EN Official Journal of the European Union C 220/17

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 July 2008 to 31 July 2008

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council (1) or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council (2) )

(2008/C 220/04)

— 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 9.7.2008 Latixa CV Therapeutics Europe Limited 15 Meadway Court Rutherford Close Stevenage Hertfordshire SG1 2EF United Kingdom This Decision is addressed to the Member States 10.7.2008 11.7.2008 Alvesco See Annex I See Annex I 14.7.2008 11.7.2008 Singulair See Annex II See Annex II 14.7.2008 14.7.2008 Octegra See Annex III See Annex III 15.7.2008 14.7.2008 Actira See Annex IV See Annex IV 16.7.2008 14.7.2008 Avalox See Annex V See Annex V 16.7.2008 22.7.2008 Oracea See Annex VI See Annex VI 23.7.2008 23.7.2008 Lamictal See Annex VII See Annex VII 28.7.2008 31.7.2008 Revlimid Celgene Europe Limited Morgan House Madeira Walk Windsor Berkshire SL4 1EP United Kingdom This Decision is addressed to the Member States 4.8.2008

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

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

ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT(S), MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State Marketing Authorisation Holder Applicant Invented Name Strength Pharmaceutical Form Route of administration Austria Nycomed Pharma GmbH EUROPLAZA Gebäude F Technologiestraße 5 A-1120 Wien Alvesco 40 Mikrogramm Dosieraerosol 40 μg Pressurised inhalation, solution Inhalation use Austria Nycomed Pharma GmbH EUROPLAZA Gebäude F Technologiestraße 5 A-1120 Wien Alvesco 80 Mikrogramm Dosieraerosol 80 μg Pressurised inhalation, solution Inhalation use Austria Nycomed Pharma GmbH EUROPLAZA Gebäude F Technologiestraße 5 A-1120 Wien Alvesco 160 Mikrogramm Dosieraerosol 160 μg Pressurised inhalation, solution Inhalation use Austria Nycomed GmbH Byk-Gulden-Straße 2 D-78467 Konstanz Amavio 40 Mikrogramm Dosieraerosol 40 μg Pressurised inhalation, solution Inhalation use Austria Nycomed GmbH Byk-Gulden-Straße 2 D-78467 Konstanz Amavio 80 Mikrogramm Dosieraerosol 80 μg Pressurised inhalation, solution Inhalation use Austria Nycomed GmbH Byk-Gulden-Straße 2 D-78467 Konstanz Amavio 160 Mikrogramm Dosieraerosol 40 μg Pressurised inhalation, solution Inhalation use Belgium Nycomed Belgium s.c.a./c.v.a. Gentsesteenweg 615 B-1080 Brussels Alvesco 40 microgram, aërosol, oplossing 40 μg Pressurised inhalation, solution Inhalation use Belgium Nycomed Belgium s.c.a./c.v.a. Gentsesteenweg 615 B-1080 Brussels Alvesco 80 microgram, aërosol, oplossing 80 μg Pressurised inhalation, solution Inhalation use Belgium Nycomed Belgium s.c.a./c.v.a. Gentsesteenweg 615 B-1080 Brussels Alvesco 160 microgram, aërosol, oplossing 160 μg Pressurised inhalation, solution Inhalation use Bulgaria Altana Pharma AG Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 40 Inhaler 40 μg Pressurised inhalation, solution Inhalation use Bulgaria Altana Pharma AG Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 80 Inhaler 80 μg Pressurised inhalation, solution Inhalation use Bulgaria Altana Pharma AG Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 160 Inhaler 160 μg Pressurised inhalation, solution Inhalation use Cyprus Nycomed GmbH Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 40 micrograms Inhaler 40 μg Pressurised inhalation, solution Inhalation use Cyprus Nycomed GmbH Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 80 micrograms Inhaler 80 μg Pressurised inhalation, solution Inhalation use Cyprus Nycomed GmbH Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 160 micrograms Inhaler 160 μg Pressurised inhalation, solution Inhalation use Czech Republic Altana Pharma AG Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 80 Inhaler 80 μg Pressurised inhalation, solution Inhalation use Czech Republic Altana Pharma AG Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 160 Inhaler 160 μg Pressurised inhalation, solution Inhalation use Denmark Altana Pharma AG Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 40 micrograms pressurised inhalation, solution 40 μg Pressurised inhalation, solution Inhalation use Denmark Altana Pharma AG Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 80 micrograms pressurised inhalation, solution 80 μg Pressurised inhalation, solution Inhalation use Denmark Altana Pharma AG Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 160 micrograms pressurised inhalation, solution 160 μg Pressurised inhalation, solution Inhalation use Estonia Nycomed GmbH Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 40 micrograms pressurised inhalation, solution 40 μg Pressurised inhalation, solution Inhalation use Estonia Nycomed GmbH Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 80 micrograms pressurised inhalation, solution 80 μg Pressurised inhalation, solution Inhalation use Estonia Nycomed GmbH Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 160 micrograms pressurised inhalation, solution 160 μg Pressurised inhalation, solution Inhalation use Finland Altana Pharma AG Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 40 micrograms pressurised inhalation, solution 40 μg Pressurised inhalation, solution Inhalation use Finland Altana Pharma AG Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 80 micrograms pressurised inhalation, solution 80 μg Pressurised inhalation, solution Inhalation use Finland Altana Pharma AG Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 160 micrograms pressurised inhalation, solution 160 μg Pressurised inhalation, solution Inhalation use France Nycomed GmbH Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 40 microgrammes, dose solution pour inhalation en flacon pressurisé 40 μg Pressurised inhalation, solution Inhalation use France Nycomed GmbH Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 80 microgrammes, dose solution pour inhalation en flacon pressurisé 80 μg Pressurised inhalation, solution Inhalation use France Nycomed GmbH Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 160 microgrammes, dose solution pour inhalation en flacon pressurisé 160 μg Pressurised inhalation, solution Inhalation use Germany Nycomed GmbH Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 40 Mikrogramm Druckgasinhalation, Lösung 40 μg Pressurised inhalation, solution Inhalation use Germany Nycomed GmbH Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 80 Mikrogramm Druckgasinhalation, Lösung 80 μg Pressurised inhalation, solution Inhalation use Germany Nycomed GmbH Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 160 Mikrogramm Druckgasinhalation, Lösung 160 μg Pressurised inhalation, solution Inhalation use Greece Nycomed Hellas S.A. Kifissias Ave 196 GR-15231 Chalandri Alvesco 80 mcg/Dose 80 μg Pressurised inhalation, solution Inhalation use Greece Nycomed Hellas S.A. Kifissias Ave 196 GR-15231 Chalandri Alvesco 160 mcg/Dose 160 μg Pressurised inhalation, solution Inhalation use Greece Nycomed Hellas S.A. Kifissias Ave 196 GR-15231 Chalandri Freathe 80 mcg/Dose 80 μg Pressurised inhalation, solution Inhalation use Greece Nycomed Hellas S.A. Kifissias Ave 196 GR-15231 Chalandri Freathe 160 mcg/Dose 160 μg Pressurised inhalation, solution Inhalation use Greece Nycomed Hellas S.A. Kifissias Ave 196 GR-15231 Chalandri Amavio 80 mcg/Dose 80 μg Pressurised inhalation, solution Inhalation use Greece Nycomed Hellas S.A. Kifissias Ave 196 GR-15231 Chalandri Amavio 160 mcg/Dose 160 μg Pressurised inhalation, solution Inhalation use Hungary Altana Pharma AG Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 40 mikrogramm túlnyomásos inhalációs oldat 40 μg Pressurised inhalation, solution Inhalation use Hungary Altana Pharma AG Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 80 mikrogramm túlnyomásos inhalációs oldat 80 μg Pressurised inhalation, solution Inhalation use Hungary Altana Pharma AG Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 160 mikrogramm túlnyomásos inhalációs oldat 160 μg Pressurised inhalation, solution Inhalation use Iceland Altana Pharma AG Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 40 innúdalyf 40 μg Pressurised inhalation, solution Inhalation use Iceland Altana Pharma AG Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 80 innúdalyf 80 μg Pressurised inhalation, solution Inhalation use Iceland Altana Pharma AG Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 160 innúdalyf 160 μg Pressurised inhalation, solution Inhalation use Ireland Nycomed GmbH Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 40 micrograms pressurised inhalation solution 40 μg Pressurised inhalation, solution Inhalation use Ireland Nycomed GmbH Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 80 micrograms pressurised inhalation solution 80 μg Pressurised inhalation, solution Inhalation use Ireland Nycomed GmbH Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 160 micrograms pressurised inhalation solution 160 μg Pressurised inhalation, solution Inhalation use Italy Altana Pharma AG Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 40 μg Pressurised inhalation, solution Inhalation use Italy Altana Pharma AG Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 80 μg Pressurised inhalation, solution Inhalation use Italy Altana Pharma AG Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 160 μg Pressurised inhalation, solution Inhalation use Latvia Altana Pharma AG Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 40 inhalators 40 μg Pressurised inhalation, solution Inhalation use Latvia Altana Pharma AG Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 80 inhalators 80 μg Pressurised inhalation, solution Inhalation use Latvia Altana Pharma AG Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 160 inhalators 160 μg Pressurised inhalation, solution Inhalation use Lithuania Altana Pharma AG Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 40 μg Pressurised inhalation, solution Inhalation use Lithuania Altana Pharma AG Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 80 μg Pressurised inhalation, solution Inhalation use Lithuania Altana Pharma AG Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 160 μg Pressurised inhalation, solution Inhalation use Luxembourg Nycomed Belgium s.c.a./c.v.a. Gentsesteenweg 615 B-1080 Brussels Alvesco 40 Aérosol doseur 40 μg Pressurised inhalation, solution Inhalation use Luxembourg Nycomed Belgium s.c.a./c.v.a. Gentsesteenweg 615 B-1080 Brussels Alvesco 80 Aérosol doseur 80 μg Pressurised inhalation, solution Inhalation use Luxembourg Nycomed Belgium s.c.a./c.v.a. Gentsesteenweg 615 B-1080 Brussels Alvesco 160 Aérosol doseur 160 μg Pressurised inhalation, solution Inhalation use Malta Nycomed GmbH Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 40 Inhaler 40 μg Pressurised inhalation, solution Inhalation use Malta Nycomed GmbH Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 80 Inhaler 80 μg Pressurised inhalation, solution Inhalation use Malta Nycomed GmbH Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 160 Inhaler 160 μg Pressurised inhalation, solution Inhalation use Netherlands Nycomed GmbH Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 40 Inhalator 40 μg Pressurised inhalation, solution Inhalation use Netherlands Nycomed GmbH Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 80 Inhalator 80 μg Pressurised inhalation, solution Inhalation use Netherlands Nycomed GmbH Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 160 Inhalator 160 μg Pressurised inhalation, solution Inhalation use Norway Altana Pharma AG Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 40 micrograms/dose inhalasjonsaerosol, oppløsing 40 μg Pressurised inhalation, solution Inhalation use Norway Altana Pharma AG Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 80 micrograms/dose inhalasjonsaerosol, oppløsing 80 μg Pressurised inhalation, solution Inhalation use Norway Altana Pharma AG Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 160 micrograms/dose inhalasjonsaerosol, oppløsing 160 μg Pressurised inhalation, Solution Inhalation use Poland Nycomed Pharma Sp. z o.o. Al. Jerozolimskie 146 A PL-02-305 Warszawa Alvesco 40 40 μg Pressurised inhalation, solution Inhalation use Poland Nycomed Pharma Sp. z o.o. Al. Jerozolimskie 146 A PL-02-305 Warszawa Alvesco 80 80 μg Pressurised inhalation, solution Inhalation use Poland Altana Pharma AG Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 160 160 μg Pressurised inhalation, solution Inhalation use Portugal Altana Pharma AG Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 40 Inalador 40 μg Pressurised inhalation, solution Inhalation use Portugal Altana Pharma AG Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 80 Inalador 80 μg Pressurised inhalation, solution Inhalation use Portugal Altana Pharma AG Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 160 Inalador 160 μg Pressurised inhalation, solution Inhalation use Romania Nycomed GmbH Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 40 Inhaler 40 μg Pressurised inhalation, solution Inhalation use Romania Nycomed GmbH Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 80 Inhaler 80 μg Pressurised inhalation, solution Inhalation use Romania Nycomed GmbH Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 160 Inhaler 160 μg Pressurised inhalation, solution Inhalation use Slovakia Altana Pharma AG Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 40 Inhalátor 40 μg Pressurised inhalation, solution Inhalation use Slovakia Altana Pharma AG Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 80 Inhalátor 80 μg Pressurised inhalation, solution Inhalation use Slovakia Altana Pharma AG Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 160 Inhalátor 160 μg Pressurised inhalation, solution Inhalation use Slovenia Altana Pharma AG Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 40 μg inhalacijska raztopina pod tlakom 40 μg Pressurised inhalation, solution Inhalation use Slovenia Altana Pharma AG Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 80 μg inhalacijska raztopina pod tlakom 80 μg Pressurised inhalation, solution Inhalation use Slovenia Altana Pharma AG Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 160 μg inhalacijska raztopina pod tlakom 160 μg Pressurised inhalation, solution Inhalation use Spain Altana Pharma AG Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 40 mcg solución para inhalación en envase a presión 40 μg Pressurised inhalation, solution Inhalation use Spain Altana Pharma AG Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 80 mcg solución para inhalación en envase a presión 80 μg Pressurised inhalation, solution Inhalation use Spain Altana Pharma AG Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 160 mcg solución para inhalación en envase a presión 160 μg Pressurised inhalation, solution Inhalation use Sweden Nycomed GmbH Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 40 μg/dose Pressurised inhalation, solution Inhalation use Sweden Nycomed GmbH Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 80 μg/dose Pressurised inhalation, solution Inhalation use Sweden Nycomed GmbH Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 160 μg/dose Pressurised inhalation, solution Inhalation use United Kingdom Nycomed GmbH Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 40 Inhaler 40 μg Pressurised inhalation, solution Inhalation use United Kingdom Nycomed GmbH Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 80 Inhaler 80 μg Pressurised inhalation, solution Inhalation use United Kingdom Nycomed GmbH Byk-Gulden-Straße 2 D-78467 Konstanz Alvesco 160 Inhaler 160 μg Pressurised inhalation, solution Inhalation use

ANNEX II LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS/MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State Marketing Authorisation Holder (Invented) name Strength Pharmaceutical Form Route of administration Content (concentration) Austria Merck Sharp & Dohme GmbH Donau-City-Straße 6 A-1220 Vienne Singulair 4 mg — Kautabletten für Kleinkinder 4 mg Chewable tablets Oral use 4 mg Belgium Merck Sherp & Dohme Chaussée de Waterloo 1135 B-1180 Bruxelles Singulair 4 mg Chewable tablets Oral use 4 mg Bulgaria Merck Sharp and Dohme Bulgaria EOOD 55, Nikola Vaptzarov blvd. EXPO 2000, east wing, sectors B1 & B2, 1st fl. BG-1407 Sofia Singulair 4 mg Granules Oral use Bulgaria Merck Sharp and Dohme Bulgaria EOOD 55, Nikola Vaptzarov blvd. EXPO 2000, east wing, sectors B1 & B2, 1st fl. BG-1407 Sofia Singulair 4 mg Chewable tablets Oral use 4 mg Cyprus Merck Sharp & Dohme B.V. Postbox 581 Waarderweg 39 2031 BN Haarlem Nederland Singulair 4 mg Granules Oral use Cyprus Merck Sharp & Dohme B.V. Postbox 581 Waarderweg 39 2031 BN Haarlem Nederland Singulair Paediatric 4 mg Chewable tablets Oral use 4 mg Czech Republic Merck Sharp & Dohme B.V. Postbox 581 Waarderweg 39 2031 BN Haarlem Nederland Singulair 4 Mini 4 mg Chewable tablets Oral use 4 mg Denmark Merck Sharp & Dohme B.V. Postbox 581 Waarderweg 39 2031 BN Haarlem Nederland Singulair 4 mg Chewable tablets Oral use 4 mg Estonia Merck Sharp & Dohme OÜ Peterburi tee 46 EE-11415 Tallinn Singulair Mini 4 mg 4 mg Granules Oral use Estonia Merck Sharp & Dohme OÜ Peterburi tee 46 EE-11415 Tallinn Singulair 4 mg 4 mg Chewable tablets Oral use 4 mg Finland Merck Sharp & Dohme B.V. Postbox 581 Waarderweg 39 2031 BN Haarlem Nederland Singulair 4 mg Granules Oral use Finland Merck Sharp & Dohme B.V. Postbox 581 Waarderweg 39 2031 BN Haarlem Nederland Singulair 4 mg Chewable tablets Oral use 4 mg Germany Dieckmann Arzneimittel GmbH Lindenplatz 1 D-85540 Haar Singulair mini 4 mg Granulat 4 mg Granules Oral use Germany Dieckmann Arzneimittel GmbH Lindenplatz 1 D-85540 Haar Singulair mini 4 mg Kautabletten 4 mg Chewable tablets Oral use 4 mg Greece VIANEX A.E. Tatoiou Street GR-146 71 Nea Erythrea/GR-146 71 Νέα Ερυθραία Singulair 4 mg Granules Oral use Greece VIANEX A.E. Tatoiou Street GR-146 71 Nea Erythrea/GR-146 71 Νέα Ερυθραία Singulair 4 mg Chewable tablets Oral use 4 mg Hungary MSD Magyarország Kft. Alkotás u. 50 H-1123 Budapest Singulair 4 mg Chewable tablets Oral use 4 mg Iceland Merck Sharp & Dohme B.V. Postbox 581 Waarderweg 39 2031 BN Haarlem Nederland Singulair 4 mg Granules Oral use Iceland Merck Sharp & Dohme B.V. Postbox 581 Waarderweg 39 2031 BN Haarlem Nederland Singulair 4 mg Chewable tablets Oral use 4 mg Ireland Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN119BU United Kingdom Singulair Paediatric 4 mg Granules Oral use Ireland Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN119BU United Kingdom Singulair Paediatric 4 mg Chewable Tablets Oral use 4 mg Italy Merck Sharp E Dohme (Italia) S.p.A. Via G. Fabbroni, 6 I-00191 Roma Singulair 4 mg Granules Oral use Italy Istituto Gentili S.p.A Via B. Croce, 37 I-56125 Pisa Montegen 4 mg Granules Oral use Italy Merck Sharp E Dohme (Italia) S.p.A. Via G. Fabbroni, 6 I-00191 Roma Singulair 4 mg Chewable tablets Oral use 4 mg Italy Istituto Gentili S.p.A Via B. Croce, 37 I-56125 Pisa Montegen 4 mg Chewable tablets Oral use 4 mg Latvia SIA “Merck Sharp & Dohme Latvija” Skanstes 13, second floor LV-1013 Riga Singulair mini 4 mg granulas 4 mg Granules Oral use Latvia SIA “Merck Sharp & Dohme Latvija” Skanstes 13, second floor LV-1013 Riga Singulair 4 mg košļājamās tabletes 4 mg Chewable tablets Oral use 4 mg Lithuania Merck Sharp & Dohme UAB, Kestucio str. 59/27 LT-08124 Vilnius Singulair Mini 4 mg Granules Oral use Lithuania Merck Sharp & Dohme UAB, Kestucio str. 59/27 LT-08124 Vilnius Singulair 4 mg Chewable tablets Oral use 4 mg Luxembourg Merck Sharp & Dohme Chaussée de Waterloo 1135 B-1180 Bruxelles Singulair Mini 4 mg Granules Oral use Luxembourg Merck Sharp & Dohme B.V. Chaussée de Waterloo 1135 B-1180 Bruxelles Singulair 4 mg Chewable tablets Oral use 4 mg Malta Merck Sharp & Dohme Hertfordshire Road Hoddesdon Hertfordshire EN11 9BU United Kingdom Singulair Paediatric 4 mg Granules 4 mg Granules Oral use Malta Merck Sharp & Dohme Hertfordshire Road Hoddesdon Hertfordshire EN11 9BU United Kingdom Singulair Paediatric 4 mg 4 mg Chewable Tablets Oral use 4 mg Netherlands Merck Sharp & Dohme B.V. Postbox 581 Waarderweg 39 2031 BN Haarlem Nederland Singulair Kleuter 4 mg Chewable tablets Oral use 4 mg Norway Merck Sharp & Dohme B.V. Postbox 581 Waarderweg 39 2031 BN Haarlem Nederland Singulair 4 mg Granules Oral use Norway Merck Sharp & Dohme B.V. Postbox 581 Waarderweg 39 2031 BN Haarlem Nederland Singulair 4 mg Chewable tablets Oral use 4 mg Poland MSD Polska Sp. z o.o. Ul. Chłodna 51 PL-00-867 Varsovie Singulair 4 4 mg Chewable tablets Oral use 4 mg Portugal Merck Sharp & Dohme, Lda. Quinta da Fonte — Edifício Vasco da Gama, n.o 19 — Porto Salvo P.O. Box 214 PT-2770-192 Paço d'Arcos Singulair Infantil 4 mg Granulado 4 mg Granules Oral use Portugal Merck Sharp & Dohme, Lda. Quinta da Fonte — Edifício Vasco da Gama, n.o 19 — Porto Salvo P.O. Box 214 PT-2770-192 Paço d'Arcos Singulair Infantil 4 mg Chewable tablets Oral use 4 mg Romania Merck Sharp & Dohme Romania S.R.L. Bucharest Business Park Şos. Bucureşti-Ploieşti, nr. 1A Corp clădire C1, Etaj 3 Sector 1, Bucarest România Singulair, granule, 4 mg/plic 4 mg Granules Oral use Romania Merck Sharp & Dohme Romania S.R.L. Bucharest Business Park Şos. Bucureşti-Ploieşti, nr.1A Corp clădire C1, Etaj 3 Sector 1, Bucarest România Singulair 4 mg, comprimate masticabile 4 mg Chewable tablets Oral use 4 mg Slovenia Merck Sharp & Dohme Šmartinska cesta 140 SLO-1000 Ljubljana Singulair 4 mg zrnca 4 mg Granules Oral use Slovenia Merck Sharp & Dohme Šmartinska cesta 140 SLO-1000 Ljubljana Singulair 4 mg žvečljive tablete 4 mg Chewable tablets Oral use 4 mg Slovakia Merck Sharp & Dohme B.V. Waarderweg 39 2031 BN Haarlem P.O. Box 581 2003 PC Haarlem Nederland Singulair 4 mg 4 mg Chewable tablets Oral use 4 mg Spain Merck Sharp and Dohme de España, SA Josefa Valcarcel, no 38 E-28027 Madrid Singulair 4 mg granulado 4 mg Granules Oral use Spain Merck Sharp and Dohme de España, SA Josefa Valcarcel, no 38 E-28027 Madrid Singulair 4 mg comprimidos masticables 4 mg Chewable tablets Oral use 4 mg Sweden Merck Sharp & Dohme B.V. Postbox 581 Waarderweg 39 2031 BN Haarlem Nederland Singulair 4 mg Granules Oral use Sweden Merck Sharp & Dohme B.V. Postbox 581 Waarderweg 39 2031 BN Haarlem Nederland Singulair 4 mg Chewable tablets Oral use 4 mg United Kingdom Merck Sharp & Dohme Limited Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom Singulair Paediatric 4 mg Granules 4 mg Granules Oral use United Kingdom Merck Sharp & Dohme Limited Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom Singulair Paediatric 4 mg Chewable tablets 4 mg Chewable Tablets Oral use 4 mg

ANNEX III LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, APPLICANT(S) MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES Member State Marketing Authorisation Holder Invented name Strength Pharmaceutical Form Route of administration Austria Bayer HealthCare AG D-51368 Leverkusen Octegra 400 mg — Filmtabletten 400 mg Film-coated tablet Oral use Belgium THERABEL PHARMA S.A. Rue Egide Van Ophem 108 B-1180 Bruxelles Proflox 400 mg 400 mg Film-coated tablet Oral use Germany Bayer HealthCare AG D-51368 Leverkusen Octegra 400 mg Filmtabletten 400 mg Film-coated tablet Oral use Greece ELPEN A.E. Pharmaceutical Industry 95 Marathonos Av. GR-190 09 Pikermi, Athens Octegra 400 mg Film-coated tablet Oral use Spain Procter and Gamble Pharmaceuticals Iberia, SL WTC Almeda park, edificio 1, 2a planta Cornellá de Llobregat — Barcelona España Octegra 400 mg comprimidos recubiertos con película 400 mg Film-coated tablet Oral use France Bayer HealthCare AG D-51368 Leverkusen Octegra 400 mg, comprimé pelliculé 400 mg Film-coated tablet Oral use Italy Innova Pharma S.p.A. Via M. Civitali, 1 I-20148 Milano Octegra 400 mg Film-coated tablet Oral use Luxembourg Therabel Pharma 110 Rue Egide Van Ochem B-1180 Bruxelles Proflox 400 mg Film-coated tablet Oral use Netherlands Bayer Healthcare AG D-51368 Leverkusen Octegra 400 mg tabletten 400 mg Film-coated tablet Oral use Portugal Bialfar — Produtos Farmacêuticos, SA À Av. da Siderurgia Nacional P.O. Box 56 P-4745-457 S. Mamede do Coronado Proflox 400 mg Film-coated tablet Oral use

ANNEX IV LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, APPLICANT(S) MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES Member State Marketing Authorisation Holder Invented name Strength Pharmaceutical Form Route of administration Austria Bayer HealthCare AG D-51368 Leverkusen Actira 400 mg — Filmtabletten 400 mg Film-coated tablet Oral use Belgium Bayer AG D-51368 Leverkusen Actira 400 mg 400 mg Film-coated tablet Oral use Germany Bayer HealthCare AG D-51368 Leverkusen Actira 400 mg Filmtabletten 400 mg Film-coated tablet Oral use Denmark Bayer HealthCare AG D-51368 Leverkusen Actira 400 mg Film-coated tablet Oral use Greece Bayer plc Bayer Schering Pharma Bayer House Strawberry Hill Newbury Berkshire RG14 1JA United Kingdom Proflox 400 mg Film-coated tablet Oral use Spain Química Farmaceútica Bayer, SL Av. Baix Llobregat, nos 3 y 5 E-08970 Sant Joan Despi — Barcelona Actira 400 mg comprimidos recubiertos con película 400 mg Film-coated tablet Oral use Finland Bayer HealthCare AG D-51368 Leverkusen Actira 400 mg Film-coated tablet Oral use Italy Sigma-Tau Industrie Farmaceutiche riunite S.p.A. Viale Shakespeare, 47 I-00144 Roma Actira 400 mg Film-coated tablet Oral use Luxembourg Bayer Healthcare AG D-51368 Leverkusen Actira 400 mg Film-coated tablet Oral use Portugal Bayer AG D-51368 Leverkusen Actira 400 mg Film-coated tablet Oral use Sweden Bayer HealthCare AG D-51368 Leverkusen Actira 400 mg Film-coated tablet Oral use

ANNEX V LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, APPLICANT(S) MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES Member State Marketing Authorisation Holder Invented name Strength Pharmaceutical Form Route of administration Austria Bayer Austria Gesellschaft m.b.H. Herbststraße 6-10 A-1160 Wien Avelox 400 mg — Filmtabletten 400 mg Film-coated tablet Oral use Belgium Bayer s.a.-n.v. Avenue Louise 143 B-1050 Bruxelles Avelox 400 mg 400 mg Film-coated tablet Oral use Cyprus Bayer Hellas S.A. Sorou 18-20 GR-151 25 Marousi, Athens Avelox 400 mg Film-coated tablet Oral use Czech Republic Bayer HealthCare AG D-51368 Leverkusen Avelox 400 mg Film-coated tablet Oral use Germany Bayer Vital GmbH D-51368 Leverkusen Avalox 400 mg Filmtabletten 400 mg Film-coated tablet Oral use Denmark Bayer HealthCare AG D-51368 Leverkusen Avelox 400 mg Film-coated tablet Oral use Estonia Bayer HealthCare AG D-51368 Leverkusen Avelox 400 mg Film-coated tablet Oral use Greece Bayer Hellas S.A. Sorou 18-20 GR-151 25 Marousi, Athens Avelox 400 mg Film-coated tablet Oral use Spain Recordati España, SL Crta. De Zeneta, 149 E-30588 Murcia Havelox 400 mg comprimidos recubiertos con película 400 mg Film-coated tablet Oral use Finland Bayer HealthCare AG D-51368 Leverkusen Avelox 400 mg Film-coated tablet Oral use France Bayer Santé 13, rue Jean Jaurès F-92807 Puteaux Cedex Izilox 400 mg, comprimé pelliculé 400 mg Film-coated tablet Oral use Hungary Bayer Hungária Kft Alkotás ut. 50 H-1123 Budapest Avelox 400 mg Film-coated tablet Oral use Ireland Bayer Limited The Atrium Blackthorn Road Dublin 18 Ireland Avelox 400 mg Film-coated tablet Oral use Italy Bayer S.p.A. Viale Certosa, 130 I-20156 Milano Avalox 400 mg Film-coated tablet Oral use Lithuania Bayer HealthCare AG D-51368 Leverkusen Avelox 400 mg Film-coated tablet Oral use Luxembourg Bayer s.a.-n.v. Avenue Louise 143 B-1050 Bruxelles Avelox 400 mg Film-coated tablet Oral use Latvia Bayer HealthCare AG D-51368 Leverkusen Avelox 400 mg Film-coated tablet Oral use Malta Bayer Vital GmbH D-51368 Leverkusen Avalox 400 mg Film-coated tablet Oral use Netherlands Bayer BV Energieweg 1 3641 RT Mijdrecht Nederland Avelox 400 mg tabletten 400 mg Film-coated tablet Oral use Poland Bayer HealthCare AG D-51368 Leverkusen Avelox 400 mg Film-coated tablet Oral use Portugal BayHealth — Comercialização de Produtos Farmacêuticos Unipessoal, Lda. Rua Quinta do Pinheiro, n.o 5 P-2794-003 Carnaxide Avelox 400 mg Film-coated tablet Oral use Sweden Bayer HealthCare AG D-51368 Leverkusen Avelox 400 mg Film-coated tablet Oral use Slovenia BAYER d.o.o. Bravničarjeva 13 SLO-1000 Ljubljana Avelox 400 mg filmsko obložene tablete 400 mg Film-coated tablet Oral use Slovakia Bayer HealthCare AG D-51368 Leverkusen Avelox 400 400 mg Film-coated tablet Oral use United Kingdom Bayer plc Bayer Schering Pharma Bayer House Strawberry Hill Newbury Berkshire RG14 1JA United Kingdom Avelox 400 mg Tablets 400 mg Film-coated tablet Oral use

ANNEX VI LIST OF THE NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANT(S) IN THE MEMBER STATES Member State Marketing Authorisation Holder Applicant Invented name Strength Pharmaceutical Form Route of administration Austria FGK Representative Service GmbH Heimeranstraße 35 D-80339 München Oracea 40 mg Modified-release capsule, hard Oral use Finland FGK Representative Service GmbH Heimeranstraße 35 D-80339 München Oracea 40 mg Prolonged-release capsule, hard Oral use Germany FGK Representative Service GmbH Heimeranstraße 35 D-80339 München Oracea 40 mg Prolonged-release capsule, hard Oral use Ireland FGK Representative Service GmbH Heimeranstraße 35 D-80339 München Oracea (1) 40 mg Modified-release capsule, hard Oral use Italy FGK Representative Service GmbH Heimeranstraße 35 D-80339 München Oracea 40 mg Prolonged-release capsule, hard Oral use Luxembourg FGK Representative Service GmbH Heimeranstraße 35 D-80339 München Oracea 40 mg Prolonged-release capsule, hard Oral use Netherlands FGK Representative Service GmbH Heimeranstraße 35 D-80339 München Oracea (1) 40 mg Prolonged-release capsule, hard Oral use Sweden FGK Representative Service GmbH Heimeranstraße 35 D-80339 München Oracea 40 mg Modified-release capsule, hard Oral use United Kingdom FGK Representative Service GmbH Heimeranstraße 35 D-80339 München Oracea 40 mg Prolonged-release capsule, hard Oral use (1) Name approval pending.