4.10.2019

Eiropas Savienības Oficiālais Vēstnesis

C 334/1

Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2019. gada 1. jūlija līdz 2019. gada 31. augustam

(Publicēts saskaņā ar Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 (1) 13. vai 38. pantu)

(2019/C 334/01)

—	Tirdzniecības atļaujas izsniegšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. pants): pieņemtas

Lēmuma datums	Zāļu nosaukums	INN (starptautiskais nepatentētais nosaukums)	Tirdzniecības atļaujas turētājs	Ieraksta numurs Kopienas reģistrā	Farmaceitiskā forma	AĶT kods (Anatomiski ķīmiski terapeitiskais kods)	Paziņojuma datums
1.7.2019.	Dovato	dolutegravirum/lamivudinum	ViiV Healthcare BV Huis ter Heideweg 62, 3705 LZ Zeist, Nederland	EU/1/19/1370	Apvalkotās tabletes	J05AR25	3.7.2019.
1.7.2019.	Xromi	hidroksikarbamīds	Nova Laboratories Ireland Limited 3rd Floor, Ulysses House, Foley Street, Dublin 1, D01 W2T2, Ireland	EU/1/19/1366	Šķīdums iekšķīgai lietošanai	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	Koncentrāts infūziju šķīduma pagatavošanai	L04AA	5.7.2019.
25.7.2019.	Cufence	trientīna dihidrohlorīda	Univar BV Schouwburgplein 30-34, 3012 CL Rotterdam, Nederland	EU/1/19/1365	Cietās kapsulas	A16AX12	29.7.2019.
25.7.2019.	LysaKare	arginīns/lizīns	Advanced Accelerator Applications 20 rue Diesel, 01630 Saint-Genis-Pouilly, France	EU/1/19/1381	Šķīdums infūzijām	V03AF11	29.7.2019.
25.7.2019.	Posaconazole Accord	posakonazola	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	Zarnās šķīstošās tabletes	J02AC04	30.7.2019.
25.7.2019.	Posaconazole AHCL	posaconazolum	Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España	EU/1/19/1380	Suspensija iekšķīgai lietošanai	J02AC04	29.7.2019.
2.8.2019.	Azacitidīna Celgene	azacitidīns	Celgene Europe B.V. Winthontlaan 6 N, 3526 KV Utrecht, Nederland	EU/1/19/1382	Pulveris injekciju suspensijas pagatavošanai	L01BC07	6.8.2019.
23.8.2019.	Giapreza	angiotensīna II acetāts	La Jolla Pharmaceutical II B.V. Herengracht 500, 1017 CB Amsterdam, Nederland	EU/1/19/1384	Koncentrāts infūziju šķīduma pagatavošanai	C01CX09	27.8.2019.
26.8.2019.	Lacosamide UCB	Lacosamidum	UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België	EU/1/19/1383	Apvalkotās tabletes Sīrups Šķīdums infūzijām	N03AX18	28.8.2019.

—	Tirdzniecības atļaujas izsniegšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. pants): noraidītas

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

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.

—	Tirdzniecības atļaujas grozīšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. pants): pieņemtas

Lēmuma datums	Zāļu nosaukums	Tirdzniecības atļaujas turētājs	Ieraksta numurs Kopienas reģistrā	Paziņojuma datums
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 Luxembourg S.A. 1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg	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 2A, 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.

—	Tirdzniecības atļaujas izsniegšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 38. pants): pieņemtas

Lēmuma datums

Zāļu nosaukums

INN (starptautiskais nepatentētais nosaukums)

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Farmaceitiskā forma

AĶT kods (Anatomiski ķīmiski terapeitiskais kods)

Paziņojuma datums

19.7.2019.

EVICTO

selamektīns

VIRBAC

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

EU/2/19/242

Spot-on šķīdums

QP54AA05

23.7.2019.

29.7.2019.

NASYM

Dzīvs novājināts liellopu respiratori sincitiālais vīruss (BRSV), celms Lym-56

Laboratorios Hipra, S.A.

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

EU/2/19/241

Liofilizāts un šķīdinātājs suspensijas injekcijām vai deguna aerosola pagatavošanai

QI02AD04

31.7.2019.

—	Tirdzniecības atļaujas grozīšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 38. pants): pieņemtas

Lēmuma datums	Zāļu nosaukums	Tirdzniecības atļaujas turētājs	Ieraksta numurs Kopienas reģistrā	Paziņojuma datums
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.

Ikvienam, kurš vēlas apskatīt publisko novērtējuma ziņojumu par attiecīgajām zālēm un ar tām saistītos lēmumus, jāsazinās ar:

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

The Netherlands

(1) OV L 136, 30.4.2004., 1. lpp.

		ISSN 1977-0952
Eiropas Savienības Oficiālais Vēstnesis		C 334

Izdevums latviešu valodā	Informācija un paziņojumi	62. gadagājums 2019. gada 4. oktobris

Saturs		Lappuse
	IV Paziņojumi
	EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI
	Eiropas Komisija
2019/C 334/01	Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2019. gada 1. jūlija līdz 2019. gada 31. augustam (Publicēts saskaņā ar Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. vai 38. pantu)	1
	EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI
2019/C 334/02	Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2019. gada 1. jūlija līdz 2019. gada 31. augustam(Lēmumi pieņemti saskaņā ar Direktīvas 2001/83/EK 34. pantu vai Direktīvas 2001/82/EK 38. pantu)	17

Lēmuma datums	Zāļu nosaukums(-i)	INN (starptautiskais nepatentētais nosaukums)	Tirdzniecības atļaujas turētājs(-i)	Attiecīgā dalībvalsts	Paziņojuma datums
4.7.2019.	Basiron AC and associated names	benzoyl peroxide	Nav piemērojams	Nav piemērojams	5.7.2019.