Filo

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

      13/Jan/20

      Omission of particulars (immediate labelling)

      19/Nov/19

      Fetcroja (cefiderocol) - Product
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      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
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      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
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      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

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      EMEA/H/C/005843

      Authorised

      Product information

      Assessment report

      21/Nov/23

      Roclanda (netarsudil
      mesylate/latanoprost) - Product
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      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
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      N/A

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      Positive (partial)

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      Opzelura (ruxolitinib) - Product
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      Opzelura (Ruxolitinib ) Assessment report

      EMEA/H/C/005361

      Akeega

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      Positive

      14/Jun/22

      Akeega (niraparib/abiraterone
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      N/A

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      EMEA/H/C/002465/X/0035

      Procysbi

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      16/Nov/21

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      Authorised

      EMEA/H/C/005367

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      Positive (partial)

      17/Jun/21

      Skytrofa (lonapegsomatropin) Product information

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      EMEA/H/C/000610/X/0063

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      EMEA/H/C/005267

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      Positive

      04/Mar/21

      Ryeqo
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      EMEA/H/C/005117

      Ozawade

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      Positive

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      Ozawade (Pitolisant) - Product
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      Ozawade (Pitolisant) Assessment report

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      EMEA/H/C/005208

      Ayvakyt

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      EMEA/H/C/004835

      Zeposia

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      Zeposia (ozanimod) - Product
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      EMEA/H/C/005243

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      08/Oct/19

      Lacosamide UCB (lacosamide) Product information

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      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

Mirasol Video Update on Sobek Copper-Gold Project – Highlighting the Recent Strategic Addition of Adjacent Rosita Property in Vicuña District, Chile

Retrieved on: 
Monday, March 4, 2024
MRZ, IEX, Mining, OTC, News, Booth, Metro Toronto Convention Centre, PDAC, Mirasol, Heart, Filo

The video presentation highlights the landmark agreement doubling the size of Mirasol’s property in the Vicuña District, combining Sobek with the adjacent Sociedad Química y Minera de Chile SA (“SQM”) Rosita property ( see news release dated February 14, 2024 ).

Key Points: 
  • The video presentation highlights the landmark agreement doubling the size of Mirasol’s property in the Vicuña District, combining Sobek with the adjacent Sociedad Química y Minera de Chile SA (“SQM”) Rosita property ( see news release dated February 14, 2024 ).
  • The eastern portion of the Rosita property positions Mirasol within 3 kilometers of the giant Filo Del Sol Project and the Potro Prospect within the Sobek North block is 3 kilometers from Lunahuasi discovery, both within the heart of the Vicuña Copper-Gold district.
  • The recent exploration progress at Sobek is also summarised in the video presentation, including the progress made refining high-priority drill targets at the Sobek Central VN Zone and Sobek North El Potro Progress.
  • The video presentation is available here on the Mirasol website: mirasolresources.com.

Climate Solutions Prize: More than $1.3 million awarded to Israeli Climate tech startups

Retrieved on: 
Wednesday, February 28, 2024
Temasek Foundation, Innovation, EV, Amazon Web Services, Building, TRL, Research, Multinational corporation, TEL, Partnership, Data compression, COP28, Hydrogen, Primary energy, Carbon, Nanotechnology, Climate change, Stock, CSP, Content as a service, Non-governmental organization, Ecosystem, Spore, Disruption, Plastic, Filo, E.ON, Biodegradable waste, Green Deal, Renewable energy

TEL AVIV, Israel, Feb. 28, 2024 /PRNewswire/ -- $1.3 million dollars were awarded to Israeli climate tech startups today as part of the startup track of the Climate Solutions Prize (CSP), an initiative that incentivizes climate innovation to address the global climate crisis. The startup track was led by Startup Nation Central together with Climate Solutions Prize Organization.

Key Points: 
  • TEL AVIV, Israel, Feb. 28, 2024 /PRNewswire/ -- $1.3 million dollars were awarded to Israeli climate tech startups today as part of the startup track of the Climate Solutions Prize (CSP), an initiative that incentivizes climate innovation to address the global climate crisis.
  • It aims to be a catalyst for climate tech innovation in both breakthrough research and the startup ecosystem.
  • The 2023 Israeli Climate Tech Landscape Map details leading companies with solutions addressing the climate crisis.
  • The Breakthrough Research Prize track was awarded in January to three Israeli research teams to propel their work on promising solutions to the climate crisis.

Mirasol Doubles the Sobek Copper-Gold Project in Vicuña District, Chile, through Option Agreement with SQM on Adjacent Rosita Property

Retrieved on: 
Wednesday, February 14, 2024
NSR, MRZ, Mining, OTC, Heart, Filo, SQM

The SQM Property (“Rosita”) covers 11,500 hectares extending the Sobek Project to the west and to the east, and unifying the Sobek Central block with the Sobek North block which was an important factor in this consolidation.

Key Points: 
  • The SQM Property (“Rosita”) covers 11,500 hectares extending the Sobek Project to the west and to the east, and unifying the Sobek Central block with the Sobek North block which was an important factor in this consolidation.
  • The eastern portion of the Rosita property positions Mirasol within 3 kilometers of the giant Filo Del Sol Project and the Sobek North block is 3 kilometers from Lunahuasi discovery both within the heart of the Vicuña Copper-Gold district.
  • “The strategic expansion of the Sobek Project to include the sought after SQM Rosita property firmly secures Mirasol as a key player amongst industry-leading companies in the globally recognized Vicuña Copper-Gold district,” Mirasol’s President and CEO Tim Heenan stated.
  • Key Terms of the Agreement:
    SQM has granted Mirasol the exclusive option to earn 80% of the Rosita Project over 6 years, subject to a 2.0% NSR royalty, by:

Global Copper Mining Market Size Projected to Reach $11.17 Billion By 2030 as Investments in Infrastructure Jump

Retrieved on: 
Thursday, January 11, 2024
EVS, Lundin Mining, FWB, Knowledge, Silver, Table, 3D, VMS, Construction, Rio Tinto, Technical report, LUMI, Learning, Heart, Culture, Zone, Mining, Copper, Zinc, Disclosure, Porcupine, MOST, Transport, Lens, PALM, Nickel, Senior, Oyu Tolgoi mine, MRE, Rio Tinto (corporation), Developed country, Gold, TSX, Technical, OTCQX, FIL, Exercise, Filo, JDS, Haines Borough, Alaska, Electronics, FCX, News, LUN, Urbanization, Molybdenum, Project, ITS

A report from Fortune Business Insights said that the global copper mining market size, which was valued at USD 8.44 billion in 2022 is projected to grow from USD 8.87 billion in 2023 to USD 11.17 billion by 2030, exhibiting a CAGR of 3.3% during the forecast period.

Key Points: 
  • A report from Fortune Business Insights said that the global copper mining market size, which was valued at USD 8.44 billion in 2022 is projected to grow from USD 8.87 billion in 2023 to USD 11.17 billion by 2030, exhibiting a CAGR of 3.3% during the forecast period.
  • Copper is essential for constructing infrastructure projects such as buildings, bridges, and electrical systems.
  • Hence, government initiatives and policies promoting infrastructure development can significantly boost the market.
  • The mining industry, mainly of copper, will likely increase significantly due to increased investment in construction and construction projects.

Mirasol Advances Exploration Program at Sobek Copper-Gold Project in Chile in Preparation for Drilling

Retrieved on: 
Thursday, December 14, 2023
Copper, Electricity, Filo, Gold, Sol, News, Rodrigo (musician), MRZ, Project, OTC, Molybdenum

VANCOUVER, British Columbia, Dec. 14, 2023 (GLOBE NEWSWIRE) -- Mirasol Resources Ltd. (TSX-V: MRZ) (OTC: MRZLF) (the “Company” or “Mirasol”) is pleased to report that exploration has resumed at the Company’s 100%-owned Sobek Copper-Gold Project (“Sobek” or “the Project”) in the Vicuña Copper-Gold-Silver District of Chile.

Key Points: 
  • VANCOUVER, British Columbia, Dec. 14, 2023 (GLOBE NEWSWIRE) -- Mirasol Resources Ltd. (TSX-V: MRZ) (OTC: MRZLF) (the “Company” or “Mirasol”) is pleased to report that exploration has resumed at the Company’s 100%-owned Sobek Copper-Gold Project (“Sobek” or “the Project”) in the Vicuña Copper-Gold-Silver District of Chile.
  • Drilling is scheduled to start at Sobek Central early in Q1 2024, following which the drill is expected to be mobilized to Sobek North.
  • “The Sobek project is located in the middle of the high-profile Vicuña Copper-Gold district in northeast Chile, positioning Mirasol adjacent to the north-south trend which hosts Filo del Sol and NGEx’s Lunahuasi discovery,” Mirasol’s President Tim Heenan stated.
  • The Project comprises a large block totaling 11,120 ha of exploration claims in three strategic locations, the North, Central and South blocks within the Vicuña Copper-Gold-Silver District.

Why Uncertain Times are Fueling Demand for Precious Metals as Safe-Haven Investments

Retrieved on: 
Thursday, November 2, 2023
Aurora, FNM, Pan-American, Press release, Palladium, PDT, Filo, Annual report, PAAS, Silver, Form 10-K, Platinum, Gold, Malartic, Metal, News, Agnico Eagle, ANY, Hercules, Safety, Meadowbank, La Colorada, FIL, Security (finance), NW, Copper, Pan American Silver, Research, NOT, PALM, Detour Gold, TSX, AISC, Canadian Malartic Corporation, NEVER, NYSE, OTCQX, OTCQB, Environment, AEM, Uncertainty, Mining, Printed circuit board, Uranium mining, Gum arabic

PALM BEACH, Fla., Nov. 2, 2023 /PRNewswire/ -- Economic uncertainty, a major driver of the present precious metal market recovery, looms big, in the global financial arena. Precious metals such as gold, silver, platinum, and palladium have traditionally been considered safe-haven investments, but current market conditions have increased the value of these assets. In an era of economic turbulence and uncertainty, precious metals shine as a beacon of financial security.  Concerns about the purchasing power of money have increased the appeal of gold, silver, platinum, and palladium. The low-interest-rate environment, which central banks have maintained to spur economic recovery, has made traditional interest-bearing investments less appealing. Investors have also become more concerned about stock market volatility and the ever-present risk of a market correction or disaster. Economic instability has created a desire for diversity, pushing investors to add precious metals to their portfolios to limit risks and hedge against the chance of a quick market recession.  A report from Fact.MR projects that the global precious metals market is projected to reach a valuation of US$ 445.76 billion by 2033. It said the gold segment has witnessed a surge in demand over the past few years and accounted for a market share of around 81.5% in 2022 and the silver segment is forecasted to expand at a CAGR of 2.5% over the next 10 years.  Active mining companies in markets include:  Regency Silver Corp. (OTCQB: RSMXF) (TSX-V: RSMX), Agnico Eagle Mines Limited (NYSE: AEM) (TSX: AEM), Hercules Silver Corp. (OTCQB: BADEF) (TSX-V: BIG), Pan American Silver Corp. (NYSE: PAAS) (TSX: PAAS), Filo Corp. (OTCQX: FLMMF) (TSX: FIL).

Key Points: 
  • A report from Fact.MR projects that the global precious metals market is projected to reach a valuation of US$ 445.76 billion by 2033.
  • The Fact.MR report said: "The comeback of safe-haven investments is one of the most noticeable trends in the precious metal market.
  • Institutions such as central banks and huge investment funds are progressively diversifying their portfolios, with precious metals driving market growth.
  • This move not only demonstrates their rising confidence in the long-term value of certain metals but also fuels the demand for precious metals.

Why Uncertain Times are Fueling Demand for Precious Metals as Safe-Haven Investments

Retrieved on: 
Thursday, November 2, 2023
Aurora, FNM, Pan-American, Press release, Palladium, PDT, Filo, Annual report, PAAS, Silver, Form 10-K, Platinum, Gold, Malartic, Metal, News, Agnico Eagle, ANY, Hercules, Safety, Meadowbank, La Colorada, FIL, Security (finance), NW, Copper, Pan American Silver, Research, NOT, PALM, Detour Gold, TSX, AISC, Canadian Malartic Corporation, NEVER, NYSE, OTCQX, OTCQB, Environment, AEM, Uncertainty, Mining, Printed circuit board, Uranium mining, Gum arabic

PALM BEACH, Fla., Nov. 2, 2023 /PRNewswire/ -- Economic uncertainty, a major driver of the present precious metal market recovery, looms big, in the global financial arena. Precious metals such as gold, silver, platinum, and palladium have traditionally been considered safe-haven investments, but current market conditions have increased the value of these assets. In an era of economic turbulence and uncertainty, precious metals shine as a beacon of financial security.  Concerns about the purchasing power of money have increased the appeal of gold, silver, platinum, and palladium. The low-interest-rate environment, which central banks have maintained to spur economic recovery, has made traditional interest-bearing investments less appealing. Investors have also become more concerned about stock market volatility and the ever-present risk of a market correction or disaster. Economic instability has created a desire for diversity, pushing investors to add precious metals to their portfolios to limit risks and hedge against the chance of a quick market recession.  A report from Fact.MR projects that the global precious metals market is projected to reach a valuation of US$ 445.76 billion by 2033. It said the gold segment has witnessed a surge in demand over the past few years and accounted for a market share of around 81.5% in 2022 and the silver segment is forecasted to expand at a CAGR of 2.5% over the next 10 years.  Active mining companies in markets include:  Regency Silver Corp. (OTCQB: RSMXF) (TSX-V: RSMX), Agnico Eagle Mines Limited (NYSE: AEM) (TSX: AEM), Hercules Silver Corp. (OTCQB: BADEF) (TSX-V: BIG), Pan American Silver Corp. (NYSE: PAAS) (TSX: PAAS), Filo Corp. (OTCQX: FLMMF) (TSX: FIL).

Key Points: 
  • A report from Fact.MR projects that the global precious metals market is projected to reach a valuation of US$ 445.76 billion by 2033.
  • The Fact.MR report said: "The comeback of safe-haven investments is one of the most noticeable trends in the precious metal market.
  • Institutions such as central banks and huge investment funds are progressively diversifying their portfolios, with precious metals driving market growth.
  • This move not only demonstrates their rising confidence in the long-term value of certain metals but also fuels the demand for precious metals.

Mirasol Refines Priority Targets Based on Results from Preliminary Drill Program at Sobek Copper Project in Chile

Retrieved on: 
Monday, August 21, 2023
Filo, HSE, 3D, Mirasol, Molybdenum, Orientation, MRZ, Mineral, Gold, Soil, Anomaly, OTC, Weather, Copper, News, Safety, Mining, Rare-earth element, Telescopic sight, Road, Sobek

The drill program was initiated late in the season when road construction allowed access for the drill rig (see news release dated June 27, 2023 ).

Key Points: 
  • The drill program was initiated late in the season when road construction allowed access for the drill rig (see news release dated June 27, 2023 ).
  • The initial targets will require follow-up drilling and several other priority targets will also be drill tested when the campaign resumes in Q4 2023.
  • However, these early results have provided some important structural data which will help to refine our drill plans,” Mirasol’s President Tim Heenan stated.
  • “We have only just started to scratch the surface at Sobek and high-priority targets of massive scale remain to be drill tested.

Mirasol Advances Maiden Drill Campaign Testing Initial Targets at Flagship Sobek Copper Project in Chile

Retrieved on: 
Tuesday, June 27, 2023
Filo, Rodrigo (musician), HSE, MRZ, Mineral, CLP, Gold, Anomaly, OTC, ASL, Weather, Copper, VN, Rare-earth element, Uranium mining, Sobek

“The potential for discovery at the high-profile Vicuña Copper-Gold district has motivated us to advance Sobek from initial boots-on-the-ground exploration to the maiden drill campaign at an extraordinary pace.

Key Points: 
  • “The potential for discovery at the high-profile Vicuña Copper-Gold district has motivated us to advance Sobek from initial boots-on-the-ground exploration to the maiden drill campaign at an extraordinary pace.
  • These Mobile MT targets were the initial focus of this season’s maiden drill campaign at Sobek Central.
  • Based on the results from the Mobile MT survey, geochemical soil anomalies and select surface rockchip results Mirasol initiated the maiden drill campaign at Sobek Central.
  • The VN-Zone targets will be the first area of focus for next seasons continuation of the maiden drill campaign at Sobek Central.