EN Official Journal of the European Union C 276/9

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 September 2008 to 30 September 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 276/03)

— 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 3.9.2008 Cozaar See Annex I See Annex I 8.9.2008 3.9.2008 Cozaar Comp See Annex II See Annex II 8.9.2008 9.9.2008 Arcoxia See Annex III See Annex III 11.9.2008 9.9.2008 Etoricoxib See Annex IV See Annex IV 11.9.2008 11.9.2008 Activelle See Annex V See Annex V 15.9.2008 11.9.2008 Rapinyl See Annex VI See Annex VI 15.9.2008 15.9.2008 Remeron See Annex VII See Annex VII 17.9.2008 23.9.2008 Gemzar See Annex VIII See Annex VIII 24.9.2008 26.9.2008 Sodium Salicylate See Annex IX See Annex IX 29.9.2008 26.9.2008 Toltrazuril See Annex X See Annex X 29.9.2008 26.9.2008 Aclasta Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom This Decision is addressed to the Member States 29.9.2008

— 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 9.9.2008 Pulairmax See Annex XI See Annex XI 11.9.2008

— Lift of 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 5.9.2008 Suramox 15 % LA — Stabox 15 % LA See Annex XII See Annex XII 9.9.2008

(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 FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State Marketing Authorisation Holder (Invented) Name Losartan potassium Strength Pharmaceutical Form Route of administration Austria Merck Sharp & Dohme GmbH Donau-City-Straße 6 A-1220 Wien Cosaar 12,5 mg — Filmtabletten 12,5 mg Film-coated tablet Oral use Austria Merck Sharp & Dohme GmbH Donau-City-Straße 6 A-1220 Wien Cosaar 50 mg — Filmtabletten 50 mg Film-coated tablet Oral use Austria Merck Sharp & Dohme GmbH Donau-City-Straße 6 A-1220 Wien Cosaar 100 mg — Filmtabletten 100 mg Film-coated tablet Oral use Belgium Merck Sharp & Dohme BV Chaussée de Waterloo, 1135 B-1180 Bruxelles Cozaar 100 mg 100 mg Film-coated tablet Oral use Belgium Merck Sharp & Dohme BV Chaussée de Waterloo, 1135 B-1180 Bruxelles Cozaar 50 MG 50 mg Film-coated tablet Oral use Belgium Merck Sharp & Dohme BV Chaussée de Waterloo, 1135 B-1180 Bruxelles Cozaar 12,5 mg 12,5 mg Film-coated tablet Oral use Belgium Merck Sharp & Dohme BV Chaussée de Waterloo, 1135 B-1180 Bruxelles Cozaar Cardio Start 21 X 12,5 mg + 14 X 50 mg Film-coated tablet Oral use Belgium Therabel Pharma S.A. Rue Egide Van Ophem, 108 B-1180 Bruxelles Loortan 100 mg 100 mg Film-coated tablet Oral use Belgium Therabel Pharma S.A. Rue Egide Van Ophem, 108 B-1180 Bruxelles Loortan 50 mg 50 mg Film-coated tablet Oral use Belgium Therabel Pharma S.A. Rue Egide Van Ophem, 108 B-1180 Bruxelles Loortan 12,50 mg 12,5 mg Film-coated tablet Oral use Belgium Therabel Pharma S.A. Rue Egide Van Ophem, 108 B-1180 Bruxelles Loortan Cardio Start 21 X 12,5 mg + 14 X 50 mg Film-coated tablet Oral use Bulgaria Merck Sharp & Dohme Bulgaria EOOD 55 Nikola Vaptzarov blvd. EXPO 2000, east wing, sections B1 & B2, 1st fl. BG-1407 Sofia Cozaar 50 mg Film-coated tablet Oral use Cyprus Merck Sharp & Dohme BV Postbus 581 2003 PC Haarlem Nederland Cozaar 50 mg Film-coated tablet Oral use Cyprus Merck Sharp & Dohme BV Postbus 581 2003 PC Haarlem Nederland Cozaar 100 mg Film-coated tablet Oral use Denmark Merck Sharp & Dohme BV Postbus 581 2003 PC Haarlem Nederland Cozaar 12,5 mg Film-coated tablet Oral use Denmark Merck Sharp & Dohme BV Postbus 581 2003 PC Haarlem Nederland Cozaar 50 mg Film-coated tablet Oral use Denmark Merck Sharp & Dohme BV Postbus 581 2003 PC Haarlem Nederland Cozaar 100 mg Film-coated tablet Oral use Denmark Merck Sharp & Dohme BV Postbus 581 2003 PC Haarlem Nederland Cozaar Startpakke 12,5 mg + 50 mg Film-coated tablet Oral use Estonia Merck Sharp & Dohme OÜ Peterburi tee 46 EE-11415 Tallinn Cozaar 100 mg Film-coated tablet Oral use Estonia Merck Sharp & Dohme OÜ Peterburi tee 46 EE-11415 Tallinn Cozaar 50 mg Film-coated tablet Oral use Estonia Merck Sharp & Dohme OÜ Peterburi tee 46 EE-11415 Tallinn Cozaar 12,5 mg 12,5 mg Film-coated tablet Oral use Finland Merck Sharp & Dohme B.V. Waarderweg 39 Postbus 581 2003 PC Haarlem Nederland Cozaar 12,5 mg Film-coated tablet Oral use Finland Merck Sharp & Dohme B.V. Waarderweg 39 Postbus 581 2003 PC Haarlem Nederland Cozaar 12,5 mg and 50 mg (initiation pack) Film-coated tablet Oral use Finland Merck Sharp & Dohme B.V. Waarderweg 39 Postbus 581 2003 PC Haarlem Nederland Cozaar 50 mg Film-coated tablet Oral use Finland Merck Sharp & Dohme B.V. Waarderweg 39 Postbus 581 2003 PC Haarlem Nederland Cozaar 100 mg Film-coated tablet Oral use France Merck Sharp Dohme Chibret 3, av. Hoche F-75114 Paris Cedex 08 Cozaar 100 mg film-coated tablets 100 mg Film-coated tablet Oral use France Merck Sharp Dohme Chibret 3, av. Hoche F-75114 Paris Cedex 08 Cozaar 50 mg scored coated tablets 50 mg Scored coated tablet Oral use Germany MSD Chibropharm GmbH Postfach 1202 D-85530 Haar Cardopal Start 12,5 mg Filmtabletten 12,5 mg Film-coated tablet Oral use Germany MSD Chibropharm GmbH Postfach 1202 D-85530 Haar Lorzaar 100 mg Filmtabletten 100 mg Film-coated tablet Oral use Germany MSD Chibropharm GmbH Postfach 1202 D-85530 Haar Lorzaar 50 mg Filmtabletten 50 mg Film-coated tablet Oral use Germany MSD Chibropharm GmbH Postfach 1202 D-85530 Haar Lorzaar Protect 100 mg Filmtabletten 100 mg Film-coated tablet Oral use Germany MSD Chibropharm GmbH Postfach 1202 D-85530 Haar Lorzaar Protect 50 mg Filmtabletten 50 mg Film-coated tablet Oral use Germany MSD Chibropharm GmbH Postfach 1202 D-85530 Haar Lorzaar Start 12,5 mg Filmtabletten 12,5 mg Film-coated tablet Oral use Germany MSD Chibropharm GmbH Postfach 1202 D-85530 Haar Pinzaar 100 mg Filmtabletten 100 mg Film-coated tablet Oral use Germany MSD Chibropharm GmbH Postfach 1202 D-85530 Haar Pinzaar 50 mg Filmtabletten 50 mg Film-coated tablet Oral use Germany VARIPHARM ARZNEIMITTEL GmbH Lindenplatz 1 D-85540 Haar Lorzaar Varipharmstart 12,5 mg Filmtabletten 12,5 mg Film-coated tablet Oral use Greece VIANEX A.E. Tatoiou Street GR-14671 Nea Erythraia Cozaar 12,5 mg Film-coated tablet Oral use Greece VIANEX A.E. Tatoiou Street GR-14671 Nea Erythraia Cozaar 50 mg Film-coated tablet Oral use Greece VIANEX A.E. Tatoiou Street GR-14671 Nea Erythraia Cozaar 100 mg Film-coated tablet Oral use Hungary Merck Sharp & Dohme Hungary Ltd 50, Alkotas u. H-1123 Budapest Cozaar 12,5 mg Film-coated tablet Oral use Hungary Merck Sharp & Dohme Hungary Ltd 50, Alkotas u. H-1123 Budapest Cozaar 50 mg Film-coated tablet Oral use Hungary Merck Sharp & Dohme Hungary Ltd 50, Alkotas u. H-1123 Budapest Cozaar 100 mg Film-coated tablet Oral use Ireland Merck Sharp & Dohme Limited Hertford Road Hoddesdon Herts EN11 9BU United Kingdom Cozaar 50 mg Film-coated tablets 50 mg Film-coated tablet Oral use Ireland Merck Sharp & Dohme Limited Hertford Road Hoddesdon Herts EN11 9BU United Kingdom Cozaar 100 mg Film-coated tablets 100 mg Film-coated tablet Oral use Ireland Merck Sharp & Dohme Limited Hertford Road Hoddesdon Herts EN11 9BU United Kingdom Cozaar 12,5 mg Film-coated tablets 12,5 mg Film-coated tablet Oral use Italy Merck Sharp & Dohme (Italia) S.p.A. Via G. Fabbroni 6 I-00191 Roma Lortaan 50 mg compresse rivestite con film 50 mg Film-coated tablet Oral use Italy Merck Sharp & Dohme (Italia) S.p.A. Via G. Fabbroni 6 I-00191 Roma Lortaan 12,5 mg compresse rivestite con film 12,5 mg Film-coated tablet Oral use Italy Merck Sharp & Dohme (Italia) S.p.A. Via G. Fabbroni 6 I-00191 Roma Lortaan 100 mg compresse rivestite con film 100 mg Film-coated tablet Oral use Italy Merck Sharp & Dohme (Italia) S.p.A. Via G. Fabbroni 6 I-00191 Roma Neo-Lotan 50 mg compresse rivestite con film 50 mg Film-coated tablet Oral use Italy Merck Sharp & Dohme (Italia) S.p.A. Via G. Fabbroni 6 I-00191 Roma Neo-Lotan 12,5 mg compresse rivestite con film 12,5 mg Film-coated tablet Oral use Italy Merck Sharp & Dohme (Italia) S.p.A. Via G. Fabbroni 6 I-00191 Roma Neo-Lotan 100 mg compresse rivestite con film 100 mg Film-coated tablet Oral use Italy Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. Viale Shakespeare 47 I-00144 Roma Losaprex 50 mg compresse rivestite con film 50 mg Film-coated tablet Oral use Italy Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. Viale Shakespeare 47 I-00144 Roma Losaprex 12,5 mg compresse rivestite con film 12.5 mg Film-coated tablet Oral use Italy Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. Viale Shakespeare 47 I-00144 Roma Losaprex 100 mg compresse rivestite con film 100 mg Film-coated tablet Oral use Latvia SIA Merck Sharp & Dohme Latvia Skanstes street 13 LV-1013 Riga Cozaar 50 mg film-coated tablets 50 mg Film-coated tablet Oral use Latvia SIA Merck Sharp & Dohme Latvia Skanstes street 13 LV-1013 Riga Cozaar 100 mg film-coated tablets 100 mg Film-coated tablet Oral use Lithuania UAB Merck Sharp & Dohme Geležinio Vilko 18A LT-01112 Vilnius Cozaar (Losartan) 12,5 mg Film-coated tablet Oral use Lithuania UAB Merck Sharp & Dohme Geležinio Vilko 18A LT-01112 Vilnius Cozaar (Losartan) 50 mg Film-coated tablet Oral use Lithuania UAB Merck Sharp & Dohme Geležinio Vilko 18A LT-01112 Vilnius Cozaar (Losartan) 100 mg Film-coated tablet Oral use Luxembourg Merck Sharp & Dohme BV Chaussée de Waterloo, 1135 B-1180 Bruxelles Cozaar 100 mg 100 mg Film-coated tablet Oral use Luxembourg Merck Sharp & Dohme BV Chaussée de Waterloo, 1135 B-1180 Bruxelles Cozaar 50 MG 50 mg Film-coated tablet Oral use Luxembourg Merck Sharp & Dohme BV Chaussée de Waterloo, 1135 B-1180 Bruxelles Cozaar 12,5 mg 12,5 mg Film-coated tablet Oral use Luxembourg Merck Sharp & Dohme BV Chaussée de Waterloo, 1135 B-1180 Bruxelles Cozaar Cardio Start 21 X 12,5 mg + 14 X 50 mg Film-coated tablet Oral use Luxembourg Therabel Pharma S.A. Rue Egide Van Ophem, 108 B-1180 Bruxelles Loortan 100 mg 100 mg Film-coated tablet Oral use Luxembourg Therabel Pharma S.A. Rue Egide Van Ophem, 108 B-1180 Bruxelles Loortan 50 mg 50 mg Film-coated tablet Oral use Luxembourg Therabel Pharma S.A. Rue Egide Van Ophem, 108 B-1180 Bruxelles Loortan 12,50 mg 12,5 mg Film-coated tablet Oral use Luxembourg Therabel Pharma S.A. Rue Egide Van Ophem, 108 B-1180 Bruxelles Loortan Cardio Start 21 X 12,5 mg + 14 X 50 mg Film-coated tablet Oral use Malta Merck Sharp & Dohme Ltd. Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom “Cozaar 100 mg” pilloli miksija b'rita 10 mg Film-coated tablet Oral use Malta Merck Sharp & Dohme Ltd. Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom “Cozaar 50 mg” pilloli miksija b'rita 50 mg Film-coated tablet Oral use The Netherlands Merck Sharp & Dohme Postbus 581 2003 PC Haarlem Nederland Cozaar 50 50 mg Film-coated tablet Oral use The Netherlands Merck Sharp & Dohme Postbus 581 2003 PC Haarlem Nederland Cozaar 100 100 mg Film-coated tablet Oral use Poland MSD Polska Sp. z o.o. Chłodna 51 PL-00-867 Warszawa Cozaar 12,5 mg Film-coated tablet Oral use Poland MSD Polska Sp. z o.o. Chłodna 51 PL-00-867 Warszawa Cozaar 50 mg Film-coated tablet Oral use Poland MSD Polska Sp. z o.o. Chłodna 51 PL-00-867 Warszawa Cozaar 100 mg Film-coated tablet Oral use Portugal Merck Sharp & Dohme, Lda. Quinta da Fonte Edifício Vasco da Gama, 19 Porto Salvo P.O. Box 214 P-2770-192 Paço d'Arcos Cozaar 50 mg Film-coated tablet Oral use Portugal Merck Sharp & Dohme, Lda. Quinta da Fonte Edifício Vasco da Gama, 19 Porto Salvo P.O. Box 214 P-2770-192 Paço d'Arcos Cozaar 100 mg 100 mg Film-coated tablet Oral use Portugal Merck Sharp & Dohme, Lda. Quinta da Fonte Edifício Vasco da Gama, 19 Porto Salvo P.O. Box 214 P-2770-192 Paço d'Arcos Cozaar IC 12,5 mg Film-coated tablet Oral use Portugal Merck Sharp & Dohme, Lda. Quinta da Fonte Edifício Vasco da Gama, 19 Porto Salvo P.O. Box 214 P-2770-192 Paço d'Arcos Cozaar IC — Titulação 12,5 mg + 50 mg Film-coated tablet Oral use Portugal LABORATÓRIO MEDINFAR Produtos Farmacêuticos, SA Rua Manuel Ribeiro de Pavia, 1-1 Venda Nova P-2700-547 Amadora Lortaan IC 12,5 mg Film-coated tablet Oral use Portugal LABORATÓRIO MEDINFAR Produtos Farmacêuticos, SA Rua Manuel Ribeiro de Pavia, 1-1 Venda Nova PT-2700-547 Amadora Lortaan IC — Titulação 12,5 mg + 50 mg Film-coated tablet Oral use Portugal LABORATÓRIO MEDINFAR Produtos Farmacêuticos, SA Rua Manuel Ribeiro de Pavia, 1-1 Venda Nova P-2700-547 Amadora Lortaan 50 mg Film-coated tablet Oral use Portugal LABORATÓRIO MEDINFAR Produtos Farmacêuticos, SA Rua Manuel Ribeiro de Pavia, 1-1 Venda Nova P-2700-547 Amadora Lortaan 100 mg 100 mg Film-coated tablet Oral use Romania Merck Sharp & Dohme Romania S.R.L. Bucharest Business Park Şos. Bucureşti-Ploieşti, Nr. 1A Clădirea C1, Etaj 3 Sector 1, Bucureşti România Cozaar, comprimate filmate, 50 mg 50 mg Film-coated tablet Oral use Slovenia Merck Sharp & Dohme, inovativna zdravila d.o.o. Šmartinska cesta 140 SLO-1000 Ljubljana Cozaar 12,5 mg filmsko obložene tablete 12,5 mg Film-coated tablet Oral use Slovenia Merck Sharp & Dohme, inovativna zdravila d.o.o. Šmartinska cesta 140 SLO-1000 Ljubljana Cozaar 50 mg filmsko obložene tablete 50 mg Film-coated tablet Oral use Slovenia Merck Sharp & Dohme, inovativna zdravila d.o.o. Šmartinska cesta 140 SLO-1000 Ljubljana Cozaar 100 mg filmsko obložene tablete 100 mg Film-coated tablet Oral use Spain Merck Sharp and Dohme de España, S.A. C/ Josefa Valcárcel, 38 E-28027 Madrid Cozaar 12,5 mg Inicio 12,5 mg Film-coated tablet Oral use Spain Merck Sharp and Dohme de España, S.A. C/ Josefa Valcárcel, 38 E-28027 Madrid Cozaar 50 mg 50 mg Film-coated tablet Oral use Spain Merck Sharp and Dohme de España, S.A. C/ Josefa Valcárcel, 38 E-28027 Madrid Cozaar 100 mg 100 mg Film-coated tablet Oral use Sweden Merck Sharp & Dohme PO Box 581 2003 PC Haarlem Nederland Cozaar 12,5 mg filmdragerade tabletter 12,5 mg Film-coated tablet Oral use Sweden Merck Sharp & Dohme PO Box 581 2003 PC Haarlem Nederland Cozaar 12,5 mg + 50 mg filmdragerade tabletter 12,5 + 50 mg Film-coated tablet Oral use Sweden Merck Sharp & Dohme PO Box 581 2003 PC Haarlem Nederland Cozaar 50 mg filmdragerade tabletter 50 mg Film-coated tablet Oral use Sweden Merck Sharp & Dohme PO Box 581 2003 PC Haarlem Nederland Cozaar 100 mg filmdragerade tabletter 100 mg Film-coated tablet Oral use United Kingdom Merck Sharp & Dohme Limited Hertford Road Hoddesdon Herts EN11 9BU United Kingdom Cozaar 50 mg Film-coated tablets 50 mg Film-coated tablet Oral use United Kingdom Merck Sharp & Dohme Limited Hertford Road Hoddesdon Herts EN11 9BU United Kingdom Cozaar 25 mg Film-coated tablets 25 mg Film-coated tablet Oral use United Kingdom Merck Sharp & Dohme Limited Hertford Road Hoddesdon Herts EN11 9BU United Kingdom Cozaar 100 mg Film-coated tablets 100 mg Film-coated tablet Oral use Iceland Merck Sharp & Dohme PO Box 581 2003 PC Haarlem Nederland Cozaar 12,5 mg Film-coated tablet Oral use Iceland Merck Sharp & Dohme PO Box 581 2003 PC Haarlem Nederland Cozaar 50 mg Film-coated tablet Oral use Iceland Merck Sharp & Dohme PO Box 581 2003 PC Haarlem Nederland Cozaar 100 mg Film-coated tablet Oral use Norway Merck Sharp & Dohme PO Box 581 2003 PC Haarlem Nederland Cozaar 12,5 mg Film-coated tablet Oral use Norway Merck Sharp & Dohme PO Box 581 2003 PC Haarlem Nederland Cozaar 50 mg Film-coated tablet Oral use Norway Merck Sharp & Dohme PO Box 581 2003 PC Haarlem Nederland Cozaar 100 mg Film-coated tablet Oral use

ANNEX II LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State Marketing Authorisation Holder (Invented) Name Losartan potassium and hydrochlorothiazide Strength Pharmaceutical Form Route of administration Austria Merck Sharp & Dohme GmbH Donau-City-Straße 6 A-1220 Wien Cosaar Plus — Filmtabletten 50 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use Austria Merck Sharp & Dohme GmbH Donau-City-Straße 6 A-1220 Wien Fortzaar-Filmtabletten 100 mg losartan potassium — 25 mg hydrochlorothiazide Film-coated tablet Oral use Belgium Merck Sharp & Dohme BV Chaussée de Waterloo, 1135 B-1180 Bruxelles Cozaar Plus Forte 100 mg/25 mg 100 mg losartan potassium — 25 mg hydrochlorothiazide Film-coated tablet Oral use Belgium Merck Sharp & Dohme BV Chaussée de Waterloo, 1135 B-1180 Bruxelles Cozaar Plus 50 mg/12,5 mg 50 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use Belgium Therabel Pharma S.A. Rue Egide Van Ophem, 108 B-1180 Bruxelles Loortan Plus Forte 100 mg/25 mg 100 mg losartan potassium — 25 mg hydrochlorothiazide Film-coated tablet Oral use Belgium Therabel Pharma S.A. Rue Egide Van Ophem, 108 B-1180 Bruxelles Loortan Plus 50 mg/12,5 mg 50 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use Bulgaria Merck Sharp & Dohme Bulgaria EOOD 55 Nikola Vaptzarov blvd. EXPO 2000, east wing, sections B1 & B2, 1st fl. BG-1407 Sofia Hyzaar 50 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use Cyprus Merck Sharp & Dohme BV Postbus 581 2003 PC Haarlem Nederland Fortzaar 100 mg losartan potassium — 25 mg hydrochlorothiazide Film-coated tablet Oral use Cyprus Merck Sharp & Dohme BV Postbus 581 2003 PC Haarlem Nederland Hyzaar 50 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use Denmark Merck Sharp & Dohme BV Postbus 581 2003 PC Haarlem Nederland Cozaar Comp. 50 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use Denmark Merck Sharp & Dohme BV Postbus 581 2003 PC Haarlem Nederland Cozaar Comp. Forte 100 mg losartan potassium — 25 mg hydrochlorothiazide Film-coated tablet Oral use Denmark Merck Sharp & Dohme BV Postbus 581 2003 PC Haarlem Nederland Cozaar Comp. 100 mg/12,5 mg 100 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use Denmark Merck Sharp & Dohme BV Postbus 581 2003 PC Haarlem Nederland Fortzaar 100 mg losartan potassium — 25 mg hydrochlorothiazide Film-coated tablets Oral use Estonia Merck Sharp & Dohme OÜ Peterburi tee 46 EE-11415 Tallinn Hyzaar 50 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use Estonia Merck Sharp & Dohme OÜ Peterburi tee 46 EE-11415 Tallinn Fortzaar 100 mg losartan potassium — 25 mg hydrochlorothiazide Film-coated tablet Oral use Finland Merck Sharp & Dohme B.V. Waarderweg 39 P.O.Box 581 2031 BN Haarlem Nederland Cozaar Comp 50 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use Finland Merck Sharp & Dohme B.V. Waarderweg 39 P.O.Box 581 2031 BN Haarlem Nederland Cozaar Comp 100 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use Finland Merck Sharp & Dohme B.V. Waarderweg 39 P.O.Box 581 2031 BN Haarlem Nederland Cozaar Comp Forte 100 mg losartan potassium — 25 mg hydrochlorothiazide Film-coated tablet Oral use France Merck Sharp Dohme Chibret 3, av. Hoche F-75114 Paris Cedex 08 Fortzaar 100 mg/25 mg comprimé pelliculé 100 mg losartan potassium — 25 mg hydrochlorothiazide Film-coated tablet Oral use France Merck Sharp Dohme Chibret 3, av. Hoche F-75114 Paris Cedex 08 Hyzaar 100 mg/25 mg comprimé pelliculé 100 mg losartan potassium — 25 mg hydrochlorothiazide Film-coated tablet Oral use France Merck Sharp Dohme Chibret 3, av. Hoche F-75114 Paris Cedex 08 Fortzaar 50 mg/12,5 mg comprimé pelliculé 50 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use France Merck Sharp Dohme Chibret 3, av. Hoche F-75114 Paris Cedex 08 Hyzaar 50 mg/12,5 mg comprimé pelliculé 50 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use France Merck Sharp Dohme Chibret 3, av. Hoche F-75114 Paris Cedex 08 Fortzaar 100 mg/12,5 mg comprimé pelliculé 100 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use Germany MSD Chibropharm GmbH Postfach 1202 D-85530 Haar Lorzaar Plus 50/12,5 mg Filmtabletten 50 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use Germany MSD Chibropharm GmbH Postfach 1202 D-85530 Haar Cardopal Plus 50/12,5 mg Filmtabletten 50 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use Germany VARIPHARM ARZNEIMITTEL GmbH Lindenplatz 1 D-85540 Haar Lorzaar Varipharm Plus 50/12,5 mg Filmtabletten 50 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use Germany MSD Chibropharm GmbH Postfach 1202 D-85530 Haar Fortzaar 100/25 mg Filmtabletten 100 mg losartan potassium — 25 mg hydrochlorothiazide Film-coated tablet Oral use Germany VARIPHARM ARZNEIMITTEL GmbH Lindenplatz 1 D-85540 Haar Fortzaar Varipharm 100/25 mg Filmtabletten 100 mg losartan potassium — 25 mg hydrochlorothiazide Film-coated tablet Oral use Germany MSD Chibropharm GmbH Postfach 1202 D-85530 Haar Lorzaar Plus Forte 100/12,5 mg Filmtabletten 100 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use Greece VIANEX A.E. Tatoiou Street GR-14671 Nea Erythraia Hyzaar 50 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use Greece VIANEX A.E. Tatoiou Street GR-14671 Nea Erythraia Hyzaar 100/25 100 mg losartan potassium — 25 mg hydrochlorothiazide Film-coated tablet Oral use Hungary Merck Sharp & Dohme Hungary Ltd 50, Alkotas u. H-1123 Budapest Hyzaar 50/12,5 mg 50 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use Hungary Merck Sharp & Dohme Hungary Ltd 50, Alkotas u. H-1123 Budapest Hyzaar Forte 100/25 mg 100 mg losartan potassium — 25 mg hydrochlorothiazide Film-coated tablet Oral use Iceland Merck Sharp & Dohme Limited Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom Cozaar' Comp 50 mg/12,5 mg film-coated tablets 50 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use Iceland Merck Sharp & Dohme Limited Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom Cozaar' Comp 100 mg/25 mg film-coated tablets 100 mg losartan potassium — 25 mg hydrochlorothiazide Film-coated tablet Oral use Iceland Merck Sharp & Dohme (Italia) S.p.A. Via G. Fabbroni 6 I-00191 Roma Hizaar 50 mg + 12,5 mg compresse rivestite con film 50 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use Ireland Merck Sharp & Dohme (Italia) S.p.A. Via G. Fabbroni 6 I-00191 Roma Hizaar 100 mg + 25 mg compresse rivestite con film 100 mg losartan potassium — 25 mg hydrochlorothiazide Film-coated tablet Oral use Ireland Merck Sharp & Dohme (Italia) S.p.A. Via G. Fabbroni 6 I-00191 Roma Forzaar 100 mg + 25 mg compresse rivestite con film 100 mg losartan potassium — 25 mg hydrochlorothiazide Film-coated tablet Oral use Italy Neopharmed S.p.A. Via G. Fabbroni, 6 I-00191 Roma Neo-Lotan Plus 50 mg + 12,5 mg compresse rivestite con film 50 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use Italy Neopharmed S.p.A. Via G. Fabbroni, 6 I-00191 Roma Neo-Lotan Plus 100 mg + 25 mg compresse rivestite con film 100 mg losartan potassium — 25 mg hydrochlorothiazide Film-coated tablet Oral use Italy Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. viale Shakespeare 47 I-00144 Roma Losazid 50 mg + 12,5 mg compresse rivestite con film 50 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use Italy Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. viale Shakespeare 47 I-00144 Roma Losazid 100 mg + 25 mg compresse rivestite con film 100 mg losartan potassium — 25 mg hydrochlorothiazide Film-coated tablet Oral use Italy SIA Merck Sharp & Dohme Latvia Skanstes street 13 LV-1013 Riga Hyzaar 50 mg/12,5 mg 50 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use Italy SIA Merck Sharp & Dohme Latvia Skanstes street 13 LV-1013 Riga Fortzaar 100 mg/25 mg 100 mg losartan potassium — 25 mg hydrochlorothiazide Film-coated tablet Oral use Italy UAB Merck Sharp & Dohme Geležinio Vilko 18A LT-01112 Vilnius Fortzaar (Losartan/Hydrochlorothiazide) 100 mg losartan potassium — 25 mg hydrochlorothiazide Film-coated tablet Oral use Latvia UAB Merck Sharp & Dohme Geležinio Vilko 18A LT-01112 Vilnius Hyzaar (Losartan/Hydrochlorothiazide) 50 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use Latvia Merck Sharp & Dohme BV Chaussée de Waterloo, 1135 B-1180 Bruxelles Cozaar Plus Forte 100 mg/25 mg 100 mg losartan potassium — 25 mg hydrochlorothiazide Film-coated tablet Oral use Lithuania Merck Sharp & Dohme BV Chaussée de Waterloo, 1135 B-1180 Bruxelles Cozaar Plus 50 mg/12,5 mg 50 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use Lithuania Therabel Pharma S.A. Rue Egide Van Ophem, 108 B-1180 Bruxelles Loortan Plus Forte 100 mg/25 mg 100 mg losartan potassium — 25 mg hydrochlorothiazide Film-coated tablet Oral use Luxembourg Therabel Pharma S.A. Rue Egide Van Ophem, 108 B-1180 Bruxelles Loortan Plus 50 mg/12,5 mg 50 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use Luxembourg Merck Sharp & Dohme Ltd Hertfordshire Road Hoddesdon Hertfordshire EN11 9BU United Kingdom “Cozaar Comp” 50/12,5 mg pilloli miksija b'rita 50 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use Luxembourg Merck Sharp & Dohme Ltd Hertfordshire Road Hoddesdon Hertfordshire EN11 9BU United Kingdom “Cozaar Comp” 100/25 mg pilloli miksija b'rita 100 mg losartan potassium — 25 mg hydrochlorothiazide Film-coated tablet Oral use Luxembourg Merck Sharp & Dohme Ltd Hertfordshire Road Hoddesdon Hertfordshire EN11 9BU United Kingdom “Cozaar Comp” 100/12,5 mg pilloli miksija b'rita 100 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use Malta Merck Sharp & Dohme Postbus 581 2003 PC Haarlem Nederland Cozaar Plus 100/12,5 100 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use Malta Merck Sharp & Dohme Postbus 581 2003 PC Haarlem Nederland Fortzaar 100/25 100 mg losartan potassium — 25 mg hydrochlorothiazide Film-coated tablet Oral use Malta Merck Sharp & Dohme Postbus 581 2003 PC Haarlem Nederland Hyzaar 50/12,5 50 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use The Netherlands MSD Polska Sp. z o.o. ul. Chłodna 51 PL-00-867 Warszawa Hyzaar 50 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use The Netherlands MSD Polska Sp. z o.o. ul. Chłodna 51 PL-00-867 Warszawa Hyzaar Forte 100 mg losartan potassium — 25 mg hydrochlorothiazide Film-coated tablet Oral use The Netherlands Merck Sharp & Dohme, Lda. Quinta da Fonte Edifício Vasco da Gama, 19 Porto Salvo P.O. Box 214 P-2770-192 Paço d'Arcos Cozaar Plus 50 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use Norway Merck Sharp & Dohme, Lda. Quinta da Fonte Edifício Vasco da Gama, 19 Porto Salvo P.O. Box 214 P-2770-192 Paço d'Arcos Cozaar Plus 100 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use Norway Merck Sharp & Dohme, Lda. Quinta da Fonte Edifício Vasco da Gama, 19 Porto Salvo P.O. Box 214 P-2770-192 Paço d'Arcos Fortzaar 100 mg losartan potassium — 25 mg hydrochlorothiazide Film-coated tablet Oral use Norway Heptafarma- Companhia Farmacêutica Sociedade Unipessoal, Lda Quinta da Fonte Edifício Vasco da Gama, 19 Porto Salvo P.O. Box 214 P-2770-192 Paço d'Arcos Siaara 100 mg losartan potassium — 25 mg hydrochlorothiazide Film-coated tablet Oral use Poland Laboratório Medinfar Produtos Farmacêuticos, SA Rua Manuel Ribeiro de Pavia, 1-1 Venda Nova P-2700-547 Amadora Lortaan Plus 50 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use Poland Laboratório Medinfar Produtos Farmacêuticos, SA Rua Manuel Ribeiro de Pavia, 1-1 Venda Nova P-2700-547 Amadora Lortaan Plus 100 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use Portugal Frosst Portuguesa Produtos Farmacêuticos, Lda. Quinte da Fonte Edificio Vasco da Gama, 19 P.O. BOX 214 Porto Salvo P-2780-730 Paço d'Arcos Losartan + Hidroclorotiazida Frosst 100 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use Portugal Merck Sharp & Dohme Romania S.R.L. Bucharest Business Park Şos. Bucureşti-Ploieşti, Nr. 1A Clădirea C1, Etaj 3 Sector 1, Bucureşti România Hyzaar® 50 mg/12,5 mg comprimate filmate 50 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use Portugal Merck Sharp & Dohme Romania S.R.L. Bucharest Business Park Şos. Bucureşti-Ploieşti, Nr. 1A Clădirea C1, Etaj 3 Sector 1, Bucureşti România Fortzaar® 100/25 mg comprimate filmate 100 mg losartan potassium — 25 mg hydrochlorothiazide Film-coated tablet Oral use Portugal Merck Sharp & Dohme, inovativna zdravila d.o.o. Šmartinska cesta 140 SLO-1000 Ljubljana Hyzaar 50 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use Portugal Merck Sharp & Dohme, inovativna zdravila d.o.o. Šmartinska cesta 140 SLO-1000 Ljubljana Hyzaar 100 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use Portugal Merck Sharp & Dohme, inovativna zdravila d.o.o. Šmartinska cesta 140 SLO-1000 Ljubljana Fortzaar 100 mg losartan potassium — 25 mg hydrochlorothiazide Film-coated tablet Oral use Portugal Merck Sharp and Dohme de España, S.A. C/ Josefa Valcárcel, 38 E-28027 Madrid Cozaar Plus 50 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use Romania Merck Sharp and Dohme de España, S.A. C/ Josefa Valcárcel, 38 E-28027 Madrid Fortzaar 100 mg losartan potassium — 25 mg hydrochlorothiazide Film-coated tablet Oral use Romania Merck Sharp & Dohme PO Box 581 2003 PC Haarlem Nederland Cozaar Comp 50 mg/12,5 mg filmdragerade tabletter 50 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use Slovenia Merck Sharp & Dohme PO Box 581 2003 PC Haarlem Nederland Cozaar Comp 100 mg/12,5 mg filmdragerade tabletter 100 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use Slovenia Merck Sharp & Dohme PO Box 581 2003 PC Haarlem Nederland Cozaar Comp Forte 100 mg/25 mg filmdragerade tabletter 100 mg losartan potassium — 25 mg hydrochlorothiazide Film-coated tablet Oral use Slovenia Merck Sharp & Dohme Limited Hertford Road Hoddesdon Herts EN11 9BU United Kingdom Cozaar-Comp 50/12,5 mg film-coated tablets 50 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use Spain Merck Sharp & Dohme Limited Hertford Road Hoddesdon Herts EN11 9BU United Kingdom Cozaar-Comp 100/25 mg film-coated tablets 100 mg losartan potassium — 25 mg hydrochlorothiazide Film-coated tablet Oral use Spain Merck Sharp & Dohme Limited Hertford Road Hoddesdon Herts EN11 9BU United Kingdom Cozaar-Comp 100 mg/12,5 mg film-coated tablets 100 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use Sweden Merck Sharp & Dohme PO Box 581 2003 PC Haarlem Nederland Cozaar-Comp 50/12,5 mg 50 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use Sweden Merck Sharp & Dohme PO Box 581 2003 PC Haarlem Nederland Cozaar-Comp Forte 100 mg losartan potassium — 25 mg hydrochlorothiazide Film-coated tablet Oral use Sweden Merck Sharp & Dohme PO Box 581 2003 PC Haarlem Nederland Cozaar-Comp 100/12,5 mg 100 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use United Kingdom MSD BV Waarderweg 39 2031 BN Haarlem Nederland Cozaar Comp 50 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use United Kingdom MSD BV Waarderweg 39 2031 BN Haarlem Nederland Cozaar Comp 100 mg losartan potassium — 12,5 mg hydrochlorothiazide Film-coated tablet Oral use United Kingdom MSD BV Waarderweg 39 2031 BN Haarlem Nederland Cozaar Comp Forte 100 mg losartan potassium — 25 mg hydrochlorothiazide Film-coated tablet Oral use

ANNEX III 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 adminitration Austria Merck Sharp & Dohme GmbH Donau-City-Straße 6 A-1220 Wien Arcoxia 90 mg Film-coated tablets Oral use Belgium Merck Sharp and Dohme Chaussée de Waterloo, 1135 B-1180 Brussels Arcoxia 90 mg Film-coated tablets Oral use Czech Republic Merck Sharp & Dohme B.V. Waanderweg 39 2031 BN Haarlem Nederland Arcoxia 90 mg Film-coated tablets Oral use Cyprus Merck Sharp & Dohme B.V. Waanderweg 39 2031 BN Haarlem Nederland Arcoxia 90 mg Film-coated tablets Oral use Denmark Merck Sharp & Dohme B.V. Waanderweg 39 2031 BN Haarlem Nederland Arcoxia 90 mg Film-coated tablets Oral use Estonia Merck Sharp & Dohme OÜ Peterburi tee 46 EE-11415 Tallinn Arcoxia 90 mg Film-coated tablets Oral use Finland Merck Sharp & Dohme B.V. Waarderweg 39 P.O Box 581 2031 BN Haarlem Nederland Arcoxia 90 mg Film-coated tablets Oral use France Merck Sharp Dohme Chibret 3, avenue Hoche F-75114 Paris Cedex 8 Arcoxia 90 mg Film-coated tablets Oral use Germany MSD Sharp & Dohme GmbH Lindenplatz 1 D-85540 Haar Arcoxia 90 mg Film-coated tablets Oral use Greece VIANEX S.A. Tatoiou Street, GR-14671 Nea Erythrea Arcoxia 90 mg Film-coated tablets Oral use Hungary Merck Sharp & Dohme Magyarország Kft. Alkotás utca 50 H-1123 Budapest Arcoxia 90 mg Film-coated tablets Oral use Iceland Merck Sharp & Dohme Regulatory Affairs Iceland Smedeland 8 DK-2600 Glostrup Arcoxia 90 mg Film-coated tablets Oral use Ireland Merck Sharp and Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9B4 United Kingdom Arcoxia 90 mg Film-coated tablets Oral use Italy Merck Sharp & Dohme S.p.A. Via G. Fabbroni, 6 I-00191 Roma Arcoxia 90 mg Film-coated tablets Oral use Latvia SIA Merck Sharp & Dohme Latvija Skanstes 13 LV-1013 Riga Arcoxia 90 mg Film-coated tablets Oral use Lithuania UAB, Merck Sharp & Dohme Lenktoji str. 27/Kestucio str. 59 LT-08124 Vilnius Arcoxia 90 mg Film-coated tablets Oral use Luxembourg Merck Sharp & Dohme Chaussee de Waterloo, 1135 B-1180 Bruxelles Arcoxia 90 mg Film-coated tablets Oral use Malta Merck, Sharp & Dohme Ltd Hertfordshire Road Hoddesdon Hertsfordshire EN11 9BU United Kindgdom Arcoxia 90 mg Film-coated tablets Oral use The Netherlands Merck Sharp & Dohme B.V. Waanderweg 39 2031 BN Haarlem Nederland Arcoxia 90 mg Film-coated tablets Oral use Norway Merck Sharp & Dohme B.V. Waanderweg 39 2031 BN Haarlem Nederland Arcoxia 90 mg Film-coated tablets Oral use Poland MSD Polska Sp. z o.o. ul. Chłodna 51 PL-00-867 Warszawa Arcoxia 90 mg Film-coated tablets Oral use Portugal Merck Sharp & Dohme, Lda. PRT Quinta da Fonte Edifício Vasco da Gama, 19 Porto Salvo P.O. Box 214 P-2770-192 Paço d'Arcos Arcoxia 90 mg Film-coated tablets Oral use Slovakia Merck Sharp & Dohme B.V.Waarderweg 39 P.O. Box 581 2031 BN Haarlem Nederland Arcoxia 90 mg Film-coated tablets Oral use Slovenia Merck Sharp & Dohme, inovativna zdravila d.o.o. Šmartinska cesta 140 SLO-1000 Ljubljana Arcoxia 90 mg Film-coated tablets Oral use Spain Merck Sharp & Dohme de España, S.A. Josefa Valcárcel, 38 E-28027 Madrid Arcoxia 90 mg Film-coated tablets Oral use Sweden Merck Sharp & Dohme BV PO Box 581 2003 PC Haarlem Nederland Arcoxia 90 mg Film-coated tablets Oral use United Kingdom Merck Sharpe & Dohme Limited Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom Arcoxia 90 mg Film-coated tablets Oral use

ANNEX IV 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 Austria Merck Sharp & Dohme GmbH Donau-City-Straße 6 A-1220 Wien Arcoxia 90 mg Film-coated tablets Oral use Auxib 90 mg Film-coated tablets Oral use Belgium Merck Sharp and Dohme Chaussée de Waterloo, 1135 B-1180 Brussels Arcoxia 90 mg Film-coated tablets Oral use Ranacox 90 mg Film-coated tablets Oral use Bulgaria Меrck Sharp & Dohme Bulgaria EOOD 55 Nikola Vaptzarov blvd. EXPO 2000, east wing, section B1 & B2 1st fl. BG-1407 Sofia Arcoxia 90 mg Film-coated tablets Oral use Czech Republic Merck Sharp & Dohme B.V. Waanderweg 39 2031 BN Haarlem Nederland Arcoxia 90 mg Film-coated tablets Oral use Cyprus Merck Sharp & Dohme BV. Waarderweg 39 2031 BN Haarlem Nederland Arcoxia 90 mg Film-coated tablets Oral use Denmark Merck Sharp & Dohme B.V. Waarderweg 39 2031 BN, Haarlem Postbox 581 Nederland Arcoxia 90 mg Film-coated tablets Oral use Estonia Merck Sharp & Dohme OÜ Peterburi tee 46 EE-11415 Tallinn Arcoxia 90 mg Film-coated tablets Oral use Finland Merck Sharp & Dohme B.V. Waarderweg 39 P.O Box 581 2031 BN Haarlem Nederland Arcoxia 90 mg Film-coated tablets Oral use Turox 90 mg Film-coated tablets Oral use France Merck Sharp Dohme Chibret 3, avenue Hoche F-75114 Paris Cedex 8 Arcoxia 90 mg Film-coated tablets Oral use Germany MSD Sharp & Dohme GmbH Lindenplatz 1 D-85540 Haar Arcoxia 90 mg Film-coated tablets Oral use Greece VIANEX S.A. Tatoiou Street, GR-14671 Nea Erythrea Arcoxia 90 mg Film-coated tablets Oral use Hungary Merck Sharp & Dohme Magyarország Kft. Alkotás utca 50 H-1123 Budapest Arcoxia 90 mg Film-coated tablets Oral use Iceland Merck Sharp & Dohme Regulatory Affairs Iceland Smedeland 8 DK-2600 Glostrup Arcoxia 90 mg Film-coated tablets Oral use Ireland Merck Sharp and Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9B4 United Kingdom Arcoxia 90 mg Film-coated tablets Oral use Italy Merck Sharp & Dohme S.p.A. Via G. Fabbroni 6 I-00191 Roma Arcoxia 90 mg Film-coated tablet Oral use Italy Istituto Gentili S.p.A. Via Benedetto Croce 37 I-56125 Pisa Algix 90 mg Film-coated tablet Oral use Italy Neopharmed S.p.A. Via G. Fabbroni 6 I-00191 Roma Recoxib 90 mg Film-coated tablets Oral use Italy Addenda Pharma S.r.l Viale Shakespeare 47 I-00144 Roma Tauxib 90 mg Film-coated tablets Oral use Latvia SIA Merck Sharp & Dohme Latvija Skanstes 13 LV-1013 Riga Arcoxia 90 mg Film-coated tablets Oral use Lithuania UAB, Merck Sharp & Dohme Lenktoji str. 27/Kestucio str. 59 LT-08124 Vilnius Arcoxia 90 mg Film-coated tablets Oral use Luxembourg Merck Sharp & Dohme Chaussee de Waterloo 1135 B-1180 Bruxelles Arcoxia 90 mg Film-coated tablets Oral use Ranacox 90 mg Film-coated tablets Oral use Malta Merck, Sharp & Dohme Ltd Hertfordshire Road Hoddesdon Hertsfordshire EN11 9BU United Kindgdom Arcoxia 90 mg Film-coated tablets Oral use The Netherlands Merck Sharp & Dohme B.V. Waanderweg 39 2031 BN Haarlem Nederland Arcoxia 90 mg Film-coated tablets Oral use Auxib 90 mg Film-coated tablets Oral use Norway Merck Sharp & Dohme B.V. Waarderweg 39 2031 BN Haarlem Nederland Arcoxia 90 mg Film-coated tablets Oral use Poland MSD Polska Sp. z o.o. ul. Chłodna 51 PL-00-867 Warszawa Arcoxia 90 mg Film-coated tablets Oral use Portugal Merck Sharp & Dohme, Lda. PRT Quinta da Fonte Edifício Vasco da Gama, 19 Porto Salvo P.O. Box 214 P-2770-192 Paço d'Arcos Arcoxia 90 mg Film-coated tablets Oral use Portugal Laboratórios Bial — Portela & Ca, S.A. PRT Av. da Siderurgia Nacional S. Mamede do Coronado Portugal Exxiv 90 mg Film-coated tablets Oral use Portugal Farmacox — Companhia Farmacêutica Sociedade Unipessoal, Lda. PRT Quinta da Fonte Edifício Vasco da Gama, 19 Porto Salvo Paço d'Arcos Portugal Turox 90 mg Film-coated tablets Oral use Romania Merck Sharp & Dohme Romania S.R.L. Bucharest Business Park Soseaua Bucuresti-Ploiesti nr. 1A Corp C1, etaj 3, sector 1 RO-013681 Bucharest Arcoxia 90 mg Film-coated tablets Oral use Slovakia Merck Sharp & Dohme B.V.Waarderweg 39 P.O. Box 581 2031 BN Haarlem Nederland Arcoxia 90 mg Film-coated tablets Oral use Slovenia Merck Sharp & Dohme, inovativna zdravila d.o.o. Šmartinska cesta 140 SLO-1000 Ljubljana Arcoxia 90 mg Film-coated tablets Oral use Spain Merck Sharp & Dohme de España, S.A. Josefa Valcárcel, 38 E-28027 Madrid Arcoxia 90 mg Film-coated tablets Oral use Spain Laboratorios Abello, S.A. Josefa Valcárcel, 38 E-28027 Madrid Exxiv 90 mg Film-coated tablets Oral use Sweden Merck Sharp & Dohme BV PO Box 581 2003 PC Haarlem Nederland Arcoxia 90 mg Film-coated tablets Oral use Turox 90 mg Film-coated tablets Oral use United Kingdom Merck Sharpe & Dohme Limited Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom Arcoxia 90 mg Film-coated tablets Oral use Auxib 90 90 mg Film-coated tablets Oral use Exxiv 90 90 mg Film-coated tablets Oral use Turox 90 90 mg Film-coated tablets Oral use

ANNEX V LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS/MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES Member State Marketing Authorisation Holder Applicant (Invented) Name Strength Pharmaceutical Form Route of administration Austria Novo Nordisk Pharma GmbH Opernring 3-5 A-1010 Wien Noviana 0,5 mg/0,1 mg Filmtabletten Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg Film-coated tablets Oral use Belgium Novo Nordisk Pharma N.V Boulevard International 55/6, B-1070 Brussel Activelle minor comprimés pelliculés Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg Film-coated tablets Oral use Bulgaria Novo Nordisk A/S Novo Allé DK-2880 Bagsværd Eviana филмирани таблетки Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg Film-coated tablets Oral use Czech Republic Novo Nordisk A/S Novo Allé DK-2880 Bagsværd Noviana potahované tablety Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg Film-coated tablets Oral use Denmark Novo Nordisk A/S Novo Allé DK-2880 Bagsværd Activelle low filmovertrukne tabletter Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg Film-coated tablets Oral use Estonia Novo Nordisk A/S Novo Allé DK-2880 Bagsværd Activelle Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg Film-coated tablets Oral use Finland Novo Nordisk A/S Novo Allé DK-2880 Bagsværd Activelle 0,5 mg/0,1 mg tabl. Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg Film-coated tablets Oral use France Novo Nordisk Pharmaceutique S.A.S 30, rue De Valmy F-92936 Paris La Défense Cedex Activelle 0,5 mg/0,1 mg, comprimé pelliculé Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg Film-coated tablets Oral use Germany Novo Nordisk A/S Novo Allé DK-2880 Bagsværd Noviana Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg Film-coated tablets Oral use Hungary Novo Nordisk A/S Novo Allé DK-2880 Bagsværd Noviana filmtabletta Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg Film-coated tablets Oral use Iceland Novo Nordisk A/S Novo Allé DK-2880 Bagsværd Activelle low 0,5 mg/0,1 mg tablets filmuhúðaðar töflur Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg Film-coated tablets Oral use Ireland Novo Nordisk A/S Novo Allé DK-2880 Bagsværd Activelle Tablets Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg Film-coated tablets Oral use Italy Novo Nordisk A/S Novo Allé DK-2880 Bagsværd Activelle 0,5 mg/0,1 mg compresse film-rivestite Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg Film-coated tablets Oral use Latvia Novo Nordisk A/S Novo Allé DK-2880 Bagsværd Noviana 0,5 mg/0,1 mg apvalkotās tabletes Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg Film-coated tablets Oral use Lithuania Novo Nordisk A/S Novo Allé DK-2880 Bagsværd Activelle Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg Film-coated tablets Oral use Luxembourg Novo Nordisk Pharma N.V Riverside Business Park Boulevard International B-1070 Brussels Activelle comprimés pelliculés Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg Film-coated tablets Oral use The Netherlands Novo Nordisk Farma B.V. Flemingweg 18 2408 AV Alphen a/d Rijn Nederland Activelle filmomhulde tabletten Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg Film-coated tablets Oral use Norway Novo Nordisk A/S Novo Allé DK-2880 Bagsværd Noviana 0,5 mg/0,1 mg tablett filmdrasjert Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg Film-coated tablets Oral use Portugal Novo Nordisk, A/S DNK Novo Allé DK-2880 Bagsværd Activelle Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg Film-coated tablets Oral use Romania Novo Nordisk A/S Novo Allé DK-2880 Bagsværd Noviana comprimate filmate Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg Film-coated tablets Oral use Slovak Republic Novo Nordisk A/S Novo Allé DK-2880 Bagsværd Noviana Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg Film-coated tablets Oral use Slovenia Novo Nordisk A/S Novo Allé DK-2880 Bagsværd Noviana filmsko obložene tablete Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg Film-coated tablets Oral use Spain Novo Nordisk A/S Novo Allé DK-2880 Bagsværd Activelle 0,5 mg/ 0,1 mg comprimidos recubiertos de película Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg Film-coated tablets Oral use Sweden Novo Nordisk A/S Novo Allé DK-2880 Bagsværd Activelle Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg Film-coated tablets Oral use United Kingdom Novo Nordisk Pharma Ltd Broadfield Park Brighton Road RH11 9RT Crawley West Sussex United Kingdom Noviana film-coated tablets Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg Film-coated tablets Oral use

ANNEX VI LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS AND MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES Member State Marketing Authorisation Holder Applicant (Invented) Name Strength Pharmaceutical Form Route of administration Austria ProStrakan Ltd Galabank Business Park Galashiels TD1 1QH United Kingdom Rapinyl 50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg Sublingual tablet Sublingual use Belgium ProStrakan Ltd Galabank Business Park Galashiels TD1 1QH United Kingdom Rapinyl 50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg Sublingual tablet Sublingual use Cyprus ProStrakan Ltd Galabank Business Park Galashiels TD1 1QH United Kingdom Rapinyl (1) 50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg Sublingual tablet Sublingual use Czech Republic ProStrakan Ltd, Galabank Business Park Galashiels TD1 1QH United Kingdom Rapinyl 50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg Sublingual tablet Sublingual use Denmark ProStrakan Ltd Galabank Business Park Galashiels TD1 1QH United Kingdom Rapinyl 50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg Sublingual tablet Sublingual use Estonia ProStrakan Ltd Galabank Business Park Galashiels TD1 1QH United Kingdom Rapinyl 50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg Sublingual tablet Sublingual use Finland ProStrakan Ltd Galabank Business Park Galashiels TD1 1QH United Kingdom Rapinyl (1) 50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg Sublingual tablet Sublingual use France ProStrakan Ltd Galabank Business Park Galashiels TD1 1QH United Kingdom Rapinyl 50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg Sublingual tablet Sublingual use Germany ProStrakan Ltd Galabank Business Park Galashiels TD1 1QH United Kingdom Rapinyl 50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg Sublingual tablet Sublingual use Greece ProStrakan Ltd Galabank Business Park Galashiels TD1 1QH United Kingdom Rapinyl 50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg Sublingual tablet Sublingual use Hungary ProStrakan Ltd Galabank Business Park Galashiels TD1 1QH United Kingdom Rapinyl 50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg Sublingual tablet Sublingual use Iceland ProStrakan Ltd Galabank Business Park Galashiels TD1 1QH United Kingdom Rapinyl 50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg Sublingual tablet Sublingual use Ireland ProStrakan Ltd Galabank Business Park Galashiels TD1 1QH United Kingdom Rapinyl 50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg Sublingual tablet Sublingual use Italy ProStrakan Ltd Galabank Business Park, Galashiels TD1 1QH United Kingdom Rapinyl (1) 50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg Sublingual tablet Sublingual use Latvia ProStrakan Ltd Galabank Business Park Galashiels TD1 1QH United Kingdom Rapinyl 50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg Sublingual tablet Sublingual use Lithuania ProStrakan Ltd Galabank Business Park Galashiels TD1 1QH United Kingdom Rapinyl 50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg Sublingual tablet Sublingual use Luxembourg ProStrakan Ltd Galabank Business Park Galashiels TD1 1QH United Kingdom Rapinyl 50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg Sublingual tablet Sublingual use Norway ProStrakan Ltd Galabank Business Park Galashiels TD1 1QH United Kingdom Rapinyl 50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg Sublingual tablet Sublingual use Poland ProStrakan Ltd Galabank Business Park Galashiels TD1 1QH United Kingdom Rapinyl 50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg Sublingual tablet Sublingual use Portugal ProStrakan Ltd Galabank Business Park Galashiels TD1 1QH United Kingdom Rapinyl 50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg Sublingual tablet Sublingual use Slovak Republic ProStrakan Ltd Galabank Business Park Galashiels TD1 1QH United Kingdom Rapinyl 50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg Sublingual tablet Sublingual use Slovenia ProStrakan Ltd Galabank Business Park Galashiels TD1 1QH United Kingdom Rapinyl 50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg Sublingual tablet Sublingual use Spain ProStrakan Ltd Galabank Business Park Galashiels TD1 1QH United Kingdom Rapinyl (1) 50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg Sublingual tablet Sublingual use Sweden ProStrakan Ltd Galabank Business Park Galashiels TD1 1QH United Kingdom Abstral 50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg Sublingual tablet Sublingual use United Kingdom ProStrakan Ltd Galabank Business Park Galashiels TD1 1QH United Kingdom Rapinyl 50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg Sublingual tablet Sublingual use (1) Name approval pending.

ANNEX VII LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State Marketing Authorisation Holder INN (Invented) Name Strength Pharmaceutical Form Route of administration Content (concentration) Austria Organon GesmbH Siebenbrunnengasse 21/D/IV A-1050 Wien Mirtazapine Remeron SolTab Schmelztabletten 15 mg Orodispersible tablets Oral use Mirtazapine Remeron SolTab Schmelztabletten 30 mg Orodispersible tablets Oral use Mirtazapine Remeron SolTab Schmelztabletten 45 mg Orodispersible tablets Oral use Belgium Organon Europe B.V. Kloosterstraat 6 5349AB Oss Nederland Delegation of power: Organon België n.v. Terhulpsesteenweg, 166 B-1170 Brussels Mirtazapine Remergon 15 mg Film-coated tablets Oral use Mirtazapine Remergon 30 mg Film-coated tablets Oral use Mirtazapine Remergon 45 mg Film-coated tablets Oral use Mirtazapine Remergon SolTab 15 mg Orodispersible tablets Oral use Mirtazapine Remergon SolTab 30 mg Orodispersible tablets Oral use Mirtazapine Remergon SolTab 45 mg Orodispersible tablets Oral use Mirtazapine Remergon 15 mg/ml Oral solution Oral use 990 mg/66 ml Cyprus C.A.Papaellinas & Co Ltd 179 Yiannos Kranidiotis Avenue 2235 Latsia, Nicosia Cyprus Mirtazapine Remeron 30 mg Film-coated tablets Oral use Czech Republic N.V. Organon Kloosterstraat 6 P.O. Box 20 5340 BH Oss Nederland Mirtazapine REMERON 15 MG 15 mg Film-coated tablets Oral use Mirtazapine REMERON 30 MG 30 mg Film-coated tablets Oral use Mirtazapine REMERON 45 MG 45 mg Film-coated tablets Oral use Mirtazapine REMERON SOLTAB 15 MG 15 mg Orodispersible tablets Oral use Mirtazapine REMERON SOLTAB 30 MG 30 mg Orodispersible tablets Oral use Mirtazapine REMERON SOLTAB 45 MG 45 mg Orodispersible tablets Oral use Denmark IMI Pharma A/S Literbuen 9 DK-2740 Skovlunde Mirtazapine Mitazon Smelt 15 mg Orodispersible tablets Oral use Mirtazapine Mitazon Smelt 30 mg Orodispersible tablets Oral use Mirtazapine Mitazon Smelt 45 mg Orodispersible tablets Oral use Mirtazapine Mitazon 30 mg Film-coated tablets Oral use N.V. Organon Kloosterstraat 6 P.O. Box 20 5340 BH Oss Nederland Mirtazapine Remeron Smelt 15 mg Orodispersible tablets Oral use Mirtazapine Remeron Smelt 30 mg Orodispersible tablets Oral use Mirtazapine Remeron Smelt 45 mg Orodispersible tablets Oral use Mirtazapine Remeron Oral, opløsning 15 mg/ml Oral solution Oral use 990 mg/66 ml Estonia N.V. Organon Kloosterstraat 6 P.O. Box 20 5340 BH Oss Nederland Mirtazapine Remeron 15 mg Film-coated tablets Oral use Mirtazapine Remeron 30 mg Film-coated tablets Oral use Mirtazapine Remeron 45 mg Film-coated tablets Oral use Mirtazapine Remeron SolTab 15 mg Orodispersible tablets Oral use Mirtazapine Remeron SolTab 30 mg Orodispersible tablets Oral use Mirtazapine Remeron SolTab 45 mg Orodispersible tablets Oral use Finland N.V. Organon Kloosterstraat 6 P.O. Box 20 5340 BH Oss Nederland Mirtazapine Remeron Soltab 15 mg Orodispersible tablets Oral use Mirtazapine Remeron Soltab 30 mg Orodispersible tablets Oral use Mirtazapine Remeron Soltab 45 mg Orodispersible tablets Oral use Mirtazapine Remeron 15 mg Film-coated tablets Oral use Mirtazapine Remeron 30 mg Film-coated tablets Oral use Mirtazapine Remeron 45 mg Film-coated tablets Oral use Mirtazapine Remeron 15 mg/ml Oral solution Oral use 990 mg/66 ml Oy Organon Ab Maistraatinportti 2 FI-00240 Helsinki Mirtazapine Mirtazon 30 mg Film-coated tablets Oral use Mirtazapine Mirtazon Smelt 15 mg Orodispersible tablets Oral use Mirtazapine Mirtazon Smelt 30 mg Orodispersible tablets Oral use Mirtazapine Mirtazon Smelt 45 mg Orodispersible tablets Oral use France Organon S.A. Immeuble Optima 10, rue Godefroy F-92821 PUTEAUX Cedex Mirtazapine Norset 15 mg Film-coated tablets Oral use Mirtazapine Norset 30 mg Film-coated tablets Oral use Mirtazapine Norset 15 mg Orodispersible tablets Oral use Mirtazapine Norset 30 mg Orodispersible tablets Oral use Mirtazapine Norset 45 mg Orodispersible tablets Oral use Mirtazapine Norset 15 mg/ml Oral solution Oral use 990 mg/66 ml Germany Organon GmbH Mittenheimer Straße 62 D-85764 Oberschleißheim Mirtazapine Remergil 15 mg Film-coated tablets Oral use Mirtazapine Remergil 30 mg Film-coated tablets Oral use Mirtazapine Remergil 45 mg Film-coated tablets Oral use Mirtazapine Remergil SolTab 15 mg Orodispersible tablets Oral use Mirtazapine Remergil SolTab 30 mg Orodispersible tablets Oral use Mirtazapine Remergil SolTab 45 mg Orodispersible tablets Oral use Mirtazapine Remergil 15 mg/ml Oral solution Oral use 990 mg/66 ml STADApharm GmbH Stadastraße 2-18 D-61118 Bad Vilbel Mirtazapine Mirtazapin STADA 15 mg Orodispersible tablets Oral use Mirtazapine Mirtazapin STADA 30 mg Orodispersible tablets Oral use Mirtazapine Mirtazapin STADA 45 mg Orodispersible tablets Oral use Greece Organon Hellas S.A. 122, Vouliagmenis Av. Helliniko GR-167 77 Athens Mirtazapine Remeron 15 mg Film-coated tablets Oral use Mirtazapine Remeron 30 mg Film-coated tablets Oral use Mirtazapine Remeron 45 mg Film-coated tablets Oral use Mirtazapine Remeron SolTab 15 mg Orodispersible tablets Oral use Mirtazapine Remeron SolTab 30 mg Orodispersible tablets Oral use Mirtazapine Remeron SolTab 45 mg Orodispersible tablets Oral use Mirtazapine Remeron 15 mg/ml Oral solution Oral use 990 mg/66 ml Hungary N.V. Organon, Kloosterstraat 6 P.O. Box 20 5340 BH Oss Nederland Mirtazapine Remeron 30 mg Film-coated tablets Oral use Mirtazapine Remeron 45 mg Film-coated tablets Oral use Mirtazapine Remeron SolTab 30 mg Orodispersible tablets Oral use Mirtazapine Remeron SolTab 45 mg Orodispersible tablets Oral use Iceland N.V. Organon Kloosterstraat 6 P.O. Box 20 5340 BH Oss Nederland Mirtazapine Remeron 15 mg Film-coated tablets Oral use Mirtazapine Remeron 30 mg Film-coated tablets Oral use Mirtazapine Remeron 45 mg Film-coated tablets Oral use Mirtazapine Remeron Smelt 15 mg Orodispersible tablets Oral use Mirtazapine Remeron Smelt 30 mg Orodispersible tablets Oral use Mirtazapine Remeron Smelt 45 mg Orodispersible tablets Oral use Mirtazapine Remeron 15 mg/ml 15 mg/ml Oral solution Oral use 990 mg/66 ml Ireland Organon Laboratories Ltd Cambridge Science Park Milton Road CB4 0FL United Kingdom Mirtazapine Zispin® film-coated tablets 15 mg Film-coated tablets Oral use Mirtazapine Zispin® film-coated tablets 30 mg Film-coated tablets Oral use Mirtazapine Zispin® film-coated tablets 45 mg Film-coated tablets Oral use Organon (Ireland) Limited PO Box 2857 Drynam Road Swords, Co. Dublin Ireland Mirtazapine Zispin® Soltab® orodispersible tablets 15 mg Orodispersible tablets Oral use Mirtazapine Zispin® Soltab® orodispersible tablets 30 mg Orodispersible tablets Oral use Mirtazapine Zispin® Soltab® orodispersible tablets 45 mg Orodispersible tablets Oral use Mirtazapine Zispin® oral solution 15 mg/ml Oral solution Oral use 990 mg/66 ml Italy N.V. Organon Kloosterstraat 6 P.O. Box 20 5340 BH Oss Nederland mirtazapine Remeron 15 mg Film-coated tablets Oral use mirtazapine Remeron 30 mg Film-coated tablets Oral use Mirtazapine Remeron 45 mg Film-coated tablets Oral use Mirtazapine Remeron 15 mg/ml Oral solution Oral use 990 mg/66 ml Mirtazapine Remeron 15 mg Orodispersible tablets Oral use Mirtazapine Remeron 30 mg Orodispersible tablets Oral use Mirtazapine Remeron 45 mg Orodispersible tablets Oral use Mirtazapine Mirtazapina Organon 15 mg Orodispersible tablets Oral use Mirtazapine Mirtazapina Organon 30 mg Orodispersible tablets Oral use Mirtazapine Mirtazapina Organon 45 mg Orodispersible tablets Oral use Latvia N.V. Organon Kloosterstraat 6 P.O. Box 20 5340 BH Oss Nederland Mirtazapine Remeron 30 mg Film-coated tablets Oral use Mirtazapine Remeron SolTab 15 mg Orodispersible tablets Oral use Mirtazapine Remeron SolTab 30 mg Orodispersible tablets Oral use Mirtazapine Remeron SolTab 45 mg Orodispersible tablets Oral use Lithuania N.V. Organon Kloosterstraat 6 P.O. Box 20 5340 BH Oss Nederland Mirtazapine Remeron 30 mg Film-coated tablets Oral use Mirtazapine Remeron Sol Tab 15 mg Orodispersible tablets Oral use Mirtazapine Remeron Sol Tab 30 mg Orodispersible tablets Oral use Mirtazapine Remeron Sol Tab 45 mg Orodispersible tablets Oral use Luxembourg Organon Europe B.V. Kloosterstraat 6 5349AB Oss Nederland Delegation of power: Organon België n.v. Terhulpsesteenweg, 166 B-1170 Brussels Mirtazapine Remergon 15 mg Film-coated tablets Oral use Mirtazapine Remergon 30 mg Film-coated tablets Oral use Mirtazapine Remergon 45 mg Film-coated tablets Oral use Mirtazapine Remergon SolTab 15 mg Orodispersible tablets Oral use Mirtazapine Remergon SolTab 30 mg Orodispersible tablets Oral use Mirtazapine Remergon SolTab 45 mg Orodispersible tablets Oral use Mirtazapine Remergon 15 mg/ml Oral solution Oral use 990 mg/66 ml The Netherlands N.V. Organon Kloosterstraat 6 Postbus 20 5340 BH Oss Nederland Mirtazapine Remeron 15 mg Film-coated tablets Oral use Mirtazapine Remeron 30 mg Film-coated tablets Oral use Mirtazapine Remeron 45 mg Film-coated tablets Oral use Mirtazapine Remeron drank 15 mg/ml Oral solution Oral use 990 mg/66 ml Mirtazapine Remeron SolTab 15 mg Orodispersible tablets Oral use Mirtazapine Remeron SolTab 30 mg Orodispersible tablets Oral use Mirtazapine Remeron SolTab 45 mg Orodispersible tablets Oral use Mirtazapine Mirtazapine orodispergeerbare tabletten 15 mg Orodispersible tablets Oral use Mirtazapine Mirtazapine orodispergeerbare tabletten 30 mg Orodispersible tablets Oral use Mirtazapine Mirtazapine orodispergeerbare tabletten 45 mg Orodispersible tablets Oral use Norway N.V. Organon Kloosterstraat 6 P.O. Box 20 5340 BH Oss Nederland Mirtazapine Remeron 30 mg Film-coated tablets Oral use Mirtazapine Remeron 45 mg Film-coated tablets Oral use Mirtazapine Remeron-S smeltetabletter 15 mg Orodispersible tablets Oral use Mirtazapine Remeron-S smeltetabletter 30 mg Orodispersible tablets Oral use Mirtazapine Remeron-S smeltetabletter 45 mg Orodispersible tablets Oral use Mirtazapine Remeron mikstur, oppløsning 15 mg/ml Oral solution Oral use 990 mg/66 ml Poland N.V. Organon Kloosterstraat 6 P.O. Box 20 5340 BH Oss Nederland Mirtazapine Remeron 30 mg Film-coated tablets Oral use Portugal Organon Portuguesa Produtos Químicos e Farmacêuticos, Lda Av. José Malhoa, 16-B -2o P-1070-159 Lisboa Mirtazapine Mirtazapina Organon 15 mg Film-coated tablets Oral use Mirtazapine Mirtazapina Organon 30 mg Film-coated tablets Oral use Mirtazapine Remeron 45 mg Film-coated tablets Oral use Mirtazapine Remeron SolTab 15 mg Orodispersible tablets Oral use Mirtazapine Remeron SolTab 30 mg Orodispersible tablets Oral use Mirtazapine Remeron SolTab 45 mg Orodispersible tablets Oral use Mirtazapine Remeron 15 mg/ml Oral solution Oral use 990 mg/66 ml Aacifar Produtos Químicos e Farmacêuticos, Lda Av. José Malhoa, 16-B -2o P-1070-159 Lisboa Mirtazapine Mirtazon 15 mg Orodispersible tablets Oral use Mirtazapine Mirtazon 30 mg Orodispersible tablets Oral use Mirtazapine Mirtazon 45 mg Orodispersible tablets Oral use Romania N.V. Organon Kloosterstraat 6 P.O. Box 20 5340 BH Oss Nederland Mirtazapine Remeron SolTab 15 mg 15 mg Orodispersible tablets Oral use Mirtazapine Remeron SolTab 30 mg 30 mg Orodispersible tablets Oral use Mirtazapine Remeron SolTab 45 mg 45 mg Orodispersible tablets Oral use Slovak Republic N.V. Organon Kloosterstraat 6 P.O. Box 20 5340 BH Oss Nederland Mirtazapine REMERON 15 mg 15 mg Film-coated tablets Oral use Mirtazapine REMERON 30 mg 30 mg Film-coated tablets Oral use Mirtazapine REMERON 45 mg 45 mg Film-coated tablets Oral use Mirtazapine REMERON Soltab 15 mg 15 mg Orodispersible tablets Oral use Mirtazapine REMERON Soltab 30 mg 30 mg Orodispersible tablets Oral use Mirtazapine REMERON Soltab 45 mg 45 mg Orodispersible tablets Oral use Spain Organon Española, S.A. Ctra. De Hospitalet, 147-149 Cityparc Ronda de Dalt Edificio Amsterdam E-08940 Cornellá de Llobregat, Barcelona Mirtazapine Rexer 15 mg Film-coated tablets Oral use Mirtazapine Rexer 30 mg Film-coated tablets Oral use Mirtazapine Rexer 45 mg Film-coated tablets Oral use Mirtazapine Rexer Flas 15 mg Orodispersible tablets Oral use Mirtazapine Rexer Flas 30 mg Orodispersible tablets Oral use Mirtazapine Rexer Flas 45 mg Orodispersible tablets Oral use Mirtazapine Rexer 15 mg/ml Oral solution Oral use 990 mg/66 ml N.V. Organon Kloosterstraat 6 P.O. Box 20 5340 BH Oss Nederland Mirtazapine Mirtazapina Organon 15 mg Orodispersible tablets Oral use Mirtazapine Mirtazapina Organon 30 mg Orodispersible tablets Oral use Mirtazapine Mirtazapina Organon 45 mg Orodispersible tablets Oral use Sweden N.V. Organon Kloosterstraat 6 P.O. Box 20 5340 BH Oss Nederland Mirtazapine Remeron 15 mg Film-coated tablets Oral use Mirtazapine Remeron 30 mg Film-coated tablets Oral use Mirtazapine Remeron 45 mg Film-coated tablets Oral use Mirtazapine Remeron 15 mg/ml Oral solution Oral use 990 mg/66 ml Mirtazapine Remeron-S 15 mg Orodispersible tablets Oral use Mirtazapine Remeron-S 30 mg Orodispersible tablets Oral use Mirtazapine Remeron-S 45 mg Orodispersible tablets Oral use Mirtazapine Mirtazapin IP 15 mg Film-coated tablets Oral use Mirtazapine Mirtazapin IP 30 mg Film-coated tablets Oral use Mirtazapine Mirtazapin IP 45 mg Film-coated tablets Oral use United Kingdom Organon Laboratories Ltd Cambridge Science Park Milton Road Cambridge CB4 0FL United Kingdom Mirtazapine Mirtazapine 15 mg tablets 15 mg Film-coated tablets Oral use Mirtazapine Mirtazapine 30 mg tablets 30 mg Film-coated tablets Oral use Mirtazapine Mirtazapine 45 mg tablets 45 mg Film-coated tablets Oral use Mirtazapine Mirtazapine 15 mg/ml oral solution 15 mg/ml Oral solution Oral use 990 mg/66 ml Mirtazapine Zispin SolTab 15 mg orodispersible tablet 15 mg Orodispersible tablets Oral use Mirtazapine Zispin SolTab 30 mg orodispersible tablet 30 mg Orodispersible tablets Oral use Mirtazapine Zispin SolTab 45 mg orodispersible tablet 45 mg Orodispersible tablets Oral use

ANNEX VIII 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 Gemzar 200 mg — Trockensubstanz zur Infusionsbereitung 200 mg Powder for solution for infusion Intravenous use Austria Eli Lilly Ges.m.b.H Kölblgasse 8-10 A-1030 Wien Gemzar 1 g — Trockensubstanz zur Infusionsbereitung 1 000 mg Powder for solution for infusion Intravenous use Belgium Eli Lilly Benelux s.a. Rue de L'Etuve, 52 B-1000 Brussels Gemzar 1000 1 000 mg Powder for solution for infusion Intravenous use Belgium Eli Lilly Benelux s.a. Rue de L'Etuve, 52 B-1000 Brussels Gemzar 200 200 mg Powder for solution for infusion Intravenous use Bulgaria Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland Gemzar 200 mg Powder for solution for infusion Intravenous use Bulgaria Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland Gemzar 1 g Powder for solution for infusion Intravenous use Czech Republic Eli Lilly ČR, s. r. o Pobřežní 1A CZ-186 00 Praha 8 Gemzar 1 g 1 g Powder for solution for infusion Intravenous use Czech Republic Eli Lilly ČR, s. r. o Pobřežní 1A CZ-186 00 Praha 8 Gemzar 200 mg 200 mg Powder for solution for infusion Intravenous use Cyprus PHADISCO LTD 185 Giannou Kranidioti Avenue CY-2234 Latsia Gemzar 200 mg Powder for solution for infusion Intravenous use Cyprus PHADISCO LTD 185 Giannou Kranidioti Avenue CY-2234 Latsia Gemzar 1 g Powder for solution for infusion Intravenous use Denmark Eli Lilly Danmark A/S Nybrovej 110 DK-2800 Kongens Lyngby Gemzar 200 mg Powder for solution for infusion Intravenous use Denmark Eli Lilly Danmark A/S Nybrovej 110 DK-2800 Kongens Lyngby Gemzar 1 g Powder for solution for infusion Intravenous use Estonia Eli Lilly Holdings Limited, Kingsclere Road, Basingstoke, Hampshire, RG21 6XA United Kingdom Gemzar 200 mg powder for solution for infusion 200 mg Powder for solution for infusion Intravenous use Estonia Eli Lilly Holdings Limited Kingsclere Road Basingstoke Hampshire RG21 6XA United Kingdom Gemzar 1 g powder for solution for infusion 1 g Powder for solution for infusion Intravenous use Finland Oy Eli Lilly Finland Ab Rajatorpantie 41 C PL 16 FI-01641 Vantaa Gemzar 200 mg powder for solution for infusion 200 mg Powder for solution for infusion Intravenous use Finland Oy Eli Lilly Finland Ab Rajatorpantie 41 C PL 16 FI-01641 Vantaa Gemzar 1 g powder for solution for infusion 1 g Powder for solution for infusion Intravenous use France LILLY France S.A.S. 13, rue Pagès F-92158 Suresnes Cedex Gemzar 1 000 mg, poudre pour solution pour perfusion 1 000 mg Powder for solution for infusion Intravenous use France LILLY France S.A.S. 13, rue Pagès F-92158 Suresnes Cedex Gemzar 200 mg, poudre pour solution pour perfusion 200 mg Powder for solution for infusion Intravenous use Germany Lilly Deutschland GmbH Teichweg 3 D-35396 Gießen Gemzar 200 mg Pulver zur Herstellung einer Infusionslösung 200 mg Powder for solution for infusion Intravenous use Germany Lilly Deutschland GmbH Teichweg 3 D-35396 Gießen Gemzar 1 g Pulver zur Herstellung einer Infusionslösung 1 000 mg Powder for solution for infusion Intravenous use Greece FARMASERVE LILLY S.A.Cl 15 Km National Road Athens-Lamia GR-14564 Athens ΓΚΕΜΖΑΡ 200 mg Powder for solution for infusion Intravenous use Greece FARMASERVE LILLY S.A.Cl 15 Km National Road Athens-Lamia GR-14564 Athens ΓΚΕΜΖΑΡ 1 000 mg Powder for solution for infusion Intravenous use Hungary Eli Lilly Nederland BV PO Box 379 3990 GD Houten Nederland Gemzar 1 g powder for injection 1 g Powder for injection Intravenous use Hungary Eli Lilly Nederland BV PO Box 379 3990 GD Houten Nederland Gemzar 200 mg powder for injection 200 mg Powder for injection Intravenous use Ireland Eli Lilly and Company Limited Lilly House Priestley Road Basingstoke Hampshire RG24 9NL United Kingdom Gemzar 200 mg powder for solution for infusion 200 mg Powder for solution for infusion Intravenous use Ireland Eli Lilly and Company Limited Lilly House Priestley Road Basingstoke Hampshire RG24 9NL United Kingdom Gemzar 1 g powder for solution for infusion 1 g Powder for solution for infusion Intravenous use Iceland Eli Lilly Denmark Nybrovej 110 DK-2800 Lyngby Gemzar 200 mg Powder for solution for infusion Intravenous use Iceland Eli Lilly Denmark Nybrovej 110 DK-2800 Lyngby Gemzar 1 g Powder for solution for infusion Intravenous use Italy Eli Lilly Italia S.P.A. Via Gramsci 731/733 I-50019 Sesto Fiorentino, Florence Gemzar 200 mg powder for solution for infusion and intravesical instillation 200 mg Powder for solution for infusion and intravesical instillation Intravenous use and intravesical use Italy Eli Lilly Italia S.P.A. Via Gramsci 731/733 I-50019 Sesto Fiorentino, Florence Gemzar 1 g powder for solution for infusion and intravesical instillation 1 g Powder for solution for infusion and intravesical instillation Intravenous use and intravesical use Latvia Eli Lilly Holdings Limited Kingsclere Road Basingstoke Hampshire RG 216XA5 United Kingdom Gemzar 1 g Powder for solution for infusion Intravenous use Latvia Eli Lilly Holdings Limited Kingsclere Road Basingstoke Hampshire RG 216XA5 United Kingdom Gemzar 200 mg Powder for solution for infusion Intravenous use Lithuania Eli Lilly Holdings Limited Kingsclere Road Basingstoke Hampshire RG 216XA5 United Kingdom Gemzar 200 mg Powder for solution for infusion Intravenous use Lithuania Eli Lilly Holdings Limited Kingsclere Road Basingstoke Hampshire RG 216XA5 United Kingdom Gemzar 1 000 mg Powder for solution for infusion Intravenous use Luxembourg Eli Lilly Benelux s.a. Rue de l'Etuve, 52 B-1000 Bruxelles Gemzar 200 mg Powder for solution for infusion Intravenous use Luxembourg Eli Lilly Benelux s.a. Rue de l'Etuve, 52 B-1000 Bruxelles Gemzar 1 g Powder for solution for infusion Intravenous use Malta Eli Lilly and Company Limited Lilly House Priestley Road Basingstoke Hampshire RG24 9NL United Kingdom Gemzar 200 mg Powder for solution for infusion Intravenous use Malta Eli Lilly and Company Limited Lilly House Priestley Road Basingstoke Hampshire RG24 9NL United Kingdom Gemzar 1 g Powder for solution for infusion Intravenous use The Netherlands Eli Lilly Nederland BV Grootslag 1-5 3991 RA Houten Nederland Gemzar 200 mg Powder for solution for infusion Intravenous use The Netherlands Eli Lilly Netherlands BV Grootslag 1-5 3991 RA Houten Nederland Gemzar 1 g Powder for solution for infusion Intravenous use Norway Eli Lilly Norge AS Postboks 6090 Etterstad N-0601 Oslo Gemzar 1 g Powder for solution for infusion Intravenous use Norway Eli Lilly Norge AS Postboks 6090 Etterstad N-0601 Oslo Gemzar 200 mg Powder for solution for infusion Intravenous use Poland Lilly France S.A.S. 2, rue du Colonel Lilly F-67642 Fegersheim Gemzar 200 mg Powder for solution for infusion Intravenous use Poland Lilly France S.A.S. 2, rue du Colonel Lilly F-67642 Fegersheim Gemzar 1 g Powder for solution for infusion Intravenous use Portugal Lilly Portugal — Produtos Farmacêuticos, Lda Rua Dr. António Loureiro Borges, 1 Piso 1 Arquiparque-Miraflores P-1499-016 Algés Gemzar 200 mg Powder for solution for infusion Intravenous use Portugal Lilly Portugal — Produtos Farmacêuticos, Lda Rua Dr. António Loureiro Borges, 1 Piso 1 Arquiparque-Miraflores P-1499-016 Algés Gemzar 1 000 mg Powder for solution for infusion Intravenous use Romania Lilly France S.A.S. 2, rue du Colonel Lilly F-67642 Fegersheim Gemzar 1 g 1 000 mg Powder for solution for infusion Intravenous use Romania Lilly France S.A.S. 2, rue du Colonel Lilly F-67642 Fegersheim Gemzar 200 mg 200 mg Powder for solution for infusion Intravenous use Slovakia Eli Lilly ČR, s. r. o. Pobřežní 1A CZ-186 00 Praha 8 Gemzar 1 g 1 g Powder for solution for infusion Intravenous use Slovakia Eli Lilly ČR, s. r. o. Pobřežní 1A CZ-186 00 Praha 8 Gemzar 200 mg 200 mg Powder for solution for infusion Intravenous use Slovenia Eli Lilly farmacevtska družba, d.o.o. Dunajska cesta 156 SLO-1000 Ljubljana Gemzar 200 mg prašek za raztopino za infundiranje 200 mg Powder for solution for infusion Intravenous use Slovenia Eli Lilly farmacevtska družba, d.o.o. Dunajska cesta 156 SLO-1000 Ljubljana Gemzar 1 g prašek za raztopino za infundiranje 1 g Powder for solution for infusion Intravenous use Spain Lilly S.A. Avenida de la Industria, 30 E-28108 Alcobendas, Madrid Gemzar 1 g powder for solution for injection 1 g Powder for solution for injection Intravenous use Spain Lilly S.A. Avenida de la Industria, 30 E-28108 Alcobendas, Madrid Gemzar 200 mg powder for solution for injection 200 mg Powder for solution for injection Intravenous use Sweden Eli Lilly Sweden AB Box 721 S-169 27 Solna Gemzar 200 mg Powder for solution for infusion Intravenous use Sweden Eli Lilly Sweden AB Box 721 S-169 27 Solna Gemzar 1 g Powder for solution for infusion Intravenous use United Kingdom Eli Lilly and Company Limited Lilly House Priestley Road Basingstoke Hampshire RG24 9NL United Kingdom Gemzar 200 mg powder for solution for infusion 200 mg Powder for solution for infusion Intravenous use United Kingdom Eli Lilly and Company Limited Lilly House Priestley Road Basingstoke Hampshire RG24 9NL United Kingdom Gemzar 1g powder for solution for infusion 1 g Powder for solution for infusion Intravenous use

ANNEX IX NAME, PHARMACEUTICAL FORMS, STRENGTH OF THE MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDER/APPLICANT Member State/Marketing Authorisation Number Marketing Authorisation Holder Product invented name Pharmaceutical Form Strength/Active substance (INN) Animal species Austria (8-00694) Chevita Tierarzneimittel Ges.m.b.H. Asprimax 850 mg/g Powder for oral solution Sodium salicylate Pigs The Netherlands (REG NL 8913) Dopharma Research B.V. NA-SALICYLAAT, 100 %, powder for solution for oral administration Powder for oral solution Sodium salicylate Calves and pigs The Netherlands (REG NL 10411) Dopharma Research B.V. NA-SALICYLAAT, 80 % WSP Powder for oral solution Sodium salicylate Calves and pigs Decentralised procedure subject to an Article 33 Referral (CD 17 April 2008) Eurovet Animal Health B.V. SOLACYL 100 %, powder for oral solution for calves and pigs Powder for oral solution Calves and pigs

ANNEX X LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE(S) OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State Invented name Marketing Authorisation Holder Company Name and Address Animal species Pharmaceutical Form Strength Indications Austria Baycox 25 mg/ml Lösung zum Eingeben für Hühner und Puten Bayer Austria Ges.m.b.H Herbststraße 6-10 A-1160 Wien Chickens and turkeys Oral solution 25 mg/ml Treatment of coccidiosis Belgium Baycox 2,5 % orale oplossing Bayer SA-NV Health Care Animal Health Louizalaan 143, Avenue Louise B-1050 Brussel Chickens and turkeys Oral solution 25 mg/ml Treatment of coccidiosis Bulgaria Baycox 2,5 % solution Bayer HealthCare AG D-51368 Leverkusen Chickens and turkeys Oral solution 25 mg/ml Treatment of coccidiosis Bulgaria Cevazuril oral solution Ceva Santé Animale La Balastrière F-33501 Libourne Cedex Broilers, breeders, pullets and turkeys Oral solution 25 mg/ml Prevention and treatment of coccidiosis Cyprus Baycox 2,5 % oral solution Bayer HealthCare AG D-51368 Leverkusen Broilers and turkeys Oral solution 25 mg/ml Treatment of coccidiosis Czech Republic Baycox 2,5 % sol. ad us. vet. Bayer s. r. o. Litvínovská 609/3 CZ-190 21 Praha 9 Chickens and turkeys Oral solution 25 mg/ml Treatment of coccidiosis France Baycox 2,5 % BAYER SANTE 13, rue Jean Jaurès F-92807 Puteaux Chickens: broilers, pullets and breeders Oral solution 25 mg/ml Prevention and treatment of coccidiosis France CEVAZURIL Ceva Santé Animale La Balastrière F-33501 Libourne Cedex Chickens: broilers, pullets and breeders Oral solution 25 mg/ml Prevention and treatment of coccidiosis Germany Baycox 2,5 % Bayer Vital GmbH D-51368 Leverkusen Chickens and turkeys Oral solution 25 mg/ml Treatment of coccidiosis Greece Baycox 2,5 % oral solution Bayer HealthCare AG D-51368 Leverkusen Broilers and turkeys Oral solution 25 mg/ml Treatment of coccidiosis Hungary Baycox 2,5 % solution A.U.V. Bayer Hungaria Kft.Co. Ltd. Alkotás u. 50 H-1123 Budapest Chickens and turkeys Oral solution 25 mg/ml Treatment of coccidiosis Ireland Baycox 2,5 % Solution Bayer Ltd Animal Health Division The Atrium Blackthorn Road Dublin 18 Ireland Chickens Oral solution 25 mg/ml Treatment and control of coccidiosis Italy Baycox soluzione 2,5 % Bayer S.p.A. Viale Certosa 130 I-20156 Milano Chickens and turkeys Oral solution 25 mg/ml Treatment of coccidiosis Italy Cevazuril (1) CEVA VETEM S.p.A. Via Colleoni 15 Agrate Brianza Italia Chickens and turkeys Oral solution 25 mg/ml Treatment of coccidiosis Poland Baycox 2,5 % Bayer HealthCare AG D-51368 Leverkusen Broilers, breeders, turkeys and pigeons Oral solution 25 mg/ml Chickens and turkeys: treatment of coccidiosis Pigeons: Treatment and prevention of coccidiosis Portugal Baycox 2,5 % oral solution Bayer Portugal S.A Rua Da Quinta do Pinheiro, No 5 P-2794-003 Carnaxide Chickens and turkeys Oral solution 25 mg/ml Treatment of coccidiosis Romania Cevazuril Ceva Santé Animale La Balastrière F-33501 Libourne Cedex Broilers, breeders, pullets and turkeys Oral solution 25 mg/ml Treatment of coccidiosis Slovakia Baycox 2,5 % sol. a.u.v. Bayer s. r. o. Litvínovská 609/3 CZ-190 21 Praha 9 Chickens and turkeys Oral solution 25 mg/ml Treatment of coccidiosis Slovenia Baycox 2,5 % w/v oral solution Bayer d.o.o. Bravničarjeva ulica 13 SLO-1000 Ljubljana Chickens and turkeys Oral solution 25 mg/ml Treatment of coccidiosis The Netherlands Baycox 2,5 % Bayer BV HealthCare Animal Health Postbus 80 3640 AB Mijdrecht Energieweg 1 3641 RT Mijdrecht Nederland Chickens and turkeys Oral solution 25 mg/ml Treatment of coccidiosis The Netherlands Baycox oplossing 2,5 % Bayer BV HealthCare Animal Health Postbus 80 3640 AB Mijdrecht Energieweg 1 3641 RT Mijdrecht Nederland Chickens and turkeys Oral solution 25 mg/ml Treatment of coccidiosis United Kingdom Baycox 2,5 % oral solution Bayer Plc Animal Health Division Bayer House Strawberry Hill Newbury Berkshire RG14 1JA United Kingdom Broilers and broiler breeders Oral solution 25 mg/ml Treatment of coccidiosis (1) The marketing authorisation is suspended on 12 June 2007.

ANNEX XI LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH(S) OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANT, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES Member State Marketing Authorisation Holder Applicant (Invented) Name Strength Pharmaceutical Form Route of administration Content (concentration) Austria IVAX Pharmaceuticals UK Ltd IVAX Quays Albert Basin Royal Docks London E16 2QJ United Kingdom Pulairmax 100 μg/Dosis Pulver zur Inhalation 100 μg Inhalation powder Inhalation use 100 micrograms Pulairmax 200 μg/Dosis Pulver zur Inhalation 200 μg Inhalation powder Inhalation use 200 micrograms Pulairmax 400 μg/Dosis Pulver zur Inhalation 400 μg Inhalation powder Inhalation use 400 micrograms Belgium IVAX Pharmaceuticals UK Ltd IVAX Quays Albert Basin Royal Docks London E16 2QJ United Kingdom Pulairmax 100 μg inhalatiepoeder 100 μg Inhalation powder Inhalation use 100 micrograms Pulairmax 200 μg inhalatiepoeder 200 μg Inhalation powder Inhalation use 200 micrograms Pulairmax 400 μg inhalatiepoeder 400 μg Inhalation powder Inhalation use 400 micrograms Cyprus IVAX Pharmaceuticals UK Ltd IVAX Quays Albert Basin Royal Docks London E16 2QJ United Kingdom Pulairmax 100 μg Σκόνη για εισπνοή 100 μg Inhalation powder Inhalation use 100 micrograms Pulairmax 200 μg Σκόνη για εισπνοή 200 μg Inhalation powder Inhalation use 200 micrograms Pulairmax 400 μg Σκόνη για εισπνοή 400 μg Inhalation powder Inhalation use 400 micrograms Czech Republic IVAX Pharmaceuticals UK Ltd IVAX Quays Albert Basin Royal Docks London E16 2QJ United Kingdom Pulmax 100 μg Prášek k inhalaci 100 μg Inhalation powder Inhalation use 100 micrograms Pulmax 200 μg Prášek k inhalaci 200 μg Inhalation powder Inhalation use 200 micrograms Pulmax 400 μg Prášek k inhalaci 400 μg Inhalation powder Inhalation use 400 micrograms Denmark IVAX Pharmaceuticals UK Ltd IVAX Quays Albert Basin Royal Docks London E16 2QJ United Kingdom Pulairmax 100 μg Inhalation powder Inhalation use 100 micrograms Pulairmax 200 μg Inhalation powder Inhalation use 200 micrograms Pulairmax 400 μg Inhalation powder Inhalation use 400 micrograms Estonia IVAX Pharmaceuticals UK Ltd IVAX Quays Albert Basin Royal Docks London E16 2QJ United Kingdom Pulairmax 100 μg Inhalation powder Inhalation use 100 micrograms Pulairmax 200 μg Inhalation powder Inhalation use 200 micrograms Pulairmax 400 μg Inhalation powder Inhalation use 400 micrograms Finland IVAX Pharmaceuticals UK Ltd IVAX Quays Albert Basin Royal Docks London E16 2QJ United Kingdom Pulairmax 100 μg inhalaatiojauhe 100 μg Inhalation powder Inhalation use 100 micrograms Pulairmax 200 μg inhalaatiojauhe 200 μg Inhalation powder Inhalation use 200 micrograms Pulairmax 400 μg inhalaatiojauhe 400 μg Inhalation powder Inhalation use 400 micrograms Germany IVAX Pharmaceuticals UK Ltd IVAX Quays Albert Basin Royal Docks London E16 2QJ United Kingdom Pulairmax 100 Mikrogramm/Dosis Pulver zur Inhalation 100 μg Inhalation powder Inhalation use 100 micrograms Pulairmax 200 Mikrogramm/Dosis Pulver zur Inhalation 200 μg Inhalation powder Inhalation use 200 micrograms Pulairmax 400 Mikrogramm/Dosis Pulver zur Inhalation 400 μg Inhalation powder Inhalation use 400 micrograms Greece IVAX Pharmaceuticals UK Ltd IVAX Quays Albert Basin Royal Docks London E16 2QJ United Kingdom Pulairmax 100 μg Κόνις για εισπνοή 100 μg Inhalation powder Inhalation use 100 micrograms Pulairmax 200 μg Κόνις για εισπνοή 200 μg Inhalation powder Inhalation use 200 micrograms Pulairmax 400 μg Κόνις για εισπνοή 400 μg Inhalation powder Inhalation use 400 micrograms Ireland IVAX Pharmaceuticals UK Ltd IVAX Quays Albert Basin Royal Docks London E16 2QJ United Kingdom Pulairmax 100 μg Inhalation Powder 100 μg Inhalation powder Inhalation use 100 micrograms Pulairmax 200 μg Inhalation Powder 200 μg Inhalation powder Inhalation use 200 micrograms Pulairmax 400 μg Inhalation Powder 400 μg Inhalation powder Inhalation use 400 micrograms Italy IVAX Pharmaceuticals UK Ltd IVAX Quays Albert Basin Royal Docks London E16 2QJ United Kingdom Pulairmax 100 polvere per inalazione 100 μg Inhalation powder Inhalation use 100 micrograms Pulairmax 200 mcg polvere per inalazione 200 μg Inhalation powder Inhalation use 200 micrograms Pulairmax 400 mcg polvere per inalazione 400 μg Inhalation powder Inhalation use 400 micrograms Latvia IVAX Pharmaceuticals UK Ltd IVAX Quays Albert Basin Royal Docks London E16 2QJ United Kingdom Pulairmax 100 μg Inhalation powder Inhalation use 100 micrograms Pulairmax 200 μg Inhalation powder Inhalation use 200 micrograms Pulairmax 400 μg Inhalation powder Inhalation use 400 micrograms Lithuania IVAX Pharmaceuticals UK Ltd IVAX Quays Albert Basin Royal Docks London E16 2QJ United Kingdom Pulairmax 100 μg Inhalation powder Inhalation use 100 micrograms Pulairmax 200 μg Inhalation powder Inhalation use 200 micrograms Pulairmax 400 μg Inhalation powder Inhalation use 400 micrograms Luxembourg IVAX Pharmaceuticals UK Ltd IVAX Quays Albert Basin Royal Docks London E16 2QJ United Kingdom Pulairmax 100 μg poudre pour inhalation 100 μg Inhalation powder Inhalation use 100 micrograms Pulairmax 200 μg poudre pour inhalation 200 μg Inhalation powder Inhalation use 200 micrograms Pulairmax 400 μg poudre pour inhalation 400 μg Inhalation powder Inhalation use 400 micrograms Malta IVAX Pharmaceuticals UK Ltd IVAX Quays Albert Basin Royal Docks London E16 2QJ United Kingdom Pulairmax 100 μg Trab li jittiehed bin-nifs 100 μg Inhalation powder Inhalation use 100 micrograms Pulairmax 200 μg Trab li jittiehed bin-nifs 200 μg Inhalation powder Inhalation use 200 micrograms Pulairmax 400 μg Trab li jittiehed bin-nifs 400 μg Inhalation powder Inhalation use 400 micrograms The Netherlands IVAX Pharmaceuticals UK Ltd IVAX Quays Albert Basin Royal Docks London E16 2QJ United Kingdom Pulmax 100 mg, inhalatiepoeder 100 μg Inhalation powder Inhalation use 100 micrograms Pulmax 200 mg, inhalatiepoeder 200 μg Inhalation powder Inhalation use 200 micrograms Pulmax 400 mg, inhalatiepoeder 400 μg Inhalation powder Inhalation use 400 micrograms Norway IVAX Pharmaceuticals UK Ltd IVAX Quays Albert Basin Royal Docks London E16 2QJ United Kingdom Pulairmax 100 μg inhalasjonspulver 100 μg Inhalation powder Inhalation use 100 micrograms Pulairmax 200 μg inhalasjonspulver 200 μg Inhalation powder Inhalation use 200 micrograms Pulairmax 400 μg inhalasjonspulver 400 μg Inhalation powder Inhalation use 400 micrograms Poland IVAX Pharmaceuticals UK Ltd IVAX Quays Albert Basin Royal Docks London E16 2QJ United Kingdom Pulmax 100 μg proszek do inhalacji 100 μg Inhalation powder Inhalation use 100 micrograms Pulmax 200 μg proszek do inhalacji 200 μg Inhalation powder Inhalation use 200 micrograms Pulmax 400 μg proszek do inhalacji 400 μg Inhalation powder Inhalation use 400 micrograms Portugal Teva Pharma — Produtos Farmaceuticos, Lda. Lagoas Park Edificio 1, Piso 3 P-2740-264 Porto Salvo Pulmax, 100 μg pó para inalação 100 μg Inhalation powder Inhalation use 100 micrograms Pulmax, 200 μg pó para inalação 200 μg Inhalation powder Inhalation use 200 micrograms Pulmax, 400 μg pó para inalação 400 μg Inhalation powder Inhalation use 400 micrograms Slovak Republic IVAX Pharmaceuticals UK Ltd IVAX Quays Albert Basin Royal Docks London E16 2QJ United Kingdom Pulmax 100 mcg Inhalačný prášok 100 μg Inhalation powder Inhalation use 100 micrograms Pulmax 200 mcg Inhalačný prášok 200 μg Inhalation powder Inhalation use 200 micrograms Pulmax 400 mcg Inhalačný prášok 400 μg Inhalation powder Inhalation use 400 micrograms Spain IVAX Pharmaceuticals UK Ltd IVAX Quays Albert Basin Royal Docks London E16 2QJ United Kingdom Budesonida TEVA 100 microgramos polvo para inhalación EFG 100 μg Inhalation powder Inhalation use 100 micrograms Budesonida TEVA 200 microgramos polvo para inhalación EFG 200 μg Inhalation powder Inhalation use 200 micrograms Budesonida TEVA 400 microgramos polvo para inhalación EFG 400 μg Inhalation powder Inhalation use 400 micrograms Sweden IVAX Pharmaceuticals UK Ltd IVAX Quays Albert Basin Royal Docks London E16 2QJ Royaume-Uni Pulairmax 100 μg Inhalation powder Inhalation use 100 micrograms Pulairmax 200 μg Inhalation powder Inhalation use 200 micrograms Pulairmax 400 μg Inhalation powder Inhalation use 400 micrograms