praha 6




Czech Republic






LIPIREX 200MG


200 MG


capsule, hard


oral use




CZ - Czech Republic







PharmaSwiss Česká Republika s.r.o., Jankovcova 1569/2c




17000 Praha 7




Czech Republic






SUPRELIP


200 MG


capsule, hard


oral use




CZ - Czech Republic







APOTEX (ČR), spol. s r.o.




Palladium, Na Poříčí 1079/3a




110 00 Praha – 1




Czech Republic






APO-FENO


200 MG


capsule, hard


oral use




DE - Germany







AbZ-Pharma GmbH




Dr.Georg-Spohn-Str. 7




D-89143 Blaubeuren




Germany






Fenofibrat AbZ 100mg Hartkapseln


100 mg


Capsule, hard


oral




DE - Germany







AbZ-Pharma GmbH




Dr.Georg-Spohn-Str. 7




D-89143 Blaubeuren




Germany






Fenofibrat AbZ 250 mg Retardkapseln


250 mg


Prolonged-release capsule, hard


oral




DE - Germany







ALIUD PHARMA GmbH




Gottlieb-Daimler-Str. 19




D-89150 Laichingen




Germany






Fenofibrat AL 250 retard


250 mg


Prolonged-release capsule, hard


oral




DE - Germany







betapharm Arzneimittel GmbH




Kobelweg 95




D-86156 Augsburg




Germany






Fenobeta 250 retard


250 mg


Prolonged-release capsule, hard


oral




DE - Germany







CHEPLAPHARM Arzneimittel GmbH




Bahnhofstr. 1a




D-17498 Mesekenhagen




Germany






Normalip pro


200 mg


Capsule, hard


oral




DE - Germany







CT Arzneimittel GmbH




Lengeder Str. 42 a




D-13407 Berlin




Germany






Fenofibrat-CT 100mg Hartkapseln


100 mg


Capsule


oral




DE - Germany







CT Arzneimittel GmbH




Lengeder Str. 42 a




D-13407 Berlin




Germany






Fenofibrat-CT 250mg Retardkapseln


250 mg


Prolonged-release capsule, hard


oral




DE - Germany







Heumann Pharma GmbH & Co. Generica KG




Südwestpark 50




D-90449 Nürnberg




Germany






Fenofibrat 200 Heumann


200 mg


Capsule, hard


oral




DE - Germany







Heumann Pharma GmbH & Co. Generica KG




Südwestpark 50




D-90449 Nürnberg




Germany






Fenofibrat 250 retard Heumann


250 mg


Prolonged-release capsule, hard


oral




DE - Germany







HEXAL AG




Industriestr. 25




D-83607 Holzkirchen




Germany






FENOFIBRAT HEXAL 160 mg Hartkapseln


160 mg


Capsule, hard


oral




DE - Germany







HEXAL AG




Industriestr. 25




D-83607 Holzkirchen




Germany






Fenofibrat Hexal 200 mg Hartkapseln


200 mg


Capsule, hard


oral




DE - Germany







Juta Pharma GmbH




Gutenbergstr. 13




D-24941 Flensburg




Germany






Fenofanton 250 mg Hartkapseln, retardiert


250 mg


Prolonged-release capsule, hard


oral




DE - Germany







Mylan dura GmbH




Wittichstr. 6




D-64295 Darmstadt




Germany






Durafenat


100 mg


Capsule, hard


oral




DE - Germany







Mylan dura GmbH




Wittichstr. 6




D-64295 Darmstadt




Germany






durafenat MF 200 mg


200 mg


Modified-release capsule, hard


oral




DE - Germany







Mylan dura GmbH




Wittichstr. 6




D-64295 Darmstadt




Germany






durafenat retard


250 mg


Prolonged-release capsule, hard


oral




DE - Germany







ratiopharm GmbH




Graf-Arco-Str. 3




D-89079 Ulm




Germany






Fenofibrat-ratiopharm 250 mg Retardkapseln


250 mg


Prolonged-release capsule, hard


oral




DE - Germany







ratiopharm GmbH




Graf-Arco-Str. 3




D-89079 Ulm




Germany






Fenofibrat-ratiopharm 100 mg Hartkapseln


100 mg


Capsule, hard


oral




DE - Germany







Sandoz Pharmaceuticals GmbH




Raiffeisenstr. 11




D-83607 Holzkirchen




Germany






Fenofibrat Sandoz 200mg Hartkapseln


200 mg


Capsule, hard


oral




DE - Germany







Abbott Arzneimittel GmbH




Hans-Boeckler-Allee 20




D-30173 Hannover




Germany






Apteor 160 mg Filmtablette


160 mg


Film-coated tablet


oral




DE - Germany







Abbott Arzneimittel GmbH




Hans-Boeckler-Allee 20




D-30173 Hannover




Germany






Elipsia 145 mg Filmtabletten


145 mg


Film-coated tablet


oral




DE - Germany







Abbott Arzneimittel GmbH




Hans-Boeckler-Allee 20




D-30173 Hannover




Germany






Liperial 145 mg Filmtablette


145 mg


Film-coated tablet


oral




DE - Germany







Abbott Arzneimittel GmbH




Hans-Boeckler-Allee 20




D-30173 Hannover




Germany






Lipidil - Ter 160 mg Filmtablette


160 mg


Film-coated tablet


oral




DE - Germany







Abbott Arzneimittel GmbH




Hans-Boeckler-Allee 20




D-30173 Hannover




Germany






Lipidil 145 ONE


145 mg


Film-coated tablet


oral




DE - Germany







Abbott Arzneimittel GmbH




Hans-Boeckler-Allee 20




D-30173 Hannover




Germany






Lipidil 200mg


200 mg


Capsule, hard


oral




DE - Germany







Abbott Arzneimittel GmbH




Hans-Boeckler-Allee 20




D-30173 Hannover




Germany






Xafenor 145 mg Filmtablette


145 mg


Film-coated tablet


oral




DE - Germany







Stadapharm GmbH




Stadastr. 2-18




D-61118 Bad Vilbel




Germany






Fenofibrat STADA 250 mg Hartkapseln, retardiert


250 mg


Prolonged-release capsule, hard


oral




DE - Germany







Winthrop Arzneimittel GmbH




Urmitzer Str. 5




D-56218 Mülheim-Kärlich




Germany






CiL 160 mg


160 mg


Capsule, hard


oral




DE - Germany







Winthrop Arzneimittel GmbH




Urmitzer Str. 5




D-56218 Mülheim-Kärlich




Germany






CIL 200 mg


200 mg


Capsule


oral




EL - Greece







SOLVAY PHARMA Μ.Ε.Π.Ε




Agiou DIMITRIOU 63




Alimos 17456




Greece






LIPIDIL


200 MG/CAP


HARD CAPSULES


ORAL




EL - Greece







SOLVAY PHARMA Μ.Ε.Π.Ε




Agiou DIMITRIOU 63




Alimos




Greece 17456






LIPIDIL (NT)


145 MG/TAB


Film-coated tablet


ORAL




EL - Greece







LABORATOIRES SMB S.A., BELGIUM




26-28 rue de la Pastorale




B-1080, Brussels




Belgium






FENOBRAT


160 MG/CAP


HARD CAPSULES


ORAL




ES - Spain







SOLVAY PHARMA




S.A.Avda. Diagonal




507 Barcelona




Spain






APTEOR


145 mg


film coated tablets


oral




ES - Spain







SOLVAY PHARMA,




S.A.Avda. Diagonal




507 Barcelona




Spain






APTEOR


160 mg


film coated tablets


oral




ES - Spain







KERN PHARMA




S.L. Venus, 72.




Poligono Industrial Colon II.Terrassa




Spain






Fenofibrato KernPharma


160 mg


capsules


oral




ES - Spain







LABORATORIOS RANBAXY




S.L.Passeig de Gracia




9 Barcelona




Spain






FENOFIBRATO RANBAXY


160 mg


film coated tablets


oral




ES - Spain







LABORATORIOS RANBAXY S.L.Passeig de Gracia




9 Barcelona






FENOFIBRATO RANBAXY


200 mg


capsules


oral




ES - Spain







LABORATORIOS RANBAXY S.L.Passeig de Gracia




9 Barcelona




Spain






FENOFIBRATO RANBAXYGEN


200 mg


capsules


oral




ES - Spain







NOVARTIS FARMACEUTICA, S.A.




Gran Via de les Corts Catalanes




764 Barcelona




Spain






Liparison Retard


250 mg


capsules


oral




ES - Spain







SOLVAY PHARMA S.A.




Avda. Diagonal




507 BARCELONA




Spain






PANLIPAL


145 mg


film coated tablets


oral




ES - Spain







SOLVAY PHARMA S.A.




Avda. Diagonal




507 BARCELONA




Spain






SECALIP


145 mg


film coated tablets


oral




ES - Spain







SOLVAY PHARMA S.A.




Avda. Diagonal




507 BARCELONA




Spain






SECALIP


200 mg


capsules


oral




ES - Spain







SOLVAY PHARMA S.A.




Avda. Diagonal




507 BARCELONA




Spain






SECALIP


250 mg


capsules


oral




ES - Spain







SOLVAY PHARMA S.A.




Avda. Diagonal




507 BARCELONA




Spain






SECALIP SUPRA


160 mg


film coated tablets


oral




ET - Estonia







Laboratoires Fournier S.A.




28 Boulevard Clemenceau




21000 Dijon




France






LIPANTHYL


200 mg


capsule


oral use




ET - Estonia







Pharmaswiss Eesti OÜ




Tammsaare tee 47




11316 Tallinn




ESTONIA






FENOLIP


160 mg


capsule, hard


oral use




FI - Finland







Laboratoires SMB S.A.




Rue de la Pastorale 26-28




1080 Brussels




Belgium






CIL


160 mg


capsules, hard


Oral use




FI - Finland







Laboratoires SMB S.A.




Rue de la Pastorale 26-28




1080 Brussels




Belgium






FENOSUP LIDOSE


160 mg


capsules, hard


Oral use




FI - Finland







Laboratoires Fournier SA




28 boulevard Clémenceau




BP 27912




21079 Dijon Cedex




France






LIPANTHYL PENTA


145 mg


film-coated tablet


Oral use




FI - Finland







Laboratoires Fournier SA




28 boulevard Clémenceau




BP 27912




21079 Dijon Cedex




France






LIPANTHYL SUPRA


160 mg


film-coated tablet


Oral use




FI - Finland







Laboratoires Fournier SA




28 boulevard Clémenceau




BP 27912




21079 Dijon Cedex




France






LIPANTHYL SUPRA


215 mg


film-coated tablet


Oral use




FR - France







Société FERLUX SA




24, avenue d'Aubière




BP 151




63804 Cournon d'Auvergne Cedex




FRANCE






CENCARAN 140 mg, gélule


140 mg


capsule


oral use




FR - France







Société FERLUX SA




24, avenue d'Aubière




BP 151




63804 Cournon d'Auvergne Cedex




France






CENCARAN 67 mg, gélule


67 mg


capsule


oral use




FR - France







Laboratoires LEURQUIN MEDIOLANUM




68-88, rue Louis Ampère




ZI des Chanoux




93330 Neuilly-sur-Marne




FRANCE






FEGENOR 140 mg, gélule


140 mg


capsule


oral use




FR - France







Laboratoires LEURQUIN MEDIOLANUM




68-88, rue Louis Ampère




ZI des Chanoux




93330 Neuilly-sur-Marne




France






FEGENOR 200 mg, gélule


200 mg


capsule


oral use




FR - France







Laboratoires LEURQUIN MEDIOLANUM




68-88, rue Louis Ampère




ZI des Chanoux




93330 Neuilly-sur-Marne




France






FEGENOR 67 mg, gélule


67 mg


capsule


oral use




FR - France







GALENIX DEVELOPPEMENT




Les Palanques




33127 Saint Jean d’Illac




FRANCE






FENATHOL 160 mg, comprimé pelliculé


160 mg


film-coated tablet


oral use




FR - France







Laboratoires LEURQUIN MEDIOLANUM




68-88, rue Louis Ampère




ZI des Chanoux




93330 Neuilly-sur-Marne




France






FENOCOR 100 mg, gélule


100 mg


capsule


oral use




FR - France







ACTAVIS France




La Boursidière Centre d'Affaires




92357 Le Plessis Robinson




FRANCE






FENOFIBRATE ACTAVIS 160 mg, comprimé


160 mg


tablet


oral use




FR - France







BIOGARAN




15, boulevard Charles de Gaulle




92700 Colombes




FRANCE






FENOFIBRATE ALMUS 160 mg, comprimé


160 mg


tablet


oral use




FR - France







ARROW GENERIQUES




26, avenue Tony Garnier




69007 Lyon




FRANCE






FENOFIBRATE ALMUS 200 mg, gélule


200 mg


capsule


oral use




FR - France







ARROW GENERIQUES




26, avenue Tony Garnier




69007 Lyon




FRANCE






FENOFIBRATE ALMUS 67 mg, gélule


67 mg


capsule


oral use




FR - France







LABORATOIRES ALTER




3, avenue de la Baltique




ZI de Courtaboeuf




91140 Villebon Sur Yvette




France






FENOFIBRATE ALTER 160 mg, comprimé


160 mg


tablet


oral use




FR - France







LABORATOIRES ALTER




3, avenue de la Baltique




ZI de Courtaboeuf




91140 Villebon Sur Yvette




FRANCE






FENOFIBRATE ALTER 300 mg, gélule


300 mg


capsule


oral use




FR - France







ARROW GENERIQUES




26, avenue Tony Garnier




69007 Lyon




FRANCE






FENOFIBRATE ARROW 160 mg, comprimé


160 mg


tablet


oral use




FR - France







ARROW GENERIQUES




26, avenue Tony Garnier




69007 Lyon




France






FENOFIBRATE ARROW 200 mg, gélule


200 mg


capsule


oral use




FR - France







ARROW GENERIQUES




26, avenue Tony Garnier




69007 Lyon




France






FENOFIBRATE ARROW 67 mg, gélule


67 mg


capsule


oral use




FR - France







Laboratoires FOURNIER SA




28, boulevard Clémenceau




21000 Dijon




FRANCE






FENOFIBRATE BIOGARAN 100 mg, gélule


100 mg


capsule


oral use




FR - France







BIOGARAN




15, boulevard Charles de Gaulle




92700 Colombes




France






FENOFIBRATE BIOGARAN 160 mg, comprimé


160 mg


tablet


oral use




FR - France







Laboratoires FOURNIER SA




28, boulevard Clémenceau




21000 Dijon




France






FENOFIBRATE BIOGARAN 200 mg, gélule


200 mg


capsule


oral use




FR - France







Laboratoires FOURNIER SA




28, boulevard Clémenceau




21000 Dijon




France






FENOFIBRATE BIOGARAN 300 mg, gélule


300 mg


capsule


oral use




FR - France







Laboratoires FOURNIER SA




28, boulevard Clémenceau




21000 Dijon




France






FENOFIBRATE BIOGARAN 67 mg, gélule


67 mg


capsule


oral use




FR - France







CLL PHARMA




Nice Premier - Arénas




455, Promenade des Anglais




06299 Nice Cedex 03




FRANCE






FENOFIBRATE CEHEL PHARMA 140 mg, gélule


140 mg


capsule


oral use




FR - France







CRISTERS




22 quai Gallieni




92150 Suresnes




FRANCE






FENOFIBRATE CRISTERS 160 mg, comprimé


160 mg


tablet


oral use




FR - France







CRISTERS




22 quai Gallieni




92150 Suresnes




France






FENOFIBRATE CRISTERS 200 mg, gélule


200 mg


capsule


oral use




FR - France







CRISTERS




22 quai Gallieni




92150 Suresnes




France






FENOFIBRATE CRISTERS 67 mg, gélule


67 mg


capsule


oral use




FR - France







CLL PHARMA




Nice Premier - Arénas




455, Promenade des Anglais




06299 Nice Cedex 03




France






FENOFIBRATE DCI PHARMA 200 mg, gélule


200 mg


capsule


oral use




FR - France







CLL PHARMA




Nice Premier - Arénas




455, Promenade des Anglais




06299 Nice Cedex 03




France






FENOFIBRATE DCI PHARMA 67 mg, gélule


67 mg


capsule


oral use




FR - France







Laboratoires FOURNIER SA




28, boulevard Clémenceau




21000 Dijon




France






FENOFIBRATE DEBAT CARDIO 140 mg, gélule


140 mg


capsule


oral use




FR - France







EG LABO - Laboratoires EuroGenerics




«Le Quintet» - bâtiment A




12, rue Danjou




92517 Boulogne Billancourt Cedex




France






FENOFIBRATE EG 145 mg, comprimé


145 mg


tablet


oral use




FR - France







EG LABO - Laboratoires EuroGenerics




«Le Quintet» - bâtiment A




12, rue Danjou




92517 Boulogne Billancourt Cedex




France






FENOFIBRATE EG 160 mg, comprimé pelliculé


160 mg


tablet


oral use




FR - France







EG LABO - Laboratoires EuroGenerics




«Le Quintet» - bâtiment A




12, rue Danjou




92517 Boulogne Billancourt Cedex




France






FENOFIBRATE EG 200 mg, gélule


200 mg


capsule


oral use




FR - France







EG LABO - Laboratoires EuroGenerics




«Le Quintet» - bâtiment A




12, rue Danjou




92517 Boulogne Billancourt Cedex




France






FENOFIBRATE EG 67 mg, gélule


67 mg


capsule


oral use




FR - France







SANOFI AVENTIS France




1-13, boulevard Romain Rolland




75014 Paris




France






FENOFIBRATE ENIREX 160 mg, comprimé pelliculé


160 mg


film-coated tablet


oral use




FR - France







TEVA SANTE




Le Palatin 1




1 cours du Triangle




92936 Paris la Défense Cedex




FRANCE






FENOFIBRATE TEVA 145 mg, comprimé


145 mg pour 1 comprimé


tablet


oral use




FR - France







ETHYPHARM




194, Bureaux de la Colline




Bâtiment D




92213 Saint-Cloud Cedex




France






FENOFIBRATE ETHYPHARM 200 mg, gélule


200 mg


capsule


oral use




FR - France







ETHYPHARM




194, Bureaux de la Colline




Bâtiment D




92213 Saint-Cloud Cedex




France






FENOFIBRATE ETHYPHARM 67 mg, gélule


67 mg


capsule


oral use




FR - France







GALENIX DEVELOPPEMENT




Les Palanques




33127 Saint Jean d’Illac




FRANCE






FENOFIBRATE EXPANPHARM 200 mg, comprimé


200 mg


tablet


oral use




FR - France







AJC INVEST




6, rue de la Rochefoucauld




16000 Angoulême




FRANCE






FENOFIBRATE EXPANPHARM 200 mg, gélule


200 mg


capsule


oral use




FR - France







GALENIX DEVELOPPEMENT




Les Palanques




33127 Saint Jean d’Illac




FRANCE






FENOFIBRATE EXPANPHARM 67 mg, comprimé


67 mg


tablet


oral use




FR - France







AJC INVEST




6, rue de la Rochefoucauld




16000 Angoulême




FRANCE






FENOFIBRATE EXPANPHARM 67 mg, gélule


67 mg


capsule


oral use




FR - France







Laboratoires FOURNIER SA




28, boulevard Clémenceau




21000 Dijon




France






FENOFIBRATE FOURNIER 100 mg, gélule


100 mg


capsule


oral use




FR - France







Laboratoires FOURNIER SA




28, boulevard Clémenceau




21000 Dijon




France






FENOFIBRATE FOURNIER 145 mg, comprimé pelliculé


145 mg


film-coated tablet


oral use




FR - France







Laboratoires FOURNIER SA




28, boulevard Clémenceau




21000 Dijon




France






FENOFIBRATE FOURNIER 160 mg, comprimé pelliculé


160 mg


film-coated tablet


oral use




FR - France







Laboratoires FOURNIER SA




28, boulevard Clémenceau




21000 Dijon




France






FENOFIBRATE FOURNIER 200 MICRONISE, gélule


200 mg


capsule


oral use




FR - France







Laboratoires FOURNIER SA




28, boulevard Clémenceau




21000 Dijon




France






FENOFIBRATE FOURNIER 300 mg, gélule


300 mg


capsule


oral use




FR - France







Laboratoires FOURNIER SA




28, boulevard Clémenceau




21000 Dijon




France






FENOFIBRATE FOURNIER 67 MICRONISE, gélule


67 mg


capsule


oral use




FR - France







SANDOZ




49, avenue Georges Pompidou




92300 Levallois-Perret




FRANCE






FENOFIBRATE G GAM 200 mg, gélule


200 mg


capsule


oral use




FR - France







SANDOZ




49, avenue Georges Pompidou




92300 Levallois-Perret




France






FENOFIBRATE G GAM 67 mg, gélule


67 mg


capsule


oral use




FR - France







GALENIX DEVELOPPEMENT




Les Palanques




33127 Saint Jean d’Illac




France






FENOFIBRATE GALENIX 160 mg, comprimé pelliculé


160 mg


film-coated tablet


oral use




FR - France







TEVA SANTE




Le Palatin 1




1 cours du Triangle




92936 Paris la Défense Cedex




FRANCE






FENOFIBRATE IVAX 100 mg, gélule


100 mg


capsule


oral use




FR - France







TEVA SANTE




Le Palatin 1




1 cours du Triangle




92936 Paris la Défense Cedex




France






FENOFIBRATE IVAX 200 mg, gélule


200 mg


capsule


oral use




FR - France







TEVA SANTE




Le Palatin 1




1 cours du Triangle




92936 Paris la Défense Cedex




France






FENOFIBRATE IVAX 300 mg, gélule


300 mg


capsule


oral use




FR - France







TEVA SANTE




Le Palatin 1




1 cours du Triangle




92936 Paris la Défense Cedex




France






FENOFIBRATE IVAX 67 mg, gélule


67 mg


capsule


oral use




FR - France







CLL PHARMA




Nice Premier - Arénas




455, Promenade des Anglais




06299 Nice Cedex 03




France






FENOFIBRATE MILGEN 200 mg, gélule


200 mg


capsule


oral use




FR - France







CLL PHARMA




Nice Premier - Arénas




455, Promenade des Anglais




06299 Nice Cedex 03




France






FENOFIBRATE MILGEN 67 mg, gélule


67 mg


capsule


oral use




FR - France







MYLAN SAS




117, allée des Parcs




69800 Saint-Priest




FRANCE






FENOFIBRATE MYLAN 100 mg, gélule


100,00 mg


capsule


oral use




FR - France







MYLAN SAS




117, allée des Parcs




69800 Saint-Priest




France






FENOFIBRATE MYLAN 160 mg, comprimé pelliculé


160 mg


film-coated tablet


oral use




FR - France







MYLAN SAS




117, allée des Parcs




69800 Saint-Priest




France






FENOFIBRATE MYLAN 200 mg, gélule


200 mg


capsule


oral use




FR - France







MYLAN SAS




117, allée des Parcs




69800 Saint-Priest




France






FENOFIBRATE MYLAN 300 mg, gélule


300,00 mg


capsule


oral use




FR - France







MYLAN SAS




117, allée des Parcs




69800 Saint-Priest




France






FENOFIBRATE MYLAN 67 mg, gélule


67 mg


capsule


oral use




FR - France







QUALIMED




117, allée des Parcs




69800 Saint-Priest




FRANCE






FENOFIBRATE QUALIMED 160 mg, comprimé pelliculé


160 mg


film-coated tablet


oral use




FR - France







QUALIMED




117, allée des Parcs




69800 Saint-Priest




France






FENOFIBRATE QUALIMED 200 mg, gélule


200 mg


capsule


oral use




FR - France







QUALIMED




117, allée des Parcs




69800 Saint-Priest




France






FENOFIBRATE QUALIMED 67 mg, gélule


67 mg


capsule


oral use




FR - France







RANBAXY PHARMACIE GENERIQUES




11-15 Quai Dion Bouton




92800 Puteaux




FRANCE






FENOFIBRATE RANBAXY 160 mg, comprimé


160 mg


tablet


oral use




FR - France







RANBAXY PHARMACIE GENERIQUES




11-15 Quai Dion Bouton




92800 Puteaux




France






FENOFIBRATE RANBAXY 200 mg, gélule


200 mg


capsule


oral use




FR - France







RANBAXY PHARMACIE GENERIQUES




11-15 Quai Dion Bouton




92800 Puteaux




France






FENOFIBRATE RANBAXY 300 mg, gélule


300 mg


capsule


oral use




FR - France







Laboratoire RATIOPHARM




19, boulevard Paul Vaillant Couturier




94200 Ivry sur Seine




FRANCE






FENOFIBRATE RATIOPHARM 160 mg, comprimé


160 mg


tablet


oral use




FR - France







Laboratoires FOURNIER SA




28, boulevard Clémenceau




21000 Dijon




France






FENOFIBRATE RATIOPHARM 200 mg, gélule


200 mg


capsule


oral use




FR - France







Laboratoire RATIOPHARM




19, boulevard Paul Vaillant Couturier




94200 Ivry sur Seine




France






FENOFIBRATE RATIOPHARM 300 mg, gélule


300 mg


capsule


oral use




FR - France







Laboratoires FOURNIER SA




28, boulevard Clémenceau




21000 Dijon




France






FENOFIBRATE RATIOPHARM 67 mg, gélule


67 mg


capsule


oral use




FR - France







RANBAXY PHARMACIE GENERIQUES




11-15 Quai Dion Bouton




92800 Puteaux




FRANCE






FENOFIBRATE RPG 100 mg, gélule


100,00 mg


capsule


oral use




FR - France







RANBAXY PHARMACIE GENERIQUES




11-15 Quai Dion Bouton




92800 Puteaux




FRANCE






FENOFIBRATE RPG 160 mg, comprimé pelliculé


160 mg


film-coated tablet


oral use




FR - France







Laboratoires FOURNIER SA




28, boulevard Clémenceau




21000 Dijon




France






FENOFIBRATE RPG 200 mg, gélule


200 mg


capsule


oral use




FR - France







Laboratoires FOURNIER SA




28, boulevard Clémenceau




21000 Dijon




France






FENOFIBRATE RPG 67 mg, gélule


67 mg


capsule


oral use




FR - France







SANDOZ




49, avenue Georges Pompidou




92300 Levallois-Perret




FRANCE






FENOFIBRATE SANDOZ 100 mg, gélule


100 mg


capsule


oral use




FR - France







SANDOZ




49, avenue Georges Pompidou




92300 Levallois-Perret




France






FENOFIBRATE SANDOZ 160 mg, comprimé


160 mg


tablet


oral use




FR - France







SANDOZ




49, avenue Georges Pompidou




92300 Levallois-Perret




France






FENOFIBRATE SANDOZ 200 mg, gélule


200 mg


capsule


oral use




FR - France







SANDOZ




49, avenue Georges Pompidou




92300 Levallois-Perret




France






FENOFIBRATE SANDOZ 300 mg, gélule


300 mg


capsule


oral use




FR - France







SANDOZ




49, avenue Georges Pompidou




92300 Levallois-Perret




France






FENOFIBRATE SANDOZ 67 mg, gélule


67 mg


capsule


oral use




FR - France







TEVA SANTE




Le Palatin 1




1 cours du Triangle




92936 Paris la Défense Cedex




France






FENOFIBRATE TEVA 100 mg, gélule


100,00 mg


capsule


oral use




FR - France







TEVA SANTE




Le Palatin 1




1 cours du Triangle




92936 Paris la Défense Cedex




France






FENOFIBRATE TEVA 160 mg, comprimé


160 mg


tablet


oral use




FR - France







TEVA SANTE




Le Palatin 1




1 cours du Triangle




92936 Paris la Défense Cedex




France






FENOFIBRATE TEVA 200 mg, gélule


200 mg


capsule


oral use




FR - France







TEVA SANTE




Le Palatin 1




1 cours du Triangle




92936 Paris la Défense Cedex




FRANCE






FENOFIBRATE TEVA 300 mg, gélule


300,00 mg


capsule


oral use




FR - France







TEVA SANTE




Le Palatin 1




1 cours du Triangle




92936 Paris la Défense Cedex




France






FENOFIBRATE TEVA 67 mg, gélule


67 mg


capsule


oral use




FR - France







SANOFI AVENTIS France




1-13, boulevard Romain Rolland




75014 Paris




France






FENOFIBRATE WINTHROP 160 mg, comprimé pelliculé


160 mg


film-coated tablet


oral use




FR - France







SANOFI AVENTIS France




1-13, boulevard Romain Rolland




75014 Paris




France






FENOFIBRATE WINTHROP 200 mg, gélule


200 mg


capsule


oral use




FR - France







SANOFI AVENTIS France




1-13, boulevard Romain Rolland




75014 Paris




France






FENOFIBRATE WINTHROP 67 mg, gélule


67 mg


capsule


oral use




FR - France







WYVERN MEDICAL LTD




Sterling House - 3A New Street




Ledbury




HR8 2DX Herefordshire




UNITED KINGDOM






FENOFIBRATE WYVERN 200 mg, gélule


200 mg


capsule


oral use




FR - France







WYVERN MEWYVERN MEDICAL LTD




Sterling House - 3A New Street




Ledbury




HR8 2DX Herefordshire




UNITED KINGDOM






FENOFIBRATE WYVERN 67 mg, gélule


67 mg


capsule


oral use




FR - France







WYVERN MEDICAL LTD




Sterling House - 3A New Street




Ledbury




HR8 2DX Herefordshire




UNITED KINGDOM






FENOFIBRATE WYVERN MEDICAL 160 mg, comprimé pelliculé


160,0 mg


film-coated tablet


oral use




FR - France







WYVERN MEDICAL LTD




Sterling House - 3A New Street




Ledbury




HR8 2DX Herefordshire




UNITED KINGDOM






FENOFIBRATE WYVERN MEDICAL 200 mg, gélule


200 mg


capsule


oral use




FR - France







WYVERN MEDICAL LTD




Sterling House - 3A New Street




Ledbury




HR8 2DX Herefordshire




UNITED KINGDOM






FENOFIBRATE WYVERN MEDICAL 67 mg, gélule


67 mg


capsule


oral use




FR - France







ZYDUS France




25, rue des Peupliers




ZAC Les Hautes Pâtures - Parc d’Activités des Peupliers




92000 Nanterre




FRANCE






FENOFIBRATE ZYDUS 160 mg, comprimé


160 mg


tablet


oral use




FR - France







ZYDUS France




25, rue des Peupliers




ZAC Les Hautes Pâtures - Parc d’Activités des Peupliers




92000 Nanterre




France






FENOFIBRATE ZYDUS 200 mg, gélule


200 mg


capsule


oral use




FR - France







ZYDUS France




25, rue des Peupliers




ZAC Les Hautes Pâtures - Parc d’Activités des Peupliers




92000 Nanterre




France






FENOFIBRATE ZYDUS 300 mg, gélule


300 mg


capsule


oral use




FR - France







ZYDUS France




25, rue des Peupliers




ZAC Les Hautes Pâtures - Parc d’Activités des Peupliers




92000 Nanterre




France






FENOFIBRATE ZYDUS 67 mg, gélule


67 mg


capsule


oral use




FR - France







SANOFI AVENTIS FRANCE




1-13, boulevard Romain Rolland




75014 Paris




FRANCE






FENOFIBRATE WINTHROP 145 mg, comprimé


145 mg


tablet


oral use




FR - France







QUALIMED




117, allée des Parcs




69800 Saint-Priest




FRANCE






FENOFIBRATE QUALIMED 145 mg, comprimé


145 mg


tablet


oral use




FR - France







LABORATOIRE RATIOPHARM




19, boulevard Paul Vaillant Couturier




94200 Ivry sur Seine




FRANCE






FENOFIBRATE RATIOPHARM 145 mg, comprimé


145 mg


tablet


oral use




FR - France







Laboratoires FOURNIER SA




28, boulevard Clémenceau




21000 Dijon




France






FENOX 100 mg, gélule


100 mg


capsule


oral use




FR - France







Laboratoires FOURNIER SA




28, boulevard Clémenceau




21000 Dijon




France






FENOX 300 mg, gélule


300 mg


capsule


oral use




FR - France







SANDOZ




49, avenue Georges Pompidou




92300 Levallois-Perret




FRANCE






FENOFIBRATE SANDOZ 145 mg, comprimé


145 mg


tablet


oral use




FR - France







GALENIX DEVELOPPEMENT




Les Palanques




33127 Saint Jean d’Illac




France






GENOTHYL 160 mg, comprimé pelliculé


160 mg


film-coated tablet


oral use




FR - France







Laboratoires FOURNIER SA




28, boulevard Clémenceau




21000 Dijon




France






LIPANTHYL 140 MICRONISE, gélule


140 mg


capsule


oral use




FR - France







Laboratoires FOURNIER SA




28, boulevard Clémenceau




21000 Dijon




France






LIPANTHYL 145 mg, comprimé pelliculé


145 mg


film-coated tablet


oral use




FR - France







Laboratoires FOURNIER SA




28, boulevard Clémenceau




21000 Dijon




France






LIPANTHYL 160 mg, comprimé pelliculé


160 mg


film-coated tablet


oral use




FR - France







Laboratoires FOURNIER SA




28, boulevard Clémenceau




21000 Dijon




France






LIPANTHYL 200 micronisé, gélule


200 mg


capsule


oral use




FR - France







Laboratoires FOURNIER SA




28, boulevard Clémenceau




21000 Dijon




France






LIPANTHYL 67 Micronisé, gélule


67 mg


capsule


oral use




FR - France







BIOGARAN




15, boulevard Charles de Gaulle




92700 Colombes




FRANCE






FENOFIBRATE BIOGARAN 145 mg, comprimé


145 mg


tablet


oral use




FR - France







ETHYPHARM




194, Bureaux de la Colline




Bâtiment D




92213 Saint-Cloud Cedex




France






LIPILFEN 160 mg, comprimé


160 mg


tablet


oral use




FR - France







MYLAN SAS




117, allée des Parcs




69800 Saint-Priest




FRANCE






FENOFIBRATE MYLAN 145 mg, comprimé


145 mg


tablet


oral use




FR - France







SANOFI AVENTIS FRANCE




1-13, boulevard Romain Rolland




75014 Paris




FRANCE






FENOFIBRATE WINTHROP 160 mg, comprimé


160 mg


tablet


oral use




FR - France







ETHYPHARM




194, Bureaux de la Colline




Bâtiment D




92213 Saint-Cloud Cedex




France






LIPIPHARM 145 mg, comprimé


145 mg


tablet


oral use




FR - France







SANOFI AVENTIS France




1-13, boulevard Romain Rolland




75014 Paris




France






LIPIREX 200 mg, gélule


200 mg


capsule


oral use




FR - France







SANOFI AVENTIS France




1-13, boulevard Romain Rolland




75014 Paris




France






LIPIREX 67 mg, gélule


67 mg


capsule


oral use




FR - France







BOUCHARA RECORDATI




68, rue Marjolin




BP 67




92302 Levallois-Perret Cedex




FRANCE






LIVESAN 200 mg, gélule


200 mg


capsule


oral use




FR - France







BOUCHARA RECORDATI




68, rue Marjolin




BP 67




92302 Levallois-Perret Cedex




France






LIVESAN 67 mg, gélule


67 mg


capsule


oral use




FR - France







Laboratoires FOURNIER SA




28, boulevard Clémenceau




21000 Dijon




France






PANLIPAL 145 mg, comprimé pelliculé


145 mg


film-coated tablet


oral use




FR - France







Laboratoires FOURNIER SA




28, boulevard Clémenceau




21000 Dijon




France






SECALIP 100 mg, gélule


100 mg


capsule


oral use




FR - France







Laboratoires FOURNIER SA




28, boulevard Clémenceau




21000 Dijon




France






SECALIP 200 mg, gélule


200 mg


capsule


oral use




FR - France







Laboratoires FOURNIER SA




28, boulevard Clémenceau




21000 Dijon




France






SECALIP 300 mg, gélule


300 mg


capsule


oral use




FR - France







Laboratoires FOURNIER SA




28, boulevard Clémenceau




21000 Dijon




France






SECALIP 67 mg, gélule


67 mg


capsule


oral use




FR - France







SUBSTIPHARM




8, rue Bellini




75116 Paris




FRANCE






SUBSTICHOL 160 mg, comprimé pelliculé


160 mg


film-coated tablet


oral use




FR - France







WYVERN MEDICAL LTD




Sterling House - 3A New Street




Ledbury




HR8 2DX Herefordshire




United Kingdom






WYVEBRATE 160 mg, comprimé pelliculé


160,0 mg


film-coated tablet


oral use




HU - Hungary







PharmaSwiss Magyarország Kft.




Zichy G. u. 5 fszt/1




1146 Budapest




Hungary






Fenobrat


250 mg


prolonged-release capsule


oral




HU - Hungary







PharmaSwiss Magyarország Kft.




Zichy G. u. 5 fszt/1




1146 Budapest




Hungary






Fenoswiss


160 mg


hard capsule


oral




HU - Hungary







Laboratoires Fournier SA




8 Bd Clemenceau




F-21000 Dijon




France






Lipidil Supra


160 mg


film-coated tablet


oral




HU - Hungary







Laboratoires Fournier SA




8 Bd Clemenceau




F-21000 Dijon




France






Lipidil Supra


215 mg


film-coated tablet


oral




HU - Hungary







Laboratoires Fournier SA




8 Bd Clemenceau




F-21000 Dijon




France






Lipanthyl NT


145 mg


film-coated tablet


oral




HU - Hungary







Laboratoires Fournier SA




8 Bd Clemenceau




F-21000 Dijon




France






Lipidil


267 mg


hard capsule


oral




IE - Ireland







Solvay Healthcare Limited




Mansbridge Road




West End




Southampton




SO18 3JD




United Kingdom






Lipantil Micro 67 mg capsules, hard


67 mg


hard capsules


oral use




IE - Ireland







Solvay Healthcare Limited




Mansbridge Road




West End




Southampton




SO18 3JD




United Kingdom






Lipantil Micro 200 mg capsules, hard


200 mg


hard capsules


oral use




IE - Ireland







Solvay Healthcare Limited




Mansbridge Road




West End




Southampton




SO18 3JD




United Kingdom






Lipantil Micro 267 mg capsules, hard


267 mg


hard capsules


oral use




IE - Ireland







Solvay Healthcare Limited




Mansbridge Road




West End




Southampton




SO18 3JD




United Kingdom






Lipantil Supra 145mg film-coated tablets


145 mg


film-coated tablets


oral use




IE - Ireland







Solvay Healthcare Limited




Mansbridge Road




West End




Southampton




SO18 3JD




United Kingdom






Lipantil Supra 160mg film-coated tablets


160 mg


film-coated tablets


oral use




IE - Ireland







Solvay Healthcare Limited




Mansbridge Road




West End




Southampton




SO18 3JD




United Kingdom






Lipantil Supra 215 mg film-coated tablets


215 mg


film-coated tablets


oral use




IT - Italy







Farmaceutici Caber Spa Viale Città D'Europa, 681 00100 ROMA




Italy






Lipsin


200 mg


Capsule


Oral




IT - Italy







Solvay Pharma Spa




Via della Libertà 30




100 95 Grugliasco




Italy






Fulcro


200 mg


Capsule


Oral




IT - Italy







Francia Farmaceutici Industria Farmaco Biologica Srl




Via dei Pestagalli, 7




20138 MILANO




Italy






Tilene


100 mg


Capsule


Oral




IT - Italy







Salus Researches Spa




Via Aurelia, 58




00165 ROMA




Italy






Nolipax


100 mg


Capsule


Oral




IT - Italy







Teofarma Srl Via Fratelli Cervi, 8 - Valle Salimbene 27010 Pavia




Italy






Lipofene


100 mg


Capsule


Oral




IT - Italy







Winthrop Pharmaceuticals Italia Srl Viale Bodio, 37/B 20158 MILANO




Italy






Fenofibrato Winthrop


200 mg


Capsule


Oral




IT - Italy







Solvay Pharma Spa




Via della Libertà 30




100 95 Grugliasco




Italy






Fulcrosupra


145 mg


Film-coated tablet


Oral




IT - Italy







Solvay Pharma Spa




Via della Libertà 30




100 95 Grugliasco




Italy






Fulcrosupra


160 mg


Film-coated tablet


Oral




IT - Italy







Solvay Pharma Spa




Via della Libertà 30




100 95 Grugliasco




Italy






Fenolibs


145 mg


Film-coated tablet


Oral




IT - Italy







Solvay Pharma Spa




Via della Libertà 30




100 95 Grugliasco




Italy






Liperial


145 mg


Film-coated tablet


Oral




LT - Lithuania







UAB PharmaSwiss




Šeimyniškių 21B




LT-09200 Vilnius




Lithuania






Fenolip


160 mg


capsule, hard


oral use




LT - Lithuania







Laboratoires Fournier S. A.




28 Boulevard Clemenceau




21000 Dijon




France






Lipanthyl 200 M


200 mg


capsule, hard


oral use




LU - Luxembourg







Leurquin Mediolanum Lab.




68-88, rue Ampere




(Z.I. Chanaux)




93330 Neuilly-sur-Seine




France






Fegenor


67 mg


capsule, hard


oral




LU - Luxembourg







Leurquin Mediolanum Lab.




68-88, rue Ampere




(Z.I. Chanaux)




93330 Neuilly-sur-Seine




France






Fegenor


200 mg


capsule, hard


oral




LU - Luxembourg







S.M.B.




26-28, rue de la Pastorale




B- 1080 Bruxelles




Belgium






Fenogal-200


200 mg


capsule, hard


oral




LU - Luxembourg







S.M.B.




26-28, rue de la Pastorale




B- 1080 Bruxelles




Belgium






Fenogal-267


267 mg


capsule, hard


oral




LU - Luxembourg







Eurogenerics SA




Esplanade Heysel, B22




B- 1020 Bruxelles




Belgium






Fenofibrate EG


67 mg


capsule, hard


oral




LU - Luxembourg







Solvay Pharma S.A.




Avenue du Brg. E. Demunter 3




B- 1090 Bruxelles




Belgium






Lipanthyl 67 Micronised


67 mg


capsule, hard


oral




LU - Luxembourg







Solvay Pharma S.A.




Avenue du Brg. E. Demunter 3




B- 1090 Bruxelles




Belgium






Lipanthyl 200 Micronised


200 mg


capsule, hard


oral




LU - Luxembourg







Solvay Pharma S.A.




Avenue du Brg. E. Demunter 3




B- 1090 Bruxelles




Belgium






Lipanthyl 267 Micronised


267 mg


capsule, hard


oral




LU - Luxembourg







Solvay Pharma S.A.




Avenue du Brg. E. Demunter 3




B- 1090 Bruxelles




Belgium






Lipanthyl Supra


160 mg


film-coated tablet


oral




LU - Luxembourg







Solvay Pharma S.A.




Avenue du Brg. E. Demunter 3




B- 1090 Bruxelles




Belgium






Lipanthyl Supra


215 mg


film-coated tablet


oral




LU - Luxembourg







Solvay Pharma S.A.




Avenue du Brg. E. Demunter 3




B- 1090 Bruxelles




Belgium






Lipanthyl Nano


145 mg


film-coated tablet


oral




LU - Luxembourg







Solvay Pharma S.A.




Avenue du Brg. E. Demunter 3




B- 1090 Bruxelles




Belgium






Liperial


145 mg


film-coated tablet


oral




LV - Latvia







SIA PharmaSwiss Latvia




Gertrudes iela 54-5




Riga, LV-1011




Latvia






Fenolip 160 mg hard capsules


160 mg


Capsules, hard


Oral use




LV - Latvia







Laboratoires Fournier S.A.




Boulevard Clemenceau 28




21000 Dijon




France






Lipanthyl 200 mg hard capsules


200 mg


Capsules, hard


Oral use




PL - Poland







Apotex Europe B.V.




Darwinweg 20




Leiden 2333 CR




Netherlands






Apo-Feno 100


100 mg


capsules


oral




PL - Poland







Apotex Europe B.V.




Darwinweg 20




Leiden




2333 CR




Netherlands






Apo-Feno 200M


200 mg


capsules, hard


oral




PL - Poland







VEDIM Sp. z o.o.




8 Kruczkowskiego St.,




00-308 Warsaw




Poland






Fenardin


267 mg


capsules, hard


oral




PL - Poland







VEDIM Sp. z o.o.




8 Kruczkowskiego st.




00-308 Warsaw




Poland






Fenardin


160 mg


capsules, hard


oral




PL - Poland







ratiopharm GmbH




Graf-Arco-Strasse 3, Ulm,




D-89079




Germany






Fenoratio 100


100 mg


capsules


oral




PL - Poland







ratiopharm GmbH




Graf-Arco-Strasse 3




89079 Ulm




Germany






Fenoratio Retard


250 mg


Prolonged-release capsules


oral




PL - Poland







Grodziskie Zakłady Farmaceutyczne „Polfa” Sp. z o.o.




5 ks. J. Poniatowskiego St.




05-825 Grodzisk Mazowiecki




Poland






Grofibrat


100 mg


capsules


oral




PL - Poland







Grodziskie Zakłady Farmaceutyczne „Polfa” Sp. z o.o.




5 ks. J. Poniatowskiego St.,




05-825 Grodzisk Mazowiecki




Poland






Grofibrat 200


200 mg


capsules


oral




PL - Poland







Laboratoires Fournier S.A.




Bd Clemenceau 28




Dijon, F-21000




France






Lipanthyl


100 mg


capsules


oral




PL - Poland







Laboratoires Fournier S.A.




Bd Clemenceau 28




Dijon, F-21000




France






Lipanthyl 200M


200 mg


capsules


oral




PL - Poland







Laboratoires Fournier S.A.




Bd Clemenceau 28




Dijon, F-21000




France






Lipanthyl 267M


267 mg


capsules


oral




PL - Poland







Laboratoires Fournier S.A.




Bd Clemenceau 28




Dijon, F-21000




France






Lipanthyl NT 145


145 mg


film-coated tablets


oral




PL - Poland







Laboratoires Fournier S.A.




Bd Clemenceau 28




Dijon, F-21000




France






Lipanthyl Supra 160


160 mg


film-coated tablets


oral




PL - Poland







Laboratoires Fournier S.A.




Bd Clemenceau 28




Dijon, F-21000




France






Lipanthyl Supra 215 mg


215 mg


film-coated tablets


oral




PL - Poland







Laboratoires Fournier S.A.




Bd Clemenceau 28




Dijon, F-21000




France






Xafenor 145


145 mg


film-coated tablets


Oral




PT - Portugal







Abbot II Products, Lda. Empreendimento Lagoas Park. Edifício 5C - 6o





2740-298 Porto Salvo




Portugal






Catalip


200 mg


capsule


Oral




PT - Portugal







Laboratórios Vitória, S.A.




Rua Elias Garcia, 28 - Venda Nova




2700-327 Amadora




Portugal






Lipofen


100 mg


capsule


Oral




PT - Portugal







Abbot II Products, Lda. Empreendimento Lagoas Park. Edifício 5C - 6o





2740-298 Porto Salvo




Portugal






Supralip 160 mg


160 mg


modified released tablet


Oral




PT - Portugal







Solvay Farma, Lda. Empreendimento Lagoas Park. Edifício 5C - 6o





2740-298 Porto Salvo




Portugal






Apteor


160 mg


modified released tablet


Oral




PT - Portugal







Solvay Farma, Lda.




Empreendimento Lagoas Park. Edifício 5C - 6o





2740-298 Porto Salvo




Portugal






Catalip 267 Micronizado


267 mg


capsule


Oral




PT - Portugal







Winthrop Farmacêutica Portugal, Lda. Empreendimento Lagoas Park, Edifício 7 - 2o/3o





2740-264 Porto Salvo




Portugal






Fenofibrato Winthrop 200 mg Cápsulas


200 mg


capsule


Oral




PT - Portugal







Alpharma ApS




Rua Virgílio Correia, 11 – A




1600-219 Lisboa




Portugal






Fenofibrato Alpharma 200 mg Cápsulas


200 mg


capsule


Oral




PT - Portugal







Solvay Farma, Lda. Empreendimento Lagoas Park. Edifício 5C - 6o





2740-298 Porto Salvo




Portugal






Supralip 145 mg


145 mg


Filmcoated tablet


Oral




PT - Portugal







Solvay Farma




Lda. Empreendimento Lagoas Park. Edifício 5C - 6o





2740-298 Porto Salvo




Portugal






Lipanthyl 145 mg


145 mg


Filmcoated tablet


Oral




PT - Portugal







Solvay Farma




Lda. Empreendimento Lagoas Park Edifício 5C - 6o





2740-298 Porto Salvo




Portugal






Apteor 145 mg


145 mg


Filmcoated tablet


Oral




PT - Portugal







Winthrop Farmacêutica Portugal




Lda. Empreendimento Lagoas Park




Edifício 7 - 2o/3o





2740-264 Porto Salvo




Portugal






Fenofibrato Winthrop 267 mg Cápsulas


267 mg


capsule


Oral




RO - Romania







LABORATOIRES FOURNIER S.A.




28 Bd. Clemenceau




21000 Dijon




France






LIPANTHYL® 100


100 mg


capsule


oral use




RO - Romania







LABORATOIRES FOURNIER S.A.




28 Bd. Clemenceau




21000 Dijon




France






FENOX 160 mg


160 mg


modified-release film-coated tablets


oral use




RO - Romania







S.C. VIM SPECTRUM S.R.L.,




Șoseaua Sighișoarei, Nr. 409, Corunca, jud Mureș




Romania






LIPIVIM


200 mg


capsules (with micronised powder)


oral use




RO - Romania







LABORATOIRES FOURNIER S.A. 28, Bd. Clemenceau




21000 Dijon




France






LIPANTHYL 67 M capsule


67 mg


capsules


oral use




RO - Romania







LABORATOIRES FOURNIER S.A. 28, Bd. Clemenceau




21000 Dijon




France






LIPANTHYL 267 M capsule


267 mg


capsules


oral use




RO - Romania







S.C. TERAPIA S.A.




Str. Fabricii Nr. 124,




Cluj-Napoca




România






LIPOFIB 160 mg


160 mg


capsules


oral use




RO - Romania







S.C. TERAPIA S.A.




Str. Fabricii Nr. 124




Cluj-Napoca




România






LIPOFIB 200 mg


200 mg


capsules


oral use




RO - Romania







LABORATOIRES FOURNIER S.A.




28 Bd. Clemenceau




21000 Dijon




France






LIPANTHYL PENTA 145 mg


145 mg


film-coated tablets


oral use




RO - Romania







LABORATOIRES FOURNIER S.A.




28 Bd. Clemenceau




21000 Dijon,




France






TRICOR 145 mg


145 mg


film-coated tablets


oral use




RO - Romania







S.C. TERAPIA S.A.




Str. Fabricii Nr. 124




Cluj-Napoca




Romania






LIPOFIB 67 mg


67 mg


capsules


oral use




RO - Romania







S.C. TERAPIA S.A.




Str. Fabricii Nr. 124




Cluj-Napoca




Romania






FENOFIBRAT TERAPIA 200 mg


200 mg


capsules


oral use




RO - Romania







S.C. TERAPIA S.A.




Str. Fabricii Nr. 124




Cluj-Napoca




Romania






LIPOFIB 267 mg


267 mg


capsules


oral use




RO - Romania







S. C. LABORMED PHARMA S. A.




Splaiul Independenței nr. 319 E




Sector 6




București




Romania






FENOFIBRAT LPH 200 mg


200 mg


capsules (micronised powder)


oral use




RO - Romania







S.C. TERAPIA S.A.




Str. Fabricii Nr. 124




Cluj-Napoca




Romania






FENOFIBRAT TERAPIA 160 mg


160 mg


film-coated tablets


oral use




RO - Romania







LABORATOIRES FOURNIER S.A.




28 Bd. Clémenceau




21 000 Dijon




France






LIPANTHYL SUPRA 160 mg


160 mg


modified-release film-coated tablets


oral use




RO - Romania







LABORATOIRES FOURNIER S.A.




28 Bd. Clémenceau




21 000 Dijon




France






LIPANTIL NANO 145 mg


145 mg


film-coated tablets


oral use




RO - Romania







LABORATOIRES FOURNIER S.A.




28 Bd. Clémenceau




21 000 Dijon




France






Lipanthyl 200 M


200 mg


capsules


oral use




SE - Sweden







Laboratoires Fournier SA




28 boulevard Clèmenceau




BP 27912 21079 DIJON Cedex




France






Lipanthyl®


67 mg


hard capsule


oral




SE - Sweden







Laboratoires Fournier SA




28 boulevard Clèmenceau




BP 27912 21079 DIJON Cedex




France






Lipanthyl®


200 mg


hard capsule


oral




SE - Sweden







Laboratoires Fournier SA




28 boulevard Clèmenceau




BP 27912 21079 DIJON Cedex




France






Lipanthyl®


267 mg


hard capsule


oral




SI - Slovenia







Laboratoires Fournier S.A.




28 boulevard Clemenceau




Dijon




France






Katalip 250 mg trde kapsule


250 mg


capsule, hard


oral use




SK - Slovakia







Zentiva a.s.




Nitrianska 100




920 27 Hlohovec




Slovakia






Febira 200


200 mg


Capsule


Oral




SK - Slovakia







Archie Samuel s.r.o.




Slunná 271/16




61700 Brno 17




Czech Republic






Fenofibrate - AS 267 mg


267 mg


Capsule, hard


Oral




SK - Slovakia







IVAX Pharmaceuticals s.r.o.




Ostravská 29




747 70 Opava-Komárov




Czech Republic






Fenofix 200


200 mg


Capsule


Oral




SK - Slovakia







LABORATOIRES S.M.B. S.A.




26-28 rue de la Pastorale




B-1080 Bruxelles




Belgium






Fenolip


160 mg


Capsule, hard


Oral




SK - Slovakia







Laboratoires FOURNIER S.A.




28Bd Clemenceau




21000 Dijon




France






LIPANTHYL 200 M


200 mg


Capsule, hard


Oral




SK - Slovakia







Laboratoires FOURNIER S.A.




28Bd Clemenceau




21000 Dijon




France






LIPANTHYL 267 M


267 mg


Capsule, hard


Oral




SK - Slovakia







Laboratoires FOURNIER S.A.




28Bd Clemenceau




21000 Dijon




France






LIPANTHYL NT 145 mg


145 mg


Film coated tablet


Oral




SK - Slovakia







Laboratoires FOURNIER S.A.




28Bd Clemenceau




21000 Dijon




France






LIPANTHYL SUPRA 160 mg


160 mg


Film coated tablet


Oral




SK - Slovakia







Laboratoires FOURNIER S.A. 28Bd Clemenceau 21000 Dijon




France






LIPANTHYL SUPRA 215 mg


215 mg


Film coated tablet


Oral




SK - Slovakia







PharmaSwiss Ćeská republika s.r.o. Jankovcova 1569/2c




170 00 Prague




Czech Republic






SUPRELIP


200 mg


Capsule, hard


Oral




UK - United Kingdom







ACTAVIS UK LIMITED




WHIDDON VALLEY




BARNSTAPLE




DEVON EX32 8NS




United Kingdom






FENOFIBRATE 67MG CAPSULES


67 mg


CAPSULE, HARD


oral use




UK - United Kingdom







ACTAVIS UK LIMITED




WHIDDON VALLEY




BARNSTAPLE




DEVON EX32 8NS




United Kingdom






FENOFIBRATE 200MG CAPSULES


200 mg


CAPSULE, HARD


oral use




UK - United Kingdom







ETHYPHARM




17/21 Rue Saint Matthieu




Houdan, F-78550




FRANCE






FENOFIBRATE 200MG CAPSULES


200 mg


CAPSULE, HARD


oral use




UK - United Kingdom







Genus Pharmaceuticals Limited




Park View House




65 London Road




NEWBURY, BERKS RG14 1JN




United Kingdom






FENOGAL 200MG CAPSULES


200 mg


CAPSULE


oral use




UK - United Kingdom







Pliva Pharma Limited




Vision House




Bedford Road




PETERSFIELD, HANTSGU32 3QB




United Kingdom






FENOFIBRATE MICRO 267MG CAPSULES


267 mg


CAPSULE, HARD


oral use




UK - United Kingdom







Ranbaxy (Uk) Limited




Cp House




97-107 Uxbridge Road




EALING, LONDON W5 5TL




United Kingdom






FENOFIBRATE 67MG CAPSULES


67 mg


CAPSULE, HARD


oral use




UK - United Kingdom







Ranbaxy (Uk) Limited




Cp House




97-107 Uxbridge Road




EALING, LONDON W5 5TL




United Kingdom






FENOFIBRATE 200MG CAPSULES


200 mg


CAPSULE, HARD


oral use




UK - United Kingdom







Ranbaxy (Uk) Limited




Cp House




97-107 Uxbridge Road




EALING, LONDON W5 5TL




United Kingdom






FENOFIBRATE 267MG CAPSULES


267 mg


CAPSULE, HARD


oral use




UK - United Kingdom







Ranbaxy (Uk) Limited




Cp House




97-107 Uxbridge Road




EALING, LONDON W5 5TL




United Kingdom






FENOFIBRATE 67MG CAPSULES


67 mg


CAPSULE, HARD


oral use




UK - United Kingdom







Ranbaxy (Uk) Limited




Cp House




97-107 Uxbridge Road




EALING, LONDON W5 5TL




United Kingdom






FENOFIBRATE 200MG CAPSULES


200 mg


CAPSULE, HARD


oral use




UK - United Kingdom







Ranbaxy (Uk) Limited




Cp House




97-107 Uxbridge Road




EALING, LONDON W5 5TL




United Kingdom






FENOFIBRATE 267MG CAPSULES


267 mg


CAPSULE, HARD


oral use




UK - United Kingdom







Solvay Healthcare Limited




Mansbridge Road, West End, SOUTHAMPTON SO18 3JD




United Kingdom






LIPANTIL MICRO 67


67 mg


CAPSULE


oral use




UK - United Kingdom







Solvay Healthcare Limited




Mansbridge Road, West End, SOUTHAMPTON SO18 3JD




United Kingdom






SUPRALIP 160 FILM-COATED TABLETS


160 mg


FILM-COATED TABLET


oral use




UK - United Kingdom







Solvay Healthcare Limited




Mansbridge Road, West End, SOUTHAMPTON SO18 3JD




United Kingdom






LIPANTIL MICRO 200


200 mg


CAPSULE


oral use




UK - United Kingdom







Solvay Healthcare Limited




Mansbridge Road, West End, SOUTHAMPTON SO18 3JD




United Kingdom






LIPANTIL® MICRO 267


267 mg


CAPSULE


oral use




UK - United Kingdom







TILLOMED LABORATORIES LIMITED




3 Howard Road, Eaton Socon




St. Neots, Cambridgeshire




PE19 8ET




United Kingdom






FENOFIBRATE 200MG CAPSULES


200 mg


CAPSULE, HARD


oral use




UK - United Kingdom







WINTHROP




Pharmaceuticals Uk Limited




One Onslow Street




Guildford, Surrey GU1 4YS




United Kingdom






FENOFIBRATE 267MG CAPSULES


267 mg


CAPSULE, HARD


oral use








Bezafibrate 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







Arcana Arzneimittel GmbH




Hütteldorfer Straße 299




A-1140 Wien




Austria






Bezafibrat „Arcana“ retard 400 mg - Filmtabletten


400 mg


film-coated tablet


oral




AT - Austria







Genericon Pharma GmbH




Hafnerstraße 211




A-8054 Graz




Austria






Bezafibrat „Genericon“ 200 mg - Dragees


200 mg


film-coated tablet


oral




AT - Austria







Genericon Pharma GmbH




Hafnerstraße 211




A-8054 Graz




Austria






Bezafibrat „Genericon“ retard 400 mg - Filmtabletten


400 mg


film-coated tablet


oral




AT - Austria







1A Pharma GmbH




Stella-Klein-Löw-Weg 17, A-1020 Wien




Austria






Bezafibrat „1A Pharma“ retard 400 mg - Filmtabletten


400 mg


film-coated tablet


oral




AT - Austria







Ratiopharm Arzneimittel




Vertriebs-GmbH




Albert-Schweitzer Gasse 3 A




1140 Wien




Austria






Bezafibrat „ratiopharm“ retard 400 mg - Filmtabletten


400 mg


prolonged-release tablet


oral




AT - Austria







Actavis Group PTC ehf




Reykjavikurvegur 76-78




IS- 220 Hafnarfjördur




Iceland






Bezalip 200 mg - Filmtabletten


200 mg


film-coated tablet


oral




AT - Austria







Actavis Group PTC ehf




Reykjavikurvegur 76-78




IS- 220 Hafnarfjördur




Iceland






Bezalip retard 400 mg - Filmtabletten


400 mg


film-coated tablet


oral




AT - Austria







Genericon Pharma GmbH




Hafnerstraße 211




A-8054 Graz




Austria






Bezaretard „Genericon“ 400 mg - Filmtabletten


400 mg


film-coated tablet


oral




AT - Austria







Stada Arzneimittel GmbH




Muthgasse 36




A-1190 Wien




Austria






Bezastad 200 mg - Filmtabletten


200 mg


film-coated tablet


oral




AT - Austria







Stada Arzneimittel GmbH




Muthgasse 36




A-1190 Wien




Austria






Bezastad retard 400 mg - Filmtabletten


400 mg


film-coated tablet


oral




BE - Belgium







ACTAVIS GROUP PTC EHF




Reykjavikuregur 76-78




220 Hafnarfjordur




Iceland






CEDUR


200 mg


coated tablet


oral




BE - Belgium







ACTAVIS GROUP PTC EHF




Reykjavikuregur 76-78




220 Hafnarfjordur




Iceland






EULITOP 400 MG


400 mg


tablet


oral




CY - Cyprus







REMEDICA LTD




Aharnon street




P.O.Box 51706




3508 Lemesos




Cyprus






LACROMID 200 FC TABLETS 200 mg


200 mg


tablets


oral




CY - Cyprus







MEDOCHEMIE LTD




1-10 Constantinoupoleos street, P.O. Box 51409




3505 Lemesos




Cyprus






ZAFIBRAL FC TABLETS 200 mg


200 mg


tablets


oral




DE - Germany







1 A Pharma GmbH




Keltenring 1 + 3




D-82041 Oberhaching




Germany






Bezafibrat 400 ret-1 A Pharma


400 mg


Prolonged-release tablet


oral




DE - Germany







AbZ-Pharma GmbH




Dr.Georg-Spohn-Str. 7




D-89143 Blaubeuren




Germany






Bezafibrat AbZ 200 mg Filmtabletten


200 mg


Film-coated tablet


oral




DE - Germany







AbZ-Pharma GmbH




Dr.Georg-Spohn-Str. 7




D-89143 Blaubeuren




Germany






Bezafibrat AbZ 400 mg Retardtabletten


400 mg


Film-coated tablet


oral




DE - Germany







Actavis Group PTC ehf




Reykjavikurvegur 76-78




IS-220 Hafnarfjördur




Iceland






Cedur


200 mg


Film-coated tablet


oral




DE - Germany







Actavis Group PTC ehf




Reykjavikurvegur 76-78




IS-220 Hafnarfjördur




Iceland






Cedur retard


400 mg


Prolonged-release tablet


oral




DE - Germany







ALIUD PHARMA GmbH




Gottlieb-Daimler-Str. 19




D-89150 Laichingen




Germany






Bezafibrat AL 200


200 mg


Film-coated tablet


oral




DE - Germany







ALIUD PHARMA GmbH




Gottlieb-Daimler-Str. 19




D-89150 Laichingen




Germany






Bezafibrat AL 400 retard


400 mg


Prolonged-release tablet


oral




DE - Germany







Berlin-Chemie AG




Glienicker Weg 125




D-12489 Berlin




Germany






Regadrin B


200 mg


Film-coated tablet


oral




DE - Germany







betapharm Arzneimittel GmbH




Kobelweg 95




D-86156 Augsburg




Germany






Bezabeta 400 retard


400 mg


Prolonged-release tablet


oral




DE - Germany







CT Arzneimittel GmbH




Lengeder Str. 42 a




D-13407 Berlin




Germany






Bezafibrat-CT 200 mg Filmtabletten


200 mg


Film-coated tablet


oral




DE - Germany







CT Arzneimittel GmbH




Lengeder Str. 42 a




D-13407 Berlin




Germany






Bezafibrat-CT 400 mg Retardtabletten


400 mg


Prolonged-release tablet


oral




DE - Germany







DOCPHARM Arzneimittelvertrieb GmbH & Co.KGaA




Greschbachstr. 7




D-76229 Karlsruhe




Germany






Bezadoc PB retard 400 mg


400 mg


Prolonged-release tablet


oral




DE - Germany







DOCPHARM Arzneimittelvertrieb GmbH & Co.KGaA




Greschbachstr. 7




D-76229 Karlsruhe




Germany


Bezadoc retard 400 mg


400 mg


Prolonged-release tablet


oral




DE - Germany







Hennig Arzneimittel GmbH & Co.KG




Liebigstr. 1-2




D-65439 Floersheim




Germany






Befibrat 200 mg Dragees


200 mg


Prolonged-release tablet


oral




DE - Germany







Hennig Arzneimittel GmbH & Co.KG




Liebigstr. 1-2




D-65439 Floersheim




Germany






Befibrat 400 mg retard Filmtabletten


400 mg


Film-coated tablet


oral




DE - Germany







Heumann Pharma GmbH & Co. Generica KG




Südwestpark 50




D-90449 Nürnberg




Germany






Bezafibrat 200 Heumann


200 mg


Film-coated tablet


oral




DE - Germany







Heumann Pharma GmbH & Co. Generica KG




Südwestpark 50




D-90449 Nürnberg




Germany






Bezafibrat 400 retard Heumann


400 mg


Prolonged-release tablet


oral




DE - Germany







HEXAL AG




Industriestr. 25




D-83607 Holzkirchen




Germany






Bezafibrat HEXAL 400 mg retard Retardtabletten


400 mg


Prolonged-release tablet


oral




DE - Germany







Mylan dura GmbH




Wittichstr. 6D




64295 Darmstadt




Germany






Bezafibrat dura 400 mg Retardtabletten


400 mg


Prolonged-release tablet


oral




DE - Germany







ratiopharm GmbH




Graf-Arco-Str. 3




D-89079 Ulm




Germany






Bezafibrat-ratiopharm 200 mg Filmtabletten


200 mg


Film-coated tablet


oral




DE - Germany







ratiopharm GmbH




Graf-Arco-Str. 3




D-89079 Ulm






Bezafibrat-ratiopharm 400 mg Retardtabletten


400 mg


Prolonged-release tablet


oral




DE - Germany







Sandoz Pharmaceuticals GmbH




Raiffeisenstr. 11




D-83607 Holzkirchen




Germany






Bezafibrat Sandoz 400 mg Retardtabletten


400 mg


Prolonged-release tablet


oral




DE - Germany







Stadapharm GmbH




Stadastr. 2-18




D-61118 Bad Vilbel




Germany






Bezafibrat Stada 200 mg überzogene Tabletten


200 mg


Film-coated tablet


oral




DE - Germany







Stadapharm GmbH




Stadastr. 2-18




D-61118 Bad Vilbel




Germany






Bezafibrat Stada 400 mg Retardtabletten


400 mg


Prolonged-release tablet


oral




DE - Germany







TAD Pharma GmbH




Heinz-Lohmann-Str. 5D




27472 Cuxhaven




Germany






Lipox Bezafibrat 400 mg Retardtabletten


400 mg


Prolonged-release tablet


oral




DE - Germany







TAD Pharma GmbH




Heinz-Lohmann-Str. 5




D-27472 Cuxhaven




Germany






Lipox Bezafibrat 400 mg Retardtabletten


400 mg


Prolonged-release tablet


oral




DE - Germany







Wörwag Pharma GmbH & Co. KG




Calwer Str. 7




D-71034 Böblingen




Germany






Bezagamma 200


200 mg


Film-coated tablet


oral




DE - Germany







Wörwag Pharma GmbH & Co. KG




Calwer Str. 7




D-71034 Böblingen




Germany






Bezagamma 400 retard


400 mg


Prolonged-release tablet


oral




EL - Greece







ACTAVIS GROUP PTC EHF., ICELAND




Reykjavikurvegur 76-78,




220, Hafnarfjordur




Iceland






BEZALIP


400 MG/TAB


PROLONGED RELEASE TABLETS


oral




ES - Spain







ACTAVIS SPAIN, S.A.




Perú 8




28290 Las Matas




Madrid




SPAIN






EULITOP


200 mg


tablets


oral




ES - Spain







ACTAVIS SPAIN




S.A.Rivera del Loira




46 - Bussines Centre Regus Office 525 Madrid




Spain






EULITOP RETARD


400 mg


film coated tablets


oral




ES - Spain







BIAL INDUSTRIAL FARMACEUTICA S.A. Alameda de Urquijo




27 Bilbao




Spain






DIFATEROL RETARD


400 mg


film coated tablets


oral




FI - Finland







Actavis




Actavis Group PTC ehf Reykjavikurvegi 76-78




220 Hafnarfjordur




Iceland






BEZALIP


400 mg


prolonged-release tablet


Oral use




FR - France







Actavis Group PTC ehf




Reykjavikurvegi 76-78




220 Hafnarfjördur




Iceland






BEFIZAL 200 mg, comprimé pelliculé


200 mg


film-coated tablet


oral use




FR - France







Actavis Group PTC ehf




Reykjavikurvegi 76-78




220 Hafnarfjördur




Iceland






BEFIZAL L.P. 400 mg, comprimé enrobé à libération prolongée


400 mg


Prolonged-release tablet


oral use




FR - France







Actavis Group PTC ehf




Reykjavikurvegi 76-78




220 Hafnarfjördur




Iceland






BEZAFIBRATE ACTAVIS 200 mg, comprimé pelliculé


200 mg


film-coated tablet


oral use




FR - France







Actavis Group PTC ehf




Reykjavikurvegi 76-78




220 Hafnarfjördur




Islande




Iceland






BEZAFIBRATE ACTAVIS L.P. 400 mg, comprimé enrobé à libération prolongée


400 mg


Prolonged-release tablet


oral use




HU - Hungary







Actavis Group PTC ehf.




Reykjavikurvegur 76-78.




IS-220




Iceland






Bezalip


400mg


modified-release film-coated tablet


oral




IT - Italy







Actavis Italy Spa




Viale Luigi Pasteur




10 - Nerviano – 20014




MILANO




Italy






Bezalip


400 mg


Prolonged release coated tablet


Oral




IT - Italy







Actavis Italy Spa




Viale Luigi Pasteur, 10 –




Nerviano –




20014 MILANO




Italy






Bezalip


200 mg


Film-coated tablet


Oral




IT - Italy







Eg Spa




Via Scarlatti Domenico, 31




20124 MILANO




Italy






Bezafibrato Eg


400 mg


Prolonged release tablet


Oral




IT - Italy







Vecchi & Piam Sapa




Via Padre Semeria, 5




16131 GENOVA




Italy






Hadiel


400 mg


Prolonged release coated tablet


Oral




LU - Luxembourg







Hexal AG




Industriestrasse, 25




D- 83607 Holzkirchen




Germany






Benzafibrat Hexal Retard


400 mg


film-coated tablet


oral




LU - Luxembourg







Actavis Group PLC Reykjavikurvegur 76-78




IS- 220 Hafnarfjordur




Iceland






Cedur


200 mg


film-coated tablet


oral




LU - Luxembourg







Actavis Group PLC




Reykjavikurvegur 76-78




IS- 220 Hafnarfjordur




Iceland






Eulitop


400 mg


tablet


oral use




MT - Malta







Hennig Arzneimittel GmbH & Co. KG Liebigstrasse 1-2




65439 Flörsheim




Germany






Befibrat


400 mg


Retard coated tablets


Oral




NL - Netherlands







Actavis Group PTC ehf, Reykjavíkurvegi 76-78




220 Hafnarfjördur




Iceland






Bezalip, tabletten 200 mg, RVG 15982


200 mg


tablets


oral




NL - Netherlands







Actavis Group PTC ehf, Reykjavíkurvegi 76-78




220 Hafnarfjördur




Iceland






Bezalip Retard, tabletten met gereguleerde afgifte 400 mg, RVG 18388


400 mg


modified release tablets


oral




PT - Portugal







Actavis Group PTC ehf., Reykjavíkurvegi, 76-78




IS-220 Hafnarfjörour






Bezalip


200 mg


film-coated tablet


Oral




PT - Portugal







Actavis Group PTC ehf., Reykjavíkurvegi, 76-78




IS-220 Hafnarfjörour




Iceland






Bezalip Retard


400 mg


Prolonged-released tablet


Oral




RO - Romania







S.C. ARENA GROUP S.A.




Str. Ștefan Mihăileanu Nr.31,




Sector 2




București




Romania






BEZAFIBRAT ARENA 200 mg


200 mg


tablets


oral use




RO - Romania







S.C. SLAVIA PHARM S.R.L.




B-dul Theodor Pallady nr. 44C




Sector 3, București




Romania






BEZAFIBRAT SLAVIA 200 mg


200 mg


tablets


oral use




RO - Romania







BERLIN CHEMIE AG




(MENARINI GROUP)




Glienicker Weg 125-127




12489 Berlin




Germany






REGADRIN® B


200 mg


coated tablets


oral use




SE - Sweden







Actavis Group PTC ehf., Reykjavikurvegur 76-78




220 Hafnarfjördur




Iceland






Bezalip®


200 mg


filmcoated tablet


oral




SE - Sweden







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




Iceland






Bezalip® Retard


400 mg


depo tablet


oral




UK - United Kingdom







Actavis Group Ptc Ehf, Reykjavikurvegi 76-78




Hafnarfirdi, Is-220,




Iceland






BEZALIP


200 mg


COATED TABLET


oral use




UK - United Kingdom







Actavis Group Ptc Ehf, Reykjavikurvegi 76-78




Hafnarfirdi, Is-220




Iceland






BEZALIP MONO


400 mg


MODIFIED-RELEASE TABLET


oral use




UK - United Kingdom







Archimedes Pharma Uk Limited




Bishops Weald House




Albion Way, Horsham,




West Sussex RH12 1AH




United Kingdom






ZIMBACOL XL


400 mg


MODIFIED-RELEASE TABLET


oral use




UK - United Kingdom







Generics (Uk) Limited




Station Close




Potters Bar,




HERTS EN6 1TL




United Kingdom






BEZAGEN XL TABLETS 400MG


400 mg


TABLET


oral use




UK - United Kingdom







Generics (Uk) Limited




Station Close




Potters Bar,




HERTS EN6 1TL




United Kingdom






BEZAFIBRATE TABLETS 200 MG


200 mg


FILM-COATED TABLET


oral use




UK - United Kingdom







Pliva Pharma Limited




Vision House




Bedford Road




Petersfield




HANTS GU32 3QB




United Kingdom






BEZAFIBRATE TABLETS 200 MG


200 mg


TABLET


oral use




UK - United Kingdom







RATIOPHARM GMBH




Graf-Arco Strasse 3




Ulm, D-89079




GERMANY






BEZAFIBRATE 200MG TABLETS


200 mg


FILM-COATED TABLET


oral use




UK - United Kingdom







SANDOZ LIMITED




37 Woolmer Way,




Borden, Hampshire GU35 9QE




United Kingdom






BEZATARD XL 400MG MODIFIED RELEASE TABLETS


400 mg


MODIFIED-RELEASE TABLET


oral use








Ciprofibrate 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 N.V.




Culliganlaan 1C




1831 Diegem




Belgium






CIPROFIBRATE MYLAN 100 MG


100 mg


capsule, hard


oral




BE - Belgium







SANOFI-AVENTIS BELGIUM N.V.




Culliganlaan 1C




1831 Diegem




Belgium






HYPERLIPEN 100 MG


100 mg


capsule, hard


oral




BG - Bulgaria







Sanofi-Aventis




Bulgaria EOOD




Blvd. Alexander Stamboliyski № 103, Office Building Sofia Tower, 8th floor, 1303 Sofia




Bulgaria






Lipanor


100 mg


Capsule, hard


Oral use




CY - Cyprus







SANOFI AVENTIS CYPRUS LTD




Charalambou Mouskou 14




2015 Strovolos




Cyprus






MODALIM TABLETS 100 mg


100 mg


tablets


oral




CZ - Czech Republic







sanofi-aventis s.r.o.




Evropská 846/176a




160 00 Praha 6




Czech Republic






LIPANOR


100 MG


capsule, hard


 




EL - Greece







Sanofi-Aventis Aebe




Syngrou Avenue 348,




Building A,




Kallithea 176 74




Attiki




Greece






SAVILEN


100 MG/CAP


HARD CAPSULES


ORAL




ET - Estonia







Sanofi-Aventis




Estonia




OÜ




Pärnu mnt 139E/211317 Tallinn




Estonia






LIPANOR


100 mg


capsule, hard


oral use




FR - France







Sanofi Aventis France




1-13 Bd Romain Rolland




75014 Paris




France






LIPANOR 100 mg, gélule


100 mg


capsule


oral use




FR - France







Biogaran




15, bd Charles de Gaulle




92700 Colombes




France






CIPROFIBRATE ALMUS 100 mg, gélule


100 mg


capsule


oral use




FR - France







Arrow




26, avenue Tony Garnier




69007 Lyon




France






CIPROFIBRATE ARROW 100 mg, gélule


100 mg


capsule


oral use




FR - France







Biogaran




15, bd Charles de Gaulle




92700 Colombes




France






CIPROFIBRATE BIOGARAN 100 mg, gélule


100 mg


capsule


oral use




FR - France







Mylan SAS




117, allée des Parcs




69800 Saint Priest




France






CIPROFIBRATE MYLAN 100 mg, gélule


100 mg


capsule


oral use




FR - France







Qualimed




117, allée des Parcs




69800 Saint Priest




France






CIPROFIBRATE QUALIMED 100 mg, gélule


100 mg


capsule


oral use




FR - France







Laboratoire Ratiopharm




19, Bd Paul Vaillant Couturier




94200 Ivry sur Seine




France






CIPROFIBRATE RATIOPHARM 100 mg, gélule


100 mg


capsule


oral use




FR - France







Biogaran




15




bd Charles de Gaulle




92700 Colombes




France






CIPROFIBRATE REF 100 mg, gélule


100 mg


capsule


oral use




FR - France







Ranbaxy Pharmacie Génériques




11-15 Quai Dion Bouton




92800 Puteaux




France






CIPROFIBRATE RPG 100 mg, gélule


100 mg


capsule


oral use




FR - France







Sandoz




49, av. Pompidou




92300 Levallois-Perret




France






CIPROFIBRATE SANDOZ 100 mg, gélule


100 mg


capsule


oral use




FR - France







TEVA SANTE




Le Palatin 1




1 cours du Triangle




92936 Paris La Défense Cedex




France






CIPROFIBRATE TEVA 100 mg, gélule


100 mg


capsule


oral use




FR - France







Sanofi Aventis France




1-13 Bd Romain Rolland




75014 Paris




France






CIPROFIBRATE WINTHROP 100 mg, gélule


100 mg


capsule


oral use




HU - Hungary







sanofi-aventis zrt.




Tó u. 1-5.




1045 Budapest




Hungary






Lipanor


100 mg


hard capsule


oral




LT - Lithuania







UAB Sanofi - Aventis Lietuva




A. Juozapaviciaus 6/2




LT-09310 Vilnius




Lithuania






Lipanor


100 mg


capsule, hard


oral use




LU - Luxembourg







Sanofi-Synthélabo SA




Twin Squares,




Navona Building




B- 1831 Diegem






Hyperlipen


100 mg


capsule, hard


oral




LV - Latvia







Sanofi-aventis Latvia SIA




Kr.Valdemara Str. 33-8




Riga, LV-1010




Latvia






Lipanor 100 mg capsules, hard


100 mg


Capsules, hard


Oral use




NL - Netherlands







Sanofi-Aventis Netherlands B.V. Kampenringweg 45 D-E




2803 PE Gouda




The Nederlands






Modalim, tabletten 100 mg, RVG 17863


100 mg


tablets


oral




PL - Poland







Sanofi-Aventis France




boulevard Romain Rolland 1-13,




F-75014 Paris,




France






Lipanor


100 mg


capsules


oral




PT - Portugal







Sanofi-Aventis - Produtos Farmacêuticos, S.A Empreendimento Lagoas Park, Edifício 7 - 3o





2740-299 Porto Salvo




Portugal






Lipanor


100 mg


capsule


Oral




PT - Portugal







Winthrop Farmacêutica Portugal, Lda. Empreendimento Lagoas Park




Edifício 7 - 2o/3o





2740-299 Porto Salvo




Portugal






Fibranin


100 mg


capsule


Oral




RO - Romania







sanofi-aventis france




1-13, boulevard Romain Rolland




75014 Paris




France






LIPANOR® 100 mg


100 mg


capsules


oral use




SK - Slovakia







sanofi-aventis Slovakia s.r.o.




Žilinská 7-9




81105 Bratislava




Slovakia






LIPANOR 100 mg


100 mg


Capsule


Oral




UK - United Kingdom







Winthrop Pharmaceuticals Uk Limited




One Onslow Street




Guildford, Surrey GU1 4YS




United Kingdom






CIPROFIBRATE 100MG TABLETS


100 mg


Tablet


Oral Use








Gemfibrozil 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







Pfizer Corporation




Austria GmbH




Floridsdorfer Hauptstraße 1




A-1210 Wien




Austria






Gevilon 450 mg - Filmtabletten


450 mg


film-coated tablet


oral




CY - Cyprus







MEDOCHEMIE LTD




1-10 Constantinoupoleos street




P.O.Box 51409




3505 Lemesos




Cyprus






IPOLIPID CAPSULES 300mg


300 mg


capsules


oral




CY - Cyprus







MEDOCHEMIE LTD, 1-10 Constantinoupoleos street P.O.Box 51409




3505 Lemesos




Cyprus






IPOLIPID CAPSULES 600mg


600 mg


capsules


oral




CY - Cyprus







REMEDICA LTD




Aharnon street




P.O.Box 51706




3508 Lemesos




Cyprus






LIPOFOR CAPSULES 300mg


300 mg


capsules


oral




CY - Cyprus







REMEDICA LTD




Aharnon street




P.O.Box 51706




3508 Lemesos




Cyprus






LIPOFOR CAPSULES 600mg


600 mg


capsules


oral




DE - Germany







1 A Pharma GmbH




Keltenring 1 + 3




D-82041 Oberhaching




Germany






Gemfi 450-1 A Pharma


450 mg


Film-coated tablet


oral




DE - Germany







1 A Pharma GmbH




Keltenring 1 + 3




D-82041 Oberhaching




Germany






Gemif 600-1 A Pharma


600 mg


Film-coated tablet


oral




DE - Germany







Pfizer Pharma GmbH




Linkstr. 10




D-10785 Berlin




Germany






Gevilon 600mg


600 mg


Film-coated tablet


oral




DE - Germany







Pfizer Pharma GmbH




Linkstr. 10D




D- 10785 Berlin




Germany






Gevilon Uno


900 mg


Film-coated tablet


oral




DE - Germany







TAD Pharma GmbH




Heinz-Lohmann-Str. 5




D-27472 Cuxhaven




Germany






Lipox Gemfi 450mg


450 mg


Film-coated tablet


oral




DE - Germany







TAD Pharma GmbH




Heinz-Lohmann-Str. 5




D-27472 Cuxhaven




Germany






Lipox Gemfi 600mg


600 mg


Film-coated tablet


oral




DK - Denmark







Alternova A/S




Lodhusvej 11




4230 Skælskør




Denmark






Gemfibrozil «Alternova»


600 mg


film coated tablets


oral




DK - Denmark







Alternova A/S




Lodhusvej 11




4230 Skælskør




Denmark






Gemfibrozil «Alternova»


900 mg


film coated tablets


oral




DK - Denmark







Pfizer ApS




Lautrupvang 8




2750 Ballerup




Denmark






Lopid


300 mg


Hard capsules


oral




DK - Denmark







Pfizer ApS




Lautrupvang 8




2750 Ballerup




Denmark






Lopid


450 mg


Film coated tablets


oral




DK - Denmark







Pfizer ApS




Lautrupvang 8




2750 Ballerup




Denmark






Lopid


600 mg


Film coated tablets


oral




EL - Greece







PFIZER HELLAS S.A.




Messogion Avenue 243




Neo Psychiko 154 51




Greece






LOPID


600 MG/TAB


Film coated tablet


ORAL




EL - Greece







PFIZER HELLAS S.A.




Messogion Avenue 243




Neo Psychiko 154 51




Greece






LOPID


900 MG/TAB


Film coated tablet


ORAL




EL - Greece







FINIXPHARM EPE




Dervenakion 38 and Sahini str




Gerakas Attikis 153 44




Greece






HOBATOLEX


600 MG/TAB


Film coated tablet


ORAL




EL - Greece







ANFARM HELLAS S.A.




Perikleous 53-57




Gerakas Attikis 153 44




Greece






FIBROLIP


600 MG/TAB


Film coated tablet


ORAL




EL - Greece







MEDICHROM S.A.




6th Km Markopolou-Koropi Avenue




Markopoulo Mesogeion 19003




Greece






GEMLIPID-MEDICHROM


600 MG/TAB


Film coated tablet


ORAL




EL - Greece







COSMOPHARM EPE




P.O. Box 42




Korinthos 20100




Greece






PRELISIN


600 MG/TAB


Film coated tablet


ORAL




EL - Greece







KLEVA AFBEE




Parnithos Avenue 189




Aharnes Attikis 136 75




Greece






NOXOBRAN


600 MG/TAB


Film coated tablet


ORAL




EL - Greece







KLEVA AFBEE




Parnithos Avenue 189




Aharnes Attikis 136 75




Greece






NOXOBRAN


900 MG/TAB


Film coated tablet


ORAL




EL - Greece







GAP S.A.




Agisilaou 46




Agios Dimitrios 17341




Greece






LISOLIP


600 MG/TAB


Film coated tablet


ORAL




EL - Greece







HRISPA ALFA PHARMACEUTICALS S.A.




(ΧΡΙΣΠΑ ΑΛΦΑ ΦΑΡΜ/ΚΗ Α.Ε.)




16th Km Marathonos Avenue




Pallini Attikis 153 44




Greece






TEROSTRANT


600 MG/TAB


Film coated tablet


ORAL




EL - Greece







BIOSPRAY ABEE




18th Km Marathonos Avenue




Pallini Attikis 153 44




Greece






PARNOXIL


600 MG/TAB


Film coated tablet


ORAL




EL - Greece







SPECIFAR ABEE




28th October str 1




Agia Barbara 123 51




Greece






FIBROSPES


600 MG/TAB


Film coated tablet


ORAL




EL - Greece







PHARMACEUTICAL INDUSTRY E.G. KORONIS S.A.




Dilou str 9




Peristeri 121 34




Greece






EKLIPID


600 MG/TAB


Film coated tablet


ORAL




EL - Greece







KLEVA AFBEE




Parnithos Avenue 189




Aharnes Attikis 136 75




Greece






ANTILIPID


600 MG/TAB


Film coated tablet


ORAL




EL - Greece







MED-ONE AFBEE




Agiou Petrou 30 and Epameinonda




Aharnes 136 75




Greece






GINETON


600 MG/TAB


Film coated tablet


ORAL




ES - Spain







BEXAL FARMACEUTICA, S.A Centro Empresarial Osa Mayor. Avda. Osa Mayor, 4 - Area BAravaca 28023 (Madrid)




Spain






GEMFIBROZILO BEXAL


600 mg


film coated tablets


oral




ES - Spain







FERMON, S.L.Alfonso XII,




587 Badalona




08918 BARCELONA




Spain






GEMFIBROZILO FERMON


600 mg


film coated tablets


oral




ES - Spain







FERMON, S.L.Alfonso XII, 587 Badalona




08918 BARCELONA




Spain






GEMFIBROZILO FERMON


900 mg


film coated tablets


oral




ES - Spain







LABORATORIO STADA, S.L.Frederic Mompou,




5 Sant Just Desvern 08960 BARCELONA




Spain






GEMFIBROZILO STADA


600 mg


film coated tablets


oral




ES - Spain







LABORATORIO STADA, S.L.Frederic Mompou,




5 Sant Just Desvern 08960 BARCELONA




Spain






GEMFIBROZILO STADA


900 mg


film coated tablets


oral




ES - Spain







USO RACIONAL




S.L.Ferraz, 10 - 1o Izda.




28008 Madrid




Spain






GEMFIBROZILO UR


900 mg


film coated tablets


oral




ES - Spain







USO RACIONAL




S.L.Ferraz, 10 - 1o Izda.




28008 Madrid




Spain






GEMFIBROZILO UR


600 mg


film coated tablets


oral




ES - Spain







PARKE DAVIS




Avda. de Europa, 20 B. Parque Empresarial La Moraleja Alcobendas MADRID




Spain






LOPID


600 mg


film coated tablets


oral




ES - Spain







PARKE DAVIS, Avda. de Europa, 20 B. Parque Empresarial La Moraleja Alcobendas MADRID




Spain






LOPID


900 mg


film coated tablets


oral




ES - Spain







LABORATORIOS MENARINI S.A Alfonso XII




587 Badalona




08918 BARCELONA




Spain






TRIALMIN


600 mg


film coated tablets


oral




ES - Spain







LABORATORIOS MENARINI S.A Alfonso XII, 587 Badalona




08918 BARCELONA




Spain






TRIALMIN


900 mg


film coated tablets


oral




ES - Spain







QUIMIFAR, S.A.Comadran,




37 Barbera del Valles




08210 BARCELONA




Spain






PILDER


600 mg


film coated tablets


oral




FI - Finland







Pfizer Oy




Tietokuja 4




00330 Helsinki




Finland






LOPID


300 mg


capsules, hard


Oral use




FI - Finland







Pfizer Oy




Tietokuja 4




00330 Helsinki




Finland






LOPID


600 mg


capsules, hard


Oral use




FR - France







Pfizer Holding France




23-25, avenue du Docteur Lannelongue




75014 Paris




France






LIPUR 450 mg, comprimé pelliculé


450 mg


film-coated tablet


oral use




HU - Hungary







TEVA Magyarország zrt.




Rákóczi út 70-72.




1074 Budapest




Hungary






Minilip


600 mg


film-coated tablet


oral




HU - Hungary







PannonPharma Kft.




Pannonpharma út 1.




7720 Pécsvárad




Hungary






Innogem


300 mg


hard capsule


oral




HU - Hungary







PannonPharma Kft.




Pannonpharma út 1.




7720 Pécsvárad




Hungary






Innogem


600 mg


film-coated tablet


oral




IE - Ireland







Pfizer Healthcare Ireland




9 Riverwalk




National Digital Park




Citywest Business Campus




Dublin 24




Ireland




UK ADDRESS:





Pfizer Ltd., Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS,




UK






Lopid 300 mg capsules


300 mg


hard capsules


oral use




IE - Ireland







Pfizer Healthcare Ireland




9 Riverwalk




National Digital Park




Citywest Business Campus




Dublin 24




Ireland




UK ADDRESS:





Pfizer Ltd., Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS




UK






Lopid 600 mg film-coated tablets


600 mg


film-coated tablets


oral use




IS - Iceland







Pfizer Aps




Lautrupsvang 8




2750 Ballerud




Denmark






Lopid


600 mg


Film-coated tablet


Oral




IS - Iceland







Pfizer Aps




Lautrupsvang 8




2750 Ballerud




Denmark






Lopid


300 mg


Capsule, hard


Oral




IT - Italy







Biores Italia Srl




Via Vittorio Grassi, 13 –




La Rustica




00155 ROMA




Italy






Lipogen


900 mg


Tablet


Oral




IT - Italy







Biores Italia Srl




Via Vittorio Grassi, 13 –




La Rustica




00155 ROMA




Italy






Lipogen


1 200 mg


Granules


Oral




IT - Italy







Boniscontro & Gazzone Srl




Via Pavia, 6




20136 MILANO




Italy






Genozil


600 mg


Film coated tablet


Oral




IT - Italy







Boniscontro & Gazzone Srl




Via Pavia, 6




20136 MILANO




Italy






Genozil


900 mg


Film coated tablet


Oral




IT - Italy







C.T. Laboratorio Farmaceutico S




Strada Solaro, 75/77




Villa Sayonara, Sanremo – IMPERIA




Italy






Fibrocit


900 mg


Tablet


Oral




IT - Italy







C.T. Laboratorio Farmaceutico Srl Strada Solaro, 75/77




Villa Sayonara, Sanremo – IMPERIA




Italy






Fibrocit


600 mg


Tablet


Oral




IT - Italy







Doc Generici Srl




Via Manuzio, 7




20124 MILANO




Italy






Gemfibrozil


900 mg


Tablet


Oral




IT - Italy







Doc Generici Srl




Via Manuzio, 7




20124 MILANO




Italy






Gemfibrozil


600 mg


Tablet


Oral




IT - Italy







Eg Spa




Via Scarlatti Domenico, 31




20124 MILANO




Italy






Gemfibrozil Eg


900 mg


Tablet


Oral




IT - Italy







Eg Spa




Via Scarlatti Domenico, 31




20124 MILANO




Italy






Gemfibrozil Eg


600 mg


Tablet


Oral




IT - Italy







Eg Spa




Via Scarlatti Domenico, 31




20124 MILANO




Italy






Gemfibrozil Eg


1 200 mg


Granules


Oral




IT - Italy







Get Srl Via Dante Alighieri, 73 18038 Sanremo – IMPERIA




Italy






Gemfibrozil


900 mg


Coated tablet


Oral




IT - Italy







Get Srl




Via Dante Alighieri, 73




18038 Sanremo – IMPERIA




Italy






Gemfibrozil


600 mg


Coated tablet


Oral




IT - Italy







Pfizer Italia Srl




Via Isonzo, 71




04100 – LATINA




Italy






Lopid


900 mg


Coated tablet


Oral




IT - Italy







Pfizer Italia Srl




Via Isonzo, 71




04100 – LATINA




Italy






Lopid


600 mg


Coated tablet


Oral




IT - Italy







Ratiopharm GmbH




Graf-Arco Strasse 3




D-89079 ULM –




Germany






Gemfibrozil


900 mg


Tablet


Oral




IT - Italy







Ratiopharm Gmbh Graf-Arco Strasse 3 D-89079 ULM




Germany






Gemfibrozil


600 mg


Tablet


Oral




IT - Italy







Ratiopharm Gmbh Graf-Arco Strasse 3 D-89079 ULM




Germany






Gemfibrozil


1 200 mg


Granules


Oral




IT - Italy







Sandoz Spa Largo Umberto Boccioni, 1 21040 Origgio – VARESE




Italy






Gemfibrozil


900 mg


Tablet


Oral




IT - Italy







Sandoz Spa Largo Umberto Boccioni, 1 21040 Origgio – VARESE




Italy






Gemfibrozil


600 mg


Tablet


Oral




IT - Italy







Teofarma Srl Via Fratelli Cervi, 8 –




Valle Salimbene




27010 Pavia




Italy






Genlip


900 mg


Tablet


Oral




IT - Italy







Teofarma Srl




Via Fratelli Cervi, 8 –




Valle Salimbene




27010 Pavia




Italy






Genlip


600 mg


Tablet


Oral




IT - Italy







Teva Italia Srl




Via Messina, 38




20154 MILANO




Italy






Gemfibrozil


900 mg


Film-coated tablet


Oral




IT - Italy







Teva Italia Srl




Via Messina, 38




20154 MILANO




Italy






Gemfibrozil


600 mg


Film-coated tablet


Oral




NL - Netherlands







Pfizer B.V.




Rivium Westlaan 142




2909 LD Capelle a/d Ijssel




The Netherlands






Lopid 300 mg, harde capsules, RVG 32546


300 mg


capsules, hard


oral




NL - Netherlands







Pfizer B.V.




Rivium Westlaan 142




2909 LD Capelle a/d Ijssel




The Netherlands






Lopid 450 mg, filmomhulde tabletten, RVG 32547


450 mg


filmcoated tablets


oral




NL - Netherlands







Pfizer B.V.




Rivium Westlaan 142




2909 LD Capelle a/d Ijssel




The Netherlands






Lopid 600, filmomhulde tabletten 600 mg, RVG 13827


600 mg


filmcoated tablets


oral




NL - Netherlands







Pfizer B.V.




Rivium Westlaan 142




2909 LD Capelle a/d Ijssel




The Netherlands






Lopid 900, filmomhulde tabletten 900 mg, RVG 16455


900 mg


filmcoated tablets


oral




NL - Netherlands







Pharmachemie BV




P.O.Box 552,




2003 RN Haarlem




The Netherlands






Gemfibrozil 600 PCH, omhulde tabletten 600 mg, RVG 25031


600 mg


filmcoated tablets


oral




NL - Netherlands







Pharmachemie BV




P.O.Box 552,




2003 RN Haarlem




The Netherlands






Gemfibrozil 900 PCH, omhulde tabletten 900 mg, RVG 25032


900 mg


filmcoated tablets


oral




NL - Netherlands







Actavis BV




P.O. Box 313,




3740 AH Baarn




The Netherlands






Gemfibrozil Actavis 600 mg tabletten, omhulde tabletten, RVG 26283


600 mg


filmcoated tablets


oral




NL - Netherlands







Actavis BV




P.O. Box 313,




3740 AH Baarn,




The Netherlands






Gemfibrozil Actavis 900 mg tabletten, omhulde tabletten, RVG 26284


900 mg


filmcoated tablets


oral




NL - Netherlands







Apotex Europe B.V.




Darwinweg 20




2333 CR Leiden




The Netherlands






Gemfibrozil Apotex 600 mg, tabletten, RVG 24878


600 mg


filmcoated tablets


oral




NL - Netherlands







Apotex Europe B.V.




Darwinweg 20




2333 CR Leiden




The Netherlands






Gemfibrozil Apotex 900 mg, tabletten, RVG 24879


900 mg


filmcoated tablets


oral




NL - Netherlands







Centrafarm Services B.V.




Postbus 289




4870 AG Etten-Leur




The Netherlands






Gemfibrozil CF 600 mg, omhulde tabletten, RVG 25184


600 mg


filmcoated tablets


oral




NL - Netherlands







Centrafarm Services B.V., Postbus 289




4870 AG Etten-Leur




The Netherlands






Gemfibrozil CF 900 mg, omhulde tabletten, RVG 25185


900 mg


filmcoated tablets


oral




NL - Netherlands







Mylan B.V.




Dieselweg 25




3752 LB Bunschoten




The Netherlands






Gemfibrozil Mylan 600 mg, tabletten, RVG 29616


600 mg


tablets


oral




NL - Netherlands







Mylan B.V.




Dieselweg 25




3752 LB Bunschoten




The Netherlands






Gemfibrozil Mylan 900 mg, tabletten, RVG 29617


900 mg


tablets


oral




NL - Netherlands







Ratiopharm Nederland BV




Ronde Tocht 11




1507 CC Zaandam




The Netherlands






Gemfibrozil Ratiopharm 600 mg, omhulde tabletten, RVG 29232


600 mg


filmcoated tablets


oral




NL - Netherlands







Ratiopharm Nederland BV




Ronde Tocht 11




1507 CC Zaandam




The Netherlands






Gemfibrozil Ratiopharm 900 mg, omhulde tabletten, RVG 29233


900 mg


filmcoated tablets


oral




NL - Netherlands







Sandoz B.V.




Veluwezoom 22




1327 AH Almere




The Netherlands






Gemfibrozil Sandoz 600 mg, filmomhulde tabletten, RVG 21426


600 mg


filmcoated tablets


oral




NL - Netherlands







Sandoz B.V.




Veluwezoom 22




1327 AH Almere




The Netherlands






Gemfibrozil Sandoz tablet 600, omhulde tabletten 600 mg, RVG 25182


600 mg


filmcoated tablets


oral




NL - Netherlands







Sandoz B.V.




Veluwezoom 22




1327 AH Almere




The Netherlands






Gemfibrozil Sandoz tablet 900, omhulde tabletten 900 mg, RVG 25183


900 mg


filmcoated tablets


oral




PT - Portugal







Angelfarma Lda.




Rua João Chagas, 53




Piso 3 1495-764 Cruz Quebrada – Dafundo




Portugal






Lipoite Forte


600 mg


coated tablet


Oral




PT - Portugal







Laboratórios Pfizer, Lda.




Lagoas Park, Edifício 10




2740-271 Porto Salvo




Portugal






Lopid


300 mg


capsule


Oral




PT - Portugal







Laboratórios Pfizer,Lda.




Lagoas Park, Edifício 10




2740-271 Porto Salvo




Portugal






Lopid 600


600 mg


film-coated tablet


Oral




PT - Portugal







Generis Farmacêutica, S.A. Office Park da Beloura




Edifício 4




Quinta da Beloura




2710-444 Sintra




Portugal






Gemfibrozil Generis


600 mg


film-coated tablet


Oral




PT - Portugal







Generis Farmacêutica S.A. Office Park da Beloura




Edifício 4, Quinta da Belou




2710-444 Sinta




Portugal






Gemfibrozil Generis


900 mg


film-coated tablet


Oral




SE - Sweden







Sandoz A/S




C.F. Tietgens




Boulevard 40




DK-5220 Odense SØ




Denmark






Gemfibrozil Sandoz


450 mg


filmcoated tablet


oral




SE - Sweden







Sandoz A/S




C.F.Tietgens




Boulevard 40




DK-5220 Odense SØ




Denmark






Gemfibrozil Sandoz


600mg


filmcoated tablet


oral




SE - Sweden







Pfizer AB




191 90 Sollentuna




Sweden






Lopid


300 mg


hard capsule


oral




SE - Sweden







Pfizer AB




191 90 Sollentuna




Sweden






Lopid


450 mg


filmcoated tablet


oral




SE - Sweden







Pfizer AB




191 90 Sollentuna




Sweden






Lopid


600 mg


filmcoated tablet


oral




SI - Slovenia







Lek farmacevtska družba d.d., Verovškova 57




SI-1000 Ljubljana




Slovenia






Elmogan 450 mg filmsko obložene tablete


450 mg


film-coated tablet


oral use




SK - Slovakia


Medochemie Ltd. 1-10 Constantinoupoleos St. P.O. Box: 51409 3505 Limassol Cyprus


IPOLIPID


300 mg


Capsule


Oral




UK - United Kingdom







PFIZER LIMITED. Walton Oaks, Dorking Road, Tadworth, Surrey KT20 7NS




United Kingdom,






LOPID CAPSULES 300 MG


300 mg


CAPSULE


oral use




UK - United Kingdom







PFIZER LIMITED. Walton Oaks, Dorking Road, Tadworth, Surrey KT20 7NS




United Kingdom






LOPID TABLETS 600 MG


600 mg


COATED TABLET


oral use




UK - United Kingdom







TEVA PHARMA BV, Industrieweg 23, PO Box 217, 3640 AE Mijdrecht,




Netherlands






GEMFIBROZIL TABLETS 600 MG


600 mg


COATED TABLET


oral use




UK - United Kingdom







Teva Uk Limited, Brampton Road, Hampden Park, Eastbourne, E Sussex BN22 9AG




United Kingdom






GEMFIBROZIL CAPSULES 300 MG


300 mg


CAPSULE


oral use




UK - United Kingdom







TILLOMED LABORATORIES LIMITED




3 Howard Road




Eaton Socon




St. Neots, Cambridgeshire




PE19 8ET




United Kingdom






GEMFIBROZIL TABLETS 600 MG


600 mg


FILM-COATED TABLET


oral use







ANNEX V

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







Cephalon GmbH




Landsberger Straße 94




80339 München,




Germany






Modasomil 100 mg - Tabletten


100 mg


tablets


oral use




Austria







Teva Pharma B.V.




Computerweg 10,




3542 DR Utrecht




The Netherlands






Modafinil TEVA 100 mg Tabletten


100 mg


tablet


oral use




Belgium







Teva Pharma B.V.




Computerweg 10,




3542 DR Utrecht




The Netherlands






MODAFINIL TEVA 100MG


100 mg


tablets


oral use




Belgium







N.V. Organon




Kloosterstraat 6,




5349 AB Oss




The Netherlands






PROVIGIL


100 mg


tablets


oral use




Cyprus







GENESIS PHARMA (CYPRUS) LTD,




2 Amfipoleos, 1st floor,




P.O.Box 23638,




2025 Strovolos, Lefkosia,




Cyprus






MODIODAL


100 MG


tablets


oral use




Czech Republic







Teva Pharmaceuticals CR, s.r.o.




Anděl City




Radlická 1c




150 00 Praha 5




Czech Republic






Modafinil-Teva 100 mg


100 mg


tablets


oral use




Czech Republic







Torrex Chiesi CZ, s.r.o.




Na Květnici 33




140 00 Praha 4




Czech Republic






Vigil


100 mg


tablets


oral use




Denmark







Cephalon France,




20, rue Charles Matigny,




94700 Maisons-Alfort,




France






Modiodal


100 mg


tablets


oral use




Denmark







Teva Denmark A/S,




Parallelvej 10,




2800 Kongens Lyngby,




Denmark






Modafinil ‘Teva’


100 mg


tablets


oral use




Finland







ORCHID EUROPE LTD




Building 3, Chiswick park 556,




Chiswick High Road




London W4 5YA




United Kingdom






MODAFINIL


100 mg


tablets


oral use




Finland







ORCHID EUROPE LTD




Building 3, Chiswick park 556,




Chiswick High Road




London W4 5YA




United Kingdom






MODAFINIL


200 mg


tablets


oral use




France







CEPHALON France




20, rue Charles Martigny




94701 Maisons-Alfort Cedex




France






MODIODAL 100 mg, comprimé


100 mg


tablets


oral use




France







CEPHALON France




20, rue Charles Martigny




94701 Maisons-Alfort Cedex




France






MODAFINIL LAFON 100 mg, comprimé


100 mg


tablets


oral use




France







TEVA SANTE




Le Palatin 1




1, cours du Triangle




92936 Paris la Défense Cedex




France






MODAFINIL TEVA 100 mg, comprimé


100 mg


tablets


oral use




Germany







Cephalon Pharma GmbH




Fraunhoferstr. 9a




D-82152 Martinsried




Germany






Vigil 100 mg Tabletten


100 mg


tablets


oral use




Greece







GENESIS PHARMA




Kiffissias Avenue 274




Halandri Athens 152 32




Greece






MODIODAL


100 MG/TAB


tablets


oral use




Hungary







TORREX Chiesi Kft.




1052 Budapest




Kristóf tér 4. III/1-3.




Hungary






VIGIL


100 mg


tablets


oral use




Iceland







Cephalon France




20, rue Charles Martigny




94700 Maisons Alfort




France






Modiodal


100 mg


tablets


oral use




Ireland







Cephalon UK Limited




1 Albany Place Hyde Way




Welwyn Garden City




Hertfordshire AL7 3BT




United Kingdom






PROVIGIL 100 mg tablets


100 MG


tablets


oral use




Ireland







Cephalon UK Limited




1 Albany Place Hyde Way




Welwyn Garden City




Hertfordshire AL7 3BT




United Kingdom






PROVIGIL 200 mg tablets


200 MG


tablets


oral use




Ireland







Teva Pharma B.V.




Computerweg 10




3542DR Utrecht




The Netherlands






Modafinil Teva 100mg tablet


100 MG


tablets


oral use




Italy







CEPHALON SRL




Piazza G. Marconi, 25




00144 ROMA




Italia






PROVIGIL


100 mg


tablets


oral use




Italy







TEVA ITALIA S.R.L.




Via Messina, 38




20154 Milano




Italia






MODAFINIL TEVA


100 mg


tablets


oral use




Luxembourg







ORGANON N.V




Kloosterstraat 6




NL-5349 AB Oss




The Netherlands






PROVIGIL


100 mg


tablets


oral use




Netherlands







Cephalon France,




20 rus Charles Martigny,




94700 Maisons-Alfort,




France






Modiodal, 100 mg tabletten


100 mg


tablets


oral use




Poland







Torrex Chiesi Pharma GmbH,




Gonzagagasse 16/16,




A-1010 Vienna,




Austria






Vigil


100 mg


tablets


oral use




Portugal







Cephalon France




20, Rue Charles Martigny




94700 Maisons-Alfort




France






Modiodal


100 mg


tablets


oral use




Portugal







Generis Farmacêutica, S.A.




Office Park da Beloura, Edifício 4,




Quinta da Beloura




2710-444 Sintra




Portugal






Modafinil Generis


100 mg


tablets


oral use




Slovakia







Teva Pharmaceuticals CR, s.r.o.,




Radlická 3185/1c




150 00, Prague,




Czech Republic






Modafinil-Teva 100 mg


100 mg


tablets


oral use




Slovakia







Torrex Chiesi Pharma GmbH,




Gonzagagasse 16/16,




1010, Vienna,




Austria






VIGIL 100 mg


100 mg


tablets


oral use




Spain







CEPHALON FRANCE,




20, Rue Charles Martigny




94700 Maisons Alfort




France






MODIODAL


100 mg


tablets


oral use




Spain







TEVA GENERICOS ESPAÑOLA, S.L




Guzmán el Bueno 133,




Edificio Britania 4oIzq..




28003 Madrid




Spain






MODAFINILO TEVA


100 mg


tablets


oral use




Sweden







Cephalon France,




20, rue Charles Martigny




94700 Maisons Alfort




France






Modiodal®


100 mg


tablets


oral use




Sweden







Teva Sweden AB,




Box 1070




251 10 Helsingborg,




Sverige






Modafinil Teva


100 mg


tablets


oral use




United Kingdom







Cephalon UK Limited




1 Albany Place Hyde Way




Welwyn Garden City




Hertfordshire AL7 3BT




United Kingdon






Provigil 100mg Tablets


100mg


tablets


oral use




United Kingdom







Cephalon UK Limited




1 Albany Place Hyde Way




Welwyn Garden City




Hertfordshire AL7 3BT




United Kingdom






Provigil 200mg Tablets


200 mg


tablets


oral use




United Kingdom







Teva UK Limited,




Brampton Road, Hampden Park, Eastbourne,




East Sussex BN22 9AG




United Kingdom






Modafinil 100mg Tablets


100 mg


tablets


oral use







ANNEX VI

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES











Member State EU/EEA


Applicant


Invented Name


Strength


Pharmaceutical Form


Route of administration




Austria







ALFRED E. TIEFENBACHER




(GmbH & Co. KG)




Van-der-Smissen-Strasse 1




22767 Hamburg




Germany






Galantamin STADA 8 mg Retardtabletten


8 mg


Prolonged-release tablet


Oral use




Austria







ALFRED E. TIEFENBACHER




(GmbH & Co. KG)




Van-der-Smissen-Strasse 1




22767 Hamburg




Germany






Galantamin STADA 16 mg Retardtabletten


16 mg


Prolonged-release tablet


Oral use




Austria







ALFRED E. TIEFENBACHER




(GmbH & Co. KG)




Van-der-Smissen-Strasse 1




22767 Hamburg




Germany






Galantamin STADA 24 mg Retardtabletten


24 mg


Prolonged-release tablet


Oral use




Czech Republic







ALFRED E. TIEFENBACHER




(GmbH & Co. KG)




Van-der-Smissen-Strasse 1




22767 Hamburg




Germany






GALASTAD 8 mg


8 mg


Prolonged-release tablet


Oral use




Czech Republic







ALFRED E. TIEFENBACHER




(GmbH & Co. KG)




Van-der-Smissen-Strasse 1




22767 Hamburg




Germany






GALASTAD 16 mg


16 mg


Prolonged-release tablet


Oral use




Czech Republic







ALFRED E. TIEFENBACHER




(GmbH & Co. KG)




Van-der-Smissen-Strasse 1




22767 Hamburg




Germany






GALASTAD 24 mg


24 mg


Prolonged-release tablet


Oral use




Denmark







STADA Arzneimittel GmbH




Muthgasse 36




1190 Wien




Austria






Galantamin STADA


8 mg


Prolonged-release tablet


Oral use




Denmark







STADA Arzneimittel GmbH




Muthgasse 36




1190 Wien




Austria






Galantamin STADA


16 mg


Prolonged-release tablet


Oral use




Denmark







STADA Arzneimittel GmbH




Muthgasse 36




1190 Wien




Austria






Galantamin STADA


24 mg


Prolonged-release tablet


Oral use




Finland







STADA Arzneimittel AG




Stadastraße 2-18




61118 Bad Vilbel




Germany






Galantamine Stada


8 mg


Prolonged-release tablet


Oral use




Finland







STADA Arzneimittel AG




Stadastraße 2-18




61118 Bad Vilbel




Germany






Galantamine Stada


16 mg


Prolonged-release tablet


Oral use




Finland







STADA Arzneimittel AG




Stadastraße 2-18




61118 Bad Vilbel




Germany






Galantamine Stada


24 mg


Prolonged-release tablet


Oral use




Ireland







STADA Arzneimittel GmbH




Muthgasse 36




1190 Wien




Austria






GALANTAX XL 8 mg prolonged-release tablets


8 mg


Prolonged-release tablet


Oral use




Ireland







STADA Arzneimittel GmbH




Muthgasse 36




1190 Wien




Austria






GALANTAX XL 16 mg prolonged-release tablets


16 mg


Prolonged-release tablet


Oral use




Ireland







STADA Arzneimittel GmbH




Muthgasse 36




1190 Wien




Austria






GALANTAX XL 24 mg prolonged-release tablets


24 mg


Prolonged-release tablet


Oral use




Portugal







STADA Arzneimittel GmbH




Muthgasse 36




1190 Wien




Austria






Galantamina Ciclum


8 mg


Prolonged-release tablet


Oral use




Portugal







STADA Arzneimittel GmbH




Muthgasse 36




1190 Wien




Austria






Galantamina Ciclum


16 mg


Prolonged-release tablet


Oral use




Portugal







STADA Arzneimittel GmbH




Muthgasse 36




1190 Wien




Austria






Galantamina Ciclum


24 mg


Prolonged-release tablet


Oral use




Slovak Republic







ALFRED E. TIEFENBACHER




(GmbH & Co. KG)




Van-der-Smissen-Strasse 1




22767 Hamburg




Germany






Galantamine Tiefenbacher 8 mg tablety s predĺženým uvoľňovaním


8 mg


Prolonged-release tablet


Oral use




Slovak Republic







ALFRED E. TIEFENBACHER




(GmbH & Co. KG)




Van-der-Smissen-Strasse 1




22767 Hamburg




Germany






Galantamine Tiefenbacher 16 mg tablety s predĺženým uvoľňovaním


16 mg


Prolonged-release tablet


Oral use




Slovak Republic







ALFRED E. TIEFENBACHER




(GmbH & Co. KG)




Van-der-Smissen-Strasse 1




22767 Hamburg




Germany






Galantamine Tiefenbacher 24 mg tablety s predĺženým uvoľňovaním


24 mg


Prolonged-release tablet


Oral use




Spain







ALFRED E. TIEFENBACHER




(GmbH & Co. KG)




Van-der-Smissen-Strasse 1




22767 Hamburg




Germany






GALANTAMINA Tiefenbacher 8 mg comprimidos de liberación prolongada


8 mg


Prolonged-release tablet


Oral use




Spain







ALFRED E. TIEFENBACHER




(GmbH & Co. KG)




Van-der-Smissen-Strasse 1




22767 Hamburg




Germany






GALANTAMINA Tiefenbacher 16 mg comprimidos de liberación prolongada


16 mg


Prolonged-release tablet


Oral use




Spain







ALFRED E. TIEFENBACHER




(GmbH & Co. KG)




Van-der-Smissen-Strasse 1




22767 Hamburg




Germany






GALANTAMINA Tiefenbacher 24 mg comprimidos de liberación prolongada


24 mg


Prolonged-release tablet


Oral use