EN Official Journal of the European Union C 236/7

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 August 2006 to 31 August 2006

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

(2006/C 236/03)

— Issuing, maintenance or modification of a national marketing authorisation

Date of the decision Name(s) of the medicinal product Holder(s) of the marketing authorization Member State concerned Date of notification 4.8.2006 Neurontin See Annex I See Annex I 8.8.2006 10.8.2006 Thelin Encysive (UK) Limited Alder Castle House 10 Noble Street London EC2V 7QJ United Kingdom The Decision is sent to all member States. 11.8.2006 21.8.2006 Prozac See Annex II See Annex II 23.8.2006 21.8.2006 Cobactan IV 4;5% See Annex III See Annex III 23.8.2006 21.8.2006 Ceftriaxone Tyrol Pharma See Annex IV See Annex IV 23.8.2006 28.8.2006 Exjade Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom The Decision is sent to all member States. 30.8.2006

— 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 28.8.2006 Cetirizine Copyfarm See Annex V See Annex V 30.8.2006

(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 FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State Marketing Authorisation Holder Applicant Invented Name Strength Pharmaceutical Form Route of administration Austria Pfizer Corporation Austria Gesellschaft m.b.H. Floridsdorfer Hauptstraße 1 A-1210 Wien Neurontin 300 mg Capsules, hard Oral use Austria Pfizer Corporation Austria Gesellschaft m.b.H. Floridsdorfer Hauptstraße 1 A-1210 Wien Neurontin 400 mg Capsules, hard Oral use Austria Pfizer Corporation Austria Gesellschaft m.b.H. Floridsdorfer Hauptstraße 1 A-1210 Wien Neurontin 600 mg Film-coated tablets Oral use Austria Pfizer Corporation Austria Gesellschaft m.b.H. Floridsdorfer Hauptstraße 1 A-1210 Wien Neurontin 800 mg Film-coated tablets Oral use Belgium Pfizer S.A. Boulevard de la Plaine, 17 B-1050 Bruxelles Neurontin 100 mg Capsules, hard Oral use Belgium Pfizer S.A. Boulevard de la Plaine, 17 B-1050 Bruxelles Neurontin 300 mg Capsules, hard Oral use Belgium Pfizer S.A. Boulevard de la Plaine, 17 B-1050 Bruxelles Neurontin 400 mg Capsules, hard Oral use Belgium Pfizer S.A. Boulevard de la Plaine, 17 B-1050 Bruxelles Neurontin 600 mg Film-coated tablets Oral use Belgium Pfizer S.A. Boulevard de la Plaine, 17 B-1050 Bruxelles Neurontin 800 mg Film-coated tablets Oral use Czech Republic Pfizer spol S R.O. Stroupežnického17 CZ-15000 Praha 5 Neurontin 100 mg Capsules, hard Oral use Czech Republic Pfizer spol S R.O. Stroupežnického17 CZ-15000 Praha 5 Neurontin 300 mg Capsules, hard Oral use Czech Republic Pfizer spol S R.O. Stroupežnického17 CZ-15000 Praha 5 Neurontin 400 mg Capsules, hard Oral use Czech Republic Pfizer spol S R.O. Stroupežnického17 CZ-15000 Praha 5 Neurontin 600 mg Film-coated tablets Oral use Czech Republic Pfizer spol S R.O. Stroupežnického17 CZ-15000 Praha 5 Neurontin 800 mg Film-coated tablets Oral use Cyprus Pfizer Hellas A.E. 243, Messoghion Ave., Neo Psychiko GR-154 51 Neurontin 300 mg Capsules, hard Oral use Cyprus Pfizer Hellas A.E. 243, Messoghion Ave., Neo Psychiko GR-154 51 Neurontin 400 mg Capsules, hard Oral use Denmark Pfizer Aps. Lautrupvang 8 DK-2750 Ballerup Gabapentin ‘Pfizer’ 300 mg Capsules, hard Oral use Denmark Pfizer Aps. Lautrupvang 8 DK-2750 Ballerup Gabapentin ‘Pfizer’ 400 mg Capsules, hard Oral use Denmark Pfizer Aps. Lautrupvang 8 DK-2750 Ballerup Gabapentin ‘Pfizer’ 600 mg Film-coated tablets Oral use Denmark Pfizer Aps. Lautrupvang 8 DK-2750 Ballerup Gabapentin ‘Pfizer’ 800 mg Film-coated tablets Oral use Estonia Pfizer Europe MA EEIG Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom Neurontin 100 mg Capsules, hard Oral use Estonia Pfizer Europe MA EEIG Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom Neurontin 300 mg Capsules, hard Oral use Estonia Pfizer Europe MA EEIG Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom Neurontin 400 mg Capsules, hard Oral use Estonia Pfizer Europe MA EEIG Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom Neurontin 600 mg Film-coated tablets Oral use Estonia Pfizer Europe MA EEIG Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom Neurontin 800 mg Film-coated tablets Oral use Finland Pfizer Oy Tietokuja 4 FIN-00330 Helsinki Neurontin 300 mg Capsules, hard Oral use Finland Pfizer Oy Tietokuja 4 FIN-00330 Helsinki Neurontin 400 mg Capsules, hard Oral use Finland Pfizer Oy Tietokuja 4 FIN-00330 Helsinki Neurontin 600 mg Film-coated tablets Oral use Finland Pfizer Oy Tietokuja 4 FIN-00330 Helsinki Neurontin 800 mg Film-coated tablets Oral use France Pfizer 23-25, avenue du Docteur Lannelongue F-75668 Paris Cedex 14 Neurontin 100 mg Capsules, hard Oral use France Pfizer 23-25, avenue du Docteur Lannelongue F-75668 Paris Cedex 14 Neurontin 300 mg Capsules, hard Oral use France Pfizer 23-25, avenue du Docteur Lannelongue F-75668 Paris Cedex 14 Neurontin 400 mg Capsules, hard Oral use France Pfizer 23-25, avenue du Docteur Lannelongue F-75668 Paris Cedex 14 Neurontin 600 mg Film-coated tablets Oral use France Pfizer 23-25, avenue du Docteur Lannelongue F-75668 Paris Cedex 14 Neurontin 800 mg Film-coated tablets Oral use Germany Parke-Davis GmbH Pfizerstrasse 1 D-76139 Karlsruhe Neurontin 100 mg Capsules, hard Oral use Germany Parke-Davis GmbH Pfizerstrasse 1 D-76139 Karlsruhe Neurontin 300 mg Capsules, hard Oral use Germany Parke-Davis GmbH Pfizerstrasse 1 D-76139 Karlsruhe Neurontin 400 mg Capsules, hard Oral use Germany Parke-Davis GmbH Pfizerstrasse 1 D-76139 Karlsruhe Neurontin 600 mg Film-coated tablets Oral use Germany Parke-Davis GmbH Pfizerstrasse 1 D-76139 Karlsruhe Neurontin 800 mg Film-coated tablets Oral use Greece Pfizer Hellas 243 Messoghion Ave. Neo Psychiko GR-154 51 Neurontin 100 mg Capsules, hard Oral use Greece Pfizer Hellas 243 Messoghion Ave. Neo Psychiko GR-154 51 Neurontin 300 mg Capsules, hard Oral use Greece Pfizer Hellas 243 Messoghion Ave. Neo Psychiko GR-154 51 Neurontin 400 mg Capsules, hard Oral use Greece Pfizer Hellas 243 Messoghion Ave. Neo Psychiko GR-154 51 Neurontin 600 mg Film-coated tablets Oral use Greece Pfizer Hellas 243 Messoghion Ave. Neo Psychiko GR-154 51 Neurontin 800 mg Film-coated tablets Oral use Iceland Pfizer Aps Lautrupvang 8 DK-2750 Ballerup Neurontin 100 mg Capsules, hard Oral use Iceland Pfizer Aps Lautrupvang 8 DK-2750 Ballerup Neurontin 300 mg Capsules, hard Oral use Iceland Pfizer Aps Lautrupvang 8 DK-2750 Ballerup Neurontin 400 mg Capsules, hard Oral use Iceland Pfizer Aps Lautrupvang 8 DK-2750 Ballerup Neurontin 600 mg Film-coated tablets Oral use Iceland Pfizer Aps Lautrupvang 8 DK-2750 Ballerup Neurontin 800 mg Film-coated tablets Oral use Ireland Pfizer Healthcare Ireland 9 Riverwalk National Digital Pk Citywest Business Campus Dublin 24 Ireland c/o Pfizer Ltd Walton Oaks Dorking Road Tadworth Surrey KT20 7NS Neurontin 100 mg Capsules, hard Oral use Ireland Pfizer Healthcare Ireland 9 Riverwalk National Digital Pk Citywest Business Campus Dublin 24 Ireland c/o Pfizer Ltd Walton Oaks Dorking Road Tadworth Surrey KT20 7NS Neurontin 300 mg Capsules, hard Oral use Ireland Pfizer Healthcare Ireland 9 Riverwalk National Digital Pk Citywest Business Campus Dublin 24 Ireland c/o Pfizer Ltd Walton Oaks Dorking Road Tadworth Surrey KT20 7NS Neurontin 400 mg Capsules, hard Oral use Ireland Pfizer Healthcare Ireland 9 Riverwalk National Digital Pk Citywest Business Campus Dublin 24 Ireland c/o Pfizer Ltd Walton Oaks Dorking Road Tadworth Surrey KT20 7NS Neurontin 600 mg Film-coated tablets Oral use Ireland Pfizer Healthcare Ireland 9 Riverwalk National Digital Pk Citywest Business Campus Dublin 24 Irlande c/o Pfizer Ltd Walton Oaks Dorking Road Tadworth Surrey KT20 7NS Neurontin 800 mg Film-coated tablets Oral use Hungary Pfizer Kft. H-1123 Budapest Alkotás u. 53. MOM Park ‘F’ épület Neurontin 100 mg Capsules, hard Oral use Hungary Pfizer Kft. H-1123 Budapest Alkotás u. 53. MOM Park ‘F’ épület Neurontin 300 mg Capsules, hard Oral use Hungary Pfizer Kft. H-1123 Budapest Alkotás u. 53. MOM Park ‘F’ épület Neurontin 400 mg Capsules, hard Oral use Hungary Pfizer Kft. H-1123 Budapest Alkotás u. 53. MOM Park ‘F’ épület Neurontin 600 mg Film-coated tablets Oral use Hungary Pfizer Kft. H-1123 Budapest Alkotás u. 53. MOM Park ‘F’ épület Neurontin 800 mg Film-coated tablets Oral use Italy Pfizer Italia S.r.l. Via Valbondione, 113 I-00188 Roma Neurontin 100 mg Capsules, hard Oral use Italy Pfizer Italia S.r.l. Via Valbondione, 113 I-00188 Roma Neurontin 300 mg Capsules, hard Oral use Italy Pfizer Italia S.r.l. Via Valbondione, 113 I-00188 Roma Neurontin 400 mg Capsules, hard Oral use Latvia Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Neurontin 100 mg Capsules, hard Oral use Latvia Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Neurontin 300 mg Capsules, hard Oral use Latvia Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Neurontin 400 mg Capsules, hard Oral use Latvia Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Neurontin 600 mg Film-coated tablets Oral use Latvia Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Neurontin 800 mg Film-coated tablets Oral use Lithuania Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Neurontin 100 mg Capsules, hard Oral use Lithuania Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Neurontin 300 mg Capsules, hard Oral use Lithuania Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Neurontin 400 mg Capsules, hard Oral use Lithuania Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Neurontin 600 mg Film-coated tablets Oral use Lithuania Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Neurontin 800 mg Film-coated tablets Oral use Luxembourg Pfizer S.A. Boulevard de la Plaine, 17 B-1050 Bruxelles Neurontin 100 mg Capsules, hard Oral use Luxembourg Pfizer S.A. Boulevard de la Plaine, 17 B-1050 Bruxelles Neurontin 300 mg Capsules, hard Oral use Luxembourg Pfizer S.A. Boulevard de la Plaine, 17 B-1050 Bruxelles Neurontin 400 mg Capsules, hard Oral use Luxembourg Pfizer S.A. Boulevard de la Plaine, 17 B-1050 Bruxelles Neurontin 600 mg Film-coated tablets Oral use Luxembourg Pfizer S.A. Boulevard de la Plaine, 17 B-1050 Bruxelles Neurontin 800 mg Film-coated tablets Oral use Malta Pfizer Hellas A.E. Alketou 5 GR-11633 Athens Neurontin 100 mg Capsules, hard Oral use Malta Pfizer Hellas A.E. Alketou 5 GR-11633 Athens Neurontin 300 mg Capsules, hard Oral use Malta Pfizer Hellas A.E. Alketou 5 GR-11633 Athens Neurontin 400 mg Capsules, hard Oral use Malta Pfizer Hellas A.E. Alketou 5 GR-11633 Athens Neurontin 600 mg Film-coated tablets Oral use Norway Pfizer AS Postboks 3 N-1324 Lysaker Neurontin 100 mg Capsules, hard Oral use Norway Pfizer AS Postboks 3 N-1324 Lysaker Neurontin 300 mg Capsules, hard Oral use Norway Pfizer AS Postboks 3 N-1324 Lysaker Neurontin 400 mg Capsules, hard Oral use Norway Pfizer AS Postboks 3 N-1324 Lysaker Neurontin 600 mg Film-coated tablets Oral use Norway Pfizer AS Postboks 3 N-1324 Lysaker Neurontin 800 mg Film-coated tablets Oral use Poland Parke-Davis GmbH Pfizerstr 1, D-76139 Karlsruhe Neurontin 100 mg Capsules, hard Oral use Poland Parke-Davis GmbH Pfizerstr 1, D-76139 Karlsruhe Neurontin 300 mg Capsules, hard Oral use Poland Parke-Davis GmbH Pfizerstr 1, D-76139 Karlsruhe Neurontin 400 mg Capsules, hard Oral use Poland Pfizer Polska Sp. z o.o. ul. Rzymowskiego 28 PL-02-697 Warszawa Neurontin 600 mg Film-coated tablets Oral use Poland Pfizer Polska Sp. z o.o. ul. Rzymowskiego 28 PL-02-697 Warszawa Neurontin 800 mg Film-coated tablets Oral use Portugal Laboratórios Pfizer Lda. Lagoas Park Edifício no 10 P-2740-271 Porto Salvo Neurontin 100 mg Capsules, hard Oral use Portugal Laboratórios Pfizer Lda. Lagoas Park Edifício no 10 P-2740-271 Porto Salvo Neurontin 300 mg Capsules, hard Oral use Portugal Laboratórios Pfizer Lda. Lagoas Park Edifício no 10 P-2740-271 Porto Salvo Neurontin 400 mg Capsules, hard Oral use Portugal Laboratórios Pfizer Lda. Lagoas Park Edifício no 10 P-2740-271 Porto Salvo Neurontin 600 mg Film-coated tablets Oral use Portugal Laboratórios Pfizer Lda. Lagoas Park Edifício no 10 P-2740-271 Porto Salvo Neurontin 800 mg Film-coated tablets Oral use The Netherlands Pfizer BV Rivium Westlaan 142 2909 LD Capelle a/d IJssel Nederland Neurontin 100 mg Capsules, hard Oral use The Netherlands Pfizer BV Rivium Westlaan 142 2909 LD Capelle a/d IJssel Nederland Neurontin 300 mg Capsules, hard Oral use The Netherlands Pfizer BV Rivium Westlaan 142 2909 LD Capelle a/d IJssel Nederland Neurontin 400 mg Capsules, hard Oral use The Netherlands Pfizer BV Rivium Westlaan 142 2909 LD Capelle a/d IJssel Nederland Neurontin 600 mg Film-coated tablets Oral use The Netherlands Pfizer BV Rivium Westlaan 142 2909 LD Capelle a/d IJssel Nederland Neurontin 800 mg Film-coated tablets Oral use Slovenia Pfizer Luxembourg SARL 283, route d'Arlon L-8011 Strassen Neurontin 100 mg Capsules, hard Oral use Slovenia Pfizer Luxembourg SARL 283, route d'Arlon L-8011 Strassen Neurontin 300 mg Capsules, hard Oral use Slovenia Pfizer Luxembourg SARL 283, route d'Arlon L-8011 Strassen Neurontin 400 mg Capsules, hard Oral use Slovenia Pfizer Luxembourg SARL 283, route d'Arlon L-8011 Strassen Neurontin 600 mg Film-coated tablets Oral use Slovenia Pfizer Luxembourg SARL 283, route d'Arlon L-8011 Strassen Neurontin 800 mg Film-coated tablets Oral use The Slovak Republic Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Contact address: Pfizer Luxembourg SARL Branch office Dubravska cesta 2, SK-841 04 Bratislava Neurontin 100 mg Capsules, hard Oral use The Slovak Republic Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Contact address: Pfizer Luxembourg SARL Branch office Dubravska cesta 2, SK-841 04 Bratislava Neurontin 300 mg Capsules, hard Oral use The Slovak Republic Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Contact address: Pfizer Luxembourg SARL Branch office Dubravska cesta 2, SK-841 04 Bratislava Neurontin 400 mg Capsules, hard Oral use The Slovak Republic Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Contact address: Pfizer Luxembourg SARL Branch office Dubravska cesta 2, SK-841 04 Bratislava Neurontin 600 mg Film-coated tablets Oral use The Slovak Republic Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Contact address: Pfizer Luxembourg SARL Branch office Dubravska cesta 2, SK-841 04 Bratislava Neurontin 800 mg Film-coated tablets Oral use Spain Parke-Davis, S.L. Avda. de Europa 20 B. Parque Empresarial La Moraleja E-28108 Alcobendas Neurontin 300 mg Capsules, hard Oral use Spain Parke-Davis, S.L. Avda. de Europa 20 B. Parque Empresarial La Moraleja E-28108 Alcobendas Neurontin 400 mg Capsules, hard Oral use Spain Parke-Davis, S.L. Avda. de Europa 20 B. Parque Empresarial La Moraleja E-28108 Alcobendas Neurontin 600 mg Film-coated tablets Oral use Spain Parke-Davis, S.L. Avda. de Europa 20 B. Parque Empresarial La Moraleja E-28108 Alcobendas Neurontin 800 mg Film-coated tablets Oral use Sweden Pfizer AB S-191 90 Sollentuna Neurontin 100 mg Capsules, hard Oral use Sweden Pfizer AB S-191 90 Sollentuna Neurontin 300 mg Capsules, hard Oral use Sweden Pfizer AB S-191 90 Sollentuna Neurontin 400 mg Capsules, hard Oral use Sweden Pfizer AB S-191 90 Sollentuna Neurontin 600 mg Film-coated tablets Oral use Sweden Pfizer AB S-191 90 Sollentuna Neurontin 800 mg Film-coated tablets Oral use United Kingdom Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom c/o Walton Oaks Dorking Road Tadworth Surrey KT20 7NS Neurontin 100 mg Capsules, hard Oral use United Kingdom Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom c/o Walton Oaks Dorking Road Tadworth Surrey KT20 7NS Neurontin 300 mg Capsules, hard Oral use United Kingdom Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom c/o Walton Oaks Dorking Road Tadworth Surrey KT20 7NS Neurontin 400 mg Capsules, hard Oral use United Kingdom Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom c/o Walton Oaks Dorking Road Tadworth Surrey KT20 7NS Neurontin 600 mg Film-coated tablets Oral use United Kingdom Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom c/o Walton Oaks Dorking Road Tadworth Surrey KT20 7NS Neurontin 800 mg Film-coated tablets Oral use

ANNEX II LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of administration Austria Eli Lilly Ges.m.b.H. Kölblgasse 8-10 A-1030 Wien Fluctine 20 mg/5 ml Oral solution Oral use Austria Eli Lilly Ges.m.b.H. Kölblgasse 8-10 A-1030 Wien Fluctine 20 mg Capsule, hard Oral use Belgium Eli Lilly Benelux S.A. rue de l'Étuve 52 Stoofstraat B-1000 Brussel Prozac 20 mg Capsule, hard Oral use Belgium Eli Lilly Benelux S.A. rue de l'Étuve 52 Stoofstraat B-1000 Brussel Prozac 20 mg/5 ml Oral solution Oral use Belgium Eli Lilly Benelux S.A. rue de l'Étuve 52 Stoofstraat B-1000 Brussel Fontex 20 mg Capsule, hard Oral use Belgium Eli Lilly Benelux S.A. rue de l'Étuve 52 Stoofstraat B-1000 Brussel Fluoxetine ‘Lilly’ 20 mg Capsule, hard Oral use France Lilly France S.A.S. 13, rue Pagès F-92158 Suresnes Cedex Prozac 20 mg Capsule, hard Oral use France Lilly France S.A.S. 13, rue Pagès F-92158 Suresnes Cedex Prozac 20 mg/5 ml Oral solution Oral use France Lilly France S.A.S. 13, rue Pagès F-92158 Suresnes Cedex Fluoxétine Lilly 20 mg Capsule, hard Oral use France LICO SARL 203, Bureaux de la Colline F-92213 Saint Cloud Fluoxétine RPG 20 mg Capsule, hard Oral use Germany Lilly Deutschland GmbH Saalburgstr. 153 D-61350 Bad Homburg Germany Fluctin 20 mg Capsule, hard Oral use Germany Lilly Deutschland GmbH Saalburgstr. 153 D-61350 Bad Homburg Fluctin 20 mg/5 ml Oral solution Oral use Greece Pharmaserve-Lilly S.A.C.I 15th KLM National Road Athens-Lamia GR-145 64 Kifissia Ladose 20 mg/5 ml Oral Solution Oral use Greece Pharmaserve-Lilly S.A.C.I 15th KLM National Road Athens-Lamia GR-145 64 Kifissia Ladose 20 mg Capsule, hard Oral use Ireland Eli Lilly & Co Ltd Kingsclere road Basingstoke Hampshire RG21 6XA United Kingdom Prozac 20 mg/5 mg Oral solution Oral use Ireland Eli Lilly & Co Ltd Kingsclere road Basingstoke Hampshire RG21 6XA United Kingdom Prozac 20 mg Capsule, hard Oral use Italy Eli Lilly Italia S.p.A. Via Gramsci 731/733 I-50019 Sesto Fiorentino (Fi) Prozac 20 mg/5 ml Oral Solution Oral use Italy Eli Lilly Italia S.p.A. Via Gramsci 731/733 I-50019 Sesto Fiorentino (Fi) Prozac 20 mg Capsule, hard Oral use Luxembourg Eli Lilly Benelux S.A Rue de l'Étuve 52 Stoofstraat B-1000 Brussel Prozac 20 mg Capsule, hard Oral use Luxembourg Eli Lilly Benelux S.A Rue de l'Étuve 52 Stoofstraat B-1000 Brussel Fontex 20 mg Capsule, hard Oral use Luxembourg Eli Lilly Benelux S.A Rue de l'Étuve 52 Stoofstraat B-1000 Brussel Prozac 20 mg/5 ml Oral Solution Oral use Portugal Lilly Portugal Produtos Farmacêuticos, Lda. Rua Dr. António Loureiro Borges 1 Piso 1 Arquiparque Miraflores 1499-016 Algés — Portugal Prozac 20 mg Capsule, hard Oral use Portugal Lilly Portugal Produtos Farmacêuticos, Lda. Rua Dr. António Loureiro Borges 1 Piso 1 Arquiparque Miraflores 1499-016 Algés — Portugal Prozac 20 mg/5 ml Oral Solution Oral use Spain Dista S.A. Avenida Industria 30 E-28108 Alcobendas — Madrid Prozac 20 mg/5 ml Oral solution Oral use Spain Dista S.A. Avenida Industria 30 E-28108 Alcobendas — Madrid Prozac 20 mg Capsule, hard Oral use Sweden Eli Lilly Sweden AB Gustav III:s boulevard 42 P.O. Box 721 S-16927 Solna Fontex 20 mg/5 ml Oral Solution Oral use The Netherlands Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland Prozac 20 mg/5 ml Oral solution Oral use The Netherlands Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland Prozac 20 mg Capsule, hard Oral use UK Eli Lilly and Co Ltd Kingsclere road Basingstoke Hampshire RG21 6XA United Kingdom Prozac 20 mg/5 ml Oral Solution Oral use UK Eli Lilly and Co Ltd Kingsclere road Basingstoke Hampshire RG21 6XA United Kingdom Prozac 20 mg Capsule, hard Oral use

ANNEX III NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER Member State Marketing Authorisation Holder Applicant Product invented name Pharmaceutical form Strength Animal species Frequency and route of administration Recommended dose Austria Intervet Gesmbh Siemensstrasse 107 A-1210 Wien Cobactan Powder and solvent for solution for injection 45 mg/ml Horse (adult and foal) Once or twice daily; Intravenous and intramuscular use 1mg cefquinome/kg bw (1 ml reconstituted solution/45 kg bw) Belgium Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer Nederland Cobactan 4.5 % Powder and solvent for solution for injection 45 mg/ml Horse (adult and foal) Once or twice daily; Intravenous and intramuscular use 1mg cefquinome/kg bw (1 ml reconstituted solution/45 kg bw) Denmark Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer Nederland Cobactan Vet. Powder and solvent for solution for injection 45 mg/ml Horse (adult and foal) Once or twice daily; Intravenous and intramuscular use 1mg cefquinome/kg bw (1 ml reconstituted solution/45 kg bw) Germany Intervet Deutschland GmbH Feldstr. 1a D-85716 Unterschleissheim Cobactan IV 4.5 % Powder and solvent for solution for injection 45 mg/ml Horse (adult and foal) Once or twice daily; Intravenous and intramuscular use 1mg cefquinome/kg bw (1 ml reconstituted solution/45 kg bw) Greece Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer Nederland Cobactan IV IM 4.5 % Powder and solvent for solution for injection 45 mg/ml Horse (adult and foal) Once or twice daily; Intravenous and intramuscular use 1mg cefquinome/kg bw (1 ml reconstituted solution/45 kg bw) Spain Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer Nederland Cobactan 4.5 % Powder and solvent for solution for injection 45 mg/ml Horse (adult and foal) Once or twice daily; Intravenous and intramuscular use 1mg cefquinome/kg bw (1 ml reconstituted solution/45 kg bw) France Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer Nederland Cobactan IV IM 4.5 % Powder and solvent for solution for injection 45 mg/ml Horse (adult and foal) Once or twice daily; Intravenous and intramuscular use 1mg cefquinome/kg bw (1 ml reconstituted solution/45 kg bw) Hungary Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer Nederland Cobactan IV 4.5 % A.U.V. Powder and solvent for solution for injection 45 mg/ml Horse (adult and foal) Once or twice daily; Intravenous and intramuscular use 1mg cefquinome/kg bw (1 ml reconstituted solution/45 kg bw) Ireland Intervet Ireland Magna Drive Magna Business Park Citywest Road Dublin 24 Ireland Cephaguard IV IM 4.5 % Powder and solvent for solution for injection 45 mg/ml Horse (adult and foal) Once or twice daily; Intravenous and intramuscular use 1mg cefquinome/kg bw (1 ml reconstituted solution/45 kg bw) Italy Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer Nederland Cobactan 4.5 % IV IM Powder and solvent for solution for injection 45 mg/ml Horse (adult and foal) Once or twice daily; Intravenous and intramuscular use 1mg cefquinome/kg bw (1 ml reconstituted solution/45 kg bw) Luxembourg Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer Nederland Cobactan 4.5 % Powder and solvent for solution for injection 45 mg/ml Horse (adult and foal) Once or twice daily; Intravenous and intramuscular use 1mg cefquinome/kg bw (1 ml reconstituted solution/45 kg bw) Netherlands Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer Nederland Cobactan 4.5 % Powder and solvent for solution for injection 45 mg/ml Horse (adult and foal) Once or twice daily; Intravenous and intramuscular use 1mg cefquinome/kg bw (1 ml reconstituted solution/45 kg bw) Poland Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer Nederland Cobactan 4.5 % Powder and solvent for solution for injection 45 mg/ml Horse (adult and foal) Once or twice daily; Intravenous and intramuscular use 1mg cefquinome/kg bw (1 ml reconstituted solution/45 kg bw) Portugal Intervet Portugal Lda. Estrada Nacional 249 PT-2725-397 Mem Martins Cobactan 4.5 % Powder and solvent for solution for injection 45 mg/ml Horse (adult and foal) Once or twice daily; Intravenous and intramuscular use 1mg cefquinome/kg bw (1 ml reconstituted solution/45 kg bw) United Kingdom Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer Nederland Cephaguard IV IM 4.5 % Powder and solvent for solution for injection 45 mg/ml Horse (adult and foal) Once or twice daily; Intravenous and intramuscular use 1mg cefquinome/kg bw (1 ml reconstituted solution/45 kg bw)

ANNEX IV LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, APPLICANTS, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES Member State Marketing Authorisation Holder Applicant Name Strength Pharmaceutical Form Route of administration Germany Sandoz GmbH Biochemiestrasse 10 A-6250 Kundl — Ceftriaxon Tyrol Pharma 1 g Pulver zur Herstellung einer Injektions- oder Infusionslösung 1 g Powder for solution for injection or infusion Intramuscular and intravenous use Germany Sandoz GmbH Biochemiestrasse 10 A-6250 Kundl — Ceftriaxon Tyrol Pharma 2 g Pulver zur Herstellung einer Infusionslösung 2 g Powder for solution for infusion Intravenous use Finland — Sandoz A/S C.F. Tietgens Boulevard 40 DK-5220 Odense SØ Lendacin 1 g injektio-/infuusiokuiva-aine liuosta varten 1 g Powder for solution for injection or infusion Intramuscular and intravenous use Finland — Sandoz A/S C.F. Tietgens Boulevard 40 DK-5220 Odense SØ Lendacin 2 g infuusiokuiva-aine liuosta varten 2 g Powder for solution for infusion Intravenous use United Kingdom — Sandoz Limited Woolmer way Bordon Hants GU35 9QE United Kingdom Ceftriaxone 1 g powder for solution for injection/infusion 1 g Powder for solution for injection or infusion Intramuscular and intravenous use United Kingdom — Sandoz Limited Woolmer way Bordon Hants GU35 9QE United Kingdom Ceftriaxone 2 g powder for solution for infusion 2 g Powder for solution for infusion Intravenous use