List of nationally authorised medicinal products
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- Julius Reynolds
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1 30 November 2017 EMA/812360/2017 Human Medicines Evaluation Division Active substance(s): mupirocin Procedure No.: PSUSA/ / Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0) Facsimile +44 (0) Send a question via our website An agency of the European Union European Medicines Agency, Reproduction provided the source is acknowledged.
2 Mupirocina ISDIN 20 mg/g pomada not available ISDIN, S.A. ES MUPIROCINA ISDIN 20 mg/g pomada not available ISDIN LDA PT MUPIROCINA ISDIN 20 mg/g pomada not available ISDIN LDA PT MUPIROCINE ARROW 2 %, pommade not available NL ARROW GENERIQUES FR Plasimine 20 mg/g pomada not available STIEFEL FARMA, S.A. ES Bactroban 2% cream not available S00159 SMITHKLINE ECHAM LTD CY Bactroban 2% cream not available MA 447/00304 ECHAM GROUP PLC MT Bactroban 2% salva not available SMITHKLINE ECHAM LTD FI Bactroban Nasal 2 % nässalva not available SMITHKLINE ECHAM LTD FI Bactroban 2 % kräm UK/H/0295/ SMITHKLINE ECHAM PLC FI Bactroban 2% Zalf not available Bactroban 2 % Salbe not available Bactroban 2% Neuszalf not available Bactroban 2% Nasensalbe not available Bactroban 2% Nasensalbe not available 0260/ Bactroban 2 % Salbe not available 0260/ Bactroban 20 mg/g mast not available UP/I /12-01/522 D.O.O. HR Bactroban 2% Nasal Ointment not available MA 447/00301 ECHAM GROUP PLC MT Bactroban 2% cream UK/H/0295/001 PL 00038/0372 ECHAM GROUP PLC UK BACTROBAN 2% Crema UK/H/0295/ S.P.A. IT Bactroban 2 % emulsiovoide UK/H/0295/ SMITHKLINE ECHAM LTD FI Bactroban UK/H/0295/ PHARMA A/S DK Bactroban 2 % - Creme UK/H/0295/ PHARMA GMBH. AT Bactroban 2% Pommade not available EMA/812360/2017 Page 2/5
3 Бактробан 2 % маз за нос not available EOOD BG BACTROBAN Ρινική αλοιφή not available AE GR Bactroban 2% Pommade nasale not available Bactroban Huidzalf 2% hydrofiele zalf 20 mg/g not available RVG B.V. NL Bactroban 2% Neuszalf 20 mg/g not available RVG B.V. NL Bactroban 20 mg/g pomada nasal not available ECHAM PORTUGUESA, PRODUTOS FARMACÊUTICOS E QUÍMICOS, LDA PT Bactroban Nasal 2% salva not available AB SE BACTROBAN NASAL Mupirocina (D.O.E.) (de calcio) Pomada para uso intranasal not available STIEFEL FARMA, S.A. ES Bactroban - Nasensalbe not available PHARMA GMBH. AT Бактробан 2 % маз not available EOOD BG BACTROBAN αλοιφή not available AE GR Bactroban 20 mg/g pomada not available STIEFEL FARMA, S.A. ES Bactroban, 20 mg/g, masc not available R/0714 EXPORT LTD PL Bactroban Nasal 20 mg/g nosní mast not available 69/384/95-C SMITHKLINE ECHAM LTD CZ BACTROBAN 20 mg/g mast not available 46/147/87-C SMITHKLINE ECHAM LTD CZ Bactroban 2 % voide not available SMITHKLINE ECHAM LTD FI Turixin 2% Nasensalbe not available GMBH & CO. KG DE Bactroban 2% Pommade not available 0260/ Bactroban 2% Pommade nasale not available 0260/ Bactroban 20 mg/g pomada nasal not available ECHAM PORTUGUESA, PRODUTOS FARMACÊUTICOS E QUÍMICOS, LDA PT Bactroban 2% salva not available AB SE Bactroban, 20 mg/g, maść do not available R/3623 EXPORT LTD PL EMA/812360/2017 Page 3/5
4 nosa Bactroban 20 mg/g krem not available 8397 EXPORT LTD PL Bactroban, salve not available PHARMA A/S DK BACTROBAN 2 %, pommade nasale not available NL17691 LABORATOIRE FR Bactroban 20 mg/g orrkenőcs not available OGYI-T-5031/01 KFT. HU Bactroban 20 mg/g kenocs not available OGYI-T-1800/01 KFT. HU BACTROBAN NASALE 2% unguento not available S.P.A. IT BACTROBAN 20mg/g unguento not available S.P.A. IT MUPISKIN 20 mg/g Unguento not available S.P.A. IT Bactroban 20 mg/g dermalna mast' not available 46/0147/87-C/S SLOVAKIA S.R.O. SK Bactroban 2% Smyrsli not available (IS) PHARMA A/S IS Bactroban Nasal 2% nefsmyrsli not available PHARMA A/S IS Bactroban Nasal not available PHARMA A/S DK Bactroban Nasal 2 % nenävoide not available SMITHKLINE ECHAM LTD FI Bactroban 2% Nasal Ointment not available PL 00038/0347 ECHAM GROUP PLC UK Bactroban Nasal Ointment 2% w/w not available PA 1077/94/2 (IRELAND) IE Bactroban 2% w/w Ointment not available PA 1077/94/1 (IRELAND) IE Bactroban 2% Ointment not available MA 447/00302 ECHAM GROUP PLC MT Bactroban 2% Ointment not available PL 00038/0319 ECHAM GROUP PLC UK Impetine 20mg/g Gel not available LABORATORIO REIG JOFRE, S.A. PT Impetine 20mg/g Gel not available LABORATORIO REIG JOFRE, S.A. PT MUPIDERM 2 pour cent, pommade not available ALMIRALL, SAS FR Mupirocina Dermogen 20 mg/g pomada not available DERMOGEN FARMA, S.A. ES Mupirocin 2% w/w Ointment not available PL 20046/0071 FOCUS PHARMACEUTICALS UK Mupirocin 20 mg/g Ointment UK/H/4991/001 PL 15011/0011 INFECTOPHARM ARZNEIMITTEL UK INFECTOPYODERM 20 mg/g UK/H/4991/ INFECTOPHARM ARZNEIMITTEL DE EMA/812360/2017 Page 4/5
5 Salbe PSEROCINA 20 mg/g unguento PL/H/0448/ INFECTOPHARM ARZNEIMITTEL IT EMA/812360/2017 Page 5/5
List of nationally authorised medicinal products
10 September 2015 EMA/677092/2015 Procedure Management and Committees Support Active substance: glatiramer Procedure no.: PSUSA/00001529/201411 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
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8 March 2018 EMA/182668/2018 Human Medicines Evaluation Division Active substance(s): triamcinolone (topical and nasal formulations) Procedure No.: PSUSA/00003017/201707 30 Churchill Place Canary Wharf
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10 September 2015 EMA/612853/2015 Procedure Management and Committees Support Active substance: tobramycin (nebuliser solution) Procedure no.: PSUSA/00009316/201412 30 Churchill Place Canary Wharf London
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10 September 2015 EMA/622830/2015 Procedure Management and Committees Support Active substance: azelastine Procedure no.: PSUSA/00000277/201412 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
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14 April 2016 EMA/284169/2016 Procedure Management and Committees Support Active substance: influenza vaccine (split virion, inactivated) (non centrally products) Procedure no.: PSUSA/00010298/201508 30
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30 November 2017 EMA/817351/2017 Human Medicines Evaluation Division Active substance: Lidocaine / prilocaine (not centrally authorised product) Procedure no.: PSUSA/00001867/201703 30 Churchill Place
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12 January 2017 EMA/36356/2017 Human Medicines Evaluation Division Active substance: hydroxyzine chloride / hydroxyzine pamoate and all fixed combination, hydroxyzine Procedure no.: PSUSA/00001696/201605
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28 September 2017 EMA/639167/2017 Human Medicines Evaluation Division Active substance: zanamivir Procedure no.: PSUSA/00003141/201701 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
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6 September 2018 EMA/615391/2018 Human Medicines Evaluation Division Active substance: tobramycin (nebuliser solution) (apart from centrally authorised product) Procedure no.: PSUSA/00009316/201712 30
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26 October 2017 EMA/690754/2017 Human Medicines Evaluation Division Active substance: fish oil / olive oil / soybean oil / triglycerides mediumchain Procedure no.: PSUSA/00010223/201702 30 Churchill Place
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29 November 2018 EMA/880324/2018 Human Medicines Evaluation Division Active substance: enalapril Procedure no.: PSUSA/00001211/201803 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
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30 November 2017 EMA/817337/2017 Human Medicines Evaluation Division Active substance: Itraconazole Procedure no.: PSUSA/00001798/201703 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
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08 March 2018 EMA/170163/2018 Human Medicines Evaluation Division Active substance: enalapril / hydrochlorothiazide Procedure no.: PSUSA/00001212/201707 30 Churchill Place Canary Wharf London E14 5EU United
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17 May 2018 EMA/303456/2018 Human Medicines Evaluation Division Active substance: bromazepam Procedure no.: PSUSA/00000435/201708 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
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09 June 2017 EMA/36849/2017 Human Medicines Evaluation Division Active substance(s): brimonidine / timolol Procedure No.: PSUSA/00000431/201609 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
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01 December 2016 Human Medicines Evaluation Division Active substance: Procedure no.: PSUSA/00002591/201604 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0)20 3660 6000 Facsimile
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06 July 2017 EMA/436040/2017 Human Medicines Evaluation Division Active substance: Procedure no.: PSUSA/00001815/201610 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0)20
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1 December 2016 EMA/750653/2016 Human Medicines Evaluation Division Active substance: valganciclovir Procedure no.: PSUSA/00003089/201603 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
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5 November 2015 EMA/230130/2016 Procedure Management and Committees Support Active substance: cabergoline Procedure no.: PSUSA/00000477/201503 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
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6 September 2018 EMA/608492/2018 Human Medicines Evaluation Division Active substance: betahistine Procedure no.: PSUSA/00000389/201712 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
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11 February 2016 EMA/255959/2016 Procedure Management and Committees Support Active substance: calcitonin salmon, synthetic analogue of eel calcitonin Procedure No.: PSUSA/00000494/201506 30 Churchill
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11 October 2017 EMA/784453/2017 Human Medicines Evaluation Division List of nationally authorised medicinal products Active substance(s): ipratropium / salbutamol Procedure No.: PSUSA/00001781/201701 30
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27 October 2016 EMA/719205/2016 Human Medicines Evaluation Division Active substance: ethinylestradiol / gestodene (except for transdermal application) Procedure no.: PSUSA/00001308/201603 30 Churchill
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1 September 2017 EMA/580096/2017 Human Medicines Evaluation Division Active substance: terbutaline Procedure no.: PSUSA/00002897/201612 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
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12 July 2018 EMA/462856/2018 Human Medicines Evaluation Division Active substance: econazole, econazole nitrate / triamcinolone acetonide, econazole nitrate / zinc oxide Procedure no.: PSUSA/00001195/201711
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21 June 2017 EMA/610895/2017 Human Medicines Evaluation Division Active substance: felbamate Procedure no.: PSUSA/00010155/201609 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
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28 September 2017 EMA/658449/2017 Human Medicines Evaluation Division Active substance: olodaterol Procedure no.: PSUSA/00010245/201703 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
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3 December 2015 EMA/98477/2016 Procedure Management and Committees Support Active substance: acarbose Procedure no.: PSUSA/00000017/201503 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
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11 January 2018 EMA/24585/2018 Human Medicines Evaluation Division Active substance: esomeprazole / naproxen Procedure no.: PSUSA/00001270/201704 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
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12 April 2018 EMA/231137/2018 Human Medicines Evaluation Division Active substance: fluvoxamine Procedure no.: PSUSA/00001458/201707 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
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29 September 2017 EMA/658556/2017 Procedure Management and Committees Support Active substance: loratadine Procedure no.: PSU/00001907/201702 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
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13 September 2017 EMA/706786/2017 Human Medicines Evaluation Division Active substance: Octenidine dihydrochloride / phenoxyethanol Procedure no.: PSUSA/00002199/201701 30 Churchill Place Canary Wharf
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5 May 2017 EMA/288255/2017 Human Medicines Evaluation Division Active substance: pilocarpine (ophthalmic formulation) Procedure no.: PSUSA/00002410/201608 30 Churchill Place Canary Wharf London E14 5EU
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12 April 2018 EMA/382206/2018 Human Medicines Evaluation Division Active substance(s): naproxen Procedure No.: PSUSA/00002125/201708 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
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6 September 2018 EMA/619619/2018 Human Medicines Evaluation Division Active substance: haemophilus influenzae / klebsiella ozaenae / klebsiella pneumoniae / moraxella catarrhalis / staphylococcus aureus
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11 October 2017 EMA/691535/2017 Human Medicines Evaluation Division Active substance: Haemophilus type b conjugate vaccines Procedure no.: PSUSA/00001584/201702 30 Churchill Place Canary Wharf London E14
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20 July 2016 EMA/270645/2015 Procedure Management and Committees Support Active substance: apomorphine Procedure no.: PSUSA/00000227/201511 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
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12 April 2018 EMA/243033/2018 Human Medicines Evaluation Division Active substance: fenofibrate Procedure no.: PSUSA/00001362/201707 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
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7 July 2016 EMA/437334/2016 Procedure Management and Committees Support Division Active substance: Terazosin Procedure no.: PSUSA/00002895/201511 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
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30 November 2017 EMA/795271/2017 Human Medicines Evaluation Division Active substance: vinorelbine Procedure no.: PSUSA/00003124/201704 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
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8 March 2018 EMA/182904/2018 Human Medicines Evaluation Division Active substance(s): fluticasone propionate / formoterol fumarate dihydrate Procedure No.: PSUSA/00010339/201707 30 Churchill Place Canary
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12 July 2018 EMA/497430/2018 Human Medicines Evaluation Division Active substance: tafluprost / timolol Procedure no.: PSUSA/00010324/201712 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
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6 September 2018 EMA/612350/2018 Human Medicines Evaluation Division Active substance: azelastine Procedure no.: PSUSA/00000277/201712 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
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12 April 2018 EMA/227889/2018 Human Medicines Evaluation Division Active substance(s): typhoid polysaccharide vaccine Procedure No.: PSUSA/00003065/201708 30 Churchill Place Canary Wharf London E14 5EU
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