Innovator brand name (for fixed combination products only) Proposed EU HBD. Active substance name (INN)
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1 1 EU Harmonised Birth Dates and related Data Lock Points, Supplementary list, 7 February Aceclofenac Almirall / UCB Aciclovir GSK Adrafinil Cephalon Aldesleukine Novartis NL=RMS Pfizer/Schwarz Alprostadil (erectile dysfunction) Pharma UK=RMS Alprostadil (peripheral arterial Pfizer product differs from Schwarz Pharma occlusive diseases) product Alprostadil (peripheral arterial Schwarz Pharma product differs from Pfizer product occlusive diseases) Atenolol + chlorthalidone Tenoretic AstraZeneca Azelaic acid Schering AG / Pfizer AT = RMS Aztreonam BMS Benazepril Novartis Benazepril + hydrochlorothiazide Cibadrex Novartis Bisoprolol Merck AG Bisoprolol + hydrochlorothiazide many product names Merck AG Botulinum Toxin A Allergan currently 6-monthly PSURs Brimonidine Allergan UK=RMS Brimonidine + timolol Combigan Allergan UK=RMS Bromperidol J&J Brotizolam Boehringer Ingelheim Budesonide AstraZeneca Budesonide + formoterol Symbicort AstraZeneca Buflomedil Abbott Buprenorphine Schering Plough Calcitonin/calcitonin salmon IE = RMS (art. 30 Referral)
2 Calcitriol Roche Abbott will submit interim PSUR < 30/10/2008 and thereafter a PSUR with DLP Takeda / AstraZeneca Candesartan Captopril BMS Captopril + hyrochlorothiazide Captea BMS / Carbomer (artificial tears) Novartis Carboplatine BMS Cefixime Astellas Ceftazidime GSK Ceftizoxime Astellas Cefuroxime Eli Lilly following DLP Cefuroxime axetil (oral) GSK following DLP Cefuroxime sodium (injection) GSK following DLP Cetirizine UCB Ciclesonide Altana UK = RMS, periodicity of PSURs is still 6 month Cicletanine Ipsen Cilazapril Roche Cilazapril + hydrochlorothiazide Vascase Plus Pfizer Ciprofloxacine + fluocinolone acetonide Cetraxal Plus SALVAT Cisplatin BMS Clenbuterol Boehringer Ingelheim Clodronate Roche / Schering Dexrazoxane Novartis FR=RMS Diclofenac sodium/misoprostol Arthrotec Pfizer UK = RMS Will maintain the current PSUR periodicity up to the renewal (March 2007). Will follow HBD of ciprofloxacin thereafter.
3 Diltiazem Dipivefrin Allergan Dronabinol Solvay Ebastine Almirall Eberconazole SALVAT Econazole J&J Econazole combinations Pevisone / Econacort Cream J&J / BMS Eprosartan Solvay Eprosartan + hydrochlorothiazide Teveten Plus Solvay Ethinyl estradiol (EE) 20 mcg/ Lorette/Lowette/ Wyeth FI=RMS levonorgestrel (LNG) 100 mcg eios/alesse Etoposide BMS Famotidine MSD Ferumoxsil (siloxane coated superparamagnetic ironoxide)(infusion) Guerbet Endorem. Fr=RMS Ferumoxsil (siloxane coated superparamagnetic ironoxide)(oral and rectal) Guerbet Lumirem Finasteride MSD SE = RMS Flecainide M Fluconazole Pfizer Flurbiprofen Abbott Fluvoxamine Solvay Gadobenate dimeglumine Bracco UK=RMS Gadobutrol Schering AG / Pfizer Gadoteric acid (intraarticular) Guerbet Artirem. NL=RMS
4 Gadoteric acid (IV and intravascular) Guerbet Dotarem. NL=RMS Gadoteridol Bracco Galactose (contrast medium) Schering AG Galactose + palmitic acid Levovist Schering AG Iobitridol Guerbet Ioxaglic acid Guerbet Ketorolac Roche Labetalol GSK Lanreotide Ipsen Levobunolol Allergan Lomefloxacin Pfizer Lomefloxacin (ophtalmic Novartis preparations) Mangafodipir GE Healthcare Mesalazine Salofalk Dr. Falk Pharma Methylprednisolone aceponate Schering AG Metolazone UCB Miglitol Bayer Modafinil Cephalon DLP second PSUR after Molsidomin Monoxidine Solvay Nabumetone GSK Naloxone BMS Nicardipine Astellas Nilvadipine Astellas Nimesulide Helsinn 6 monthly PSUR, following DLP Nimodipine Bayer Ofloxacin
5 2 Ofloxacin (ophtalmic Allergan 99 preparations) 100 Olsalazine 101 Oxitropium 102 Oxybutynin 103 Pantoprazole Pantoprazole + Amoxicilline + ZacPac UCB Boehringer Ingelheim Altana Altana 104 clarithromycine 105 Phloroglucinol Phloroglucinol, Spasfon Cephalon Cephalon 106 Trimethylphloroglucinol 107 Piracetam 108 Pirenzepine 109 Pyrazinamide 110 Ramipril + felodipine Ramipril + furosemide Tazko Lasitace / Ramipril Pfizer Boehringer Ingelheim Ramipril + hydrochlorothiazide Furosemid Aventis Cotriatec Ramipril + piretanide Trialix/Prilace/Aretensin /Arelix Rocuronium Organon Simvastatin MSD Simvastatin, 10 mg, pharmacy status, only in UK, has different BD and DLP Somatostatin Somatropin Ferring Zomacton; FR=RMS Somatropin Eli Lilly Humatrope; NL=RMS Somatropin Maxomat; national MA in FR Somatropin Pfizer Genotropin; DK=RMS Somatropin Novonordisk Norditropin; DK=RMS Somatropin Merck Serono Saizen; IT=RMS Terbinafine Novartis
6 2 Thyrotropine releasing hormone UCB 124 (synthetic) 125 Tiotropium Boehringer Ingelheim NL=RMS 126 Tobramycin (for inhalation) Novartis UK=RMS 127 Trandolapril + verapamil Tarka Abbott NL=RMS 128 Trazodone BMS 129 Urapidil Altana 130 Ursodeoxycholic acid Dr. Falk Pharma
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