EN Official Journal of the European Union C 61/18

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2010 to 31 December 2010

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

2011/C 61/02

— 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 13.12.2010 Lipitor and associated names See Annex I See Annex I 14.12.2010 3.12.2010 Prevora See Annex II See Annex II 6.12.2010 29.11.2010 Leflunomide ratiopharm Ratiopharm GmbH, Graf-Arco-Straße 3, D-89079 Ulm, Deutschland These Decisions are addressed to the Member States 1.12.2010 13.12.2010 Revlimid Celgene Europe Limited, Riverside House, Riverside Walk, Windsor, Berkshire SL4 1NA, United Kingdom These Decisions are addressed to the Member States 14.12.2010





— Suspension of a national marketing authorization

Date of the decision Name(s) of the medicinal product Holder(s) of the marketing authorization Member State concerned Date of notification 29.11.2010 Ketoprofen containing topical products See Annex III See Annex III 1.12.2010

(1) OJ L 311, 28.11.2001, p. 67.

(2) OJ L 311, 28.11.2001, p. 1.

ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, 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 Austria Pfizer Corporation Austria Ges.m.b.H. Floridsdorfer Hauptstrasse 1 A - 1210 Wien Austria Sortis 10 mg - Filmtabletten 10 mg Film-coated tablet Oral use Austria Pfizer Corporation Austria Ges.m.b.H. Floridsdorfer Hauptstrasse 1 A - 1210 Wien Austria Sortis 20 mg - Filmtabletten 20 mg Film-coated tablet Oral use Austria Pfizer Corporation Austria Ges.m.b.H. Floridsdorfer Hauptstrasse 1 A - 1210 Wien Austria Sortis 40 mg - Filmtabletten 40 mg Film-coated tablet Oral use Austria Pfizer Corporation Austria Ges.m.b.H. Floridsdorfer Hauptstrasse 1 A - 1210 Wien Austria Sortis 80 mg - Filmtabletten 80 mg Film-coated tablet Oral use Belgium Pfizer SA Boulevard de la Plaine 17 B-1050 Brussels Belgium Lipitor 10 mg Film-coated tablet Oral use Belgium Pfizer SA Boulevard de la Plaine 17 B-1050 Brussels Belgium Lipitor 20 mg Film-coated tablet Oral use Belgium Pfizer SA Boulevard de la Plaine 17 B-1050 Brussels Belgium Lipitor 40 mg Film-coated tablet Oral use Belgium Pfizer SA Boulevard de la Plaine 17 B-1050 Brussels Belgium Lipitor 80 mg Film-coated tablet Oral use Bulgaria Pfizer Europe MA EEIG, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom Sortis 10 mg Film-coated tablet Oral use Bulgaria Pfizer Europe MA EEIG, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom Sortis 20 mg Film-coated tablet Oral use Bulgaria Pfizer Europe MA EEIG, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom Sortis 40 mg Film-coated tablet Oral use Bulgaria Pfizer Europe MA EEIG, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom Sortis 80 mg Film-coated tablet Oral use Cyprus Pfizer Hellas A. E. 243, Messoghion Ave., 154 51 Νeo Psychiko, Athens Greece Lipitor 10 mg Film-coated tablet Oral use Cyprus Pfizer Hellas A. E. 243, Messoghion Ave., 154 51 Νeo Psychiko, Athens Greece Lipitor 20 mg Film-coated tablet Oral use Cyprus Pfizer Hellas A. E. 243, Messoghion Ave., 154 51 Νeo Psychiko, Athens Greece Lipitor 40 mg Film-coated tablet Oral use Czech Republic Pfizer. s r.o Stroupežnického 17 150 00 Prague 5 Czech Republic Sortis 10 mg Film-coated tablet Oral use Czech Republic Pfizer. s r.o Stroupežnického 17 150 00 Prague 5 Czech Republic Sortis 20 mg Film-coated tablet Oral use Czech Republic Pfizer. s r.o Stroupežnického 17 150 00 Prague 5 Czech Republic Sortis 40 mg Film-coated tablet Oral use Czech Republic Pfizer. s r.o Stroupežnického 17 150 00 Prague 5 Czech Republic Sortis 80 mg Film-coated tablet Oral use Denmark Pfizer ApS Lautrupvang 8 2750 Ballerup Denmark Zarator 10 mg Film-coated tablet Oral use Denmark Pfizer ApS Lautrupvang 8 2750 Ballerup Denmark Zarator 20 mg Film-coated tablet Oral use Denmark Pfizer ApS Lautrupvang 8 2750 Ballerup Denmark Zarator 40 mg Film-coated tablet Oral use Denmark Pfizer ApS Lautrupvang 8 2750 Ballerup Denmark Zarator 80 mg Film-coated tablet Oral use Estonia Pfizer Europe MA EEIG, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom Sortis 10 mg Film-coated tablet Oral use Estonia Pfizer Europe MA EEIG, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom Sortis 20 mg Film-coated tablet Oral use Estonia Pfizer Europe MA EEIG, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom Sortis 40 mg Film-coated tablet Oral use Estonia Pfizer Europe MA EEIG, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom Sortis 80 mg 80 mg Film-coated tablet Oral use Finland Pfizer Oy Tietokuja 4 00330 Helsinki Finland Lipitor 10 mg Film-coated tablet Oral use Finland Pfizer Oy Tietokuja 4 00330 Helsinki Finland Lipitor 20 mg Film-coated tablet Oral use Finland Pfizer Oy Tietokuja 4 00330 Helsinki Finland Lipitor 40 mg Film-coated tablet Oral use Finland Pfizer Oy Tietokuja 4 00330 Helsinki Finland Lipitor 80 mg Film-coated tablet Oral use Finland Pfizer Oy Tietokuja 4 00330 Helsinki Finland Orbeos 10 mg Film-coated tablet Oral use Finland Pfizer Oy Tietokuja 4 00330 Helsinki Finland Orbeos 20 mg Film-coated tablet Oral use Finland Pfizer Oy Tietokuja 4 00330 Helsinki Finland Orbeos 40 mg Film-coated tablet Oral use Finland Pfizer Oy Tietokuja 4 00330 Helsinki Finland Orbeos 80 mg Film-coated tablet Oral use France Pfizer Holding France 23-25 Avenue du Docteur Lannelongue 75668 Paris Cedex 14 France Tahor 10 mg Film-coated tablet Oral use France Pfizer Holding France 23-25 Avenue du Docteur Lannelongue 75668 Paris Cedex 14 France Tahor 20 mg Film-coated tablet Oral use France Pfizer Holding France 23-25 Avenue du Docteur Lannelongue 75668 Paris Cedex 14 France Tahor 40 mg Film-coated tablet Oral use France Pfizer Holding France 23-25 Avenue du Docteur Lannelongue 75668 Paris Cedex 14 France Tahor 80 mg Film-coated tablet Oral use Germany Pfizer Pharma GmbH Linkstraße 10 10785 Berlin Germany Sortis 10 mg 10 mg Film-coated tablet Oral use Germany Pfizer Pharma GmbH Linkstraße 10 10785 Berlin Germany Sortis 20 mg 20 mg Film-coated tablet Oral use Germany Pfizer Pharma GmbH Linkstraße 10 10785 Berlin Germany Sortis 40 mg 40 mg Film-coated tablet Oral use Germany Pfizer Pharma GmbH Linkstraße 10 10785 Berlin Germany Sortis 80 mg 80 mg Film-coated tablet Oral use Germany Pfizer Pharma GmbH Linkstraße 10 10785 Berlin Germany Liprimar 10 mg 10 mg Film-coated tablet Oral use Germany Pfizer Pharma GmbH Linkstraße 10 10785 Berlin Germany Liprimar 20 mg 20 mg Film-coated tablet Oral use Germany Pfizer Pharma GmbH Linkstraße 10 10785 Berlin Germany Liprimar 40 mg 40 mg Film-coated tablet Oral use Germany Pfizer Pharma GmbH Linkstraße 10 10785 Berlin Germany Liprimar 80 mg 80 mg Film-coated tablet Oral use Germany Pfizer Pharma GmbH Linkstraße 10 10785 Berlin Germany Atorvastatin Pfizer 10 mg 10 mg Film-coated tablet Oral use Germany Pfizer Pharma GmbH Linkstraße 10 10785 Berlin Germany Atorvastatin Pfizer 20 mg 20 mg Film-coated tablet Oral use Germany Pfizer Pharma GmbH Linkstraße 10 10785 Berlin Germany Atorvastatin Pfizer 40 mg 40 mg Film-coated tablet Oral use Germany Pfizer Pharma GmbH Linkstraße 10 10785 Berlin Germany Atorvastatin Pfizer 80 mg 80 mg Film-coated tablet Oral use Greece Pfizer Hellas A. E. 243, Messoghion Ave., 154 51 Νeo Psychiko, Athens Greece Lipitor 10 mg Film-coated tablet Oral use Greece Pfizer Hellas A. E. 243, Messoghion Ave., 154 51 Νeo Psychiko, Athens Greece Lipitor 20 mg Film-coated tablet Oral use Greece Pfizer Hellas A. E. 243, Messoghion Ave., 154 51 Νeo Psychiko, Athens Greece Lipitor 40 mg Film-coated tablet Oral use Greece Pfizer Hellas A. E. 243, Messoghion Ave., 154 51 Νeo Psychiko, Athens Greece Lipitor 80 mg Film-coated tablet Oral use Greece WIN MEDICA Ltd 41 Papadiamantopoulou Street 115 28 Ilisia, Athens Greece Zarator 10 mg Film-coated tablet Oral use Greece WIN MEDICA Ltd 41 Papadiamantopoulou Street 115 28 Ilisia, Athens Greece Zarator 20 mg Film-coated tablet Oral use Greece WIN MEDICA Ltd 41 Papadiamantopoulou Street 115 28 Ilisia, Athens Greece Zarator 40 mg Film-coated tablet Oral use Greece Pfizer Hellas A. E. 243, Messoghion Ave., 154 51 Νeo Psychiko, Athens, Greece Edovin 10 mg Film-coated tablet Oral use Greece Pfizer Hellas A. E. 243, Messoghion Ave., 154 51 Νeo Psychiko, Athens, Greece Edovin 20 mg Film-coated tablet Oral use Greece Pfizer Hellas A. E. 243, Messoghion Ave., 154 51 Νeo Psychiko, Athens, Greece Edovin 40 mg Film-coated tablet Oral use Hungary Pfizer KFT, 1123 Budapest, Alkotás u. 53. MOM Park ‘F’ Ép. Hungary Sortis 10 mg Film-coated tablet Oral use Hungary Pfizer KFT, 1123 Budapest, Alkotás u. 53. MOM Park ‘F’ Ép. Hungary Sortis 20 mg Film-coated tablet Oral use Hungary Pfizer KFT, 1123 Budapest, Alkotás u. 53. MOM Park ‘F’ Ép. Hungary Sortis 40 mg Film-coated tablet Oral use Hungary Pfizer KFT, 1123 Budapest, Alkotás u. 53. MOM Park ‘F’ Ép. Hungary Sortis 80 mg Film-coated tablet Oral use Hungary C.P. Pharma Gyógyszerkereskedelmi Kft. 2040 Budaörs Vasút u. 11., Hungary Obradon 10 mg Film-coated tablet Oral use Hungary C.P. Pharma Gyógyszerkereskedelmi Kft. 2040 Budaörs Vasút u. 11. Hungary Obradon 20 mg Film-coated tablet Oral use Hungary C.P. Pharma Gyógyszerkereskedelmi Kft. 2040 Budaörs Vasút u. 11. Hungary Obradon 40 mg Film-coated tablet Oral use Hungary C.P. Pharma Gyógyszerkereskedelmi Kft. 2040 Budaörs Vasút u. 11. Hungary Obradon 80 mg Film-coated tablet Oral use Iceland Pfizer ApS Lautrupvang 8 2750 Ballerup Denmark Zarator 10 mg Film-coated tablet Oral use Iceland Pfizer ApS Lautrupvang 8 2750 Ballerup Denmark Zarator 20 mg Film-coated tablet Oral use Iceland Pfizer ApS Lautrupvang 8 2750 Ballerup Denmark Zarator 40 mg Film-coated tablet Oral use Iceland Pfizer ApS Lautrupvang 8 2750 Ballerup Denmark Zarator 80 mg Film-coated tablet Oral use Ireland Pfizer Ireland Pharmaceuticals, Pottery Road, Dun Laoghaire, Co Dublin Ireland Lipitor 10 mg Film-coated tablet Oral use Ireland Pfizer Ireland Pharmaceuticals, Pottery Road, Dun Laoghaire, Co Dublin Ireland Lipitor 20 mg Film-coated tablet Oral use Ireland Pfizer Ireland Pharmaceuticals, Pottery Road, Dun Laoghaire, Co Dublin Ireland Lipitor 40 mg Film-coated tablet Oral use Ireland Pfizer Ireland Pharmaceuticals, Pottery Road, Dun Laoghaire, Co Dublin Ireland Lipitor 80 mg Film-coated tablet Oral use Italy Pfizer Italia S.r.l. Via Isonzo, 71 04100 Latina Italy Xarator 10 mg Film-coated tablet Oral use Italy Pfizer Italia S.r.l. Via Isonzo, 71 04100 Latina Italy Xarator 20 mg Film-coated tablet Oral use Italy Pfizer Italia S.r.l. Via Isonzo, 71 04100 Latina Italy Xarator 40 mg Film-coated tablet Oral use Italy Pfizer Italia S.r.l. Via Isonzo, 71 04100 Latina Italy Xarator 80 mg Film-coated tablet Oral use Italy Bioindustria Farmaceutici S.r.l Via Isonzo, 71 04100 Latina Italy Lipitor 10 mg Film-coated tablet Oral use Italy Bioindustria Farmaceutici S.r.l Via Isonzo, 71 04100 Latina Italy Lipitor 20 mg Film-coated tablet Oral use Italy Bioindustria Farmaceutici S.r.l Via Isonzo, 71 04100 Latina Italy Lipitor 40 mg Film-coated tablet Oral use Italy Bioindustria Farmaceutici S.r.l Via Isonzo, 71 04100 Latina Italy Lipitor 80 mg Film-coated tablet Oral use Italy Pfizer Italia S.r.l. Via Isonzo, 71 04100 Latina Italy Torvast 10 mg Film-coated tablet Oral use Italy Pfizer Italia S.r.l. Via Isonzo, 71 04100 Latina Italy Torvast 20 mg Film-coated tablet Oral use Italy Pfizer Italia S.r.l. Via Isonzo, 71 04100 Latina Italy Torvast 40 mg Film-coated tablet Oral use Italy Pfizer Italia S.r.l. Via Isonzo, 71 04100 Latina Italy Torvast 80 mg Film-coated tablet Oral use Italy Laboratori Guidotti S.p.A. Via Livornese 897 - La Vettola 56122 Pisa Italy Totalip 10 mg Film-coated tablet Oral use Italy Laboratori Guidotti S.p.A. Via Livornese 897 - La Vettola 56122 Pisa Italy Totalip 20 mg Film-coated tablet Oral use Italy Laboratori Guidotti S.p.A. Via Livornese 897 - La Vettola 56122 Pisa Italy Totalip 40 mg Film-coated tablet Oral use Italy Laboratori Guidotti S.p.A. Via Livornese 897 - La Vettola 56122 Pisa Italy Totalip 80 mg Film-coated tablet Oral use Latvia Pfizer Limited Ramsgate Road, Sandwich Kent CT13 9NJ United Kingdom Sortis 10 mg Film-coated tablet Oral use Latvia Pfizer Limited Ramsgate Road, Sandwich Kent CT13 9NJ United Kingdom Sortis 20 mg Film-coated tablet Oral use Latvia Pfizer Limited Ramsgate Road, Sandwich Kent CT13 9NJ United Kingdom Sortis 40 mg Film-coated tablet Oral use Latvia Pfizer Limited Ramsgate Road, Sandwich Kent CT13 9NJ United Kingdom Sortis 80 mg Film-coated tablet Oral use Lithuania Pfizer Limited Ramsgate Road, Sandwich Kent CT13 9NJ United Kingdom Sortis 10 mg Film-coated tablet Oral use Lithuania Pfizer Limited Ramsgate Road, Sandwich Kent CT13 9NJ United Kingdom Sortis 20 mg Film-coated tablet Oral use Lithuania Pfizer Limited Ramsgate Road, Sandwich Kent CT13 9NJ United Kingdom Sortis 40 mg Film-coated tablet Oral use Lithuania Pfizer Limited Ramsgate Road, Sandwich Kent CT13 9NJ United Kingdom Sortis 80 mg Film-coated tablet Oral use Luxembourg Pfizer SA Boulevard de la Plaine 17 B-1050 Brussels Belgium Lipitor 10 mg Film-coated tablet Oral use Luxembourg Pfizer SA Boulevard de la Plaine 17 B-1050 Brussels Belgium Lipitor 20 mg Film-coated tablet Oral use Luxembourg Pfizer SA Boulevard de la Plaine 17 B-1050 Brussels Belgium Lipitor 40 mg Film-coated tablet Oral use Luxembourg Pfizer SA Boulevard de la Plaine 17 B-1050 Brussels Belgium Lipitor 80 mg Film-coated tablet Oral use Malta Pfizer Hellas S.A. 243, Messoghion Ave., 154 51 Νeo Psychiko, Athens, Greece Lipitor 10 mg Film-coated tablet Oral use Malta Pfizer Hellas S.A. 243, Messoghion Ave., 154 51 Νeo Psychiko, Athens, Greece Lipitor 20 mg Film-coated tablet Oral use Malta Pfizer Hellas S.A. 243, Messoghion Ave., 154 51 Νeo Psychiko, Athens, Greece Lipitor 40 mg Film-coated tablet Oral use Malta Pfizer Hellas S.A. 243, Messoghion Ave., 154 51 Νeo Psychiko, Athens, Greece Lipitor 80 mg Film-coated tablet Oral use Netherlands Pfizer bv Rivium Westlaan 142 2909 LD Capelle a/d IJssel The Netherlands Lipitor 10 10 mg Film-coated tablet Oral use Netherlands Pfizer bv Rivium Westlaan 142 2909 LD Capelle a/d IJssel The Netherlands Lipitor 20 20 mg Film-coated tablet Oral use Netherlands Pfizer bv Rivium Westlaan 142 2909 LD Capelle a/d IJssel The Netherlands Lipitor 40 40 mg Film-coated tablet Oral use Netherlands Pfizer bv Rivium Westlaan 142 2909 LD Capelle a/d IJssel The Netherlands Lipitor 80 80 mg Film-coated tablet Oral use Norway Pfizer AS Pb. 3 1324 Lysaker Norway Lipitor 10 mg Film-coated tablet Oral use Norway Pfizer AS Pb. 3 1324 Lysaker Norway Lipitor 20 mg Film-coated tablet Oral use Norway Pfizer AS Pb. 3 1324 Lysaker Norway Lipitor 40 mg Film-coated tablet Oral use Norway Pfizer AS Pb. 3 1324 Lysaker Norway Lipitor 80 mg Film-coated tablet Oral use Poland Pfizer Europe MA EEIG, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom Sortis 10 10 mg Film-coated tablet Oral use Poland Pfizer Europe MA EEIG, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom Sortis 20 20 mg Film-coated tablet Oral use Poland Pfizer Europe MA EEIG, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom Sortis 40 40 mg Film-coated tablet Oral use Poland Pfizer Polska Sp.z o.o. ul. Rzymowskiego 28 02-697 Warszawa Poland Sortis 80 80 mg Film-coated tablet Oral use Portugal Laboratorios Pfizer, Lda. Lagoas Park, Edifício 10 2740-271 Porto Salvo Portugal Zarator 10 mg Film-coated tablet Oral use Portugal Laboratorios Pfizer, Lda. Lagoas Park, Edifício 10 2740-271 Porto Salvo Portugal Zarator 20 mg Film-coated tablet Oral use Portugal Laboratorios Pfizer, Lda. Lagoas Park, Edifício 10 2740-271 Porto Salvo Portugal Zarator 40 mg Film-coated tablet Oral use Portugal Laboratorios Pfizer, Lda. Lagoas Park, Edifício 10 2740-271 Porto Salvo Portugal Zarator 80 mg Film-coated tablet Oral use Portugal Parke-Davis - Produtos Farmaceuticos Lda. Lagoas Park, Edifício 10 2740-271 Porto Salvo Portugal Atorvastatina Parke-Davis 10 mg Film-coated tablet Oral use Portugal Parke-Davis - Produtos Farmaceuticos Lda. Lagoas Park, Edifício 10 2740-271 Porto Salvo Portugal Atorvastatina Parke-Davis 20 mg Film-coated tablet Oral use Portugal Parke-Davis - Produtos Farmaceuticos Lda. Lagoas Park, Edifício 10 2740-271 Porto Salvo Portugal Atorvastatina Parke-Davis 40 mg Film-coated tablet Oral use Portugal Parke-Davis - Produtos Farmaceuticos Lda. Lagoas Park, Edifício 10 2740-271 Porto Salvo Portugal Atorvastatina Parke-Davis 80 mg Film-coated tablet Oral use Portugal Farmogene - Produtos Farmacêuticos, Lda Lagoas Park, Edifício 10 2740-271 Porto Salvo Portugal Texzor 10 mg Film-coated tablet Oral use Portugal Farmogene - Produtos Farmacêuticos, Lda Lagoas Park, Edifício 10 2740-271 Porto Salvo Portugal Texzor 20 mg Film-coated tablet Oral use Portugal Farmogene - Produtos Farmacêuticos, Lda Lagoas Park, Edifício 10 2740-271 Porto Salvo Portugal Texzor 40 mg Film-coated tablet Oral use Portugal Farmogene - Produtos Farmacêuticos, Lda Lagoas Park, Edifício 10 2740-271 Porto Salvo Portugal Texzor 80 mg Film-coated tablet Oral use Romania Pfizer Europe MA EEIG Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom Sortis 10 mg Film-coated tablet Oral use Romania Pfizer Europe MA EEIG Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom Sortis 20 mg Film-coated tablet Oral use Romania Pfizer Europe MA EEIG Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom Sortis 40 mg Film-coated tablet Oral use Romania Pfizer Europe MA EEIG Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom Sortis 80 mg Film-coated tablet Oral use Slovak Republic Pfizer Europe MA EEIG Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom Sortis 10 mg Film-coated tablet Oral use Slovak Republic Pfizer Europe MA EEIG Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom Sortis 20 mg Film-coated tablet Oral use Slovak Republic Pfizer Europe MA EEIG Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom Sortis 40 mg Film-coated tablet Oral use Slovak Republic Pfizer Europe MA EEIG Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom Sortis 80 mg Film-coated tablet Oral use Slovenia Pfizer Luxembourg SARL 51, Avenue J. F. Kennedy L-1855 Luxembourg Luxembourg Sortis 10 mg filmsko obložene tablete 10 mg Film-coated tablet Oral use Slovenia Pfizer Luxembourg SARL 51, Avenue J. F. Kennedy L-1855 Luxembourg Luxembourg Sortis 20 mg filmsko obložene tablete 20 mg Film-coated tablet Oral use Slovenia Pfizer Luxembourg SARL 51, Avenue J. F. Kennedy L-1855 Luxembourg Luxembourg Sortis 40 mg filmsko obložene tablete 40 mg Film-coated tablet Oral use Slovenia Pfizer Luxembourg SARL 51, Avenue J. F. Kennedy L-1855 Luxembourg Luxembourg Sortis 80 mg filmsko obložene tablete 80 mg Film-coated tablet Oral use Spain Parke Davis. S.L. Avda. de Europa 20B Parque Empresarial la Moraleja 28108 Alcobendas, (Madrid) Spain Zarator 10 mg comprimidos recubiertos con película 10 mg Film-coated tablet Oral use Spain Parke Davis. S.L. Avda. de Europa 20B Parque Empresarial la Moraleja 28108 Alcobendas, (Madrid) Spain Zarator 20 mg comprimidos recubiertos con película 20 mg Film-coated tablet Oral use Spain Parke Davis. S.L. Avda. de Europa 20B Parque Empresarial la Moraleja 28108 Alcobendas, (Madrid) Spain Zarator 40 mg comprimidos recubiertos con película 40 mg Film-coated tablet Oral use Spain Parke Davis. S.L. Avda. de Europa 20B Parque Empresarial la Moraleja 28108 Alcobendas, (Madrid) Spain Zarator 80 mg comprimidos recubiertos con película 80 mg Film-coated tablet Oral use Spain Pfizer, S.A. Avda. de Europa 20B Parque Empresarial la Moraleja 28108 Alcobendas, (Madrid) Spain Cardyl 10 mg comprimidos recubiertos con película 10 mg Film-coated tablet Oral use Spain Pfizer, S.A. Avda. de Europa 20B Parque Empresarial la Moraleja 28108 Alcobendas, (Madrid) Spain Cardyl 20 mg comprimidos recubiertos con película 20 mg Film-coated tablet Oral use Spain Pfizer, S.A. Avda. de Europa 20B Parque Empresarial la Moraleja 28108 Alcobendas, (Madrid) Spain Cardyl 40 mg comprimidos recubiertos con película 40 mg Film-coated tablet Oral use Spain Pfizer, S.A. Avda. de Europa 20B Parque Empresarial la Moraleja 28108 Alcobendas, (Madrid) Spain Cardyl 80 mg comprimidos recubiertos con película 80 mg Film-coated tablet Oral use Spain Nostrum Farma, S.A., Avda. de Europa 20B Parque Empresarial la Moraleja 28108 Alcobendas, (Madrid) Spain Atorvastatina Nostrum 10 mg comprimidos recubiertos con película 10 mg Film-coated tablet Oral use Spain Nostrum Farma, S.A., Avda. de Europa 20B Parque Empresarial la Moraleja 28108 Alcobendas, (Madrid) Spain Atorvastatina Nostrum 20 mg comprimidos recubiertos con película 20 mg Film-coated tablet Oral use Spain Nostrum Farma, S.A., Avda. de Europa 20B Parque Empresarial la Moraleja 28108 Alcobendas, (Madrid) Spain Atorvastatina Nostrum 40 mg comprimidos recubiertos con película 40 mg Film-coated tablet Oral use Spain Nostrum Farma, S.A., Avda. de Europa 20B Parque Empresarial la Moraleja 28108 Alcobendas, (Madrid) Spain Atorvastatina Nostrum 80 mg comprimidos recubiertos con película 80 mg Film-coated tablet Oral use Spain PHARMACIA GRUPO PFIZER, S.L. Avda. de Europa 20B Parque Empresarial la Moraleja 28108 Alcobendas, (Madrid) Spain Atorvastatina Pharmacia 10 mg comprimidos recubiertos con película 10 mg Film-coated tablet Oral use Spain PHARMACIA GRUPO PFIZER, S.L. Avda. de Europa 20B Parque Empresarial la Moraleja 28108 Alcobendas, (Madrid) Spain Atorvastatina Pharmacia 20 mg comprimidos recubiertos con película 20 mg Film-coated tablet Oral use Spain PHARMACIA GRUPO PFIZER, S.L. Avda. de Europa 20B Parque Empresarial la Moraleja 28108 Alcobendas, (Madrid) Spain Atorvastatina Pharmacia 40 mg comprimidos recubiertos con película 40 mg Film-coated tablet Oral use Spain PHARMACIA GRUPO PFIZER, S.L. Avda. de Europa 20B Parque Empresarial la Moraleja 28108 Alcobendas, (Madrid) Spain Atorvastatina Pharmacia 80 mg comprimidos recubiertos con película 80 mg Film-coated tablet Oral use Spain Almirall S.A. General Mitre, 151 08022 - Barcelona Spain Prevencor 10 mg comprimidos recubiertos con película 10 mg Film-coated tablet Oral use Spain Almirall S.A. General Mitre, 151 08022 - Barcelona Spain Prevencor 20 mg comprimidos recubiertos con película 20 mg Film-coated tablet Oral use Spain Almirall S.A. General Mitre, 151 08022 - Barcelona Spain Prevencor 40 mg comprimidos recubiertos con película 40 mg Film-coated tablet Oral use Spain Almirall S.A. General Mitre, 151 08022 - Barcelona Spain Prevencor 80 mg comprimidos recubiertos con película 80 mg Film-coated tablet Oral use Sweden Pfizer AB 191 90 Sollentuna Sweden Lipitor 10 mg Film-coated tablet Oral use Sweden Pfizer AB 191 90 Sollentuna Sweden Lipitor 20 mg Film-coated tablet Oral use Sweden Pfizer AB 191 90 Sollentuna Sweden Lipitor 40 mg Film-coated tablet Oral use Sweden Pfizer AB 191 90 Sollentuna Sweden Lipitor 80 mg Film-coated tablet Oral use United Kingdom Pfizer Ireland Pharmaceuticals, Pottery Road Dun Laoghaire, Co Dublin Ireland Lipitor 10 mg Film-coated tablet Oral use United Kingdom Pfizer Ireland Pharmaceuticals, Pottery Road Dun Laoghaire, Co Dublin Ireland Lipitor 20 mg Film-coated tablet Oral use United Kingdom Pfizer Ireland Pharmaceuticals, Pottery Road Dun Laoghaire, Co Dublin Ireland Lipitor 40 mg Film-coated tablet Oral use United Kingdom Pfizer Ireland Pharmaceuticals, Pottery Road Dun Laoghaire, Co Dublin Ireland Lipitor 80 mg Film-coated tablet Oral use

ANNEX II LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANT, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES Member State EU/EEA Marketing authorisation holder Applicant (Invented) Name Strength Pharmaceutical form Route of administration Content (concentration) Ireland CHX Technologies Europe Limited Guinness Enterprise Centre Taylor’s Lane Dublin 8, Ireland Prevora 100 mg/ml Dental Solution 100 mg per ml solution Dental solution Dental use (supra-gingival to the hard tissue only) 100 mg/ml United Kingdom CHX Technologies Europe Limited Guinness Enterprise Centre Taylor’s Lane Dublin 8, Ireland Prevora 100 mg/ml Dental Solution 100 mg per ml solution Dental solution Dental use (supra-gingival to the hard tissue only) 100 mg/ml