MVA

Distribution Transformer Market worth $24.9 billion | MarketsandMarkets™

Retrieved on: 
Monday, May 6, 2024
Investment, Distribution transformer, Population growth, Schneider Electric, Eaton Corporation, City, MEA, Electricity, Mitsubishi Electric, Urbanization, MVA, Automation, Acquisition, Economic development, Power rating, Siemens Energy, Market development, Electric power

The industrial segment secures the second-largest market share within the Distribution Transformer Market by end user segment, driven by several key factors.

Key Points: 
  • The industrial segment secures the second-largest market share within the Distribution Transformer Market by end user segment, driven by several key factors.
  • The 0.5 MVA segment captures a significant market share within the power rating segment of the Distribution Transformer Market for several compelling reasons.
  • Distribution Transformer Market - Key Benefits of Buying the Report:
    This report studies the Distribution Transformer Market based on mounting, phase, power range, insulation, end user, and region.
  • Market Penetration: Comprehensive information on Distribution Transformer Market products offered by the top 25 players in the market.

Distribution Transformer Market worth $24.9 billion | MarketsandMarkets™

Retrieved on: 
Monday, May 6, 2024
Investment, Distribution transformer, Population growth, Schneider Electric, Eaton Corporation, City, MEA, Electricity, Mitsubishi Electric, Urbanization, MVA, Automation, Acquisition, Economic development, Power rating, Siemens Energy, Market development, Electric power

The industrial segment secures the second-largest market share within the Distribution Transformer Market by end user segment, driven by several key factors.

Key Points: 
  • The industrial segment secures the second-largest market share within the Distribution Transformer Market by end user segment, driven by several key factors.
  • The 0.5 MVA segment captures a significant market share within the power rating segment of the Distribution Transformer Market for several compelling reasons.
  • Distribution Transformer Market - Key Benefits of Buying the Report:
    This report studies the Distribution Transformer Market based on mounting, phase, power range, insulation, end user, and region.
  • Market Penetration: Comprehensive information on Distribution Transformer Market products offered by the top 25 players in the market.

ACTG Announces Launch of Clinical Trial Evaluating Combination of Three Novel Immune-based Therapies for HIV Cure

Retrieved on: 
Friday, April 19, 2024
Infection, ChAdOx1, HIV/AIDS, University, Bangladesh Technical Education Board, Cell, Gilead Sciences, Safety, CD4, Tissue, University of Pittsburgh, UNC, UM1, ACTG, Hook effect, Vesatolimod, Research, Toll-like receptor 7, Vaccine, University of Oxford, MVA, NIAID, University of North Carolina, Viral load, TLR7, Diagnosis, HIV, Immune system, Ageing

A5374 (Triple Immune Strategy for HIV Remission) is a multi-site, randomized, placebo-controlled trial.

Key Points: 
  • A5374 (Triple Immune Strategy for HIV Remission) is a multi-site, randomized, placebo-controlled trial.
  • After enrollment, participants will continue taking their HIV medications and will either receive a series of novel treatments or placebo.
  • Carefully monitored analytic treatment interruptions are an important part of HIV cure clinical trials.
  • ACTG is led by Dr. Currier and Joseph J. Eron, M.D., UNC (ACTG Vice-Chair).

New Study Shows Veracyte’s Decipher Prostate Test is Prognostic for Prostate Cancer Progression Among Patients Undergoing Active Surveillance

Retrieved on: 
Monday, April 22, 2024
Oncology, Data Management, Health, Technology, Health Technology, Software, Biotechnology, Radiation, Patient, Prostate, Risk, Safety, JCO, MVA, Prostate cancer, Disease, Urology, Intelligence, Neoplasm, Biomarker, Waiting, GRID, Medical imaging

(Nasdaq: VCYT), a leading cancer diagnostics company, today announced that a new study published in JCO Precision Oncology shows that, among patients undergoing Active Surveillance (AS) for prostate cancer, the Decipher Prostate Genomic Classifier is prognostic for identifying those whose disease is likely to progress.

Key Points: 
  • (Nasdaq: VCYT), a leading cancer diagnostics company, today announced that a new study published in JCO Precision Oncology shows that, among patients undergoing Active Surveillance (AS) for prostate cancer, the Decipher Prostate Genomic Classifier is prognostic for identifying those whose disease is likely to progress.
  • The findings make the Decipher test the only gene expression test to have treatment-outcome data from a prospective, multi-center, phase 2, randomized trial in the AS population.
  • “The findings from the ENACT trial analysis demonstrate that the Decipher Prostate test is a predictor of disease progression on AS,” said Elai Davicioni, Ph.D., Veracyte’s medical director for Urology.
  • The findings also demonstrated the use of Decipher GRID (Genomic Resource for Intelligent Discovery) as a research tool to help advance scientific understanding of prostate cancer.

Table of decisions of labelling exemption requests falling under article 63 of Directive 2001/83/EC examined by the Quality Review of Documents (QRD) Group

Retrieved on: 
Thursday, April 25, 2024
Artesunate, QRD, Cysteamine, Daunorubicin/cytarabine, Sutimlimab, Authorization, Positive, SFL, Latanoprost, Obiltoxaximab, Mitapivat, European Medicines Agency, Janssen COVID-19 vaccine, Potassium, Ertapenem, Etranacogene dezaparvovec, Request, MVA, Brexucabtagene autoleucel, Ebola, Imipenem/cilastatin/relebactam, Relugolix/estradiol/norethisterone acetate, CHMP, Pfizer–BioNTech COVID-19 vaccine, Pitolisant, Naloxone, Bupivacaine, Atidarsagene autotemcel, Defibrotide, Rilpivirine, Moderna COVID-19 vaccine, Filo, Pertuzumab, Tafasitamab, Trastuzumab, AstraZeneca, Potassium citrate, COVID-19, INN, JCOVDEN, N/A, Alfa, Assessment, Setmelanotide, Casirivimab/imdevimab, Fair

18 April 2024

Key Points: 
    • 18 April 2024
      EMA/934543/2022 Rev.3
      Human Medicines Division

      Table of decisions of labelling exemption requests falling under article 63 of Directive 2001/83/EC examined by the Quality Review of Documents (QRD) Group
      Related information
      Exemptions to labelling and package-leaflet obligations | European Medicines Agency
      Recommendations for the implementation of the exemptions to the labelling and package leaflet obligations in the centralised procedure

      MA status

      Product number

      Product name

      Article 63(1) request (orphan
      products)2

      Outcome 63(1)
      orphan products2

      Article 63(3) request for omission of
      certain particulars

      Outcome 63(3) omission of
      certain particulars

      Outcome date

      Product information

      Authorised

      EMEA/H/C/005352

      Upstaza

      Translation exemption (outer and
      immediate labelling)

      Positive (partial)

      Omission of particulars (immediate labelling)

      Positive (partial)

      07/Mar/24

      Upstaza (eladocagene exuparvovec) - N/A
      Product information

      Authorised

      EMEA/H/C/005269/X/0033

      Kaftrio

      Translation exemption (outer,
      intermediate and immediate
      labelling)

      Positive (partial)

      21/Nov/23

      Kaftrio
      (elexacaftor/tezacaftor/ivacaftor) Product information
      Rezzayo (rezafungin) - Product
      information

      N/A

      Authorised

      EMEA/H/C/005900

      Rezzayo

      Omission of particulars (immediate labelling)

      Positive

      30/Aug/23

      Authorised

      EMEA/H/C/005933

      Catiolanze

      Omission of particulars (immediate labelling)

      Positive

      13/Jul/23

      Catiolanze (latanoprost) - Product
      information

      N/A

      Authorised

      EMEA/H/C/005756

      Apretude

      Omission of particulars (immediate labelling)

      Positive (partial)

      03/Jul/23

      Apretude, (cabotegravir) - Product
      information

      Apretude (cabotegravir) Assessment report

      Authorised

      EMEA/H/C/005985

      Tepkinly

      Positive (partial)

      14/Jun/23

      Tepkinly (epcoritamab) - Product
      information

      Tepkinly (epcoritamab) Assessment report

      Authorised

      EMEA/H/C/005849/X/0003

      Vyvgart

      Positive

      10/Mar/23

      Vyvgart (efgartigimod alfa) - Product Vyvgart (efgartigimod alfa) information
      Assessment report

      Authorised

      EMEA/H/C/005122

      Omvoh

      Omission of particulars (immediate labelling)

      Positive

      04/Jan/23

      Omvoh (mirikizumab) - Product
      information

      Omvoh (mirikizumab) Assessment report

      Authorised

      EMEA/H/C/004258

      Alofisel

      Omission of particulars (outer labelling)

      Positive (temporary)

      17/Nov/22

      Alofisel (darvadstrocel) - Product
      information

      N/A

      Authorised

      EMEA/H/C/005343

      Mvabea

      Omission of particulars (outer labelling)

      Positive (partial)

      Translation exemption (outer and immediate Positive
      labelling)

      26/Oct/22

      N/A

      EMEA/H/C/005337

      Zabdeno

      Omission of particulars (outer labelling)

      Positive (partial)

      Translation exemption (outer and immediate Positive
      labelling)

      26/Oct/22

      Authorised

      EMEA/H/C/005343

      Mvabea

      Omission of particulars (outer labelling)

      Positive (partial)

      Translation exemption (outer and immediate Positive (partial)
      labelling)

      13/Oct/22

      Authorised

      EMEA/H/C/005337

      Zabdeno

      Omission of particulars (outer labelling)

      Positive (partial)

      Translation exemption (outer and immediate Positive (partial)
      labelling)

      13/Oct/22

      Authorised

      EMEA/H/C/005484

      Loargys

      Mvabea (Ebola vaccine (MVA BN Filo
      [recombinant]) - Product
      information
      Zabdeno (Ad26.ZEBOV-GP
      [recombinant]) - Product
      information
      Mvabea (Ebola vaccine (MVA BN Filo
      [recombinant]) - Product
      information
      Zabdeno (Ad26.ZEBOV-GP
      [recombinant]) - Product
      information
      Loargys (pegzilarginase) - Product
      information

      Authorised

      Authorised

      EMEA/H/C/005703

      Pombiliti

      Omission of particulars (immediate labelling)

      Positive

      13/Oct/22

      Pombiliti (cipaglucosidase alfa) Product information

      Pombiliti (cipaglucosidase alfa) Assessment report

      Authorised

      EMEA/H/C/005695

      Opfolda

      Omission of particulars (immediate labelling)

      Positive

      13/Oct/22

      Opfolda (miglustat) - Product
      information

      N/A

      Authorised

      EMEA/H/C/006016

      Imjudo

      Omission of particulars (immediate labelling)

      Positive

      13/Oct/22

      IMJUDO - Product information

      Imjudo - Assessment report

      Authorised

      EMEA/H/C/004650

      Tremelimumab
      AstraZeneca

      Omission of particulars (immediate labelling)

      Positive

      13/Oct/22

      Tremelimumab AstraZeneca Product information

      Tremelimumab AstraZeneca Assessment report

      Authorised

      EMEA/H/C/005776

      Enjaymo

      13/Sep/22

      Enjaymo (Sutimlimab) - Product
      information

      N/A

      Authorised

      EMEA/H/C/005035

      Filsuvez

      Authorised

      EMEA/H/C/004827

      Hemgenix

      Authorised

      EMEA/H/C/005751

      Columvi

      Translation exemption (outer,
      immediate labelling and package
      leaflet)
      Translation exemption (outer
      labelling)

      Translation exemption (outer,
      immediate labelling and package
      leaflet)

      Article 63(3) request for translation
      exemption

      Positive (partial)

      13/Oct/22

      Translation exemption (outer, immediate
      labelling and package leaflet)

      Translation exemption (outer,
      immediate labelling and package
      leaflet)

      Outcome 63(3) request for
      translation exemption

      Positive (partial)

      Positive

      Assessment report

      N/A

      N/A

      N/A

      N/A

      Loargys (pegzilarginase) Assessment report

      Omission of particulars (immediate labelling)

      Positive

      08/Aug/22

      Filsuvez (birch bark extract) Product information

      N/A

      Omission of particulars (outer labelling)

      Negative

      14/Jun/22

      Hemgenix - Product information

      Hemgenix - Assessment report

      Omission of particulars (immediate labelling)

      Positive

      14/Jun/22

      Columvi, INN-glofitamab
      (europa.eu)

      N/A

      Authorised

      EMEA/H/C/005848

      Pemetrexed Baxter

      Omission of particulars (immediate labelling)

      Positive

      14/Jun/22

      Pemetrexed Baxter - Product
      information

      Pemetrexed Baxter - Assessment
      report

      Authorised

      EMEA/H/C/005246/X/0002

      Byfavo

      Omission of particulars (immediate labelling)

      Negative

      14/Jun/22

      Byfavo - Product information

      N/A

      Authorised

      EMEA/H/C/005815

      Ertapenem SUN

      Omission of particulars (immediate labelling)

      Positive

      11/May/22

      Ertapenem SUN (ertapenem) Product information

      Ertapenem SUN (ertapenem) Assessment report

      Authorised

      EMEA/H/C/004850

      Xenpozyme

      12/Apr/22

      Xenpozyme (olipudase alfa) Product information

      Xenpozyme (olipudase alfa) Assessment report

      Authorised

      EMEA/H/C/005769

      Herwenda

      10/Mar/22

      Herwenda (trastuzumab) - Product
      information

      N/A

      Authorised

      EMEA/H/C/005540

      Pyrukynd

      10/Mar/22

      Pyrukynd - Product information

      N/A

      Authorised

      EMEA/H/C/005680

      Lunsumio

      10/Mar/22

      Lunsumio (mosunetuzumab) Product information

      N/A

      Authorised

      EMA/H/C/004577

      Ebvallo

      Translation exemption (outer,
      immediate labelling and package
      leaflet)

      Positive (partial)

      10/Mar/22

      Ebvallo - Product information

      Ebvallo - Assessment report

      Authorised

      EMEA/H/C/004929

      Kimmtrak

      Translation exemption (outer and
      immediate labelling)

      Positive

      16/Nov/21

      Kimmtrak (tebentafusp) - Product
      information

      Kimmtrak (tebentafusp) Assessment report

      Authorised

      EMEA/H/C/005378

      Nulibry

      Translation exemption (outer and
      immediate labelling)

      Positive (partial)

      16/Nov/21

      Nulibry - Product information

      N/A

      Authorised

      EMEA/H/C/005849

      Vyvgart

      Omission of particulars (outer and immediate Positive (partial)
      labelling)

      16/Nov/21

      Vyvgart (efgartigimod alfa) - Product Vyvgart (efgartigimod alfa) information
      Assessment report

      Authorised

      EMEA/H/C/005973

      Paxlovid

      Omission of particulars (outer labelling)

      Positive

      Translation exemption (outer, immediate
      labelling and package leaflet)

      Positive (partial)

      16/Nov/21

      Paxlovid (nirmatrelvir + ritonavir) Product information

      Authorised

      EMEA/H/C/005788

      Evusheld

      Omission of particulars (outer labelling)

      Positive

      Translation exemption (outer, immediate
      labelling and package leaflet)

      Positive (partial)

      13/Oct/21

      Evusheld (ixagevimab, cilgavimab) - N/A
      Product information

      Authorised

      EMEA/H/C/005553

      Aspaveli

      Omission of particulars (immediate labelling)

      Positive

      08/Oct/21

      Aspaveli (pegcetacoplan) - Product
      information

      Aspaveli (pegcetacoplan) Assessment report

      Authorised

      EMEA/H/C/005814

      Ronapreve

      Omission of particulars (immediate labelling)

      Positive

      24/Sep/21

      Ronapreve (casirivimab and
      imdevimab) - Produt information

      Ronapreve (casirivimab and
      imdevimab) - Assessment report

      Authorised

      EMEA/H/C/005550

      Artesunate Amivas

      14/Sep/21

      Artesunate Amivas (artesunate) Product information

      Artesunate Amivas (Artesunate) Assessment report

      Authorised

      EMEA/H/C/005854

      Regkirona

      Omission of particulars (outer and immediate Positive
      labelling)

      Translation exemption (outer, immediate
      labelling and package leaflet)

      Positive (partial)

      28/Jul/21

      Regkirona (regdanvimab) - Product
      information

      Regkirona (regdanvimab) Assessment report

      Authorised

      EMEA/H/C/005676

      Xevudy

      Omission of particulars (outer labelling)

      Positive

      Translation exemption (outer, immediate
      labelling and package leaflet)

      Positive (partial)

      28/Jul/21

      Xevudy (sotrovimab) - Product
      information

      Xevudy (sotrovimab) Assessment report

      Authorised

      EMEA/H/C/005182

      Trodelvy

      Omission of particulars (immediate labelling)

      Positive

      17/Jun/21

      Trodelvy (sacituzumab govitecan) Product information

      Trodelvy (sacituzumab govitecan)
      - Assessment report

      Authorised

      EMEA/H/C/005681

      Pepaxti

      Omission of particulars (immediate labelling)

      Positive

      17/Jun/21

      Pepaxti (melphalan flufenamide) Product information

      N/A

      Authorised

      EMEA/H/C/005035

      Filsuvez

      Translation exemption (outer,
      intermediate, immediate labelling
      and package leaflet)

      Positive (partial)

      17/Jun/21

      Filsuvez (birch bark extract) Product information

      N/A

      Authorised

      EMEA/H/C/005095

      Carvykti

      Translation exemption (outer and
      immediate labelling)

      Positive

      17/Jun/21

      Carvykti (Ciltacaptagene autoleucel) - Carvykti (ciltacabtagene
      Product information
      autoleucel) - Assessment report

      Authorised

      EMEA/H/C/005467

      Voraxaze

      Translation exemption (outer,
      intermediate, immediate labelling
      and package leaflet)

      Positive (partial)

      17/Jun/21

      Voraxaze (glucarpidase) - Product
      information

      Authorised

      EMEA/H/C/005501

      Nexviadyme

      Omission of particulars (immediate labelling)

      17/Jun/21

      Nexviadyme (avalglucosidase alfa) - Nexviadyme (avalglucosidase
      Product information
      alfa) - Assessment report

      Authorised

      EMEA/H/C/004662

      Abecma

      Omission of particulars (outer and immediate Positive (partial)
      labelling)

      03/Jun/21

      Abecma (idecabtagene vicleucel) Product information

      Abecma (idecabtagene vicleucel) Assessment report

      Authorised

      EMEA/H/C/004275/II/0021

      Crysvita

      Positive

      06/May/21

      Crysvita (burosumab) - Product
      information

      N/A

      Authorised

      EMEA/H/C/005475

      Voxzogo

      Positive (partial)

      04/Mar/21

      Voxzogo (vosoritide) - Product
      information

      Voxzogo (vosoritide) - CHMP
      assessment report

      Authorised

      EMEA/H/C/005737

      Jcovden

      Omission of particulars (outer, immediate
      labelling and package leaflet)

      Positive

      01/Mar/21

      Authorised

      EMEA/H/C/005327

      Abevmy

      Omission of particulars (immediate labelling)

      Positive

      JCOVDEN [COVID-19 vaccine
      (Ad26.COV2-S [recombinant]) Product information
      Abevmy (bevacizumab) - Product
      information

      JCOVDEN [COVID-19 Vaccine
      Janssen (Ad26.COV2-S,
      recombinant)] - Assessment
      Abevmy (bevacizumab) Assessment report

      Translation exemption (outer,
      immediate labelling and package
      leaflet)

      Positive

      Omission of particulars (immediate labelling)

      Translation exemption (outer,
      intermediate and immediate
      labelling)

      Translation exemption (outer,
      immediate labelling and package
      leaflet)

      Translation exemption (outer,
      immediate labelling and package
      leaflet)
      Translation exemption (outer and
      immediate labelling)

      Positive

      Positive (partial)

      Omission of particulars (immediate labelling)

      Positive

      Omission of particulars (immediate labelling)

      Positive (partial)

      Translation exemption (outer labelling)

      Positive

      Positive (partial)

      Positive

      Translation exemption (outer, immediate
      labelling and package leaflet)

      Positive

      13/Jan/21

      Paxlovid (nimatrelvir + ritonavir) Assessment report

      Voraxaze (glucarpidase) Assessment report

      Authorised

      EMEA/H/C/005791

      Spikevax

      Omission of particulars (outer, immediate
      labelling and package leaflet)

      Translation exemption (outer, immediate
      labelling and package leaflet)

      Positive

      01/Jan/21

      Spikevax - Product information

      Spikevax - Assessment report

      Authorised

      EMEA/H/C/005735

      Comirnaty

      Omission of particulars (outer and immediate Positive
      labelling)

      Translation exemption (outer and immediate
      labelling)

      Positive

      17/Dec/20

      Comirnaty (tozinameran,
      tozinameran/riltozinameran,
      tozinameran/famtozinameran) Alymsys (bevacizumab) - Product
      information

      Comirnaty (tozinameran,
      tozinameran/riltozinamearn,
      tozinamearn/famtozinameran) N/A

      Authorised

      EMEA/H/C/005286

      Alymsis

      Omission of particulars (immediate labelling)

      Positive

      20/Oct/20

      Authorised

      EMEA/H/C/005556

      Oyavas

      Omission of particulars (immediate labelling)

      Positive

      20/Oct/20

      Oyavas (bevacizumab) - Product
      information

      N/A

      Authorised

      EMEA/H/C/005145

      Evrysdi

      Omission of particulars (immediate labelling)

      Negative

      20/Oct/20

      Evrysdy (risdiplam) - Product
      information

      Evrysdi (risdiplam) - Assessment
      report

      Authorised

      EMEA/H/C/005089

      Imcivree

      20/Oct/20

      Imcivree (setmelanotide) - Product
      information

      Imcivree (setmelanotide) Assessment report

      Authorised

      EMEA/H/C/004662

      Abecma

      Omission of particulars (outer and
      intermediate labelling)

      Positive (partial)

      20/Oct/20

      Abecma (idecabtagene vicleucel) Product information

      Abecma (decabtagene vicleucel) Assessment report

      Authorised

      EMEA/H/C/004731

      Breyanzi

      Omission of particulars (outer and
      intermediate labelling)

      Positive (partial)

      20/Oct/20

      Breyanzi (lisocabtagene maraleucel) - N/A
      Product information

      Authorised

      EMEA/H/C/005386

      Phesgo

      Omission of particulars (immediate labelling)

      Positive

      13/Oct/20

      EMEA/H/C/005102

      Tecartus

      Omission of particulars (immediate labelling)

      Positive

      05/Oct/20

      Authorised

      EMEA/H/C/005675

      Vaxzevria

      Omission of particulars (outer and immediate Positive
      labelling)

      Phesgo (pertuzumab/trastuzumab) - Phesgo (pertuzumab /
      Product information
      trastuzumab) - Assessment
      report
      Tecartus (autologous anti-CD19Tecartus (autologous anti-CD19transduced CD3+ cells) - Product
      transduced CD3+ cells) information
      Assessment report
      Vaxzevria - Product information
      Vaxzevria - Assessment report

      Authorised

      Authorised

      EMEA/H/C/005246

      Byfavo

      Omission of particulars (immediate labelling)

      Positive

      16/Jun/20

      Byfavo (remimazolam) - Product
      information

      Byfavo (remimazolam) Assessment report

      Authorised

      EMEA/H/C/004586

      Exparel liposomal

      Omission of particulars (immediate labelling)

      Positive

      16/Jun/20

      Exparel liposomal (bupivacaine) Product information

      Exparel liposomal (bupivacaine) Assessment report

      Authorised

      EMEA/H/C/004954/X/0004/G

      Ultomiris

      Omission of particulars (immediate labelling)

      Positive

      16/Jun/20

      Ultomiris (ravulizumab) - Product
      information

      N/A

      Authorised

      EMEA/H/C/004976

      Vocabria

      Omission of particulars (immediate labelling)

      Positive

      16/Jun/20

      Vocabria (cabotegravir) - Product
      information

      N/A

      Authorised

      EMEA/H/C/005060

      Rekambys

      Omission of particulars (immediate labelling)

      Positive

      16/Jun/20

      Rekambys (rilpivirine) - Product
      information

      N/A

      Authorised

      EMEA/H/C/005436

      Minjuvi

      Omission of particulars (immediate labelling)

      Positive

      16/Jun/20

      Minjuvi (tafasitamab) - Product
      information

      N/A

      Authorised

      EMEA/H/C/005681

      Pepaxti

      Omission of particulars (immediate labelling)

      Positive

      16/Jun/20

      Pepaxti (melphalan flufenamide) Product information

      N/A

      Authorised

      EMEA/H/C/004379

      Amglidia

      Translation exemption (outer,
      immediate labelling and package
      leaflet)

      Negative

      16/Jun/20

      Amglidia (glibenclamide) - Product
      information

      N/A

      Authorised

      EMEA/H/C/005271

      Zokinvy

      Translation exemption (outer,
      immediate labelling and package
      leaflet)

      Positive

      16/Jun/20

      Zokinvy (lonafarnib) - Product
      information

      N/A

      Authorised

      EMEA/H/C/002393

      Defitelio

      Translation exemption (outer,
      immediate labelling and package
      leaflet)

      Positive (partial)

      16/Jun/20

      Defitelio (defibrotide) - Product
      information

      N/A

      Authorised

      EMEA/H/C/005622

      Veklury

      15/May/20

      Veklury (remdesivir) - Product
      information

      Veklury (remdesivir) Assessment report

      Authorised

      EMEA/H/C/005269

      Kaftrio

      Translation exemption (outer,
      intermediate, immediate labelling
      and package leaflet)

      Positive (partial)

      22/May/20

      Kaftrio
      (elexacaftor/tezacaftor/ivacaftor) Product information

      N/A

      Authorised

      EMEA/H/C/005167

      Dovprela

      Translation exemption (outer and
      immediate labelling)

      Positive

      27/Mar/20

      Dovprela (pretomanid) - Product
      information

      Dovprela (pretomanid) Assessment report

      Authorised

      EMEA/H/C/004077/X/0032

      Darzalex

      20/Mar/20

      Darzalex (daratumumab) - Product
      information

      N/A

      Authorised

      EMEA/H/C/002614

      Sirturo

      Translation exemption (outer and
      immediate labelling)

      Positive

      03/Mar/20

      Sirturo (bedaquiline) - Product
      information

      N/A

      Authorised

      EMEA/H/C/005321

      Libmeldy

      Translation exemption (outer,
      intermediate, immediate labelling
      and lot information sheet)

      Positive

      03/Mar/20

      Libmeldy (atidarsagene autotemcel) - Libmeldy (atidarsagene
      Product information
      autotemcel) - Assessment report

      Authorised

      EMEA/H/C/004849

      Idefirix

      Translation exemption (outer and
      immediate labelling)

      Positive

      03/Mar/20

      Idefirix (imlifidase) - Product
      information

      Idefirix (imlifidase) - Assessment
      report

      Authorised

      EMEA/H/C/000829/X/0122/G

      Pradaxa

      03/Mar/20

      Pradaxa (dabigatran etexilate) Product information

      Pradaxa (dabigatran etexilate) Assessment report

      Translation exemption (outer and
      immediate labelling)

      Positive

      Positive

      Omission of particulars (immediate labelling)

      Omission of particulars (immediate labelling)

      Omission of particulars (immediate labelling)

      Omission of particulars (immediate labelling)

      Positive

      Positive

      Positive

      Positive

      Translation exemption (outer and immediate
      labelling)

      Positive

      07/Jul/20

      Authorised

      EMEA/H/C/003855

      Coagadex

      Translation exemption (outer and
      immediate labelling)

      Positive

      Authorised

      EMEA/H/C/005352

      Upstaza

      Translation exemption (outer and
      immediate labelling)

      Positive (partial)

      Authorised

      EMEA/H/C/003855

      Coagadex

      Translation exemption (outer and
      immediate labelling)

      Positive

      Authorised

      EMEA/H/C/004829

      Fetcroja

      Authorised

      EMEA/H/C/005169

      Obiltoxaximab SFL

      Translation exemption (outer
      labelling and package leaflet)

      Authorised

      EMEA/H/C/005830

      Roctavian

      Translation exemption (outer
      labelling and package leaflet)

      Authorised

      EMEA/H/C/005205

      Zynrelef

      Omission of particulars (immediate labelling)

      Positive

      08/Oct/19

      Authorised

      EMEA/H/C/003860/N/0027

      Nucala

      Omission of particulars (immediate labelling)

      Positive

      08/Oct/19

      Nucala (mepolizumab) - Product
      information

      N/A

      Authorised

      EMEA/H/C/004808

      Recarbrio

      Omission of particulars (immediate labelling)

      Positive

      08/Oct/19

      Authorised

      EMEA/H/C/004750

      Zolgensma

      Translation exemption (outer and
      immediate labelling)

      Positive (partial)

      26/Mar/19

      Recarbrio
      (imipenem/cilastatin/relebactam) Product information
      Zolgensma (Onasemnogene
      abeparvovec) - Product information

      Authorised

      EMEA/H/C/005407

      Sibnayal

      Translation exemption (outer and
      immediate labelling)

      Positive

      26/Mar/19

      Sibnayal (potassium citrate and
      potassium hydrogen carbonate) Product information

      Recarbrio
      (imipenem/cilastatin/relebactam) Assessment report
      Zolgensma (Onasemnogene
      abeparvovec) - Assessment
      report
      Sibnayal (potassium citrate and
      potassium hydrogen carbonate) Assessment report

      Authorised

      EMEA/H/C/005830

      Roctavian

      Translation exemption (outer and
      immediate labelling)

      Positive (partial)

      26/Mar/19

      Authorised

      EMEA/H/C/004282

      Vyxeos liposomal

      Translation exemption (outer,
      immediate labelling and package
      leaflet)

      Positive (partial)

      09/Oct/18

      ROCTAVIAN (valoctocogene
      Roctavian (valoctocogene
      roxaparvovec) - Product information roxaparvovec) - Assessment
      report
      Vyxeos liposomal
      N/A
      (daunorubicin/cytarabine) - Product
      information

      Authorised

      EMEA/H/C/005407

      Sibnayal

      Translation exemption (outer and
      immediate labelling)

      Positive

      09/Oct/18

      Sibnayal (potassium citrate and
      potassium hydrogen carbonate) Product information

      Sibnayal (potassium citrate and
      potassium hydrogen carbonate) Assessment report

      Authorised

      EMEA/H/C/004275

      Crysvita

      Translation exemption (outer,
      immediate labelling and package
      leaflet)

      Positive (partial)

      Oct/17

      Crysvita (burosumab) - Product
      information

      Crysvita (busorumab) Assessment report

      Omission of particulars (immediate labelling)

      Positive (partial)

      03/Mar/20

      Coagadex (human coagulation factor N/A
      X) - Product information

      03/Mar/20

      Upstaza (eladocagene exuparvovec) - Upstaza (eladocagene
      Product information
      exuparvovec) - Assessment
      report
      Coagadex (human coagulation factor N/A
      X) - Product information

      13/Jan/20

      Omission of particulars (immediate labelling)

      19/Nov/19

      Fetcroja (cefiderocol) - Product
      information

      Positive (partial)

      08/Oct/19

      Positive (partial)

      08/Oct/19

      Obiltoxaximab SFL (obiltoxaximab) - Obiltoxaximab SFL
      Product information
      (obiltoxaximab) - Assessment
      report
      ROCTAVIAN (valoctocogene
      Roctavian (valoctocogene
      roxaparvovec) - Product information roxaparvovec) - Assessment
      report
      Zynrelef (bupivacaine/meloxicam) - Zynrelef (bupivacaine/meloxicam)
      Product information
      - Assessment report

      Omission of particulars (immediate labelling)

      Omission of particulars (outer labelling)

      Positive

      Negative

      Positive

      Fetcroja (cefiderocol) Assessment report

      18 April 2024
      EMA/934543/2022 Rev.3
      Human Medicines Division

      Table of decisions of labelling exemption requested with the aim to create multilingual packages and examined by the Quality Review of Documents (QRD) Group
      Related information
      Exemptions to labelling and package-leaflet obligations | European Medicines Agency
      Recommendations for the implementation of the exemptions to the labelling and package leaflet obligations in the centralised procedure

      MA status

      Product number

      Product name

      Request for omission of particulars

      Outcome request for Request for translation exemption
      omission of
      particulars

      Authorised

      EMEA/H/C/005107/N/0022

      Roclanda

      Omission of particulars (immediate labelling)

      Positive

      Authorised

      EMEA/H/C/004452/X/0028

      Erleada

      Omission of particulars (immediate labelling)

      Authorised

      EMEA/H/C/000697

      Suboxone

      Authorised

      EMEA/H/C/005843

      Authorised

      Product information

      Assessment report

      21/Nov/23

      Roclanda (netarsudil
      mesylate/latanoprost) - Product
      information

      N/A

      Positive

      10/Mar/23

      Erleada, INN - apalutamide
      (europa.eu)

      Erleada (apalutamide) Assessment report

      Omission of particulars (immediate labelling)

      Positive

      13/Oct/22

      Suboxone (naloxone) - Product
      information

      N/A

      Opzelura

      Omission of particulars (immediate labelling)

      Positive (partial)

      13/Oct/22

      Opzelura (ruxolitinib) - Product
      information

      Opzelura (Ruxolitinib ) Assessment report

      EMEA/H/C/005361

      Akeega

      Omission of particulars (immediate labelling)

      Positive

      14/Jun/22

      Akeega (niraparib/abiraterone
      acetate) - Product information

      N/A

      Authorised

      EMEA/H/C/002465/X/0035

      Procysbi

      Omission of particulars (immediate labelling)

      Positive

      16/Nov/21

      Procysbi (mercaptamine
      bitartrate) - Product information

      N/A

      Authorised

      EMEA/H/C/005367

      Skytrofa

      Omission of particulars (immediate labelling)

      Positive (partial)

      17/Jun/21

      Skytrofa (lonapegsomatropin) Product information

      Skytrofa (lonapegsomatropin) Assessment report

      Authorised

      EMEA/H/C/000610/X/0063

      Noxafil

      Omission of particulars (immediate labelling)

      Positive

      17/Jun/21

      Noxafil (posaconazole) - Product
      information

      N/A

      Authorised

      EMEA/H/C/005267

      Ryeqo

      Omission of particulars (immediate labelling)

      Positive

      04/Mar/21

      Ryeqo
      N/A
      (Relugolix/Estradiol/Norethistero
      ne acetate) - Product information

      Authorised

      EMEA/H/C/005117

      Ozawade

      Omission of particulars (outer and immediate labelling)

      Positive

      04/Mar/21

      Ozawade (Pitolisant) - Product
      information

      Ozawade (Pitolisant) Assessment report

      Authorised

      EMEA/H/C/005208

      Ayvakyt

      Omission of particulars (immediate labelling)

      Negative

      20/Jun/20

      AYVAKYT (avapritinib) - Product
      information

      N/A

      Authorised

      EMEA/H/C/004835

      Zeposia

      Omission of particulars (immediate labelling)

      Positive (partial)

      08/Oct/19

      Zeposia (ozanimod) - Product
      information

      Zeposia (ozanimod) - Public
      assessment report

      Authorised

      EMEA/H/C/005243

      Lacosamide UCB

      Omission of particulars (immediate labelling)

      Positive

      08/Oct/19

      Lacosamide UCB (lacosamide) Product information

      N/A

      Authorised

      EMEA/H/C/004452

      Erleada

      Omission of particulars (immediate labelling)

      Positive

      09/Oct/18

      Erleada (apalutamide) - Product
      information

      Erleada (apalutamide) - Public
      assessment report

      Translation exemption (immediate labelling)

      Outcome translation Outcome date
      exemption

      Positive

Data Center World’s Expo Hall to Feature Hundreds of Innovative Products and Services Data Center Facilities and IT Professionals Need to Know to Plan, Manage and Optimize Data Centers

Retrieved on: 
Monday, April 8, 2024
Networks, Internet, Data Management, Technology, Software, Transfer, LTD, Transport, Carbon, HVAC, Starline, HTF, Cavitation, Virginia Transformer Corporation, Network throughput, Vertiv, MVA, Exhibition, Safety, DCIM, Fiber, Electricity, Control, Server Technology, DLC, GIGABYTE, PEAK, AI, Fluid mechanics, Network, Expo Hall, Gesellschaft mit beschränkter Haftung, Energy, GWP, Mining, Immersion, Corrosion engineering, Temperature, CPI, Hybrid, Recycling, HPC, Corrosion, Data center, DDC, Peak (automotive products), Business analyst, Dell

Data Center World , the leading global conference for data center facilities and IT professionals, will feature hundreds of innovative products and services in the Expo Hall.

Key Points: 
  • Data Center World , the leading global conference for data center facilities and IT professionals, will feature hundreds of innovative products and services in the Expo Hall.
  • The technologies will provide data center facilities and IT professionals with all the information they need to plan, manage and optimize their data centers.
  • Data Center World is AFCOM’s annual gathering of IT and data center professionals.
  • Future-proof your data center with hybrid liquid-air cooling, intelligent power handling, and enterprise environment controls by DDC’s DCIM monitoring software.

Google Cloud and Mercedes-Benz Deepen Partnership to Power New Customer Experiences with AI

Retrieved on: 
Tuesday, April 9, 2024
Cloud, Google Cloud, Partnership, BigQuery, Mercedes-Benz, Research, ADAS, AI, Software, LAS, MVA, Advanced driver-assistance system, Gemini, System, Customer service

LAS VEGAS, April 9, 2024 /PRNewswire/ -- Cloud Next '24, LAS VEGAS — Google Cloud today announced an expansion of its strategic partnership with Mercedes-Benz, helping the automaker transform key customer experiences with AI and generative AI (gen AI) technologies on Google Cloud's Vertex AI platform.

Key Points: 
  • Google Cloud AI technologies to propel customer-facing use cases across e-commerce, customer service, and marketing
    LAS VEGAS, April 9, 2024 /PRNewswire/ -- Cloud Next '24, LAS VEGAS — Google Cloud today announced an expansion of its strategic partnership with Mercedes-Benz, helping the automaker transform key customer experiences with AI and generative AI (gen AI) technologies on Google Cloud's Vertex AI platform.
  • With Google Cloud, Mercedes-Benz is building new ways to deliver the most intelligent vehicles to our customers and to create personalized, intuitive experiences," said Ola Källenius, Chief Executive Officer, Mercedes-Benz.
  • Finally, Mercedes-Benz has also been leveraging Google Cloud's Vertex AI platform to maximize the value of its customer data, which it manages with Google Cloud's data warehouse platform, BigQuery.
  • The partnership has also included YouTube as part of the Mercedes infotainment experience, and the carmaker leveraging a number of Google Cloud's AI, data, and open infrastructure solutions.

Global Transformer Report 2023-2024: Statistics and Analysis, Descriptive Market and Technical Information - ResearchAndMarkets.com

Retrieved on: 
Monday, March 11, 2024
Technology, Energy, Other Energy, Other Technology, EVS, Electricity, MVA, Dry, Transformer

The "Transformer Report Edition 11, 2023 - Vol 1 & 2" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Transformer Report Edition 11, 2023 - Vol 1 & 2" report has been added to ResearchAndMarkets.com's offering.
  • This combination has caused an almost unprecedented increase in the transformer market.
  • Unveiling a New Standard of Market Reporting: Redefining Industry Norms
    Annual market 2021-2028 in USD and MVA, installed capacity, and average price in USD/kVA
    In this 11th edition of the Transformer Report an analysis of the accuracy of the reported market data is introduced and discussed.
  • Market analysis of transformer production, imports, exports, sales - Power transformers (PT) / Distribution transformers (DT) / Dry-type transformers (Dry MV and Dry LV)
    Prices and factors determining transformer prices - consumption, materials price trends, inflation

GeoVax Achieves Milestone in Transition to Commercially Validated Manufacturing System

Retrieved on: 
Wednesday, March 6, 2024
COVID-19, Biotechnology, GeoVax, City, Cancer, Immunodeficiency, Vaccine, CDMO, Biomedicine, Oxford Biomedica, Good, Infection, Genetics, CGMP, MVA, CEF

ATLANTA, GA, March 06, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced a significant milestone toward implementation of a validated chicken embryonic fibroblast (CEF) based production system for the company’s MVA-based vaccines, with the release of its first lot of GEO-CM04S1 (next-generation Covid-19 vaccine) produced with a commercial manufacturing platform. This milestone marks the successful completion of the transfer and scale-up of manufacturing from the research-focused Center for Biomedicine & Genetics at City of Hope (Duarte, CA) to the experienced CDMO ABL Europe (a subsidiary of Oxford Biomedica), the Company’s cGMP (current Good Manufacturing Procedures) manufacturing partner.

Key Points: 
  • This milestone marks the successful completion of the transfer and scale-up of manufacturing from the research-focused Center for Biomedicine & Genetics at City of Hope (Duarte, CA) to the experienced CDMO ABL Europe (a subsidiary of Oxford Biomedica), the Company’s cGMP (current Good Manufacturing Procedures) manufacturing partner.
  • David Dodd, GeoVax President and CEO, commented, “The successful establishment of cGMP production at ABL Europe represents great progress for GeoVax and the CM04S1 program.
  • This latest manufacturing milestone also validates our choice of ABL Europe as our partner for cGMP production of our MVA-based vaccine candidates.
  • These developments signify GeoVax's commitment to improving vaccine accessibility through cost-effective and scalable manufacturing processes.”

GeoVax Reports 2023 Year-End Financial Results and Provides Business Update

Retrieved on: 
Thursday, February 29, 2024
Research, Smallpox, GeoVax, Matrix (biology), Neoplasm, Vaccine, Virus-like particle, ABL, COVID-19, Biotechnology, NIH, Hospital, Security (finance), Congress, Immunity, CGMP, DNA, Therapy, Pfizer, Acute leukemia, AACR, MUC-1, Conference, Vaccination, Safety, Chronic lymphocytic leukemia, Antigen, Patent, Clinical trial, Infection, MVA, SARS-CoV-2, Messenger, Cancer, CLL, Immunodeficiency, Risk, VP40, Death, Patient, HIV, Travel

ATLANTA, GA, Feb. 29, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced its financial results and key operational accomplishments for the year ended December 31, 2023.

Key Points: 
  • ET
    ATLANTA, GA, Feb. 29, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced its financial results and key operational accomplishments for the year ended December 31, 2023.
  • Results to date have demonstrated safety of this therapy and consistent reduction in treated tumors.
  • Cash Position: GeoVax reported cash balances of $6.5 million on December 31, 2023, as compared to $27.6 on December 31, 2022.
  • ET today, February 29, 2024, to review financial results and provide an update on corporate developments.