2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19
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 number Note 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) 123I-hippuran 19960119 201301 201304
No, except if required nationally by a competent
authority
Other 123I-MIBG
19950131 201301 201304
No, except if required nationally by a competent
authority
Other 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 acebutolol
19771031 201212 Sanofi Aventis
The PSURs submitted in accordance with DLP 201212 will be the last assessed by DK. Another P-RMS will have to be appointed among Belgium,
Czech Republic, Finland, France, Italy, Luxemburg, The Netherlands, United-Kingdom
as of next DLP
DK/H/PSUR/0026/002 201303
No, except if required nationally by a competent
authority
Work Sharing
aceclofenac
19900319 201403 Almirall HU/H/PSUR/0030/002 201406 Yes Work Sharing
acetylsalicylic acid
19570105 201302 201305
No, except if required nationally by a competent
authority
Other acetylsalicylic acid
combinations 201302 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 acipimox
19761208 201212 Pfizer DK/H/PSUR/0028/002 201303
No, except if required nationally by a competent
authority
Work Sharing acitretin
19871201 201310 Actavis DK/H/PSUR/0024/003 yearly PSURs 201401 Yes Work Sharing
acrivastine
201212 201303
No, except if required nationally by a competent
authority
Other
acrivastine + pseudoephedrine
Duact 19901231 201212 GSK DK/H/PSUR/0027/002 201303
No, except if required nationally by a competent
authority
Work Sharing 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 201304 Yes Other alimemazine 19560605 201212 201303
No, except if required nationally by a competent
authority
2 as amended? MRP/DCP) 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39
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
allopurinol
19660101 201212 201303
No, except if required nationally by a competent
authority
Other allopurinol + benzbromarone
201212 201303
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 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
alprazolam
19800312 201303 Pfizer FR/H/PSUR/0036/002 201306
No, except if required nationally by a competent
authority
Work Sharing aluminium +/or calcium +/or
magnesium antacids 201301 201304
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 amantadine
19651214 201212 201303
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 amphetamine
201301 201304
No, except if required nationally by a competent
authority
Other
amphetamine +
dextroamphetamine 201301 201304
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 amsacrine
19820423 01/06/2014 NordMedica NL/H/PSUR/0011/002 30/08/2014
No, except if required nationally by a competent
authority
2
products only) by default) Directive 2001/83/EC
as amended? Products including MRP/DCP) 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 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 Riamet, Coartem 19981014 201310 Novartis UK/H/PSUR/0049/002 201401 Yes Work Sharing
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 atorvastatin (paediatric
indication) 07/11/1996 31/10/2013 29/01/2014
No, except if required nationally by a competent
authority
Other atracurium
19821216 201212 GSK DE/H/PSUR/0029/002 201303
No, except if required nationally by a competent
authority
Work Sharing aureomycine
19920818 201303 201306
No, except if required nationally by a competent
authority
Other azelastine
20/11/1990 201309 Meda AT/H/PSUR/0038/001 201312
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 azoximer bromide
22/10/2002 31/08/2014 29/11/2014
No, except if required nationally by a competent
authority
Other 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 bambuterol
19901207 201212 AstraZeneca SE/H/PSUR/0040/002 201303
No, except if required nationally by a competent
authority
Work Sharing 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 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 benazepril +
hydrochlorothiazide Cibadrex 19920519 201305 Novartis FR/H/PSUR/0043/002 201308
No, except if required nationally by a competent
authority
Work Sharing 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 benztropine mesylate
19590713 201212 201303
No, except if required nationally by a competent
authority
2 as amended? MRP/DCP) 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 benzylbenzoate 201302 201305
No, except if required nationally by a competent
authority
Other 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 bicalutamide
19950228 201402 AstraZeneca DK/H/PSUR/0006/003 201405 Yes Work Sharing
bifonazole
19821201 201212 201303
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
19550816 201308 Abbott AT/H/PSUR/0039/001 201311
No, except if required nationally by a competent
authority
Work Sharing biperiden
16/08/1955 15/08/2013 13/11/2013
No, except if required nationally by a competent
authority
Other botulinum toxin A
19891229 201212 Allergan IE/H/PSUR/0015/007 201303
No, except if required nationally by a competent
authority
Work Sharing 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
bromazepam
19730901 31/08/2014 Roche FR/H/PSUR/0066/002 29/11/2014 Yes Work Sharing
brompheniramine
08/08/1959 31/08/2014 29/11/2014
No, except if required nationally by a competent authority Other brotizolam 19830515 201312 Boehringer Ingelheim PT/H/PSUR/0001/003 201305
No, except if required nationally by a competent
authority
Work Sharing budesonide
19920430 201304 AstraZeneca / Dr.
Falk Pharma DK/H/PSUR/0041/002 201307
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 buflomedil
19790523 201405 Amdipharm PT/H/PSUR/0004/003 07/06/2451
No, except if required nationally by a competent
authority
Work Sharing 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 buprenorphine
19820330 31/07/2014 Reckitt &
Benckiser FR/H/PSUR/0012/003 29/10/2014 Yes Work Sharing
caffeine
19690414 201302 201305
No, except if required nationally by a competent
authority
Other calcium +/or aluminium +/or
magnesium antacids 201301 201304
No, except if required nationally by a competent
authority
Other calcium carbonate,
colecalciferol 01/01/1960 201310 Nycomed AT/H/PSUR/0040/001 201401
No, except if required nationally by a competent
authority
2
products only) by default) Directive 2001/83/EC
as amended? Products including MRP/DCP) 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 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 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 carbachol
19651110 201301 201304
No, except if required nationally by a competent
authority
Other carbamazepine
19611212 201212 201303
No, except if required nationally by a competent
authority
Other carbidopa monohydrate
Not Available* 31/10/2013 29/01/2014 Yes Other
carbidopa, levodopa 13/08/1973 01/10/2013 30/12/2013 Yes Other
carbolevure
19690331 201302 201305
No, except if required nationally by a competent
authority
Other carboplatine
19860123 201301 BMS FR/H/PSUR/0034/002 201304
No, except if required nationally by a competent
authority
Work Sharing carteolol
19840307 201403 Laboratoire Théa SK/H/PSUR/0002/003 201406
No, except if required nationally by a competent
authority
Work Sharing 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 cefotaxime
19791218 201212 Sanofi Aventis AT/H/PSUR/0022/002 201303
No, except if required nationally by a competent
authority
Work Sharing cefoxitin
19770316 201303 201306
No, except if required nationally by a competent
authority
Other cefprozil
19911223 201212 BMS SI/H/PSUR/0003/002 201303
No, except if required nationally by a competent
authority
Work Sharing 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 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 chlorprothixene
19590331 201303 Lundbeck LV/H/PSUR/0003/002 201306
No, except if required nationally by a competent
authority
Work Sharing chlortalidone + metoprolol
19781213 201212 201303
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 cholecalciferol concentrate +
sodium fluoride 201212 201303
No, except if required nationally by a competent
authority
2 as amended? MRP/DCP) 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 choline salicylate 19631210 201303 201306
No, except if required nationally by a competent
authority
Other ciclosporine
19821215 201212 Novartis EE/H/PSUR/0007/002 201303
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 cinitapride
19930311 201306 Almirall ES/H/PSUR/0001/002 201309
No, except if required nationally by a competent
authority
Work Sharing ciprofloxacin
19870131 201301
Bayer Schering for systemic formulations and Alcon for ophtalmic/otic formulations NO/H/PSUR/0010/002 201304
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 ciprofloxacine combinations
201301 201304
No, except if required nationally by a competent
authority
Other cisapride
201303 201306
No, except if required nationally by a competent
authority
Other cisplatin
19781219 201212 201303
No, except if required nationally by a competent
authority
Other 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 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 clofibrate
201212 201303
No, except if required nationally by a competent
authority
Other clonixin
19750228 201302 201305
No, except if required nationally by a competent
authority
Other cocaine
201212 201303
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 Other colistimethate sodium 08/10/1962 31/12/2013 31/03/2014
No, except if required nationally by a competent
authority
2
products only) by default) Directive 2001/83/EC
as amended? Products including MRP/DCP) 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 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
cyamemazine
19710614 201212 201303
No, except if required nationally by a competent
authority
Other cyclizine
201301 201304
No, except if required nationally by a competent
authority
Other dacarbazine
19780201 201302 201305
No, except if required nationally by a competent
authority
Other danaparoid
19921201 201311 Organon IE/H/PSUR/0004/003 201402
No, except if required nationally by a competent
authority
Work Sharing dapoxetine
17/12/2008 17/12/2013 17/03/2014
No, except if required nationally by a competent
authority
Other
desogestrel 19980701 201307 Organon SE/H/PSUR/0001/003 201310 Yes 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 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 dienogest + estradiol
Climodien 20001213 201306 Bayer Schering NL/H/PSUR/0001/003 201309
No, except if required nationally by a competent
authority
Work Sharing 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 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 diphtheria vaccine (adsorbed)
14/11/1979 01/04/2013 30/06/2013
No, except if required nationally by a competent authority Other 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 201304 Yes Work Sharing
dorzolamide + timolol
Cosopt 19980306 201302 MSD DK/H/PSUR/0001/003 201305
No, except if required nationally by a competent
authority
Work Sharing drospirenone, ethinylestradiol
07/03/2000 06/09/2013 05/12/2013
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 19960101 201305 Almirall DK/H/PSUR/0043/002 201308 Yes Work Sharing
ebastine, pseudoephedrine
Not Available* 31/05/2013 29/08/2013
No, except if required nationally by a competent
authority
2 as amended? MRP/DCP) 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 enalapril 20041101 201303 MSD SE/H/PSUR/0037/002 201306
No, except if required nationally by a competent
authority
Work Sharing epirubicin
19820628 30/06/2014 Pfizer DK/H/PSUR/0016/003 28/09/2014 Yes 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 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
ethinylestradiol + lynestrenol
19730330 201303 201306
No, except if required nationally by a competent
authority
Other ethyl esters of iodised fatty
acids from poppyseed oil 19890331 201301 201304
No, except if required nationally by a competent
authority
Other etoposide
19760217 201302 BMS DK/H/PSUR/0029/002 201305
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 exametazime
19860201 201301 Ge Healthcare DK/H/PSUR/0040/002 201304
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 Sharing
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 Other famciclovir
19931210 201212 Novartis UK/H/PSUR/0073/002 201303
No, except if required nationally by a competent
authority
Work Sharing 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
felodipine
19871231 201212 AstraZeneca SK/H/PSUR/0006/002 201303
No, except if required nationally by a competent
authority
Work Sharing
felodipine + metoprolol
19921231 201212 201303
No, except if required nationally by a competent
authority
Other 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
fenofibrate 04/11/1974 31/07/2014 29/10/2014 Yes Other
fenoldopam
201212 201303
No, except if required nationally by a competent
authority
Other fenoprofen
201301 201304
No, except if required nationally by a competent
authority
2
products only) by default) Directive 2001/83/EC
as amended? Products including MRP/DCP) 165 166 167 168 169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 fenoterol 201302 201305
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
fenspiride 08/12/1993 08/04/2014 07/07/2014 Yes Other
ferumoxides
Not Available* 30/08/2014 28/11/2014
No, except if required nationally by a competent authority
Other ferumoxsil (siloxane coated
superparamagnetic ironoxide) 19930122 201305 Guerbet DK/H/PSUR/0044/002 201308
No, except if required nationally by a competent
authority
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
finasteride 19980417 201308 MSD SE/H/PSUR/0002/007 yearly PSURs 201311 Yes Work Sharing
fluconazole
19880303 201403 Pfizer DK/H/PSUR/0008/003 201406 Yes Work Sharing
flunitrazepam
20000101 201310 Roche
Innovator product withdrawn from IE (last procedure number
was IE/H/PSUR/0039/001). Need for new P-RMS
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 fluphenazine
19591218 201212 201303
No, except if required nationally by a competent
authority
Other flurbiprofen
19761110 201311 Abbott IT/H/PSUR/0001/003 201402
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 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 fosfomycin (IV formulation)
19830713 201307 Sanofi Aventis FR/H/PSUR/0061/002 201310
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 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 gadodiamide
19930201 201301 Ge Healthcare DK/H/PSUR/0061/001 201304
No, except if required nationally by a competent
authority
Work Sharing gadoteridol
19921029 201302 Bracco DK/H/PSUR/0030/002 201305
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
2 as amended? MRP/DCP) 188 189 190 191 192 193 194 195 196 197 198 199 200 201 202 203 204 205 206 207 208 209 gestrinone 19830121 201301 201304
No, except if required nationally by a competent
authority
Other glipizide
19711120 201301 201304
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 heparinoid
19910101 201301 201304
No, except if required nationally by a competent
authority
Other heparinoid + ibuprofen
201301 201304
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 coagulation factor IX
12/07/1985 201307 Baxter 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 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 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 hydralazine
19520313 201303 201306
No, except if required nationally by a competent
authority
Other hydrochlorothiazide
19581222 201212 201303
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 hydrocortisone + lidocaine
19500101 201212 201303
No, except if required nationally by a competent
authority
Other hydrocortisone + urea
201212 201303
No, except if required nationally by a competent
authority
Other hydroquinidine
19940311 201403 Sanofi Aventis ES/H/PSUR/0004/002 201406
No, except if required nationally by a competent
authority
2
products only) by default) Directive 2001/83/EC
as amended? Products including MRP/DCP) 210 211 212 213 214 215 216 217 218 219 220 221 222 223 224 225 226 227 228 229 230 231 232 hydrotalcite
19920301 201303 Bayer Schering HU/H/PSUR/0022/002 201306
No, except if required nationally by a competent
authority
Work Sharing hydroxycarbamide
22/03/1966 21/03/2014 19/06/2014
No, except if required nationally by a competent
authority
Other hypromellose
201212 201303
No, except if required nationally by a competent
authority
Other
ibuprofen 19/02/1969 18/02/2014 19/05/2014 Yes Other
ibuprofen, pseudoephedrine 18/09/1989 18/07/2013 16/10/2013 Yes Other
ibutilide
19951228 201212 Pfizer SE/H/PSUR/0035/002 201303
No, except if required nationally by a competent
authority
Work Sharing icodextrin
Not Available* 30/04/2014 29/07/2014
No, except if required nationally by a competent authority
Other idarubicin
19891129 201311 Pfizer AT/H/PSUR/0005/003 201402
No, except if required nationally by a competent
authority
Work Sharing 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 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 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 29/07/2013
No, except if required nationally by a competent
authority
Other influenza vaccine (surface
antigen, inactivated, virosome) Not Available* 30/04/2013 29/07/2013
No, except if required nationally by a competent
authority
Other influenza vaccine (whole virion,
inactivated) 01/11/1970 30/04/2013 29/07/2013
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 interferon alfa-2a
19860202 201212 Roche NL/H/PSUR/0044/002 201303
No, except if required nationally by a competent authority Work Sharing interferon gamma-1b 19920928 201301 Boehringer Ingelheim NL/H/PSUR/0050/002 201304
No, except if required nationally by a competent
authority
Work Sharing 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 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 isoniazide, rifampicin
01/05/1968 01/05/2013 30/07/2013
No, except if required nationally by a competent
authority
2 as amended? MRP/DCP) 233 234 235 236 237 238 239 240 241 242 243 244 245 246 247 248 249 250 251 252 253 254 255
ispaghula husk + mebeverine
201302 201305
No, except if required nationally by a competent
authority
Other isradipine
19890103 201301 Novartis CZ/H/PSUR/0019/002 201304
No, except if required nationally by a competent
authority
Work Sharing itopride
30/06/1995 30/06/2013 28/09/2013
No, except if required nationally by a competent
authority
Other ivermectin
20041119 201304 MSD FR/H/PSUR/0037/002 201307
No, except if required nationally by a competent
authority
Work Sharing ketamine
19681210 201212 201303
No, except if required nationally by a competent
authority
Other ketoprofen (topical use only) 19850910 201309 Sanofi Aventis /
Bayer Schering SE/H/PSUR/0049/003 yearly PSURs 201312 Yes Work Sharing
labetalol
19770304 201302 GSK
Aspen Pharma NO/H/PSUR/0011/002 201305
No, except if required nationally by a competent
authority
Work Sharing 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
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 lanthanum carbonate hydrate
Not Available* 18/03/2014 16/06/2014
No, except if required nationally by a competent
authority
Other 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
lenograstim 11/10/1991 31/10/2013 29/01/2014 Yes Other
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
levobunolol 19890608 01/06/2014 Allergan CZ/H/PSUR/0006/003 30/08/2014 Yes Work Sharing
levobupivicaine
19990101 201212 Abbott SE/H/PSUR/0036/002 201303
No, except if required nationally by a competent
authority
Work Sharing
levodopa Not Available* 31/10/2013 29/01/2014 Yes Other
levosalbutamol
Not Available* 31/01/2014 01/05/2014
No, except if required nationally by a competent
authority
Other levosimendan
20000922 201309 Orion SE/H/PSUR/0004/003 201312
No, except if required nationally by a competent
authority
Work Sharing lidocain + zinc oxide
19911121 201212 201303
No, except if required nationally by a competent
authority
Other lidocaine
19481001 201212 201303
No, except if required nationally by a competent
authority
Other lidocaine hydrochloride +
chlorhexidine hydrochloride 19900824 201212 201303
No, except if required nationally by a competent
authority
Other linezolid
20000418 201304 Pfizer UK/H/PSUR/0037/005 yearly PSURs 201307
No, except if required nationally by a competent
authority
2
products only) by default) Directive 2001/83/EC
as amended? Products including MRP/DCP) 256 257 258 259 260 261 262 263 264 265 266 267 268 269 270 271 272 273 274 275 276 277 278 279 linsidomine 19871229 201212 201303
No, except if required nationally by a competent
authority
Other liothyronine
19971216 201212 201303
No, except if required nationally by a competent
authority
Other lithium
19670220 201302 201305
No, except if required nationally by a competent
authority
Other lofepramine
19760227 201301 201304
No, except if required nationally by a competent
authority
Other
lomustine 19760126 201306 BMS SK/H/PSUR/0007/002 201309 Yes Work Sharing
loracarbef
19911231 201212 201303
No, except if required nationally by a competent
authority
Other 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 lovastatin
19870721 201307 MSD ES/H/PSUR/0002/002 201310
No, except if required nationally by a competent
authority
Work Sharing loxapine
19611220 201212 201303
No, except if required nationally by a competent
authority
Other lynestrenol
19730320 201303 201306
No, except if required nationally by a competent
authority
Other lysine acetylsalicylic acid +
metoclopramide 19931208 201212 201303
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 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 magnesium +/or calcium +/or
aluminium antacids 201301 201304
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 marine fish oil
201301 201304
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
mefloquine 19850517 30/04/2013 Roche DE/H/PSUR/0022/003 13/02/2014 29/07/2013 Yes Work Sharing
meloxicam
19950508 201307 Boehringer
Ingelheim FR/H/PSUR/0001/002 201310
No, except if required nationally by a competent
authority
Work Sharing menotrophin
201212 201303
No, except if required nationally by a competent
authority
Other mephenesin
19750120 201301 201304
No, except if required nationally by a competent
authority
Other mepivacaine
19560401 201303 AstraZeneca DK/H/PSUR/0057/001 201306
No, except if required nationally by a competent
authority
2 as amended? MRP/DCP) 280 281 282 283 284 285 286 287 288 289 290 291 292 293 294 295 296 297 298 299 300 301 302 303 304 305 306
mepivacaine + adrenaline
Carbocaine-Adrenaline 19560401 201303 Astrazeneca DK/H/PSUR/0058/001 201306
No, except if required nationally by a competent
authority
Work Sharing meprobamate
25/07/1963 31/10/2013 29/01/2014
No, except if required nationally by a competent
authority
Other mesalazine
Salofalk 19840220 201302 Dr. Falk Pharma UK/H/PSUR/0052/002 201305
No, except if required nationally by a competent
authority
Work Sharing 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 Other
methoxsalen
19580331 201303 201306
No, except if required nationally by a competent
authority
Other methylphenidate
19541006 201310 Novartis UK/H/PSUR/0068/005 Yearly PSURs 201401
No, except if required nationally by a competent
authority
Work Sharing methylphenobarbital
201303 201306
No, except if required nationally by a competent
authority
Other metopimazine
19660603 201212 201303
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 Other
mirtazapine
19940901 201309 Organon NL/H/PSUR/0006/003 201312
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 Sharing
mitoxantrone 15/06/1981 30/06/2013 28/09/2013 Yes Other
mivacurium
19920122 201301 GSK IE/H/PSUR/0031/002 201304
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
moxifloxacin (systemic use) 19990531 201305 Bayer Schering DE/H/PSUR/0023/004 2 yearly PSURs 201308 Yes Work Sharing
muromonab-cd3
03/06/1986 15/05/2013 13/08/2013
No, except if required nationally by a competent
authority
Other nafarelin
19900215 201302 Pfizer NO/H/PSUR/0012/002 201305
No, except if required nationally by a competent
authority
Work Sharing
nalbuphine 15/05/1979 01/05/2013 30/07/2013 Yes Other
naproxen
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 nicardipine
19810531 201305 Astellas IT/H/PSUR/0021/002 201308
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
nicotinic acid, simvastatin Not Available* 01/07/2013 29/09/2013 Yes Other
niflumic acid (morniflumate)
19600101 201301 201304
No, except if required nationally by a competent
authority
2
products only) by default) Directive 2001/83/EC
as amended? Products including MRP/DCP) 307 308 309 310 311 312 313 314 315 316 317 318 319 320 321 322 323 324 325 326 327 328 329 330 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 nilvadipine
19890101 201212 Astellas IE/H/PSUR/0035/002 201303
No, except if required nationally by a competent
authority
Work Sharing nimesulide
19970811 201212 Helsinn IT/H/PSUR/0023/007 201303
No, except if required nationally by a competent
authority
Work Sharing 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 nortriptyline
19630331 201303 Lundbeck EE/H/PSUR/0010/002 201306
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 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 orciprenaline
19611101 201212 201303
No, except if required nationally by a competent
authority
Other oxacillin
19620101 201301 201304
No, except if required nationally by a competent
authority
Other oxatomide
201301 J&J PT/H/PSUR/0005/005 yearly PSURs 201304
No, except if required nationally by a competent
authority
Work Sharing oxazepam
19631211 201212 201303
No, except if required nationally by a competent
authority
Other
oxcarbazepine 19990810 201308 Novartis DK/H/PSUR/0002/003 201311 Yes Work Sharing
oxytocin
02/06/1955 30/06/2014 28/09/2014
No, except if required nationally by a competent authority
Other paclitaxel
19921229 201212 BMS NL/H/PSUR/0045/002 201303
No, except if required nationally by a competent
authority
Work Sharing
pancuronium 01/01/1991 01/12/2013 01/03/2014 Yes Other
panthenol
201303 201306
No, except if required nationally by a competent
authority
Other paracetamol (IV formulation)
201301 BMS FR/H/PSUR/0072/001 201304
No, except if required nationally by a competent
authority
Work Sharing paracetamol combinations with
acetyl salicylic acid 201302 201305
No, except if required nationally by a competent
authority
Other paricalcitol
19980417 201308 Abbott ES/H/PSUR/0016/003 201311
No, except if required nationally by a competent
authority
Work Sharing paroxetine
19901211 201212 GSK NL/H/PSUR/0023/004 201303
No, except if required nationally by a competent
authority
2 as amended? MRP/DCP) 331 332 333 334 335 336 337 338 339 340 341 342 343 344 345 346 347 348 349 350 351 352 353 354
patent blue V sodium 31/03/1974 30/04/2013 29/07/2013 Yes Other
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 pentaerithrityl tetranitrate
201212 201303
No, except if required nationally by a competent
authority
Other pentoxyverine
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 pilocarpine + timolol
19890213 201302 201305
No, except if required nationally by a competent
authority
Other
pimecrolimus 20011214 201303 Novartis DK/H/PSUR/0009/006 yearly PSURs 201306 Yes Work Sharing
pimozide
19710215 201302 201305
No, except if required nationally by a competent
authority
Other pipecuronium
19820501 201212 201303
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 piribedil
19901001 201403 Servier LV/H/PSUR/0004/002 201406
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 pitavastatin
17/07/2003 16/07/2013 14/10/2013
No, except if required nationally by a competent
authority
Other potassium bicarbonate +
sodium alginate 201301 201304
No, except if required nationally by a competent
authority
Other potassium bicarbonate +
sodium bicarbonate 19961031 201301 201304
No, except if required nationally by a competent
authority
Other pravastatin
19890331 201403 BMS FR/H/PSUR/0007/003 201406
No, except if required nationally by a competent
authority
Work Sharing pravastatin + 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 prazepam
19741218 201212 201303
No, except if required nationally by a competent
authority
Other pristinamycin
19610327 201303 201306
No, except if required nationally by a competent
authority
2
products only) by default) Directive 2001/83/EC
as amended? Products including MRP/DCP) 355 356 357 358 359 360 361 362 363 364 365 366 367 368 369 370 371 372 373 374 375 376 377 protamine 19511231 201301 201304
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 pyrantel
19701220 201212 201303
No, except if required nationally by a competent
authority
Other pyrazinamide
19560125 201302 201305
No, except if required nationally by a competent
authority
Other pyritinol
19600117 201212 201303
No, except if required nationally by a competent
authority
Other 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 quinidine
201301 201304
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 rabbit anti-human thymocyte
19840416 201212 Genzyme EE/H/PSUR/0008/002 201303
No, except if required nationally by a competent
authority
Work Sharing racecadotril
Not Available* 31/03/2014 29/06/2014
No, except if required nationally by a competent
authority
Other reserpine
201212 201303
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
ribavirin (i.v. application) 20020409 201307 Roche NL/H/PSUR/0036/005 yearly PSURs 201310 Yes Work Sharing
rizatriptan
19980211 201306 MSD NL/H/PSUR/0002/002 201309
No, except if required nationally by a competent
authority
Work Sharing
ropinirole 19960708 201307 GSK FR/H/PSUR/0010/002 201310 Yes Work Sharing
rupatadine
20051212 201212 J. Uriach y Cia
PSUR frequency changed to 6-month in Feb2012, when pediatric oral solution was
authorised.
ES/H/PSUR/0009/004 6 months 201306 201303
No, except if required nationally by a competent
authority
Work Sharing 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
sertindole 20020711 201301 Lundbeck UK/H/PSUR/0004/002 6-monthly PSURs 201304 Yes 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
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 sodium iodide [123I]
19950131 201303 Ge Healthcare DK/H/PSUR/0056/001 201306
No, except if required nationally by a competent
authority
2 as amended? MRP/DCP) 378 379 380 381 382 383 384 385 386 387 388 389 390 391 392 393 394 395 396 397 398 399 400 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 sotalol
22/08/1973 21/08/2014 19/11/2014
No, except if required nationally by a competent authority
Other stannous fluoride + medronate
19820201 201301 201304
No, except if required nationally by a competent
authority
Other stibogluconate
19660330 201303 201306
No, except if required nationally by a competent
authority
Other sulbactam
19871116 201311 Pfizer AT/H/PSUR/0004/003 201402
No, except if required nationally by a competent
authority
Work Sharing sulfaguanidine
19740107 201301 201304
No, except if required nationally by a competent
authority
Other sulproston
19801217 201304 Bayer Schering FR/H/PSUR/0038/002 201307
No, except if required nationally by a competent
authority
Work Sharing
suxamethonium 14/08/1952 31/08/2014 29/11/2014 Yes Other
tauroselcholic acid [75Se]
19850121 201301 Ge Healthcare HU/H/PSUR/0021/002 201304
No, except if required nationally by a competent
authority
Work Sharing technetium (99mTc) bicisate
19831008 201310 LANTHEUS MI DK/H/PSUR/0012/003 201401
No, except if required nationally by a competent
authority
Work Sharing technetium (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 technetium(99mTc) macrosalb
19900302 201302 Ge Healthcare DK/H/PSUR/0048/002 201305
No, except if required nationally by a competent
authority
Work Sharing technetium(99mTc) sestamibi
19871209 201212 201303
No, except if required nationally by a competent
authority
Other terconazole
201212 201303
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 thioperazine
19591214 201212 201303
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 thyroxine combinations
19680527 201212 201303
No, except if required nationally by a competent
authority
Other tibolone
19871201 201312 Organon SE/H/PSUR/0006/003 201305
No, except if required nationally by a competent
authority
Work Sharing tick-borne encephalitis Vaccine
(inactivated) 29/01/2001 31/01/2014 01/05/2014
No, except if required nationally by a competent
authority
2
products only) by default) Directive 2001/83/EC
as amended? Products including MRP/DCP) 401 402 403 404 405 406 407 408 409 410 411 412 413 414 415 416 417 418 419 420 421 422 423 424 425 tinzaparine 19910228 201302 201305
No, except if required nationally by a competent
authority
Other 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 tirofiban
20030514 201305 IROKO DE/H/PSUR/0001/002 201308
No, except if required nationally by a competent
authority
Work Sharing tixocortol
19761118 201311 Pfizer FR/H/PSUR/0004/002 201402
No, except if required nationally by a competent
authority
Work Sharing tizanidine
19831215 201212 Novartis FI/H/PSUR/0020/002 201303
No, except if required nationally by a competent
authority
Work Sharing tolterodine
19970905 201309 Pfizer SE/H/PSUR/0003/003 201312
No, except if required nationally by a competent
authority
Work Sharing tosylchloramide
201303 201306
No, except if required nationally by a competent
authority
Other
tramadol 18/04/1973 22/05/2014 20/08/2014 Yes Other
trandolapril
19920219 201402 Abbott NL/H/PSUR/0027/002 201405
No, except if required nationally by a competent
authority
Work Sharing tranexamic acid
19660121 201301 201304
No, except if required nationally by a competent
authority
Other
treprostinil Not Available* 01/05/2013 30/07/2013 Yes Other
triamcinolone (opthalmic
formulations) 31/03/2011 31/03/2014 29/06/2014
No, except if required nationally by a competent
authority
Other tridecanamine undecylenate
201301 201304
No, except if required nationally by a competent
authority
Other triethanolamine salicylate
201301 201304
No, except if required nationally by a competent
authority
Other 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 Other
typhoid 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 valaciclovir
19941220 201212 GSK CZ/H/PSUR/0018/002 201303
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 varicella vaccine (live)
17/10/1994 17/10/2013 15/01/2014
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
vecuronium bromide 19901101 201311 Organon CZ/H/PSUR/0002/003 201402 Yes Work Sharing
verapamil
19630125 201301 201304
No, except if required nationally by a competent
authority
2 as amended? MRP/DCP) 426 427 428 429 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
zafirlukast
19961231 201212 AstraZeneca IE/H/PSUR/0030/002 201303
No, except if required nationally by a competent
authority
