# Il-Ġurnal Uffiċjali C 334/2019

| | ISSN 1977-0987 |
| --- | --- |
| Il-Ġurnal Uffiċjali
  tal-Unjoni Ewropea | C 334 |
| | |
| Edizzjoni bil-Malti | Informazzjoni u Avviżi | Volum 624 ta' Ottubru 2019 |

ISSN 1977-0987

Il-Ġurnal Uffiċjali

tal-Unjoni Ewropea

C 334

Edizzjoni bil-Malti

Informazzjoni u Avviżi

Volum 624 ta' Ottubru 2019

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| Werrej | Paġna |
| --- | --- |
| | IV   Informazzjoni |
| | INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA |
| | Il-Kummissjoni Ewropea |
| 2019/C 334/01 | Sommarju ta’ deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Lulju 2019 sal-31 ta’ Awwissu 2019  (Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill) | 1 |
| | INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA |
| 2019/C 334/02 | Sommarju ta’ deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali minn 1 July 2019 sa 31 August 2019(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE jew l-Artikolu 38 tad-Direttiva 2001/82/KE) | 17 |

Werrej

Paġna

IV   Informazzjoni

INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA

Il-Kummissjoni Ewropea

2019/C 334/01

Sommarju ta’ deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Lulju 2019 sal-31 ta’ Awwissu 2019  (Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill)

(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill)

1

INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA

2019/C 334/02

Sommarju ta’ deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali minn 1 July 2019 sa 31 August 2019(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE jew l-Artikolu 38 tad-Direttiva 2001/82/KE)

(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE jew l-Artikolu 38 tad-Direttiva 2001/82/KE)

17

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| MT | |
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MT

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IV Informazzjoni

INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA

Il-Kummissjoni Ewropea

| 4.10.2019 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 334/1 |
| --- | --- | --- | --- |

4.10.2019

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 334/1

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Sommarju ta’ deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Lulju 2019 sal-31 ta’ Awwissu 2019

(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill
   (1))

(2019/C 334/01)

| — | Ħruġ ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat |
| --- | --- |

—

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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 1.7.2019 | Dovato | dolutegravir/lamivudine | ViiV Healthcare BV
  Huis ter Heideweg 62, 3705 LZ Zeist, Nederland | EU/1/19/1370 | Pillola miksija b’rita | J05AR25 | 3.7.2019 |
| 1.7.2019 | Xromi | hydroxycarbamide | Nova Laboratories Ireland Limited
  3rd Floor, Ulysses House, Foley Street, Dublin 1, D01 W2T2, Ireland | EU/1/19/1366 | Soluzzjoni orali | L01XX05 | 3.7.2019 |
| 2.7.2019 | Ultomiris | Ravulizumab | Alexion Europe SAS
  103-105 Rue Anatole France, 92300 Levallois-Perret, France | EU/1/19/1371 | Konċentrat għal soluzzjoni għal infużjoni | L04AA | 5.7.2019 |
| 25.7.2019 | Cufence | trientine dihydrochloride | Univar BV
  Schouwburgplein 30-34, 3012 CL Rotterdam, Nederland | EU/1/19/1365 | Kapsula, iebsa | A16AX12 | 29.7.2019 |
| 25.7.2019 | LysaKare | arginine/lysine | Advanced Accelerator Applications
  20 rue Diesel, 01630 Saint-Genis-Pouilly, France | EU/1/19/1381 | Soluzzjoni għal infużjoni | V03AF11 | 29.7.2019 |
| 25.7.2019 | Posaconazole Accord | posaconazole | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, Barcelona, 08039 Barcelona, España | EU/1/19/1379 | Pillola gastro-reżistenti | J02AC04 | 30.7.2019 |
| 25.7.2019 | Posaconazole AHCL | posaconazole | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/19/1380 | Suspensjoni Orali | J02AC04 | 29.7.2019 |
| 2.8.2019 | Azacitidine Celgene | azacitidine | Celgene Europe B.V.
  Winthontlaan 6 N, 3526 KV Utrecht, Nederland | EU/1/19/1382 | Trab għal suspensjoni għall-injezzjoni | L01BC07 | 6.8.2019 |
| 23.8.2019 | Giapreza | Aċetattal-anġjotensina II | La Jolla Pharmaceutical II B.V.
  Herengracht 500, 1017 CB Amsterdam, Nederland | EU/1/19/1384 | Konċentrat għal soluzzjoni għal infużjoni | C01CX09 | 27.8.2019 |
| 26.8.2019 | Lacosamide UCB | Lacosamide | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/19/1383 | Mistura Pillola miksija b’rita Soluzzjoni għal infużjoni | N03AX18 | 28.8.2019 |

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

1.7.2019

Dovato

dolutegravir/lamivudine

ViiV Healthcare BV

Huis ter Heideweg 62, 3705 LZ Zeist, Nederland

EU/1/19/1370

Pillola miksija b’rita

J05AR25

3.7.2019

1.7.2019

Xromi

hydroxycarbamide

Nova Laboratories Ireland Limited

3rd Floor, Ulysses House, Foley Street, Dublin 1, D01 W2T2, Ireland

EU/1/19/1366

Soluzzjoni orali

L01XX05

3.7.2019

2.7.2019

Ultomiris

Ravulizumab

Alexion Europe SAS

103-105 Rue Anatole France, 92300 Levallois-Perret, France

EU/1/19/1371

Konċentrat għal soluzzjoni għal infużjoni

L04AA

5.7.2019

25.7.2019

Cufence

trientine dihydrochloride

Univar BV

Schouwburgplein 30-34, 3012 CL Rotterdam, Nederland

EU/1/19/1365

Kapsula, iebsa

A16AX12

29.7.2019

25.7.2019

LysaKare

arginine/lysine

Advanced Accelerator Applications

20 rue Diesel, 01630 Saint-Genis-Pouilly, France

EU/1/19/1381

Soluzzjoni għal infużjoni

V03AF11

29.7.2019

25.7.2019

Posaconazole Accord

posaconazole

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, Barcelona, 08039 Barcelona, España

EU/1/19/1379

Pillola gastro-reżistenti

J02AC04

30.7.2019

25.7.2019

Posaconazole AHCL

posaconazole

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España

EU/1/19/1380

Suspensjoni Orali

J02AC04

29.7.2019

2.8.2019

Azacitidine Celgene

azacitidine

Celgene Europe B.V.

Winthontlaan 6 N, 3526 KV Utrecht, Nederland

EU/1/19/1382

Trab għal suspensjoni għall-injezzjoni

L01BC07

6.8.2019

23.8.2019

Giapreza

Aċetattal-anġjotensina II

La Jolla Pharmaceutical II B.V.

Herengracht 500, 1017 CB Amsterdam, Nederland

EU/1/19/1384

Konċentrat għal soluzzjoni għal infużjoni

C01CX09

27.8.2019

26.8.2019

Lacosamide UCB

Lacosamide

UCB Pharma S.A.

Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België

EU/1/19/1383

Mistura Pillola miksija b’rita Soluzzjoni għal infużjoni

N03AX18

28.8.2019

| — | Ħruġ ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Miċħud |
| --- | --- |

—

Ħruġ ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Miċħud

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Data ta’ notifika |
| --- | --- | --- | --- | --- |
| 11.7.2019 | Cabazitaxel Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | — | 15.7.2019 |
| 8.8.2019 | Doxolipad | TLC Biopharmaceuticals B.V.
  J.H. Oortweg 19, 2333CH Leiden, Netherlands | — | 12.8.2019 |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta’ notifika

11.7.2019

Cabazitaxel Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

—

15.7.2019

8.8.2019

Doxolipad

TLC Biopharmaceuticals B.V.

J.H. Oortweg 19, 2333CH Leiden, Netherlands

—

12.8.2019

| — | Modifika ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat |
| --- | --- |

—

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 |
| --- | --- | --- | --- | --- |
| 1.7.2019 | Benlysta | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/11/700 | 3.7.2019 |
| 1.7.2019 | Cetrotide | Merck Europe B.V.
  Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland | EU/1/99/100 | 3.7.2019 |
| 1.7.2019 | Comtan | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/98/081 | 3.7.2019 |
| 1.7.2019 | Eliquis | Bristol-Myers Squibb/Pfizer EEIG
  Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland | EU/1/11/691 | 3.7.2019 |
| 1.7.2019 | Eviplera | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/11/737 | 3.7.2019 |
| 1.7.2019 | Exviera | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/14/983 | 3.7.2019 |
| 1.7.2019 | Fiasp | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/16/1160 | 3.7.2019 |
| 1.7.2019 | Instanyl | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/09/531 | 3.7.2019 |
| 1.7.2019 | Mimpara | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/04/292 | 3.7.2019 |
| 1.7.2019 | Ravicti | Immedica Pharma AB
  SE-113 29 Stockholm, Sverige | EU/1/15/1062 | 3.7.2019 |
| 1.7.2019 | Symtuza | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/17/1225 | 3.7.2019 |
| 1.7.2019 | Xarelto | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/08/472 | 3.7.2019 |
| 4.7.2019 | Dukoral | Valneva Sweden AB
  105 21 Stockholm, Sverige | EU/1/03/263 | 8.7.2019 |
| 4.7.2019 | IKERVIS | Santen Oy
  Niittyhaankatu 20, 33720 Tampere, Suomi | EU/1/15/990 | 8.7.2019 |
| 4.7.2019 | Kaletra | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/01/172 | 8.7.2019 |
| 4.7.2019 | Nerlynx | Pierre Fabre Médicament
  45, place Abel Gance, 92100 Boulogne-Billancourt, France | EU/1/18/1311 | 9.7.2019 |
| 4.7.2019 | Orphacol | Laboratoires CTRS
  63 rue de l’Est, 92100 Boulogne-Billancourt, France | EU/1/13/870 | 8.7.2019 |
| 4.7.2019 | Prolia | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/10/618 | 8.7.2019 |
| 4.7.2019 | Verkazia | Santen Oy
  Niittyhaankatu 20, 33720 Tampere, Suomi | EU/1/17/1219 | 8.7.2019 |
| 4.7.2019 | Zinforo | Pfizer Ireland Pharmaceuticals
  Operations Support Group, Ringaskiddy, County Cork, Ireland | EU/1/12/785 | 8.7.2019 |
| 8.7.2019 | Emtricitabine/Tenofovir disoproxil Krka d.d. | Krka d. d., Novo mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/17/1182 | 10.7.2019 |
| 8.7.2019 | Hefiya | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/18/1287 | 10.7.2019 |
| 8.7.2019 | Pazenir | ratiopharm GmbH
  Graf-Arco-Straße 3, 89079 Ulm, Deutschland | EU/1/18/1317 | 10.7.2019 |
| 8.7.2019 | Tecentriq | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/17/1220 | 10.7.2019 |
| 8.7.2019 | Tremfya | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/17/1234 | 10.7.2019 |
| 8.7.2019 | Viekirax | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/14/982 | 10.7.2019 |
| 8.7.2019 | Xultophy | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/14/947 | 10.7.2019 |
| 9.7.2019 | Elocta | Swedish Orphan Biovitrum AB (publ)
  112 76 Stockholm, Sverige | EU/1/15/1046 | 11.7.2019 |
| 11.7.2019 | Ammonaps | Immedica Pharma AB
  SE-113 29 Stockholm, Sverige | EU/1/99/120 | 15.7.2019 |
| 11.7.2019 | Defitelio | Gentium S.r.I.
  Piazza XX Settembre, 2, 22079 Villa Guardia (CO), Italia | EU/1/13/878 | 15.7.2019 |
| 11.7.2019 | Gliolan | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstraße 6, 22880 Wedel, Deutschland | EU/1/07/413 | 15.7.2019 |
| 11.7.2019 | Halimatoz | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/18/1288 | 15.7.2019 |
| 11.7.2019 | Tasigna | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/07/422 | 15.7.2019 |
| 18.7.2019 | Jentadueto | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/12/780 | 29.7.2019 |
| 18.7.2019 | Myocet | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/00/141 | 22.7.2019 |
| 18.7.2019 | Norvir | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/96/016 | 22.7.2019 |
| 18.7.2019 | Xadago | Zambon S.p.A.
  Via Lillo del Duca 10, 20091 Bresso (MI), Italia | EU/1/14/984 | 22.7.2019 |
| 18.7.2019 | Xyrem | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/05/312 | 22.7.2019 |
| 19.7.2019 | Besponsa | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/17/1200 | 23.7.2019 |
| 19.7.2019 | Colobreathe | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/11/747 | 23.7.2019 |
| 19.7.2019 | Edistride | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/15/1052 | 23.7.2019 |
| 19.7.2019 | Exjade | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/06/356 | 23.7.2019 |
| 19.7.2019 | HyQvia | Baxalta Innovations GmbH
  Industriestraße 67, 1221 Wien, Österreich | EU/1/13/840 | 23.7.2019 |
| 19.7.2019 | Incruse Ellipta | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/14/922 | 23.7.2019 |
| 19.7.2019 | Lartruvo | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/16/1143 | 23.7.2019 |
| 19.7.2019 | Truvada | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/04/305 | 23.7.2019 |
| 19.7.2019 | Truxima | Celltrion Healthcare Hungary Kft.
  Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország | EU/1/16/1167 | 23.7.2019 |
| 25.7.2019 | Abasaglar | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/14/944 | 29.7.2019 |
| 25.7.2019 | Abraxane | Celgene Europe B.V.
  Winthontlaan 6 N, 3526 KV Utrecht, Nederland | EU/1/07/428 | 29.7.2019 |
| 25.7.2019 | Anoro Ellipta | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/14/898 | 29.7.2019 |
| 25.7.2019 | Blitzima | Celltrion Healthcare Hungary Kft.
  Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország | EU/1/17/1205 | 29.7.2019 |
| 25.7.2019 | Corbilta | Orion Corporation
  Orionintie 1, 02200 Espoo, Suomi | EU/1/13/859 | 29.7.2019 |
| 25.7.2019 | Deltyba | Otsuka Novel Products GmbH
  Erika-Mann-Straße 21, 80636 München, Deutschland | EU/1/13/875 | 29.7.2019 |
| 25.7.2019 | Edistride | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/15/1052 | 29.7.2019 |
| 25.7.2019 | Forxiga | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/12/795 | 29.7.2019 |
| 25.7.2019 | Gardasil 9 | MSD VACCINS
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/15/1007 | 29.7.2019 |
| 25.7.2019 | Genvoya | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/15/1061 | 29.7.2019 |
| 25.7.2019 | Hepsera | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/03/251 | 29.7.2019 |
| 25.7.2019 | Herceptin | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/00/145 | 29.7.2019 |
| 25.7.2019 | KANJINTI | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/18/1281 | 29.7.2019 |
| 25.7.2019 | Lixiana | Daiichi Sankyo Europe GmbH
  Zielstattstraße 48, 81379 München, Deutschland | EU/1/15/993 | 29.7.2019 |
| 25.7.2019 | Maviret | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/17/1213 | 29.7.2019 |
| 25.7.2019 | NexoBrid | MediWound Germany GmbH
  Eisenstraße 5, 65428 Ruesselsheim, Deutschland | EU/1/12/803 | 29.7.2019 |
| 25.7.2019 | Ofev | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/14/979 | 29.7.2019 |
| 25.7.2019 | Ontruzant | Samsung Bioepis NL B.V.
  Olof Palmestraat 10, 2616 LR Delft, Nederland | EU/1/17/1241 | 29.7.2019 |
| 25.7.2019 | Ritemvia | Celltrion Healthcare Hungary Kft.
  Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország | EU/1/17/1207 | 29.7.2019 |
| 25.7.2019 | Rolufta Ellipta | GlaxoSmithKline Trading Services Limited
  Currabinny, Carrigaline, County Cork, Ireland | EU/1/17/1174 | 29.7.2019 |
| 25.7.2019 | Roteas | Daiichi Sankyo Europe GmbH
  Zielstattstraße 48, 81379 München, Deutschland | EU/1/16/1152 | 29.7.2019 |
| 25.7.2019 | Telmisartan Teva Pharma | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/11/719 | 29.7.2019 |
| 25.7.2019 | Temozolomide SUN | Sun Pharmaceutical Industries Europe BV
  Polarisavenue 87, 2132 JH Hoofddorp, Nederland | EU/1/11/697 | 29.7.2019 |
| 25.7.2019 | Translarna | PTC Therapeutics International Limited
  5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland | EU/1/13/902 | 29.7.2019 |
| 25.7.2019 | Uptravi | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/15/1083 | 29.7.2019 |
| 25.7.2019 | Visudyne | CHEPLAPHARM Arzneimittel GmbH
  Ziegelhof 24, 17489 Greifswald, Deutschland | EU/1/00/140 | 29.7.2019 |
| 25.7.2019 | Vizamyl | GE Healthcare AS
  Nycoveien 1, 0485, Oslo, Norge | EU/1/14/941 | 29.7.2019 |
| 25.7.2019 | Xigduo | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/13/900 | 29.7.2019 |
| 25.7.2019 | Zalmoxis | MolMed S.p.A.
  Via Olgettina 58, 20132 Milano, Italia | EU/1/16/1121 | 29.7.2019 |
| 25.7.2019 | Zinforo | Pfizer Ireland Pharmaceuticals
  Operations Support Group, Ringaskiddy, County Cork, Ireland | EU/1/12/785 | 29.7.2019 |
| 25.7.2019 | Zometa | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/01/176 | 29.7.2019 |
| 31.7.2019 | Aclasta | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/05/308 | 2.8.2019 |
| 31.7.2019 | Adenuric | Menarini International Operations Lussemburgu S.A.
  1 avenue de la Gare, 1611 Lussemburgu, Grand-Duché de Lussemburgu | EU/1/08/447 | 5.8.2019 |
| 31.7.2019 | Adjupanrix | GlaxoSmithKline Biologicals S.A.
  rue de l’Institut 89, 1330 Rixensart, Belgique | EU/1/09/578 | 2.8.2019 |
| 31.7.2019 | Duloxetine Lilly | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/14/972 | 2.8.2019 |
| 31.7.2019 | Fiasp | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/16/1160 | 2.8.2019 |
| 31.7.2019 | Flebogamma DIF | Instituto Grifols, S.A.
  Can Guasch 2, Parets del Vallès, 08150 Barcelona, Espaňa | EU/1/07/404 | 2.8.2019 |
| 31.7.2019 | Forxiga | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/12/795 | 2.8.2019 |
| 31.7.2019 | Inovelon | Eisai GmbH
  Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland | EU/1/06/378 | 2.8.2019 |
| 31.7.2019 | Invirase | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/96/026 | 2.8.2019 |
| 31.7.2019 | Ketoconazole HRA | Laboratoire HRA Pharma
  200 avenue de Paris, 92320 Chatillon, France | EU/1/14/965 | 2.8.2019 |
| 31.7.2019 | Nucala | GlaxoSmithKline Trading Services Limited
  Currabinny, Carrigaline, County Cork, Ireland | EU/1/15/1043 | 2.8.2019 |
| 31.7.2019 | Rezolsta | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/14/967 | 2.8.2019 |
| 31.7.2019 | Stalevo | Orion Corporation
  Orionintie 1, 02200 Espoo, Suomi | EU/1/03/260 | 2.8.2019 |
| 31.7.2019 | Tadalafil Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/14/961 | 2.8.2019 |
| 31.7.2019 | Thalidomide Celgene | Celgene Europe B.V.
  Winthontlaan 6 N, 3526 KV Utrecht, Nederland | EU/1/08/443 | 2.8.2019 |
| 31.7.2019 | Trazimera | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/18/1295 | 2.8.2019 |
| 31.7.2019 | Vargatef | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/14/954 | 2.8.2019 |
| 31.7.2019 | Vimpat | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/08/470 | 2.8.2019 |
| 31.7.2019 | Xydalba | Allergan Pharmaceuticals International Limited
  Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland | EU/1/14/986 | 2.8.2019 |
| 1.8.2019 | Cyramza | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/14/957 | 5.8.2019 |
| 1.8.2019 | Dupixent | Sanofi-Aventis groupe
  54 rue La Boétie, 75008 Paris, France | EU/1/17/1229 | 5.8.2019 |
| 1.8.2019 | Ebymect | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/15/1051 | 5.8.2019 |
| 1.8.2019 | Faslodex | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/03/269 | 5.8.2019 |
| 1.8.2019 | Harvoni | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/14/958 | 6.8.2019 |
| 1.8.2019 | Herzuma | Celltrion Healthcare Hungary Kft.
  Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország | EU/1/17/1257 | 6.8.2019 |
| 1.8.2019 | Hirobriz Breezhaler | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/09/594 | 6.8.2019 |
| 1.8.2019 | Laventair Ellipta | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/14/899 | 6.8.2019 |
| 2.8.2019 | Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/17/1222 | 6.8.2019 |
| 2.8.2019 | IMBRUVICA | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/14/945 | 6.8.2019 |
| 2.8.2019 | JETREA | Oxurion NV
  Gaston Geenslaan 1, 3001 Leuven, België | EU/1/13/819 | 6.8.2019 |
| 2.8.2019 | Praxbind | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/15/1056 | 7.8.2019 |
| 8.8.2019 | InductOs | Medtronic BioPharma B.V.
  Earl Bakkenstraat 10, 6422 PJ Heerlen, Nederland | EU/1/02/226 | 12.8.2019 |
| 8.8.2019 | Levodopa/Carbidopa/Entacapone Orion | Orion Corporation
  Orionintie 1, 02200 Espoo, Suomi | EU/1/11/706 | 12.8.2019 |
| 8.8.2019 | Stivarga | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/13/858 | 12.8.2019 |
| 8.8.2019 | Teysuno | Nordic Group B.V.
  Siriusdreef 22, 2132 WT Hoofddorp, Nederland | EU/1/11/669 | 12.8.2019 |
| 9.8.2019 | Jivi | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/18/1324 | 13.8.2019 |
| 9.8.2019 | Travatan | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/01/199 | 13.8.2019 |
| 9.8.2019 | Truberzi | Allergan Pharmaceuticals International Limited
  Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland | EU/1/16/1126 | 13.8.2019 |
| 9.8.2019 | Victoza | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/09/529 | 13.8.2019 |
| 14.8.2019 | Oslif Breezhaler | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/09/586 | 19.8.2019 |
| 23.8.2019 | Aimovig | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/18/1293 | 27.8.2019 |
| 23.8.2019 | Brimica Genuair | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/14/963 | 27.8.2019 |
| 23.8.2019 | Cinacalcet Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/15/1054 | 27.8.2019 |
| 23.8.2019 | Cometriq | Ipsen Pharma
  65 quai Georges Gorse, 92100 Boulogne-Billancourt, France | EU/1/13/890 | 27.8.2019 |
| 23.8.2019 | Duaklir Genuair | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/14/964 | 27.8.2019 |
| 23.8.2019 | Elmiron | bene-Arzneimittel GmbH
  Herterichstraße 1-3, 81479 München, Deutschland | EU/1/17/1189 | 27.8.2019 |
| 23.8.2019 | Empliciti | Bristol-Myers Squibb Pharma EEIG
  Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland | EU/1/16/1088 | 27.8.2019 |
| 23.8.2019 | Firdapse | BioMarin International Limited
  Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland | EU/1/09/601 | 27.8.2019 |
| 23.8.2019 | Flucelvax Tetra | Seqirus Netherlands B.V.
  Paasheuvelweg 28, 1105BJ Amsterdam, Netherlands | EU/1/18/1326 | 27.8.2019 |
| 23.8.2019 | Fluenz Tetra | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/13/887 | 27.8.2019 |
| 23.8.2019 | Nordimet | Nordic Group B.V.
  Siriusdreef 22, 2132 WT Hoofddorp, Nederland | EU/1/16/1124 | 27.8.2019 |
| 23.8.2019 | Otezla | Celgene Europe B.V.
  Winthontlaan 6 N, 3526 KV Utrecht, Nederland | EU/1/14/981 | 27.8.2019 |
| 23.8.2019 | Ovitrelle | Merck Europe B.V.
  Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland | EU/1/00/165 | 27.8.2019 |
| 23.8.2019 | Renagel | Genzyme Europe B.V.
  Paasheuvelweg 25, 1105 BP Amsterdam, Nederland | EU/1/99/123 | 27.8.2019 |
| 23.8.2019 | Sevelamer carbonate Winthrop | Genzyme Europe B.V.
  Paasheuvelweg 25, 1105 BP Amsterdam, Nederland | EU/1/14/952 | 27.8.2019 |
| 23.8.2019 | Sovaldi | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/13/894 | 27.8.2019 |
| 23.8.2019 | Spinraza | Biogen Netherlands B.V.
  Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland | EU/1/17/1188 | 27.8.2019 |
| 23.8.2019 | Trulicity | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/14/956 | 27.8.2019 |
| 23.8.2019 | Zerbaxa | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/15/1032 | 27.8.2019 |
| 26.8.2019 | Emadine | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/98/095 | 28.8.2019 |
| 26.8.2019 | Imraldi | Samsung Bioepis NL B.V.
  Olof Palmestraat 10, 2616 LR Delft, Nederland | EU/1/17/1216 | 28.8.2019 |
| 26.8.2019 | Jylamvo | Therakind (Europe) Limited
  3 Inn’s Quay, Dublin 7, D07 PW4F, Ireland | EU/1/17/1172 | 28.8.2019 |
| 26.8.2019 | KEYTRUDA | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/15/1024 | 28.8.2019 |
| 26.8.2019 | Levitra | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/03/248 | 28.8.2019 |
| 26.8.2019 | Mycophenolate mofetil Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/07/439 | 28.8.2019 |
| 26.8.2019 | Nevanac | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/07/433 | 28.8.2019 |
| 26.8.2019 | Onbrez Breezhaler | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/09/593 | 28.8.2019 |
| 26.8.2019 | Prasugrel Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/18/1273 | 28.8.2019 |
| 26.8.2019 | PREVYMIS | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/17/1245 | 28.8.2019 |
| 26.8.2019 | Renvela | Genzyme Europe B.V.
  Paasheuvelweg 25, 1105 BP Amsterdam, Nederland | EU/1/09/521 | 28.8.2019 |
| 26.8.2019 | Soliris | Alexion Europe SAS
  103-105 rue Anatole France, 92300 Levallois-Perret, France | EU/1/07/393 | 28.8.2019 |
| 26.8.2019 | TAGRISSO | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/16/1086 | 28.8.2019 |
| 26.8.2019 | Tasmar | Meda AB
  Pipers väg 2 A, 170 09 Solna, Sverige | EU/1/97/044 | 28.8.2019 |
| 26.8.2019 | Tecentriq | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/17/1220 | 28.8.2019 |
| 26.8.2019 | Vargatef | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/14/954 | 28.8.2019 |
| 26.8.2019 | Vivanza | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/03/249 | 28.8.2019 |
| 31.8.2019 | Kisqali | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/17/1221 | 2.8.2019 |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta’ notifika

1.7.2019

Benlysta

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/11/700

3.7.2019

1.7.2019

Cetrotide

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

EU/1/99/100

3.7.2019

1.7.2019

Comtan

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/98/081

3.7.2019

1.7.2019

Eliquis

Bristol-Myers Squibb/Pfizer EEIG

Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland

EU/1/11/691

3.7.2019

1.7.2019

Eviplera

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/11/737

3.7.2019

1.7.2019

Exviera

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/14/983

3.7.2019

1.7.2019

Fiasp

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/16/1160

3.7.2019

1.7.2019

Instanyl

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/09/531

3.7.2019

1.7.2019

Mimpara

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/04/292

3.7.2019

1.7.2019

Ravicti

Immedica Pharma AB

SE-113 29 Stockholm, Sverige

EU/1/15/1062

3.7.2019

1.7.2019

Symtuza

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/17/1225

3.7.2019

1.7.2019

Xarelto

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/08/472

3.7.2019

4.7.2019

Dukoral

Valneva Sweden AB

105 21 Stockholm, Sverige

EU/1/03/263

8.7.2019

4.7.2019

IKERVIS

Santen Oy

Niittyhaankatu 20, 33720 Tampere, Suomi

EU/1/15/990

8.7.2019

4.7.2019

Kaletra

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/01/172

8.7.2019

4.7.2019

Nerlynx

Pierre Fabre Médicament

45, place Abel Gance, 92100 Boulogne-Billancourt, France

EU/1/18/1311

9.7.2019

4.7.2019

Orphacol

Laboratoires CTRS

63 rue de l’Est, 92100 Boulogne-Billancourt, France

EU/1/13/870

8.7.2019

4.7.2019

Prolia

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/10/618

8.7.2019

4.7.2019

Verkazia

Santen Oy

Niittyhaankatu 20, 33720 Tampere, Suomi

EU/1/17/1219

8.7.2019

4.7.2019

Zinforo

Pfizer Ireland Pharmaceuticals

Operations Support Group, Ringaskiddy, County Cork, Ireland

EU/1/12/785

8.7.2019

8.7.2019

Emtricitabine/Tenofovir disoproxil Krka d.d.

Krka d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/17/1182

10.7.2019

8.7.2019

Hefiya

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/18/1287

10.7.2019

8.7.2019

Pazenir

ratiopharm GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

EU/1/18/1317

10.7.2019

8.7.2019

Tecentriq

Roche Registration GmbH

Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland

EU/1/17/1220

10.7.2019

8.7.2019

Tremfya

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/17/1234

10.7.2019

8.7.2019

Viekirax

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/14/982

10.7.2019

8.7.2019

Xultophy

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/14/947

10.7.2019

9.7.2019

Elocta

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

EU/1/15/1046

11.7.2019

11.7.2019

Ammonaps

Immedica Pharma AB

SE-113 29 Stockholm, Sverige

EU/1/99/120

15.7.2019

11.7.2019

Defitelio

Gentium S.r.I.

Piazza XX Settembre, 2, 22079 Villa Guardia (CO), Italia

EU/1/13/878

15.7.2019

11.7.2019

Gliolan

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

EU/1/07/413

15.7.2019

11.7.2019

Halimatoz

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/18/1288

15.7.2019

11.7.2019

Tasigna

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/07/422

15.7.2019

18.7.2019

Jentadueto

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/12/780

29.7.2019

18.7.2019

Myocet

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/00/141

22.7.2019

18.7.2019

Norvir

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/96/016

22.7.2019

18.7.2019

Xadago

Zambon S.p.A.

Via Lillo del Duca 10, 20091 Bresso (MI), Italia

EU/1/14/984

22.7.2019

18.7.2019

Xyrem

UCB Pharma S.A.

Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België

EU/1/05/312

22.7.2019

19.7.2019

Besponsa

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België

EU/1/17/1200

23.7.2019

19.7.2019

Colobreathe

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/747

23.7.2019

19.7.2019

Edistride

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/15/1052

23.7.2019

19.7.2019

Exjade

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/06/356

23.7.2019

19.7.2019

HyQvia

Baxalta Innovations GmbH

Industriestraße 67, 1221 Wien, Österreich

EU/1/13/840

23.7.2019

19.7.2019

Incruse Ellipta

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/14/922

23.7.2019

19.7.2019

Lartruvo

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/16/1143

23.7.2019

19.7.2019

Truvada

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/04/305

23.7.2019

19.7.2019

Truxima

Celltrion Healthcare Hungary Kft.

Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország

EU/1/16/1167

23.7.2019

25.7.2019

Abasaglar

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/14/944

29.7.2019

25.7.2019

Abraxane

Celgene Europe B.V.

Winthontlaan 6 N, 3526 KV Utrecht, Nederland

EU/1/07/428

29.7.2019

25.7.2019

Anoro Ellipta

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/14/898

29.7.2019

25.7.2019

Blitzima

Celltrion Healthcare Hungary Kft.

Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország

EU/1/17/1205

29.7.2019

25.7.2019

Corbilta

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/13/859

29.7.2019

25.7.2019

Deltyba

Otsuka Novel Products GmbH

Erika-Mann-Straße 21, 80636 München, Deutschland

EU/1/13/875

29.7.2019

25.7.2019

Edistride

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/15/1052

29.7.2019

25.7.2019

Forxiga

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/12/795

29.7.2019

25.7.2019

Gardasil 9

MSD VACCINS

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/15/1007

29.7.2019

25.7.2019

Genvoya

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/15/1061

29.7.2019

25.7.2019

Hepsera

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/03/251

29.7.2019

25.7.2019

Herceptin

Roche Registration GmbH

Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland

EU/1/00/145

29.7.2019

25.7.2019

KANJINTI

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/18/1281

29.7.2019

25.7.2019

Lixiana

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/15/993

29.7.2019

25.7.2019

Maviret

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/17/1213

29.7.2019

25.7.2019

NexoBrid

MediWound Germany GmbH

Eisenstraße 5, 65428 Ruesselsheim, Deutschland

EU/1/12/803

29.7.2019

25.7.2019

Ofev

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/14/979

29.7.2019

25.7.2019

Ontruzant

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

EU/1/17/1241

29.7.2019

25.7.2019

Ritemvia

Celltrion Healthcare Hungary Kft.

Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország

EU/1/17/1207

29.7.2019

25.7.2019

Rolufta Ellipta

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

EU/1/17/1174

29.7.2019

25.7.2019

Roteas

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/16/1152

29.7.2019

25.7.2019

Telmisartan Teva Pharma

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/719

29.7.2019

25.7.2019

Temozolomide SUN

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, 2132 JH Hoofddorp, Nederland

EU/1/11/697

29.7.2019

25.7.2019

Translarna

PTC Therapeutics International Limited

5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland

EU/1/13/902

29.7.2019

25.7.2019

Uptravi

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/15/1083

29.7.2019

25.7.2019

Visudyne

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24, 17489 Greifswald, Deutschland

EU/1/00/140

29.7.2019

25.7.2019

Vizamyl

GE Healthcare AS

Nycoveien 1, 0485, Oslo, Norge

EU/1/14/941

29.7.2019

25.7.2019

Xigduo

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/13/900

29.7.2019

25.7.2019

Zalmoxis

MolMed S.p.A.

Via Olgettina 58, 20132 Milano, Italia

EU/1/16/1121

29.7.2019

25.7.2019

Zinforo

Pfizer Ireland Pharmaceuticals

Operations Support Group, Ringaskiddy, County Cork, Ireland

EU/1/12/785

29.7.2019

25.7.2019

Zometa

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/01/176

29.7.2019

31.7.2019

Aclasta

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/05/308

2.8.2019

31.7.2019

Adenuric

Menarini International Operations Lussemburgu S.A.

1 avenue de la Gare, 1611 Lussemburgu, Grand-Duché de Lussemburgu

EU/1/08/447

5.8.2019

31.7.2019

Adjupanrix

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, 1330 Rixensart, Belgique

EU/1/09/578

2.8.2019

31.7.2019

Duloxetine Lilly

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/14/972

2.8.2019

31.7.2019

Fiasp

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/16/1160

2.8.2019

31.7.2019

Flebogamma DIF

Instituto Grifols, S.A.

Can Guasch 2, Parets del Vallès, 08150 Barcelona, Espaňa

EU/1/07/404

2.8.2019

31.7.2019

Forxiga

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/12/795

2.8.2019

31.7.2019

Inovelon

Eisai GmbH

Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland

EU/1/06/378

2.8.2019

31.7.2019

Invirase

Roche Registration GmbH

Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland

EU/1/96/026

2.8.2019

31.7.2019

Ketoconazole HRA

Laboratoire HRA Pharma

200 avenue de Paris, 92320 Chatillon, France

EU/1/14/965

2.8.2019

31.7.2019

Nucala

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

EU/1/15/1043

2.8.2019

31.7.2019

Rezolsta

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/967

2.8.2019

31.7.2019

Stalevo

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/03/260

2.8.2019

31.7.2019

Tadalafil Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/14/961

2.8.2019

31.7.2019

Thalidomide Celgene

Celgene Europe B.V.

Winthontlaan 6 N, 3526 KV Utrecht, Nederland

EU/1/08/443

2.8.2019

31.7.2019

Trazimera

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België

EU/1/18/1295

2.8.2019

31.7.2019

Vargatef

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/14/954

2.8.2019

31.7.2019

Vimpat

UCB Pharma S.A.

Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België

EU/1/08/470

2.8.2019

31.7.2019

Xydalba

Allergan Pharmaceuticals International Limited

Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland

EU/1/14/986

2.8.2019

1.8.2019

Cyramza

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/14/957

5.8.2019

1.8.2019

Dupixent

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/17/1229

5.8.2019

1.8.2019

Ebymect

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/15/1051

5.8.2019

1.8.2019

Faslodex

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/03/269

5.8.2019

1.8.2019

Harvoni

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/14/958

6.8.2019

1.8.2019

Herzuma

Celltrion Healthcare Hungary Kft.

Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország

EU/1/17/1257

6.8.2019

1.8.2019

Hirobriz Breezhaler

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/09/594

6.8.2019

1.8.2019

Laventair Ellipta

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/14/899

6.8.2019

2.8.2019

Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/17/1222

6.8.2019

2.8.2019

IMBRUVICA

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/945

6.8.2019

2.8.2019

JETREA

Oxurion NV

Gaston Geenslaan 1, 3001 Leuven, België

EU/1/13/819

6.8.2019

2.8.2019

Praxbind

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/15/1056

7.8.2019

8.8.2019

InductOs

Medtronic BioPharma B.V.

Earl Bakkenstraat 10, 6422 PJ Heerlen, Nederland

EU/1/02/226

12.8.2019

8.8.2019

Levodopa/Carbidopa/Entacapone Orion

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/11/706

12.8.2019

8.8.2019

Stivarga

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/13/858

12.8.2019

8.8.2019

Teysuno

Nordic Group B.V.

Siriusdreef 22, 2132 WT Hoofddorp, Nederland

EU/1/11/669

12.8.2019

9.8.2019

Jivi

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/18/1324

13.8.2019

9.8.2019

Travatan

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/01/199

13.8.2019

9.8.2019

Truberzi

Allergan Pharmaceuticals International Limited

Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland

EU/1/16/1126

13.8.2019

9.8.2019

Victoza

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/09/529

13.8.2019

14.8.2019

Oslif Breezhaler

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/09/586

19.8.2019

23.8.2019

Aimovig

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/18/1293

27.8.2019

23.8.2019

Brimica Genuair

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/14/963

27.8.2019

23.8.2019

Cinacalcet Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/15/1054

27.8.2019

23.8.2019

Cometriq

Ipsen Pharma

65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/13/890

27.8.2019

23.8.2019

Duaklir Genuair

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/14/964

27.8.2019

23.8.2019

Elmiron

bene-Arzneimittel GmbH

Herterichstraße 1-3, 81479 München, Deutschland

EU/1/17/1189

27.8.2019

23.8.2019

Empliciti

Bristol-Myers Squibb Pharma EEIG

Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland

EU/1/16/1088

27.8.2019

23.8.2019

Firdapse

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland

EU/1/09/601

27.8.2019

23.8.2019

Flucelvax Tetra

Seqirus Netherlands B.V.

Paasheuvelweg 28, 1105BJ Amsterdam, Netherlands

EU/1/18/1326

27.8.2019

23.8.2019

Fluenz Tetra

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/13/887

27.8.2019

23.8.2019

Nordimet

Nordic Group B.V.

Siriusdreef 22, 2132 WT Hoofddorp, Nederland

EU/1/16/1124

27.8.2019

23.8.2019

Otezla

Celgene Europe B.V.

Winthontlaan 6 N, 3526 KV Utrecht, Nederland

EU/1/14/981

27.8.2019

23.8.2019

Ovitrelle

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

EU/1/00/165

27.8.2019

23.8.2019

Renagel

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/99/123

27.8.2019

23.8.2019

Sevelamer carbonate Winthrop

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/14/952

27.8.2019

23.8.2019

Sovaldi

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/13/894

27.8.2019

23.8.2019

Spinraza

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland

EU/1/17/1188

27.8.2019

23.8.2019

Trulicity

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/14/956

27.8.2019

23.8.2019

Zerbaxa

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1032

27.8.2019

26.8.2019

Emadine

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/98/095

28.8.2019

26.8.2019

Imraldi

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

EU/1/17/1216

28.8.2019

26.8.2019

Jylamvo

Therakind (Europe) Limited

3 Inn’s Quay, Dublin 7, D07 PW4F, Ireland

EU/1/17/1172

28.8.2019

26.8.2019

KEYTRUDA

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1024

28.8.2019

26.8.2019

Levitra

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/03/248

28.8.2019

26.8.2019

Mycophenolate mofetil Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/07/439

28.8.2019

26.8.2019

Nevanac

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/07/433

28.8.2019

26.8.2019

Onbrez Breezhaler

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/09/593

28.8.2019

26.8.2019

Prasugrel Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/18/1273

28.8.2019

26.8.2019

PREVYMIS

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/17/1245

28.8.2019

26.8.2019

Renvela

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/09/521

28.8.2019

26.8.2019

Soliris

Alexion Europe SAS

103-105 rue Anatole France, 92300 Levallois-Perret, France

EU/1/07/393

28.8.2019

26.8.2019

TAGRISSO

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/16/1086

28.8.2019

26.8.2019

Tasmar

Meda AB

Pipers väg 2 A, 170 09 Solna, Sverige

EU/1/97/044

28.8.2019

26.8.2019

Tecentriq

Roche Registration GmbH

Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland

EU/1/17/1220

28.8.2019

26.8.2019

Vargatef

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/14/954

28.8.2019

26.8.2019

Vivanza

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/03/249

28.8.2019

31.8.2019

Kisqali

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/17/1221

2.8.2019

| — | Ħruġ ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat |
| --- | --- |

—

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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 19.7.2019 | EVICTO | selamektin | VIRBAC
  1ère avenue – 2065 m – LID, 06516 Carros, France | EU/2/19/242 | Taħlita likwida għall-użu lokalizzat | QP54AA05 | 23.7.2019 |
| 29.7.2019 | NASYM | Virus sinktjali respiratorju bovin ħaj attenwat (BRSV, Bovine Respiratory Syncytial Virus - Virus Sinktjali Respiratorju Bovin), razza Lym-56 | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, 17170 Amer (Girona), España | EU/2/19/241 | Lijoliliżat u solvent għal sospensjoni għall-injezzjoni jew sprej għall-imnieħer | QI02AD04 | 31.7.2019 |

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

19.7.2019

EVICTO

selamektin

VIRBAC

1ère avenue – 2065 m – LID, 06516 Carros, France

EU/2/19/242

Taħlita likwida għall-użu lokalizzat

QP54AA05

23.7.2019

29.7.2019

NASYM

Virus sinktjali respiratorju bovin ħaj attenwat (BRSV, Bovine Respiratory Syncytial Virus - Virus Sinktjali Respiratorju Bovin), razza Lym-56

Laboratorios Hipra, S.A.

Avda. La Selva, 135, 17170 Amer (Girona), España

EU/2/19/241

Lijoliliżat u solvent għal sospensjoni għall-injezzjoni jew sprej għall-imnieħer

QI02AD04

31.7.2019

| — | Modifika ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat |
| --- | --- |

—

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 |
| --- | --- | --- | --- | --- |
| 1.7.2019 | Osurnia | Elanco GmbH
  Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland | EU/2/14/170 | 3.7.2019 |
| 4.7.2019 | Bravecto Plus | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/18/224 | 9.7.2019 |
| 29.7.2019 | Advocate | Bayer Animal Health GmbH
  D-51368 Leverkusen, Deutschland | EU/2/03/039 | 31.7.2019 |
| 9.8.2019 | Vectormune ND | CEVA-Phylaxia Co. Ltd
  Szállás u. 5, 1107 Budapest, Magyarország | EU/2/15/188 | 13.8.2019 |
| 19.8.2019 | NexGard | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | EU/2/13/159 | 21.8.2019 |
| 19.8.2019 | NEXGARD SPECTRA | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | EU/2/14/177 | 21.8.2019 |
| 29.8.2019 | Bovilis Blue-8 | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/17/218 | 2.9.2019 |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta’ notifika

1.7.2019

Osurnia

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/14/170

3.7.2019

4.7.2019

Bravecto Plus

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/18/224

9.7.2019

29.7.2019

Advocate

Bayer Animal Health GmbH

D-51368 Leverkusen, Deutschland

EU/2/03/039

31.7.2019

9.8.2019

Vectormune ND

CEVA-Phylaxia Co. Ltd

Szállás u. 5, 1107 Budapest, Magyarország

EU/2/15/188

13.8.2019

19.8.2019

NexGard

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/13/159

21.8.2019

19.8.2019

NEXGARD SPECTRA

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/14/177

21.8.2019

29.8.2019

Bovilis Blue-8

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/17/218

2.9.2019

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 |
| --- |
| Domenico Scarlattilaan 6 |
| 1083 HS Amsterdam |
| The Netherlands |

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

The Netherlands

---

(1)  ĠU L 136, 30.4.04, p. 1.

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INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA

| 4.10.2019 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 334/17 |
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4.10.2019

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 334/17

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Sommarju ta’ deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali minn 1 July 2019 sa 31 August 2019

(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE
   (1) jew l-Artikolu 38 tad-Direttiva 2001/82/KE (2))

(2019/C 334/02)

| — | Ir-rifjut ta’ modifika ta’ awtorizzazzjoni nazzjonali għat-tqegħid fis-suq |
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Ir-rifjut ta’ modifika ta’ awtorizzazzjoni nazzjonali 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 |
| --- | --- | --- | --- | --- | --- |
| 4.7.2019 | Basiron AC and associated names | benzoyl peroxide | Mhux applikabbli | Mhux applikabbli | 5.7.2019 |

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

4.7.2019

Basiron AC and associated names

benzoyl peroxide

Mhux applikabbli

Mhux applikabbli

5.7.2019

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(1)  ĠU L 311, 28.11.2001, p. 67.

(2)  ĠU L 311, 28.11.2001, p. 1.

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