1 3 4 5 6 7 8 acetylsalicylic acid s 9 acetylsalicylic acid, esomeprazole 10 aciclovir, hydrocortisone 11 acipimox 1 acitretin 13 acrivastine A B C D E F G H I J K L 13I-hippuran 13I-MIBG acamprosate acebutolol aceclofenac acetylsalicylic acid List of substances under PSUR scheme and other substances contained in Products with DLP synchronised status March 013 - In red font: changes made since last publication in November 01 19960119 01301 01304 19950131 01301 01304 1987074 01/07/014 Merck KGaA IE/H/PSUR/0011/003 9/09/014 19771031 011 Sanofi Aventis The PSURs submitted in accordance with DLP 011 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/006/00 01303 scheme or s (contained in 19900319 01403 Almirall HU/H/PSUR/0030/00 01406 Yes 19570105 0130 01305 0130 01305 1/08/011 9/08/013 7/11/013 31/07/009 31/07/013 9/10/013 1976108 011 Pfizer DK/H/PSUR/008/00 01303 1987101 01310 Actavis DK/H/PSUR/004/003 yearly PSURs 01401 Yes 011 01303 14 acrivastine + pseudoephedrine 15 adapalene, benzoyl peroxide 16 ajmaline 17 algeldrate 18 alimemazine 19 Duact 1990131 011 GSK DK/H/PSUR/007/00 01303 30/09/007 30/09/013 9/1/013 /0/1990 /08/013 0/11/013 01301 01304 Yes 19560605 011 01303 List of substances under PSUR scheme and other substances contained in NAPs with DLP synchronised - March 013
allergen products for treatment: grass and cereal pollen, single or mixes (oral preparations, solid forms) native 0 allopurinol 1 allopurinol + benzbromarone almitrine 3 almotriptan 4 alprazolam 5 aluminium +/or calcium +/or magnesium antacids 6 alverine 7 alverine + simeticone 8 amantadine 9 ambroxol, clenbuterol 30 amifostine 31 aminohippurate 3 aminosalicylate sodium 33 amitriptyline hydrochloride, chlordiazepoxide 34 amphetamine 35 amphetamine + dextroamphetamine 36 ampicillin 37 ampicillin + cloxacillin 38 amsacrine 39 0/10/006 4/06/013 /09/013 19660101 011 01303 011 01303 10/1/198 30/04/013 9/07/013 199913 30/06/014 Almirall ES/H/PSUR/0008/003 8/09/014 1980031 01303 Pfizer FR/H/PSUR/0036/00 01306 01301 01304 1950010 0130 01305 19900605 0130 01305 1965114 011 01303 7/06/1984 17/09/013 16/1/013 Not Available* 01/03/014 30/05/014 196304 0130 01305 Not Available* 05/10/013 03/01/014 Not Available* 31/01/014 01/05/014 01301 01304 01301 01304 1960301 01303 01306 01303 01306 198043 01/06/014 NordMedica NL/H/PSUR/0011/00 30/08/014 scheme or s (contained in List of substances under PSUR scheme and other substances contained in NAPs with DLP synchronised - March 013
apomorphine 40 A B C D E F G H I J K L scheme or s (contained in 41 4 artemether + lumefantrin Riamet, Coartem 19981014 01310 Novartis UK/H/PSUR/0049/00 01401 Yes artemether, lumefantrin (dispersible tablet) 5/04/01 4/04/013 3/07/013 43 atenolol 44 atenolol + indapamide 45 atomoxetine 46 atorvastatin (paediatric indication) 47 atracurium 48 aureomycine 49 azelastine 50 azithromycin 51 azoximer bromide 5 bacillus clausii multiantibioresistant spores 53 bambuterol 54 beclometasone dipropionate, formoterol fumarate 55 beclometasone dipropionate, salbutamol micronized 56 bemiparin 57 benazepril + hydrochlorothiazide 58 bendamustine hydrochloride 59 benzatropine 60 benztropine mesylate 61 8/05/001 8/05/013 6/08/013 aprotinin, human coagulation factor viii, human fibrinogen Not Available* 01/1/013 01/03/014 1976019 0130 01305 0130 01305 6/11/00 6/11/013 4/0/014 07/11/1996 31/10/013 9/01/014 198116 011 GSK DE/H/PSUR/009/00 01303 1990818 01303 01306 0/11/1990 01309 Meda AT/H/PSUR/0038/001 0131 19910404 01404 Pfizer FI/H/PSUR/0007/003 9/07/014 /10/00 31/08/014 9/11/014 19781103 01311 Sanofi Aventis IT/H/PSUR/000/003 0140 1990107 011 AstraZeneca SE/H/PSUR/0040/00 01303 Not Available* 14/07/013 1/10/013 Not Available* 01/01/014 01/04/014 19980416 01304 Laboratorios farmacéuticos ROVI, S.A. ES/H/PSUR/000/00 01307 Cibadrex 1990519 01305 Novartis FR/H/PSUR/0043/00 01308 07/07/010 06/07/013 04/10/013 01303 01306 19590713 011 01303 List of substances under PSUR scheme and other substances contained in NAPs with DLP synchronised - March 013
benzylbenzoate A B C D E F G H I J K L 6 benzylnicotine + camphora + dimethyl sulphate + turpentine 63 oil bicalutamide 64 bifonazole 65 bilastine 66 biperiden 67 biperiden 68 botulinum toxin A 69 bovine aprotinin, human coagulation factor xiii, human fibrinogen, human fibronectin, 70 plasminogen bromazepam 71 brompheniramine 7 brotizolam 73 budesonide 74 budesonide + formoterol 75 buflomedil 76 bupivacaine 77 bupivacaine hydrochloride, epinephrine 78 buprenorphine 79 caffeine 80 81 8 calcium +/or aluminium +/or magnesium antacids calcium carbonate, colecalciferol 0130 01305 Capsicam 19940101 01303 JSC Grindeks LV/H/PSUR/0008/00 01306 scheme or s (contained in 199508 0140 AstraZeneca DK/H/PSUR/0006/003 01405 Yes 198101 011 01303 08/09/010 07/03/014 05/06/014 19550816 01308 Abbott AT/H/PSUR/0039/001 01311 16/08/1955 15/08/013 13/11/013 198919 011 Allergan IE/H/PSUR/0015/007 01303 11/08/1998 10/08/013 08/11/013 19730901 31/08/014 Roche FR/H/PSUR/0066/00 9/11/014 Yes 08/08/1959 31/08/014 9/11/014 19830515 0131 1990430 01304 Boehringer Ingelheim AstraZeneca / Dr. Falk Pharma PT/H/PSUR/0001/003 01305 DK/H/PSUR/0041/00 01307 Symbicort 000085 01308 AstraZeneca SE/H/PSUR/001/004 01311 1979053 01405 Amdipharm PT/H/PSUR/0004/003 07/06/451 7/04/1966 6/04/014 5/07/014 7/04/1966 6/04/014 5/07/014 1980330 31/07/014 Reckitt & Benckiser FR/H/PSUR/001/003 9/10/014 Yes 19690414 0130 01305 01301 01304 01/01/1960 01310 Nycomed AT/H/PSUR/0040/001 01401 List of substances under PSUR scheme and other substances contained in NAPs with DLP synchronised - March 013
calcium carbonate, colecalciferol 83 calcium levofolinate 84 captopril + hyrochlorothiazide 85 carbachol 86 carbamazepine 87 carbidopa monohydrate 88 89 94 cefoxitin 95 cefprozil 96 cetalkonium + choline salicylate 97 chloramphenicol + aminoacids + Vitamin A 98 chlornitrofenol 99 chloroquine phosphate, proguanil hydrochloride 100 chlorpromazine 101 chlorprothixene 10 chlortalidone + metoprolol 103 chlortalidone + reserpine 104 cholecalciferol concentrate + sodium fluoride 105 15/07/1981 31/10/013 9/01/014 19910309 01303 01306 Captea 19800415 01304 BMS / Sanofi Aventis FR/H/PSUR/0050/00 01307 19651110 01301 01304 196111 011 01303 scheme or s (contained in Not Available* 31/10/013 9/01/014 Yes carbidopa, levodopa 13/08/1973 01/10/013 30/1/013 Yes carbolevure 19690331 0130 01305 90 carboplatine 1986013 01301 BMS FR/H/PSUR/0034/00 01304 91 carteolol 19840307 01403 Laboratoire Théa SK/H/PSUR/000/003 01406 9 ce (conjugated estrogens), mpa (medroxyprogesterone acetate) 01/08/1987 31/08/014 9/11/014 93 cefotaxime 1979118 011 Sanofi Aventis AT/H/PSUR/00/00 01303 19770316 01303 01306 199113 011 BMS SI/H/PSUR/0003/00 01303 1995044 01303 01306 01303 01306 0130 01305 Not Available* 15/11/013 13/0/014 195059 31/05/014 Sanofi Aventis FR/H/PSUR/0065/00 9/08/014 19590331 01303 Lundbeck LV/H/PSUR/0003/00 01306 1978113 011 01303 196006 0130 01305 011 01303 List of substances under PSUR scheme and other substances contained in NAPs with DLP synchronised - March 013
choline salicylate A B C D E F G H I J K L 106 ciclosporine 107 cilastatin + imipenem 108 cinitapride 109 ciprofloxacin 110 ciprofloxacin hydrochloride, dexamethasone acetate (ear 111 drops, suspension) ciprofloxacine s 11 cisapride 113 cisplatin 114 clebopride 115 clenbuterol 116 clobazam 117 clobetasol 118 clofibrate 119 clonixin 10 cocaine 11 codeine + ibuprofen 1 colchicine 13 colistimethate sodium 14 1963110 01303 01306 198115 011 Novartis EE/H/PSUR/0007/00 01303 Tienam 1984068 7/06/014 MSD NO/H/PSUR/0003/00 5/09/014 19930311 01306 Almirall ES/H/PSUR/0001/00 01309 19870131 01301 31/05/01 30/04/013 Bayer Schering for systemic formulations and Alcon for ophtalmic/otic formulations Alcon Pharma GmbH NO/H/PSUR/0010/00 01304 DE volunteered to act as P-RMS DE/H/PSUR/0047/001 9/07/013 01301 01304 01303 01306 1978119 011 01303 19790 30/06/014 Almirall ES/H/PSUR/0005/003 8/09/014 1/1/1980 17/09/013 16/1/013 1970006 0130 01305 197301 0130 01305 011 01303 197508 0130 01305 011 01303 19930305 01303 01306 scheme or s (contained in 30/07/1947 30/07/013 8/10/013 Yes 08/10/196 31/1/013 31/03/014 List of substances under PSUR scheme and other substances contained in NAPs with DLP synchronised - March 013
scheme or s (contained in collagenase clostridium histolyticum (all indications except for treatment of 1/1/1969 31/1/013 31/03/014 Dupuytren s contracture in adult patients with a palpable 15 cord) cyamemazine 19710614 011 01303 16 cyclizine 01301 01304 17 dacarbazine 1978001 0130 01305 18 danaparoid 199101 01311 Organon IE/H/PSUR/0004/003 0140 19 dapoxetine 17/1/008 17/1/013 17/03/014 130 131 desogestrel 19980701 01307 Organon SE/H/PSUR/0001/003 01310 Yes dexibuprofen 000075 31/08/014 Gebro Pharma AT/H/PSUR/0009/003 9/11/014 13 dextromethorphan Not Available* hydrobromide, salbutamol 31/01/014 01/05/014 133 sulfate dienogest 0/1/009 0/1/013 0/03/014 134 dienogest + estradiol Climodien 000113 01306 Bayer Schering NL/H/PSUR/0001/003 01309 135 dihydroergotamine + etilefrine 1980319 01303 01306 136 dihydrotachysterol 19590401 01303 01306 137 dinoprostone 6/09/197 30/09/013 Pfizer SE accepts to act as P-RMS SE/H/PSUR/0051/001 9/1/013 138 diphtheria vaccine (adsorbed) 14/11/1979 01/04/013 30/06/013 139 domperidone / domperidone maleate, cinnarizine The previous entry "domperidone maleate, 19780300 01301 J&J cinnarizine " with procedure number BE/H/PSUR/000/00X BE/H/PSUR/0005/003 yearly PSURs 01304 Yes has been merged with the entry 140 "domperidone " standalone dorzolamide + timolol Cosopt 19980306 0130 MSD DK/H/PSUR/0001/003 01305 141 drospirenone, ethinylestradiol 07/03/000 06/09/013 05/1/013 14 dutasteride, tamsulosin 0/11/001 hydrochloride 19/05/013 17/08/013 143 144 ebastine ebastine, pseudoephedrine 19960101 01305 Almirall DK/H/PSUR/0043/00 01308 Yes Not Available* 31/05/013 9/08/013 145 List of substances under PSUR scheme and other substances contained in NAPs with DLP synchronised - March 013
enalapril A B C D E F G H I J K L 146 epirubicin 147 ethinylestradiol + gestodene 148 ethinylestradiol + levonorgestrel 158 felodipine Minesse, Harmonet, Tri-minulet, Minulet, Mirelle, Meliane, Femovan, Milvane 0041101 01303 MSD SE/H/PSUR/0037/00 01306 scheme or s (contained in 198068 30/06/014 Pfizer DK/H/PSUR/0016/003 8/09/014 Yes 19990614 / 19950317 / 1998017 / 19860709 01403 Pfizer / Bayer Schering Combination transferred from FR to DK DK/H/PSUR/0060/001 01406 Nordette, Stediril, Follimin, Trinordiol, Nordiol, Ovran 1, Neogestrenol, Stedirild, Lorette, Lowette, 196504 / 1976047 / Pfizer / Bayer Alesse, Loette, 01304 DK/H/PSUR/0054/00 01307 196504 / Schering Gravistat 15, 1997037 Microgynon, Monostep, Minisiston, Triquilar, Miranova, 149 Neogynon ethinylestradiol + lynestrenol 19730330 01303 01306 150 ethyl esters of iodised fatty 19890331 01301 01304 acids from poppyseed oil 151 etoposide 1976017 0130 BMS DK/H/PSUR/009/00 01305 15 etoricoxib 00013 01303 MSD UK/H/PSUR/003/005 yearly PSURs 01306 153 exametazime 1986001 01301 Ge Healthcare DK/H/PSUR/0040/00 01304 154 155 ezetimibe + simvastatin Inegy 004040 01403 MSD DE/H/PSUR/000/00 01406 Yes F(ab ) fragments of equine 156 /05/000 1/05/013 19/08/013 antirabies immunoglobulin famciclovir 1993110 011 Novartis UK/H/PSUR/0073/00 01303 157 felbamate 19940515 01309 Merck & Co. Innovator product withdrawn from FR (last procedure number was FR/H/PSUR/000/001). Need for new P-RMS 0131 Yes 1987131 011 AstraZeneca SK/H/PSUR/0006/00 01303 159 felodipine + metoprolol 199131 011 01303 160 felodipine + ramipril AstraZeneca / Unimax, Tazko 19890110 01303 SE/H/PSUR/0038/00 01306 161 Sanofi Aventis fenofibrate 16 fenoldopam 04/11/1974 31/07/014 9/10/014 Yes 011 01303 163 fenoprofen 01301 01304 164 List of substances under PSUR scheme and other substances contained in NAPs with DLP synchronised - March 013
scheme or s (contained in fenoterol 0130 01305 165 fenoterol + ipratropium Boehringer Berodual 0130 NL/H/PSUR/0046/00 01305 166 Ingelheim 167 fenspiride 08/1/1993 08/04/014 07/07/014 Yes ferumoxides Not Available* 30/08/014 8/11/014 nationally by a 168 competent ferumoxsil (siloxane coated superparamagnetic ironoxide) 199301 01305 Guerbet DK/H/PSUR/0044/00 01308 169 ferumoxtran-10 (superparamagnetic ironoxide) 1994083 31/08/014 Guerbet FR/H/PSUR/0013/003 9/11/014 170 171 finasteride 19980417 01308 MSD SE/H/PSUR/000/007 yearly PSURs 01311 Yes fluconazole 19880303 01403 Pfizer DK/H/PSUR/0008/003 01406 Yes 17 flunitrazepam Innovator product withdrawn from IE (last procedure number 0000101 01310 Roche 01401 was IE/H/PSUR/0039/001). Need for new P-RMS 173 fluorescein (systemic use) 30/11/1971 30/04/014 9/07/014 nationally by a 174 competent fluorodopa Not Available* 10/03/014 08/06/014 175 fluphenazine 1959118 011 01303 176 flurbiprofen 19761110 01311 Abbott IT/H/PSUR/0001/003 0140 177 folinic acid / (di)sodium folinate 1980304 / calcium folinate 31/08/014 Bracco IT/H/PSUR/004/00 9/11/014 178 formoterol 1990069 31/05/014 AstraZeneca SE/H/PSUR/0009/003 9/08/014 179 fosfomycin (IV formulation) 19830713 01307 Sanofi Aventis FR/H/PSUR/0061/00 01310 180 fosfomycin (oral formulation) 1986087 01307 Zambon FR/H/PSUR/0064/00 01310 181 furosemide, spironolactone 11/01/1961 01/01/014 01/04/014 18 fusidic acid 31/05/196 30/05/013 8/08/013 183 gadodiamide 1993001 01301 Ge Healthcare DK/H/PSUR/0061/001 01304 184 gadoteridol 199109 0130 Bracco DK/H/PSUR/0030/00 01305 185 ganciclovir 15/06/1988 14/06/013 1/09/013 186 187 gemcitabine 1995011 01301 Eli Lilly SE/H/PSUR/0043/00 01304 Yes List of substances under PSUR scheme and other substances contained in NAPs with DLP synchronised - March 013
gestrinone 1983011 01301 01304 188 glipizide 1971110 01301 01304 189 glucose, potassium chloride Not Available* 17/04/014 16/07/014 190 guaifenesin, salbutamol sulfate Not Available* 31/01/014 01/05/014 191 haemophilus type b and meningococcal group c 19/1/005 01/0/014 0/05/014 19 conjugate vaccine haemophilus type b conjugate 06/0/199 vaccines 06/0/014 07/05/014 193 heparinoid 19910101 01301 01304 194 heparinoid + ibuprofen 01301 01304 195 hepatitis a (inactivated), typhoid polysaccharide vaccine /06/1999 /06/014 0/09/014 196 (adsorbed). hepatitis A vaccine (inactivated, 14/1/1999 virosome) 01/01/014 01/04/014 197 hepatitis A vaccines 01/01/199 (inactivated, adsorbed) 01/01/014 01/04/014 198 human coagulation factor IX 1/07/1985 01307 Baxter AT/H/PSUR/0041/001 01310 199 human coagulation factor VII 01/11/1975 01310 Baxter AT/H/PSUR/004/001 01401 00 human coagulation factor VIII 04/0/1977 (inhibitor bypassing fraction) 31/01/014 AT/H/PSUR/0043/001 01/05/014 01 human hemin 05/05/1995 31/05/013 9/08/013 0 human plasma (pooled and treated for virus inactivation) 31/05/006 8/0/014 9/05/014 03 hydralazine 1950313 01303 01306 04 hydrochlorothiazide 19581 011 01303 05 hydrocortisone 05/08/195 31/08/014 9/11/014 06 hydrocortisone + lidocaine 19500101 011 01303 07 hydrocortisone + urea 011 01303 08 hydroquinidine 19940311 01403 Sanofi Aventis ES/H/PSUR/0004/00 01406 09 nationally by a competent nationally by a competent nationally by a competent nationally by a competent scheme or s (contained in List of substances under PSUR scheme and other substances contained in NAPs with DLP synchronised - March 013
scheme or s (contained in hydrotalcite 1990301 01303 Bayer Schering HU/H/PSUR/00/00 01306 10 hydroxycarbamide /03/1966 1/03/014 19/06/014 11 hypromellose 011 01303 1 13 ibuprofen 19/0/1969 18/0/014 19/05/014 Yes 14 ibuprofen, pseudoephedrine 18/09/1989 18/07/013 16/10/013 Yes ibutilide 199518 011 Pfizer SE/H/PSUR/0035/00 01303 15 icodextrin Not Available* 30/04/014 9/07/014 nationally by a 16 competent idarubicin 1989119 01311 Pfizer AT/H/PSUR/0005/003 0140 17 ifenprodil 19740306 01303 01306 18 indapamide, perindopril 30/08/001 4/10/013 /01/014 19 indobufen 19840505 04/05/014 Pfizer IT/H/PSUR/0004/003 0/08/014 0 influenza vaccine (H1N1)ν (split 15/09/009 virion, inactivated) 9/11/013 7/0/014 1 influenza vaccine (H1N1)ν (surface antigens, inactivated, 04/11/009 31/05/013 9/08/013 prepared in cell cultures, adjuvanted) influenza vaccine (surface 3/04/000 antigen, inactivated) 30/04/013 9/07/013 3 influenza vaccine (surface antigen, inactivated, virosome) Not Available* 30/04/013 9/07/013 4 influenza vaccine (whole virion, 01/11/1970 inactivated) 30/04/013 9/07/013 5 inosine dimepranol acedoben 01/08/1978 01/08/013 30/10/013 6 interferon alfa-a 198600 011 Roche NL/H/PSUR/0044/00 01303 7 interferon gamma-1b Boehringer 199098 01301 NL/H/PSUR/0050/00 01304 8 Ingelheim ipratropium 14/08/1974 0/11/013 18/0/014 9 ipratropium, salbutamol /03/1994 14/01/014 14/04/014 30 irinotecan 19950505 04/05/014 Pfizer FR/H/PSUR/0009/003 0/08/014 31 isoniazide, rifampicin 01/05/1968 01/05/013 30/07/013 3 List of substances under PSUR scheme and other substances contained in NAPs with DLP synchronised - March 013
scheme or s (contained in ispaghula husk + mebeverine 0130 01305 33 isradipine 19890103 01301 Novartis CZ/H/PSUR/0019/00 01304 34 itopride 30/06/1995 30/06/013 8/09/013 35 ivermectin 0041119 01304 MSD FR/H/PSUR/0037/00 01307 36 ketamine 1968110 011 01303 37 ketoprofen (topical use only) 38 19850910 01309 Sanofi Aventis / Bayer Schering SE/H/PSUR/0049/003 yearly PSURs 0131 Yes labetalol GSK 19770304 0130 NO/H/PSUR/0011/00 01305 39 Aspen Pharma lactobacillus acidophilus 01/01/1983 30/06/014 8/09/014 nationally by a 40 competent lactobacillus fermentum, lactobacillus rhamnosus, Not Available* 30/06/014 8/09/014 nationally by a lactobacillus salivarius, competent 41 lactobacillus vaginalis lanreotide 19940516 16/05/014 Ipsen UK/H/PSUR/0010/003 14/08/014 4 lanthanum carbonate hydrate Not Available* 18/03/014 16/06/014 43 latanoprost (products with paediatric indication) Re-start of the PSUR with 6 monthly submissions following 19960605 01310 Pfizer the extension of the indication UK/H/PSUR/0064/006 6-monthly PSURs 01401 for children (Article 9 44 paediatric). 45 lenograstim lercanidipine 11/10/1991 31/10/013 9/01/014 Yes 199603 31/08/014 Recordati UK/H/PSUR/0011/00 9/11/014 46 47 levobunolol levobupivicaine 19890608 01/06/014 Allergan CZ/H/PSUR/0006/003 30/08/014 Yes 19990101 011 Abbott SE/H/PSUR/0036/00 01303 48 49 levodopa levosalbutamol Not Available* 31/10/013 9/01/014 Yes Not Available* 31/01/014 01/05/014 50 levosimendan 00009 01309 Orion SE/H/PSUR/0004/003 0131 51 lidocain + zinc oxide 1991111 011 01303 5 lidocaine 19481001 011 01303 53 lidocaine hydrochloride + 1990084 011 01303 chlorhexidine hydrochloride 54 linezolid 0000418 01304 Pfizer UK/H/PSUR/0037/005 yearly PSURs 01307 55 List of substances under PSUR scheme and other substances contained in NAPs with DLP synchronised - March 013
scheme or s (contained in linsidomine 198719 011 01303 56 liothyronine 1997116 011 01303 57 lithium 196700 0130 01305 58 lofepramine 197607 01301 01304 59 60 lomustine 1976016 01306 BMS SK/H/PSUR/0007/00 01309 Yes loracarbef 1991131 011 01303 61 losartan + hydrochlorothiazide Hyzaar, Cozaar Plus, Fortzaar 1995015 0130 MSD NL/H/PSUR/0057/00 01305 6 lovastatin 1987071 01307 MSD ES/H/PSUR/000/00 01310 63 loxapine 196110 011 01303 64 lynestrenol 1973030 01303 01306 65 lysine acetylsalicylic acid + 1993108 011 01303 metoclopramide 66 macrogol 3350 15/04/1991 31/05/013 9/08/013 67 macrogol 4000 19950505 01305 Ipsen FR/H/PSUR/006/00 01308 68 macrogol 4000 and Fortrans 19950505 01305 Ipsen FR/H/PSUR/0063/001 01308 s 69 magnesium +/or calcium +/or 01301 01304 aluminium antacids 70 mannitol Not Available* 8/0/014 9/05/014 71 marine fish oil 01301 01304 7 measles vaccine (live attenuated) 5/10/1966 04/05/014 0/08/014 nationally by a 73 competent mebeverine 19641110 0130 01305 74 75 mefloquine 19850517 30/04/013 Roche DE/H/PSUR/00/003 13/0/014 9/07/013 Yes meloxicam Boehringer 19950508 01307 FR/H/PSUR/0001/00 01310 76 Ingelheim menotrophin 011 01303 77 mephenesin 1975010 01301 01304 78 mepivacaine 19560401 01303 AstraZeneca DK/H/PSUR/0057/001 01306 79 List of substances under PSUR scheme and other substances contained in NAPs with DLP synchronised - March 013
scheme or s (contained in mepivacaine + adrenaline Carbocaine- 19560401 01303 Astrazeneca DK/H/PSUR/0058/001 01306 80 Adrenaline meprobamate 5/07/1963 31/10/013 9/01/014 81 mesalazine Salofalk 198400 0130 Dr. Falk Pharma UK/H/PSUR/005/00 01305 8 methadone 01/01/1930 01/05/013 30/07/013 83 methionine 0010718 01303 01306 84 85 methotrexate 01/01/196 30/06/014 8/09/014 Yes methoxsalen 19580331 01303 01306 86 methylphenidate 19541006 01310 Novartis UK/H/PSUR/0068/005 Yearly PSURs 01401 87 methylphenobarbital 01303 01306 88 metopimazine 19660603 011 01303 89 midodrine 06/0/1974 06/06/013 04/09/013 90 91 mifepristone 31/05/1988 31/05/013 9/08/013 Yes mirtazapine 19940901 01309 Organon NL/H/PSUR/0006/003 0131 9 93 misoprostol 1984068 30/06/014 Pfizer DK/H/PSUR/0014/003 8/09/014 Yes 94 mitoxantrone 15/06/1981 30/06/013 8/09/013 Yes mivacurium 19901 01301 GSK IE/H/PSUR/0031/00 01304 95 modafinil 19940901 01308 Cephalon DE/H/PSUR/0044/003 yearly PSURs 01311 96 97 moxifloxacin (systemic use) 19990531 01305 Bayer Schering DE/H/PSUR/003/004 yearly PSURs 01308 Yes muromonab-cd3 03/06/1986 15/05/013 13/08/013 98 nafarelin 1990015 0130 Pfizer NO/H/PSUR/001/00 01305 99 300 nalbuphine 15/05/1979 01/05/013 30/07/013 Yes naproxen 04/08/1961 03/08/014 01/11/014 nationally by a 301 competent neostigmine 1930701 01303 01306 30 nicardipine 19810531 01305 Astellas IT/H/PSUR/001/00 01308 303 nicorandil 1990009 0130 Merck AT/H/PSUR/003/00 01305 304 305 nicotinic acid, simvastatin Not Available* 01/07/013 9/09/013 Yes niflumic acid (morniflumate) 19600101 01301 01304 306 List of substances under PSUR scheme and other substances contained in NAPs with DLP synchronised - March 013
scheme or s (contained in nifuratel 19650504 0130 01305 307 nifuratel + nystatin 1976101 01303 01306 308 nilvadipine 19890101 011 Astellas IE/H/PSUR/0035/00 01303 309 nimesulide 19970811 011 Helsinn IT/H/PSUR/003/007 01303 310 nitrazepam 1965030 01303 01306 311 nitrofurantoin 195308 0130 01305 31 nitrous oxide Not Available* 03/03/014 01/06/014 313 nortriptyline 19630331 01303 Lundbeck EE/H/PSUR/0010/00 01306 314 octreotide 1995063 30/06/014 Novartis IE/H/PSUR/0010/003 8/09/014 315 olpadronic acid Not Available* 01/01/014 01/04/014 316 opium prepared, paracetamol 1/10/010 30/09/013 9/1/013 317 orciprenaline 19611101 011 01303 318 oxacillin 1960101 01301 01304 319 oxatomide 01301 J&J PT/H/PSUR/0005/005 yearly PSURs 01304 30 oxazepam 1963111 011 01303 31 3 oxcarbazepine 19990810 01308 Novartis DK/H/PSUR/000/003 01311 Yes oxytocin 0/06/1955 30/06/014 8/09/014 nationally by a 33 competent paclitaxel 19919 011 BMS NL/H/PSUR/0045/00 01303 34 35 pancuronium 01/01/1991 01/1/013 01/03/014 Yes panthenol 01303 01306 36 paracetamol (IV formulation) 01301 BMS FR/H/PSUR/007/001 01304 37 paracetamol s with 0130 01305 acetyl salicylic acid 38 paricalcitol 19980417 01308 Abbott ES/H/PSUR/0016/003 01311 39 paroxetine 1990111 011 GSK NL/H/PSUR/003/004 01303 330 List of substances under PSUR scheme and other substances contained in NAPs with DLP synchronised - March 013
scheme or s (contained in 331 patent blue V sodium 31/03/1974 30/04/013 9/07/013 Yes pefloxacin 19840807 31/08/014 Sanofi Aventis FR/H/PSUR/0049/003 9/11/014 33 pentaerithrityl tetranitrate 011 01303 333 pentoxyverine 15/1/1954 31/1/013 31/03/014 334 perphenazine 1951015 0130 01305 335 pethidine 1941038 01303 01306 336 phendimetrazine 01303 01306 337 phenylbutazone 195019 0130 01305 338 pilocarpine + timolol 1989013 0130 01305 339 340 pimecrolimus 001114 01303 Novartis DK/H/PSUR/0009/006 yearly PSURs 01306 Yes pimozide 1971015 0130 01305 341 pipecuronium 1980501 011 01303 34 pipobroman 01/07/1966 30/06/013 8/09/013 343 pipotiazine 197031 01303 01306 344 pirenzepine 1979013 01303 01306 345 piribedil 19901001 01403 Servier LV/H/PSUR/0004/00 01406 346 piroxicam 19790403 01/04/014 Pfizer UK/H/PSUR/0009/003 30/06/014 347 pitavastatin 17/07/003 16/07/013 14/10/013 348 potassium bicarbonate + 01301 01304 sodium alginate 349 potassium bicarbonate + 19961031 01301 01304 sodium bicarbonate 350 pravastatin 19890331 01403 BMS FR/H/PSUR/0007/003 01406 351 pravastatin + acetylsalicylic Selktine Plus ASA 19890331 01403 BMS FR/H/PSUR/0011/004 01406 acid 35 prazepam 1974118 011 01303 353 pristinamycin 1961037 01303 01306 354 List of substances under PSUR scheme and other substances contained in NAPs with DLP synchronised - March 013
375 simvastatin 376 sodium iodide [ 13 I] 377 scheme or s (contained in protamine 1951131 01301 01304 355 protirelin 01/01/1974 01/01/014 01/04/014 356 pyrantel 197010 011 01303 357 pyrazinamide 1956015 0130 01305 358 pyritinol 19600117 011 01303 359 quetiapine 19970731 31/07/014 AstraZeneca NL/H/PSUR/001/005 9/10/014 360 quinidine 01301 01304 361 quinine 15/01/1951 30/11/013 8/0/014 36 rabbit anti-human thymocyte 19840416 011 Genzyme EE/H/PSUR/0008/00 01303 363 racecadotril Not Available* 31/03/014 9/06/014 364 reserpine 011 01303 365 reviparin 05/07/001 04/07/013 0/10/013 366 367 ribavirin (i.v. application) 000409 01307 Roche NL/H/PSUR/0036/005 yearly PSURs 01310 Yes rizatriptan 1998011 01306 MSD NL/H/PSUR/000/00 01309 368 369 ropinirole 19960708 01307 GSK FR/H/PSUR/0010/00 01310 Yes rupatadine PSUR frequency changed to 6- month in Feb01, when 00511 011 J. Uriach y Cia ES/H/PSUR/0009/004 6 months 01306 01303 pediatric oral solution was 370 authorised. saccharomyces boulardii Not Available* 07/0/014 08/05/014 371 salbutamol 31/01/1969 31/01/014 01/05/014 37 secnidzole 19730605 01303 01306 373 sertindole 374 000711 01301 Lundbeck UK/H/PSUR/0004/00 6-monthly PSURs 01304 Yes sertraline 19900301 01403 Pfizer The P-RMSship was transferred from SK to NL, as NL is the rapporteur for the innovator NL/H/PSUR/0059/00 01406 product Zoloft 19880406 05/04/014 MSD IE/H/PSUR/0009/003 04/07/014 19950131 01303 Ge Healthcare DK/H/PSUR/0056/001 01306 List of substances under PSUR scheme and other substances contained in NAPs with DLP synchronised - March 013
scheme or s (contained in solifenacin 0040608 08/06/014 Astellas NL/H/PSUR/001/00 06/09/014 378 sotalol /08/1973 1/08/014 19/11/014 nationally by a 379 competent stannous fluoride + medronate 198001 01301 01304 380 stibogluconate 19660330 01303 01306 381 sulbactam 19871116 01311 Pfizer AT/H/PSUR/0004/003 0140 38 sulfaguanidine 19740107 01301 01304 383 sulproston 1980117 01304 Bayer Schering FR/H/PSUR/0038/00 01307 384 385 suxamethonium 14/08/195 31/08/014 9/11/014 Yes tauroselcholic acid [ 75 Se] 1985011 01301 Ge Healthcare HU/H/PSUR/001/00 01304 386 technetium (99mTc) bicisate 19831008 01310 LANTHEUS MI DK/H/PSUR/001/003 01401 387 technetium (99mTc) oxidronate 1983031 01303 01306 388 technetium (99mTc) Not Available* pertechnetate 7/03/014 5/06/014 389 technetium( 99m Tc) macrosalb 1990030 0130 Ge Healthcare DK/H/PSUR/0048/00 01305 390 technetium(99mtc) sestamibi 1987109 011 01303 391 terconazole 011 01303 39 testosterone undecylate 5/11/003 injection 4/11/013 /0/014 393 thiocolchicoside 19560704 01303 01306 394 thioperazine 1959114 011 01303 395 thioridazine 1959001 0130 01305 396 thyrotropine releasing hormone 19790501 0130 01305 (synthetic) 397 thyroxine s 1968057 011 01303 398 tibolone 1987101 0131 Organon SE/H/PSUR/0006/003 01305 399 tick-borne encephalitis Vaccine 9/01/001 (inactivated) 31/01/014 01/05/014 400 List of substances under PSUR scheme and other substances contained in NAPs with DLP synchronised - March 013
scheme or s (contained in tinzaparine 199108 0130 01305 401 tioconazole 19810413 01/04/014 Pfizer PT/H/PSUR/0003/003 30/06/014 40 tirofiban 0030514 01305 IROKO DE/H/PSUR/0001/00 01308 403 tixocortol 19761118 01311 Pfizer FR/H/PSUR/0004/00 0140 404 tizanidine 1983115 011 Novartis FI/H/PSUR/000/00 01303 405 tolterodine 19970905 01309 Pfizer SE/H/PSUR/0003/003 0131 406 tosylchloramide 01303 01306 407 408 tramadol 18/04/1973 /05/014 0/08/014 Yes trandolapril 199019 0140 Abbott NL/H/PSUR/007/00 01405 409 tranexamic acid 1966011 01301 01304 410 411 treprostinil Not Available* 01/05/013 30/07/013 Yes triamcinolone (opthalmic 31/03/011 formulations) 31/03/014 9/06/014 41 tridecanamine undecylenate 01301 01304 413 triethanolamine salicylate 01301 01304 414 trifluridine 01303 01306 415 trimeperidine Not Available* 8/08/013 6/11/013 416 417 trimetazidine 06/08/001 06/08/013 04/11/013 Yes typhoid polysaccharide vaccine 05/08/1998 05/08/014 03/11/014 nationally by a 418 competent typhoid vaccine (live, attenuated) 1/1/1984 0/07/014 30/09/014 nationally by a 419 competent valaciclovir 199410 011 GSK CZ/H/PSUR/0018/00 01303 40 valsartan 19960513 01304 Novartis SE/H/PSUR/004/004 01307 41 varicella vaccine (live) 17/10/1994 17/10/013 15/01/014 4 varicella zoster-immunoglobine 9/1/1995 31/1/013 31/03/014 43 44 vecuronium bromide 19901101 01311 Organon CZ/H/PSUR/000/003 0140 Yes verapamil 1963015 01301 01304 45 List of substances under PSUR scheme and other substances contained in NAPs with DLP synchronised - March 013
scheme or s (contained in vincristine 1995041 01303 01306 46 yellow fever vaccine (live) 7/01/1986 0/1/013 0/03/014 47 48 yohimbine 01/06/1944 31/05/013 9/08/013 Yes zafirlukast 1996131 011 AstraZeneca IE/H/PSUR/0030/00 01303 49 List of substances under PSUR scheme and other substances contained in NAPs with DLP synchronised - March 013