Summary of Community decisions on marketing authorizations in respect of medicinal products from  20 November 2005  to  30 November 2005 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2005-12-30
Institutions: European Commission
Subjects: market approval, medicinal product, pharmaceutical legislation

C 334/38

EN

Official Journal of the European Union

30.12.2005

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 20 November 2005 to 30 November 2005

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

(2005/C 334/08)

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

28.11.2005

28.11.2005

Celocoxib

Etoricoxib

See Annex I

See Annex I

29.11.2005

See Annex II

See Annex II

29.11.2005

28.11.2005

Lumiracoxib

See Annex III

See Annex III

29.11.2005

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

30.12.2005

EN

Official Journal of the European Union

C 334/39

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

Pfizer Corporation Austria Ges.m.b.H.
Seidengasse 33-35
A-1071 Wien

Pfizer Corporation Austria Ges.m.b.H.
Seidengasse 33-35
A-1071 Wien

Belgique/België

Κύπρος

Česká republika

Pharmacia NV/SA
Rijksweg 12
B-2870 Puurs

Pharmacia NV/SA
Rijksweg 12
B-2870 Puurs

Pharmacia NV/SA
Rijksweg 12
B-2870 Puurs

Pharmacia NV/SA
Rijksweg 12
B-2870 Puurs

Markides & Vouros Ltd.
5a-B Pargas Str
P.O.Box 22002
1515 Lefkosia
Cyprus

Markides & Vouros Ltd.
5a-B Pargas Str
P.O.Box 22002
1515 Lefkosia
Cyprus

Pharmacia Ltd.
Davy Avenue
Know Hill
Milton Keynes MK5 8PH
United Kingdom

Pharmacia Ltd.
Davy Avenue
Know Hill
Milton Keynes MK5 8PH
United Kingdom

Celebrex

200 mg

Capsules

Oral

Solexa

100 mg

Capsules

Oral

Solexa

200 mg

Capsules

Oral

Celebrex

100 mg

Capsules

Oral

Celebrex

200 mg

Capsules

Oral

Solexa

100 mg

Capsules

Oral

Solexa

200 mg

Capsules

Oral

Celebrex

100 mg

Capsules

Oral

Celebrex

200 mg

Capsules

Oral

Celebrex

100 mg

Capsules

Oral

Celebrex

200 mg

Capsules

Oral

C 334/40

EN

Official Journal of the European Union

30.12.2005

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical
Form

Route of
administration

Danmark

Pfizer ApS
Lautrupvang 8
DK-2750 Ballerup

Pfizer ApS
Lautrupvang 8
DK-2750 Ballerup

Pfizer ApS
Lautrupvang 8
DK-2750 Ballerup

Pfizer ApS
Lautrupvang 8
DK-2750 Ballerup

Eesti

Pfizer H.C.P. Corporation Eesti
Pirita tee 20
EE-10127 Tallinn

Pfizer H.C.P. Corporation Eesti
Pirita tee 20
EE-10127 Tallinn

Suomi

Pfizer Oy
Tietokuja 4
FIN-00330 Helsinki

Pfizer Oy
Tietokuja 4
FIN-00330 Helsinki

Pfizer Oy
Tietokuja 4
FIN-00330 Helsinki

Pfizer Oy
Tietokuja 4
FIN-00330 Helsinki

Celebra

100 mg

Capsules

Oral

Celebra

200 mg

Capsules

Oral

Solexa

100 mg

Capsules

Oral

Solexa

200 mg

Capsules

Oral

Celebrex

100 mg

Capsules

Oral

Celebrex

200 mg

Capsules

Oral

Celebra

100 mg

Capsules

Oral

Celebra

200 mg

Capsules

Oral

Solexa

100 mg

Capsules

Oral

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

Cardel
23-25, avenue du Docteur Lannelongue
F-75668 Paris Cedex 14

Cardel
23-25, avenue du Docteur Lannelongue
F-75668 Paris Cedex 14

Celebrex

200 mg

Capsules

Oral

Solexa

100 mg

Capsules

Oral

Solexa

200 mg

Capsules

Oral

30.12.2005

EN

Official Journal of the European Union

C 334/41

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical
Form

Route of
administration

Deutschland

Ελλάδα

Pharmacia GmbH
Pfizerstr. 1
D-76139 Karlsruhe

Pharmacia GmbH
Pfizerstr. 1
D-76139 Karlsruhe

Pharmacia GmbH
Pfizerstr. 1
D-76139 Karlsruhe

Pharmacia GmbH
Pfizerstr. 1
D-76139 Karlsruhe

Pfizer Hellas A.E.
5, Alketou Street
GR-116 33 Athens

Pfizer Hellas A.E.
5, Alketou Street
GR-116 33 Athens

Pfizer Hellas A.E.
5, Alketou Street
GR-116 33 Athens

Pfizer Hellas A.E.
5, Alketou Street
GR-116 33 Athens

Celebra

200 mg

Capsules

Oral

Celebra

100 mg

Capsules

Oral

Celebrex

200 mg

Capsules

Oral

Celebrex

100 mg

Capsules

Oral

Celebrex

100 mg

Capsules

Oral

Celebrex

200 mg

Capsules

Oral

Aclarex

100 mg

Capsules

Oral

Aclarex

200 mg

Capsules

Oral

Magyarország

Pfizer Kft.
Alkotás utca 53. MOM Park ‘F’ Épület
H-1123 Budapest

Celebrex

200 mg

Capsules

Oral

Island

Ireland

Pfizer ApS
Lautrupvang 8
DK-2750 Ballerup

Pfizer ApS
Lautrupvang 8
DK-2750 Ballerup

Pharmacia Ireland Limited
Airways Industrial Estate
Dublin 17
Ireland

Pharmacia Ireland Limited
Airways Industrial Estate
Dublin 17
Ireland

Pharmacia Ireland Limited
Airways Industrial Estate
Dublin 17
Ireland

Pharmacia Ireland Limited
Airways Industrial Estate
Dublin 17
Ireland

Celebra

100 mg

Capsules

Oral

Celebra

200 mg

Capsules

Oral

Celebrex

100 mg

Capsules

Oral

Celebrex

200 mg

Capsules

Oral

Solexa

100 mg

Capsules

Oral

Solexa

200 mg

Capsules

Oral

C 334/42

EN

Official Journal of the European Union

30.12.2005

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical
Form

Route of
administration

Italia

Latvija

Lietuva

Luxembourg

Pharmacia Italia S.p.A.
Via Robert Koch, 1-2
I-20152 Milano

Pharmacia Italia S.p.A.
Via Robert Koch, 1-2
I-20152 Milano

Sefarma S.r.l.
Via Robert Koch, 1-2
I-20152 Milano

Sefarma S.r.l.
Via Robert Koch, 1-2
I-20152 Milano

Pfizer Italia S.r.l.
Strada Statale 156 KM 50
I-04010 Borgo San Michele, Latina

Pfizer Italia S.r.l.
Strada Statale 156 KM 50
I-04010 Borgo San Michele, Latina

Pharmacia Italia S.p.A.
Via Robert Koch, 1-2
I-20152 Milano

Pharmacia Italia S.p.A.
Via Robert Koch, 1-2
I-20152 Milano

Pfizer Ltd.
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Pfizer Ltd.
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Pfizer H.C.P. Corporation
Representation Office in Lithuania
A. Gostauto 40 a
LT-01112 Vilnius

Pfizer H.C.P. Corporation
Representation Office in Lithuania
A. Gostauto 40 a
LT-01112 Vilnius

Pharmacia NV/SA
Rijksweg 12
B-2870 Puurs

Pharmacia NV/SA
Rijksweg 12
B-2870 Puurs

Pharmacia NV/SA
Rijksweg 12
B-2870 Puurs

Pharmacia NV/SA
Rijksweg 12
B-2870 Puurs

Artilog

100 mg

Capsules

Oral

Artilog

200 mg

Capsules

Oral

Artrid

100 mg

Capsules

Oral

Artrid

200 mg

Capsules

Oral

Solexa

100 mg

Capsules

Oral

Solexa

200 mg

Capsules

Oral

Celebrex

100 mg

Capsules

Oral

Celebrex

200 mg

Capsules

Oral

Celebrex

100 mg

Capsules

Oral

Celebrex

200 mg

Capsules

Oral

Celebrex

100 mg

Capsules

Oral

Celebrex

200 mg

Capsules

Oral

Celebrex

100 mg

Capsules

Oral

Celebrex

200 mg

Capsules

Oral

Solexa

100 mg

Capsules

Oral

Solexa

200 mg

Capsules

Oral

30.12.2005

EN

Official Journal of the European Union

C 334/43

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical
Form

Route of
administration

Malta

Norge

Polska

Portugal

Slovenská
republika

Slovenija

Pfizer Hellas A. E.
5, Alketou Street
GR-116 33 Athens

Pfizer Hellas A. E.
5, Alketou Street
GR-116 33 Athens

Pfizer AS
Postboks 3
N-1324 Lysaker

Pfizer AS
Postboks 3
N-1324 Lysaker

Pharmacia Ltd.
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Pharmacia Ltd.
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Laboratórios Pfizer, Lda.
Lagoas Park, Edifício n.o 10
P-2740-244 Porto Salvo

Laboratórios Pfizer, Lda.
Lagoas Park, Edifício n.o 10
P-2740-244 Porto Salvo

Lab. Medinfar — Produtos Farmacêuticos S.A.
R. Manuel Ribeiro de Pavia, n.o 1 — Venda Nova
P-2700-547 Amadora

Lab. Medinfar — Produtos Farmacêuticos S.A.
R. Manuel Ribeiro de Pavia, n.o 1 — Venda Nova
P-2700-547 Amadora

Pfizer Europe MA EEIG
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Pfizer Europe MA EEIG
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Pfizer Luxembourg SARL
283, route d'Arlon
L-8011 Strassen

Pfizer Luxembourg SARL
283, route d'Arlon
L-8011 Strassen

Celebrex

100 mg

Capsules

Oral

Celebrex

200 mg

Capsules

Oral

Celebra

100 mg

Capsules

Oral

Celebra

200 mg

Capsules

Oral

Celebrex

100 mg

Capsules

Oral

Celebrex

200 mg

Capsules

Oral

Celebrex

100 mg

Capsules

Oral

Celebrex

200 mg

Capsules

Oral

Solexa

100 mg

Capsules

Oral

Solexa

200 mg

Capsules

Oral

Celebrex

100 mg

Capsules

Oral

Celebrex

200 mg

Capsules

Oral

Celebrex

100 mg

Capsules

Oral

Celebrex

200 mg

Capsules

Oral

C 334/44

EN

Official Journal of the European Union

30.12.2005

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical
Form

Route of
administration

España

Sverige

Pharmacia Spain S.A.
Avenida de Europa, 20-B
Parque Empresarial La Moraleja
E-28108 Alcobendas, Madrid

Pharmacia Spain S.A.
Avenida de Europa, 20-B
Parque Empresarial La Moraleja
E-28108 Alcobendas, Madrid

Pharmacia Spain S.A.
Avenida de Europa, 20-B
Parque Empresarial La Moraleja
E-28108 Alcobendas, Madrid

Pharmacia Spain S.A.
Avenida de Europa, 20-B
Parque Empresarial La Moraleja
E-28108 Alcobendas, Madrid

Pfizer AB
Nytorpsvägen 36
P.O. Box 501
S-183 25 Täby

Pfizer AB
Nytorpsvägen 36
P.O. Box 501
S-183 25 Täby

Pfizer AB
Nytorpsvägen 36
P.O. Box 501
S-183 25 Täby

Pfizer AB
Nytorpsvägen 36
P.O. Box 501
S-183 25 Täby

Pfizer AB
Nytorpsvägen 36
P.O. Box 501
S-183 25 Täby

Pfizer AB
Nytorpsvägen 36
P.O. Box 501
S-183 25 Täby

Pfizer AB
Nytorpsvägen 36
P.O. Box 501
S-183 25 Täby

Pfizer AB
Nytorpsvägen 36
P.O. Box 501
S-183 25 Täby

Celebrex

100 mg

Capsules

Oral

Artilog

100 mg

Capsules

Oral

Celebrex

200 mg

Capsules

Oral

Artilog

200 mg

Capsules

Oral

Celebra

100 mg

Capsules

Oral

Celebra

200 mg

Capsules

Oral

Solexa

100 mg

Capsules

Oral

Solexa

200 mg

Capsules

Oral

Celora

100 mg

Capsules

Oral

Celora

200 mg

Capsules

Oral

Aclarix

100 mg

Capsules

Oral

Aclarix

200 mg

Capsules

Oral

30.12.2005

EN

Official Journal of the European Union

C 334/45

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical
Form

Route of
administration

Nederland

United Kingdom

Pfizer bv
Rivium Westlaan 142
2909 LD Capelle a/d IJssel
Nederland

Pfizer bv
Rivium Westlaan 142
2909 LD Capelle a/d IJssel
Nederland

Pfizer bv
Rivium Westlaan 142
2909 LD Capelle a/d IJssel
Nederland

Pfizer bv
Rivium Westlaan 142
2909 LD Capelle a/d IJssel
Nederland

Pfizer Ltd.
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Pfizer Ltd.
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Pfizer Ltd.
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Pfizer Ltd.
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Celebrex

100 mg

Capsules

Oral

Celebrex

200 mg

Capsules

Oral

Solexa

100 mg

Capsules

Oral

Solexa

200 mg

Capsules

Oral

Celebrex

100 mg

Capsules

Oral

Celebrex

200 mg

Capsules

Oral

Solexa

100 mg

Capsules

Oral

Solexa

200 mg

Capsules

Oral

C 334/46

EN

Official Journal of the European Union

30.12.2005

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

Κύπρος

Danmark

Merck Sharp & Dohme BV
Chaussée de Waterloo, 1135
B-1180 Bruxelles

Merck Sharp & Dohme BV
Chaussée de Waterloo, 1135
B-1180 Bruxelles

Merck Sharp & Dohme BV
Chaussée de Waterloo, 1135
B-1180 Bruxelles

Merck Sharp & Dohme BV
Chaussée de Waterloo, 1135
B-1180 Bruxelles

Merck Sharp & Dohme BV
Chaussée de Waterloo, 1135
B-1180 Bruxelles

Merck Sharp & Dohme BV
Chaussée de Waterloo, 1135
B-1180 Bruxelles

Merck Sharp & Dohme BV
Waarderweg 39
Postbus 581
2003 PC Haarlem
Nederland

Merck Sharp & Dohme BV
Waarderweg 39
Postbus 581
2003 PC Haarlem
Nederland

Merck Sharp & Dohme BV
Waarderweg 39
Postbus 581
2003 PC Haarlem
Nederland

Merck Sharp & Dohme BV
Waarderweg 39
Postbus 581
2003 PC Haarlem
Nederland

Merck Sharp & Dohme BV
Waarderweg 39
Postbus 581
2003 PC Haarlem
Nederland

Merck Sharp & Dohme BV
Waarderweg 39
Postbus 581
2003 PC Haarlem
Nederland

Arcoxia

60 mg

Film-coated
tablet

Oral use

Arcoxia

90 mg

Film-coated
tablet

Oral use

Arcoxia

120 mg

Film-coated
tablet

Oral use

Ranacox

60 mg

Film-coated
tablet

Oral use

Ranacox

90 mg

Film-coated
tablet

Oral use

Ranacox

120 mg

Film-coated
tablet

Oral use

Arcoxia

60 mg

Film-coated
tablet

Oral use

Arcoxia

90 mg

Film-coated
tablet

Oral use

Arcoxia

120 mg

Film-coated
tablet

Oral use

Arcoxia

60 mg

Film-coated
tablet

Oral use

Arcoxia

90 mg

Film-coated
tablet

Oral use

Arcoxia

120 mg

Film-coated
tablet

Oral use

30.12.2005

EN

Official Journal of the European Union

C 334/47

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical
Form

Route of
administration

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

MSD Sharp & Dohme GmbH
Lindenplatz 1
D-85540 Haar

MSD Sharp & Dohme GmbH
Lindenplatz 1
D-85540 Haar

MSD Sharp & Dohme GmbH
Lindenplatz 1
D-85540 Haar

MSD Sharp & Dohme GmbH
Lindenplatz 1
D-85540 Haar

MSD Sharp & Dohme GmbH
Lindenplatz 1
D-85540 Haar

MSD Sharp & Dohme GmbH
Lindenplatz 1
D-85540 Haar

MSD Sharp & Dohme GmbH
Lindenplatz 1
D-85540 Haar

Etoricoxib MSD

90 mg

Film-coated
tablet

Oral use

Etoricoxib MSD

60 mg

Film-coated
tablet

Oral use

Auxib

120 mg

Film-coated
tablet

Oral use

Auxib

90 mg

Film-coated
tablet

Oral use

Auxib

60 mg

Film-coated
tablet

Oral use

Arcoxia

120 mg

Film-coated
tablet

Oral use

Arcoxia

90 mg

Film-coated
tablet

Oral use

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

Suomi

Merck Sharp & Dohme OÜ
Peterburi tee 46
EE-11415 Tallinn

Merck Sharp & Dohme OÜ
Peterburi tee 46
EE-11415 Tallinn

Merck Sharp & Dohme BV
Waarderweg 39
Postbus 581
2003 PC Haarlem
Nederland

Merck Sharp & Dohme BV
Waarderweg 39
Postbus 581
2003 PC Haarlem
Nederland

Arcoxia

90 mg

Film-coated
tablet

Oral use

Arcoxia

120 mg

Film-coated
tablet

Oral use

Arcoxia

60 mg

Film-coated
tablet

Oral use

Arcoxia

90 mg

Film-coated
tablet

Oral use

C 334/48

EN

Official Journal of the European Union

30.12.2005

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical
Form

Route of
administration

Ελλάδα

Merck Sharp & Dohme BV
Waarderweg 39
Postbus 581
2003 PC Haarlem
Nederland

Merck Sharp & Dohme BV
Waarderweg 39
Postbus 581
2003 PC Haarlem
Nederland

Merck Sharp & Dohme BV
Waarderweg 39
Postbus 581
2003 PC Haarlem
Nederland

Merck Sharp & Dohme BV
Waarderweg 39
Postbus 581
2003 PC Haarlem
Nederland

Vianex SA
Tatoiou Street 18 Km
Athens-Lamia National Road
GR-14671 Nea Erythrea — Athene

Vianex SA
Tatoiou Street 18 Km
Athens-Lamia National Road
GR-14671 Nea Erythrea — Athene
Griekenland

Vianex SA
Tatoiou Street 18 Km
Athens-Lamia National Road
GR-14671 Nea Erythrea — Athene

Vianex SA
Tatoiou Street 18 Km
Athens-Lamia National Road
GR-14671 Nea Erythrea — Athene

Vianex SA
Tatoiou Street 18 Km
Athens-Lamia National Road
GR-14671 Nea Erythrea — Athene

Vianex SA
Tatoiou Street 18 Km
Athens-Lamia National Road
GR-14671 Nea Erythrea — Athene

Magyarország

MSD Hungary Ltd.
Alkotás utca 50
H-1123 Budapest

MSD Hungary Ltd.
Alkotás utca 50
H-1123 Budapest

MSD Hungary Ltd.
Alkotás utca 50
H-1123 Budapest

Arcoxia

120 mg

Film-coated
tablet

Oral use

Turox

60 mg

Film-coated
tablet

Oral use

Turox

90 mg

Film-coated
tablet

Oral use

Turox

120 mg

Film-coated
tablet

Oral use

Arcoxia

60 mg

Film-coated
tablet

Oral use

Arcoxia

90 mg

Film-coated
tablet

Oral use

Arcoxia

120 mg

Film-coated
tablet

Oral use

Turox

60 mg

Film-coated
tablet

Oral use

Turox

90 mg

Film-coated
tablet

Oral use

Turox

120 mg

Film-coated
tablet

Oral use

Arcoxia

60 mg

Film-coated
tablet

Oral use

Arcoxia

90 mg

Film-coated
tablet

Oral use

Arcoxia

120 mg

Film-coated
tablet

Oral use

30.12.2005

EN

Official Journal of the European Union

C 334/49

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical
Form

Route of
administration

Ireland

Island

Merck Sharp & Dohme Ltd
Hertford Road
Hoddesdon
Hertfordshire EN11 9BU
United Kingdom

Merck Sharp & Dohme Ltd
Hertford Road
Hoddesdon
Hertfordshire EN11 9BU
United Kingdom

Merck Sharp & Dohme Ltd
Hertford Road
Hoddesdon
Hertfordshire EN11 9BU
United Kingdom

Merck Sharp & Dohme BV
Waarderweg 39
Postbus 581
2003 PC Haarlem
Nederland

Merck Sharp & Dohme BV
Waarderweg 39
Postbus 581
2003 PC Haarlem
Nederland

Merck Sharp & Dohme BV
Waarderweg 39
Postbus 581
2003 PC Haarlem
Nederland

Arcoxia

60 mg

Film-coated
tablet

Oral use

Arcoxia

90 mg

Film-coated
tablet

Oral use

Arcoxia

120 mg

Film-coated
tablet

Oral use

Arcoxia

60 mg

Film-coated
tablet

Oral use

Arcoxia

90 mg

Film-coated
tablet

Oral use

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

Merck Sharp & Dohme Italia SpA
Via G. Fabbroni, 6
I-00191 Roma

Istituto Gentili SpA
Via Benedetto Croce, 37
I-56125 Pisa

Istituto Gentili SpA
Via Benedetto Croce, 37
I-56125 Pisa

Istituto Gentili SpA
Via Benedetto Croce, 37
I-56125 Pisa

Neopharmed SpA
Via G. Fabbroni, 6
I-00191 Roma

Arcoxia

90 mg

Film-coated
tablet

Oral use

Arcoxia

120 mg

Film-coated
tablet

Oral use

Algix

60 mg

Film-coated
tablet

Oral use

Algix

90 mg

Film-coated
tablet

Oral use

Algix

120 mg

Film-coated
tablet

Oral use

Recoxib

60 mg

Film-coated
tablet

Oral use

C 334/50

EN

Official Journal of the European Union

30.12.2005

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical
Form

Route of
administration

Neopharmed SpA
Via G. Fabbroni, 6
I-00191 Roma

Neopharmed SpA
Via G. Fabbroni, 6
I-00191 Roma

Addenda Pharma Srl
Via dei Santi Pietro e Paolo, 30
I-00144 Roma

Addenda Pharma Srl
Via dei Santi Pietro e Paolo, 30
I-00144 Roma

Addenda Pharma Srl
Via dei Santi Pietro e Paolo, 30
I-00144 Roma

SIA ‘Merck Sharp & Dohme Latvija’
Skanstes iela 13
LV-1013 Riga

SIA ‘Merck Sharp & Dohme Latvija’
Skanstes iela 13
LV-1013 Riga

SIA ‘Merck Sharp & Dohme Latvija’
Skanstes iela 13
LV-1013 Riga

Recoxib

90 mg

Film-coated
tablet

Oral use

Recoxib

120 mg

Film-coated
tablet

Oral use

Tauxib

60 mg

Film-coated
tablet

Oral use

Tauxib

90 mg

Film-coated
tablet

Oral use

Tauxib

120 mg

Film-coated
tablet

Oral use

Arcoxia

60 mg

Film-coated
tablet

Oral use

Arcoxia

90 mg

Film-coated
tablet

Oral use

Arcoxia

120 mg

Film-coated
tablet

Oral use

Latvija

Lietuva

Merck Sharp & Dohme UAB, Lithuania
Gelezinio Vilko 18A
LT-01112 Vilnius

Arcoxia

60 mg

Film-coated
tablet

Oral use

Luxembourg

Merck Sharp & Dohme UAB, Lithuania
Gelezinio Vilko 18A
LT-01112 Vilnius

Merck Sharp & Dohme UAB, Lithuania
Gelezinio Vilko 18A
LT-01112 Vilnius

Merck Sharp & Dohme SA
Chaussée de Waterloo 1135
B-1180 Bruxelles

Merck Sharp & Dohme SA
Chaussée de Waterloo 1135
B-1180 Bruxelles

Merck Sharp & Dohme SA
Chaussée de Waterloo 1135
B-1180 Bruxelles

Merck Sharp & Dohme SA
Chaussée de Waterloo 1135
B-1180 Bruxelles

Merck Sharp & Dohme SA
Chaussée de Waterloo 1135
B-1180 Bruxelles

Merck Sharp & Dohme SA
Chaussée de Waterloo 1135
B-1180 Bruxelles

Arcoxia

90 mg

Film-coated
tablet

Oral use

Arcoxia

120 mg

Film-coated
tablet

Oral use

Arcoxia

60 mg

Film-coated
tablet

Oral use

Arcoxia

90 mg

Film-coated
tablet

Oral use

Arcoxia

120 mg

Film-coated
tablet

Oral use

Ranacox

60 mg

Film-coated
tablet

Oral use

Ranacox

90 mg

Film-coated
tablet

Oral use

Ranacox

120 mg

Film-coated
tablet

Oral use

30.12.2005

EN

Official Journal of the European Union

C 334/51

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical
Form

Route of
administration

Malta

Nederland

Norge

Merck Sharp & Dohme Ltd
Hertford Road
Hoddesdon
Hertfordshire EN11 9BU
United Kingdom

Merck Sharp & Dohme Ltd
Hertford Road
Hoddesdon
Hertfordshire EN11 9BU
United Kingdom

Merck Sharp & Dohme Ltd
Hertford Road
Hoddesdon
Hertfordshire EN11 9BU
United Kingdom

Merck Sharp & Dohme BV
Waarderweg 39
Postbus 581
2003 PC Haarlem
Nederland

Merck Sharp & Dohme BV
Waarderweg 39
Postbus 581
2003 PC Haarlem
Nederland

Merck Sharp & Dohme BV
Waarderweg 39
Postbus 581
2003 PC Haarlem
Nederland

Merck Sharp & Dohme BV
Waarderweg 39
Postbus 581
2003 PC Haarlem
Nederland

Merck Sharp & Dohme BV
Waarderweg 39
Postbus 581
2003 PC Haarlem
Nederland

Merck Sharp & Dohme BV
Waarderweg 39
Postbus 581
2003 PC Haarlem
Nederland

Merck Sharp & Dohme BV
Waarderweg 39
Postbus 581
2003 PC Haarlem
Nederland

Merck Sharp & Dohme BV
Waarderweg 39
Postbus 581
2003 PC Haarlem
Nederland

Merck Sharp & Dohme BV
Waarderweg 39
Postbus 581
2003 PC Haarlem
Nederland

Arcoxia

60 mg

Film-coated
tablet

Oral use

Arcoxia

90 mg

Film-coated
tablet

Oral use

Arcoxia

120 mg

Film-coated
tablet

Oral use

Arcoxia

60 mg

Film-coated
tablet

Oral use

Arcoxia

90 mg

Film-coated
tablet

Oral use

Arcoxia

120 mg

Film-coated
tablet

Oral use

Auxib

60 mg

Film-coated
tablet

Oral use

Auxib

90 mg

Film-coated
tablet

Oral use

Auxib

120 mg

Film-coated
tablet

Oral use

Arcoxia

60 mg

Film-coated
tablet

Oral use

Arcoxia

90 mg

Film-coated
tablet

Oral use

Arcoxia

120 mg

Film-coated
tablet

Oral use

C 334/52

EN

Official Journal of the European Union

30.12.2005

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical
Form

Route of
administration

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

Merck Sharp & Dohme GmbH
Donau-City Straße 6
A-1220 Wien

Merck Sharp & Dohme GmbH
Donau-City Straße 6
A-1220 Wien

Merck Sharp & Dohme GmbH
Donau-City Straße 6
A-1220 Wien

Merck Sharp & Dohme GmbH
Donau-City Straße 6
A-1220 Wien

MSD Polska Sp. z.o.o.
ul. Puławska 303
PL-02-785 Warszawa

MSD Polska Sp. z.o.o.
ul. Puławska 303
PL-02-785 Warszawa

MSD Polska Sp. z.o.o.
ul. Puławska 303
PL-02-785 Warszawa

Polska

Arcoxia

90 mg

Film-coated
tablet

Oral use

Arcoxia

120 mg

Film-coated
tablet

Oral use

Auxib

60 mg

Film-coated
tablet

Oral use

Auxib

90 mg

Film-coated
tablet

Oral use

Auxib

120 mg

Film-coated
tablet

Oral use

Arcoxia

60 mg

Film-coated
tablet

Oral use

Arcoxia

90 mg

Film-coated
tablet

Oral use

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

Merck Sharp & Dohme, Lda
Quinta Da Fonte
Edifício Vasco da Gama, n.o 19, Porto Salvo
P-2770-192 Paço d'Arcos

Laboratórios BIAL-Portela S.A.
Av. Da Siderurgia Nacional
P-4745-457 S. Mamede do Coronado

Laboratórios BIAL-Portela S.A.
Av. Da Siderurgia Nacional
P-4745-457 S. Mamede do Coronado

Laboratórios BIAL-Portela S.A.
Av. Da Siderurgia Nacional
P-4745-457 S. Mamede do Coronado

Arcoxia

90 mg

Film-coated
tablet

Oral use

Arcoxia

120 mg

Film-coated
tablet

Oral use

Exxiv

60 mg

Film-coated
tablet

Oral use

Exxiv

90 mg

Film-coated
tablet

Oral use

Exxiv

120 mg

Film-coated
tablet

Oral use

30.12.2005

EN

Official Journal of the European Union

C 334/53

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical
Form

Route of
administration

Slovenija

Slovenská
republika

España

Farmacox-Companhia Farmacêutica, Lda.
Quinta Da Fonte
Edifício Vasco da Gama, n.o 19, Porto Salvo
P-2770-192 Paço d'Arcos

Farmacox-Companhia Farmacêutica, Lda.
Quinta Da Fonte
Edifício Vasco da Gama, n.o 19, Porto Salvo
P-2770-192 Paço d'Arcos

Farmacox-Companhia Farmacêutica, Lda.
Quinta Da Fonte
Edifício Vasco da Gama, n.o 19, Porto Salvo
P-2770-192 Paço d'Arcos

Merck Sharp & Dohme Ltd.
Šmartinska cesta 140
SI-1000 Ljubljana

Merck Sharp & Dohme Ltd.
Šmartinska cesta 140
SI-1000 Ljubljana

Merck Sharp & Dohme Ltd.
Šmartinska cesta 140
SI-1000 Ljubljana

Merck Sharp & Dohme BV
Waarderweg 39
Postbus 581
2003 PC Haarlem
Nederland

Merck Sharp & Dohme BV
Waarderweg 39
Postbus 581
2003 PC Haarlem
Nederland

Merck Sharp & Dohme BV
Waarderweg 39
Postbus 581
2003 PC Haarlem
Nederland

Merck Sharp & Dohme de España S.A.
Josefa Valcárcel 38
E-Madrid 28027

Merck Sharp & Dohme de España S.A.
Josefa Valcárcel 38
E-Madrid 28027

Merck Sharp & Dohme de España S.A.
Josefa Valcárcel 38
E-Madrid 28027

Laboratorios Abelló S.A.
Josefa Valcárcel 38
E-Madrid 28027

Laboratorios Abelló S.A.
Josefa Valcárcel 38
E-Madrid 28027

Laboratorios Abelló S.A.
Josefa Valcárcel 38
E-Madrid 28027

Turox

60 mg

Film-coated
tablet

Oral use

Turox

90 mg

Film-coated
tablet

Oral use

Turox

120 mg

Film-coated
tablet

Oral use

Arcoxia

60 mg

Film-coated
tablet

Oral use

Arcoxia

90 mg

Film-coated
tablet

Oral use

Arcoxia

120 mg

Film-coated
tablet

Oral use

Arcoxia

60 mg

Film-coated
tablet

Oral use

Arcoxia

90 mg

Film-coated
tablet

Oral use

Arcoxia

120 mg

Film-coated
tablet

Oral use

Arcoxia

60 mg

Film-coated
tablet

Oral use

Arcoxia

90 mg

Film-coated
tablet

Oral use

Arcoxia

120 mg

Film-coated
tablet

Oral use

Exxiv

60 mg

Film-coated
tablet

Oral use

Exxiv

90 mg

Film-coated
tablet

Oral use

Exxiv

120 mg

Film-coated
tablet

Oral use

C 334/54

EN

Official Journal of the European Union

30.12.2005

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical
Form

Route of
administration

Česká republika

United Kingdom

Merck Sharp & Dohme BV
Waarderweg 39
Postbus 581
2003 PC Haarlem
Nederland

Merck Sharp & Dohme BV
Waarderweg 39
Postbus 581
2003 PC Haarlem
Nederland

Merck Sharp & Dohme BV
Waarderweg 39
Postbus 581
2003 PC Haarlem
Nederland

Merck Sharp & Dohme Ltd
Hertford Road
Hoddesdon
Hertfordshire EN11 9BU
United Kingdom

Merck Sharp & Dohme Ltd
Hertford Road
Hoddesdon
Hertfordshire EN11 9BU
United Kingdom

Merck Sharp & Dohme Ltd
Hertford Road
Hoddesdon
Hertfordshire EN11 9BU
United Kingdom

Merck Sharp & Dohme Ltd
Hertford Road
Hoddesdon
Hertfordshire EN11 9BU
United Kingdom

Merck Sharp & Dohme Ltd
Hertford Road
Hoddesdon
Hertfordshire EN11 9BU
United Kingdom

Merck Sharp & Dohme Ltd
Hertford Road
Hoddesdon
Hertfordshire EN11 9BU
United Kingdom

Merck Sharp & Dohme Ltd
Hertford Road
Hoddesdon
Hertfordshire EN11 9BU
United Kingdom

Merck Sharp & Dohme Ltd
Hertford Road
Hoddesdon
Hertfordshire EN11 9BU
United Kingdom

Arcoxia

60 mg

Film-coated
tablet

Oral use

Arcoxia

90 mg

Film-coated
tablet

Oral use

Arcoxia

120 mg

Film-coated
tablet

Oral use

Arcoxia

60 mg

Film-coated
tablet

Oral use

Arcoxia

90 mg

Film-coated
tablet

Oral use

Arcoxia

120 mg

Film-coated
tablet

Oral use

Auxib

60 mg

Film-coated
tablet

Oral use

Auxib

90 mg

Film-coated
tablet

Oral use

Auxib

120 mg

Film-coated
tablet

Oral use

Exxiv

60 mg

Film-coated
tablet

Oral use

Exxiv

90 mg

Film-coated
tablet

Oral use

30.12.2005

EN

Official Journal of the European Union

C 334/55

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical
Form

Route of
administration

Sverige

Merck Sharp & Dohme Ltd
Hertford Road
Hoddesdon
Hertfordshire EN11 9BU
United Kingdom

Merck Sharp & Dohme Ltd
Hertford Road
Hoddesdon
Hertfordshire EN11 9BU
United Kingdom

Merck Sharp & Dohme Ltd
Hertford Road
Hoddesdon
Hertfordshire EN11 9BU
United Kingdom

Merck Sharp & Dohme Ltd
Hertford Road
Hoddesdon
Hertfordshire EN11 9BU
United Kingdom

Merck Sharp & Dohme BV
Waarderweg 39
Postbus 581
2003 PC Haarlem
Nederland

Merck Sharp & Dohme BV
Waarderweg 39
Postbus 581
2003 PC Haarlem
Nederland

Merck Sharp & Dohme BV
Waarderweg 39
Postbus 581
2003 PC Haarlem
Nederland

Merck Sharp & Dohme BV
Waarderweg 39
Postbus 581
2003 PC Haarlem
Nederland

Merck Sharp & Dohme BV
Waarderweg 39
Postbus 581
2003 PC Haarlem
Nederland

Merck Sharp & Dohme BV
Waarderweg 39
Postbus 581
2003 PC Haarlem
Nederland

Exxiv

120 mg

Film-coated
tablet

Oral use

Turox

60 mg

Film-coated
tablet

Oral use

Turox

90 mg

Film-coated
tablet

Oral use

Turox

120 mg

Film-coated
tablet

Oral use

Arcoxia

60 mg

Film-coated
tablet

Oral use

Arcoxia

90 mg

Film-coated
tablet

Oral use

Arcoxia

120 mg

Film-coated
tablet

Oral use

Turox

60 mg

Film-coated
tablet

Oral use

Turox

90 mg

Film-coated
tablet

Oral use

Turox

120 mg

Film-coated
tablet

Oral use

C 334/56

EN

Official Journal of the European Union

30.12.2005

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

Novartis Pharmaceuticals UK Ltd
Frimley Business Park
Frimley
Camberley Surrey GU16 7SR
United Kingdom

Novartis Pharmaceuticals UK Ltd
Frimley Business Park
Frimley
Camberley Surrey GU16 7SR
United Kingdom

Novartis Pharmaceuticals UK Ltd
Frimley Business Park
Frimley
Camberley Surrey GU16 7SR
United Kingdom

Novartis Pharmaceuticals UK Ltd
Frimley Business Park
Frimley
Camberley Surrey GU16 7SR
United Kingdom

Novartis Pharmaceuticals UK Ltd
Frimley Business Park
Frimley
Camberley Surrey GU16 7SR
United Kingdom

Novartis Pharmaceuticals UK Ltd
Frimley Business Park
Frimley
Camberley Surrey GU16 7SR
United Kingdom

Novartis Pharmaceuticals UK Ltd
Frimley Business Park
Frimley
Camberley Surrey GU16 7SR
United Kingdom

Novartis Pharmaceuticals UK Ltd
Frimley Business Park
Frimley
Camberley Surrey GU16 7SR
United Kingdom

Prexige

100 mg

Film-coated
tablet

Oral

Prexige

200 mg

Film-coated
tablet

Oral

Prexige

400 mg

Film-coated
tablet

Oral

Lumiracoxib

100 mg

Film-coated
tablet

Oral

Lumiracoxib

200 mg

Film-coated
tablet

Oral

Lumiracoxib

400 mg

Film-coated
tablet

Oral

Frexocel

100 mg

Film-coated
tablet

Oral

Frexocel

200 mg

Film-coated
tablet

Oral

Frexocel

400 mg

Film-coated
tablet

Oral

30.12.2005

EN

Official Journal of the European Union

C 334/57

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical
Form

Route of
administration

Novartis Pharmaceuticals UK Ltd
Frimley Business Park
Frimley
Camberley Surrey GU16 7SR
United Kingdom

Novartis Pharmaceuticals UK Ltd
Frimley Business Park
Frimley
Camberley Surrey GU16 7SR
United Kingdom

Novartis Pharmaceuticals UK Ltd
Frimley Business Park
Frimley
Camberley Surrey GU16 7SR
United Kingdom

Novartis Pharmaceuticals UK Ltd
Frimley Business Park
Frimley
Camberley Surrey GU16 7SR
United Kingdom

Novartis Pharmaceuticals UK Ltd
Frimley Business Park
Frimley
Camberley Surrey GU16 7SR
United Kingdom

Novartis Pharmaceuticals UK Ltd
Frimley Business Park
Frimley
Camberley Surrey GU16 7SR
United Kingdom

Stellige

100 mg

Film-coated
tablet

Oral

Stellige

200 mg

Film-coated
tablet

Oral

Stellige

400 mg

Film-coated
tablet

Oral

Exforge

100 mg

Film-coated
tablet

Oral

Exforge

200 mg

Film-coated
tablet

Oral

Exforge

400 mg

Film-coated
tablet

Oral