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SEC(2019) 170/2 Bruxelles, le 3 avril 2019 NOTE JOURNALIÈRE / DAY NOTE / TAGESVERMERK DÉCISIONS ADOPTÉES PAR LA COMMISSION PAR PROCÉDURE DE DÉLÉGATION

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COMMISSION EUROPÉENNE

SECRÉTARIAT GÉNÉRAL

SEC(2019) 170/2 Bruxelles, le 3 avril 2019

NOTE JOURNALIÈRE / DAY NOTE / TAGESVERMERK

DÉCISIONS ADOPTÉES PAR LA COMMISSION PAR PROCÉDURE DE DÉLÉGATION DECISIONS ADOPTED BY THE COMMISSION BY DELEGATION PROCEDURE

VON DER KOMMISSION IM VERFAHREN DER DELEGATION ANGENOMMENE BESCHLÜSSE

MARDI 2 AVRIL 2019

RTD DG Recherche et innovation DL/2019/2458 - C(2019) 2732

- COMMISSION IMPLEMENTING DECISION on the review of the legality of an act of the Executive Agency for Small and Medium-sized Enterprises pursuant to Council Regulation (EC) No 58/2003.

SANTE DG Santé et Sécurité Alimentaire DL/2019/2414 - C(2019) 2687

- COMMISSION IMPLEMENTING DECISION on the annual renewal of the conditional marketing authorisation for the orphan medicinal product for human use

"Deltyba - delamanid", granted by Decision C(2014)2916(final), and amending that Decision.

DL/2019/2415 - C(2019) 2688

- COMMISSION IMPLEMENTING DECISION granting marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council for "Kromeya - adalimumab", a medicinal product for human use.

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DL/2019/2416 - C(2019) 2689

- COMMISSION IMPLEMENTING DECISION amending the marketing

authorisation granted by Decision C(2012)9945(final) for "Betmiga - mirabegron", a medicinal product for human use following an assessment of a periodic safety update report under Article 28 of Regulation (EC) No 726/2004.

DL/2019/2417 - C(2019) 2690

- COMMISSION IMPLEMENTING DECISION amending the marketing

authorisation granted by Decision C(2015)4317(final) for “Lumark - lutetium, isotope of mass 177”, a medicinal product for human use.

DL/2019/2418 - C(2019) 2691

- COMMISSION IMPLEMENTING DECISION concerning, in the framework of Article 31 of Directive 2001/83/EC of the European Parliament and of the Council, the marketing authorisation granted by Decision C(2007)199 for “Irbesartan Zentiva - Irbesartan", medicinal product for human use.

DL/2019/2419 - C(2019) 2692

- COMMISSION IMPLEMENTING DECISION amending the marketing

authorisation granted by Decision C(2016)2948(final) for “Empliciti - elotuzumab”, a medicinal product for human use.

DL/2019/2420 - C(2019) 2693

- DÉCISION D'EXÉCUTION DE LA COMMISSION portant autorisation de mise sur le marché du médicament à usage humain "Vizimpro - dacomitinib" au titre du règlement n° 726/2004 du Parlement européen et du Conseil.

DL/2019/2421 - C(2019) 2694

- DÉCISION D'EXÉCUTION DE LA COMMISSION modifiant l’autorisation de mise sur le marché du médicament à usage humain «Clopidogrel BGR - Clopidogrel» octroyée par la décision C(2009)7419.

DL/2019/2422 - C(2019) 2695

- COMMISSION IMPLEMENTING DECISION renewing and amending the

marketing authorisation for the medicinal product for human use "Afinitor - everolimus", granted by Decision C(2009)6251.

DL/2019/2423 - C(2019) 2696

- COMMISSION IMPLEMENTING DECISION of XXX amending the marketing authorisation granted by Decision C(2008)8812 for “Vidaza - Azacitidine”, a medicinal product for human use.

(3)

DL/2019/2424 - C(2019) 2697

- COMMISSION IMPLEMENTING DECISION of XXX amending the marketing authorisation granted by Decision C(2018)1966(final) for "Steglujan - ertugliflozin / sitagliptin", a medicinal product for human use following an assessment of a periodic safety update report under Article 28 of Regulation (EC) No 726/2004.

DL/2019/2425 - C(2019) 2698

- COMMISSION IMPLEMENTING DECISION concerning, in the framework of Article 31 of Directive 2001/83/EC of the European Parliament and of the Council, the marketing authorisations of medicinal products for human use which contain the active substances “candesartan”, “irbesartan”, “losartan”, “olmesartan”, “valsartan”.

DL/2019/2426 - C(2019) 2699

- COMMISSION IMPLEMENTING DECISION of XXX granting marketing

authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council for "Idacio - adalimumab", a medicinal product for human use.

DL/2019/2427 - C(2019) 2700

- COMMISSION IMPLEMENTING DECISION amending the marketing

authorisation granted by Decision C(2018)1903(final) for "Steglatro - ertugliflozin", a medicinal product for human use following an assessment of a periodic safety update report under Article 28 of Regulation (EC) No 726/2004.

DL/2019/2428 - C(2019) 2701

- COMMISSION IMPLEMENTING DECISION amending the marketing

authorisation granted by Decision C(2017)5427(final) for “Zykadia - ceritinib”, a medicinal product for human use.

DL/2019/2429 - C(2019) 2702

- COMMISSION IMPLEMENTING DECISION amending the marketing

authorisation granted by Decision C(2015)4299(final) for “Opdivo - nivolumab”, a medicinal product for human use.

DL/2019/2430 - C(2019) 2703

- COMMISSION IMPLEMENTING DECISION amending the marketing

authorisation granted by Decision C(2011)4469(final) for “NULOJIX - belatacept”, a medicinal product for human use.

DL/2019/2431 - C(2019) 2704

- COMMISSION IMPLEMENTING DECISION amending the marketing

authorisation granted by Decision C(2011)5192(final) for “Yervoy - ipilimumab”, a medicinal product for human use.

(4)

DL/2019/2432 - C(2019) 2705

- COMMISSION IMPLEMENTING DECISION withdrawing, at the holder's request, the marketing authorisation granted by Decision C(2015)8294(final) for "Numient - levodopa / carbidopa", a medicinal product for human use.

DL/2019/2433 - C(2019) 2706

- COMMISSION IMPLEMENTING DECISION amending the marketing

authorisation granted by Decision C(2011)3595(final) for “Eliquis - apixaban”, a medicinal product for human use.

DL/2019/2434 - C(2019) 2707

- COMMISSION IMPLEMENTING DECISION concerning, in the framework of Article 31 of Directive 2001/83/EC of the European Parliament and of the Council, the marketing authorisation granted by Decision C(2007)175 for “Copalia - amlodipine / valsartan", medicinal product for human use.

DL/2019/2435 - C(2019) 2708

- COMMISSION IMPLEMENTING DECISION concerning, in the framework of Article 31 of Directive 2001/83/EC of the European Parliament and of the Council, the marketing authorisation granted by Decision C(2007)172 for “Dafiro - amlodipine / valsartan", medicinal product for human use.

DL/2019/2436 - C(2019) 2709

- COMMISSION IMPLEMENTING DECISION concerning, in the framework of Article 31 of Directive 2001/83/EC of the European Parliament and of the Council, the marketing authorisation granted by Decision C(2009)8136 for “Exforge HCT - amlodipine besylate / valsartan / hydrochlorothiazide", medicinal product for human use.

DL/2019/2437 - C(2019) 2710

- DÉCISION D'EXÉCUTION DE LA COMMISSION concernant, dans le cadre de l’article 31 de la directive 2001/83/CE du Parlement européen et du Conseil, l’autorisation de mise sur le marché du médicament à usage humain «Karvea - Irbésartan» octroyée par la décision C(97)2754(final).

DL/2019/2438 - C(2019) 2711

- DÉCISION D'EXÉCUTION DE LA COMMISSION concernant, dans le cadre de l’article 31 de la directive 2001/83/CE du Parlement européen et du Conseil, l’autorisation de mise sur le marché du médicament à usage humain «Karvezide - Irbésartan / hydrochlorothiazide» octroyée par la décision C(1998)3174.

DL/2019/2439 - C(2019) 2712

- COMMISSION IMPLEMENTING DECISION renewing and amending the

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DL/2019/2440 - C(2019) 2713

- COMMISSION IMPLEMENTING DECISION renewing and amending the

marketing authorisation for the orphan medicinal product for human use "Sylvant - siltuximab", granted by Decision C(2014)3557(final).

DL/2019/2441 - C(2019) 2714

- COMMISSION IMPLEMENTING DECISION amending the marketing

authorisation granted by Decision C(2012)2845(final) for "Capecitabine Accord - capecitabine", a medicinal product for human use following an assessment of a periodic safety update report under Article 28 of Regulation (EC) No 726/2004.

DL/2019/2442 - C(2019) 2715

- DÉCISION D'EXÉCUTION DE LA COMMISSION modifiant l’autorisation de mise sur le marché du médicament à usage humain «Zonisamide Mylan - zonisamide» octroyée par la décision C(2016)2023(final).

SG Secrétariat général

DL/2019/2411 - C(2019) 2686

- Commission decision on a confirmatory application GESTDEM 2018/6336.

SJ Service juridique

DL/2019/2410 - C(2019) 2685

- DÉCISION DE LA COMMISSION portant approbation de pouvoirs dans des affaires contentieuses devant la Cour de justice et le Tribunal.

DL/2019/2448 - C(2019) 2720

- DÉCISION DE LA COMMISSION portant approbation de pouvoirs dans des affaires contentieuses devant la Cour de justice et le Tribunal.

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(authentification des actes) du règlement intérieur de la Commission.

Pour le Secrétaire général,

Jordi AYET PUIGARNAU Directeur du greffe

Authentification n°:

Références

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