Not the law itself: Notice

Address https://gelex.eu/eli/EU/notice/oj/C/2005/334/08@2005-11-30/en

Contents

1. Preamble
2. ANNEX
3. ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES AND NORWAY AND ICELAND
4. ANNEX II LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES AND NORWAY AND ICELAND
5. ANNEX III LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES AND NORWAY AND ICELAND

Date of the decision Name(s) of the medicinal product Holder(s) of the marketing authorization Member State concerned Date of notification 28.11.2005 Celocoxib See Annex I See Annex I 29.11.2005 28.11.2005 Etoricoxib See Annex II See Annex II 29.11.2005 28.11.2005 Lumiracoxib See Annex III See Annex III 29.11.2005

ANNEX

ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES AND NORWAY AND ICELAND

Member State Marketing Authorisation Holder Invented name Strength Pharmaceutical Form Route of administration Österreich Pfizer Corporation Austria Ges.m.b.H. Seidengasse 33-35 A-1071 Wien Celebrex 100 mg Capsules Oral Pfizer Corporation Austria Ges.m.b.H. Seidengasse 33-35 A-1071 Wien Celebrex 200 mg Capsules Oral Pfizer Corporation Austria Ges.m.b.H. Seidengasse 33-35 A-1071 Wien Solexa 100 mg Capsules Oral Pfizer Corporation Austria Ges.m.b.H. Seidengasse 33-35 A-1071 Wien Solexa 200 mg Capsules Oral Belgique/België Pharmacia NV/SA Rijksweg 12 B-2870 Puurs Celebrex 100 mg Capsules Oral Pharmacia NV/SA Rijksweg 12 B-2870 Puurs Celebrex 200 mg Capsules Oral Pharmacia NV/SA Rijksweg 12 B-2870 Puurs Solexa 100 mg Capsules Oral Pharmacia NV/SA Rijksweg 12 B-2870 Puurs Solexa 200 mg Capsules Oral Κύπρος Markides & Vouros Ltd. 5a-B Pargas Str P.O.Box 22002 1515 Lefkosia Cyprus Celebrex 100 mg Capsules Oral Markides & Vouros Ltd. 5a-B Pargas Str P.O.Box 22002 1515 Lefkosia Cyprus Celebrex 200 mg Capsules Oral Česká republika Pharmacia Ltd. Davy Avenue Know Hill Milton Keynes MK5 8PH United Kingdom Celebrex 100 mg Capsules Oral Pharmacia Ltd. Davy Avenue Know Hill Milton Keynes MK5 8PH United Kingdom Celebrex 200 mg Capsules Oral Danmark Pfizer ApS Lautrupvang 8 DK-2750 Ballerup Celebra 100 mg Capsules Oral Pfizer ApS Lautrupvang 8 DK-2750 Ballerup Celebra 200 mg Capsules Oral Pfizer ApS Lautrupvang 8 DK-2750 Ballerup Solexa 100 mg Capsules Oral Pfizer ApS Lautrupvang 8 DK-2750 Ballerup Solexa 200 mg Capsules Oral Eesti Pfizer H.C.P. Corporation Eesti Pirita tee 20 EE-10127 Tallinn Celebrex 100 mg Capsules Oral Pfizer H.C.P. Corporation Eesti Pirita tee 20 EE-10127 Tallinn Celebrex 200 mg Capsules Oral Suomi Pfizer Oy Tietokuja 4 FIN-00330 Helsinki Celebra 100 mg Capsules Oral Pfizer Oy Tietokuja 4 FIN-00330 Helsinki Celebra 200 mg Capsules Oral Pfizer Oy Tietokuja 4 FIN-00330 Helsinki Solexa 100 mg Capsules Oral Pfizer Oy Tietokuja 4 FIN-00330 Helsinki Solexa 200 mg Capsules Oral France Pfizer Holding France 23-25, avenue du Docteur Lannelongue F-75668 Paris Cedex 14 Celebrex 100 mg Capsules Oral Pfizer Holding France 23-25, avenue du Docteur Lannelongue F-75668 Paris Cedex 14 Celebrex 200 mg Capsules Oral Cardel 23-25, avenue du Docteur Lannelongue F-75668 Paris Cedex 14 Solexa 100 mg Capsules Oral Cardel 23-25, avenue du Docteur Lannelongue F-75668 Paris Cedex 14 Solexa 200 mg Capsules Oral Deutschland Pharmacia GmbH Pfizerstr. 1 D-76139 Karlsruhe Celebra 200 mg Capsules Oral Pharmacia GmbH Pfizerstr. 1 D-76139 Karlsruhe Celebra 100 mg Capsules Oral Pharmacia GmbH Pfizerstr. 1 D-76139 Karlsruhe Celebrex 200 mg Capsules Oral Pharmacia GmbH Pfizerstr. 1 D-76139 Karlsruhe Celebrex 100 mg Capsules Oral Ελλάδα Pfizer Hellas A.E. 5, Alketou Street GR-116 33 Athens Celebrex 100 mg Capsules Oral Pfizer Hellas A.E. 5, Alketou Street GR-116 33 Athens Celebrex 200 mg Capsules Oral Pfizer Hellas A.E. 5, Alketou Street GR-116 33 Athens Aclarex 100 mg Capsules Oral Pfizer Hellas A.E. 5, Alketou Street GR-116 33 Athens Aclarex 200 mg Capsules Oral Magyarország Pfizer Kft. Alkotás utca 53. MOM Park F Épület H-1123 Budapest Celebrex 200 mg Capsules Oral Island Pfizer ApS Lautrupvang 8 DK-2750 Ballerup Celebra 100 mg Capsules Oral Pfizer ApS Lautrupvang 8 DK-2750 Ballerup Celebra 200 mg Capsules Oral Ireland Pharmacia Ireland Limited Airways Industrial Estate Dublin 17 Ireland Celebrex 100 mg Capsules Oral Pharmacia Ireland Limited Airways Industrial Estate Dublin 17 Ireland Celebrex 200 mg Capsules Oral Pharmacia Ireland Limited Airways Industrial Estate Dublin 17 Ireland Solexa 100 mg Capsules Oral Pharmacia Ireland Limited Airways Industrial Estate Dublin 17 Ireland Solexa 200 mg Capsules Oral Italia Pharmacia Italia S.p.A. Via Robert Koch, 1-2 I-20152 Milano Artilog 100 mg Capsules Oral Pharmacia Italia S.p.A. Via Robert Koch, 1-2 I-20152 Milano Artilog 200 mg Capsules Oral Sefarma S.r.l. Via Robert Koch, 1-2 I-20152 Milano Artrid 100 mg Capsules Oral Sefarma S.r.l. Via Robert Koch, 1-2 I-20152 Milano Artrid 200 mg Capsules Oral Pfizer Italia S.r.l. Strada Statale 156 KM 50 I-04010 Borgo San Michele, Latina Solexa 100 mg Capsules Oral Pfizer Italia S.r.l. Strada Statale 156 KM 50 I-04010 Borgo San Michele, Latina Solexa 200 mg Capsules Oral Pharmacia Italia S.p.A. Via Robert Koch, 1-2 I-20152 Milano Celebrex 100 mg Capsules Oral Pharmacia Italia S.p.A. Via Robert Koch, 1-2 I-20152 Milano Celebrex 200 mg Capsules Oral Latvija Pfizer Ltd. Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Celebrex 100 mg Capsules Oral Pfizer Ltd. Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Celebrex 200 mg Capsules Oral Lietuva Pfizer H.C.P. Corporation Representation Office in Lithuania A. Gostauto 40 a LT-01112 Vilnius Celebrex 100 mg Capsules Oral Pfizer H.C.P. Corporation Representation Office in Lithuania A. Gostauto 40 a LT-01112 Vilnius Celebrex 200 mg Capsules Oral Luxembourg Pharmacia NV/SA Rijksweg 12 B-2870 Puurs Celebrex 100 mg Capsules Oral Pharmacia NV/SA Rijksweg 12 B-2870 Puurs Celebrex 200 mg Capsules Oral Pharmacia NV/SA Rijksweg 12 B-2870 Puurs Solexa 100 mg Capsules Oral Pharmacia NV/SA Rijksweg 12 B-2870 Puurs Solexa 200 mg Capsules Oral Malta Pfizer Hellas A. E. 5, Alketou Street GR-116 33 Athens Celebrex 100 mg Capsules Oral Pfizer Hellas A. E. 5, Alketou Street GR-116 33 Athens Celebrex 200 mg Capsules Oral Norge Pfizer AS Postboks 3 N-1324 Lysaker Celebra 100 mg Capsules Oral Pfizer AS Postboks 3 N-1324 Lysaker Celebra 200 mg Capsules Oral Polska Pharmacia Ltd. Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Celebrex 100 mg Capsules Oral Pharmacia Ltd. Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Celebrex 200 mg Capsules Oral Portugal Laboratórios Pfizer, Lda. Lagoas Park, Edifício n.o 10 P-2740-244 Porto Salvo Celebrex 100 mg Capsules Oral Laboratórios Pfizer, Lda. Lagoas Park, Edifício n.o 10 P-2740-244 Porto Salvo Celebrex 200 mg Capsules Oral Lab. Medinfar — Produtos Farmacêuticos S.A. R. Manuel Ribeiro de Pavia, n.o 1 — Venda Nova P-2700-547 Amadora Solexa 100 mg Capsules Oral Lab. Medinfar — Produtos Farmacêuticos S.A. R. Manuel Ribeiro de Pavia, n.o 1 — Venda Nova P-2700-547 Amadora Solexa 200 mg Capsules Oral Slovenská republika Pfizer Europe MA EEIG Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Celebrex 100 mg Capsules Oral Pfizer Europe MA EEIG Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Celebrex 200 mg Capsules Oral Slovenija Pfizer Luxembourg SARL 283, route d'Arlon L-8011 Strassen Celebrex 100 mg Capsules Oral Pfizer Luxembourg SARL 283, route d'Arlon L-8011 Strassen Celebrex 200 mg Capsules Oral España Pharmacia Spain S.A. Avenida de Europa, 20-B Parque Empresarial La Moraleja E-28108 Alcobendas, Madrid Celebrex 100 mg Capsules Oral Pharmacia Spain S.A. Avenida de Europa, 20-B Parque Empresarial La Moraleja E-28108 Alcobendas, Madrid Artilog 100 mg Capsules Oral Pharmacia Spain S.A. Avenida de Europa, 20-B Parque Empresarial La Moraleja E-28108 Alcobendas, Madrid Celebrex 200 mg Capsules Oral Pharmacia Spain S.A. Avenida de Europa, 20-B Parque Empresarial La Moraleja E-28108 Alcobendas, Madrid Artilog 200 mg Capsules Oral Sverige Pfizer AB Nytorpsvägen 36 P.O. Box 501 S-183 25 Täby Celebra 100 mg Capsules Oral Pfizer AB Nytorpsvägen 36 P.O. Box 501 S-183 25 Täby Celebra 200 mg Capsules Oral Pfizer AB Nytorpsvägen 36 P.O. Box 501 S-183 25 Täby Solexa 100 mg Capsules Oral Pfizer AB Nytorpsvägen 36 P.O. Box 501 S-183 25 Täby Solexa 200 mg Capsules Oral Pfizer AB Nytorpsvägen 36 P.O. Box 501 S-183 25 Täby Celora 100 mg Capsules Oral Pfizer AB Nytorpsvägen 36 P.O. Box 501 S-183 25 Täby Celora 200 mg Capsules Oral Pfizer AB Nytorpsvägen 36 P.O. Box 501 S-183 25 Täby Aclarix 100 mg Capsules Oral Pfizer AB Nytorpsvägen 36 P.O. Box 501 S-183 25 Täby Aclarix 200 mg Capsules Oral Nederland Pfizer bv Rivium Westlaan 142 2909 LD Capelle a/d IJssel Nederland Celebrex 100 mg Capsules Oral Pfizer bv Rivium Westlaan 142 2909 LD Capelle a/d IJssel Nederland Celebrex 200 mg Capsules Oral Pfizer bv Rivium Westlaan 142 2909 LD Capelle a/d IJssel Nederland Solexa 100 mg Capsules Oral Pfizer bv Rivium Westlaan 142 2909 LD Capelle a/d IJssel Nederland Solexa 200 mg Capsules Oral United Kingdom Pfizer Ltd. Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Celebrex 100 mg Capsules Oral Pfizer Ltd. Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Celebrex 200 mg Capsules Oral Pfizer Ltd. Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Solexa 100 mg Capsules Oral Pfizer Ltd. Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Solexa 200 mg Capsules Oral

ANNEX II LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES AND NORWAY AND ICELAND

Member State Marketing Authorisation Holder Invented name Strength Pharmaceutical Form Route of administration Belgique/België Merck Sharp & Dohme BV Chaussée de Waterloo, 1135 B-1180 Bruxelles Arcoxia 60 mg Film-coated tablet Oral use Merck Sharp & Dohme BV Chaussée de Waterloo, 1135 B-1180 Bruxelles Arcoxia 90 mg Film-coated tablet Oral use Merck Sharp & Dohme BV Chaussée de Waterloo, 1135 B-1180 Bruxelles Arcoxia 120 mg Film-coated tablet Oral use Merck Sharp & Dohme BV Chaussée de Waterloo, 1135 B-1180 Bruxelles Ranacox 60 mg Film-coated tablet Oral use Merck Sharp & Dohme BV Chaussée de Waterloo, 1135 B-1180 Bruxelles Ranacox 90 mg Film-coated tablet Oral use Merck Sharp & Dohme BV Chaussée de Waterloo, 1135 B-1180 Bruxelles Ranacox 120 mg Film-coated tablet Oral use Κύπρος Merck Sharp & Dohme BV Waarderweg 39 Postbus 581 2003 PC Haarlem Nederland Arcoxia 60 mg Film-coated tablet Oral use Merck Sharp & Dohme BV Waarderweg 39 Postbus 581 2003 PC Haarlem Nederland Arcoxia 90 mg Film-coated tablet Oral use Merck Sharp & Dohme BV Waarderweg 39 Postbus 581 2003 PC Haarlem Nederland Arcoxia 120 mg Film-coated tablet Oral use Danmark Merck Sharp & Dohme BV Waarderweg 39 Postbus 581 2003 PC Haarlem Nederland Arcoxia 60 mg Film-coated tablet Oral use Merck Sharp & Dohme BV Waarderweg 39 Postbus 581 2003 PC Haarlem Nederland Arcoxia 90 mg Film-coated tablet Oral use Merck Sharp & Dohme BV Waarderweg 39 Postbus 581 2003 PC Haarlem Nederland Arcoxia 120 mg Film-coated tablet Oral use Deutschland MSD Sharp & Dohme GmbH Lindenplatz 1 D-85540 Haar Etoricoxib MSD 120 mg Film-coated tablet Oral use MSD Sharp & Dohme GmbH Lindenplatz 1 D-85540 Haar Etoricoxib MSD 90 mg Film-coated tablet Oral use MSD Sharp & Dohme GmbH Lindenplatz 1 D-85540 Haar Etoricoxib MSD 60 mg Film-coated tablet Oral use MSD Sharp & Dohme GmbH Lindenplatz 1 D-85540 Haar Auxib 120 mg Film-coated tablet Oral use MSD Sharp & Dohme GmbH Lindenplatz 1 D-85540 Haar Auxib 90 mg Film-coated tablet Oral use MSD Sharp & Dohme GmbH Lindenplatz 1 D-85540 Haar Auxib 60 mg Film-coated tablet Oral use MSD Sharp & Dohme GmbH Lindenplatz 1 D-85540 Haar Arcoxia 120 mg Film-coated tablet Oral use MSD Sharp & Dohme GmbH Lindenplatz 1 D-85540 Haar Arcoxia 90 mg Film-coated tablet Oral use MSD Sharp & Dohme GmbH Lindenplatz 1 D-85540 Haar Arcoxia 60 mg Film-coated tablet Oral use Eesti Merck Sharp & Dohme OÜ Peterburi tee 46 EE-11415 Tallinn Arcoxia 60 mg Film-coated tablet Oral use Merck Sharp & Dohme OÜ Peterburi tee 46 EE-11415 Tallinn Arcoxia 90 mg Film-coated tablet Oral use Merck Sharp & Dohme OÜ Peterburi tee 46 EE-11415 Tallinn Arcoxia 120 mg Film-coated tablet Oral use Suomi Merck Sharp & Dohme BV Waarderweg 39 Postbus 581 2003 PC Haarlem Nederland Arcoxia 60 mg Film-coated tablet Oral use Merck Sharp & Dohme BV Waarderweg 39 Postbus 581 2003 PC Haarlem Nederland Arcoxia 90 mg Film-coated tablet Oral use Merck Sharp & Dohme BV Waarderweg 39 Postbus 581 2003 PC Haarlem Nederland Arcoxia 120 mg Film-coated tablet Oral use Merck Sharp & Dohme BV Waarderweg 39 Postbus 581 2003 PC Haarlem Nederland Turox 60 mg Film-coated tablet Oral use Merck Sharp & Dohme BV Waarderweg 39 Postbus 581 2003 PC Haarlem Nederland Turox 90 mg Film-coated tablet Oral use Merck Sharp & Dohme BV Waarderweg 39 Postbus 581 2003 PC Haarlem Nederland Turox 120 mg Film-coated tablet Oral use Ελλάδα Vianex SA Tatoiou Street 18 Km Athens-Lamia National Road GR-14671 Nea Erythrea — Athene Arcoxia 60 mg Film-coated tablet Oral use Vianex SA Tatoiou Street 18 Km Athens-Lamia National Road GR-14671 Nea Erythrea — Athene Griekenland Arcoxia 90 mg Film-coated tablet Oral use Vianex SA Tatoiou Street 18 Km Athens-Lamia National Road GR-14671 Nea Erythrea — Athene Arcoxia 120 mg Film-coated tablet Oral use Vianex SA Tatoiou Street 18 Km Athens-Lamia National Road GR-14671 Nea Erythrea — Athene Turox 60 mg Film-coated tablet Oral use Vianex SA Tatoiou Street 18 Km Athens-Lamia National Road GR-14671 Nea Erythrea — Athene Turox 90 mg Film-coated tablet Oral use Vianex SA Tatoiou Street 18 Km Athens-Lamia National Road GR-14671 Nea Erythrea — Athene Turox 120 mg Film-coated tablet Oral use Magyarország MSD Hungary Ltd. Alkotás utca 50 H-1123 Budapest Arcoxia 60 mg Film-coated tablet Oral use MSD Hungary Ltd. Alkotás utca 50 H-1123 Budapest Arcoxia 90 mg Film-coated tablet Oral use MSD Hungary Ltd. Alkotás utca 50 H-1123 Budapest Arcoxia 120 mg Film-coated tablet Oral use Ireland Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom Arcoxia 60 mg Film-coated tablet Oral use Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom Arcoxia 90 mg Film-coated tablet Oral use Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom Arcoxia 120 mg Film-coated tablet Oral use Island Merck Sharp & Dohme BV Waarderweg 39 Postbus 581 2003 PC Haarlem Nederland Arcoxia 60 mg Film-coated tablet Oral use Merck Sharp & Dohme BV Waarderweg 39 Postbus 581 2003 PC Haarlem Nederland Arcoxia 90 mg Film-coated tablet Oral use Merck Sharp & Dohme BV Waarderweg 39 Postbus 581 2003 PC Haarlem Nederland Arcoxia 120 mg Film-coated tablet Oral use Italia Merck Sharp & Dohme Italia SpA Via G. Fabbroni, 6 I-00191 Roma Arcoxia 60 mg Film-coated tablet Oral use Merck Sharp & Dohme Italia SpA Via G. Fabbroni, 6 I-00191 Roma Arcoxia 90 mg Film-coated tablet Oral use Merck Sharp & Dohme Italia SpA Via G. Fabbroni, 6 I-00191 Roma Arcoxia 120 mg Film-coated tablet Oral use Istituto Gentili SpA Via Benedetto Croce, 37 I-56125 Pisa Algix 60 mg Film-coated tablet Oral use Istituto Gentili SpA Via Benedetto Croce, 37 I-56125 Pisa Algix 90 mg Film-coated tablet Oral use Istituto Gentili SpA Via Benedetto Croce, 37 I-56125 Pisa Algix 120 mg Film-coated tablet Oral use Neopharmed SpA Via G. Fabbroni, 6 I-00191 Roma Recoxib 60 mg Film-coated tablet Oral use Neopharmed SpA Via G. Fabbroni, 6 I-00191 Roma Recoxib 90 mg Film-coated tablet Oral use Neopharmed SpA Via G. Fabbroni, 6 I-00191 Roma Recoxib 120 mg Film-coated tablet Oral use Addenda Pharma Srl Via dei Santi Pietro e Paolo, 30 I-00144 Roma Tauxib 60 mg Film-coated tablet Oral use Addenda Pharma Srl Via dei Santi Pietro e Paolo, 30 I-00144 Roma Tauxib 90 mg Film-coated tablet Oral use Addenda Pharma Srl Via dei Santi Pietro e Paolo, 30 I-00144 Roma Tauxib 120 mg Film-coated tablet Oral use Latvija SIA Merck Sharp & Dohme Latvija Skanstes iela 13 LV-1013 Riga Arcoxia 60 mg Film-coated tablet Oral use SIA Merck Sharp & Dohme Latvija Skanstes iela 13 LV-1013 Riga Arcoxia 90 mg Film-coated tablet Oral use SIA Merck Sharp & Dohme Latvija Skanstes iela 13 LV-1013 Riga Arcoxia 120 mg Film-coated tablet Oral use Lietuva Merck Sharp & Dohme UAB, Lithuania Gelezinio Vilko 18A LT-01112 Vilnius Arcoxia 60 mg Film-coated tablet Oral use Merck Sharp & Dohme UAB, Lithuania Gelezinio Vilko 18A LT-01112 Vilnius Arcoxia 90 mg Film-coated tablet Oral use Merck Sharp & Dohme UAB, Lithuania Gelezinio Vilko 18A LT-01112 Vilnius Arcoxia 120 mg Film-coated tablet Oral use Luxembourg Merck Sharp & Dohme SA Chaussée de Waterloo 1135 B-1180 Bruxelles Arcoxia 60 mg Film-coated tablet Oral use Merck Sharp & Dohme SA Chaussée de Waterloo 1135 B-1180 Bruxelles Arcoxia 90 mg Film-coated tablet Oral use Merck Sharp & Dohme SA Chaussée de Waterloo 1135 B-1180 Bruxelles Arcoxia 120 mg Film-coated tablet Oral use Merck Sharp & Dohme SA Chaussée de Waterloo 1135 B-1180 Bruxelles Ranacox 60 mg Film-coated tablet Oral use Merck Sharp & Dohme SA Chaussée de Waterloo 1135 B-1180 Bruxelles Ranacox 90 mg Film-coated tablet Oral use Merck Sharp & Dohme SA Chaussée de Waterloo 1135 B-1180 Bruxelles Ranacox 120 mg Film-coated tablet Oral use Malta Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom Arcoxia 60 mg Film-coated tablet Oral use Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom Arcoxia 90 mg Film-coated tablet Oral use Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom Arcoxia 120 mg Film-coated tablet Oral use Nederland Merck Sharp & Dohme BV Waarderweg 39 Postbus 581 2003 PC Haarlem Nederland Arcoxia 60 mg Film-coated tablet Oral use Merck Sharp & Dohme BV Waarderweg 39 Postbus 581 2003 PC Haarlem Nederland Arcoxia 90 mg Film-coated tablet Oral use Merck Sharp & Dohme BV Waarderweg 39 Postbus 581 2003 PC Haarlem Nederland Arcoxia 120 mg Film-coated tablet Oral use Merck Sharp & Dohme BV Waarderweg 39 Postbus 581 2003 PC Haarlem Nederland Auxib 60 mg Film-coated tablet Oral use Merck Sharp & Dohme BV Waarderweg 39 Postbus 581 2003 PC Haarlem Nederland Auxib 90 mg Film-coated tablet Oral use Merck Sharp & Dohme BV Waarderweg 39 Postbus 581 2003 PC Haarlem Nederland Auxib 120 mg Film-coated tablet Oral use Norge Merck Sharp & Dohme BV Waarderweg 39 Postbus 581 2003 PC Haarlem Nederland Arcoxia 60 mg Film-coated tablet Oral use Merck Sharp & Dohme BV Waarderweg 39 Postbus 581 2003 PC Haarlem Nederland Arcoxia 90 mg Film-coated tablet Oral use Merck Sharp & Dohme BV Waarderweg 39 Postbus 581 2003 PC Haarlem Nederland Arcoxia 120 mg Film-coated tablet Oral use Österreich Merck Sharp & Dohme GmbH Donau-City Straße 6 A-1220 Wien Arcoxia 60 mg Film-coated tablet Oral use Merck Sharp & Dohme GmbH Donau-City Straße 6 A-1220 Wien Arcoxia 90 mg Film-coated tablet Oral use Merck Sharp & Dohme GmbH Donau-City Straße 6 A-1220 Wien Arcoxia 120 mg Film-coated tablet Oral use Merck Sharp & Dohme GmbH Donau-City Straße 6 A-1220 Wien Auxib 60 mg Film-coated tablet Oral use Merck Sharp & Dohme GmbH Donau-City Straße 6 A-1220 Wien Auxib 90 mg Film-coated tablet Oral use Merck Sharp & Dohme GmbH Donau-City Straße 6 A-1220 Wien Auxib 120 mg Film-coated tablet Oral use Polska MSD Polska Sp. z.o.o. ul. Puławska 303 PL-02-785 Warszawa Arcoxia 60 mg Film-coated tablet Oral use MSD Polska Sp. z.o.o. ul. Puławska 303 PL-02-785 Warszawa Arcoxia 90 mg Film-coated tablet Oral use MSD Polska Sp. z.o.o. ul. Puławska 303 PL-02-785 Warszawa Arcoxia 120 mg Film-coated tablet Oral use Portugal Merck Sharp & Dohme, Lda Quinta Da Fonte Edifício Vasco da Gama, n.o 19, Porto Salvo P-2770-192 Paço d'Arcos Arcoxia 60 mg Film-coated tablet Oral use Merck Sharp & Dohme, Lda Quinta Da Fonte Edifício Vasco da Gama, n.o 19, Porto Salvo P-2770-192 Paço d'Arcos Arcoxia 90 mg Film-coated tablet Oral use Merck Sharp & Dohme, Lda Quinta Da Fonte Edifício Vasco da Gama, n.o 19, Porto Salvo P-2770-192 Paço d'Arcos Arcoxia 120 mg Film-coated tablet Oral use Laboratórios BIAL-Portela S.A. Av. Da Siderurgia Nacional P-4745-457 S. Mamede do Coronado Exxiv 60 mg Film-coated tablet Oral use Laboratórios BIAL-Portela S.A. Av. Da Siderurgia Nacional P-4745-457 S. Mamede do Coronado Exxiv 90 mg Film-coated tablet Oral use Laboratórios BIAL-Portela S.A. Av. Da Siderurgia Nacional P-4745-457 S. Mamede do Coronado Exxiv 120 mg Film-coated tablet Oral use Farmacox-Companhia Farmacêutica, Lda. Quinta Da Fonte Edifício Vasco da Gama, n.o 19, Porto Salvo P-2770-192 Paço d'Arcos Turox 60 mg Film-coated tablet Oral use Farmacox-Companhia Farmacêutica, Lda. Quinta Da Fonte Edifício Vasco da Gama, n.o 19, Porto Salvo P-2770-192 Paço d'Arcos Turox 90 mg Film-coated tablet Oral use Farmacox-Companhia Farmacêutica, Lda. Quinta Da Fonte Edifício Vasco da Gama, n.o 19, Porto Salvo P-2770-192 Paço d'Arcos Turox 120 mg Film-coated tablet Oral use Slovenija Merck Sharp & Dohme Ltd. Šmartinska cesta 140 SI-1000 Ljubljana Arcoxia 60 mg Film-coated tablet Oral use Merck Sharp & Dohme Ltd. Šmartinska cesta 140 SI-1000 Ljubljana Arcoxia 90 mg Film-coated tablet Oral use Merck Sharp & Dohme Ltd. Šmartinska cesta 140 SI-1000 Ljubljana Arcoxia 120 mg Film-coated tablet Oral use Slovenská republika Merck Sharp & Dohme BV Waarderweg 39 Postbus 581 2003 PC Haarlem Nederland Arcoxia 60 mg Film-coated tablet Oral use Merck Sharp & Dohme BV Waarderweg 39 Postbus 581 2003 PC Haarlem Nederland Arcoxia 90 mg Film-coated tablet Oral use Merck Sharp & Dohme BV Waarderweg 39 Postbus 581 2003 PC Haarlem Nederland Arcoxia 120 mg Film-coated tablet Oral use España Merck Sharp & Dohme de España S.A. Josefa Valcárcel 38 E-Madrid 28027 Arcoxia 60 mg Film-coated tablet Oral use Merck Sharp & Dohme de España S.A. Josefa Valcárcel 38 E-Madrid 28027 Arcoxia 90 mg Film-coated tablet Oral use Merck Sharp & Dohme de España S.A. Josefa Valcárcel 38 E-Madrid 28027 Arcoxia 120 mg Film-coated tablet Oral use Laboratorios Abelló S.A. Josefa Valcárcel 38 E-Madrid 28027 Exxiv 60 mg Film-coated tablet Oral use Laboratorios Abelló S.A. Josefa Valcárcel 38 E-Madrid 28027 Exxiv 90 mg Film-coated tablet Oral use Laboratorios Abelló S.A. Josefa Valcárcel 38 E-Madrid 28027 Exxiv 120 mg Film-coated tablet Oral use Česká republika Merck Sharp & Dohme BV Waarderweg 39 Postbus 581 2003 PC Haarlem Nederland Arcoxia 60 mg Film-coated tablet Oral use Merck Sharp & Dohme BV Waarderweg 39 Postbus 581 2003 PC Haarlem Nederland Arcoxia 90 mg Film-coated tablet Oral use Merck Sharp & Dohme BV Waarderweg 39 Postbus 581 2003 PC Haarlem Nederland Arcoxia 120 mg Film-coated tablet Oral use United Kingdom Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom Arcoxia 60 mg Film-coated tablet Oral use Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom Arcoxia 90 mg Film-coated tablet Oral use Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom Arcoxia 120 mg Film-coated tablet Oral use Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom Auxib 60 mg Film-coated tablet Oral use Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom Auxib 90 mg Film-coated tablet Oral use Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom Auxib 120 mg Film-coated tablet Oral use Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom Exxiv 60 mg Film-coated tablet Oral use Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom Exxiv 90 mg Film-coated tablet Oral use Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom Exxiv 120 mg Film-coated tablet Oral use Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom Turox 60 mg Film-coated tablet Oral use Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom Turox 90 mg Film-coated tablet Oral use Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom Turox 120 mg Film-coated tablet Oral use Sverige Merck Sharp & Dohme BV Waarderweg 39 Postbus 581 2003 PC Haarlem Nederland Arcoxia 60 mg Film-coated tablet Oral use Merck Sharp & Dohme BV Waarderweg 39 Postbus 581 2003 PC Haarlem Nederland Arcoxia 90 mg Film-coated tablet Oral use Merck Sharp & Dohme BV Waarderweg 39 Postbus 581 2003 PC Haarlem Nederland Arcoxia 120 mg Film-coated tablet Oral use Merck Sharp & Dohme BV Waarderweg 39 Postbus 581 2003 PC Haarlem Nederland Turox 60 mg Film-coated tablet Oral use Merck Sharp & Dohme BV Waarderweg 39 Postbus 581 2003 PC Haarlem Nederland Turox 90 mg Film-coated tablet Oral use Merck Sharp & Dohme BV Waarderweg 39 Postbus 581 2003 PC Haarlem Nederland Turox 120 mg Film-coated tablet Oral use

ANNEX III LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES AND NORWAY AND ICELAND

Member State Marketing Authorisation Holder Invented name Strength Pharmaceutical Form Route of administration United Kingdom Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley Camberley Surrey GU16 7SR United Kingdom Prexige 100 mg Film-coated tablet Oral Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley Camberley Surrey GU16 7SR United Kingdom Prexige 200 mg Film-coated tablet Oral Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley Camberley Surrey GU16 7SR United Kingdom Prexige 400 mg Film-coated tablet Oral Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley Camberley Surrey GU16 7SR United Kingdom Lumiracoxib 100 mg Film-coated tablet Oral Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley Camberley Surrey GU16 7SR United Kingdom Lumiracoxib 200 mg Film-coated tablet Oral Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley Camberley Surrey GU16 7SR United Kingdom Lumiracoxib 400 mg Film-coated tablet Oral Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley Camberley Surrey GU16 7SR United Kingdom Frexocel 100 mg Film-coated tablet Oral Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley Camberley Surrey GU16 7SR United Kingdom Frexocel 200 mg Film-coated tablet Oral Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley Camberley Surrey GU16 7SR United Kingdom Frexocel 400 mg Film-coated tablet Oral Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley Camberley Surrey GU16 7SR United Kingdom Stellige 100 mg Film-coated tablet Oral Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley Camberley Surrey GU16 7SR United Kingdom Stellige 200 mg Film-coated tablet Oral Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley Camberley Surrey GU16 7SR United Kingdom Stellige 400 mg Film-coated tablet Oral Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley Camberley Surrey GU16 7SR United Kingdom Exforge 100 mg Film-coated tablet Oral Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley Camberley Surrey GU16 7SR United Kingdom Exforge 200 mg Film-coated tablet Oral Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley Camberley Surrey GU16 7SR United Kingdom Exforge 400 mg Film-coated tablet Oral

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1. 2005-11-30