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A B C D E F G H I J K L
Active substance name (INN)
Innovator brand
name (for fixed
combination
products only)
EU HBDDLP (year
and month)Firm's Name Comments
Allocated P-RMS /
Procedure number
Note on PSUR
cycleNext DLP
Submission of
PSURs by
(DLP + 90
days by
default)
Are PSURs
required for
products referred
to in Articles
10(1), 10a, 14 and
16a of Directive
2001/83/EC as
amended?
Substances under PSUR
Work Sharing scheme
or Others (contained in
Nationally Authorised
Products including
MRP/DCP)
sulbactam
19871116 201311 Pfizer AT/H/PSUR/0004/003 201402
No, except if
required nationally
by a competent
authority
Work Sharing
idarubicin
19891129 201311 Pfizer AT/H/PSUR/0005/003 201402
No, except if
required nationally
by a competent
authority
Work Sharing
dexibuprofen
20000725 31/08/2014 Gebro Pharma AT/H/PSUR/0009/003 29/11/2014
No, except if
required nationally
by a competent
authority
Work Sharing
nicorandil
19900209 201302 Merck AT/H/PSUR/0023/002 201305
No, except if
required nationally
by a competent
authority
Work Sharing
azelastine
20/11/1990 201309 Meda
Request from MEDA Pharma
GmbH & Co.KG to amend
the DLP to 31/12/2014.
Request agreed by the P-
RMS AT. The substance has
been moved to the EURD
list as detailed in the cover
note "Assessment of
Periodic Safety Update
Reports for National
Authorised" Product
AT/H/PSUR/0038/001 201312
No, except if
required nationally
by a competent
authority
Work Sharing
biperiden
19550816 201308 Abbott AT/H/PSUR/0039/001 201311
No, except if
required nationally
by a competent
authority
Work Sharing
calcium carbonate,
colecalciferol 01/01/1960 201310 Nycomed AT/H/PSUR/0040/001 201401
No, except if
required nationally
by a competent
authority
Work Sharing
human coagulation factor IX
12/07/1985 201307 Baxter
The PSURs submitted for
products containing
human coagulation factor
IX and authorised
nationally will be
assessed under a single
assessment procedure
with the centrally
authorised product
Nonafact. For more
details, please refer to
the EURD list:
http://www.emea.europa
.eu/ema/index.jsp?curl=p
ages/regulation/documen
t_listing/document_listing
_000361.jsp&mid=WC0b
01ac058066f910
AT/H/PSUR/0041/001 201310
No, except if
required nationally
by a competent
authority
Work Sharing
human coagulation factor VII
01/11/1975 201310 Baxter AT/H/PSUR/0042/001 201401
No, except if
required nationally
by a competent
authority
Work Sharing
List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised
Status July 2013 - In brown font: changes made since last publication on 30th June 2013
PSUR Work Sharing list - July 2013
2
A B C D E F G H I J K L
Active substance name (INN)
Innovator brand
name (for fixed
combination
products only)
EU HBDDLP (year
and month)Firm's Name Comments
Allocated P-RMS /
Procedure number
Note on PSUR
cycleNext DLP
Submission of
PSURs by
(DLP + 90
days by
default)
Are PSURs
required for
products referred
to in Articles
10(1), 10a, 14 and
16a of Directive
2001/83/EC as
amended?
Substances under PSUR
Work Sharing scheme
or Others (contained in
Nationally Authorised
Products including
MRP/DCP)
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
human coagulation factor
VIII (inhibitor bypassing
fraction)04/02/1977 31/01/2014 AT/H/PSUR/0043/001 01/05/2014
No, except if
required nationally
by a competent
authority
Work Sharing
domperidone / domperidone
maleate, cinnarizine
19780300 201301 J&J
The previous entry
"domperidone maleate,
cinnarizine " with
procedure number
BE/H/PSUR/0020/00X
has been merged with
the entry "domperidone "
standalone
BE/H/PSUR/0005/003 yearly PSURs 201401 201304 Yes Work Sharing
vecuronium bromide 19901101 201311 Organon CZ/H/PSUR/0002/003 201402 Yes Work Sharinglevobunolol 19890608 01/06/2014 Allergan CZ/H/PSUR/0006/003 30/08/2014 Yes Work Sharingtirofiban
20030514 201305 IROKO DE/H/PSUR/0001/002 201308
No, except if
required nationally
by a competent
authority
Work Sharing
ezetimibe + simvastatin Inegy 20040402 201403 MSD DE/H/PSUR/0020/002 201406 Yes Work Sharingmefloquine 19850517 30/04/2013 Roche DE/H/PSUR/0022/003 19/02/2014 29/07/2013 Yes Work Sharingmoxifloxacin (systemic use)
19990531 201305 Bayer Schering DE/H/PSUR/0023/004 2 yearly PSURs 201308 Yes Work Sharing
dienogest + ethinylestradiol
Valette 19950214 201303 Bayer Schering
Omitted from the
publication on
27/03/2013
DE/H/PSUR/0030/002 201306
No, except if
required nationally
by a competent
authority
Work Sharing
gabapentin
19930205 201302 PfizerSubstance omitted in
publication of March 2013DE/H/PSUR/0035/002 201305
No, except if
required nationally
by a competent
authority
Work Sharing
modafinil
19940901 201308 Cephalon DE/H/PSUR/0044/003 yearly PSURs 201311
No, except if
required nationally
by a competent
authority
Work Sharing
ciprofloxacin hydrochloride,
dexamethasone acetate (ear
drops, suspension)31/05/2012 30/04/2013
Alcon Pharma
GmbH
DE volunteered to act as
P-RMSDE/H/PSUR/0047/001 29/07/2013
No, except if
required nationally
by a competent
authority
Work Sharing
atorvastatin (paediatric
indication) 07/11/1996 31/10/2013 PfizerDE accepts to act as P-
RMSDE/H/PSUR/0048/001 yearly PSURs 29/01/2014
No, except if
required nationally
by a competent
authority
Other
dorzolamide + timolol
Cosopt 19980306 201302 MSD DK/H/PSUR/0001/003 201305
No, except if
required nationally
by a competent
authority
Work Sharing
oxcarbazepine 19990810 201308 Novartis DK/H/PSUR/0002/003 201311 Yes Work Sharingbicalutamide 19950228 201402 AstraZeneca DK/H/PSUR/0006/003 201405 Yes Work Sharingfluconazole
19880303 201403 Pfizer DK/H/PSUR/0008/003 201406
No, except if
required nationally
by a competent
authority
Work Sharing
pimecrolimus 20011214 201303 Novartis DK/H/PSUR/0009/006 yearly PSURs 201403 201306 Yes Work Sharingtechnetium (99mTc) bicisate
19831008 201310 LANTHEUS MI DK/H/PSUR/0012/003 201401
No, except if
required nationally
by a competent
authority
Work Sharing
misoprostol 19840628 30/06/2014 Pfizer DK/H/PSUR/0014/003 28/09/2014 Yes Work Sharingepirubicin 19820628 30/06/2014 Pfizer DK/H/PSUR/0016/003 28/09/2014 Yes Work Sharingacitretin 19871201 201310 Actavis DK/H/PSUR/0024/003 yearly PSURs 201401 Yes Work Sharing
PSUR Work Sharing list - July 2013
2
A B C D E F G H I J K L
Active substance name (INN)
Innovator brand
name (for fixed
combination
products only)
EU HBDDLP (year
and month)Firm's Name Comments
Allocated P-RMS /
Procedure number
Note on PSUR
cycleNext DLP
Submission of
PSURs by
(DLP + 90
days by
default)
Are PSURs
required for
products referred
to in Articles
10(1), 10a, 14 and
16a of Directive
2001/83/EC as
amended?
Substances under PSUR
Work Sharing scheme
or Others (contained in
Nationally Authorised
Products including
MRP/DCP)
34
35
36
37
38
39
40
41
42
43
44
45
46
47
etoposide
19760217 201302 BMS DK/H/PSUR/0029/002 201305
No, except if
required nationally
by a competent
authority
Work Sharing
gadoteridol 19921029 201302 Bracco DK/H/PSUR/0030/002 201305 Yes Work Sharingbudesonide
19920430 201304AstraZeneca /
Dr. Falk PharmaDK/H/PSUR/0041/002 201307
No, except if
required nationally
by a competent
authority
Work Sharing
ebastine 19960101 201305 Almirall DK/H/PSUR/0043/002 201308 Yes Work Sharingferumoxsil (siloxane coated
superparamagnetic
ironoxide)19930122 201305 Guerbet DK/H/PSUR/0044/002 201308
No, except if
required nationally
by a competent
authority
Work Sharing
technetium(99m
Tc) macrosalb
19900302 201302 Ge Healthcare DK/H/PSUR/0048/002 201305
No, except if
required nationally
by a competent
authority
Work Sharing
ethinylestradiol +
levonorgestrel
Nordette, Stediril,
Follimin, Trinordiol,
Nordiol, Ovran 21,
Neogestrenol,
Stediril-d, Lorette,
Lowette, Alesse,
Loette, Gravistat
125, Microgynon,
Monostep,
Minisiston,
Triquilar, Miranova,
Neogynon
19650422 /
19760427 /
19650422 /
19970327
201304Pfizer / Bayer
ScheringDK/H/PSUR/0054/002 201307
No, except if
required nationally
by a competent
authority
Work Sharing
sodium iodide [123
I]
19950131 201303 Ge Healthcare DK/H/PSUR/0056/001 201306
No, except if
required nationally
by a competent
authority
Work Sharing
mepivacaine
19560401 201303 AstraZeneca DK/H/PSUR/0057/001 201306
No, except if
required nationally
by a competent
authority
Work Sharing
mepivacaine + adrenalineCarbocaine-
Adrenaline19560401 201303 Astrazeneca DK/H/PSUR/0058/001 201306
No, except if
required nationally
by a competent
authority
Work Sharing
ethinylestradiol + gestodene
Minesse,
Harmonet, Tri-
minulet, Minulet,
Mirelle, Meliane,
Femovan, Milvane
19990614 /
19950317 /
19980127 /
19860709
201403Pfizer / Bayer
Schering
Combination transferred
from FR to DK
Awaiting outcome of the
on-going EU referral
procedure to know
whether the DLP needs to
be modified.
DK/H/PSUR/0060/001 201406
No, except if
required nationally
by a competent
authority
Work Sharing
nortriptyline
19630331 201303 Lundbeck EE/H/PSUR/0010/002 201306
No, except if
required nationally
by a competent
authority
Work Sharing
cinitapride
19930311 201306 Almirall ES/H/PSUR/0001/002 201309
No, except if
required nationally
by a competent
authority
Work Sharing
lovastatin
19870721 201307 MSD ES/H/PSUR/0002/002 201310
No, except if
required nationally
by a competent
authority
Work Sharing
PSUR Work Sharing list - July 2013
2
A B C D E F G H I J K L
Active substance name (INN)
Innovator brand
name (for fixed
combination
products only)
EU HBDDLP (year
and month)Firm's Name Comments
Allocated P-RMS /
Procedure number
Note on PSUR
cycleNext DLP
Submission of
PSURs by
(DLP + 90
days by
default)
Are PSURs
required for
products referred
to in Articles
10(1), 10a, 14 and
16a of Directive
2001/83/EC as
amended?
Substances under PSUR
Work Sharing scheme
or Others (contained in
Nationally Authorised
Products including
MRP/DCP)
48
49
50
51
52
53
54
55
56
57
58
59
60
61
hydroquinidine
19940311 201403 Sanofi Aventis ES/H/PSUR/0004/002 201406
No, except if
required nationally
by a competent
authority
Work Sharing
clebopride
19790222 30/06/2014 Almirall ES/H/PSUR/0005/003 28/09/2014
No, except if
required nationally
by a competent
authority
Work Sharing
almotriptan
19991223 30/06/2014 Almirall ES/H/PSUR/0008/003 28/09/2014
No, except if
required nationally
by a competent
authority
Work Sharing
rupatadine
20051212 201306 J. Uriach y Cia
PSUR frequency changed
to 6-month in Feb2012,
when pediatric oral
solution was authorised.
ES/H/PSUR/0009/005 6 months 201312 201309
No, except if
required nationally
by a competent
authority
Work Sharing
paricalcitol
19980417 201308 Abbott ES/H/PSUR/0016/003 201311
No, except if
required nationally
by a competent
authority
Work Sharing
bemiparin
19980416 201304
Laboratorios
farmacéuticos
ROVI, S.A.
ES/H/PSUR/0020/002 201307
No, except if
required nationally
by a competent
authority
Work Sharing
gasiloxe
10/11/2011 26/07/2013Venter Pharma
S.L.
New active substance
added with ES as P-RMSES/H/PSUR/0022/001 6 months 26/01/2014 04/10/2013
No, except if
required nationally
by a competent
authority
Work Sharing
azithromycin
19910404 201404 Pfizer FI/H/PSUR/0007/003 29/07/2014
No, except if
required nationally
by a competent
authority
Work Sharing
meloxicam
19950508 201307Boehringer
IngelheimFR/H/PSUR/0001/002 201310
No, except if
required nationally
by a competent
authority
Work Sharing
tixocortol / chlorhexidine
gluconate, tixocortol pivalate
19761118 201311 Pfizer
As agreed by FR,
products containing the
combinations
"chlorhexidine gluconate,
tixocortol pivalate " will
be assesssed together
with "tixocortol
standalone ". The
combination has
therefore been removed
from the EURD list.
FR/H/PSUR/0004/002 201402
No, except if
required nationally
by a competent
authority
Work Sharing
pravastatin
19890331 201403 BMS FR/H/PSUR/0007/003 201406
No, except if
required nationally
by a competent
authority
Work Sharing
irinotecan
19950505 04/05/2014 Pfizer FR/H/PSUR/0009/003 02/08/2014
No, except if
required nationally
by a competent
authority
Work Sharing
ropinirole 19960708 201307 GSK FR/H/PSUR/0010/002 201310 Yes Work Sharingpravastatin + acetylsalicylic
acid Selktine Plus ASA 19890331 201403 BMS FR/H/PSUR/0011/004 201406
No, except if
required nationally
by a competent
authority
Work Sharing
PSUR Work Sharing list - July 2013
2
A B C D E F G H I J K L
Active substance name (INN)
Innovator brand
name (for fixed
combination
products only)
EU HBDDLP (year
and month)Firm's Name Comments
Allocated P-RMS /
Procedure number
Note on PSUR
cycleNext DLP
Submission of
PSURs by
(DLP + 90
days by
default)
Are PSURs
required for
products referred
to in Articles
10(1), 10a, 14 and
16a of Directive
2001/83/EC as
amended?
Substances under PSUR
Work Sharing scheme
or Others (contained in
Nationally Authorised
Products including
MRP/DCP)
62
63
64
65
66
67
68
69
70
71
72
73
74
75
76
77
78
79
80
buprenorphine19820330 31/07/2014
Reckitt &
BenckiserFR/H/PSUR/0012/003 29/10/2014 Yes Work Sharing
ferumoxtran-10
(superparamagnetic
ironoxide)19940823 31/08/2014 Guerbet FR/H/PSUR/0013/003 29/11/2014
No, except if
required nationally
by a competent
authority
Work Sharing
alprazolam 19800312 201303 Pfizer FR/H/PSUR/0036/002 201306 Yes Work Sharingivermectin
20041119 201304 MSD FR/H/PSUR/0037/002 201307
No, except if
required nationally
by a competent
authority
Work Sharing
sulproston
19801217 201304 Bayer Schering FR/H/PSUR/0038/002 201307
No, except if
required nationally
by a competent
authority
Work Sharing
benazepril +
hydrochlorothiazide Cibadrex 19920519 201305 Novartis FR/H/PSUR/0043/002 201308
No, except if
required nationally
by a competent
authority
Work Sharing
pefloxacin
19840807 31/08/2014 Sanofi Aventis FR/H/PSUR/0049/003 29/11/2014
No, except if
required nationally
by a competent
authority
Work Sharing
captopril +
hyrochlorothiazide Captea 19800415 201304BMS / Sanofi
AventisFR/H/PSUR/0050/002 201307
No, except if
required nationally
by a competent
authority
Work Sharing
fosfomycin (IV formulation)
19830713 201307 Sanofi Aventis FR/H/PSUR/0061/002 201310
No, except if
required nationally
by a competent
authority
Work Sharing
macrogol 4000
19950505 201305 Ipsen FR/H/PSUR/0062/002 201308
No, except if
required nationally
by a competent
authority
Work Sharing
macrogol 4000 and
combinations Fortrans 19950505 201305 Ipsen FR/H/PSUR/0063/001 201308
No, except if
required nationally
by a competent
authority
Work Sharing
fosfomycin (oral formulation)
19860827 201307 Zambon FR/H/PSUR/0064/002 201310
No, except if
required nationally
by a competent
authority
Work Sharing
chlorpromazine
19520529 31/05/2014 Sanofi Aventis FR/H/PSUR/0065/002 29/08/2014
No, except if
required nationally
by a competent
authority
Work Sharing
bromazepam 19730901 31/08/2014 Roche FR/H/PSUR/0066/002 29/11/2014 Yes Work Sharingparacetamol (IV formulation)
201301 BMS FR/H/PSUR/0072/001 yearly PSURs 07/05/2014 201304 Yes Work Sharing
hydrotalcite
19920301 201303 Bayer Schering HU/H/PSUR/0022/002 201306
No, except if
required nationally
by a competent
authority
Work Sharing
aceclofenac 19900319 201403 Almirall HU/H/PSUR/0030/002 201406 Yes Work Sharingdanaparoid
19921201 201311 Organon IE/H/PSUR/0004/003 201402
No, except if
required nationally
by a competent
authority
Work Sharing
simvastatin
19880406 05/04/2014 MSD IE/H/PSUR/0009/003 04/07/2014
No, except if
required nationally
by a competent
authority
Work Sharing
PSUR Work Sharing list - July 2013
2
A B C D E F G H I J K L
Active substance name (INN)
Innovator brand
name (for fixed
combination
products only)
EU HBDDLP (year
and month)Firm's Name Comments
Allocated P-RMS /
Procedure number
Note on PSUR
cycleNext DLP
Submission of
PSURs by
(DLP + 90
days by
default)
Are PSURs
required for
products referred
to in Articles
10(1), 10a, 14 and
16a of Directive
2001/83/EC as
amended?
Substances under PSUR
Work Sharing scheme
or Others (contained in
Nationally Authorised
Products including
MRP/DCP)
81
82
83
84
85
86
87
88
89
90
91
92
93
94
95
octreotide
19950623 30/06/2014 Novartis IE/H/PSUR/0010/003 28/09/2014
No, except if
required nationally
by a competent
authority
Work Sharing
acamprosate
19870724 01/07/2014 Merck KGaA IE/H/PSUR/0011/003 29/09/2014
No, except if
required nationally
by a competent
authority
Work Sharing
flurbiprofen
19761110 201311 Abbott IT/H/PSUR/0001/003 201402
No, except if
required nationally
by a competent
authority
Work Sharing
bacillus clausii multi-
antibioresistant spores 19781103 201311 Sanofi Aventis IT/H/PSUR/0002/003 201402
No, except if
required nationally
by a competent
authority
Work Sharing
indobufen
19840505 04/05/2014 Pfizer IT/H/PSUR/0004/003 02/08/2014
No, except if
required nationally
by a competent
authority
Work Sharing
ioxaglic acid
19790800 201302 GuerbetSubstance omitted in
publication of March 2013IT/H/PSUR/0020/003 201305
No, except if
required nationally
by a competent
authority
Work Sharing
nicardipine
19810531 201305 Astellas IT/H/PSUR/0021/002 201308
No, except if
required nationally
by a competent
authority
Work Sharing
folinic acid / (di)sodium
folinate / calcium folinate 19820304 31/08/2014 Bracco IT/H/PSUR/0024/002 29/11/2014
No, except if
required nationally
by a competent
authority
Work Sharing
chlorprothixene
19590331 201303 Lundbeck LV/H/PSUR/0003/002 201306
No, except if
required nationally
by a competent
authority
Work Sharing
piribedil
19901001 201403 Servier LV/H/PSUR/0004/002 201406
No, except if
required nationally
by a competent
authority
Work Sharing
benzylnicotine + camphora +
dimethyl sulphate +
turpentine oilCapsicam 19940101 201303 JSC Grindeks LV/H/PSUR/0008/002 201306
No, except if
required nationally
by a competent
authority
Work Sharing
dienogest + estradiol
Climodien 20001213 201306 Bayer Schering NL/H/PSUR/0001/003 201309
No, except if
required nationally
by a competent
authority
Work Sharing
rizatriptan
19980211 201306 MSD NL/H/PSUR/0002/002 201309
No, except if
required nationally
by a competent
authority
Work Sharing
mirtazapine
19940901 201309 Organon NL/H/PSUR/0006/003 201312
No, except if
required nationally
by a competent
authority
Work Sharing
amsacrine
19820423 01/06/2014 NordMedica NL/H/PSUR/0011/002 30/08/2014
No, except if
required nationally
by a competent
authority
Work Sharing
PSUR Work Sharing list - July 2013
2
A B C D E F G H I J K L
Active substance name (INN)
Innovator brand
name (for fixed
combination
products only)
EU HBDDLP (year
and month)Firm's Name Comments
Allocated P-RMS /
Procedure number
Note on PSUR
cycleNext DLP
Submission of
PSURs by
(DLP + 90
days by
default)
Are PSURs
required for
products referred
to in Articles
10(1), 10a, 14 and
16a of Directive
2001/83/EC as
amended?
Substances under PSUR
Work Sharing scheme
or Others (contained in
Nationally Authorised
Products including
MRP/DCP)
96
97
98
99
100
101
102
103
104
105
106
107
108
109
110
111
solifenacin
20040608 08/06/2014 Astellas NL/H/PSUR/0012/002 06/09/2014
No, except if
required nationally
by a competent
authority
Work Sharing
quetiapine
19970731 31/07/2014 AstraZeneca NL/H/PSUR/0021/005 29/10/2014
No, except if
required nationally
by a competent
authority
Work Sharing
trandolapril
19920219 201402 Abbott NL/H/PSUR/0027/002 201405
No, except if
required nationally
by a competent
authority
Work Sharing
ribavirin (i.v. application) 20020409 201307 Roche NL/H/PSUR/0036/005 yearly PSURs 201310 Yes Work Sharingdrospirenone,
ethinylestradiol 07/03/2000 06/09/2013 Bayer Schering NL/H/PSUR/0037/003 05/12/2013
No, except if
required nationally
by a competent
authority
Other
fenoterol + ipratropium
Berodual 201302Boehringer
IngelheimNL/H/PSUR/0046/002 201305
No, except if
required nationally
by a competent
authority
Work Sharing
trandolapril + verapamil
Tarka 19950316 201303 AbbottCombination omitted in
publication of March 2013NL/H/PSUR/0047/002 201306
No, except if
required nationally
by a competent
authority
Work Sharing
losartan +
hydrochlorothiazide
Hyzaar, Cozaar
Plus, Fortzaar 19950215 201302 MSD NL/H/PSUR/0057/002 201305
No, except if
required nationally
by a competent
authority
Work Sharing
sertraline
19900301 201403 Pfizer
The P-RMSship was
transferred from SK to
NL, as NL is the
rapporteur for the
innovator product Zoloft®
NL/H/PSUR/0059/002 201406
No, except if
required nationally
by a competent
authority
Work Sharing
cilastatin + imipenem
Tienam 19840628 27/06/2014 MSD NO/H/PSUR/0003/002 25/09/2014
No, except if
required nationally
by a competent
authority
Work Sharing
labetalol
19770304 201302GSK
Aspen PharmaNO/H/PSUR/0011/002 201305
No, except if
required nationally
by a competent
authority
Work Sharing
nafarelin
19900215 201302 Pfizer NO/H/PSUR/0012/002 201305
No, except if
required nationally
by a competent
authority
Work Sharing
brotizolam
19830515 201312Boehringer
IngelheimPT/H/PSUR/0001/003 201403
No, except if
required nationally
by a competent
authority
Work Sharing
tioconazole
19810413 01/04/2014 Pfizer PT/H/PSUR/0003/003 30/06/2014
No, except if
required nationally
by a competent
authority
Work Sharing
buflomedil
19790523 201405 Amdipharm PT/H/PSUR/0004/003 201408
No, except if
required nationally
by a competent
authority
Work Sharing
oxatomide
201301 J&J PT/H/PSUR/0005/005 yearly PSURs 201401 201304
No, except if
required nationally
by a competent
authority
Work Sharing
PSUR Work Sharing list - July 2013
2
A B C D E F G H I J K L
Active substance name (INN)
Innovator brand
name (for fixed
combination
products only)
EU HBDDLP (year
and month)Firm's Name Comments
Allocated P-RMS /
Procedure number
Note on PSUR
cycleNext DLP
Submission of
PSURs by
(DLP + 90
days by
default)
Are PSURs
required for
products referred
to in Articles
10(1), 10a, 14 and
16a of Directive
2001/83/EC as
amended?
Substances under PSUR
Work Sharing scheme
or Others (contained in
Nationally Authorised
Products including
MRP/DCP)
112
113
114
115
116
117
118
119
120
121
122
123
124
125
126
127
128
129
desogestrel
19980701 201307 Organon SE/H/PSUR/0001/003 201310
No, except if
required nationally
by a competent
authority
Work Sharing
finasteride 19980417 201308 MSD SE/H/PSUR/0002/007 yearly PSURs 201311 Yes Work Sharingtolterodine
19970905 201309 Pfizer SE/H/PSUR/0003/003 201312
No, except if
required nationally
by a competent
authority
Work Sharing
levosimendan
20000922 201309 Orion SE/H/PSUR/0004/003 201312
No, except if
required nationally
by a competent
authority
Work Sharing
tibolone
19871201 201312 Organon SE/H/PSUR/0006/003 201403
No, except if
required nationally
by a competent
authority
Work Sharing
formoterol
19900629 31/05/2014 AstraZeneca SE/H/PSUR/0009/003 29/08/2014
No, except if
required nationally
by a competent
authority
Work Sharing
latanoprost + timolol
Xalcom 19960605 04/06/2014 PfizerMissing from the previous
publicaion on 27.03.13SE/H/PSUR/0010/003 02/09/2014
No, except if
required nationally
by a competent
authority
Work Sharing
budesonide + formoterol
Symbicort 20000825 201308 AstraZeneca SE/H/PSUR/0012/004 201311
No, except if
required nationally
by a competent
authority
Work Sharing
valsartan
19960513 201304 Novartis SE/H/PSUR/0024/004 201307
No, except if
required nationally
by a competent
authority
Work Sharing
enalapril
20041101 201303 MSD SE/H/PSUR/0037/002 201306
No, except if
required nationally
by a competent
authority
Work Sharing
felodipine + ramipril
Unimax, Tazko 19890110 201303AstraZeneca /
Sanofi AventisSE/H/PSUR/0038/002 201306
No, except if
required nationally
by a competent
authority
Work Sharing
ketoprofen (topical use only)19850910 201309
Sanofi Aventis /
Bayer ScheringSE/H/PSUR/0049/003 yearly PSURs 201312 Yes Work Sharing
dinoprostone
26/09/1972 30/09/2013 PfizerSE accepts to act as P-
RMSSE/H/PSUR/0051/001 29/12/2013
No, except if
required nationally
by a competent
authority
Work Sharing
doxylamine07/04/1948 28/08/2013 Bayer
SE volunteered to act as
P-RMS.SE/H/PSUR/0052/001 6 months 28/02/2014 06/11/2013 Yes Work Sharing
carteolol
19840307 201403Laboratoire
Théa SK/H/PSUR/0002/003 201406
No, except if
required nationally
by a competent
authority
Work Sharing
lomustine 19760126 201306 BMS SK/H/PSUR/0007/002 201309 Yes Work Sharingsertindole
20020711 201307 Lundbeck UK/H/PSUR/0004/003 6-monthly PSURs 201401 201310
No, except if
required nationally
by a competent
authority
Work Sharing
piroxicam
19790403 01/04/2014 Pfizer UK/H/PSUR/0009/003 30/06/2014
No, except if
required nationally
by a competent
authority
Work Sharing
PSUR Work Sharing list - July 2013
2
A B C D E F G H I J K L
Active substance name (INN)
Innovator brand
name (for fixed
combination
products only)
EU HBDDLP (year
and month)Firm's Name Comments
Allocated P-RMS /
Procedure number
Note on PSUR
cycleNext DLP
Submission of
PSURs by
(DLP + 90
days by
default)
Are PSURs
required for
products referred
to in Articles
10(1), 10a, 14 and
16a of Directive
2001/83/EC as
amended?
Substances under PSUR
Work Sharing scheme
or Others (contained in
Nationally Authorised
Products including
MRP/DCP)
130
131
132
133
134
135
136
137
138
139
140
141
142
143
144
lanreotide
19940516 16/05/2014 Ipsen UK/H/PSUR/0010/003 14/08/2014
No, except if
required nationally
by a competent
authority
Work Sharing
lercanidipine
19960322 31/08/2014 Recordati UK/H/PSUR/0011/002 29/11/2014
No, except if
required nationally
by a competent
authority
Work Sharing
etoricoxib
20020213 201303 MSD UK/H/PSUR/0032/005 yearly PSURs 201306
No, except if
required nationally
by a competent
authority
Work Sharing
artemether + lumefantrin
Riamet, Coartem 19981014 201310 Novartis UK/H/PSUR/0049/002 201401
No, except if
required nationally
by a competent
authority
Work Sharing
mesalazine
Salofalk 19840220 201302 Dr. Falk Pharma UK/H/PSUR/0052/002 201305
No, except if
required nationally
by a competent
authority
Work Sharing
latanoprost (products with
paediatric indication)
19960605 201310 Pfizer
Re-start of the PSUR
cycle with 6 monthly
submissions following the
extension of the
indication for children
(Article 29 paediatric).
UK/H/PSUR/0064/006 6-monthly PSURs 201401
No, except if
required nationally
by a competent
authority
Work Sharing
methylphenidate
19541006 201310 Novartis UK/H/PSUR/0068/005 Yearly PSURs 201401
No, except if
required nationally
by a competent
authority
Work Sharing
lubiprostone
31/01/2006 31/07/2013
Sucampo
Pharma Europe,
Ltd
UK volunteered to act as
P-RMSUK/H/PSUR/0077/001 6-monthly PSURs 31/01/2014 09/10/2013
No, except if
required nationally
by a competent
authority
Work Sharing
acetylsalicylic Acid, bisoprolol
05/11/2010 05/11/2013ASA Pharma
PLC
UK volunteered to act as
P-RMSUK/H/PSUR/0078/001 6-monthly PSURs 05/05/2014 14/01/2014
No, except if
required nationally
by a competent
authority
Work Sharing
clevidipine
23/11/2011 23/05/2013
The Medicines
Company UK
Ltd
UK volunteered to act as
P-RMSUK/H/PSUR/0079/001 6-monthly PSURs 23/11/2013 01/08/2013
No, except if
required nationally
by a competent
authority
Work Sharing
lisdexamfetamine
01/02/2013 31/07/2013
Shire
Pharmaceutical
Contracts Ltd.
UK volunteered to act as
P-RMSUK/H/PSUR/0080/001 6-monthly PSURs 31/01/2014 09/10/2013
No, except if
required nationally
by a competent
authority
Work Sharing
acetylsalicylic acid
19570105 201302 201305
No, except if
required nationally
by a competent
authority
Other
acetylsalicylic acid
combinations201302
Deletion of the entries
"Substance +
combinations" as it
causes confusion for
stakeholders
201305
No, except if
required nationally
by a competent
authority
Other
acetylsalicylic acid,
esomeprazole 12/08/2011 29/08/2013 27/11/2013
No, except if
required nationally
by a competent
authority
Other
aciclovir, hydrocortisone
31/07/2009 31/07/2013 29/10/2013
No, except if
required nationally
by a competent
authority
Other
PSUR Work Sharing list - July 2013
2
A B C D E F G H I J K L
Active substance name (INN)
Innovator brand
name (for fixed
combination
products only)
EU HBDDLP (year
and month)Firm's Name Comments
Allocated P-RMS /
Procedure number
Note on PSUR
cycleNext DLP
Submission of
PSURs by
(DLP + 90
days by
default)
Are PSURs
required for
products referred
to in Articles
10(1), 10a, 14 and
16a of Directive
2001/83/EC as
amended?
Substances under PSUR
Work Sharing scheme
or Others (contained in
Nationally Authorised
Products including
MRP/DCP)
145
146
147
148
149
150
151
152
153
154
155
156
157
158
159
adapalene, benzoyl peroxide
30/09/2007 30/09/2013 29/12/2013
No, except if
required nationally
by a competent
authority
Other
ajmaline
22/02/1990 22/08/2013 20/11/2013
No, except if
required nationally
by a competent
authority
Other
algeldrate
201301
Substance moved to the
EURD list with DLP
09/11/2025 and 13 years
frequency; without
request for generics
PSUR.
201304 Yes Other
allergen products for
treatment: grass and cereal
pollen, single or mixes (oral
preparations, solid forms)
native
20/10/2006 24/06/2013 22/09/2013
No, except if
required nationally
by a competent
authority
Other
almitrine
10/12/1982 30/04/2013 29/07/2013
No, except if
required nationally
by a competent
authority
Other
alverine
19500210 201302 201305
No, except if
required nationally
by a competent
authority
Other
alverine + simeticone
19900605 201302 201305
No, except if
required nationally
by a competent
authority
Other
ambroxol, clenbuterol
27/06/1984 17/09/2013 16/12/2013
No, except if
required nationally
by a competent
authority
Other
amifostine
Not Available* 01/03/2014 30/05/2014
No, except if
required nationally
by a competent
authority
Other
aminohippurate
19630224 201302 201305
No, except if
required nationally
by a competent
authority
Other
aminosalicylate sodium
Not Available* 05/10/2013 03/01/2014
No, except if
required nationally
by a competent
authority
Other
amitriptyline hydrochloride,
chlordiazepoxide Not Available* 31/01/2014 01/05/2014
No, except if
required nationally
by a competent
authority
Other
ampicillin
19620301 201303 201306
No, except if
required nationally
by a competent
authority
Other
ampicillin + cloxacillin
201303 201306
No, except if
required nationally
by a competent
authority
Other
apomorphine
28/05/2001 28/05/2013 26/08/2013
No, except if
required nationally
by a competent
authority
Other
PSUR Work Sharing list - July 2013
2
A B C D E F G H I J K L
Active substance name (INN)
Innovator brand
name (for fixed
combination
products only)
EU HBDDLP (year
and month)Firm's Name Comments
Allocated P-RMS /
Procedure number
Note on PSUR
cycleNext DLP
Submission of
PSURs by
(DLP + 90
days by
default)
Are PSURs
required for
products referred
to in Articles
10(1), 10a, 14 and
16a of Directive
2001/83/EC as
amended?
Substances under PSUR
Work Sharing scheme
or Others (contained in
Nationally Authorised
Products including
MRP/DCP)
160
161
162
163
164
165
166
167
168
169
170
171
172
173
174
aprotinin, human coagulation
factor viii, human fibrinogen Not Available* 01/12/2013 01/03/2014
No, except if
required nationally
by a competent
authority
Other
artemether, lumefantrin
(dispersible tablet) 25/04/2012 24/04/2013 23/07/2013
No, except if
required nationally
by a competent
authority
Other
atenolol
19760219 201302 201305
No, except if
required nationally
by a competent
authority
Other
atenolol + indapamide
201302 201305
No, except if
required nationally
by a competent
authority
Other
atomoxetine
26/11/2002 26/11/2013 24/02/2014
No, except if
required nationally
by a competent
authority
Other
aureomycine
19920818 201303 201306
No, except if
required nationally
by a competent
authority
Other
azoximer bromide
22/10/2002 31/08/2014 29/11/2014
No, except if
required nationally
by a competent
authority
Other
beclometasone dipropionate,
formoterol fumarate Not Available* 14/07/2013 12/10/2013
No, except if
required nationally
by a competent
authority
Other
beclometasone dipropionate,
salbutamol micronized Not Available* 01/01/2014 01/04/2014
No, except if
required nationally
by a competent
authority
Other
bendamustine hydrochloride
07/07/2010 06/07/2013 04/10/2013
No, except if
required nationally
by a competent
authority
Other
benzatropine
201303 201306
No, except if
required nationally
by a competent
authority
Other
benzylbenzoate
201302 201305
No, except if
required nationally
by a competent
authority
Other
bilastine
08/09/2010 07/03/2014 05/06/2014
No, except if
required nationally
by a competent
authority
Other
biperiden
16/08/1955 15/08/2013 13/11/2013
No, except if
required nationally
by a competent
authority
Other
bovine aprotinin, human
coagulation factor xiii, human
fibrinogen, human
fibronectin, plasminogen
11/08/1998 10/08/2013 08/11/2013
No, except if
required nationally
by a competent
authority
Other
PSUR Work Sharing list - July 2013
2
A B C D E F G H I J K L
Active substance name (INN)
Innovator brand
name (for fixed
combination
products only)
EU HBDDLP (year
and month)Firm's Name Comments
Allocated P-RMS /
Procedure number
Note on PSUR
cycleNext DLP
Submission of
PSURs by
(DLP + 90
days by
default)
Are PSURs
required for
products referred
to in Articles
10(1), 10a, 14 and
16a of Directive
2001/83/EC as
amended?
Substances under PSUR
Work Sharing scheme
or Others (contained in
Nationally Authorised
Products including
MRP/DCP)
175
176
177
178
179
180
181
182
183
184
185
186
187
188
189
190
191
brompheniramine
08/08/1959 31/08/2014 29/11/2014
No, except if
required nationally
by a competent
authority
Other
bupivacaine
27/04/1966 26/04/2014 25/07/2014
No, except if
required nationally
by a competent
authority
Other
bupivacaine hydrochloride,
epinephrine 27/04/1966 26/04/2014 25/07/2014
No, except if
required nationally
by a competent
authority
Other
caffeine
19690414 201302 201305
No, except if
required nationally
by a competent
authority
Other
calcium carbonate,
colecalciferol 15/07/1981 31/10/2013 29/01/2014
No, except if
required nationally
by a competent
authority
Other
calcium levofolinate
19910309 201303 201306
No, except if
required nationally
by a competent
authority
Other
carbidopa monohydrate Not Available* 31/10/2013 29/01/2014 Yes Othercarbidopa, levodopa 13/08/1973 01/10/2013 30/12/2013 Yes Othercarbolevure
19690331 201302 201305
No, except if
required nationally
by a competent
authority
Other
ce (conjugated estrogens),
mpa (medroxyprogesterone
acetate)01/08/1987 31/08/2014 29/11/2014
No, except if
required nationally
by a competent
authority
Other
cefoxitin
19770316 201303 201306
No, except if
required nationally
by a competent
authority
Other
cetalkonium + choline
salicylate 19950424 201303 201306
No, except if
required nationally
by a competent
authority
Other
chloramphenicol +
aminoacids + Vitamin A 201303 201306
No, except if
required nationally
by a competent
authority
Other
chlornitrofenol
201302 201305
No, except if
required nationally
by a competent
authority
Other
chloroquine phosphate,
proguanil hydrochloride Not Available* 15/11/2013 13/02/2014
No, except if
required nationally
by a competent
authority
Other
chlortalidone + reserpine
19620206 201302 201305
No, except if
required nationally
by a competent
authority
Other
choline salicylate
19631210 201303 201306
No, except if
required nationally
by a competent
authority
Other
PSUR Work Sharing list - July 2013
2
A B C D E F G H I J K L
Active substance name (INN)
Innovator brand
name (for fixed
combination
products only)
EU HBDDLP (year
and month)Firm's Name Comments
Allocated P-RMS /
Procedure number
Note on PSUR
cycleNext DLP
Submission of
PSURs by
(DLP + 90
days by
default)
Are PSURs
required for
products referred
to in Articles
10(1), 10a, 14 and
16a of Directive
2001/83/EC as
amended?
Substances under PSUR
Work Sharing scheme
or Others (contained in
Nationally Authorised
Products including
MRP/DCP)
192
193
194
195
196
197
198
199
200
201
202
203
204
205
206
cisapride
201303 201306
No, except if
required nationally
by a competent
authority
Other
clenbuterol
12/12/1980 17/09/2013 16/12/2013
No, except if
required nationally
by a competent
authority
Other
clobazam
19700206 201302 201305
No, except if
required nationally
by a competent
authority
Other
clobetasol
19730221 201302 201305
No, except if
required nationally
by a competent
authority
Other
clonixin
19750228 201302 201305
No, except if
required nationally
by a competent
authority
Other
codeine + ibuprofen
19930305 201303 201306
No, except if
required nationally
by a competent
authority
Other
colchicine 30/07/1947 30/07/2013 28/10/2013 Yes Othercolistimethate sodium
08/10/1962 31/12/2013 31/03/2014
No, except if
required nationally
by a competent
authority
Other
collagenase clostridium
histolyticum (all indications
except for treatment of
Dupuytren’s contracture in
adult patients with a palpable
cord)
12/12/1969 31/12/2013 31/03/2014
No, except if
required nationally
by a competent
authority
Other
cyproterone, ethinylestradiol
31/05/2014
Outcome of EU referral
Article 107i on Diane: 1
year PSUR cycle with
next DLP on 31/05/2014.
yearly PSURs 29/08/2014
No, except if
required nationally
by a competent
authority
Other
dacarbazine
19780201 201302 201305
No, except if
required nationally
by a competent
authority
Other
dapoxetine
17/12/2008 17/12/2013 17/03/2014
No, except if
required nationally
by a competent
authority
Other
dextromethorphan
hydrobromide, salbutamol
sulfateNot Available* 31/01/2014 01/05/2014
No, except if
required nationally
by a competent
authority
Other
dienogest
02/12/2009 02/12/2013 02/03/2014
No, except if
required nationally
by a competent
authority
Other
dihydroergotamine +
etilefrine 19820319 201303 201306
No, except if
required nationally
by a competent
authority
Other
PSUR Work Sharing list - July 2013
2
A B C D E F G H I J K L
Active substance name (INN)
Innovator brand
name (for fixed
combination
products only)
EU HBDDLP (year
and month)Firm's Name Comments
Allocated P-RMS /
Procedure number
Note on PSUR
cycleNext DLP
Submission of
PSURs by
(DLP + 90
days by
default)
Are PSURs
required for
products referred
to in Articles
10(1), 10a, 14 and
16a of Directive
2001/83/EC as
amended?
Substances under PSUR
Work Sharing scheme
or Others (contained in
Nationally Authorised
Products including
MRP/DCP)
207
208
209
210
211
212
213
214
215
216
217
218
219
220
221
dihydrotachysterol
19590401 201303 201306
No, except if
required nationally
by a competent
authority
Other
diphtheria vaccine (adsorbed)
14/11/1979 01/04/2013 30/06/2013
No, except if
required nationally
by a competent
authority
Other
dutasteride, tamsulosin
hydrochloride 20/11/2001 19/05/2013HU kindly volunteered to
act as P-RMSHU/H/PSUR/0033/001 17/08/2013
No, except if
required nationally
by a competent
authority
Work Sharing
ebastine, pseudoephedrine
Not Available* 31/05/2013 29/08/2013
No, except if
required nationally
by a competent
authority
Other
ethinylestradiol + lynestrenol
19730330 201303 201306
No, except if
required nationally
by a competent
authority
Other
F(ab’)2 fragments of equine
antirabies immunoglobulin 22/05/2000 21/05/2013 19/08/2013
No, except if
required nationally
by a competent
authority
Other
felbamate
19940515 201309 Merck & Co.
Innovator product
withdrawn from FR (last
procedure number was
FR/H/PSUR/0002/001).
Need for new P-RMS
201312 Yes Work Sharing
fenofibrate 04/11/1974 31/07/2014 29/10/2014 Yes Otherfenoterol
201302 201305
No, except if
required nationally
by a competent
authority
Other
fenspiride 08/12/1993 08/04/2014 07/07/2014 Yes Otherferumoxides
Not Available* 30/08/2014 28/11/2014
No, except if
required nationally
by a competent
authority
Other
flunitrazepam
20000101 201310Roche
CHEPLAPHARM
Innovator product
withdrawn from IE (last
procedure number was
IE/H/PSUR/0039/001).
Need for new P-RMS
The MAH stated that the
product is still available in
DE, AT, GR and IT.
201401
No, except if
required nationally
by a competent
authority
Work Sharing
fluorescein (systemic use)
30/11/1971 30/04/2014 29/07/2014
No, except if
required nationally
by a competent
authority
Other
fluorodopa
Not Available* 10/03/2014 08/06/2014
No, except if
required nationally
by a competent
authority
Other
furosemide, spironolactone
11/01/1961 01/01/2014 01/04/2014
No, except if
required nationally
by a competent
authority
Other
PSUR Work Sharing list - July 2013
2
A B C D E F G H I J K L
Active substance name (INN)
Innovator brand
name (for fixed
combination
products only)
EU HBDDLP (year
and month)Firm's Name Comments
Allocated P-RMS /
Procedure number
Note on PSUR
cycleNext DLP
Submission of
PSURs by
(DLP + 90
days by
default)
Are PSURs
required for
products referred
to in Articles
10(1), 10a, 14 and
16a of Directive
2001/83/EC as
amended?
Substances under PSUR
Work Sharing scheme
or Others (contained in
Nationally Authorised
Products including
MRP/DCP)
222
223
224
225
226
227
228
229
230
231
232
233
234
fusidic acid
22797 30/05/2013HU kindly volunteered to
act as P-RMSHU/H/PSUR/0032/001 28/08/2013
No, except if
required nationally
by a competent
authority
Work Sharing
ganciclovir
15/06/1988 14/06/2013 12/09/2013
No, except if
required nationally
by a competent
authority
Other
glucose, potassium chloride
Not Available* 17/04/2014 16/07/2014
No, except if
required nationally
by a competent
authority
Other
guaifenesin, salbutamol
sulfate Not Available* 31/01/2014 01/05/2014
No, except if
required nationally
by a competent
authority
Other
haemophilus type b and
meningococcal group c
conjugate vaccine19/12/2005 01/02/2014 02/05/2014
No, except if
required nationally
by a competent
authority
Other
haemophilus type b
conjugate vaccines 06/02/1992 06/02/2014 07/05/2014
No, except if
required nationally
by a competent
authority
Other
hepatitis a (inactivated),
typhoid polysaccharide
vaccine (adsorbed).22/06/1999 22/06/2014 20/09/2014
No, except if
required nationally
by a competent
authority
Other
hepatitis A vaccine
(inactivated, virosome) 14/12/1999 01/01/2014 01/04/2014
No, except if
required nationally
by a competent
authority
Other
hepatitis A vaccines
(inactivated, adsorbed) 01/01/1992 01/01/2014 01/04/2014
No, except if
required nationally
by a competent
authority
Other
human hemin
05/05/1995 31/05/2013 29/08/2013
No, except if
required nationally
by a competent
authority
Other
human plasma (pooled and
treated for virus inactivation) 31/05/2006 28/02/2014 29/05/2014
No, except if
required nationally
by a competent
authority
Other
human plasma protease C1
inhibitor 23/07/1979 04/08/2013 02/11/2013
No, except if
required nationally
by a competent
authorityhydralazine
19520313 201303 201306
No, except if
required nationally
by a competent
authority
Other
PSUR Work Sharing list - July 2013
2
A B C D E F G H I J K L
Active substance name (INN)
Innovator brand
name (for fixed
combination
products only)
EU HBDDLP (year
and month)Firm's Name Comments
Allocated P-RMS /
Procedure number
Note on PSUR
cycleNext DLP
Submission of
PSURs by
(DLP + 90
days by
default)
Are PSURs
required for
products referred
to in Articles
10(1), 10a, 14 and
16a of Directive
2001/83/EC as
amended?
Substances under PSUR
Work Sharing scheme
or Others (contained in
Nationally Authorised
Products including
MRP/DCP)
235
236
237
238
239
240
241
242
243
244
245
hydrocortisone /
hydrocortisone (indicated in
adrenal insufficiency except
the modified release tablets
formulation)
05/08/1952 31/08/2014
This entry has been
renamed
"Hydrocortisone /
Hydrocortisone
(indicated in adrenal
insufficiency except
the modified release
tablets formulation ” in
order to avoid confusion
with the CAP included in
the EURD list and to
harmonise the DLP of the
products concerned.
29/11/2014
No, except if
required nationally
by a competent
authority
Other
hydroxycarbamide
22/03/1966 21/03/2014 19/06/2014
No, except if
required nationally
by a competent
authority
Other
ibuprofen 19/02/1969 18/02/2014 19/05/2014 Yes Otheribuprofen, pseudoephedrine 18/09/1989 18/07/2013 16/10/2013 Yes Othericodextrin
Not Available* 30/04/2014 29/07/2014
No, except if
required nationally
by a competent
authority
Other
ifenprodil
19740306 201303 201306
No, except if
required nationally
by a competent
authority
Other
indapamide, perindopril
30/08/2001 24/10/2013 22/01/2014
No, except if
required nationally
by a competent
authority
Other
influenza vaccine (H1N1)ν
(split virion, inactivated) 15/09/2009 29/11/2013 27/02/2014
No, except if
required nationally
by a competent
authority
Other
influenza vaccine (H1N1)ν
(surface antigens,
inactivated, prepared in cell
cultures, adjuvanted)
04/11/2009 31/05/2013 29/08/2013
No, except if
required nationally
by a competent
authority
Other
influenza vaccine (surface
antigen, inactivated)
23/04/2000 30/04/2013
Vaccine covered by the EURD
list entry "Seasonal influenza
vaccines ". Therefore deletion
from the PSUR WS list required
Seasonal influenza
vaccines:
PSUR frequency of
8 months from
1/9/2012 to
30/04/2013 and 4
months from
01/05/13 to
31/08/2013
31/08/2013 09/07/2013
No, except if
required nationally
by a competent
authority
Other
influenza vaccine (surface
antigen, inactivated,
virosome)
Not Available* 30/04/2013
Vaccine covered by the EURD
list entry "Seasonal influenza
vaccines ". Therefore deletion
from the PSUR WS list required
Seasonal influenza
vaccines:
PSUR frequency of
8 months from
1/9/2012 to
30/04/2013 and 4
months from
01/05/13 to
31/08/2013
31/08/2013 09/07/2013
No, except if
required nationally
by a competent
authority
Other
PSUR Work Sharing list - July 2013
2
A B C D E F G H I J K L
Active substance name (INN)
Innovator brand
name (for fixed
combination
products only)
EU HBDDLP (year
and month)Firm's Name Comments
Allocated P-RMS /
Procedure number
Note on PSUR
cycleNext DLP
Submission of
PSURs by
(DLP + 90
days by
default)
Are PSURs
required for
products referred
to in Articles
10(1), 10a, 14 and
16a of Directive
2001/83/EC as
amended?
Substances under PSUR
Work Sharing scheme
or Others (contained in
Nationally Authorised
Products including
MRP/DCP)
246
247
248
249
250
influenza vaccine (whole
virion, inactivated)
01/11/1970 30/04/2013
Vaccine covered by the EURD
list entry "Seasonal influenza
vaccines ". Therefore deletion
from the PSUR WS list required
Seasonal influenza
vaccines:
PSUR frequency of
8 months from
1/9/2012 to
30/04/2013 and 4
months from
01/05/13 to
31/08/2013
31/08/2013 09/07/2013
No, except if
required nationally
by a competent
authority
Other
influenza vaccine (split virion,
inactivated) - (non centrally
authorised products)
08/08/1996 30/04/2013 Novartis
PSURs for seasonal
influenza vaccines will be
assessed separately: at
national level for
National/MRP/DCP
products and by the
PRAC for Centrally
Authorised Products
This entry notably covers
Begrivac, Fluarix alpha-
Rix Influsplit SSW, Fluarix
Tetra, Vaxigrip, Afluria,
Mutagrip
Seasonal influenza
vaccines
PSUR frequency of
8 months from 1st
September 30th
April and 4 months
from 1st May to
31st August
31/08/2013 09/07/2013
No, except if
required nationally
by a competent
authority
Other
influenza vaccine (split virion,
inactivated, prepared in cell
cultures)
20/09/2010 30/04/2013 BAXTER S.P.A
PSURs for seasonal
influenza vaccines will be
assessed separately: at
national level for
National/MRP/DCP
products and by the
PRAC for Centrally
Authorised Products
This entry notably covers
Preflucel
Seasonal influenza
vaccines
PSUR frequency of
8 months from 1st
September 30th
April and 4 months
from 1st May to
31st August
31/08/2013 09/07/2013
No, except if
required nationally
by a competent
authority
Other
influenza vaccine (surface
antigen, inactivated,
virosome)
31/10/2001 30/04/2013CRUCELL ITALY
S.R.L.
PSURs for seasonal
influenza vaccines will be
assessed separately: at
national level for
National/MRP/DCP
products and by the
PRAC for Centrally
Authorised Products
This entry notably covers
ISIFLU and INFLEXAL V
Seasonal influenza
vaccines
PSUR frequency of
8 months from 1st
September 30th
April and 4 months
from 1st May to
31st August
31/08/2013 09/07/2013
No, except if
required nationally
by a competent
authority
Other
influenza vaccine (surface
antigen, inactivated,
adjuvanted)
23/04/2000 30/04/2013 Novartis
PSURs for seasonal
influenza vaccines will be
assessed separately: at
national level for
National/MRP/DCP
products and by the
PRAC for Centrally
Authorised Products
This entry notably covers
FLUAD
Seasonal influenza
vaccines
PSUR frequency of
8 months from 1st
September 30th
April and 4 months
from 1st May to
31st August
31/08/2013 09/07/2013
No, except if
required nationally
by a competent
authority
Other
PSUR Work Sharing list - July 2013
2
A B C D E F G H I J K L
Active substance name (INN)
Innovator brand
name (for fixed
combination
products only)
EU HBDDLP (year
and month)Firm's Name Comments
Allocated P-RMS /
Procedure number
Note on PSUR
cycleNext DLP
Submission of
PSURs by
(DLP + 90
days by
default)
Are PSURs
required for
products referred
to in Articles
10(1), 10a, 14 and
16a of Directive
2001/83/EC as
amended?
Substances under PSUR
Work Sharing scheme
or Others (contained in
Nationally Authorised
Products including
MRP/DCP)
251
252
253
254
255
256
257
258
259
260
261
262
263
264
influenza vaccine (surface
antigen, inactivated)
16/02/1998 30/04/2013Abbott
Biologicals B.V.
PSURs for seasonal
influenza vaccines will be
assessed separately: at
national level for
National/MRP/DCP
products and by the
PRAC for Centrally
Authorised Products
This entry notably covers
Influvac, Xanaflu, Vaccino
Influenzale Novartis,
FLUVIRIN, Vacciflu,
Batrevac, AGRIPPAL
Seasonal influenza
vaccines
PSUR frequency of
8 months from 1st
September 30th
April and 4 months
from 1st May to
31st August
31/08/2013 09/07/2013
No, except if
required nationally
by a competent
authority
Other
inosine dimepranol acedoben
01/08/1978 01/08/2013 30/10/2013
No, except if
required nationally
by a competent
authority
Other
ipratropium
14/08/1974 20/11/2013Boehringer
Ingelheim
HU kindly volunteered to
act as P-RMSHU/H/PSUR0034/001 18/02/2014
No, except if
required nationally
by a competent
authority
Work Sharing
ipratropium, salbutamol
22/03/1994 14/01/2014HU kindly volunteered to
act as P-RMSHU/H/PSUR0035/001 14/04/2014
No, except if
required nationally
by a competent
authority
Work Sharing
isoniazide, rifampicin
01/05/1968 01/05/2013 30/07/2013
No, except if
required nationally
by a competent
authority
Other
ispaghula husk + mebeverine
201302 201305
No, except if
required nationally
by a competent
authority
Other
itopride
30/06/1995 30/06/2013 28/09/2013
No, except if
required nationally
by a competent
authority
Other
lactobacillus acidophilus
01/01/1983 30/06/2014 28/09/2014
No, except if
required nationally
by a competent
authority
Other
lactobacillus fermentum,
lactobacillus rhamnosus,
lactobacillus salivarius,
lactobacillus vaginalis
Not Available* 30/06/2014 28/09/2014
No, except if
required nationally
by a competent
authority
Other
lanthanum carbonate hydrate
Not Available* 18/03/2014 16/06/2014
No, except if
required nationally
by a competent
authority
Other
lenograstim 11/10/1991 31/10/2013 29/01/2014 Yes Otherlevodopa Not Available* 31/10/2013 29/01/2014 Yes Otherlevosalbutamol
Not Available* 31/01/2014
Deletion of this entry as
levosalbutamol has been
merged with salbutamol
01/05/2014
No, except if
required nationally
by a competent
authority
Other
lithium
19670220 201302 201305
No, except if
required nationally
by a competent
authority
Other
PSUR Work Sharing list - July 2013
2
A B C D E F G H I J K L
Active substance name (INN)
Innovator brand
name (for fixed
combination
products only)
EU HBDDLP (year
and month)Firm's Name Comments
Allocated P-RMS /
Procedure number
Note on PSUR
cycleNext DLP
Submission of
PSURs by
(DLP + 90
days by
default)
Are PSURs
required for
products referred
to in Articles
10(1), 10a, 14 and
16a of Directive
2001/83/EC as
amended?
Substances under PSUR
Work Sharing scheme
or Others (contained in
Nationally Authorised
Products including
MRP/DCP)
265
266
267
268
269
270
271
272
273
274
275
276
277
278
279
280
281
282
283
lynestrenol
19730320 201303 201306
No, except if
required nationally
by a competent
authority
Other
macrogol 3350
15/04/1991 31/05/2013 29/08/2013
No, except if
required nationally
by a competent
authority
Other
mannitol
Not Available* 28/02/2014 29/05/2014
No, except if
required nationally
by a competent
authority
Other
measles vaccine (live
attenuated) 25/10/1966 04/05/2014 02/08/2014
No, except if
required nationally
by a competent
authority
Other
mebeverine
19641110 201302 201305
No, except if
required nationally
by a competent
authority
Other
meprobamate
25/07/1963 31/10/2013 29/01/2014
No, except if
required nationally
by a competent
authority
Other
methadone
01/01/1930 01/05/2013 30/07/2013
No, except if
required nationally
by a competent
authority
Other
methionine
20010718 201303 201306
No, except if
required nationally
by a competent
authority
Other
methotrexate 01/01/1962 30/06/2014 28/09/2014 Yes Othermethoxsalen
19580331 201303 201306
No, except if
required nationally
by a competent
authority
Other
methylphenobarbital
201303 201306
No, except if
required nationally
by a competent
authority
Other
midodrine
06/02/1974 06/06/2013 04/09/2013
No, except if
required nationally
by a competent
authority
Other
mifepristone 31/05/1988 31/05/2013 29/08/2013 Yes Othermitoxantrone 15/06/1981 30/06/2013 28/09/2013 Yes Othermuromonab-cd3
03/06/1986 15/05/2013 13/08/2013
No, except if
required nationally
by a competent
authority
Other
nalbuphine 15/05/1979 01/05/2013 30/07/2013 Yes Othernaproxen
04/08/1961 03/08/2014 01/11/2014
No, except if
required nationally
by a competent
authority
Other
neostigmine
19320701 201303 201306
No, except if
required nationally
by a competent
authority
Other
nicotinic acid, simvastatin Not Available* 01/07/2013 29/09/2013 Yes Other
PSUR Work Sharing list - July 2013
2
A B C D E F G H I J K L
Active substance name (INN)
Innovator brand
name (for fixed
combination
products only)
EU HBDDLP (year
and month)Firm's Name Comments
Allocated P-RMS /
Procedure number
Note on PSUR
cycleNext DLP
Submission of
PSURs by
(DLP + 90
days by
default)
Are PSURs
required for
products referred
to in Articles
10(1), 10a, 14 and
16a of Directive
2001/83/EC as
amended?
Substances under PSUR
Work Sharing scheme
or Others (contained in
Nationally Authorised
Products including
MRP/DCP)
284
285
286
287
288
289
290
291
292
293
294
295
296
297
298
299
300
nifuratel
19650504 201302 201305
No, except if
required nationally
by a competent
authority
Other
nifuratel + nystatin
19761012 201303 201306
No, except if
required nationally
by a competent
authority
Other
nitrazepam
19650302 201303 201306
No, except if
required nationally
by a competent
authority
Other
nitrofurantoin
19530228 201302 201305
No, except if
required nationally
by a competent
authority
Other
nitrous oxide
Not Available* 03/03/2014 01/06/2014
No, except if
required nationally
by a competent
authority
Other
olpadronic acid
Not Available* 01/01/2014 01/04/2014
No, except if
required nationally
by a competent
authority
Other
opium prepared, paracetamol
12/10/2010 30/09/2013 29/12/2013
No, except if
required nationally
by a competent
authority
Other
oxytocin
02/06/1955 30/06/2014 28/09/2014
No, except if
required nationally
by a competent
authority
Other
pancuronium 01/01/1991 01/12/2013 01/03/2014 Yes Otherpanthenol
201303 201306
No, except if
required nationally
by a competent
authority
Other
paracetamol combinations
with acetyl salicylic acid201302
Deletion of the entries
"Substance +
combinations" as it
causes confusion for
stakeholders
201305
No, except if
required nationally
by a competent
authority
Other
patent blue V sodium 31/03/1974 30/04/2013 29/07/2013 Yes Otherpentoxyverine
15/12/1954 31/12/2013 31/03/2014
No, except if
required nationally
by a competent
authority
Other
perphenazine
19521015 201302 201305
No, except if
required nationally
by a competent
authority
Other
pethidine
19410328 201303 201306
No, except if
required nationally
by a competent
authority
Other
phendimetrazine
201303 201306
No, except if
required nationally
by a competent
authority
Other
phenylbutazone
19520219 201302 201305
No, except if
required nationally
by a competent
authority
Other
PSUR Work Sharing list - July 2013
2
A B C D E F G H I J K L
Active substance name (INN)
Innovator brand
name (for fixed
combination
products only)
EU HBDDLP (year
and month)Firm's Name Comments
Allocated P-RMS /
Procedure number
Note on PSUR
cycleNext DLP
Submission of
PSURs by
(DLP + 90
days by
default)
Are PSURs
required for
products referred
to in Articles
10(1), 10a, 14 and
16a of Directive
2001/83/EC as
amended?
Substances under PSUR
Work Sharing scheme
or Others (contained in
Nationally Authorised
Products including
MRP/DCP)
301
302
303
304
305
306
307
308
309
310
311
312
313
pilocarpine + timolol
19890213 201302 201305
No, except if
required nationally
by a competent
authority
Other
pimozide
19710215 201302 201305
No, except if
required nationally
by a competent
authority
Other
pipobroman
01/07/1966 30/06/2013 28/09/2013
No, except if
required nationally
by a competent
authority
Other
pipotiazine
19720321 201303 201306
No, except if
required nationally
by a competent
authority
Other
pirenzepine
19790213 201303 201306
No, except if
required nationally
by a competent
authority
Other
pitavastatin
17/07/2003 16/07/2013 14/10/2013
No, except if
required nationally
by a competent
authority
Other
pristinamycin
19610327 201303 201306
No, except if
required nationally
by a competent
authority
Other
protirelin
01/01/1974 01/01/2014 01/04/2014
No, except if
required nationally
by a competent
authority
Other
pyrazinamide
19560125 201302 201305
No, except if
required nationally
by a competent
authority
Other
quinine
15/01/1951 30/11/2013 28/02/2014
No, except if
required nationally
by a competent
authority
Other
racecadotril
Not Available* 31/03/2014 29/06/2014
No, except if
required nationally
by a competent
authority
Other
reviparin
05/07/2001 04/07/2013
Following the last PSUR
WS assessment
(DE/H/PSUR/0045/001),
the next DLP will be
14/01/2015. The
substance was therefore
moved to the EURD list in
line with the document
"Assessment of Periodic
Safety Update Reports
for National Authorised"
02/10/2013
No, except if
required nationally
by a competent
authority
Other
saccharomyces boulardii
Not Available* 07/02/2014 08/05/2014
No, except if
required nationally
by a competent
authority
Other
PSUR Work Sharing list - July 2013
2
A B C D E F G H I J K L
Active substance name (INN)
Innovator brand
name (for fixed
combination
products only)
EU HBDDLP (year
and month)Firm's Name Comments
Allocated P-RMS /
Procedure number
Note on PSUR
cycleNext DLP
Submission of
PSURs by
(DLP + 90
days by
default)
Are PSURs
required for
products referred
to in Articles
10(1), 10a, 14 and
16a of Directive
2001/83/EC as
amended?
Substances under PSUR
Work Sharing scheme
or Others (contained in
Nationally Authorised
Products including
MRP/DCP)
314
315
316
317
318
319
320
321
322
323
324
325
326
327
328
329
330
levosalbutamol / salbutamol
31/01/1969 31/01/2014 01/05/2014
No, except if
required nationally
by a competent
authority
Other
secnidzole
19730605 201303 201306
No, except if
required nationally
by a competent
authority
Other
sotalol
22/08/1973 21/08/2014 19/11/2014
No, except if
required nationally
by a competent
authority
Other
stibogluconate
19660330 201303 201306
No, except if
required nationally
by a competent
authority
Other
suxamethonium 14/08/1952 13/08/2014 11/11/2014 Yes Othertechnetium (99mTc)
oxidronate 19830321 201303 201306
No, except if
required nationally
by a competent
authority
Other
technetium (99mTc)
pertechnetate Not Available* 27/03/2014 25/06/2014
No, except if
required nationally
by a competent
authority
Other
testosterone undecylate
injection 25/11/2003 24/11/2013 22/02/2014
No, except if
required nationally
by a competent
authority
Other
thiocolchicoside
19560704 201303 201306
No, except if
required nationally
by a competent
authority
Other
thioridazine
19590201 201302 201305
No, except if
required nationally
by a competent
authority
Other
thyrotropine releasing
hormone (synthetic) 19790501 201302 201305
No, except if
required nationally
by a competent
authority
Other
tick-borne encephalitis
Vaccine (inactivated) 29/01/2001 31/01/2014 01/05/2014
No, except if
required nationally
by a competent
authority
Other
tinzaparine
19910228 201302 201305
No, except if
required nationally
by a competent
authority
Other
tosylchloramide
201303 201306
No, except if
required nationally
by a competent
authority
Other
tramadol 18/04/1973 22/05/2014 20/08/2014 Yes Othertreprostinil
21/05/2002 21/05/2013
DLP changed from
01/05/2013 following
request from the
innovator company to
align DLP with IBD
19/08/2013 Yes Other
triamcinolone (intraocular
formulations) 31/03/2011 31/03/2014
Name of the formulation
changed from "ophtalmic"
to "intraocular"
yearly PSURs 29/06/2014
No, except if
required nationally
by a competent
authority
Other
PSUR Work Sharing list - July 2013
2
A B C D E F G H I J K L
Active substance name (INN)
Innovator brand
name (for fixed
combination
products only)
EU HBDDLP (year
and month)Firm's Name Comments
Allocated P-RMS /
Procedure number
Note on PSUR
cycleNext DLP
Submission of
PSURs by
(DLP + 90
days by
default)
Are PSURs
required for
products referred
to in Articles
10(1), 10a, 14 and
16a of Directive
2001/83/EC as
amended?
Substances under PSUR
Work Sharing scheme
or Others (contained in
Nationally Authorised
Products including
MRP/DCP)
331
332
333
334
335
336
337
338
339
340
trifluridine
201303 201306
No, except if
required nationally
by a competent
authority
Other
trimeperidine
Not Available* 28/08/2013 26/11/2013
No, except if
required nationally
by a competent
authority
Other
trimetazidine 06/08/2001 06/08/2013 04/11/2013 Yes Othertyphoid polysaccharide
vaccine 05/08/1998 05/08/2014 03/11/2014
No, except if
required nationally
by a competent
authority
Other
typhoid vaccine (live,
attenuated) 12/12/1984 02/07/2014 30/09/2014
No, except if
required nationally
by a competent
authority
Other
varicella vaccine (live)
17/10/1994 17/10/2013
Request from Sanofi to
change the DLP to
16/03/2014 and PSUR
frequency to 1 year.
The request will be
considered by the RMS of
Viravax during the on-
going PSUR assessment
26/12/2013
No, except if
required nationally
by a competent
authority
Other
varicella zoster-
immunoglobine 29/12/1995 31/12/2013 31/03/2014
No, except if
required nationally
by a competent
authority
Other
vincristine
19950412 201303 201306
No, except if
required nationally
by a competent
authority
Other
yellow fever vaccine (live)
27/01/1986 02/12/2013 02/03/2014
No, except if
required nationally
by a competent
authority
Other
yohimbine 01/06/1944 31/05/2013 29/08/2013 Yes Other
PSUR Work Sharing list - July 2013