ISSN 1977-0987
Il-Ġurnal Uffiċjali
tal-Unjoni Ewropea
C 465
Edizzjoni bil-Malti
Informazzjoni u Avviżi
Volum 61
27 ta' Diċembru 2018
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ISSN 1977-0987 |
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Il-Ġurnal Uffiċjali tal-Unjoni Ewropea |
C 465 |
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Edizzjoni bil-Malti |
Informazzjoni u Avviżi |
Volum 61 |
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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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2018/C 465/01 |
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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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27.12.2018 |
MT |
Il-Ġurnal Uffiċjali tal-Unjoni Ewropea |
C 465/1 |
Sommarju ta’ deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali minn 1 November 2018 sa 30 November 2018
(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill (1))
(2018/C 465/01)
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— |
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 |
|
14.11.2018 |
Emgality |
galcanezumab |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
EU/1/18/1330 |
Soluzzjoni għall-injezzjoni |
N02CX08 |
16.11.2018 |
|
20.11.2018 |
Apealea |
paclitaxel |
Oasmia Pharmaceutical AB Vallongatan 1, 75228 Uppsala, Sverige |
EU/1/18/1292 |
Trab għal soluzzjoni għall-infużjoni |
L01CD01 |
22.11.2018 |
|
20.11.2018 |
Buvidal |
buprenorphine |
Camurus AB Ideon Science Park, 223 70 Lund, Sverige |
EU/1/18/1336 |
Soluzzjoni li terħi l-mediċina fuq tul ta’ żmien għall-injezzjoni |
N07BC01 |
22.11.2018 |
|
20.11.2018 |
Fulphila |
pegfilgrastim |
Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France |
EU/1/18/1329 |
Soluzzjoni għall-injezzjoni |
L03AA13 |
22.11.2018 |
|
20.11.2018 |
Pelmeg |
pegfilgrastim |
Cinfa Biotech S.L. Travesía de Roncesvalles 1, 31699 Olloki (Navarra), España |
EU/1/18/1328 |
Soluzzjoni għall-injezzjoni |
L03AA13 |
22.11.2018 |
|
20.11.2018 |
Vabomere |
meropenem/vaborbactam |
Rempex London Limited 115L Milton Park, Abingdon, Oxfordshire, OX14 4SA United Kingdom |
EU/1/18/1334 |
Trab għal konċentrat għal soluzzjoni għall-infużjoni |
J01DH52 |
22.11.2018 |
|
20.11.2018 |
Venclyxto |
venetoclax |
AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland |
EU/1/16/1138 |
Pillola miksija b’rita |
L01XX52 |
22.11.2018 |
|
22.11.2018 |
Alunbrig |
brigatinib |
Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark |
EU/1/18/1264 |
Pillola miksija b’rita |
L01XE43 |
26.11.2018 |
|
22.11.2018 |
Delstrigo |
doravirine/lamivudine/tenofovir disoproxil |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/18/1333 |
Pillola miksija b’rita |
J05AG24 |
26.11.2018 |
|
22.11.2018 |
Jivi |
damoctocog alfa pegol |
Bayer AG D-51368 Leverkusen, Deutschland |
EU/1/18/1324 |
Trab u solvent għal soluzzjoni għall-injezzjoni |
B02BD02 |
26.11.2018 |
|
22.11.2018 |
Luxturna |
voretigene neparvovec |
Spark Therapeutics Ireland Ltd Studio G3,The Tower, Trinity Technology & Enterprise Campus, Pearse Street, Dublin 2, Ireland |
EU/1/18/1331 |
Konċentrat u solvent għal soluzzjoni għal injezzjoni |
Pending |
5.12.2018 |
|
22.11.2018 |
Pifeltro |
doravirine |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/18/1332 |
Pillola miksija b’rita |
J05AG06 |
27.11.2018 |
|
22.11.2018 |
Poteligeo |
Mogamulizumab |
Kyowa Kirin Holdings B.V. Bloemlaan 2, 2132 NP Hoofddorp, Nederland |
EU/1/18/1335 |
Konċentrat għal soluzzjoni għal infużjoni |
L01XC25 |
26.11.2018 |
|
22.11.2018 |
TAKHZYRO |
lanadelumab |
Shire Pharmaceuticals Ireland Limited Block 2 & 3 Miesian Plaza, 50 – 58 Baggot Street Lower, Dublin 2, IRELAND |
EU/1/18/1340 |
Soluzzjoni għall-injezzjoni |
B06AC05 |
26.11.2018 |
|
22.11.2018 |
Ziextenzo |
pegfilgrastimas |
Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich |
EU/1/18/1327 |
Soluzzjoni għall-injezzjoni |
L03AA13 |
26.11.2018 |
|
— |
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 |
|
8.11.2018 |
Benepali |
Samsung Bioepis NL B.V. Olof Palmestraat 10, 2616 LR Delft, Nederland |
EU/1/15/1074 |
13.11.2018 |
|
8.11.2018 |
Benepali |
Samsung Bioepis NL B.V. Olof Palmestraat 10, 2616 LR Delft, Nederland |
EU/1/15/1074 |
15.11.2018 |
|
8.11.2018 |
Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva |
Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika |
EU/1/17/1210 |
12.11.2018 |
|
8.11.2018 |
Flixabi |
Samsung Bioepis NL B.V. Olof Palmestraat 10, 2616 LR Delft, Nederland |
EU/1/16/1106 |
15.11.2018 |
|
8.11.2018 |
Irbesartan HCT Zentiva |
Zentiva k.s. U kabelovny 130, 102 37 Praha 10, Česká republika |
EU/1/06/377 |
12.11.2018 |
|
8.11.2018 |
Neupro |
UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België |
EU/1/05/331 |
12.11.2018 |
|
8.11.2018 |
Ontruzant |
Samsung Bioepis NL B.V. Olof Palmestraat 10, 2616 LR Delft, Nederland |
EU/1/17/1241 |
16.11.2018 |
|
8.11.2018 |
Ruconest |
Pharming Group N.V. Darwinweg 24, 2333 CR Leiden, Nederland |
EU/1/10/641 |
12.11.2018 |
|
8.11.2018 |
Spinraza |
Biogen Netherlands B.V. Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland |
EU/1/17/1188 |
12.11.2018 |
|
8.11.2018 |
Tracleer |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/02/220 |
12.11.2018 |
|
8.11.2018 |
Xeljanz |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België |
EU/1/17/1178 |
12.11.2018 |
|
12.11.2018 |
Bemfola |
Gedeon Richter Plc. Gyömrői út 19-21., 1103 Budapest, Magyarország |
EU/1/13/909 |
14.11.2018 |
|
12.11.2018 |
CABOMETYX |
Ipsen Pharma 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France |
EU/1/16/1136 |
14.11.2018 |
|
12.11.2018 |
Clopidogrel ratiopharm |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/14/975 |
14.11.2018 |
|
12.11.2018 |
Desloratadine ratiopharm |
ratiopharm GmbH Graf-Arco-Straße 3, 89079 Ulm, Deutschland |
EU/1/11/746 |
14.11.2018 |
|
12.11.2018 |
Ebymect |
AstraZeneca AB 151 85 Södertälje, Sverige |
EU/1/15/1051 |
14.11.2018 |
|
12.11.2018 |
Edistride |
AstraZeneca AB 151 85 Södertälje, Sverige |
EU/1/15/1052 |
14.11.2018 |
|
12.11.2018 |
Exviera |
AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland |
EU/1/14/983 |
14.11.2018 |
|
12.11.2018 |
Forxiga |
AstraZeneca AB 151 85 Södertälje, Sverige |
EU/1/12/795 |
14.11.2018 |
|
12.11.2018 |
Jinarc |
Otsuka Pharmaceutical Netherlands B.V. Herikerbergweg 292, 1101 CT, Amsterdam, Nederland |
EU/1/15/1000 |
14.11.2018 |
|
12.11.2018 |
Laventair Ellipta |
GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland |
EU/1/14/899 |
14.11.2018 |
|
12.11.2018 |
Olanzapine Mylan |
Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France |
EU/1/08/475 |
7.12.2018 |
|
12.11.2018 |
Xigduo |
AstraZeneca AB 151 85 Södertälje, Sverige |
EU/1/13/900 |
14.11.2018 |
|
14.11.2018 |
Benlysta |
GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland |
EU/1/11/700 |
16.11.2018 |
|
14.11.2018 |
Daptomycin Hospira |
Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom |
EU/1/17/1175 |
16.11.2018 |
|
14.11.2018 |
Incruse Ellipta |
GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland |
EU/1/14/922 |
16.11.2018 |
|
14.11.2018 |
Izba |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/13/905 |
16.11.2018 |
|
14.11.2018 |
Latuda |
Aziende Chimiche Riunite Angelini Francesco – A.C.R.A.F. S.p.A. Viale Amelia 70, 00181 Roma, Italia |
EU/1/14/913 |
16.11.2018 |
|
14.11.2018 |
Laventair Ellipta |
GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland |
EU/1/14/899 |
16.11.2018 |
|
14.11.2018 |
Tecfidera |
Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom |
EU/1/13/837 |
16.11.2018 |
|
20.11.2018 |
Brineura |
BioMarin International Limited Shanbally, Ringaskiddy, County Cork, Ireland |
EU/1/17/1192 |
22.11.2018 |
|
20.11.2018 |
Brintellix |
H. Lundbeck A/S Ottiliavej 9, 2500 Valby, Danmark |
EU/1/13/891 |
22.11.2018 |
|
20.11.2018 |
Emtricitabine/Tenofovir disoproxil Krka |
Krka d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija |
EU/1/16/1151 |
22.11.2018 |
|
20.11.2018 |
Fluenz Tetra |
AstraZeneca AB 151 85 Södertälje, Sverige |
EU/1/13/887 |
22.11.2018 |
|
20.11.2018 |
Incruse Ellipta |
GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland |
EU/1/14/922 |
22.11.2018 |
|
20.11.2018 |
Levetiracetam Hospira |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België |
EU/1/13/889 |
22.11.2018 |
|
20.11.2018 |
Neuraceq |
Life Radiopharma Berlin GmbH Max-Planck-Straße 4, 12489 Berlin, Deutschland |
EU/1/13/906 |
22.11.2018 |
|
20.11.2018 |
NovoSeven |
Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark |
EU/1/96/006 |
22.11.2018 |
|
20.11.2018 |
Orfadin |
Swedish Orphan Biovitrum International AB 112 76 Stockholm, Sverige |
EU/1/04/303 |
23.11.2018 |
|
20.11.2018 |
Ozurdex |
Allergan Pharmaceuticals Ireland Castlebar Road, Westport, County Mayo, Ireland |
EU/1/10/638 |
22.11.2018 |
|
20.11.2018 |
PREZISTA |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/06/380 |
22.11.2018 |
|
20.11.2018 |
Rapiscan |
GE Healthcare AS Nycoveien 1, 0485, Oslo, Norge |
EU/1/10/643 |
22.11.2018 |
|
20.11.2018 |
Rezolsta |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/14/967 |
22.11.2018 |
|
20.11.2018 |
Selincro |
H. Lundbeck A/S Ottiliavej 9, 2500 Valby, Danmark |
EU/1/12/815 |
22.11.2018 |
|
20.11.2018 |
Symtuza |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/17/1225 |
22.11.2018 |
|
20.11.2018 |
Zoledronic acid Accord |
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
EU/1/13/834 |
22.11.2018 |
|
22.11.2018 |
Atripla |
Bristol-Myers Squibb and Gilead Sciences Limited IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland |
EU/1/07/430 |
26.11.2018 |
|
22.11.2018 |
Bexsero |
GlaxoSmithKline Vaccines S.r.l. Via Fiorentina, 1, 53100 Siena, Italia |
EU/1/12/812 |
26.11.2018 |
|
22.11.2018 |
Docetaxel Zentiva |
Zentiva k.s. U kabelovny 130, 102 37 Praha 10, Česká republika |
EU/1/07/384 |
26.11.2018 |
|
22.11.2018 |
Efient |
Daiichi Sankyo Europe GmbH Zielstattstraße 48, 81379 München, Deutschland |
EU/1/08/503 |
26.11.2018 |
|
22.11.2018 |
Erivedge |
Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |
EU/1/13/848 |
26.11.2018 |
|
22.11.2018 |
GILENYA |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/11/677 |
28.11.2018 |
|
22.11.2018 |
Inlyta |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België |
EU/1/12/777 |
26.11.2018 |
|
22.11.2018 |
Ixiaro |
Valneva Austria GmbH Campus Vienna Biocenter 3, 1030 Wien, Österreich |
EU/1/08/501 |
26.11.2018 |
|
22.11.2018 |
Kalydeco |
Vertex Pharmaceuticals (Ireland) Limited 28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland |
EU/1/12/782 |
26.11.2018 |
|
22.11.2018 |
Kentera |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/03/270 |
26.11.2018 |
|
22.11.2018 |
Kyprolis |
Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland |
EU/1/15/1060 |
26.11.2018 |
|
22.11.2018 |
Levetiracetam Hospira |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België |
EU/1/13/889 |
26.11.2018 |
|
22.11.2018 |
Mirvaso |
Galderma International Tour Europlaza, 20 avenue André Prothin, La Défense 4, La Défense Cedex 92927, France |
EU/1/13/904 |
26.11.2018 |
|
22.11.2018 |
Nyxoid |
Mundipharma Corporation (Ireland) Limited Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland |
EU/1/17/1238 |
26.11.2018 |
|
22.11.2018 |
Ranexa |
Menarini International Operations Lussemburgu S.A. 1 avenue de la Gare, 1611 Lussemburgu, Grand-Duché de Lussemburgu |
EU/1/08/462 |
26.11.2018 |
|
22.11.2018 |
Soliris |
Alexion Europe SAS 1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France |
EU/1/07/393 |
27.11.2018 |
|
22.11.2018 |
Synflorix |
GlaxoSmithKline Biologicals S.A. rue de l’Institut 89, 1330 Rixensart, Belgique |
EU/1/09/508 |
26.11.2018 |
|
22.11.2018 |
Viekirax |
AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland |
EU/1/14/982 |
26.11.2018 |
|
22.11.2018 |
Wakix |
Bioprojet Pharma 9 rue Rameau, 75002 Paris, France |
EU/1/15/1068 |
26.11.2018 |
|
22.11.2018 |
Zinforo |
Pfizer Ireland Pharmaceuticals Operations Support Group, Ringaskiddy, County Cork, Ireland |
EU/1/12/785 |
26.11.2018 |
|
26.11.2018 |
alli |
GlaxoSmithKline Dungarvan Limited Knockbrack, Dungarvan, Co. Waterford, Ireland |
EU/1/07/401 |
29.11.2018 |
|
26.11.2018 |
Anoro Ellipta |
Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
EU/1/14/898 |
28.11.2018 |
|
26.11.2018 |
Darunavir Krka d.d. |
Krka d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija |
EU/1/17/1248 |
28.11.2018 |
|
26.11.2018 |
Docetaxel Zentiva |
Zentiva k.s. U kabelovny 130, 102 37 Praha 10, Česká republika |
EU/1/07/384 |
28.11.2018 |
|
26.11.2018 |
Kalydeco |
Vertex Pharmaceuticals (Ireland) Limited 28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland |
EU/1/12/782 |
28.11.2018 |
|
26.11.2018 |
Leflunomide ratiopharm |
ratiopharm GmbH Graf-Arco-Straße 3, 89079 Ulm, Deutschland |
EU/1/10/654 |
28.11.2018 |
|
26.11.2018 |
Orkambi |
Vertex Pharmaceuticals (Ireland) Limited 28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland |
EU/1/15/1059 |
28.11.2018 |
|
26.11.2018 |
PHEBURANE |
Eurocept International BV Trapgans 5, 1244 RL Ankeveen, Nederland |
EU/1/13/822 |
28.11.2018 |
|
26.11.2018 |
Zeffix |
GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland |
EU/1/99/114 |
28.11.2018 |
|
28.11.2018 |
AMGEVITA |
Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland |
EU/1/16/1164 |
30.11.2018 |
|
28.11.2018 |
Pregabalin Zentiva k.s |
Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika |
EU/1/16/1166 |
30.11.2018 |
|
— |
Irtirar ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 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 |
|
12.11.2018 |
Eperzan |
GlaxoSmithKline Trading Services Limited Currabinny, Carrigaline, County Cork, Ireland |
EU/1/13/908 |
14.11.2018 |
|
— |
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 |
|
19.11.2018 |
Osurnia |
Elanco GmbH Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland |
EU/2/14/170 |
21.11.2018 |
|
19.11.2018 |
Rheumocam |
Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, Ireland |
EU/2/07/078 |
21.11.2018 |
|
26.11.2018 |
Econor |
Elanco GmbH Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland |
EU/2/98/010 |
28.11.2018 |
|
26.11.2018 |
Inflacam |
Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, Ireland |
EU/2/11/134 |
29.11.2018 |
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 |