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Harmonised Bds Suppl 20070 ABCDEF 1 EU Harmonised Birth Dates and related Data Lock Points, Supplementary list, 7 February 2007 Innovator brand name First DLP after Proposed Active substance name (INN) (for fixed combination 30 October Firm's Name Comments EU HBD products only) 2005 2 3 Aceclofenac 19900319 20080331 Almirall / UCB 4 Aciclovir 19810610 20060630 GSK 5 Adrafinil 19810710 20060131 Cephalon 6 Aldesleukine 19890703 20051231 Novartis NL=RMS Pfizer/Schwarz 7 Alprostadil (erectile dysfunction) 19840128 20080131 Pharma UK=RMS Alprostadil (peripheral arterial 19810723 20060731 Pfizer product differs from Schwarz Pharma 8 occlusive diseases) product Alprostadil (peripheral arterial 19841128 20051128 Schwarz Pharma product differs from Pfizer product 9 occlusive diseases) 10 Atenolol + chlorthalidone Tenoretic 19970909 20080908 AstraZeneca Azelaic acid 19881027 20060102 Schering AG / Pfizer AT = RMS 11 12 Aztreonam 19840804 20060803 BMS 13 Benazepril 19891128 20071130 Novartis Benazepril + hydrochlorothiazide Cibadrex 19920519 20070531 Novartis 14 15 Bisoprolol 19860128 20070930 Merck AG Bisoprolol + hydrochlorothiazide many product names 19920130 20061103 Merck AG 16 17 Botulinum Toxin A 19960906 20061030 Allergan currently 6-monthly PSURs 18 Brimonidine 19960906 20080930 Allergan UK=RMS 19 Brimonidine + timolol Combigan 19960906 20080930 Allergan UK=RMS 20 Bromperidol 20061115 J&J 21 Brotizolam 19830515 20071231 Boehringer Ingelheim 22 Budesonide 19920430 20070430 AstraZeneca 23 Budesonide + formoterol Symbicort 20000825 20070825 AstraZeneca 24 Buflomedil 19790523 20080522 Abbott 25 Buprenorphine 19820330 20080730 Schering Plough 26 Calcitonin/calcitonin salmon 19761206 20060630 Sanofi Aventis IE = RMS (art. 30 Referral) ABCDEF Innovator brand name First DLP after Proposed Active substance name (INN) (for fixed combination 30 October Firm's Name Comments EU HBD products only) 2005 2 Calcitriol 19780101 20060117 Roche Abbott will submit interim PSUR < 30/10/2008 and thereafter a PSUR with DLP 27 200901 Takeda / 28 Candesartan 19970429 20060428 AstraZeneca 29 Captopril 19800415 20070414 BMS Captopril + hyrochlorothiazide Captea 19800415 20070414 BMS / Sanofi Aventis 30 31 Carbomer (artificial tears) 19850101 20080131 Novartis 32 Carboplatine 19860123 20070122 BMS 33 Cefixime 19870630 20060630 Astellas 34 Ceftazidime 19831017 20061017 GSK 35 Ceftizoxime 19811207 20061004 Astellas 36 Cefuroxime 19860110 20060110 Eli Lilly following DLP 200904 37 Cefuroxime axetil (oral) 19870818 20060818 GSK following DLP 200904 38 Cefuroxime sodium (injection) 19780407 20060407 GSK following DLP 200904 39 Cetirizine 19861106 20061105 UCB Ciclesonide 20040224 200611 Altana UK = RMS, periodicity of PSURs is still 6 40 month 41 Cicletanine 19860728 20060131 Ipsen 42 Cilazapril 19900221 20051231 Roche Cilazapril + hydrochlorothiazide Vascase Plus 19911228 20051231 Pfizer 43 Will maintain the current PSUR periodicity up to the renewal (March Ciprofloxacine + fluocinolone 2007). Will follow HBD of ciprofloxacin 44 acetonide Cetraxal Plus 200203 200601 SALVAT thereafter. 45 Cisplatin 19781219 20061218 BMS 46 Clenbuterol 19801212 20070917 Boehringer Ingelheim 47 Clodronate 19870529 20060228 Roche / Schering 48 Dexrazoxane 19920217 20060228 Novartis FR=RMS 49 Diclofenac sodium/misoprostol Arthrotec 19910718 20060930 Pfizer UK = RMS ABCDEF Innovator brand name First DLP after Proposed Active substance name (INN) (for fixed combination 30 October Firm's Name Comments EU HBD products only) 2005 2 50 Diltiazem 19790502 20060531 Sanofi Aventis 51 Dipivefrin 19780919 20070930 Allergan 52 Dronabinol 19850531 20060531 Solvay Ebastine 19960101 20070531 Almirall 53 54 Eberconazole 200403 200601 SALVAT 55 Econazole 20061115 J&J Econazole combinations Pevisone / Econacort 20061115 J&J / BMS 56 Cream 57 Eprosartan 19970430 20060406 Solvay 58 Eprosartan + hydrochlorothiazide Teveten Plus 19970430 20060406 Solvay Ethinyl estradiol (EE) 20 mcg/ Lorette/Lowette/ 19970327 20060326 Wyeth FI=RMS 59 levonorgestrel (LNG) 100 mcg eios/Alesse 60 Etoposide 19760217 20070216 BMS 61 Famotidine 19840921 20080920 MSD Ferumoxsil (siloxane coated superparamagnetic 62 ironoxide)(infusion) 19940823 20080831 Guerbet Endorem. Fr=RMS Ferumoxsil (siloxane coated superparamagnetic 63 ironoxide)(oral and rectal) 19930122 20070531 Guerbet Lumirem 64 Finasteride 19980417 20070818 MSD SE = RMS 65 Flecainide 19820625 20060624 3M 66 Fluconazole 19880303 20080331 Pfizer 67 Flurbiprofen 19790901 20071109 Abbott 68 Fluvoxamine 19830713 20060712 Solvay 69 Gadobenate dimeglumine 19970722 20061130 Bracco UK=RMS 70 Gadobutrol 19980820 200602 Schering AG / Pfizer 71 Gadoteric acid (intraarticular) 20020131 20070731 Guerbet Artirem. NL=RMS ABCDEF Innovator brand name First DLP after Proposed Active substance name (INN) (for fixed combination 30 October Firm's Name Comments EU HBD products only) 2005 2 Gadoteric acid (IV and 72 intravascular) 19890308 20070930 Guerbet Dotarem. NL=RMS 73 Gadoteridol 19921029 20070228 Bracco 74 Galactose (contrast medium) 19901107 20070630 Schering AG 75 Galactose + palmitic acid Levovist 19950621 20070630 Schering AG 76 Iobitridol 19940824 20070430 Guerbet 77 Ioxaglic acid 197908 20070228 Guerbet 78 Ketorolac 19890720 20060731 Roche 79 Labetalol 19770304 20070228 GSK 80 Lanreotide 19940516 20051130 Ipsen 81 Levobunolol 19890608 20080630 Allergan 82 Lomefloxacin 19890602 20070630 Pfizer Lomefloxacin (ophtalmic 19941005 20071031 Novartis 83 preparations) 84 Mangafodipir 19970601 20060531 GE Healthcare 85 Mesalazine Salofalk 19840220 200702 Dr. Falk Pharma 86 Methylprednisolone aceponate 19901117 20051106 Schering AG 87 Metolazone 19910101 20071201 UCB 88 Miglitol 19960801 20060801 Bayer 89 Modafinil 19940901 20090831 Cephalon DLP second PSUR after 30 October 2005 90 Molsidomin 19770906 20060906 Sanofi Aventis 91 Monoxidine 19910123 20060122 Solvay 92 Nabumetone 19840315 20060315 GSK 93 Naloxone 19750414 20070413 BMS 94 Nicardipine 19810531 20060531 Astellas 95 Nilvadipine 19890101 20061231 Astellas Nimesulide 19970811 20061214 Helsinn 6 monthly PSUR, following DLP 20070615 96 97 Nimodipine 19871101 20061101 Bayer 98 Ofloxacin 19850416 20060416 Sanofi Aventis ABCDEF Innovator brand name First DLP after Proposed Active substance name (INN) (for fixed combination 30 October Firm's Name Comments EU HBD products only) 2005 2 Ofloxacin (ophtalmic 19890502 20060416 Allergan 99 preparations) 100 Olsalazine 19860601 20060531 UCB 101 Oxitropium 19820504 20071004 Boehringer Ingelheim 102 Oxybutynin 19840717 20060717 Sanofi Aventis 103 Pantoprazole 19940823 20060823 Altana Pantoprazole + Amoxicilline + ZacPac 19940823 20060823 Altana 104 clarithromycine 105 Phloroglucinol 19920218 20060918 Cephalon Phloroglucinol, Spasfon 19920218 20060918 Cephalon 106 Trimethylphloroglucinol 107 Piracetam 19881209 20071231 Pfizer 108 Pirenzepine 19790213 20070316 Boehringer Ingelheim 109 Pyrazinamide 19820215 20070215 Sanofi Aventis 110 Ramipril + felodipine Tazko 19890110 20060110 Sanofi Aventis Ramipril + furosemide Lasitace / Ramipril- 19860416 20080416 Sanofi Aventis 111 Furosemid Aventis 112 Ramipril + hydrochlorothiazide Cotriatec 19890110 20060110 Sanofi Aventis Ramipril + piretanide Trialix/Prilace/Aretensin 19930812 20080812 Sanofi Aventis 113 /Arelix 114 Rocuronium 19940317 20080228 Organon Simvastatin 19880406 20080405 MSD Simvastatin, 10 mg, pharmacy status, only 115 in UK, has different BD and DLP 116 Somatostatin 19791203 20060630 Sanofi Aventis 117 Somatropin 19910611 20080331 Ferring Zomacton; FR=RMS 118 Somatropin 19870308 20080331 Eli Lilly Humatrope; NL=RMS 119 Somatropin 19880329 20080331 Sanofi Aventis Maxomat; national MA in FR 120 Somatropin 19870127 20080331 Pfizer Genotropin; DK=RMS 121 Somatropin 19990301 20080331 Novonordisk Norditropin; DK=RMS 122 Somatropin 19880725 20080331 Merck Serono Saizen; IT=RMS 123 Terbinafine 19901003 20060930 Novartis ABCDEF Innovator brand name First DLP after Proposed Active substance name (INN) (for fixed combination 30 October Firm's Name Comments EU HBD products only) 2005 2 Thyrotropine releasing hormone 19790501 20070228 UCB 124 (synthetic) 125 Tiotropium 20011009 20081009 Boehringer Ingelheim NL=RMS 126 Tobramycin (for inhalation) 19991210 20051231 Novartis UK=RMS 127 Trandolapril + verapamil Tarka 19950316 20070315 Abbott NL=RMS 128 Trazodone 19770606 20080605 BMS 129 Urapidil 19800731 20060721 Altana 130 Ursodeoxycholic acid 19791127 20081104 Dr. Falk Pharma.
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