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
