ISSN 1977-0960
Europos Sąjungos
oficialusis leidinys
C 229
Leidimas lietuvių kalba
Informacija ir pranešimai
59 tomas
2016m. birželio 24d.
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ISSN 1977-0960 |
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Europos Sąjungos oficialusis leidinys |
C 229 |
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Leidimas lietuvių kalba |
Informacija ir pranešimai |
59 tomas |
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Pranešimo Nr. |
Turinys |
Puslapis |
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IV Pranešimai |
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EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI |
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Europos Komisija |
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2016/C 229/01 |
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LT |
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IV Pranešimai
EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI
Europos Komisija
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24.6.2016 |
LT |
Europos Sąjungos oficialusis leidinys |
C 229/1 |
Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2016 m. gegužės 1 d. iki 2016 m. gegužės 31 d.
(Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 (1) 13 straipsnį arba 38 straipsnį)
(2016/C 229/01)
— Rinkodaros leidimo suteikimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnis): Priimta
|
Sprendimo data |
Vaisto pavadinimas |
INN (Tarptautinis nepatentuotas pavadinimas) |
Rinkodaros leidimo turėtojas |
Įrašo numeris Bendrijos vaistų registre |
Farmacinė forma |
ATC kodas (Anatominis terapinis cheminis kodas) |
Pranešimo data |
|
2016 5 11 |
Empliciti |
elotuzumabas |
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |
EU/1/16/1088 |
Milteliai koncentratui infuziniam tirpalui |
L01XC23 |
2016 5 13 |
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2016 5 11 |
IDELVION |
albutrepenonakogas alfa |
CSL Behring GmbH Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland |
EU/1/16/1095 |
Milteliai ir tirpiklis injekciniam tirpalui |
B02BD04 |
2016 5 13 |
|
2016 5 12 |
ALPROLIX |
eftrenonakogo alfa (eftrenonacogum alfa) |
Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom |
EU/1/16/1098 |
Milteliai ir tirpiklis injekciniam tirpalui |
B02BD04 |
2016 5 13 |
|
2016 5 12 |
Uptravi |
seleksipagas |
Actelion Registration Ltd Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom |
EU/1/15/1083 |
Plėvele dengta tabletė |
B01AC27 |
2016 5 19 |
|
2016 5 20 |
Darzalex |
Daratumumabas |
Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België |
EU/1/16/1101 |
Koncentratas infuziniam tirpalui |
L01XC24 |
2016 5 24 |
|
2016 5 20 |
Pandeminė vakcina nuo gripo H5N1 MedImmune |
Pandeminė vakcina nuo gripo (H5N1) (gyvoji susilpninta, į nosį) |
MedImmune, LLC Lagelandseweg 78, NL-6545 CG Nijmegen, Nederland |
EU/1/16/1089 |
Nosies purškalas, suspensija |
J07BB03 |
2016 5 24 |
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2016 5 26 |
Galafold |
Migalastatas |
Amicus Therapeutics UK Ltd Phoenix House, Oxford Road, Tatling End, Gerrards Cross, Buckinghamshire SL9 7AP, United Kingdom |
EU/1/15/1082 |
Kieta kapsulė |
Pending |
2016 5 31 |
|
2016 5 26 |
Neparvis |
sakubitrilas/valsartanas |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/16/1103 |
Plėvele dengta tabletė |
C09DX04 |
2016 5 30 |
|
2016 5 26 |
Palonosetron Accord |
palonosetronas |
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
EU/1/16/1104 |
Injekcinis tirpalas |
A04AA05 |
2016 5 31 |
— Rinkodaros leidimo pakeitimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnis): Priimta
|
Sprendimo data |
Vaisto pavadinimas |
Rinkodaros leidimo turėtojas |
Įrašo numeris Bendrijos vaistų registre |
Pranešimo data |
|
2016 5 2 |
Bortezomib Accord |
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
EU/1/15/1019 |
2016 5 4 |
|
2016 5 2 |
Combivir |
ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom |
EU/1/98/058 |
2016 5 4 |
|
2016 5 2 |
Ebilfumin |
Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Ísland |
EU/1/14/915 |
2016 5 4 |
|
2016 5 2 |
ellaOne |
Laboratoire HRA Pharma 15 rue Béranger, F-75003 Paris, France |
EU/1/09/522 |
2016 5 4 |
|
2016 5 2 |
HALAVEN |
Eisai Europe Limited European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom |
EU/1/11/678 |
2016 5 4 |
|
2016 5 2 |
Harvoni |
Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom |
EU/1/14/958 |
2016 5 4 |
|
2016 5 2 |
Ixiaro |
Valneva Austria GmbH Campus Vienna Biocenter 3, A-1030 Wien, Österreich |
EU/1/08/501 |
2016 5 4 |
|
2016 5 2 |
Lyxumia |
Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France |
EU/1/12/811 |
2016 5 4 |
|
2016 5 2 |
Norvir |
AbbVie Ltd Maidenhead, SL6 4UB, United Kingdom |
EU/1/96/016 |
2016 5 4 |
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2016 5 2 |
Quadramet |
CIS bio international Boite Postale 32, F-91192 Gif-sur-Yvette, France |
EU/1/97/057 |
2016 5 4 |
|
2016 5 2 |
Synflorix |
GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique |
EU/1/09/508 |
2016 5 4 |
|
2016 5 2 |
Tafinlar |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/13/865 |
2016 5 4 |
|
2016 5 11 |
Desloratadine Actavis |
Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Ísland |
EU/1/11/745 |
2016 5 13 |
|
2016 5 11 |
Humalog |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
EU/1/96/007 |
2016 5 13 |
|
2016 5 11 |
Humira |
AbbVie Ltd Maidenhead, SL6 4UB, United Kingdom |
EU/1/03/256 |
2016 5 13 |
|
2016 5 11 |
Imatinib Medac |
medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6, D-22880 Wedel, Deutschland |
EU/1/13/876 |
2016 5 13 |
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2016 5 11 |
Inlyta |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/12/777 |
2016 5 13 |
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2016 5 11 |
Opdivo |
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |
EU/1/15/1014 |
2016 5 13 |
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2016 5 11 |
Plenadren |
ViroPharma SPRL-BVBA rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België |
EU/1/11/715 |
2016 5 13 |
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2016 5 11 |
Zerit |
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |
EU/1/96/009 |
2016 5 13 |
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2016 5 12 |
Brimica Genuair |
AstraZeneca AB SE-151 85 Södertälje, Sverige |
EU/1/14/963 |
2016 5 16 |
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2016 5 12 |
Clopidogrel Mylan |
Mylan S.A.S 117 allée des Parcs, F-69800 Saint Priest, France |
EU/1/09/559 |
2016 5 17 |
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2016 5 12 |
Desloratadine Teva |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/11/732 |
2016 5 17 |
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2016 5 12 |
Docetaxel Winthrop |
Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony CEDEX, France |
EU/1/07/384 |
2016 5 17 |
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2016 5 12 |
Enurev Breezhaler |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/12/789 |
2016 5 16 |
|
2016 5 12 |
Glybera |
uniQure biopharma B.V. Meibergdreef 61, NL-1105 BA Amsterdam, Nederland |
EU/1/12/791 |
2016 5 17 |
|
2016 5 12 |
Integrilin |
Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
EU/1/99/109 |
2016 5 16 |
|
2016 5 12 |
NovoEight |
Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark |
EU/1/13/888 |
2016 5 17 |
|
2016 5 12 |
Seebri Breezhaler |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/12/788 |
2016 5 16 |
|
2016 5 12 |
Tepadina |
ADIENNE S.r.l. Via Galileo Galilei 19, 20867 Caponago (MB), Italia |
EU/1/10/622 |
2016 5 16 |
|
2016 5 12 |
Tovanor Breezhaler |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/12/790 |
2016 5 16 |
|
2016 5 13 |
Hexacima |
Sanofi Pasteur SA 2 avenue Pont Pasteur, F-69007 Lyon, France |
EU/1/13/828 |
2016 5 24 |
|
2016 5 17 |
Capecitabine SUN |
Sun Pharmaceutical Industries Europe BV Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland |
EU/1/13/831 |
2016 5 19 |
|
2016 5 17 |
Champix |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/06/360 |
2016 5 19 |
|
2016 5 17 |
Epivir |
ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom |
EU/1/96/015 |
2016 5 19 |
|
2016 5 17 |
Imatinib Teva |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/12/808 |
2016 5 19 |
|
2016 5 17 |
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 |
2016 5 19 |
|
2016 5 20 |
Ceprotin |
Baxter AG Industriestrasse 67, A-1221 Wien, Österreich |
EU/1/01/190 |
2016 5 24 |
|
2016 5 20 |
Clopidogrel Krka d.d. |
Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija |
EU/1/09/562 |
2016 5 24 |
|
2016 5 20 |
Gazyvaro |
Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
EU/1/14/937 |
2016 5 24 |
|
2016 5 20 |
Hexyon |
Sanofi Pasteur MSD SNC 162 avenue Jean Jaurès, 69007 Lyon, France |
EU/1/13/829 |
2016 5 24 |
|
2016 5 26 |
Actos |
Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark |
EU/1/00/150 |
2016 5 30 |
|
2016 5 26 |
Afinitor |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/09/538 |
2016 5 30 |
|
2016 5 26 |
Buccolam |
Shire Services BVBA rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België |
EU/1/11/709 |
2016 5 30 |
|
2016 5 26 |
Capecitabine medac |
medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6, D-22880 Wedel, Deutschland |
EU/1/12/802 |
2016 5 30 |
|
2016 5 26 |
Cayston |
Gilead Sciences International Limited Granta Park, Abington, Cambridge CB21 6GT, United Kingdom |
EU/1/09/543 |
2016 5 31 |
|
2016 5 26 |
Cinryze |
Shire Services BVBA rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België |
EU/1/11/688 |
2016 5 30 |
|
2016 5 26 |
Clopidogrel/Acetylsalicylic acid Teva |
Teva Pharma B.V. Swensweg 5, 2031GA Haarlem, Nederland |
EU/1/14/942 |
2016 5 30 |
|
2016 5 26 |
Clopidogrel HCS |
HCS bvba H. Kennisstraat 53, B-2650 Edegem, België |
EU/1/10/651 |
2016 5 30 |
|
2016 5 26 |
Clopidogrel Teva |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/09/540 |
2016 5 30 |
|
2016 5 26 |
Competact |
Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark |
EU/1/06/354 |
2016 5 30 |
|
2016 5 26 |
Conbriza |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/09/511 |
2016 5 31 |
|
2016 5 26 |
Constella |
Allergan Pharmaceuticals International Ltd. Clonshaugh Business and Technology Park Coolock Dublin D17 E400, Ireland |
EU/1/12/801 |
2016 5 30 |
|
2016 5 26 |
DepoCyte |
Pacira Limited Wessex House, Marlow Road, Bourne End, Buckinghamshire, SL8 5SP, United Kingdom |
EU/1/01/187 |
2016 5 28 |
|
2016 5 26 |
Dexdor |
Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi |
EU/1/11/718 |
2016 5 30 |
|
2016 5 26 |
Duaklir Genuair |
AstraZeneca AB SE-151 85 Södertälje, Sverige |
EU/1/14/964 |
2016 5 30 |
|
2016 5 26 |
Ferriprox |
Apotex Europe B.V. Darwinweg 20, NL- 2333 CR Leiden, Nederland |
EU/1/99/108 |
2016 5 30 |
|
2016 5 26 |
Firazyr |
Shire Orphan Therapies GmbH Friedrichstraße 149, D-10117 Berlin, Deutschland |
EU/1/08/461 |
2016 5 30 |
|
2016 5 26 |
Glubrava |
Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark |
EU/1/07/421 |
2016 5 30 |
|
2016 5 26 |
Glustin |
Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark |
EU/1/00/151 |
2016 5 30 |
|
2016 5 26 |
HyQvia |
Baxalta Innovations GmbH Industriestrasse 67, A-1221 Wien, Österreich |
EU/1/13/840 |
2016 5 30 |
|
2016 5 26 |
IMBRUVICA |
Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België |
EU/1/14/945 |
2016 5 30 |
|
2016 5 26 |
Imnovid |
Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom |
EU/1/13/850 |
2016 5 31 |
|
2016 5 26 |
Levodopa/Carbidopa/Entacapone Orion |
Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi |
EU/1/11/706 |
2016 5 30 |
|
2016 5 26 |
Liprolog |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
EU/1/01/195 |
2016 5 30 |
|
2016 5 26 |
Mabthera |
Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
EU/1/98/067 |
2016 5 31 |
|
2016 5 26 |
Neulasta |
Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland |
EU/1/02/227 |
2016 5 30 |
|
2016 5 26 |
Nexium Control |
Pfizer Consumer Healthcare Limited Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom |
EU/1/13/860 |
2016 5 31 |
|
2016 5 26 |
Rixubis |
Baxalta Innovations GmbH Industriestrasse 67, A-1221 Wien, Österreich |
EU/1/14/970 |
2016 5 30 |
|
2016 5 26 |
Strimvelis |
GlaxoSmithKline Trading Services Limited Currabinny, Carrigaline, County Cork, Ireland |
EU/1/16/1097 |
2016 5 30 |
|
2016 5 26 |
Tandemact |
Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark |
EU/1/06/366 |
2016 5 30 |
|
2016 5 26 |
Taxotere |
Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony CEDEX, France |
EU/1/95/002 |
2016 5 30 |
|
2016 5 26 |
Trevicta |
Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België |
EU/1/14/971 |
2016 5 30 |
|
2016 5 26 |
Vibativ |
Clinigen Healthcare Limited Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom |
EU/1/11/705 |
2016 5 28 |
|
2016 5 26 |
Victoza |
Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark |
EU/1/09/529 |
2016 5 30 |
|
2016 5 26 |
XALKORI |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/12/793 |
2016 5 31 |
|
2016 5 26 |
Ytracis |
CIS bio international Boite Postale 32, F-91192 Gif-sur-Yvette, France |
EU/1/03/250 |
2016 5 30 |
|
2016 5 26 |
Zytiga |
Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België |
EU/1/11/714 |
2016 5 30 |
— Rinkodaros leidimo pakeitimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 38 straipsnis): Priimta
|
Sprendimo data |
Vaisto pavadinimas |
Rinkodaros leidimo turėtojas |
Įrašo numeris Bendrijos vaistų registre |
Pranešimo data |
|
2016 5 3 |
Suvaxyn PCV |
Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/09/099 |
2016 5 20 |
|
2016 5 17 |
Apoquel |
Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/13/154 |
2016 5 19 |
|
2016 5 17 |
Bravecto |
Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland |
EU/2/13/158 |
2016 5 19 |
|
2016 5 17 |
MS-H Vaccine |
Pharmsure International Ltd Unit 28, Moorlands Trading Estate, Moor Lane, Metheringham Lincolnshire, LN4 3HX, United Kingdom |
EU/2/11/126 |
2016 5 19 |
|
2016 5 17 |
Proteq West Nile |
Merial 29 avenue Tony Garnier, F-69007 Lyon, France |
EU/2/11/129 |
2016 5 19 |
|
2016 5 26 |
Aivlosin |
ECO Animal Health Ltd 78 Coombe Road, New Malden, Surrey KT3 4QS United Kingdom |
EU/2/04/044 |
2016 5 31 |
— Rinkodaros leidimo atšaukimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 38 straipsnis)
|
Sprendimo data |
Vaisto pavadinimas |
Rinkodaros leidimo turėtojas |
Įrašo numeris Bendrijos vaistų registre |
Pranešimo data |
|
2016 5 26 |
RevitaCAM |
Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/12/138 |
2016 5 30 |
Norintieji susipažinti su nagrinėjamųjų vaistų vieša vertinimo ataskaita ir su ja susijusiais sprendimais, gali kreiptis į:
|
European Medicines Agency |
|
30 Churchill Place |
|
Canary Wharf |
|
London E14 5EU |
|
United Kingdom |
(1) OL L 136, 2004 4 30, p. 1.