Obiltoxaximab

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: 
목요일, 4월 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

NightHawk Biosciences Provides Q1 2023 Business Update

Retrieved on: 
월요일, 5월 15, 2023
NYSE, Nighthawk, Research, CDMO, Investment, Obiltoxaximab, Consultant, Pharmaceutical industry, Cryptocurrency, Scorpius

For the three months ended March 31, 2022 we recognized $0.2 million of grant revenue for qualified expenditures under the CPRIT grant.

Key Points: 
  • For the three months ended March 31, 2022 we recognized $0.2 million of grant revenue for qualified expenditures under the CPRIT grant.
  • As of March 31, 2023, we had a grants receivable balance of $1.5 million for the final CPRIT tranche, and received those funds in April 2023. .
  • Selling, general and administrative expenses were $6.8 million and $3.8 million for the three months ended March 31, 2023 and 2022, respectively.
  • As of March 31, 2023, the Company had approximately $28.6 million in cash, cash equivalents, and short-term investments.

NightHawk Biosciences Provides 2022 Year End Business Update

Retrieved on: 
금요일, 3월 31, 2023
Insurance, Obiltoxaximab, Marketing, Bank statement, Scorpion, CMC, Disclosure, Research, Nighthawk, Sale, Government, Acquisition, Investment, Immune system, Depreciation, NYSE, Cryptocurrency, Pharmaceutical industry, Elusys Therapeutics

For the year ended December 31, 2021, the Company recognized revenue of $2.1 million for qualified expenditures under the CPRIT grant.

Key Points: 
  • For the year ended December 31, 2021, the Company recognized revenue of $2.1 million for qualified expenditures under the CPRIT grant.
  • Selling, general and administrative (“SGA”) expenses for the years ended December 31, 2022 and 2021 were $21.1 million and $16.8 million, respectively.
  • Research and development expenses increased to $23.5 million from $16.5 million for the years ended December 31, 2022 and 2021, respectively.
  • As of December 31, 2022, the Company had approximately $44.3 million in cash, cash equivalents, and short-term investments.

Heat Biologics Announces Planned Name Change to NightHawk Biosciences, Reflecting Company’s Evolution, Therapeutic Pipeline Expansion, Vertical Integration and New Biodefense Capabilities

Retrieved on: 
화요일, 4월 19, 2022
Drug development, Annual report, Thought, Marketing, Adult, Nighthawk, Twitter, Research, Bacillus anthracis, Life, Private Securities Litigation Reform Act, Hypersensitivity, Drug discovery, GLOBE, Anaphylaxis, Terminology, Patient, Sale, Infection, American Association for Cancer Research, Form 10-K, Kansas State University, Scorpion, Efficiency, Growth, Heat Biologics, Company, Immune system, Anthrax, Ecosystem, Discovery, Nasdaq, Maintenance, SEC, Joint Chiefs of Staff, NYSE, Investment, Safety, American Association, Acquisition, Chief of staff, Risk, AACR, Obiltoxaximab, Therapy, Time, Pharmaceutical industry, Pelican, Elusys Therapeutics, Heat

In connection with the name change, the Companys ticker will change to NHWK, effective May 3, 2022.

Key Points: 
  • In connection with the name change, the Companys ticker will change to NHWK, effective May 3, 2022.
  • The Company believes this fully-integrated ecosystem enables a more rapid delivery of medical innovations with increased quality and efficiency.
  • Scorpion is expected to host the grand opening of its San Antonio facility following completion of construction in Q3, 2022.
  • About Heat Biologics / NightHawk Biosciences, Inc.
    Heat Biologics (to become NightHawk Biosciences) is a fully-integrated biopharmaceutical company focused on the development of new drugs from discovery through manufacturing.

Heat Biologics Provides Year-End 2021 Business Update

Retrieved on: 
월요일, 3월 14, 2022
Large-cell lung carcinoma, Maintenance, Contract, D&O, American Association for Cancer Research, Regulatory T cell, Survival, Pathogen, Â, Private Securities Litigation Reform Act, DOD, Infection, IPR, Growth, Severe acute respiratory syndrome coronavirus 2, Therapy, Disease, Program, CMC, NSCLC, Safety, Heat Biologics, Drug development, Company, Marketing, Immune system, FDA, GLOBE, Patient, SEC, Vaccine, Anthrax, Malaria, Time, The American, Annual report, Research, Cancer, Conference, Quality control, Nasdaq, Sale, NIH, Association, Terminology, AACR, D, Investment, Obiltoxaximab, Form 10-K, Acquisition, Efficiency, NYSE, COVID-19, Pharmaceutical industry, Elusys Therapeutics, Heat

DURHAM, N.C., March 14, 2022 (GLOBE NEWSWIRE) -- Heat Biologics, Inc. (Heat) (NYSE American: HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, today provided strategic, financial, and operational updates for the year ended December 31, 2021.

Key Points: 
  • DURHAM, N.C., March 14, 2022 (GLOBE NEWSWIRE) -- Heat Biologics, Inc. (Heat) (NYSE American: HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, today provided strategic, financial, and operational updates for the year ended December 31, 2021.
  • Jeff Wolf, Chief Executive Officer of Heat, commented, 2021 was a transformative year for Heat as we progress our strategic evolution to become a fully-integrated biopharmaceutical company.
  • With the formation of Skunkworx Bio, we have ramped up our in-house discovery of biologics for our preclinical and clinical development efforts.
  • Heat Biologics is a biopharmaceutical company focused on developing first-in-class therapies and vaccines to modulate the immune system.

Elusys Therapeutics Finalizes HHS Contract to Deliver ANTHIM®, Its Treatment for Inhalation Anthrax, to the U.S. Department of Health and Human Services

Retrieved on: 
월요일, 1월 31, 2022
NDS, Traffic barrier, Safety, Risk, Patient, Anaphylaxis, Therapy, Obiltoxaximab, Meningitis, Food, NASDAQ, Assistant, Infection, Headache, Office of the Assistant Secretary for Preparedness and Response, Cough, HHS, Anthrax, Human, Itch, Heat Biologics, Mab, Population, Death, Pharmacokinetics, Diphenhydramine, Hives, ASPR, Adult, Pre-medical, Bacillus anthracis, Hypersensitivity, Injection, Office of Inspector General, U.S. Department of Health and Human Services, Health Canada, GLOBE, Use, Acquisition, Pain, Time, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, FDA, IV, Nasal congestion, Vaccine, Pharmaceutical industry, Bacillus, Elusys Therapeutics, Heat

PARSIPPANY, N.J., Jan. 31, 2022 (GLOBE NEWSWIRE) -- Elusys Therapeutics, Inc. (Elusys) announced today that it has finalized a contract with the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS) for the continued supply of ANTHIM (obiltoxaximab), an anthrax antitoxin, for use against a potential anthrax attack.

Key Points: 
  • If all options are exercised, the total contract value will be $80,864,000 with completion of the contract expected by the first half of 2023.
  • The acquisition is expected to close during the first quarter of 2022 and is subject to customary closing conditions.
  • Elusys, based in Parsippany, NJ, is focused on the development of antibody therapeutics for the treatment of infectious disease.
  • In July 2020, Health Canada approved ANTHIMs New Drug Submission (NDS) for the treatment of inhalation anthrax.

Obiltoxaximab Receives Marketing Authorization From European Commission For The Treatment Of Inhalation Anthrax

Retrieved on: 
수요일, 12월 2, 2020
Medical specialties, Health, Monoclonal antibodies, Obiltoxaximab, Elusys Therapeutics, Immunology, Anthrax, Anthim, Antitoxin

PARSIPPANY, N.J., Dec. 2, 2020 /PRNewswire/ -- Elusys Therapeutics, Inc. (Elusys) today announced that the European Commission has approved obiltoxaximab, the company's monoclonal antibody (mAb) anthrax antitoxin for the treatment of inhalation anthrax.

Key Points: 
  • PARSIPPANY, N.J., Dec. 2, 2020 /PRNewswire/ -- Elusys Therapeutics, Inc. (Elusys) today announced that the European Commission has approved obiltoxaximab, the company's monoclonal antibody (mAb) anthrax antitoxin for the treatment of inhalation anthrax.
  • This EU approval for obiltoxaximab will be automatically converted to a UK marketing authorization on January 1, 2021.
  • SFL Pharmaceuticals Deutschland GmbH (SFL Pharmaceuticals) will act as marketing authorization holder (MAH) in the EU and the UK on behalf of Elusys, the originator of the product.
  • In July 2020, Health Canada approved Anthim's New Drug Submission (NDS) for the treatment of inhalation anthrax.

Obiltoxaximab Receives Marketing Authorization From European Commission For The Treatment Of Inhalation Anthrax

Retrieved on: 
수요일, 12월 2, 2020
Medical specialties, Health, Monoclonal antibodies, Obiltoxaximab, Elusys Therapeutics, Immunology, Anthrax, Anthim, Antitoxin

PARSIPPANY, N.J., Dec. 2, 2020 /PRNewswire/ -- Elusys Therapeutics, Inc. (Elusys) today announced that the European Commission has approved obiltoxaximab, the company's monoclonal antibody (mAb) anthrax antitoxin for the treatment of inhalation anthrax.

Key Points: 
  • PARSIPPANY, N.J., Dec. 2, 2020 /PRNewswire/ -- Elusys Therapeutics, Inc. (Elusys) today announced that the European Commission has approved obiltoxaximab, the company's monoclonal antibody (mAb) anthrax antitoxin for the treatment of inhalation anthrax.
  • This EU approval for obiltoxaximab will be automatically converted to a UK marketing authorization on January 1, 2021.
  • SFL Pharmaceuticals Deutschland GmbH (SFL Pharmaceuticals) will act as marketing authorization holder (MAH) in the EU and the UK on behalf of Elusys, the originator of the product.
  • In July 2020, Health Canada approved Anthim's New Drug Submission (NDS) for the treatment of inhalation anthrax.