13 September 2017 EMA/704704/2017 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: Diacerein
Procedure no.: PSUSA/00001026/201612
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© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.
Product Name
MRP/DCP Authorisation
MAH of product in the Member
Member State where
(in authorisation country)
Number
State
product is authorised
IDEALITE CAPS 50mg/CAP
not available
50438/15-12-2008
RAFARM SA.
GR
DIACERIL, 50mg/cap,
not available
92283/15/14-1-2016
PROTON PHARMA S.A.
GR
not available
3400938659993
BIOGARAN
FR
MYOBLOC
not available
17277/17-2-2016
GENEPHARM S.A.
GR
DIACEREINE CRISTERS 50
not available
34009 396 564 3 4
CRISTERS
FR
not available
34009 396 566 6 3
CRISTERS
FR
not available
34009 575 770 7 0
CRISTERS
FR
not available
34009 575 771 3 1
CRISTERS
FR
not available
3400938810530
BIOGARAN
FR
not available
90531/14/18/05/2015
VOCATE ΦΑΡΜΑΚΕΥΤΙΚΗ ΑΕ
GR
Diacerein/Norma®
not available
44501/10
NORMA HELLAS S.A.
GR
ART 50 mg, gélule
not available
34009 335 529 3 0
LABORATOIRES NEGMA
FR
ZONDAR 50 mg, gélule
not available
335 530-1
NIVERPHARM
FR
Diacereína NORMON 50
not available
75871
LABORATORIOS NORMON,
ES
National Authorisation Number
καψάκια σκληρά DIACÉRÉINE BIOGARAN® 50 mg, gélule
mg, gélule DIACEREINE CRISTERS 50 mg, gélule DIACEREINE CRISTERS 50 mg, gélule DIACEREINE CRISTERS 50 mg, gélule DIACÉRÉINE REF® 50 mg, gélule Arthrofar: 50mg/cap καψάκιο μαλακό
mg cápsulas duras EFG Artrolyt 50 mg Kapseln
S.A. not available
List of nationally authorised medicinal products Diacerein - PSUSA/00001026/201612 EMA/704704/2017
1-24324
TRB CHEMEDICA (AUSTRIA)
AT
Page 2/4
Product Name
MRP/DCP Authorisation
(in authorisation country)
Number
National Authorisation Number
MAH of product in the Member
Member State where
State
product is authorised
GMBH VERBORIL 50 mg Kapseln
not available
1-24325
TRB CHEMEDICA (AUSTRIA)
AT
GMBH ARTRODAR 50 mg tvrdé
not available
29/0329/01-S
TRB CHEMEDICA (AUSTRIA)
ARTRODAR tvrdé tobolky
not available
29/485/00-C
TRB CHEMEDICA (AUSTRIA)
GLIZOLAN 50 mg cápsulas
not available
64.544
ROTTAPHARM, S.L.
ES
GALAXDAR 50 mg
not available
64.554
LACER S.A.
ES
Artrolyt 50mg cápsulas
not available
2522787
NEO-FARMACÊUTICA, S.A.
PT
Artrolyt 50mg cápsulas
not available
2688687
NEO-FARMACÊUTICA, S.A.
PT
Artrolyt 50mg cápsulas
not available
2522886
NEO-FARMACÊUTICA, S.A.
PT
FISIODAR 50 mg capsule
not available
025448010
ABIOGEN PHARMA S.P.A.
IT
not available
025448022
ABIOGEN PHARMA S.P.A.
IT
not available
NL 30718
MYLAN S.A.S
FR
not available
NL35418
EG LABO - LABORATOIRES
FR
kapsuly
SK
GMBH CZ
GMBH
cápsulas
rigide FISIODAR 50 mg capsule rigide DIACEREINE MYLAN 50 mg, gélule DIACEREINE EG 50 mg, gélule ARTHROREIN 50 mg
EUROGENERICS not available
36155/6-05-2016
σκληρά καψάκια INFLABION®
PHARMANEL COMMERCIAL
GR
PHARMACEUTICAL S.A. not available
List of nationally authorised medicinal products Diacerein - PSUSA/00001026/201612 EMA/704704/2017
36157/8-5-2016
HELP ABEE
GR
Page 3/4
Product Name
MRP/DCP Authorisation
(in authorisation country)
Number
REINOST
not available
Diacereína NORMON 50
not available
MAH of product in the Member
Member State where
State
product is authorised
63472/15/09-06-2016
PHARMAZAC SA
GR
75871
LABORATORIOS NORMON,
ES
National Authorisation Number
mg cápsulas duras EFG DESEREIN 50mg/cap,
S.A. not available
15752/28-03-2013
MEDILAT MEDICAL
VERBORIL
not available
31521/10-5-2012
ANGELINI PHARMA HELLAS
REUMANISAL CAPS 50MG
not available
40332/07
BROS LTD
GR
DIACEREINE ZENTIVA 50
not available
34009 575 764 7 9
SANOFI-AVENTIS FRANCE
FR
not available
34009 396 537 6 1
SANOFI-AVENTIS FRANCE
FR
not available
34009 575 763 0 1
SANOFI-AVENTIS FRANCE
FR
not available
34009 396 538 2 2
SANOFI-AVENTIS FRANCE
FR
καψάκιο σκληρό
GR
PHARMACEUTICAL PRODUCTS GR
S.A.
MG, GELULE DIACEREINE ZENTIVA 50 MG, GELULE DIACEREINE ZENTIVA 50 MG, GELULE DIACEREINE ZENTIVA 50 MG, GELULE
List of nationally authorised medicinal products Diacerein - PSUSA/00001026/201612 EMA/704704/2017
Page 4/4
