# C_2014059EN.01000101.xml

| 28.2.2014 | EN | Official Journal of the European Union | C 59/1 |
| --------- | -- | -------------------------------------- | ------ |

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2014 to 31 January 2014

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council( 1 ))

(2014/C 59/01)

—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --------------------------------------------------------------------------------------------------------------- | ----------------------------- | ---------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | --------------------------------------------------------------------------------------------------------------- | ----------------------------------------------- | ----------------------------------------- |
| 08.01.2014 | Diacomit | Stiripentol | Biocodex 7 avenue Gallieni, F-94250 Gentilly, France | Biocodex | 7 avenue Gallieni, F-94250 Gentilly, France | EU/1/06/367 | Capsule, hard
Powder for oral suspension |
| Biocodex | | | | | | | |
| 7 avenue Gallieni, F-94250 Gentilly, France | | | | | | | |
| 08.01.2014 | Levetiracetam Hospira | levetiracetam | Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | Hospira UK Limited | Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | EU/1/13/889 | Concentrate for solution for infusion |
| Hospira UK Limited | | | | | | | |
| Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | | | | | | | |
| 16.01.2014 | Sovaldi | sofosbuvir | Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom | Gilead Sciences International Limited | Cambridge CB21 6GT, United Kingdom | EU/1/13/894 | Film-coated tablet |
| Gilead Sciences International Limited | | | | | | | |
| Cambridge CB21 6GT, United Kingdom | | | | | | | |
| 16.01.2014 | Tivicay | dolutegravir | ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | ViiV Healthcare UK Limited | 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/13/892 | Film-coated tablet |
| ViiV Healthcare UK Limited | | | | | | | |
| 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | | | | | | | |
| 16.01.2014 | Xigduo | dapagliflozin/metformin | Bristol-Myers Squibb/AstraZeneca EEIG Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom | Bristol-Myers Squibb/AstraZeneca EEIG | Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom | EU/1/13/900 | Film-coated tablet |
| Bristol-Myers Squibb/AstraZeneca EEIG | | | | | | | |
| Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom | | | | | | | |
| 16.01.2014 | Zoledronic acid Accord | zoledronic acid | Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | Accord Healthcare Limited | Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/13/834 | Concentrate for solution for infusion |
| Accord Healthcare Limited | | | | | | | |
| Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | | | | | | | |
| 30.01.2014 | Tecfidera | Dimethyl fumarate | Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | Biogen Idec Limited | Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/13/837 | Gastro-resistant capsule, hard |
| Biogen Idec Limited | | | | | | | |
| Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | | | | | | | |

—   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --------------------------------------------------------------------------------------------------------------- | ----------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------- | --------------------------------------------------------------------------------------------------------------- |
| 08.01.2014 | BYDUREON | Bristol-Myers Squibb/AstraZeneca EEIG Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom | Bristol-Myers Squibb/AstraZeneca EEIG | Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom |
| Bristol-Myers Squibb/AstraZeneca EEIG | | | | |
| Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom | | | | |
| 08.01.2014 | Ibandronic acid Accord | Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | Accord Healthcare Limited | Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
| Accord Healthcare Limited | | | | |
| Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | | | | |
| 08.01.2014 | Intelence | Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België | Janssen-Cilag International NV | Turnhoutseweg 30, B-2340 Beerse, België |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg 30, B-2340 Beerse, België | | | | |
| 08.01.2014 | Pramipexole Accord | Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | Accord Healthcare Limited | Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
| Accord Healthcare Limited | | | | |
| Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | | | | |
| 09.01.2014 | Tractocile | Ferring Pharmaceuticals A/S Kay Fiskers Plads 11, DK-2300 København S, Danmark | Ferring Pharmaceuticals A/S | Kay Fiskers Plads 11, DK-2300 København S, Danmark |
| Ferring Pharmaceuticals A/S | | | | |
| Kay Fiskers Plads 11, DK-2300 København S, Danmark | | | | |
| 10.01.2014 | NovoRapid | Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark | Novo Nordisk A/S | Novo Allé, DK-2880 Bagsvaerd, Danmark |
| Novo Nordisk A/S | | | | |
| Novo Allé, DK-2880 Bagsvaerd, Danmark | | | | |
| 10.01.2014 | VELCADE | Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België | Janssen-Cilag International NV | Turnhoutseweg 30, B-2340 Beerse, België |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg 30, B-2340 Beerse, België | | | | |
| 10.01.2014 | Zeffix | Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | Glaxo Group Ltd | 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
| Glaxo Group Ltd | | | | |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | | | | |
| 16.01.2014 | Adenuric | Menarini International Operations Luxembourg S.A. 1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg | Menarini International Operations Luxembourg S.A. | 1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg |
| Menarini International Operations Luxembourg S.A. | | | | |
| 1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg | | | | |
| 16.01.2014 | Arzerra | Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | Glaxo Group Ltd | 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
| Glaxo Group Ltd | | | | |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | | | | |
| 16.01.2014 | Dacogen | Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België | Janssen-Cilag International NV | Turnhoutseweg 30, B-2340 Beerse, België |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg 30, B-2340 Beerse, België | | | | |
| 16.01.2014 | Evra | Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België | Janssen-Cilag International NV | Turnhoutseweg 30, B-2340 Beerse, België |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg 30, B-2340 Beerse, België | | | | |
| 16.01.2014 | Firdapse | BioMarin Europe Ltd 164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom | BioMarin Europe Ltd | 164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom |
| BioMarin Europe Ltd | | | | |
| 164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom | | | | |
| 16.01.2014 | INOmax | Linde Healthcare AB SE-181 81 Lidingö, Sverige | Linde Healthcare AB | SE-181 81 Lidingö, Sverige |
| Linde Healthcare AB | | | | |
| SE-181 81 Lidingö, Sverige | | | | |
| 16.01.2014 | IOA | Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Limited | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Limited | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 16.01.2014 | Nimvastid | Krka, d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija | Krka, d. d., Novo mesto | Šmarješka cesta 6, 8501 Novo mesto, Slovenija |
| Krka, d. d., Novo mesto | | | | |
| Šmarješka cesta 6, 8501 Novo mesto, Slovenija | | | | |
| 16.01.2014 | Rapiscan | Rapidscan Pharma Solutions EU Ltd. Regent's Place, 338 Euston Road, London NW1 3BT, United Kingdom | Rapidscan Pharma Solutions EU Ltd. | Regent's Place, 338 Euston Road, London NW1 3BT, United Kingdom |
| Rapidscan Pharma Solutions EU Ltd. | | | | |
| Regent's Place, 338 Euston Road, London NW1 3BT, United Kingdom | | | | |
| 16.01.2014 | Ribavirin Teva | Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, NL-3542 DR Utrecht, Nederland |
| Teva Pharma B.V. | | | | |
| Computerweg 10, NL-3542 DR Utrecht, Nederland | | | | |
| 16.01.2014 | Ribavirin Teva Pharma BV | Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, NL-3542 DR Utrecht, Nederland |
| Teva Pharma B.V. | | | | |
| Computerweg 10, NL-3542 DR Utrecht, Nederland | | | | |
| 16.01.2014 | Zoely | Theramex S.r.l. Via Messina 38, 20154 Milano, Italia | Theramex S.r.l. | Via Messina 38, 20154 Milano, Italia |
| Theramex S.r.l. | | | | |
| Via Messina 38, 20154 Milano, Italia | | | | |
| 16.01.2014 | Zytiga | Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België | Janssen-Cilag International NV | Turnhoutseweg 30, B-2340 Beerse, België |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg 30, B-2340 Beerse, België | | | | |
| 17.01.2014 | Ameluz | Biofrontera Bioscience GmbH Hemmelrather Weg 201, D-51377 Leverkusen, Deutschland | Biofrontera Bioscience GmbH | Hemmelrather Weg 201, D-51377 Leverkusen, Deutschland |
| Biofrontera Bioscience GmbH | | | | |
| Hemmelrather Weg 201, D-51377 Leverkusen, Deutschland | | | | |
| 17.01.2014 | Prialt | Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom | Eisai Limited | European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom |
| Eisai Limited | | | | |
| European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom | | | | |
| 22.01.2014 | Clopidogrel DURA | Mylan dura GmbH Wittichstraße 6, D-64295 Darmstadt, Deutschland | Mylan dura GmbH | Wittichstraße 6, D-64295 Darmstadt, Deutschland |
| Mylan dura GmbH | | | | |
| Wittichstraße 6, D-64295 Darmstadt, Deutschland | | | | |
| 22.01.2014 | Insulatard | Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark | Novo Nordisk A/S | Novo Allé, DK-2880 Bagsvaerd, Danmark |
| Novo Nordisk A/S | | | | |
| Novo Allé, DK-2880 Bagsvaerd, Danmark | | | | |
| 22.01.2014 | Kaletra | AbbVie Ltd Maidenhead, SL6 4XE, United Kingdom | AbbVie Ltd | Maidenhead, SL6 4XE, United Kingdom |
| AbbVie Ltd | | | | |
| Maidenhead, SL6 4XE, United Kingdom | | | | |
| 22.01.2014 | Leflunomide ratiopharm | ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | ratiopharm GmbH | Graf-Arco-Straße 3, D-89079 Ulm, Deutschland |
| ratiopharm GmbH | | | | |
| Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | | | | |
| 22.01.2014 | Temozolomide Sandoz | Sandoz Pharmaceuticals GmbH Raiffeisenstraße 11, D-83607 Holzkirchen, Deutschland | Sandoz Pharmaceuticals GmbH | Raiffeisenstraße 11, D-83607 Holzkirchen, Deutschland |
| Sandoz Pharmaceuticals GmbH | | | | |
| Raiffeisenstraße 11, D-83607 Holzkirchen, Deutschland | | | | |
| 22.01.2014 | Victrelis | Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Limited | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Limited | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 22.01.2014 | Zebinix | BIAL — Portela & Ca, SA A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado, Portugal | BIAL — Portela & Ca, SA | A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado, Portugal |
| BIAL — Portela & Ca, SA | | | | |
| A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado, Portugal | | | | |
| 24.01.2014 | Jentadueto | Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim International GmbH | Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | | | | |
| 29.01.2014 | Levemir | Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark | Novo Nordisk A/S | Novo Allé, DK-2880 Bagsvaerd, Danmark |
| Novo Nordisk A/S | | | | |
| Novo Allé, DK-2880 Bagsvaerd, Danmark | | | | |
| 29.01.2014 | Levetiracetam Accord | Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | Accord Healthcare Limited | Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
| Accord Healthcare Limited | | | | |
| Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | | | | |
| 29.01.2014 | Rienso | Takeda Pharma A/S PO Box 88, Langebjerg 1, DK-4000 Roskilde, Danmark | Takeda Pharma A/S | PO Box 88, Langebjerg 1, DK-4000 Roskilde, Danmark |
| Takeda Pharma A/S | | | | |
| PO Box 88, Langebjerg 1, DK-4000 Roskilde, Danmark | | | | |
| 29.01.2014 | RotaTeq | Sanofi Pasteur MSD, SNC 8 rue Jonas Salk, F-69007 Lyon, France | Sanofi Pasteur MSD, SNC | 8 rue Jonas Salk, F-69007 Lyon, France |
| Sanofi Pasteur MSD, SNC | | | | |
| 8 rue Jonas Salk, F-69007 Lyon, France | | | | |
| 29.01.2014 | Wilzin | Orphan Europe S.A.R.L. Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France | Orphan Europe S.A.R.L. | Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France |
| Orphan Europe S.A.R.L. | | | | |
| Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France | | | | |
| 29.01.2014 | XALKORI | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
| Pfizer Limited | | | | |
| Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | | | | |
| 31.01.2014 | Crixivan | Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Limited | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Limited | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 31.01.2014 | Docetaxel Winthrop | Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony CEDEX, France | Aventis Pharma S.A. | 20 avenue Raymond Aron, F-92165 Antony CEDEX, France |
| Aventis Pharma S.A. | | | | |
| 20 avenue Raymond Aron, F-92165 Antony CEDEX, France | | | | |
| 31.01.2014 | Nexavar | Bayer Pharma AG D-13342 Berlin, Deutschland | Bayer Pharma AG | D-13342 Berlin, Deutschland |
| Bayer Pharma AG | | | | |
| D-13342 Berlin, Deutschland | | | | |
| 31.01.2014 | Sildenafil Teva | Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, NL-3542 DR Utrecht, Nederland |
| Teva Pharma B.V. | | | | |
| Computerweg 10, NL-3542 DR Utrecht, Nederland | | | | |
| 31.01.2014 | Travatan | Alcon Laboratories (UK) Ltd. Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom | Alcon Laboratories (UK) Ltd. | Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom |
| Alcon Laboratories (UK) Ltd. | | | | |
| Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom | | | | |
| 31.01.2014 | Zoledronic acid Hospira | Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | Hospira UK Limited | Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom |
| Hospira UK Limited | | | | |
| Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | | | | |

—   Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --------------------------------------------------- | ----------------------------- | ----------------------------------------------------------------------- | --------------------------------------------- | --------------------------------------------------- |
| 16.01.2014 | BLUEVAC BTV8 | CZ Veterinaria, S.A. La Relva s/n, P.O. Box 16, E-36400 Porriño, España | CZ Veterinaria, S.A. | La Relva s/n, P.O. Box 16, E-36400 Porriño, España |
| CZ Veterinaria, S.A. | | | | |
| La Relva s/n, P.O. Box 16, E-36400 Porriño, España | | | | |
| 16.01.2014 | Contacera | Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | Zoetis Belgium S.A. | Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |
| Zoetis Belgium S.A. | | | | |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | | | | |
| 24.01.2014 | Proteq West Nile | Merial 29 avenue Tony Garnier, F-69007 Lyon, France | Merial | 29 avenue Tony Garnier, F-69007 Lyon, France |
| Merial | | | | |
| 29 avenue Tony Garnier, F-69007 Lyon, France | | | | |
| 29.01.2014 | Suvaxyn PCV | Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | Zoetis Belgium S.A. | Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |
| Zoetis Belgium S.A. | | | | |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | | | | |

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

| The European Medicines Agency |
| --------------------------------- |
| 7, Westferry Circus, Canary Wharf |
| UK — LONDON E14 4H |

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( 1 )  OJ L 136, 30.4.04, p. 1.

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