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List of substances under PSUR Work Sharing scheme and other substances contained in NAPs with DLP synchronised - June 2013
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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 HBD DLP (year and month) Firm's Name Comments Allocated P-RMS /
Procedure numberNote on PSUR
cycle Next 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=pages/regulation/document_listing/document_listing_000361.jsp&mid=WC
0b01ac058066f910
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 synchronisedStatus June 2013 - In red font: changes made since last publication on 31st May 2013
List of substances under PSUR Work Sharing scheme and other substances contained in NAPs with DLP synchronised - June 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 HBD DLP (year and month) Firm's Name Comments Allocated P-RMS /
Procedure numberNote on PSUR
cycle Next 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
131415
161718
19
20
21
22
23
24
252627
2829
30313233
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 ScheringOmitted 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-RMS DE/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 Pfizer DE accepts to act as P-
RMS DE/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
List of substances under PSUR Work Sharing scheme and other substances contained in NAPs with DLP synchronised - June 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 HBD DLP (year and month) Firm's Name Comments Allocated P-RMS /
Procedure numberNote on PSUR
cycle Next 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)
3435
3637
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 201304 AstraZeneca / Dr. Falk Pharma DK/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(99mTc) macrosalb19900302 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
201304 Pfizer / Bayer Schering DK/H/PSUR/0054/002 201307
No, except if required nationally
by a competent authority
Work Sharing
sodium iodide [123I]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-Adrenaline 19560401 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
201403 Pfizer / Bayer Schering
Combination transferred from FR to DK 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
List of substances under PSUR Work Sharing scheme and other substances contained in NAPs with DLP synchronised - June 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 HBD DLP (year and month) Firm's Name Comments Allocated P-RMS /
Procedure numberNote on PSUR
cycle Next 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
5960
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 201304Laboratorios
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 26.07.2013 Venter Pharma S.L.
New active substance added with ES as P-RMS ES/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 201307 Boehringer Ingelheim FR/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
List of substances under PSUR Work Sharing scheme and other substances contained in NAPs with DLP synchronised - June 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 HBD DLP (year and month) Firm's Name Comments Allocated P-RMS /
Procedure numberNote on PSUR
cycle Next 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
6364
65
66
67
68
69
70
71
72
73
7475
76
7778
79
buprenorphine 19820330 31.07.2014 Reckitt & Benckiser FR/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 201304 BMS / Sanofi
Aventis FR/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
List of substances under PSUR Work Sharing scheme and other substances contained in NAPs with DLP synchronised - June 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 HBD DLP (year and month) Firm's Name Comments Allocated P-RMS /
Procedure numberNote on PSUR
cycle Next 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)
80
81
82
83
84
85
86
87
88
89
90
91
92
93
94
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
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 oil
Capsicam 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
List of substances under PSUR Work Sharing scheme and other substances contained in NAPs with DLP synchronised - June 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 HBD DLP (year and month) Firm's Name Comments Allocated P-RMS /
Procedure numberNote on PSUR
cycle Next 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)
95
96
97
9899
100
101
102
103
104
105
106
107
108
109
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
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 201302 Boehringer Ingelheim NL/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 2013
NL/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 201302 GSKAspen Pharma NO/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 201312 Boehringer Ingelheim PT/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
List of substances under PSUR Work Sharing scheme and other substances contained in NAPs with DLP synchronised - June 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 HBD DLP (year and month) Firm's Name Comments Allocated P-RMS /
Procedure numberNote on PSUR
cycle Next 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)
110
111
112113
114
115
116
117
118
119
120
121
122
123
124
125
126
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
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 27.03.13
SE/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 201303 AstraZeneca / Sanofi Aventis SE/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 Schering SE/H/PSUR/0049/003 yearly PSURs 201312 Yes Work Sharing
dinoprostone
26.09.1972 30.09.2013 Pfizer SE accepts to act as P-RMS SE/H/PSUR/0051/001 29.12.2013
No, except if required nationally
by a competent authority
Work Sharing
doxylamine 07.04.1948 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 201403 Laboratoire Théa SK/H/PSUR/0002/003 201406
No, except if required nationally
by a competent authority
Work Sharing
List of substances under PSUR Work Sharing scheme and other substances contained in NAPs with DLP synchronised - June 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 HBD DLP (year and month) Firm's Name Comments Allocated P-RMS /
Procedure numberNote on PSUR
cycle Next 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)
127
128
129
130
131
132
133
134
135
136
137
138
139
140
141
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
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 31.07.2013Sucampo
Pharma Europe, Ltd
UK volunteered to act as P-RMS UK/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 05.11.2013 ASA Pharma PLC
UK volunteered to act as P-RMS UK/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 23.05.2013The Medicines Company UK
Ltd
UK volunteered to act as P-RMS UK/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 31.07.2013Shire
Pharmaceutical Contracts Ltd.
UK volunteered to act as P-RMS UK/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
List of substances under PSUR Work Sharing scheme and other substances contained in NAPs with DLP synchronised - June 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 HBD DLP (year and month) Firm's Name Comments Allocated P-RMS /
Procedure numberNote on PSUR
cycle Next 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)
142
143
144
145
146
147
148
149
150
151
152
153
154
155
acetylsalicylic acid combinations
201302
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
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
List of substances under PSUR Work Sharing scheme and other substances contained in NAPs with DLP synchronised - June 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 HBD DLP (year and month) Firm's Name Comments Allocated P-RMS /
Procedure numberNote on PSUR
cycle Next 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)
156
157
158
159
160
161
162
163
164
165
166
167
168
169
170
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
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
List of substances under PSUR Work Sharing scheme and other substances contained in NAPs with DLP synchronised - June 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 HBD DLP (year and month) Firm's Name Comments Allocated P-RMS /
Procedure numberNote on PSUR
cycle Next 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)
171
172
173
174
175
176
177
178
179
180181182
183
184
185
186
187
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
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
List of substances under PSUR Work Sharing scheme and other substances contained in NAPs with DLP synchronised - June 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 HBD DLP (year and month) Firm's Name Comments Allocated P-RMS /
Procedure numberNote on PSUR
cycle Next 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)
188
189
190
191
192
193
194
195
196
197198
199
200
201
202
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
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
List of substances under PSUR Work Sharing scheme and other substances contained in NAPs with DLP synchronised - June 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 HBD DLP (year and month) Firm's Name Comments Allocated P-RMS /
Procedure numberNote on PSUR
cycle Next 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)
203
204
205
206
207
208
209
210
211
212
213214
215216
217
dapoxetine
17.12.2008 17.12.2013 17.03.2014
No, except if required nationally
by a competent authority
Other
dextromethorphan hydrobromide, salbutamol sulfate
Not 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
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 19.05.2013 17.08.2013
No, except if required nationally
by a competent authority
Other
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
List of substances under PSUR Work Sharing scheme and other substances contained in NAPs with DLP synchronised - June 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 HBD DLP (year and month) Firm's Name Comments Allocated P-RMS /
Procedure numberNote on PSUR
cycle Next 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)
218
219
220
221
222
223
224
225
226
227
228
229
230
231
flunitrazepam
20000101 201310 RocheCHEPLAPHARM
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
fusidic acid
31/05/1962 30.05.2013 28.08.2013
No, except if required nationally
by a competent authority
Other
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 vaccine
19.12.2005 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
List of substances under PSUR Work Sharing scheme and other substances contained in NAPs with DLP synchronised - June 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 HBD DLP (year and month) Firm's Name Comments Allocated P-RMS /
Procedure numberNote on PSUR
cycle Next 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)
232
233
234
235
236237238
239
240
241
242
243
244
245
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 authority
hydralazine
19520313 201303 201306
No, except if required nationally
by a competent authority
Other
hydrocortisone
05/08/1952 31.08.2014 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
List of substances under PSUR Work Sharing scheme and other substances contained in NAPs with DLP synchronised - June 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 HBD DLP (year and month) Firm's Name Comments Allocated P-RMS /
Procedure numberNote on PSUR
cycle Next 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
251
252
253
254
255256257
258
259
260
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
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 20.11.2013 18.02.2014
No, except if required nationally
by a competent authority
Other
ipratropium, salbutamol
22.03.1994 14.01.2014 14.04.2014
No, except if required nationally
by a competent authority
Other
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 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
lynestrenol
19730320 201303 201306
No, except if required nationally
by a competent authority
Other
List of substances under PSUR Work Sharing scheme and other substances contained in NAPs with DLP synchronised - June 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 HBD DLP (year and month) Firm's Name Comments Allocated P-RMS /
Procedure numberNote on PSUR
cycle Next 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)
261
262
263
264
265
266
267268
269
270
271272273
274275
276
277278
279
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 Othernifuratel
19650504 201302 201305
No, except if required nationally
by a competent authority
Other
List of substances under PSUR Work Sharing scheme and other substances contained in NAPs with DLP synchronised - June 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 HBD DLP (year and month) Firm's Name Comments Allocated P-RMS /
Procedure numberNote on PSUR
cycle Next 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)
280
281
282
283
284
285
286287
288
289290
291
292
293
294
295
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 acid
201302
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
List of substances under PSUR Work Sharing scheme and other substances contained in NAPs with DLP synchronised - June 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 HBD DLP (year and month) Firm's Name Comments Allocated P-RMS /
Procedure numberNote on PSUR
cycle Next 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)
296
297
298
299
300
301
302
303
304
305
306
307
308
309
310
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 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
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
List of substances under PSUR Work Sharing scheme and other substances contained in NAPs with DLP synchronised - June 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 HBD DLP (year and month) Firm's Name Comments Allocated P-RMS /
Procedure numberNote on PSUR
cycle Next 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)
311
312313
314
315
316
317
318
319
320
321
322323
324
325
326
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
trifluridine
201303 201306
No, except if required nationally
by a competent authority
Other
List of substances under PSUR Work Sharing scheme and other substances contained in NAPs with DLP synchronised - June 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 HBD DLP (year and month) Firm's Name Comments Allocated P-RMS /
Procedure numberNote on PSUR
cycle Next 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)
327328
329
330
331
332
333
334335
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