# C_2013121EN.01000201.xml

| 26.4.2013 | EN | Official Journal of the European Union | C 121/2 |
| --------- | -- | -------------------------------------- | ------- |

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2013 to 31 March 2013

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

2013/C 121/02

—   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 |
| --------------------------------------------------------------------- | ----------------------------- | --------------------------------------------------------- | ------------------------------------------------------------------------------------------------ | --------------------------------------------- | --------------------------------------------------------------------- | ----------------------------------------------- | -------------------------------------- |
| 4.3.2013 | Perjeta | pertuzumab | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | Roche Registration Limited | 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/13/813 | Concentrate for solution for infusion |
| Roche Registration Limited | | | | | | | |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | | | | | | | |
| 13.3.2013 | Actelsar HCT | telmisartan/hydrochlorothiazide | Actavis Group PTC ehf. Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland | Actavis Group PTC ehf. | Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland | EU/1/13/817 | Tablet |
| Actavis Group PTC ehf. | | | | | | | |
| Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland | | | | | | | |
| 13.3.2013 | JETREA | OCRIPLASMIN | ThromboGenics NV Gaston Geenslaan 1, B-3001 Leuven, België | ThromboGenics NV | Gaston Geenslaan 1, B-3001 Leuven, België | EU/1/13/819 | Concentrate for solution for injection |
| ThromboGenics NV | | | | | | | |
| Gaston Geenslaan 1, B-3001 Leuven, België | | | | | | | |
| 13.3.2013 | Tolucombi | telmisartan/hydrochlorothiazide | Krka, d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija | Krka, d. d., Novo mesto | Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/13/821 | Tablet |
| Krka, d. d., Novo mesto | | | | | | | |
| Šmarješka cesta 6, 8501 Novo mesto, Slovenija | | | | | | | |
| 22.3.2013 | Bexsero | Meningococcal group B Vaccine (rDNA, component, adsorbed) | Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, 53100 Siena, Italia | Novartis Vaccines and Diagnostics S.r.l. | Via Fiorentina, 1, 53100 Siena, Italia | EU/1/12/812 | Suspension for injection |
| Novartis Vaccines and Diagnostics S.r.l. | | | | | | | |
| Via Fiorentina, 1, 53100 Siena, Italia | | | | | | | |
| 27.3.2013 | Bosulif | Bosutinib | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/13/818 | Film-coated tablet |
| Pfizer Limited | | | | | | | |
| Ramsgate Road, Sandwich, Kent CT13 9NJ, 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 |
| --------------------------------------------------------------------------------------------------------------- | ----------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------- | --------------------------------------------------------------------------------------------------------------- |
| 6.3.2013 | Byetta | 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 | | | | |
| 6.3.2013 | 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 | | | | |
| 6.3.2013 | Ozurdex | Allergan Pharmaceuticals Ireland Castlebar Road, Westport, Co. Mayo, Ireland | Allergan Pharmaceuticals Ireland | Castlebar Road, Westport, Co. Mayo, Ireland |
| Allergan Pharmaceuticals Ireland | | | | |
| Castlebar Road, Westport, Co. Mayo, Ireland | | | | |
| 6.3.2013 | Ranexa | 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 | | | | |
| 11.3.2013 | Champix | 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 | | | | |
| 11.3.2013 | Qutenza | Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland | Astellas Pharma Europe B.V. | Sylviusweg 62, NL-2333 BE Leiden, Nederland |
| Astellas Pharma Europe B.V. | | | | |
| Sylviusweg 62, NL-2333 BE Leiden, Nederland | | | | |
| 11.3.2013 | Victoza | 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 | | | | |
| 13.3.2013 | 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 | | | | |
| 13.3.2013 | Efficib | 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 | | | | |
| 13.3.2013 | Firazyr | Shire Orphan Therapies GmbH Friedrichstrasse 149, D-10117 Berlin, Deutschland | Shire Orphan Therapies GmbH | Friedrichstrasse 149, D-10117 Berlin, Deutschland |
| Shire Orphan Therapies GmbH | | | | |
| Friedrichstrasse 149, D-10117 Berlin, Deutschland | | | | |
| 13.3.2013 | 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 | | | | |
| 13.3.2013 | Ganfort | Allergan Pharmaceuticals Ireland, (514125) Castlebar Road, Westport, County Mayo, Ireland | Allergan Pharmaceuticals Ireland, (514125) | Castlebar Road, Westport, County Mayo, Ireland |
| Allergan Pharmaceuticals Ireland, (514125) | | | | |
| Castlebar Road, Westport, County Mayo, Ireland | | | | |
| 13.3.2013 | Iscover | Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France | Sanofi-Aventis groupe | 54 rue La Boétie, F-75008 Paris, France |
| Sanofi-Aventis groupe | | | | |
| 54 rue La Boétie, F-75008 Paris, France | | | | |
| 13.3.2013 | Janumet | 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 | | | | |
| 13.3.2013 | Optimark | Mallinckrodt Deutschland GmbH Josef-Dietzgen-Strasse 1, 53773 Hennef, Deutschland | Mallinckrodt Deutschland GmbH | Josef-Dietzgen-Strasse 1, 53773 Hennef, Deutschland |
| Mallinckrodt Deutschland GmbH | | | | |
| Josef-Dietzgen-Strasse 1, 53773 Hennef, Deutschland | | | | |
| 13.3.2013 | Pegasys | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | Roche Registration Limited | 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
| Roche Registration Limited | | | | |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | | | | |
| 13.3.2013 | Privigen | CSL Behring GmbH Emil-von-Behring-Strasse 76, D-35041 Marburg, Deutschland | CSL Behring GmbH | Emil-von-Behring-Strasse 76, D-35041 Marburg, Deutschland |
| CSL Behring GmbH | | | | |
| Emil-von-Behring-Strasse 76, D-35041 Marburg, Deutschland | | | | |
| 13.3.2013 | Velmetia | 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 | | | | |
| 13.3.2013 | Vidaza | Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | Celgene Europe Limited | 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom |
| Celgene Europe Limited | | | | |
| 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | | | | |
| 22.3.2013 | Daliresp | Takeda GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | Takeda GmbH | Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland |
| Takeda GmbH | | | | |
| Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | | | | |
| 22.3.2013 | DaTSCAN | GE Healthcare Limited Little Chalfont, Bucks HP7 9NA, United Kingdom | GE Healthcare Limited | Little Chalfont, Bucks HP7 9NA, United Kingdom |
| GE Healthcare Limited | | | | |
| Little Chalfont, Bucks HP7 9NA, United Kingdom | | | | |
| 22.3.2013 | Daxas | Takeda GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | Takeda GmbH | Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland |
| Takeda GmbH | | | | |
| Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | | | | |
| 22.3.2013 | Emend | 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 | | | | |
| 22.3.2013 | Ivemend | 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 | | | | |
| 22.3.2013 | Libertek | Takeda GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | Takeda GmbH | Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland |
| Takeda GmbH | | | | |
| Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | | | | |
| 22.3.2013 | Pixuvri | CTI Life Sciences Ltd Biopark, Broadwater Road, Welwyn Garden City, Hertfordshire AL73AX, United Kingdom | CTI Life Sciences Ltd | Biopark, Broadwater Road, Welwyn Garden City, Hertfordshire AL73AX, United Kingdom |
| CTI Life Sciences Ltd | | | | |
| Biopark, Broadwater Road, Welwyn Garden City, Hertfordshire AL73AX, United Kingdom | | | | |
| 26.3.2013 | Combivir | 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 |
| ViiV Healthcare UK Limited | | | | |
| 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | | | | |
| 26.3.2013 | Daliresp | Takeda GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | Takeda GmbH | Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland |
| Takeda GmbH | | | | |
| Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | | | | |
| 26.3.2013 | Daxas | Takeda GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | Takeda GmbH | Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland |
| Takeda GmbH | | | | |
| Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | | | | |
| 26.3.2013 | Epivir | 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 |
| ViiV Healthcare UK Limited | | | | |
| 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | | | | |
| 26.3.2013 | Kivexa | 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 |
| ViiV Healthcare UK Limited | | | | |
| 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | | | | |
| 26.3.2013 | Libertek | Takeda GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | Takeda GmbH | Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland |
| Takeda GmbH | | | | |
| Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | | | | |
| 26.3.2013 | Privigen | CSL Behring GmbH Emil-von-Behring-Strasse 76, D-35041 Marburg, Deutschland | CSL Behring GmbH | Emil-von-Behring-Strasse 76, D-35041 Marburg, Deutschland |
| CSL Behring GmbH | | | | |
| Emil-von-Behring-Strasse 76, D-35041 Marburg, Deutschland | | | | |
| 26.3.2013 | Telzir | 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 |
| ViiV Healthcare UK Limited | | | | |
| 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | | | | |
| 26.3.2013 | Trizivir | 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 |
| ViiV Healthcare UK Limited | | | | |
| 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | | | | |
| 26.3.2013 | Ziagen | 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 |
| ViiV Healthcare UK Limited | | | | |
| 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | | | | |
| 27.3.2013 | Cervarix | GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique | GlaxoSmithKline Biologicals S.A. | rue de l'Institut 89, 1330 Rixensart, Belgique |
| GlaxoSmithKline Biologicals S.A. | | | | |
| rue de l'Institut 89, 1330 Rixensart, Belgique | | | | |

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

| 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 |
| --------------------------------------------------------------------- | ----------------------------- | ------------------------------------------------------------------------------------------------ | --------------------------------------------- | --------------------------------------------------------------------- |
| 27.3.2013 | Bondenza | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | Roche Registration Limited | 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
| Roche Registration Limited | | | | |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | | | | |
| 27.3.2013 | Possia | AstraZeneca AB SE-151 85 Södertälje, Sverige | AstraZeneca AB | SE-151 85 Södertälje, Sverige |
| AstraZeneca AB | | | | |
| SE-151 85 Södertälje, Sverige | | | | |

—   Suspension of a marketing authorization (Article 20 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

| 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 |
| ---------------------------------------------------------------- | ----------------------------- | -------------------------------------------------------------------------------------------- | --------------------------------------------- | ---------------------------------------------------------------- |
| 22.3.2013 | Pelzont | 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 | | | | |
| 22.3.2013 | Tredaptive | 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 | | | | |
| 22.3.2013 | Trevaclyn | 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 | | | | |

—   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 |
| -------------------------------------------------------- | ----------------------------- | ---------------------------------------------------------------------------------- | --------------------------------------------- | -------------------------------------------------------- |
| 6.3.2013 | Loxicom | Norbrook Laboratories Ltd Station Works, Newry, Co. Down, BT35 6JP, United Kindgom | Norbrook Laboratories Ltd | Station Works, Newry, Co. Down, BT35 6JP, United Kindgom |
| Norbrook Laboratories Ltd | | | | |
| Station Works, Newry, Co. Down, BT35 6JP, United Kindgom | | | | |
| 6.3.2013 | ProteqFlu | 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 | | | | |
| 6.3.2013 | ProteqFlu-Te | 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 | | | | |

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, 30.4.2004, p. 1.

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