EN Official Journal of the European Union C 287/12

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1.10.2006 to 31.10.2006

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

(2006/C 287/04)

— 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 11.10.2006 Doxastad (doxazosin) Art 29 See Annex I See Annex I 13.10.2006 11.10.2006 Doxazosin Winthrop (doxazosin) Art 29 - See Annex II See Annex II 13.10.2006 11.10.2006 Cardoreg (doxazosin) Art 29 See Annex III See Annex III 13.10.2006 11.10.2006 Doxagamma (doxazosin) Art 29 See Annex IV See Annex IV 13.10.2006 11.10.2006 Doxazosin Retard Arrow (doxazosin) Art 29 See Annex V See Annex V 13.10.2006 13.10.2006 Cobactan DC Art 39 See Annex VI See Annex VI 16.10.2006

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

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

ANNEX I LIST OF THE NAMES, PHARMACEUTICAL 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 Applicant Invented name Strength Pharmaceutical Form Route of administration Estonia STADA Arzneimittel AG Stadastr. 2-18, D-61118 Bad Vilbel Tél: 0049 6101 603301 Fax: 0049 6101 603151 Doxalfa 4 mg toimeainet prolongeeritult vabastavad tabletid 4 mg Prolonged-release tablet Oral Latvia STADA Arzneimittel AG Stadastr. 2-18, D-61118 Bad Vilbel Tél:: 0049 6101 603301 Fax: 0049 6101 603151 Doxalfa 4 mg ilgstošās darbības tabletes 4 mg Prolonged-release tablet Oral Lithuania STADA Arzneimittel AG Stadastr. 2-18, D-61118 Bad Vilbel Tél: 0049 6101 603301 Fax: 0049 6101 603151 Doxalfa 4 mg pailginto atpalaidavimo tabletės 4 mg Prolonged-release tablet Oral Netherlands Cerntrafarm Services B.V. Nieuwe Donk 9 4879 AC Etten-Leur Nederland Tél: 0031 765 081000 Fax: 0031 765 035614 Doxazosine retard CF 4mg, tabletten met gereguleerde afgifte 4 mg Prolonged-release tablet Oral Spain Laboratorio STADA, S.L. Frederic Mompou, 5 08960 Sant Just Desvern E-Barcelone Tél: 0034934738889 Fax: 0034934737495 DOXAZOSINA NEO STADA 4 mg comprimidos de liberación prolongada EEG 4 mg Prolonged-release tablet Oral Sweden STADA Arzneimittel AG Stadastr. 2-18, D.61118 Bad Vilbel Tél: 0049 6101 603301 Fax: 0049 6101 603151 Doxastad 4mg depottablett 4 mg Prolonged-release tablet Oral United Kingdom Genus Pharmaceuticals Benham Valence, Speen Newbury Berkshire RG20 8LU United Kingdom Tél: 01635 568400 Fax: 01635 568401 Doxadura XL 4 mg 4 mg Prolonged-release tablet Oral

ANNEX II 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 Applicant Name Strength Pharmaceutical Form Route of administration Denmark Winthrop Pharmaceuticals UK Ltd 1 Onslow Street Guildford Surrey GU1 4YS Royaume-Uni Tél: 00 44 (0) 1483554831 Fax: 00 44 (0) 1483554831 Doxazosin ‘Winthrop’ 4 mg Prolonged release tablets Oral Germany Winthrop Arzneimittel GmbH Industriestrasse 10 82256 D-Furstenfeldbruck Tél: 0049 (0) 81 41 3572 324 Fax: 0049 (0) 81 41 3572 329 Doxazosin Winthrop 4 mg Retardtabletten 4 mg Prolonged release tablets Oral Hungary Chinoin Pharmaceuticals and Chemical Works Co Ltd 1045 H-Budapest, To utca 1-5 Tél: 0036 1 505 0000 Fax: 0036 1 505 0005 Doxazosin Winthrop 4mg Tablettes 4 mg Prolonged release tablets Oral Poland Winthrop Medicaments 1-13 Bd Romain Rolland F-75014, Paris Tél: 0033 (0) 1 57 63 33 33 Fax: 0033 (0) 1 57 63 33 30 DOXAWIN XL 4 mg Prolonged release tablets Oral Slovakia Winthrop Médicaments 1-13 Bd Romain Rolland F-75014 Paris Tél: 0033 (0) 1 57 63 33 33 Fax: 0033 (0) 1 57 63 33 30 Doxazosin Winthrop XL 4 mg 4 mg Prolonged release tablets Oral Spain Winthrop Pharmaceuticals UK Ltd 1 Onslow Street Guildford Surrey GU1 4YS United Kingdom Tél: 00 44 (0) 1483554831 Fax: 00 44 (0) 1483554831 Doxazosina WINTHROP 4 mg comprimidos de liberación prolongada EFG 4 mg Prolonged release tablets Oral United Kingdom Winthrop Pharmaceuticals UK Ltd 1 Onslow Street Guildford Surrey GU1 4YS United Kingdom Slocinx XL 4mg Tablets 4 mg Prolonged release tablets Oral

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 Applicant Invented name Strength Pharmaceutical Form Route of administration Czech Republic Ratiopharm GmBH Graf-Arco-Strasse 3 D-89079 Ulm Tél: 0049 731 40202 Fax: 0049 731 4027330 Lansoprazol-ratiopharm 4 mg Hartkapseln 4 mg Prolonged release tablets Oral Denmark Pharmcom Oy Keijumaki 6B 30 FIN-02130 Espoo Tél: 00358 407 075670 Fax: 00358 94524872 Cardoreg 4 mg depottabletter 4 mg Prolonged release tablets Oral Hungary Ratiopharm Hungaria Kft. Uzoki utca 36/a H-1145 Budapest Tél: 0036 1 2732730 Fax: 0036 1 2732731 Doxazosin-ratiopharm retard 4 mg tabletta 4 mg Prolonged release tablets Oral Poland Ratiopharm GmBH Graf-Arco-Strasse 3 D-89079 Ulm Tél: 0049 731 40202 Fax: 0049 731 4027330 Doxazosin-ratiopharm retard PR4 4 mg Prolonged release tablets Oral Slovakia Ratiopharm GmBH Graf-Arco-Strasse 3 D-89079 Ulm Tél: 0049 731 40202 Fax:0049 731 4027330 Doxazosin-ratiopharm retard 4 mg 4 mg Prolonged release tablets Oral United Kingdom Ratiopharm GmBH Graf-Arco-Strasse 3 D-89079 Ulm Tél: 0049 731 40202 Fax: 0049 731 4027330 DoxaCard XL 4 mg prolonged release tablets 4 mg Prolonged release tablets Oral

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 Applicant Invented name Strength Pharmaceutical Form Route of administration Denmark Generics [UK] Ltd. Station Close Potters Bar Herts EN6 1TL. United Kingdom Tél: 00 44 1707 853000 Fax: 00 44 1707 650734 Doxagamma 4mg Prolonged-release tablet oral United Kingdom Generics [UK] Ltd., Station Close, Potters Bar, Herts,EN6 1TL. United Kingdom Tél: 00 44 1707 853000 Fax: 00 44 1707 650734 Doxzogen XL 4mg Tablets 4mg Prolonged-release tablet oral

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 Applicant Name Strength Pharmaceutical Form Route of administration Denmark Arrow Generics UK Ltd Unit 2 Eastman Way Stevenage Hertfordshire, SG1 4SZ United Kingdom Tél.: 00 44 207 612 7612 Fax: 00 44 207 612 7620 Doxazosin ‘Arrow’, 4mg depottabletter 4 mg Prolonged release tablets Oral Portugal Arrowblue Produtos Farndacêuticos S.A. Torre Fernão Magalhães 10o Esq., Av. D. João II — P-Lisbonne Tél.: 00 351 21 896 51 05 Fax: 00 351 21896 51 05 Doxazosin Arrow 4mg comprimido de libertaçao prolongada 4 mg Prolonged release tablets Oral Slovenia Arrow Generics UK Ltd Unit 2 Eastman Way Stevenage Hertfordshire, SG1 4SZ United Kingdom Tél.: 00 44 207 612 7612 Fax: 00 44 207 612 7620 Doksazosin Arrow 4mg tablete s podaljšanim sproščanjem 4 mg Prolonged release tablets Oral United Kingdom Arrow Generics UK Ltd Unit 2 Eastman Way Stevenage Hertfordshire, SG1 4SZ United Kingdom Tél.: 00 44 207 612 7612 Fax: 00 44 207 612 7620 Cardozin XL 4mg 4 mg Prolonged release tablets Oral