ISSN 1977-0987
Il-Ġurnal Uffiċjali
tal-Unjoni Ewropea
C 229
Edizzjoni bil-Malti
Informazzjoni u Avviżi
Volum 59
24 ta' Ġunju 2016
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ISSN 1977-0987 |
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Il-Ġurnal Uffiċjali tal-Unjoni Ewropea |
C 229 |
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Edizzjoni bil-Malti |
Informazzjoni u Avviżi |
Volum 59 |
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Avviż Nru |
Werrej |
Paġna |
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IV Informazzjoni |
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INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA |
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Il-Kummissjoni Ewropea |
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2016/C 229/01 |
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MT |
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IV Informazzjoni
INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA
Il-Kummissjoni Ewropea
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24.6.2016 |
MT |
Il-Ġurnal Uffiċjali tal-Unjoni Ewropea |
C 229/1 |
Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Mejju 2016 sal-31 ta’ Mejju 2016
(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill (1))
(2016/C 229/01)
— Ħruġ ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat
|
Data tad-deċiżjoni |
Isem tal-prodott mediċinali |
INN (Denominazzjoni Internazzjonali Komuni) |
Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq |
Numru tal-entrata fir-Reġistru Komunitarju |
Forma farmaċewtika |
Kodiċi ATC (Kodiċi Anatomiku Terapewtiku Kimiku) |
Data ta' notifika |
|
11.5.2016 |
Empliciti |
elotuzumab |
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |
EU/1/16/1088 |
Trab għal konċentrat għal soluzzjoni għall-infużjoni |
L01XC23 |
13.5.2016 |
|
11.5.2016 |
IDELVION |
albutrepenonacog alfa |
CSL Behring GmbH Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland |
EU/1/16/1095 |
Trab u solvent għal soluzzjoni għall-injezzjoni |
B02BD04 |
13.5.2016 |
|
12.5.2016 |
ALPROLIX |
eftrenonacog alfa |
Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom |
EU/1/16/1098 |
Trab u solvent għal soluzzjoni għall-injezzjoni |
B02BD04 |
13.5.2016 |
|
12.5.2016 |
Uptravi |
selexipag |
Actelion Registration Ltd Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom |
EU/1/15/1083 |
Pillola miksija b’rita |
B01AC27 |
19.5.2016 |
|
20.5.2016 |
Darzalex |
Daratumumab |
Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België |
EU/1/16/1101 |
Konċentrat għal soluzzjoni għal infużjoni |
L01XC24 |
24.5.2016 |
|
20.5.2016 |
Tilqima kontra l-influwenza Pandemika H5N1 MedImmune |
Tilqima kontra l-influwenza pandemika (H5N1) (ħajja attenwata, għall-imnieħer) |
MedImmune, LLC Lagelandseweg 78, NL-6545 CG Nijmegen, Nederland |
EU/1/16/1089 |
Sprej ta’ l-imnieħer, suspensjoni |
J07BB03 |
24.5.2016 |
|
26.5.2016 |
Galafold |
migalastat |
Amicus Therapeutics UK Ltd Phoenix House, Oxford Road, Tatling End, Gerrards Cross, Buckinghamshire SL9 7AP, United Kingdom |
EU/1/15/1082 |
Kapsula, iebsa |
Pending |
31.5.2016 |
|
26.5.2016 |
Neparvis |
sacubitril/valsartan |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/16/1103 |
Pillola miksija b’rita |
C09DX04 |
30.5.2016 |
|
26.5.2016 |
Palonosetron Accord |
palonosetron |
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
EU/1/16/1104 |
Soluzzjoni għall-injezzjoni |
A04AA05 |
31.5.2016 |
— Modifika ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat
|
Data tad-deċiżjoni |
Isem tal-prodott mediċinali |
Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq |
Numru tal-entrata fir-Reġistru Komunitarju |
Data ta' notifika |
|
2.5.2016 |
Bortezomib Accord |
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
EU/1/15/1019 |
4.5.2016 |
|
2.5.2016 |
Combivir |
ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom |
EU/1/98/058 |
4.5.2016 |
|
2.5.2016 |
Ebilfumin |
Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Ísland |
EU/1/14/915 |
4.5.2016 |
|
2.5.2016 |
ellaOne |
Laboratoire HRA Pharma 15 rue Béranger, F-75003 Paris, France |
EU/1/09/522 |
4.5.2016 |
|
2.5.2016 |
HALAVEN |
Eisai Europe Limited European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom |
EU/1/11/678 |
4.5.2016 |
|
2.5.2016 |
Harvoni |
Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom |
EU/1/14/958 |
4.5.2016 |
|
2.5.2016 |
Ixiaro |
Valneva Austria GmbH Campus Vienna Biocenter 3, A-1030 Wien, Österreich |
EU/1/08/501 |
4.5.2016 |
|
2.5.2016 |
Lyxumia |
Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France |
EU/1/12/811 |
4.5.2016 |
|
2.5.2016 |
Norvir |
AbbVie Ltd Maidenhead, SL6 4UB, United Kingdom |
EU/1/96/016 |
4.5.2016 |
|
2.5.2016 |
Quadramet |
CIS bio international Boite Postale 32, F-91192 Gif-sur-Yvette, France |
EU/1/97/057 |
4.5.2016 |
|
2.5.2016 |
Synflorix |
GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique |
EU/1/09/508 |
4.5.2016 |
|
2.5.2016 |
Tafinlar |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/13/865 |
4.5.2016 |
|
11.5.2016 |
Desloratadine Actavis |
Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Ísland |
EU/1/11/745 |
13.5.2016 |
|
11.5.2016 |
Humalog |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
EU/1/96/007 |
13.5.2016 |
|
11.5.2016 |
Humira |
AbbVie Ltd Maidenhead, SL6 4UB, United Kingdom |
EU/1/03/256 |
13.5.2016 |
|
11.5.2016 |
Imatinib Medac |
medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6, D-22880 Wedel, Deutschland |
EU/1/13/876 |
13.5.2016 |
|
11.5.2016 |
Inlyta |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/12/777 |
13.5.2016 |
|
11.5.2016 |
Opdivo |
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |
EU/1/15/1014 |
13.5.2016 |
|
11.5.2016 |
Plenadren |
ViroPharma SPRL-BVBA rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België |
EU/1/11/715 |
13.5.2016 |
|
11.5.2016 |
Zerit |
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |
EU/1/96/009 |
13.5.2016 |
|
12.5.2016 |
Brimica Genuair |
AstraZeneca AB SE-151 85 Södertälje, Sverige |
EU/1/14/963 |
16.5.2016 |
|
12.5.2016 |
Clopidogrel Mylan |
Mylan S.A.S 117 allée des Parcs, F-69800 Saint Priest, France |
EU/1/09/559 |
17.5.2016 |
|
12.5.2016 |
Desloratadine Teva |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/11/732 |
17.5.2016 |
|
12.5.2016 |
Docetaxel Winthrop |
Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony CEDEX, France |
EU/1/07/384 |
17.5.2016 |
|
12.5.2016 |
Enurev Breezhaler |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/12/789 |
16.5.2016 |
|
12.5.2016 |
Glybera |
uniQure biopharma B.V. Meibergdreef 61, NL-1105 BA Amsterdam, Nederland |
EU/1/12/791 |
17.5.2016 |
|
12.5.2016 |
Integrilin |
Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
EU/1/99/109 |
16.5.2016 |
|
12.5.2016 |
NovoEight |
Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark |
EU/1/13/888 |
17.5.2016 |
|
12.5.2016 |
Seebri Breezhaler |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/12/788 |
16.5.2016 |
|
12.5.2016 |
Tepadina |
ADIENNE S.r.l. Via Galileo Galilei 19, 20867 Caponago (MB), Italia |
EU/1/10/622 |
16.5.2016 |
|
12.5.2016 |
Tovanor Breezhaler |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/12/790 |
16.5.2016 |
|
13.5.2016 |
Hexacima |
Sanofi Pasteur SA 2 avenue Pont Pasteur, F-69007 Lyon, France |
EU/1/13/828 |
24.5.2016 |
|
17.5.2016 |
Capecitabine SUN |
Sun Pharmaceutical Industries Europe BV Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland |
EU/1/13/831 |
19.5.2016 |
|
17.5.2016 |
Champix |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/06/360 |
19.5.2016 |
|
17.5.2016 |
Epivir |
ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom |
EU/1/96/015 |
19.5.2016 |
|
17.5.2016 |
Imatinib Teva |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/12/808 |
19.5.2016 |
|
17.5.2016 |
Wilzin |
Orphan Europe S.A.R.L. Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France |
EU/1/04/286 |
19.5.2016 |
|
20.5.2016 |
Ceprotin |
Baxter AG Industriestrasse 67, A-1221 Wien, Österreich |
EU/1/01/190 |
24.5.2016 |
|
20.5.2016 |
Clopidogrel Krka d.d. |
Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija |
EU/1/09/562 |
24.5.2016 |
|
20.5.2016 |
Gazyvaro |
Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
EU/1/14/937 |
24.5.2016 |
|
20.5.2016 |
Hexyon |
Sanofi Pasteur MSD SNC 162 avenue Jean Jaurès, 69007 Lyon, France |
EU/1/13/829 |
24.5.2016 |
|
26.5.2016 |
Actos |
Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark |
EU/1/00/150 |
30.5.2016 |
|
26.5.2016 |
Afinitor |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/09/538 |
30.5.2016 |
|
26.5.2016 |
Buccolam |
Shire Services BVBA rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België |
EU/1/11/709 |
30.5.2016 |
|
26.5.2016 |
Capecitabine medac |
medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6, D-22880 Wedel, Deutschland |
EU/1/12/802 |
30.5.2016 |
|
26.5.2016 |
Cayston |
Gilead Sciences International Limited Granta Park, Abington, Cambridge CB21 6GT, United Kingdom |
EU/1/09/543 |
31.5.2016 |
|
26.5.2016 |
Cinryze |
Shire Services BVBA rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België |
EU/1/11/688 |
30.5.2016 |
|
26.5.2016 |
Clopidogrel/Acetylsalicylic acid Teva |
Teva Pharma B.V. Swensweg 5, 2031GA Haarlem, Nederland |
EU/1/14/942 |
30.5.2016 |
|
26.5.2016 |
Clopidogrel HCS |
HCS bvba H. Kennisstraat 53, B-2650 Edegem, België |
EU/1/10/651 |
30.5.2016 |
|
26.5.2016 |
Clopidogrel Teva |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/09/540 |
30.5.2016 |
|
26.5.2016 |
Competact |
Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark |
EU/1/06/354 |
30.5.2016 |
|
26.5.2016 |
Conbriza |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/09/511 |
31.5.2016 |
|
26.5.2016 |
Constella |
Allergan Pharmaceuticals International Ltd. Clonshaugh Business and Technology Park Coolock Dublin D17 E400, Ireland |
EU/1/12/801 |
30.5.2016 |
|
26.5.2016 |
DepoCyte |
Pacira Limited Wessex House, Marlow Road, Bourne End, Buckinghamshire, SL8 5SP, United Kingdom |
EU/1/01/187 |
28.5.2016 |
|
26.5.2016 |
Dexdor |
Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi |
EU/1/11/718 |
30.5.2016 |
|
26.5.2016 |
Duaklir Genuair |
AstraZeneca AB SE-151 85 Södertälje, Sverige |
EU/1/14/964 |
30.5.2016 |
|
26.5.2016 |
Ferriprox |
Apotex Europe B.V. Darwinweg 20, NL- 2333 CR Leiden, Nederland |
EU/1/99/108 |
30.5.2016 |
|
26.5.2016 |
Firazyr |
Shire Orphan Therapies GmbH Friedrichstraße 149, D-10117 Berlin, Deutschland |
EU/1/08/461 |
30.5.2016 |
|
26.5.2016 |
Glubrava |
Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark |
EU/1/07/421 |
30.5.2016 |
|
26.5.2016 |
Glustin |
Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark |
EU/1/00/151 |
30.5.2016 |
|
26.5.2016 |
HyQvia |
Baxalta Innovations GmbH Industriestrasse 67, A-1221 Wien, Österreich |
EU/1/13/840 |
30.5.2016 |
|
26.5.2016 |
IMBRUVICA |
Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België |
EU/1/14/945 |
30.5.2016 |
|
26.5.2016 |
Imnovid |
Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom |
EU/1/13/850 |
31.5.2016 |
|
26.5.2016 |
Levodopa/Carbidopa/Entacapone Orion |
Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi |
EU/1/11/706 |
30.5.2016 |
|
26.5.2016 |
Liprolog |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
EU/1/01/195 |
30.5.2016 |
|
26.5.2016 |
Mabthera |
Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
EU/1/98/067 |
31.5.2016 |
|
26.5.2016 |
Neulasta |
Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland |
EU/1/02/227 |
30.5.2016 |
|
26.5.2016 |
Nexium Control |
Pfizer Consumer Healthcare Limited Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom |
EU/1/13/860 |
31.5.2016 |
|
26.5.2016 |
Rixubis |
Baxalta Innovations GmbH Industriestrasse 67, A-1221 Wien, Österreich |
EU/1/14/970 |
30.5.2016 |
|
26.5.2016 |
Strimvelis |
GlaxoSmithKline Trading Services Limited Currabinny, Carrigaline, County Cork, Ireland |
EU/1/16/1097 |
30.5.2016 |
|
26.5.2016 |
Tandemact |
Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark |
EU/1/06/366 |
30.5.2016 |
|
26.5.2016 |
Taxotere |
Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony CEDEX, France |
EU/1/95/002 |
30.5.2016 |
|
26.5.2016 |
Trevicta |
Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België |
EU/1/14/971 |
30.5.2016 |
|
26.5.2016 |
Vibativ |
Clinigen Healthcare Limited Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom |
EU/1/11/705 |
28.5.2016 |
|
26.5.2016 |
Victoza |
Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark |
EU/1/09/529 |
30.5.2016 |
|
26.5.2016 |
XALKORI |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/12/793 |
31.5.2016 |
|
26.5.2016 |
Ytracis |
CIS bio international Boite Postale 32, F-91192 Gif-sur-Yvette, France |
EU/1/03/250 |
30.5.2016 |
|
26.5.2016 |
Zytiga |
Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België |
EU/1/11/714 |
30.5.2016 |
— Modifika ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat
|
Data tad-deċiżjoni |
Isem tal-prodott mediċinali |
Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq |
Numru tal-entrata fir-Reġistru Komunitarju |
Data ta' notifika |
|
3.5.2016 |
Suvaxyn PCV |
Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/09/099 |
20.5.2016 |
|
17.5.2016 |
Apoquel |
Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/13/154 |
19.5.2016 |
|
17.5.2016 |
Bravecto |
Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland |
EU/2/13/158 |
19.5.2016 |
|
17.5.2016 |
Proteq West Nile |
Merial 29 avenue Tony Garnier, F-69007 Lyon, France |
EU/2/11/129 |
19.5.2016 |
|
17.5.2016 |
Vaċċine MS-H |
Pharmsure International Ltd Unit 28, Moorlands Trading Estate, Moor Lane, Metheringham Lincolnshire, LN4 3HX, United Kingdom |
EU/2/11/126 |
19.5.2016 |
|
26.5.2016 |
Aivlosin |
ECO Animal Health Ltd 78 Coombe Road, New Malden, Surrey KT3 4QS United Kingdom |
EU/2/04/044 |
31.5.2016 |
— Irtirar ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill)
|
Data tad-deċiżjoni |
Isem tal-prodott mediċinali |
Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq |
Numru tal-entrata fir-Reġistru Komunitarju |
Data ta' notifika |
|
26.5.2016 |
RevitaCAM |
Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/12/138 |
30.5.2016 |
Kull min jixtieq jikkonsulta r-rapport ta' evalwazzjoni pubblika dwar il-prodotti mediċinali kkonċernati u d-deċiżjonijiet marbuta magħhom għandu jikkuntattja lil:
|
European Medicines Agency |
|
30 Churchill Place |
|
Canary Wharf |
|
London E14 5EU |
|
United Kingdom |
(1) ĠU L 136, 30.4.2004, p. 1.