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

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