# C_2009024EN.01000801.xml

| 30.1.2009 | EN | Official Journal of the European Union | C 24/8 |
| --------- | -- | -------------------------------------- | ------ |

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

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

(2009/C 24/06)

—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): 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 |
| -------------------------- | --------------------------------------------- | ----------------------------------------- | --------------------------------------------------------------------------------------- | --------------------------------------------- | ---------------------- | ------------------------------------------------ | -------------------- |
| 1.12.2008 | Irbesartan Krka | Irbesartan | KRKA d.d. Šmarješka cesta 6 SLO-8501 Novo mesto | KRKA d.d. | Šmarješka cesta 6 | SLO-8501 Novo mesto | EU/1/08/480/001-018 |
| KRKA d.d. | | | | | | | |
| Šmarješka cesta 6 | | | | | | | |
| SLO-8501 Novo mesto | | | | | | | |
| 1.12.2008 | Vildagliptin/metformin hydrochloride Novartis | Vildagliptin/metformin hydrochloride | Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom | Novartis Europharm Limited | Wimblehurst Road | Horsham | West Sussex RH12 5AB |
| Novartis Europharm Limited | | | | | | | |
| Wimblehurst Road | | | | | | | |
| Horsham | | | | | | | |
| West Sussex RH12 5AB | | | | | | | |
| United Kingdom | | | | | | | |
| 1.12.2008 | Zomarist | Vildagliptin/metformin hydrochloride | Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom | Novartis Europharm Limited | Wimblehurst Road | Horsham | West Sussex RH12 5AB |
| Novartis Europharm Limited | | | | | | | |
| Wimblehurst Road | | | | | | | |
| Horsham | | | | | | | |
| West Sussex RH12 5AB | | | | | | | |
| United Kingdom | | | | | | | |
| 2.12.2008 | Kuvan | Sapropterin dihydrochloride | Merck KgaA Frankfurter Straße 250 D-64293 Darmstadt | Merck KgaA | Frankfurter Straße 250 | D-64293 Darmstadt | EU/1/08/481/001-003 |
| Merck KgaA | | | | | | | |
| Frankfurter Straße 250 | | | | | | | |
| D-64293 Darmstadt | | | | | | | |
| 17.12.2008 | Vidaza | Azacitidine | Celgene Europe Ltd Riverside House Riverside Walk Windsor SL4 1NA United Kingdom | Celgene Europe Ltd | Riverside House | Riverside Walk | Windsor SL4 1NA |
| Celgene Europe Ltd | | | | | | | |
| Riverside House | | | | | | | |
| Riverside Walk | | | | | | | |
| Windsor SL4 1NA | | | | | | | |
| United Kingdom | | | | | | | |
| 18.12.2008 | Pramipexole Teva | Pramipexole | Teva Pharma B.V. Computerweg 10 DR Utrecht 3542 Nederland | Teva Pharma B.V. | Computerweg 10 | DR Utrecht 3542 | Nederland |
| Teva Pharma B.V. | | | | | | | |
| Computerweg 10 | | | | | | | |
| DR Utrecht 3542 | | | | | | | |
| Nederland | | | | | | | |

—   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): 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 |
| --------------------------------------- | ----------------------------- | ---------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | ---------------------------------- |
| 1.12.2008 | Sustiva | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom | Bristol-Myers Squibb Pharma EEIG | Uxbridge Business Park |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park | | | | |
| Sanderson Road | | | | |
| Uxbridge UB8 1DH | | | | |
| United Kingdom | | | | |
| 2.12.2008 | Axura | Merz Pharmaceuticals GmbH Eckenheimer Landstr. 100-104 D-60318 Frankfurt/Main | Merz Pharmaceuticals GmbH | Eckenheimer Landstr. 100-104 |
| Merz Pharmaceuticals GmbH | | | | |
| Eckenheimer Landstr. 100-104 | | | | |
| D-60318 Frankfurt/Main | | | | |
| 2.12.2008 | Ebixa | H. Lundbeck A/S Ottiliavej 9 DK-2500 Valby | H. Lundbeck A/S | Ottiliavej 9 |
| H. Lundbeck A/S | | | | |
| Ottiliavej 9 | | | | |
| DK-2500 Valby | | | | |
| 2.12.2008 | Herceptin | Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom | Roche Registration Limited | 6 Falcon Way |
| Roche Registration Limited | | | | |
| 6 Falcon Way | | | | |
| Shire Park | | | | |
| Welwyn Garden City | | | | |
| AL7 1TW | | | | |
| United Kingdom | | | | |
| 2.12.2008 | Rebetol | Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/Brussel | Schering Plough Europe | Rue de Stalle, 73/Stallestraat, 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73/Stallestraat, 73 | | | | |
| B-1180 Bruxelles/Brussel | | | | |
| 4.12.2008 | Xigris | Eli Lilly Nederland B.V., Grootslag 1-5 3991 RA Houten Nederland | Eli Lilly Nederland B.V., | Grootslag 1-5 |
| Eli Lilly Nederland B.V., | | | | |
| Grootslag 1-5 | | | | |
| 3991 RA Houten | | | | |
| Nederland | | | | |
| 4.12.2008 | Visudyne | Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom | Novartis Europharm Limited | Wimblehurst Road |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road | | | | |
| Horsham | | | | |
| West Sussex RH12 5AB | | | | |
| United Kingdom | | | | |
| 4.12.2008 | Noxafil | SP Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/Brussel | SP Europe | Rue de Stalle, 73/Stallestraat, 73 |
| SP Europe | | | | |
| Rue de Stalle, 73/Stallestraat, 73 | | | | |
| B-1180 Bruxelles/Brussel | | | | |
| 4.12.2008 | Ammonaps | Swedish Orphan International AB Drottninggatan 98 S-111 60 Stockholm | Swedish Orphan International AB | Drottninggatan 98 |
| Swedish Orphan International AB | | | | |
| Drottninggatan 98 | | | | |
| S-111 60 Stockholm | | | | |
| 5.12.2008 | Optimark | Covidien Deutschland GmbH Gewerbepark 1 D-93333 Neustadt/Donau | Covidien Deutschland GmbH | Gewerbepark 1 |
| Covidien Deutschland GmbH | | | | |
| Gewerbepark 1 | | | | |
| D-93333 Neustadt/Donau | | | | |
| 5.12.2008 | ViraferonPeg | Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/Brussel | Schering Plough Europe | Rue de Stalle, 73/Stallestraat, 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73/Stallestraat, 73 | | | | |
| B-1180 Bruxelles/Brussel | | | | |
| 5.12.2008 | Norvir | Abbott Laboratories Ltd Queenborough Kent ME11 5EL United Kingdom | Abbott Laboratories Ltd | Queenborough |
| Abbott Laboratories Ltd | | | | |
| Queenborough | | | | |
| Kent ME11 5EL | | | | |
| United Kingdom | | | | |
| 5.12.2008 | PegIntron | Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/Brussel | Schering Plough Europe | Rue de Stalle, 73/Stallestraat, 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73/Stallestraat, 73 | | | | |
| B-1180 Bruxelles/Brussel | | | | |
| 5.12.2008 | MabCampath | Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden Nederland | Genzyme Europe B.V. | Gooimeer 10 |
| Genzyme Europe B.V. | | | | |
| Gooimeer 10 | | | | |
| 1411 DD Naarden | | | | |
| Nederland | | | | |
| 12.12.2008 | Mixtard | Novo Nordisk A/S Novo Allé DK-2880 Bagsværd | Novo Nordisk A/S | Novo Allé |
| Novo Nordisk A/S | | | | |
| Novo Allé | | | | |
| DK-2880 Bagsværd | | | | |
| 16.12.2008 | Prezista | Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse | Janssen-Cilag International NV | Turnhoutseweg, 30 |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg, 30 | | | | |
| B-2340 Beerse | | | | |
| 16.12.2008 | Faslodex | AstraZeneca UK Limited Alderley Park Macclesfield Cheshire SK10 4TG United Kingdom | AstraZeneca UK Limited | Alderley Park |
| AstraZeneca UK Limited | | | | |
| Alderley Park | | | | |
| Macclesfield | | | | |
| Cheshire SK10 4TG | | | | |
| United Kingdom | | | | |
| 16.12.2008 | Somavert | Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom | Pfizer Ltd | Ramsgate Road |
| Pfizer Ltd | | | | |
| Ramsgate Road | | | | |
| Sandwich | | | | |
| Kent CT 13 9NJ | | | | |
| United Kingdom | | | | |
| 17.12.2008 | Temodal | Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/Brussel | Schering Plough Europe | Rue de Stalle, 73/Stallestraat, 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73/Stallestraat, 73 | | | | |
| B-1180 Bruxelles/Brussel | | | | |
| 17.12.2008 | Fareston | Orion Corporation Orionintie 1 FIN-02200 Espoo | Orion Corporation | Orionintie 1 |
| Orion Corporation | | | | |
| Orionintie 1 | | | | |
| FIN-02200 Espoo | | | | |
| 17.12.2008 | NovoNorm | Novo Nordisk A/S Novo Allé DK-2880 Bagsværd | Novo Nordisk A/S | Novo Allé |
| Novo Nordisk A/S | | | | |
| Novo Allé | | | | |
| DK-2880 Bagsværd | | | | |
| 17.12.2008 | Actrapid | Novo Nordisk A/S Novo Allé DK-2880 Bagsværd | Novo Nordisk A/S | Novo Allé |
| Novo Nordisk A/S | | | | |
| Novo Allé | | | | |
| DK-2880 Bagsværd | | | | |
| 17.12.2008 | Prandin | Novo Nordisk A/S Novo Allé DK-2880 Bagsværd | Novo Nordisk A/S | Novo Allé |
| Novo Nordisk A/S | | | | |
| Novo Allé | | | | |
| DK-2880 Bagsværd | | | | |
| 17.12.2008 | Avandia | SmithKline Beecham plc 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom | SmithKline Beecham plc | 980 Great West Road |
| SmithKline Beecham plc | | | | |
| 980 Great West Road | | | | |
| Brentford | | | | |
| Middlesex TW8 9GS | | | | |
| United Kingdom | | | | |
| 17.12.2008 | Hepsera | Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom | Gilead Sciences International Limited | Cambridge CB21 6GT |
| Gilead Sciences International Limited | | | | |
| Cambridge CB21 6GT | | | | |
| United Kingdom | | | | |
| 17.12.2008 | Exjade | Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom | Novartis Europharm Limited | Wimblehurst Road |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road | | | | |
| Horsham | | | | |
| West Sussex RH12 5AB | | | | |
| United Kingdom | | | | |
| 17.12.2008 | Avonex | Biogen Idec Ltd Innovation House 70 Norden Road Maidenhead Berkshire SL6 4AY United Kingdom | Biogen Idec Ltd | Innovation House |
| Biogen Idec Ltd | | | | |
| Innovation House | | | | |
| 70 Norden Road | | | | |
| Maidenhead | | | | |
| Berkshire SL6 4AY | | | | |
| United Kingdom | | | | |
| 17.12.2008 | Actraphane | Novo Nordisk A/S Novo Allé DK-2880 Bagsværd | Novo Nordisk A/S | Novo Allé |
| Novo Nordisk A/S | | | | |
| Novo Allé | | | | |
| DK-2880 Bagsværd | | | | |
| 19.12.2008 | Tysabri | Elan Pharma International Ltd Monksland Athlone County Westmeath Ireland | Elan Pharma International Ltd | Monksland |
| Elan Pharma International Ltd | | | | |
| Monksland | | | | |
| Athlone County Westmeath | | | | |
| Ireland | | | | |
| 22.12.2008 | Telzir | Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom | Glaxo Group Ltd | Greenford Road |
| Glaxo Group Ltd | | | | |
| Greenford Road | | | | |
| Greenford | | | | |
| Middlesex UB6 0NN | | | | |
| United Kingdom | | | | |
| 22.12.2008 | Arixtra | Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom | Glaxo Group Ltd | Greenford Road |
| Glaxo Group Ltd | | | | |
| Greenford Road | | | | |
| Greenford | | | | |
| Middlesex UB6 0NN | | | | |
| United Kingdom | | | | |
| 22.12.2008 | Lyrica | Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom | Pfizer Ltd | Ramsgate Road |
| Pfizer Ltd | | | | |
| Ramsgate Road | | | | |
| Sandwich | | | | |
| Kent CT 13 9NJ | | | | |
| United Kingdom | | | | |
| 22.12.2008 | Cholestagel | Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden Nederland | Genzyme Europe B.V. | Gooimeer 10 |
| Genzyme Europe B.V. | | | | |
| Gooimeer 10 | | | | |
| 1411 DD Naarden | | | | |
| Nederland | | | | |
| 22.12.2008 | Vectibix | Amgen Europe B.V. Minervum 7061 4817 ZK Breda Nederland | Amgen Europe B.V. | Minervum 7061 |
| Amgen Europe B.V. | | | | |
| Minervum 7061 | | | | |
| 4817 ZK Breda | | | | |
| Nederland | | | | |
| 22.12.2008 | Prezista | Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse | Janssen-Cilag International NV | Turnhoutseweg, 30 |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg, 30 | | | | |
| B-2340 Beerse | | | | |
| 22.12.2008 | Invanz | Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom | Merck Sharp & Dohme Ltd | Hertford Road |
| Merck Sharp & Dohme Ltd | | | | |
| Hertford Road | | | | |
| Hoddesdon | | | | |
| Hertfordshire EN11 9BU | | | | |
| United Kingdom | | | | |
| 22.12.2008 | Cerezyme | Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden Nederland | Genzyme Europe B.V. | Gooimeer 10 |
| Genzyme Europe B.V. | | | | |
| Gooimeer 10 | | | | |
| 1411 DD Naarden | | | | |
| Nederland | | | | |
| 22.12.2008 | Atripla | Bristol-Myers Squibb and Gilead Sciences Limited Unit 13 Stillorgan Industrial Park Blackrock Co. Dublin Ireland | Bristol-Myers Squibb and Gilead | Sciences Limited |
| Bristol-Myers Squibb and Gilead | | | | |
| Sciences Limited | | | | |
| Unit 13 | | | | |
| Stillorgan Industrial Park | | | | |
| Blackrock | | | | |
| Co. Dublin | | | | |
| Ireland | | | | |
| 22.12.2008 | Revlimid | Celgene Europe Limited Riverside House Riverside Walk Windsor Berkshire SL4 1NA United Kingdom | Celgene Europe Limited | Riverside House |
| Celgene Europe Limited | | | | |
| Riverside House | | | | |
| Riverside Walk | | | | |
| Windsor | | | | |
| Berkshire SL4 1NA | | | | |
| United Kingdom | | | | |
| 22.12.2008 | Enbrel | Wyeth Europa Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom | Wyeth Europa Limited | Huntercombe Lane South Taplow |
| Wyeth Europa Limited | | | | |
| Huntercombe Lane South Taplow | | | | |
| Maidenhead | | | | |
| Berkshire SL6 0PH | | | | |
| United Kingdom | | | | |
| 22.12.2008 | Truvada | Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom | Gilead Sciences | International Limited |
| Gilead Sciences | | | | |
| International Limited | | | | |
| Cambridge CB21 6GT | | | | |
| United Kingdom | | | | |
| 22.12.2008 | Evra | Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse | Janssen-Cilag International NV | Turnhoutseweg, 30 |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg, 30 | | | | |
| B-2340 Beerse | | | | |
| 22.12.2008 | Aptivus | Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein | Boehringer Ingelheim International GmbH | Binger Straße 173 |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Straße 173 | | | | |
| D-55216 Ingelheim am Rhein | | | | |

—   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): Rejected

| 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 |
| --------------------------------------- | ----------------------------- | ------------------------------------------------------------------------------------ | --------------------------------------------- | -------------------- |
| 8.12.2008 | Xeristar | Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein | Boehringer Ingelheim International GmbH | Binger Straße 173 |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Straße 173 | | | | |
| D-55216 Ingelheim am Rhein | | | | |
| 8.12.2008 | Cymbalta | Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland | Eli Lilly Nederland B.V. | Grootslag 1-5 |
| Eli Lilly Nederland B.V. | | | | |
| Grootslag 1-5 | | | | |
| 3991 RA Houten | | | | |
| Nederland | | | | |

—   Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004)

| 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 |
| -------------------- | ----------------------------- | ------------------------------------------------------ | --------------------------------------------- | -------------------- |
| 5.12.2008 | Parareg | Dompé Biotec S.p.A. Via San Martino, 12 I-20122 Milano | Dompé Biotec S.p.A. | Via San Martino, 12 |
| Dompé Biotec S.p.A. | | | | |
| Via San Martino, 12 | | | | |
| I-20122 Milano | | | | |
| 5.12.2008 | Neupopeg | Dompé Biotec S.p.A. Via San Martino, 12 I-20122 Milano | Dompé Biotec S.p.A. | Via San Martino, 12 |
| Dompé Biotec S.p.A. | | | | |
| Via San Martino, 12 | | | | |
| I-20122 Milano | | | | |
| 5.12.2008 | Nespo | Dompé Biotec S.p.A. Via San Martino, 12 I-20122 Milano | Dompé Biotec S.p.A. | Via San Martino, 12 |
| Dompé Biotec S.p.A. | | | | |
| Via San Martino, 12 | | | | |
| I-20122 Milano | | | | |

—   Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004): 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 |
| ----------------------------- | ----------------------------- | ----------------------------------------- | ---------------------------------------------------------------------------------------------------- | --------------------------------------------- | --------------------- | ------------------------------------------------ | -------------------- |
| 9.12.2008 | Acticam | Meloxicam | Omnipharm Ltd The Spire Egypt Road Nottingham NG7 7GD United Kingdom | Omnipharm Ltd | The Spire | Egypt Road | Nottingham NG7 7GD |
| Omnipharm Ltd | | | | | | | |
| The Spire | | | | | | | |
| Egypt Road | | | | | | | |
| Nottingham NG7 7GD | | | | | | | |
| United Kingdom | | | | | | | |
| EU/2/08/088/004 | Solution for injection | | | | | | |
| 16.12.2008 | Onsior | Robenacoxib | Novartis Animal Health UK Ltd Frimley Business Park Frimley/Camberley Surrey GU16 7SR United Kingdom | Novartis Animal Health UK Ltd | Frimley Business Park | Frimley/Camberley | Surrey GU16 7SR |
| Novartis Animal Health UK Ltd | | | | | | | |
| Frimley Business Park | | | | | | | |
| Frimley/Camberley | | | | | | | |
| Surrey GU16 7SR | | | | | | | |
| United Kingdom | | | | | | | |
| EU/2/08/089/020 | Solution for injection | | | | | | |

—   Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004): 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 |
| --------------------------- | ----------------------------- | ---------------------------------------------------------------------------- | --------------------------------------------- | ---------------------- |
| 5.12.2008 | Locatim | Biokema Anstalt Aeulestraße 38 FL-9490 Vaduz, Fürstentum Liechtenstein | Biokema Anstalt | Aeulestraße 38 |
| Biokema Anstalt | | | | |
| Aeulestraße 38 | | | | |
| FL-9490 Vaduz, | | | | |
| Fürstentum Liechtenstein | | | | |
| 9.12.2008 | Flexicam | Omnipharm Ltd The Spire Egypt Road Nottingham NG7 7GD United Kingdom | Omnipharm Ltd | The Spire |
| Omnipharm Ltd | | | | |
| The Spire | | | | |
| Egypt Road | | | | |
| Nottingham NG7 7GD | | | | |
| United Kingdom | | | | |
| 16.12.2008 | Equilis StrepE | Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer Nederland | Intervet International B.V. | Wim de Körverstraat 35 |
| Intervet International B.V. | | | | |
| Wim de Körverstraat 35 | | | | |
| 5831 AN Boxmeer | | | | |
| Nederland | | | | |

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 |
| London E14 4HB |
| United Kingdom |

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( 1 )  OJ L 136, 30.4. 2004, p. 1.

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