A B C D E F G H I J K L

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1 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 In red font: changes made since last publication in November /07/014 Merck KGaA IE/H/PSUR/0011/003 9/09/ 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/ scheme or s (contained in Almirall HU/H/PSUR/0030/ Yes /08/011 9/08/013 7/11/013 31/07/009 31/07/013 9/10/ Pfizer DK/H/PSUR/008/ Actavis DK/H/PSUR/004/003 yearly PSURs Yes acrivastine + pseudoephedrine 15 adapalene, benzoyl peroxide 16 ajmaline 17 algeldrate 18 alimemazine 19 Duact GSK DK/H/PSUR/007/ /09/007 30/09/013 9/1/013 /0/1990 /08/013 0/11/ Yes List of substances under PSUR scheme and other substances contained in NAPs with DLP synchronised - March 013

2 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/ /1/198 30/04/013 9/07/ /06/014 Almirall ES/H/PSUR/0008/003 8/09/ Pfizer FR/H/PSUR/0036/ /06/ /09/013 16/1/013 Not Available* 01/03/014 30/05/ Not Available* 05/10/013 03/01/014 Not Available* 31/01/014 01/05/ /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

3 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 Novartis UK/H/PSUR/0049/ Yes artemether, lumefantrin (dispersible tablet) 5/04/01 4/04/013 3/07/ 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/ /11/00 6/11/013 4/0/014 07/11/ /10/013 9/01/ GSK DE/H/PSUR/009/ /11/ Meda AT/H/PSUR/0038/ Pfizer FI/H/PSUR/0007/003 9/07/014 /10/00 31/08/014 9/11/ Sanofi Aventis IT/H/PSUR/000/ AstraZeneca SE/H/PSUR/0040/ Not Available* 14/07/013 1/10/013 Not Available* 01/01/014 01/04/ Laboratorios farmacéuticos ROVI, S.A. ES/H/PSUR/000/ Cibadrex Novartis FR/H/PSUR/0043/ /07/010 06/07/013 04/10/ List of substances under PSUR scheme and other substances contained in NAPs with DLP synchronised - March 013

4 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 calcium +/or aluminium +/or magnesium antacids calcium carbonate, colecalciferol Capsicam JSC Grindeks LV/H/PSUR/0008/ scheme or s (contained in AstraZeneca DK/H/PSUR/0006/ Yes /09/010 07/03/014 05/06/ Abbott AT/H/PSUR/0039/ /08/ /08/013 13/11/ Allergan IE/H/PSUR/0015/ /08/ /08/013 08/11/ /08/014 Roche FR/H/PSUR/0066/00 9/11/014 Yes 08/08/ /08/014 9/11/ Boehringer Ingelheim AstraZeneca / Dr. Falk Pharma PT/H/PSUR/0001/ DK/H/PSUR/0041/ Symbicort AstraZeneca SE/H/PSUR/001/ 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/ /07/014 Reckitt & Benckiser FR/H/PSUR/001/003 9/10/014 Yes /01/ Nycomed AT/H/PSUR/0040/ List of substances under PSUR scheme and other substances contained in NAPs with DLP synchronised - March 013

5 calcium carbonate, colecalciferol 83 calcium levofolinate 84 captopril + hyrochlorothiazide 85 carbachol 86 carbamazepine 87 carbidopa monohydrate 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 /07/ /10/013 9/01/ Captea BMS / Sanofi Aventis FR/H/PSUR/0050/ scheme or s (contained in Not Available* 31/10/013 9/01/014 Yes carbidopa, levodopa 13/08/ /10/013 30/1/013 Yes carbolevure carboplatine BMS FR/H/PSUR/0034/ carteolol Laboratoire Théa SK/H/PSUR/000/ ce (conjugated estrogens), mpa (medroxyprogesterone acetate) 01/08/ /08/014 9/11/ cefotaxime Sanofi Aventis AT/H/PSUR/00/ BMS SI/H/PSUR/0003/ Not Available* 15/11/013 13/0/ /05/014 Sanofi Aventis FR/H/PSUR/0065/00 9/08/ Lundbeck LV/H/PSUR/0003/ List of substances under PSUR scheme and other substances contained in NAPs with DLP synchronised - March 013

6 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 Novartis EE/H/PSUR/0007/ Tienam /06/014 MSD NO/H/PSUR/0003/00 5/09/ Almirall ES/H/PSUR/0001/ /05/01 30/04/013 Bayer Schering for systemic formulations and Alcon for ophtalmic/otic formulations Alcon Pharma GmbH NO/H/PSUR/0010/ DE volunteered to act as P-RMS DE/H/PSUR/0047/001 9/07/ /06/014 Almirall ES/H/PSUR/0005/003 8/09/014 1/1/ /09/013 16/1/ scheme or s (contained in 30/07/ /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

7 scheme or s (contained in collagenase clostridium histolyticum (all indications except for treatment of 1/1/ /1/013 31/03/014 Dupuytren s contracture in adult patients with a palpable 15 cord) cyamemazine cyclizine dacarbazine danaparoid Organon IE/H/PSUR/0004/ dapoxetine 17/1/008 17/1/013 17/03/ desogestrel Organon SE/H/PSUR/0001/ Yes dexibuprofen /08/014 Gebro Pharma AT/H/PSUR/0009/003 9/11/ dextromethorphan Not Available* hydrobromide, salbutamol 31/01/014 01/05/ sulfate dienogest 0/1/009 0/1/013 0/03/ dienogest + estradiol Climodien Bayer Schering NL/H/PSUR/0001/ dihydroergotamine + etilefrine dihydrotachysterol dinoprostone 6/09/197 30/09/013 Pfizer SE accepts to act as P-RMS SE/H/PSUR/0051/001 9/1/ diphtheria vaccine (adsorbed) 14/11/ /04/013 30/06/ domperidone / domperidone maleate, cinnarizine The previous entry "domperidone maleate, J&J cinnarizine " with procedure number BE/H/PSUR/000/00X BE/H/PSUR/0005/003 yearly PSURs Yes has been merged with the entry 140 "domperidone " standalone dorzolamide + timolol Cosopt MSD DK/H/PSUR/0001/ drospirenone, ethinylestradiol 07/03/000 06/09/013 05/1/ dutasteride, tamsulosin 0/11/001 hydrochloride 19/05/013 17/08/ ebastine ebastine, pseudoephedrine Almirall DK/H/PSUR/0043/ Yes Not Available* 31/05/013 9/08/ List of substances under PSUR scheme and other substances contained in NAPs with DLP synchronised - March 013

8 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 MSD SE/H/PSUR/0037/ scheme or s (contained in /06/014 Pfizer DK/H/PSUR/0016/003 8/09/014 Yes / / / Pfizer / Bayer Schering Combination transferred from FR to DK DK/H/PSUR/0060/ Nordette, Stediril, Follimin, Trinordiol, Nordiol, Ovran 1, Neogestrenol, Stedirild, Lorette, Lowette, / / Pfizer / Bayer Alesse, Loette, DK/H/PSUR/0054/ / Schering Gravistat 15, Microgynon, Monostep, Minisiston, Triquilar, Miranova, 149 Neogynon ethinylestradiol + lynestrenol ethyl esters of iodised fatty acids from poppyseed oil 151 etoposide BMS DK/H/PSUR/009/ etoricoxib MSD UK/H/PSUR/003/005 yearly PSURs exametazime Ge Healthcare DK/H/PSUR/0040/ ezetimibe + simvastatin Inegy MSD DE/H/PSUR/000/ Yes F(ab ) fragments of equine 156 /05/000 1/05/013 19/08/013 antirabies immunoglobulin famciclovir Novartis UK/H/PSUR/0073/ felbamate Merck & Co. Innovator product withdrawn from FR (last procedure number was FR/H/PSUR/000/001). Need for new P-RMS 0131 Yes AstraZeneca SK/H/PSUR/0006/ felodipine + metoprolol felodipine + ramipril AstraZeneca / Unimax, Tazko SE/H/PSUR/0038/ Sanofi Aventis fenofibrate 16 fenoldopam 04/11/ /07/014 9/10/014 Yes fenoprofen List of substances under PSUR scheme and other substances contained in NAPs with DLP synchronised - March 013

9 scheme or s (contained in fenoterol fenoterol + ipratropium Boehringer Berodual 0130 NL/H/PSUR/0046/ Ingelheim 167 fenspiride 08/1/ /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) Guerbet DK/H/PSUR/0044/ ferumoxtran-10 (superparamagnetic ironoxide) /08/014 Guerbet FR/H/PSUR/0013/003 9/11/ finasteride MSD SE/H/PSUR/000/007 yearly PSURs Yes fluconazole Pfizer DK/H/PSUR/0008/ Yes 17 flunitrazepam Innovator product withdrawn from IE (last procedure number Roche was IE/H/PSUR/0039/001). Need for new P-RMS 173 fluorescein (systemic use) 30/11/ /04/014 9/07/014 nationally by a 174 competent fluorodopa Not Available* 10/03/014 08/06/ fluphenazine flurbiprofen Abbott IT/H/PSUR/0001/ folinic acid / (di)sodium folinate / calcium folinate 31/08/014 Bracco IT/H/PSUR/004/00 9/11/ formoterol /05/014 AstraZeneca SE/H/PSUR/0009/003 9/08/ fosfomycin (IV formulation) Sanofi Aventis FR/H/PSUR/0061/ fosfomycin (oral formulation) Zambon FR/H/PSUR/0064/ furosemide, spironolactone 11/01/ /01/014 01/04/ fusidic acid 31/05/196 30/05/013 8/08/ gadodiamide Ge Healthcare DK/H/PSUR/0061/ gadoteridol Bracco DK/H/PSUR/0030/ ganciclovir 15/06/ /06/013 1/09/ gemcitabine Eli Lilly SE/H/PSUR/0043/ Yes List of substances under PSUR scheme and other substances contained in NAPs with DLP synchronised - March 013

10 gestrinone glipizide glucose, potassium chloride Not Available* 17/04/014 16/07/ guaifenesin, salbutamol sulfate Not Available* 31/01/014 01/05/ haemophilus type b and meningococcal group c 19/1/005 01/0/014 0/05/ conjugate vaccine haemophilus type b conjugate 06/0/199 vaccines 06/0/014 07/05/ heparinoid heparinoid + ibuprofen hepatitis a (inactivated), typhoid polysaccharide vaccine /06/1999 /06/014 0/09/ (adsorbed). hepatitis A vaccine (inactivated, 14/1/1999 virosome) 01/01/014 01/04/ hepatitis A vaccines 01/01/199 (inactivated, adsorbed) 01/01/014 01/04/ human coagulation factor IX 1/07/ Baxter AT/H/PSUR/0041/ human coagulation factor VII 01/11/ Baxter AT/H/PSUR/004/ human coagulation factor VIII 04/0/1977 (inhibitor bypassing fraction) 31/01/014 AT/H/PSUR/0043/001 01/05/ human hemin 05/05/ /05/013 9/08/013 0 human plasma (pooled and treated for virus inactivation) 31/05/006 8/0/014 9/05/ hydralazine hydrochlorothiazide hydrocortisone 05/08/195 31/08/014 9/11/ hydrocortisone + lidocaine hydrocortisone + urea hydroquinidine Sanofi Aventis ES/H/PSUR/0004/ 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

11 scheme or s (contained in hydrotalcite Bayer Schering HU/H/PSUR/00/ hydroxycarbamide /03/1966 1/03/014 19/06/ hypromellose ibuprofen 19/0/ /0/014 19/05/014 Yes 14 ibuprofen, pseudoephedrine 18/09/ /07/013 16/10/013 Yes ibutilide Pfizer SE/H/PSUR/0035/ icodextrin Not Available* 30/04/014 9/07/014 nationally by a 16 competent idarubicin Pfizer AT/H/PSUR/0005/ ifenprodil indapamide, perindopril 30/08/001 4/10/013 /01/ indobufen /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/ /08/013 30/10/013 6 interferon alfa-a Roche NL/H/PSUR/0044/ interferon gamma-1b Boehringer NL/H/PSUR/0050/ Ingelheim ipratropium 14/08/1974 0/11/013 18/0/014 9 ipratropium, salbutamol /03/ /01/014 14/04/ irinotecan /05/014 Pfizer FR/H/PSUR/0009/003 0/08/ isoniazide, rifampicin 01/05/ /05/013 30/07/013 3 List of substances under PSUR scheme and other substances contained in NAPs with DLP synchronised - March 013

12 scheme or s (contained in ispaghula husk + mebeverine isradipine Novartis CZ/H/PSUR/0019/ itopride 30/06/ /06/013 8/09/ ivermectin MSD FR/H/PSUR/0037/ ketamine ketoprofen (topical use only) Sanofi Aventis / Bayer Schering SE/H/PSUR/0049/003 yearly PSURs 0131 Yes labetalol GSK NO/H/PSUR/0011/ Aspen Pharma lactobacillus acidophilus 01/01/ /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 /05/014 Ipsen UK/H/PSUR/0010/003 14/08/014 4 lanthanum carbonate hydrate Not Available* 18/03/014 16/06/ latanoprost (products with paediatric indication) Re-start of the PSUR with 6 monthly submissions following Pfizer the extension of the indication UK/H/PSUR/0064/006 6-monthly PSURs for children (Article 9 44 paediatric). 45 lenograstim lercanidipine 11/10/ /10/013 9/01/014 Yes /08/014 Recordati UK/H/PSUR/0011/00 9/11/ levobunolol levobupivicaine /06/014 Allergan CZ/H/PSUR/0006/003 30/08/014 Yes Abbott SE/H/PSUR/0036/ levodopa levosalbutamol Not Available* 31/10/013 9/01/014 Yes Not Available* 31/01/014 01/05/ levosimendan Orion SE/H/PSUR/0004/ lidocain + zinc oxide lidocaine lidocaine hydrochloride chlorhexidine hydrochloride 54 linezolid Pfizer UK/H/PSUR/0037/005 yearly PSURs List of substances under PSUR scheme and other substances contained in NAPs with DLP synchronised - March 013

13 scheme or s (contained in linsidomine liothyronine lithium lofepramine lomustine BMS SK/H/PSUR/0007/ Yes loracarbef losartan + hydrochlorothiazide Hyzaar, Cozaar Plus, Fortzaar MSD NL/H/PSUR/0057/ lovastatin MSD ES/H/PSUR/000/ loxapine lynestrenol lysine acetylsalicylic acid metoclopramide 66 macrogol /04/ /05/013 9/08/ macrogol Ipsen FR/H/PSUR/006/ macrogol 4000 and Fortrans Ipsen FR/H/PSUR/0063/ s 69 magnesium +/or calcium +/or aluminium antacids 70 mannitol Not Available* 8/0/014 9/05/ marine fish oil measles vaccine (live attenuated) 5/10/ /05/014 0/08/014 nationally by a 73 competent mebeverine mefloquine /04/013 Roche DE/H/PSUR/00/003 13/0/014 9/07/013 Yes meloxicam Boehringer FR/H/PSUR/0001/ Ingelheim menotrophin mephenesin mepivacaine AstraZeneca DK/H/PSUR/0057/ List of substances under PSUR scheme and other substances contained in NAPs with DLP synchronised - March 013

14 scheme or s (contained in mepivacaine + adrenaline Carbocaine Astrazeneca DK/H/PSUR/0058/ Adrenaline meprobamate 5/07/ /10/013 9/01/ mesalazine Salofalk Dr. Falk Pharma UK/H/PSUR/005/ methadone 01/01/ /05/013 30/07/ methionine methotrexate 01/01/196 30/06/014 8/09/014 Yes methoxsalen methylphenidate Novartis UK/H/PSUR/0068/005 Yearly PSURs methylphenobarbital metopimazine midodrine 06/0/ /06/013 04/09/ mifepristone 31/05/ /05/013 9/08/013 Yes mirtazapine Organon NL/H/PSUR/0006/ misoprostol /06/014 Pfizer DK/H/PSUR/0014/003 8/09/014 Yes 94 mitoxantrone 15/06/ /06/013 8/09/013 Yes mivacurium GSK IE/H/PSUR/0031/ modafinil Cephalon DE/H/PSUR/0044/003 yearly PSURs moxifloxacin (systemic use) Bayer Schering DE/H/PSUR/003/004 yearly PSURs Yes muromonab-cd3 03/06/ /05/013 13/08/ nafarelin Pfizer NO/H/PSUR/001/ nalbuphine 15/05/ /05/013 30/07/013 Yes naproxen 04/08/ /08/014 01/11/014 nationally by a 301 competent neostigmine nicardipine Astellas IT/H/PSUR/001/ nicorandil Merck AT/H/PSUR/003/ nicotinic acid, simvastatin Not Available* 01/07/013 9/09/013 Yes niflumic acid (morniflumate) List of substances under PSUR scheme and other substances contained in NAPs with DLP synchronised - March 013

15 scheme or s (contained in nifuratel nifuratel + nystatin nilvadipine Astellas IE/H/PSUR/0035/ nimesulide Helsinn IT/H/PSUR/003/ nitrazepam nitrofurantoin nitrous oxide Not Available* 03/03/014 01/06/ nortriptyline Lundbeck EE/H/PSUR/0010/ octreotide /06/014 Novartis IE/H/PSUR/0010/003 8/09/ olpadronic acid Not Available* 01/01/014 01/04/ opium prepared, paracetamol 1/10/010 30/09/013 9/1/ orciprenaline oxacillin oxatomide J&J PT/H/PSUR/0005/005 yearly PSURs oxazepam oxcarbazepine Novartis DK/H/PSUR/000/ Yes oxytocin 0/06/ /06/014 8/09/014 nationally by a 33 competent paclitaxel BMS NL/H/PSUR/0045/ pancuronium 01/01/ /1/013 01/03/014 Yes panthenol paracetamol (IV formulation) BMS FR/H/PSUR/007/ paracetamol s with acetyl salicylic acid 38 paricalcitol Abbott ES/H/PSUR/0016/ paroxetine GSK NL/H/PSUR/003/ List of substances under PSUR scheme and other substances contained in NAPs with DLP synchronised - March 013

16 scheme or s (contained in 331 patent blue V sodium 31/03/ /04/013 9/07/013 Yes pefloxacin /08/014 Sanofi Aventis FR/H/PSUR/0049/003 9/11/ pentaerithrityl tetranitrate pentoxyverine 15/1/ /1/013 31/03/ perphenazine pethidine phendimetrazine phenylbutazone pilocarpine + timolol pimecrolimus Novartis DK/H/PSUR/0009/006 yearly PSURs Yes pimozide pipecuronium pipobroman 01/07/ /06/013 8/09/ pipotiazine pirenzepine piribedil Servier LV/H/PSUR/0004/ piroxicam /04/014 Pfizer UK/H/PSUR/0009/003 30/06/ pitavastatin 17/07/003 16/07/013 14/10/ potassium bicarbonate sodium alginate 349 potassium bicarbonate sodium bicarbonate 350 pravastatin BMS FR/H/PSUR/0007/ pravastatin + acetylsalicylic Selktine Plus ASA BMS FR/H/PSUR/0011/ acid 35 prazepam pristinamycin List of substances under PSUR scheme and other substances contained in NAPs with DLP synchronised - March 013

17 375 simvastatin 376 sodium iodide [ 13 I] 377 scheme or s (contained in protamine protirelin 01/01/ /01/014 01/04/ pyrantel pyrazinamide pyritinol quetiapine /07/014 AstraZeneca NL/H/PSUR/001/005 9/10/ quinidine quinine 15/01/ /11/013 8/0/ rabbit anti-human thymocyte Genzyme EE/H/PSUR/0008/ racecadotril Not Available* 31/03/014 9/06/ reserpine reviparin 05/07/001 04/07/013 0/10/ ribavirin (i.v. application) Roche NL/H/PSUR/0036/005 yearly PSURs Yes rizatriptan MSD NL/H/PSUR/000/ ropinirole GSK FR/H/PSUR/0010/ Yes rupatadine PSUR frequency changed to 6- month in Feb01, when J. Uriach y Cia ES/H/PSUR/0009/004 6 months pediatric oral solution was 370 authorised. saccharomyces boulardii Not Available* 07/0/014 08/05/ salbutamol 31/01/ /01/014 01/05/ secnidzole sertindole Lundbeck UK/H/PSUR/0004/00 6-monthly PSURs Yes sertraline Pfizer The P-RMSship was transferred from SK to NL, as NL is the rapporteur for the innovator NL/H/PSUR/0059/ product Zoloft /04/014 MSD IE/H/PSUR/0009/003 04/07/ Ge Healthcare DK/H/PSUR/0056/ List of substances under PSUR scheme and other substances contained in NAPs with DLP synchronised - March 013

18 scheme or s (contained in solifenacin /06/014 Astellas NL/H/PSUR/001/00 06/09/ sotalol /08/1973 1/08/014 19/11/014 nationally by a 379 competent stannous fluoride + medronate stibogluconate sulbactam Pfizer AT/H/PSUR/0004/ sulfaguanidine sulproston Bayer Schering FR/H/PSUR/0038/ suxamethonium 14/08/195 31/08/014 9/11/014 Yes tauroselcholic acid [ 75 Se] Ge Healthcare HU/H/PSUR/001/ technetium (99mTc) bicisate LANTHEUS MI DK/H/PSUR/001/ technetium (99mTc) oxidronate technetium (99mTc) Not Available* pertechnetate 7/03/014 5/06/ technetium( 99m Tc) macrosalb Ge Healthcare DK/H/PSUR/0048/ technetium(99mtc) sestamibi terconazole testosterone undecylate 5/11/003 injection 4/11/013 /0/ thiocolchicoside thioperazine thioridazine thyrotropine releasing hormone (synthetic) 397 thyroxine s tibolone Organon SE/H/PSUR/0006/ tick-borne encephalitis Vaccine 9/01/001 (inactivated) 31/01/014 01/05/ List of substances under PSUR scheme and other substances contained in NAPs with DLP synchronised - March 013

19 scheme or s (contained in tinzaparine tioconazole /04/014 Pfizer PT/H/PSUR/0003/003 30/06/ tirofiban IROKO DE/H/PSUR/0001/ tixocortol Pfizer FR/H/PSUR/0004/ tizanidine Novartis FI/H/PSUR/000/ tolterodine Pfizer SE/H/PSUR/0003/ tosylchloramide tramadol 18/04/1973 /05/014 0/08/014 Yes trandolapril Abbott NL/H/PSUR/007/ tranexamic acid treprostinil Not Available* 01/05/013 30/07/013 Yes triamcinolone (opthalmic 31/03/011 formulations) 31/03/014 9/06/ tridecanamine undecylenate triethanolamine salicylate trifluridine trimeperidine Not Available* 8/08/013 6/11/ trimetazidine 06/08/001 06/08/013 04/11/013 Yes typhoid polysaccharide vaccine 05/08/ /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 GSK CZ/H/PSUR/0018/ valsartan Novartis SE/H/PSUR/004/ varicella vaccine (live) 17/10/ /10/013 15/01/014 4 varicella zoster-immunoglobine 9/1/ /1/013 31/03/ vecuronium bromide Organon CZ/H/PSUR/000/ Yes verapamil List of substances under PSUR scheme and other substances contained in NAPs with DLP synchronised - March 013

20 scheme or s (contained in vincristine yellow fever vaccine (live) 7/01/1986 0/1/013 0/03/ yohimbine 01/06/ /05/013 9/08/013 Yes zafirlukast AstraZeneca IE/H/PSUR/0030/ List of substances under PSUR scheme and other substances contained in NAPs with DLP synchronised - March 013

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