ISSN 1977-0987
Il-Ġurnal Uffiċjali
tal-Unjoni Ewropea
C 439
Edizzjoni bil-Malti
Informazzjoni u Avviżi
Volum 58
30 ta' Diċembru 2015
|
ISSN 1977-0987 |
||
|
Il-Ġurnal Uffiċjali tal-Unjoni Ewropea |
C 439 |
|
|
|
||
|
Edizzjoni bil-Malti |
Informazzjoni u Avviżi |
Volum 58 |
|
Avviż Nru |
Werrej |
Paġna |
|
|
IV Informazzjoni |
|
|
|
INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA |
|
|
|
Il-Kummissjoni Ewropea |
|
|
2015/C 439/01 |
||
|
2015/C 439/02 |
|
MT |
|
IV Informazzjoni
INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA
Il-Kummissjoni Ewropea
|
30.12.2015 |
MT |
Il-Ġurnal Uffiċjali tal-Unjoni Ewropea |
C 439/1 |
Sommarju ta’ deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Novembru 2015 sat-30 ta’ Novembru 2015
(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill (1))
(2015/C 439/01)
— 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 |
|
9.11.2015 |
Edistride |
dapagliflozin |
AstraZeneca AB SE-151 85 Södertälje, Sverige |
EU/1/15/1052 |
Pillola miksija b’rita |
A10BX09 |
12.11.2015 |
|
11.11.2015 |
Obizur |
Susoctocog alfa |
Baxalta Innovations GmbH Industriestrasse 67, A-1221 Vienna, Österreich |
EU/1/15/1035 |
Trab u solvent għal soluzzjoni għall-injezzjoni |
B02BD14 |
13.11.2015 |
|
16.11.2015 |
Aripiprazole Accord |
aripiprazole |
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
EU/1/15/1045 |
Pillola |
N05AX12 |
19.11.2015 |
|
16.11.2015 |
Ebymect |
dapagliflozin/metformin |
AstraZeneca AB SE-151 85 Södertälje, Sverige |
EU/1/15/1051 |
Pillola miksija b’rita |
A10BD15 |
18.11.2015 |
|
16.11.2015 |
Votubia |
Everolimus |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/11/710 |
Pillola |
L01XE10 |
23.11.2015 |
|
19.11.2015 |
Cinacalcet Mylan |
cinacalcet |
Mylan S.A.S 117 allée des Parcs, F-69800 Saint Priest, France |
EU/1/15/1054 |
Pillola miksija b’rita |
H05BX01 |
23.11.2015 |
|
19.11.2015 |
Elocta |
efmoroctocog alfa |
Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom |
EU/1/15/1046 |
Trab u solvent għal soluzzjoni għall-injezzjoni |
Pending |
23.11.2015 |
|
19.11.2015 |
Entresto |
sacubitril/valsartan |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/15/1058 |
Pillola miksija b’rita |
C09DX04 |
23.11.2015 |
|
19.11.2015 |
Genvoya |
elvitegraviras/kobicistatas/emtricitabinas/tenofoviro alafenamidas |
Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom |
EU/1/15/1061 |
Pillola miksija b’rita |
J05AR18 |
23.11.2015 |
|
19.11.2015 |
IONSYS |
fentanyl |
Incline Therapeutics Europe Ltd 21 St. Thomas Street, Bristol, BS1 6JS, United Kingdom |
EU/1/15/1050 |
Sistema li tgħaddi l-mediċina minn ġol-ġilda |
N02AB03 |
23.11.2015 |
|
19.11.2015 |
Kyprolis |
carfilzomib |
Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland |
EU/1/15/1060 |
Trab għal soluzzjoni għall-infużjoni |
L01XX45 |
23.11.2015 |
|
19.11.2015 |
Numient |
levodopa/carbidopa |
Impax Laboratories (Netherlands) BV WTC Schiphol Airport Schiphol Boulevard 231, 1118 BH Amsterdam Schiphol, Nederland |
EU/1/15/1044 |
Kapsula li terħi il-mediċina b’mod modifikat, iebsa |
N04BA02 |
23.11.2015 |
|
19.11.2015 |
Orkambi |
Lumacaftor/ivacaftor |
Vertex Pharmaceuticals (Europe) Limited 2 Kingdom Street, London W2 6BD, United Kingdom |
EU/1/15/1059 |
Pillola miksija b’rita |
R07AX30 |
24.11.2015 |
|
20.11.2015 |
Cotellic |
cobimetinib |
Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
EU/1/15/1048 |
Pillola miksija b’rita |
Pending |
24.11.2015 |
|
20.11.2015 |
Kolbam |
Aċidu koliku |
Retrophin Europe Limited 25/28 North Wall Quay, Dublin 1, Ireland |
EU/1/13/895 |
Kapsula, iebsa |
A05AA03 |
24.11.2015 |
|
20.11.2015 |
Pemetrexed Hospira |
pemetrexed |
Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom |
EU/1/15/1057 |
Trab għal konċentrat għal soluzzjoni għall-infużjoni |
L01BA04 |
24.11.2015 |
|
20.11.2015 |
Praxbind |
idarucizumab |
Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland |
EU/1/15/1056 |
Trab u solvent għal soluzzjoni għall-injezzjoni/infużjoni |
V03AB |
24.11.2015 |
|
23.11.2015 |
Blincyto |
blinatumomab |
Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland |
EU/1/15/1047 |
Trab għal konċentrat għal soluzzjoni għall-infużjoni |
L01XC19 |
25.11.2015 |
|
27.11.2015 |
Pemetrexed medac |
pemetrexed |
medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6, D-22880 Wedel, Deutschland |
EU/1/15/1038 |
Trab għal konċentrat għal soluzzjoni għall-infużjoni |
L01BA04 |
1.12.2015 |
|
27.11.2015 |
Ravicti |
Glycerol phenylbutyrate |
Horizon Therapeutics Limited 90 Long Acre, Covent Garden, London WC2E 9RZ, United Kingdom |
EU/1/15/1062 |
Likwidu Orali |
A16AX09 |
1.12.2015 |
— 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 |
|
3.11.2015 |
Dexdor |
Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi |
EU/1/11/718 |
5.11.2015 |
|
3.11.2015 |
Ventavis |
Bayer Pharma AG D-13342 Berlin, Deutschland |
EU/1/03/255 |
5.11.2015 |
|
6.11.2015 |
Relvar Ellipta |
Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
EU/1/13/886 |
10.11.2015 |
|
6.11.2015 |
Vedrop |
Orphan Europe S.A.R.L. Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France |
EU/1/09/533 |
10.11.2015 |
|
10.11.2015 |
InductOs |
Medtronic BioPharma B.V. Earl Bakkenstraat 10, NL-6422 PJ Heerlen, Nederland |
EU/1/02/226 |
12.11.2015 |
|
11.11.2015 |
Aranesp |
Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland |
EU/1/01/185 |
13.11.2015 |
|
11.11.2015 |
Comtan |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/98/081 |
13.11.2015 |
|
11.11.2015 |
Nplate |
Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland |
EU/1/08/497 |
13.11.2015 |
|
11.11.2015 |
Revestive |
NPS Pharma Holdings Limited 5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland |
EU/1/12/787 |
13.11.2015 |
|
11.11.2015 |
Ristfor |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/10/620 |
13.11.2015 |
|
16.11.2015 |
Imatinib Accord |
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
EU/1/13/845 |
18.11.2015 |
|
16.11.2015 |
Kalydeco |
Vertex Pharmaceuticals (Europe) Limited 2 Kingdom Street, London W2 6BD, United Kingdom |
EU/1/12/782 |
19.11.2015 |
|
16.11.2015 |
Suboxone |
Indivior UK Limited 103-105 Bath Road, Slough, Berkshire, SL1 3UH, United Kingdom |
EU/1/06/359 |
18.11.2015 |
|
19.11.2015 |
ADCETRIS |
Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark |
EU/1/12/794 |
23.11.2015 |
|
19.11.2015 |
Alimta |
Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland |
EU/1/04/290 |
23.11.2015 |
|
19.11.2015 |
Carbaglu |
Orphan Europe S.A.R.L. Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France |
EU/1/02/246 |
23.11.2015 |
|
19.11.2015 |
Colobreathe |
Forest Laboratories UK Ltd. Whiddon Valley Barnstaple, North Devon, EX32 8NS, United Kingdom |
EU/1/11/747 |
23.11.2015 |
|
19.11.2015 |
Cosentyx |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/14/980 |
23.11.2015 |
|
19.11.2015 |
Cubicin |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/05/328 |
23.11.2015 |
|
19.11.2015 |
Cystadane |
Orphan Europe S.A.R.L. Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France |
EU/1/06/379 |
23.11.2015 |
|
19.11.2015 |
Entacapone Teva |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/10/665 |
23.11.2015 |
|
19.11.2015 |
Exelon |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/98/066 |
23.11.2015 |
|
19.11.2015 |
GILENYA |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/11/677 |
23.11.2015 |
|
19.11.2015 |
HALAVEN |
Eisai Europe Limited European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom |
EU/1/11/678 |
23.11.2015 |
|
19.11.2015 |
Humira |
AbbVie Ltd Maidenhead, SL6 4UB, United Kingdom |
EU/1/03/256 |
23.11.2015 |
|
19.11.2015 |
Ifirmacombi |
Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija |
EU/1/11/673 |
23.11.2015 |
|
19.11.2015 |
Imnovid |
Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom |
EU/1/13/850 |
23.11.2015 |
|
19.11.2015 |
Isentress |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/07/436 |
23.11.2015 |
|
19.11.2015 |
JEVTANA |
Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France |
EU/1/11/676 |
23.11.2015 |
|
19.11.2015 |
Krystexxa |
Crealta Pharmaceuticals Ireland Limited Commercial House, Millbank Business Park, Lower Lucan Road, Lucan, Co.Dublin, Ireland |
EU/1/12/810 |
23.11.2015 |
|
19.11.2015 |
Lamivudine/Zidovudine Teva |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/10/663 |
23.11.2015 |
|
19.11.2015 |
Macugen |
PharmaSwiss Česká republika s.r.o. Jankovcova 1569/2c 17000 Praha 7 Česká republika |
EU/1/05/325 |
24.11.2015 |
|
19.11.2015 |
Mirvaso |
Galderma International Tour Europlaza, 20 avenue André Prothin, La Défense 4, La Défense Cedex 92927, France |
EU/1/13/904 |
23.11.2015 |
|
19.11.2015 |
NovoNorm |
Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark |
EU/1/98/076 |
23.11.2015 |
|
19.11.2015 |
Optimark |
Mallinckrodt Deutschland GmbH Josef-Dietzgen-Strasse 1, D-53773 Hennef, Deutschland |
EU/1/07/398 |
23.11.2015 |
|
19.11.2015 |
Prandin |
Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark |
EU/1/00/162 |
23.11.2015 |
|
19.11.2015 |
Prometax |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/98/092 |
23.11.2015 |
|
19.11.2015 |
Ranexa |
Menarini International Operations Lussemburgu S.A. 1 avenue de la Gare, L-1611 Lussemburgu, Grand-Duché de Lussemburgu |
EU/1/08/462 |
23.11.2015 |
|
19.11.2015 |
Simulect |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/98/084 |
23.11.2015 |
|
19.11.2015 |
Teysuno |
Nordic Group B.V. Siriusdreef 22, NL-2132 WT Hoofddorp, Nederland |
EU/1/11/669 |
23.11.2015 |
|
19.11.2015 |
Thalidomide Celgene |
Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom |
EU/1/08/443 |
23.11.2015 |
|
19.11.2015 |
Thymanax |
Servier (Ireland) Industries Limited Gorey Road, Arklow, Co. Wicklow, Ireland |
EU/1/08/498 |
23.11.2015 |
|
19.11.2015 |
Valdoxan |
Les Laboratoires Servier 50 rue Carnot, F-92284 Suresnes CEDEX, France |
EU/1/08/499 |
23.11.2015 |
|
19.11.2015 |
Vfend |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/02/212 |
23.11.2015 |
|
19.11.2015 |
XALKORI |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/12/793 |
23.11.2015 |
|
19.11.2015 |
Xenical |
Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
EU/1/98/071 |
23.11.2015 |
|
20.11.2015 |
EDURANT |
Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België |
EU/1/11/736 |
24.11.2015 |
|
20.11.2015 |
Volibris |
Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
EU/1/08/451 |
25.11.2015 |
|
23.11.2015 |
alli |
Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
EU/1/07/401 |
25.11.2015 |
|
23.11.2015 |
Bosulif |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/13/818 |
25.11.2015 |
|
23.11.2015 |
GILENYA |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/11/677 |
25.11.2015 |
|
23.11.2015 |
XALKORI |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/12/793 |
25.11.2015 |
|
23.11.2015 |
Xiapex |
Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm, Sverige |
EU/1/11/671 |
25.11.2015 |
|
27.11.2015 |
CellCept |
Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
EU/1/96/005 |
1.12.2015 |
|
27.11.2015 |
Iclusig |
ARIAD Pharma Ltd Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom |
EU/1/13/839 |
1.12.2015 |
|
27.11.2015 |
Pandemic influenza vaccine H5N1 BAXTER |
Nanotherapeutics Bohumil, s.r.o. Bohumil 138, 28163 Jevany, Česká republika |
EU/1/09/571 |
1.12.2015 |
|
27.11.2015 |
Quinsair |
Raptor Pharmaceuticals Europe BV Naritaweg 165, NL-1043 BW Amsterdam, Nederland |
EU/1/14/973 |
1.12.2015 |
|
27.11.2015 |
Rapamune |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/01/171 |
2.12.2015 |
|
27.11.2015 |
Revinty Ellipta |
Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
EU/1/14/929 |
1.12.2015 |
|
27.11.2015 |
Rivastigmine HEXAL |
Hexal AG Industriestrasse 25, D-83607 Holzkirchen, Deutschland |
EU/1/09/589 |
30.11.2015 |
|
27.11.2015 |
Rivastigmine Sandoz |
Sandoz GmbH Biochemiestrasse 10, A-6250 Kundl, Österreich |
EU/1/09/599 |
2.12.2015 |
|
27.11.2015 |
Xtandi |
Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland |
EU/1/13/846 |
1.12.2015 |
|
30.11.2015 |
Celvapan |
Nanotherapeutics Bohumil, s.r.o. Bohumil 138, 28163 Jevany, Česká republika |
EU/1/08/506 |
2.12.2015 |
|
30.11.2015 |
Rivastigmine 1 A Pharma |
1 A Pharma GmbH Keltenring 1 + 3, D-82041 Oberhaching, Deutschland |
EU/1/09/585 |
2.12.2015 |
|
30.11.2015 |
Vepacel |
Nanotherapeutics Bohumil, s.r.o. Bohumil 138, 28163 Jevany, Česká republika |
EU/1/12/752 |
2.12.2015 |
— 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 |
|
30.11.2015 |
Nivolumab BMS |
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |
EU/1/15/1026 |
2.12.2015 |
— Sospensjoni ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 20 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 |
|
20.11.2015 |
InductOs |
Medtronic BioPharma B.V. Earl Bakkenstraat 10, NL-6422 PJ Heerlen, Nederland |
EU/1/02/226 |
24.11.2015 |
— Ħruġ 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 |
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 |
|
6.11.2015 |
Simparica |
sarolaner |
Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/15/191 |
Pilloli li tomgħodhom |
QP53BX06 |
10.11.2015 |
|
6.11.2015 |
Suvaxyn Circo + MH RTU |
Vaċċin (inattivat) tal-porcine circovirus u porcine enzootic pneumonia |
Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/15/190 |
Emulsjoni għall-injezzjoni |
QI09AL |
10.11.2015 |
|
6.11.2015 |
Zycortal |
desoxycortone |
Dechra Limited Snaygill Industrial Estate, Keighley Road, Skipton, North Yorkshire BD23 2RW, United Kingdom |
EU/2/15/189 |
Suspensjoni għall-injezzjoni |
QH02AA03 |
10.11.2015 |
— 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 |
|
6.11.2015 |
Hiprabovis IBR Marker Live |
Laboratorios Hipra, S.A. Avda. La Selva, 135, E-17170- Amer (Girona), España |
EU/2/10/114 |
10.11.2015 |
|
9.11.2015 |
Nobivac Bb |
Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland |
EU/2/02/034 |
11.11.2015 |
|
19.11.2015 |
Zolvix |
Novartis Healthcare A/S Edvard Thomsens Vej 14, DK-2300 København S, Danmark |
EU/2/09/101 |
23.11.2015 |
|
20.11.2015 |
Leucofeligen FeLV/RCP |
Virbac 1ère Avenue – 2065 m – L.I.D., F-06516 Carros CEDEX, France |
EU/2/09/097 |
24.11.2015 |
|
27.11.2015 |
Leucogen |
Virbac 1ère Avenue – 2065 m – L.I.D., F-06516 Carros CEDEX, France |
EU/2/09/096 |
1.12.2015 |
Kull min jixtieq jikkonsulta r-rapport ta’ evalwazzjoni pubblika dwar il-prodotti mediċinali kkonċernati u d-deċiżjonijiet marbuta magħhom għandu jikkuntattja lil:
|
The European Medicines Agency |
|
7, Westferry Circus, Canary Wharf |
|
UK – LONDON E14 4H |
|
30.12.2015 |
MT |
Il-Ġurnal Uffiċjali tal-Unjoni Ewropea |
C 439/12 |
Sommarju ta’ deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Novembru 2015 sat-30 ta’ Novembru 2015
(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE (1) jew l-Artikolu 38 tad-Direttiva 2001/82/KE (2))
(2015/C 439/02)
— Ħruġ, manteniment jew modifika ta’ awtorizzazzjoni għat-tqegħid fis-suq
|
Data tad-deċiżjoni |
Isem/Ismijiet tal-prodott mediċinali |
INN (Denominazzjoni Internazzjonali Komuni) |
Detentur(i) tal-awtorizzazzjoni għat-tqegħid fis-suq |
Stat Membru kkonċernat |
Data ta’ notifika |
|
27.11.2015 |
Repaglinide |
repaglinide |
Mhux applikabbli |
Mhux applikabbli |
30.11.2015 |
|
23.11.2015 |
Orlistat |
Orlistat |
Mhux applikabbli |
Mhux applikabbli |
24.11.2015 |
|
20.11.2015 |
Rivastigmine |
Rivastigmine |
Mhux applikabbli |
Mhux applikabbli |
24.11.2015 |
(1) ĠU L 311, 28.11.01, p. 67.