ECO STAR ISI CLEAN

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  • Klimata pārmaiņas:
  • Ecolab
  • Autorizācija numurs:
  • 108609E
  • Pēdējā atjaunošana:
  • 12-03-2018

22-3-2019

Lumpy skin disease III. Data collection and analysis

Lumpy skin disease III. Data collection and analysis

Published on: Thu, 21 Mar 2019 In 2018, no lumpy skin disease (LSD) outbreaks were reported in the Balkan region, after the decline reported in 2017 (385) compared to 2016 (7,483). This confirms the effectiveness of the vaccination campaign based on the LSD homologous vaccine strain which continued throughout 2018 with over 2.5 million animals vaccinated, keeping the mean vaccination coverage above 70%. In 2018, LSD outbreaks were reported in Russia, Turkey and Georgia. In Russia, the LSD epidemics expa...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-3-2019

Probiotic Lactina® for chickens and rabbits

Probiotic Lactina® for chickens and rabbits

Published on: Tue, 19 Mar 2019 Following a request from the European Commission, the European Food Safety Authority Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Probiotic Lactina® for chickens for fattening and rabbits. The additive is a preparation containing viable cells of six strains of lactic acid bacteria intended for use in feed at the proposed dose of 2.5 × 109CFU/kg complete feedingstuffs. The ...

Europe - EFSA - European Food Safety Authority EFSA Journal

14-3-2019

Safety evaluation of the food enzyme β‐glucanase, xylanase and cellulase from Mycothermus thermophiloides (strain NZYM‐ST)

Safety evaluation of the food enzyme β‐glucanase, xylanase and cellulase from Mycothermus thermophiloides (strain NZYM‐ST)

Published on: Fri, 08 Mar 2019 The food enzyme has three declared activities (endo‐1,3(4)‐β‐glucanase EC 3.2.1.6, endo‐1,4‐β‐xylanase EC 3.2.1.8 and cellulase (endo‐1,4‐β‐d‐glucanase EC 3.2.1.4)) and is produced with a non‐genetically modified Mycothermus thermophiloides strain by Novozymes A/S. It is intended to be used in baking and brewing processes. For the two intended uses, based on the maximum use levels recommended and individual data from the EFSA Comprehensive European Food Database, dietary e...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-3-2019

Phytophthora ramorum: monitor its spread and eradicate contaminated sites

Phytophthora ramorum: monitor its spread and eradicate contaminated sites

First detected in France in the Finistère region in May 2017, the plant pathogen Phytophthora ramorum poses a significant risk for many ornamental and forest-growing plants (rhododendrons, vibernum and larch trees). ANSES issues recommendations to monitor the spread of this fungus-like microorganism, prevent the risk of its introduction and eradicate outbreaks where it is already found.

France - Agence Nationale du Médicament Vétérinaire

12-3-2019

Vaginal mesh from Bard removed from the EU markets

Vaginal mesh from Bard removed from the EU markets

The company Bard has decided to stop the sale of vaginal mesh implants on the markets in the EU. The decision is based on commercial reasons according to Bard.

Danish Medicines Agency

9-3-2019

Safety evaluation of the food enzyme 4‐α‐glucanotransferase from Aeribacillus pallidus (strain AE‐SAS)

Safety evaluation of the food enzyme 4‐α‐glucanotransferase from Aeribacillus pallidus (strain AE‐SAS)

Published on: Fri, 08 Mar 2019 The food enzyme 4‐α‐glucanotransferase (1,4‐α‐d‐glucan:1,4‐α‐d‐glucan 4‐α‐d‐glycosyltransferase, EC 2.4.1.25) is produced with a non‐genetically modified Aeribacillus pallidus (previously identified as Geobacillus pallidus) strain from Amano Enzyme Inc. The food enzyme is intended to be used in baking processes and in starch processing for the production of modified dextrins. For baking processes, based on the maximum use levels recommended and individual data from the EFS...

Europe - EFSA - European Food Safety Authority EFSA Journal

27-3-2019

Pemetrexed Accord (Accord Healthcare S.L.U.)

Pemetrexed Accord (Accord Healthcare S.L.U.)

Pemetrexed Accord (Active substance: pemetrexed) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1669 of Wed, 27 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4072/T/06

Europe -DG Health and Food Safety

21-3-2019

The #FDA expects significant attendance from the public and advises attendees to plan appropriately. We recommend that you arrive early to avoid long lines and inconveniences. #FDA #MedicalDevice

The #FDA expects significant attendance from the public and advises attendees to plan appropriately. We recommend that you arrive early to avoid long lines and inconveniences. #FDA #MedicalDevice

The #FDA expects significant attendance from the public and advises attendees to plan appropriately. We recommend that you arrive early to avoid long lines and inconveniences. #FDA #MedicalDevice

FDA - U.S. Food and Drug Administration

21-3-2019

The committee will discuss and make recommendations regarding the benefits and risks of #BreastImplants. Meeting materials are now available:  https://go.usa.gov/xEehs  #FDA #MedicalDevice

The committee will discuss and make recommendations regarding the benefits and risks of #BreastImplants. Meeting materials are now available: https://go.usa.gov/xEehs  #FDA #MedicalDevice

The committee will discuss and make recommendations regarding the benefits and risks of #BreastImplants. Meeting materials are now available: https://go.usa.gov/xEehs  #FDA #MedicalDevice

FDA - U.S. Food and Drug Administration

20-3-2019

EU/3/13/1154 (Diamond ROC EOOD)

EU/3/13/1154 (Diamond ROC EOOD)

EU/3/13/1154 (Active substance: Fosbretabulin tromethamine) - Transfer of orphan designation - Commission Decision (2019)2145 of Wed, 20 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003817

Europe -DG Health and Food Safety

19-3-2019

Loxicom (Norbrook Laboratories (Ireland) Limited)

Loxicom (Norbrook Laboratories (Ireland) Limited)

Loxicom (Active substance: Meloxicam) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2179 of Tue, 19 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/141/T/32

Europe -DG Health and Food Safety

19-3-2019

EU/3/18/2101 (TMC Pharma (EU) Limited)

EU/3/18/2101 (TMC Pharma (EU) Limited)

EU/3/18/2101 (Active substance: Setmelanotide) - Transfer of orphan designation - Commission Decision (2019)2155 of Tue, 19 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004764

Europe -DG Health and Food Safety

19-3-2019

EU/3/16/1703 (TMC Pharma (EU) Limited)

EU/3/16/1703 (TMC Pharma (EU) Limited)

EU/3/16/1703 (Active substance: Setmelanotide) - Transfer of orphan designation - Commission Decision (2019)2154 of Tue, 19 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004730

Europe -DG Health and Food Safety

19-3-2019

EU/3/16/1688 (TMC Pharma (EU) Limited)

EU/3/16/1688 (TMC Pharma (EU) Limited)

EU/3/16/1688 (Active substance: Setmelanotide) - Transfer of orphan designation - Commission Decision (2019)2153 of Tue, 19 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004734

Europe -DG Health and Food Safety

19-3-2019

EU/3/18/2052 (Dicerna Ireland Limited)

EU/3/18/2052 (Dicerna Ireland Limited)

EU/3/18/2052 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against lactate dehydrogenase A mRNA and containing four modified nucleosides which form a ligand cluster of four N-acetylgalactosamine residues) - Transfer of orphan designation - Commission Decision (2019)2156 of Tue, 19 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004770

Europe -DG Health and Food Safety

19-3-2019

EU/3/10/823 (Amryt Pharmaceuticals Designated Activity Company)

EU/3/10/823 (Amryt Pharmaceuticals Designated Activity Company)

EU/3/10/823 (Active substance: Lomitapide) - Transfer of orphan designation - Commission Decision (2019)2152 of Tue, 19 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004233

Europe -DG Health and Food Safety

18-3-2019

EU/3/16/1633 (Diamond ROC EOOD)

EU/3/16/1633 (Diamond ROC EOOD)

EU/3/16/1633 (Active substance: Fosbretabulin tromethamine) - Transfer of orphan designation - Commission Decision (2019)2151 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003815

Europe -DG Health and Food Safety

18-3-2019

EU/3/15/1587 (Diamond ROC EOOD)

EU/3/15/1587 (Diamond ROC EOOD)

EU/3/15/1587 (Active substance: Combretastatin A1 diphosphate) - Transfer of orphan designation - Commission Decision (2019)2149 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003811

Europe -DG Health and Food Safety

18-3-2019

EU/3/15/1584 (Diamond ROC EOOD)

EU/3/15/1584 (Diamond ROC EOOD)

EU/3/15/1584 (Active substance: Variant of recombinant human fibroblast growth factor 19) - Transfer of orphan designation - Commission Decision (2019)2148 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003801

Europe -DG Health and Food Safety

18-3-2019

EU/3/14/1329 (Diamond ROC EOOD)

EU/3/14/1329 (Diamond ROC EOOD)

EU/3/14/1329 (Active substance: Variant of recombinant human fibroblast growth factor 19) - Transfer of orphan designation - Commission Decision (2019)2147 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003809

Europe -DG Health and Food Safety

18-3-2019

EU/3/14/1247 (Diamond ROC EOOD)

EU/3/14/1247 (Diamond ROC EOOD)

EU/3/14/1247 (Active substance: Autologous dendritic cells pulsed with tumour antigen-derived synthetic peptides (MAGE-1, HER-2, AIM-2, TRP-2, gp-100, and interleukin-13 receptor alpha)) - Transfer of orphan designation - Commission Decision (2019)2146 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003818

Europe -DG Health and Food Safety

18-3-2019

EU/3/04/195 (Diamond ROC EOOD)

EU/3/04/195 (Diamond ROC EOOD)

EU/3/04/195 (Active substance: 2-Methoxy-5-[(1Z)-2-(3,4,5-trimethoxyphenyl)ethenyl]-phenol) - Transfer of orphan designation - Commission Decision (2019)2144 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003813

Europe -DG Health and Food Safety

18-3-2019

EU/3/07/471 (BPL Bioproducts Laboratory GmbH)

EU/3/07/471 (BPL Bioproducts Laboratory GmbH)

EU/3/07/471 (Active substance: Human coagulation factor X) - Transfer of orphan designation - Commission Decision (2019)2158 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004129

Europe -DG Health and Food Safety

18-3-2019

EU/3/16/1742 (Worphmed Srl)

EU/3/16/1742 (Worphmed Srl)

EU/3/16/1742 (Active substance: Acebutolol hydrochloride) - Transfer of orphan designation - Commission Decision (2019)2157 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004715

Europe -DG Health and Food Safety

15-3-2019

Ongentys (Bial - Portela and Ca, SA)

Ongentys (Bial - Portela and Ca, SA)

Ongentys (Active substance: opicapone) - Centralised - Yearly update - Commission Decision (2019)2113 of Fri, 15 Mar 2019

Europe -DG Health and Food Safety

15-3-2019

Intrarosa (Endoceutics S.A.)

Intrarosa (Endoceutics S.A.)

Intrarosa (Active substance: prasterone) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2063 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/004138/T/0005

Europe -DG Health and Food Safety

15-3-2019

NovoMix (Novo Nordisk A/S)

NovoMix (Novo Nordisk A/S)

NovoMix (Active substance: Insulin aspart) - Centralised - 2-Monthly update - Commission Decision (2019)2114 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/000308/II/0095

Europe -DG Health and Food Safety

15-3-2019

Zoledronic acid Accord (Accord Healthcare S.L.U.)

Zoledronic acid Accord (Accord Healthcare S.L.U.)

Zoledronic acid Accord (Active substance: zoledronic acid) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2071 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/002667/T/0007

Europe -DG Health and Food Safety

15-3-2019

EU/3/14/1249 (Akcea Therapeutics Ireland Limited)

EU/3/14/1249 (Akcea Therapeutics Ireland Limited)

EU/3/14/1249 (Active substance: Phosphorothioate oligonucleotide targeted to apolipoprotein C-III) - Transfer of orphan designation - Commission Decision (2019)2104 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004954

Europe -DG Health and Food Safety

15-3-2019

EU/3/19/2139 (Clinical Network Services (NL) B.V.)

EU/3/19/2139 (Clinical Network Services (NL) B.V.)

EU/3/19/2139 (Active substance: Autologous adult live cultured osteoblasts) - Transfer of orphan designation - Commission Decision (2019)2105 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004280

Europe -DG Health and Food Safety

15-3-2019

EU/3/06/349 (Vectura Ireland Limited)

EU/3/06/349 (Vectura Ireland Limited)

EU/3/06/349 (Active substance: Apomorphine hydrochloride (inhalation use)) - Transfer of orphan designation - Commission Decision (2019)2115 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004495

Europe -DG Health and Food Safety

15-3-2019

EU/3/15/1597 (Otsuka Pharmaceutical Netherlands B.V.)

EU/3/15/1597 (Otsuka Pharmaceutical Netherlands B.V.)

EU/3/15/1597 (Active substance: Sodium (2R,3S,5R)-5-(4-amino-2-oxo-1,3,5-triazin-1(2H)-yl)-2-(hydroxymethyl)tetrahydrofuran-3-yl ((2R,3S,5R)-5-(2-amino-6-oxo-1H-purin-9(6H)-yl)-3-hydroxytetrahydrofuran-2-yl)methyl phosphate) - Transfer of orphan designation - Commission Decision (2019)2107 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004914

Europe -DG Health and Food Safety

15-3-2019

EU/3/11/936 (BPL Bioproducts Laboratory GmbH)

EU/3/11/936 (BPL Bioproducts Laboratory GmbH)

EU/3/11/936 (Active substance: Human haptoglobin) - Transfer of orphan designation - Commission Decision (2019)2106 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004485

Europe -DG Health and Food Safety

15-3-2019

EU/3/16/1800 (Boyd Consultants Limited)

EU/3/16/1800 (Boyd Consultants Limited)

EU/3/16/1800 (Active substance: Dantrolene sodium) - Transfer of orphan designation - Commission Decision (2019)2111 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005192

Europe -DG Health and Food Safety

15-3-2019

EU/3/16/1629 (Boyd Consultants Limited)

EU/3/16/1629 (Boyd Consultants Limited)

EU/3/16/1629 (Active substance: Exenatide) - Transfer of orphan designation - Commission Decision (2019)2110 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005191

Europe -DG Health and Food Safety

15-3-2019

EU/3/14/1396 (Boyd Consultants Limited)

EU/3/14/1396 (Boyd Consultants Limited)

EU/3/14/1396 (Active substance: Adenovirus serotype 5 containing partial E1A deletion and an integrin-binding domain) - Transfer of orphan designation - Commission Decision (2019)2109 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005074

Europe -DG Health and Food Safety

15-3-2019

EU/3/11/895 (Boyd Consultants Limited)

EU/3/11/895 (Boyd Consultants Limited)

EU/3/11/895 (Active substance: Hydroxy-propyl-beta-cyclodextrin) - Transfer of orphan designation - Commission Decision (2019)2108 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005321

Europe -DG Health and Food Safety

14-3-2019

#SpringBreak2019 is upon us, and proper contact lens care is important. The @US_FDA encourages everyone to take care of their contact lenses by proper cleaning, routine exams, and doctor's visits.

#SpringBreak2019 is upon us, and proper contact lens care is important. The @US_FDA encourages everyone to take care of their contact lenses by proper cleaning, routine exams, and doctor's visits.

#SpringBreak2019 is upon us, and proper contact lens care is important. The @US_FDA encourages everyone to take care of their contact lenses by proper cleaning, routine exams, and doctor's visits.

FDA - U.S. Food and Drug Administration

14-3-2019

Aivlosin (ECO Animal Health Europe Limited)

Aivlosin (ECO Animal Health Europe Limited)

Aivlosin (Active substance: Tylvalosin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2091 of Thu, 14 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/83/T/77

Europe -DG Health and Food Safety

14-3-2019

Reconcile (Pegasus Laboratories Ireland Limited)

Reconcile (Pegasus Laboratories Ireland Limited)

Reconcile (Active substance: Fluoxetine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2089 of Thu, 14 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/133/T/31

Europe -DG Health and Food Safety

13-3-2019

Luminity (Lantheus EU Limited)

Luminity (Lantheus EU Limited)

Luminity (Active substance: perflutren) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2049 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/654/T/27

Europe -DG Health and Food Safety

13-3-2019

Qarziba (EUSA Pharma (Netherlands) B.V.)

Qarziba (EUSA Pharma (Netherlands) B.V.)

Qarziba (Active substance: dinutuximab beta) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2061 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/3918/T/10

Europe -DG Health and Food Safety

13-3-2019

Cresemba (Basilea Pharmaceutica Deutschland GmbH)

Cresemba (Basilea Pharmaceutica Deutschland GmbH)

Cresemba (Active substance: isavuconazole) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2069 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2734/T/20

Europe -DG Health and Food Safety

13-3-2019

Stayveer (Janssen Pharmaceutica N.V.)

Stayveer (Janssen Pharmaceutica N.V.)

Stayveer (Active substance: bosentan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2065 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2644/T/25

Europe -DG Health and Food Safety

13-3-2019

Varuby (TESARO Bio Netherlands B.V.)

Varuby (TESARO Bio Netherlands B.V.)

Varuby (Active substance: rolapitant) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2068 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4196/T/15

Europe -DG Health and Food Safety

13-3-2019

Senshio (Shionogi B.V.)

Senshio (Shionogi B.V.)

Senshio (Active substance: ospemifene) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2066 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2780/T/26

Europe -DG Health and Food Safety

13-3-2019

Slenyto (RAD Neurim Pharmaceuticals EEC SARL)

Slenyto (RAD Neurim Pharmaceuticals EEC SARL)

Slenyto (Active substance: melatonin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2064 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4425/T/04

Europe -DG Health and Food Safety

13-3-2019

Actrapid (Novo Nordisk A/S)

Actrapid (Novo Nordisk A/S)

Actrapid (Active substance: Insulin human (rDNA)) - Centralised - Yearly update - Commission Decision (2019)2070 of Wed, 13 Mar 2019

Europe -DG Health and Food Safety

13-3-2019

Herceptin (Roche Registration GmbH)

Herceptin (Roche Registration GmbH)

Herceptin (Active substance: trastuzumab) - Centralised - Yearly update - Commission Decision (2019) 2059 of Wed, 13 Mar 2019

Europe -DG Health and Food Safety

13-3-2019

INOmax (Linde Healthcare AB)

INOmax (Linde Healthcare AB)

INOmax (Active substance: Nitric oxide) - Centralised - Yearly update - Commission Decision (2019)2060 of Wed, 13 Mar 2019

Europe -DG Health and Food Safety

13-3-2019

Ferriprox (Apotex Europe B.V.)

Ferriprox (Apotex Europe B.V.)

Ferriprox (Active substance: Deferiprone) - Centralised - 2-Monthly update - Commission Decision (2019)2057 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/236/II/0126/G

Europe -DG Health and Food Safety

13-3-2019

Praluent (Sanofi-Aventis groupe)

Praluent (Sanofi-Aventis groupe)

Praluent (Active substance: alirocumab) - Centralised - 2-Monthly update - Commission Decision (2019)2058 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/3882/II/0042

Europe -DG Health and Food Safety

12-3-2019

Quinolone and fluoroquinolone medicinal products for systemic and inhalation use

Quinolone and fluoroquinolone medicinal products for systemic and inhalation use

Quinolone and fluoroquinolone medicinal products for systemic and inhalation use (Active substance: nalidixic acid, pipemidic acid, cinoxacin, enoxacin, pefloxacin, lomefloxacin, ciprofloxacin, levofloxacin, ofloxacin, moxifloxacin, norfloxacin, prulifloxacin, rufloxacin, flumequine) - Community Referrals - Art 31 - Commission Decision (2019)2050 of Tue, 12 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/A-31/1452/C/2789

Europe -DG Health and Food Safety

11-3-2019

EU/3/14/1337 (ESPL Regulatory Consulting Limited)

EU/3/14/1337 (ESPL Regulatory Consulting Limited)

EU/3/14/1337 (Active substance: Acamprosate calcium) - Transfer of orphan designation - Commission Decision (2019)1944 of Mon, 11 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004283

Europe -DG Health and Food Safety

8-3-2019

Today, the @US_FDA issued a Letter to Healthcare Providers about the increasing number of adverse events associated with surgical staplers for internal use. Read more about the #FDA's recommendations:  https://go.usa.gov/xEGS5  #MedicalDevicepic.twitter.c

Today, the @US_FDA issued a Letter to Healthcare Providers about the increasing number of adverse events associated with surgical staplers for internal use. Read more about the #FDA's recommendations: https://go.usa.gov/xEGS5  #MedicalDevicepic.twitter.c

Today, the @US_FDA issued a Letter to Healthcare Providers about the increasing number of adverse events associated with surgical staplers for internal use. Read more about the #FDA's recommendations: https://go.usa.gov/xEGS5  #MedicalDevice pic.twitter.com/WkmB2yKqUz

FDA - U.S. Food and Drug Administration

8-3-2019

EU/3/12/968 (Clinical Network Services (NL) B.V.)

EU/3/12/968 (Clinical Network Services (NL) B.V.)

EU/3/12/968 (Active substance: Human monoclonal antibody targeting Staphylococcus aureus alpha-toxin) - Transfer of orphan designation - Commission Decision (2019)1940 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004447

Europe -DG Health and Food Safety

8-3-2019

EU/3/17/1894 (Granzer Regulatory Consulting and Services)

EU/3/17/1894 (Granzer Regulatory Consulting and Services)

EU/3/17/1894 (Active substance: Recombinant human antibody directed against misfolded human superoxide dismutase 1) - Transfer of orphan designation - Commission Decision (2019)1943 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004025

Europe -DG Health and Food Safety

8-3-2019

EU/3/14/1281 (Vertex Pharmaceuticals (Ireland) Limited)

EU/3/14/1281 (Vertex Pharmaceuticals (Ireland) Limited)

EU/3/14/1281 (Active substance: 1-(2,2-difluoro-1,3-benzodioxol-5-yl)-N-{1-[(2R)-2,3-dihydroxypropyl]-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl}cyclopropanecarboxamide) - Transfer of orphan designation - Commission Decision (2019)1953 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004132

Europe -DG Health and Food Safety

8-3-2019

EU/3/08/563 (Vertex Pharmaceuticals (Ireland) Limited)

EU/3/08/563 (Vertex Pharmaceuticals (Ireland) Limited)

EU/3/08/563 (Active substance: Recombinant derivative of C3 transferase) - Transfer of orphan designation - Commission Decision (2019)1952 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004115

Europe -DG Health and Food Safety

8-3-2019

EU/3/15/1487 (Leadiant GmbH)

EU/3/15/1487 (Leadiant GmbH)

EU/3/15/1487 (Active substance: Reduced oxydised N-acetyl heparin) - Transfer of orphan designation - Commission Decision (2019)1951 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004452

Europe -DG Health and Food Safety

8-3-2019

EU/3/16/1757 (Imago BioSciences B.V.)

EU/3/16/1757 (Imago BioSciences B.V.)

EU/3/16/1757 (Active substance: N-[(2S)-5-{[(1R,2S)-2-(4-fluorophenyl)cyclopropyl]amino}-1-(4-methylpiperazin-1-yl)-1-oxopentan-2-yl]-4-(1H-1,2,3-triazol-1-yl)benzamide, bis-tosylate salt) - Transfer of orphan designation - Commission Decision (2019)1954 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003424

Europe -DG Health and Food Safety

8-3-2019

EU/3/06/381 (Clinical Network Services (NL) B.V.)

EU/3/06/381 (Clinical Network Services (NL) B.V.)

EU/3/06/381 (Active substance: Human monoclonal antibody against Pseudomonas aeruginosa serotype O11) - Transfer of orphan designation - Commission Decision (2019)1941 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004486

Europe -DG Health and Food Safety

8-3-2019

EU/3/14/1285 (Clinuvel Europe Limited)

EU/3/14/1285 (Clinuvel Europe Limited)

EU/3/14/1285 (Active substance: Afamelanotide) - Transfer of orphan designation - Commission Decision (2019)1950 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004300

Europe -DG Health and Food Safety