ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS, PACKAGING AND PACKAGE SIZES IN THE MEMBER STATES EMEA 2002 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged ANNEX I Marketing Authorisation Route of Member State Invented name Strength Pharmaceutical Form Packaging Package-size Holder administration Austria Bayer Austria Gesellschaft Lipobay 0.1 mg Film-coated tablet Oral use Blister 14, 20, 28, 30, G.m.b.H. 50, 98, 100 and Lerchenfelder Guertel 9-11 160 tablets A-1164 Wien Austria Bayer Austria Gesellschaft Lipobay 0.2 mg Film-coated tablet Oral use Blister 14, 20, 28, 30, G.m.b.H. 50, 98, 100 and Lerchenfelder Guertel 9-11 160 tablets A-1164 Wien Austria Bayer Austria Gesellschaft Lipobay 0.3 mg Film-coated tablet Oral use Blister 30 tablets G.m.b.H. Lerchenfelder Guertel 9-11 A-1164 Wien Austria Bayer Austria Gesellschaft Lipobay 0.4 mg Film-coated tablet Oral use Blister 30 tablets G.m.b.H. Lerchenfelder Guertel 9-11 A-1164 Wien Austria Bayer Austria Gesellschaft Liposterol 0.4 mg Film-coated tablet Oral use Blister 30 tablets G.m.b.H. Lerchenfelder Guertel 9-11 A-1164 Wien CPMP/811/02 1 EMEA 2002 Belgium Bayer NV Lipobay 0.1 mg Film-coated tablet Oral use Blister 14, 20, 28, 30, Louizalaan 143 50, 98, 100 and B-1050 Brussel 160 tablets Belgium Belgium Bayer NV Lipobay 0.2 mg Film-coated tablet Oral use Blister 14, 20, 28, 30, Louizalaan 143 50, 98, 100 and B-1050 Brussel 160 tablets Belgium Belgium Bayer NV Lipobay 0.3 mg Film-coated tablet Oral use Blister 14, 20, 28, 30, Louizalaan 143 50, 98, 100 and B-1050 Brussel 160 tablets Belgium Belgium Bayer NV Lipobay 0.4 mg Film-coated tablet Oral use Blister 14, 20, 28, 30, Louizalaan 143 50, 98, 100 and B-1050 Brussel 160 tablets Belgium Belgium Fournier Pharma S.A. Cholstat 0.4 mg Film-coated tablet Oral use Blister 14, 20, 28, 30, Rue des Trois Arbres, 16b 50, 98, 100 and B-1180 Bruxelles 160 tablets Belgium Denmark Bayer AG Lipobay 0.1 mg Film-coated tablet Oral use Blister 28 tablets Monheim D-51368 Leverkusen Germany CPMP/811/02 2 EMEA 2002 Denmark Bayer AG Lipobay 0.2 mg Film-coated tablet Oral use Blister 28 and 98 tablets Monheim D-51368 Leverkusen Germany Denmark Bayer AG Lipobay 0.3 mg Film-coated tablet Oral use Blister 28 and 98 tablets Monheim D-51368 Leverkusen Germany Denmark Bayer AG Lipobay 0.4 mg Film-coated tablet Oral use Blister 28 and 98 tablets Monheim D-51368 Leverkusen Germany Finland Bayer AG Lipobay 0.1 mg Film-coated tablet Oral use Blister 14, 20, 28, 30, Monheim 50, 98, 100 and D-51369 Leverkusen 160 tablets Germany Finland Bayer AG Lipobay 0.2 mg Film-coated tablet Oral use Blister 14, 20, 28, 30, Monheim 50, 98, 100 and D-51369 Leverkusen 160 tablets Germany Finland Bayer AG Lipobay 0.3 mg Film-coated tablet Oral use Blister 14, 20, 28, 30, Monheim 50, 98, 100 and D-51369 Leverkusen 160 tablets Germany CPMP/811/02 3 EMEA 2002 Finland Bayer AG Lipobay 0.4 mg Film-coated tablet Oral use Blister 14, 20, 28, 30, Monheim 50, 98, 100 and D-51369 Leverkusen 160 tablets Germany France Fournier Cholstat 0.1 mg Film-coated tablet Oral use Blister 14, 20, 28, 30, 9, rue Petitot 50, 98, 100 F-21000 Dijon tablets 160 tablets (hospital) France Fournier Cholstat 0.2 mg Film-coated tablet Oral use Blister 14, 20, 28 and 9, rue Petitot 30 tablets F-21000 Dijon 50, 98, 100 and 160 tablets (hospital) France Fournier Cholstat 0.3 mg Film-coated tablet Oral use Blister 14, 20, 28 and 9, rue Petitot 30 tablets F-21000 Dijon 50, 98, 100 and 160 tablets (hospital) France Fournier Cholstat 0.4 mg Film-coated tablet Oral use Blister 14, 20, 28 and 9, rue Petitot 30 tablets F-21000 Dijon 50, 98, 100 and 160 tablets (hospital) CPMP/811/02 4 EMEA 2002 France Bayer Pharma Staltor 0.1 mg Film-coated tablet Oral use Blister 14, 20, 28, 30, 13, rue Jean Jaurès 50, 98, 100 F-92807 Puteaux Cedex tablets 160 tablets (hospital) France Bayer Pharma Staltor 0.2 mg Film-coated tablet Oral use Blister 14, 20, 28, 30, 13, rue Jean Jaurès 50, 98, 100 F-92807 Puteaux Cedex tablets 160 tablets (hospital) France Bayer Pharma Staltor 0.3 mg Film-coated tablet Oral use Blister 14, 20, 28 and 13, rue Jean Jaurès 30 tablets F-92807 Puteaux Cedex 50, 98, 100 and 160 tablets (hospital) France Bayer Pharma Staltor 0.4 mg Film-coated tablet Oral use Blister 14, 20, 28 and 13, rue Jean Jaurès 30 tablets F-92807 Puteaux Cedex 50, 98, 100 and 160 tablets (hospital) Germany Bayer Vital GmbH & Co. Lipobay 0.1 mg Film-coated tablet Oral use Blister 30, 50, 100 (OP) KG 10x16 (AP) Geb. D162 D-51368 Leverkusen CPMP/811/02 5 EMEA 2002 Germany Bayer Vital GmbH & Co. Lipobay 0.2 mg Film-coated tablet Oral use Blister 30, 50, 100 (OP) KG 10x16 (AP) Geb. D162 D-51368 Leverkusen Germany Bayer Vital GmbH & Co. Lipobay 0.3 mg Film-coated tablet Oral use Blister 30, 50, 100 (OP) KG 10x16 (AP) Geb. D162 D-51368 Leverkusen Germany Bayer Vital GmbH & Co. Lipobay 0.4 mg Film-coated tablet Oral use Blister 20, 30, 50, 100 KG (OP) Geb. D162 160 (AP) D-51368 Leverkusen 20 (UM) Germany Bayer AG Pharma Vazqol 0.1 mg Film-coated tablet Oral use Blister 30, 50, 100 (OP) Deutschland 10x16 (AP) D-51368 Leverkusen Germany Bayer AG Pharma Vazqol 0.2 mg Film-coated tablet Oral use Blister 30, 50, 100 (OP) Deutschland 10x16 (AP) D-51368 Leverkusen Germany Bayer AG Pharma Vazqol 0.3 mg Film-coated tablet Oral use Blister 30, 50, 100 (OP) Deutschland 10x16 (AP) D-51368 Leverkusen Germany Bayer AG Pharma Vazqol 0.4 mg Film-coated tablet Oral use Blister 20, 30, 50, 100 Deutschland (OP) D-51368 Leverkusen 160 (AP) 20 (UM) CPMP/811/02 6 EMEA 2002 Germany Fournier Pharma GmbH Zenas 0.1 mg Film-coated tablet Oral use Blister 30, 50, 100 (OP) Justus-von-Liebig-Str. 16 10x16 (AP) D-66280 Sulzbach Germany Fournier Pharma GmbH Zenas 0.2 mg Film-coated tablet Oral use Blister 30, 50, 100 (OP) Justus-von-Liebig-Str. 16 10x16 (AP) D-66280 Sulzbach Germany Fournier Pharma GmbH Zenas 0.3 mg Film-coated tablet Oral use Blister 30, 50, 100 (OP) Justus-von-Liebig-Str. 16 10x16 (AP) D-66280 Sulzbach Germany Fournier Pharma GmbH Zenas 0.4 mg Film-coated tablet Oral use Blister 20, 30, 50, 100 Justus-von-Liebig-Str. 16 (OP) D-66280 Sulzbach 20 (UM) Greece Bayer Hellas ABEE Lipoban 0.1 mg Film-coated tablet Oral use Blister 14, 28, 30, 50, Ακακίων 54Α 98 and 100 GR-15125 Μαρούσι Αθήνα tablets Greece Bayer Hellas ABEE Lipoban 0.2 mg Film-coated tablet Oral use Blister 14, 28, 30, 50, Ακακίων 54Α 98 and 100 GR-15125 Μαρούσι Αθήνα tablets Greece Bayer Hellas ABEE Lipoban 0.3 mg Film-coated tablet Oral use Blister 14, 28, 30, 50, Ακακίων 54Α 98 and 100 GR-15125 Μαρούσι Αθήνα tablets Greece Bayer Hellas ABEE Lipoban 0.4 mg Film-coated tablet Oral use Blister 14, 20, 28, 30, Ακακίων 54Α 50, 98, 100 and GR-15125 Μαρούσι Αθήνα 160 tablets CPMP/811/02 7 EMEA 2002 Greece Elpen AE Eltina 0.1 mg Film-coated tablet Oral use Blister 14, 28, 30, 50, 21ο χλµ Λεωφ. Μαραθώνα 98 and 100 GR- 19009 Πικέρµι Αττική tablets Greece Elpen AE Eltina 0.2 mg Film-coated tablet Oral use Blister 14, 28, 30, 50, 21ο χλµ Λεωφ. Μαραθώνα 98 and 100 GR- 19009 Πικέρµι Αττική tablets Greece Elpen AE Eltina 0.3 mg Film-coated tablet Oral use Blister 14, 28, 30, 50, 21ο χλµ Λεωφ. Μαραθώνα 98 and 100 GR- 19009 Πικέρµι Αττική tablets Greece Elpen AE Eltina 0.4 mg Film-coated tablet Oral use Blister 14, 20, 28, 30, 21ο χλµ Λεωφ. Μαραθώνα 50, 98, 100 and GR- 19009 Πικέρµι Αττική 160 tablets Iceland Bayer AG Lipobay 0.1 mg Film-coated tablet Oral use Blister 28 and 98 tablets Bayerwerk D-51368 Leverkusen Germany Iceland Bayer AG Lipobay 0.2 mg Film-coated tablet Oral use Blister 28 tablets Bayerwerk D-51368 Leverkusen Germany Iceland Bayer AG Lipobay 0.3 mg Film-coated tablet Oral use Blister 98 tablets Bayerwerk D-51368 Leverkusen Germany CPMP/811/02 8 EMEA 2002 Iceland Bayer AG Lipobay 0.4 mg Film-coated tablet Oral use Blister 28 and 98 tablets Bayerwerk D-51368 Leverkusen Germany Ireland Bayer PLC Lipobay 0.1 mg Film-coated tablet Oral use Blister 14, 20, 28, 30, Bayer House 50, 98, 100 and Strawberry Hill 160 tablets Newbury Berkshire RG14 1JA – UK, United Kingdom Ireland Bayer PLC Lipobay 0.2 mg Film-coated tablet Oral use Blister 14, 20, 28, 30, Bayer House 50, 98, 100 and Strawberry Hill 160 tablets Newbury Berkshire RG14 1JA – UK, United Kingdom Ireland Bayer PLC Lipobay 0.3 mg Film-coated tablet Oral use Blister 14, 20, 28, 30, Bayer House 50, 98, 100 and Strawberry Hill 160 tablets Newbury Berkshire RG14 1JA – UK, United Kingdom Ireland Bayer PLC Lipobay 0.4 mg Film-coated tablet Oral use Blister 14, 20, 28, 30, Bayer House 50, 98, 100 and Strawberry Hill 160 tablets Newbury Berkshire RG14 1JA – UK, United Kingdom CPMP/811/02 9 EMEA 2002 Italy Bayer S.p.A.