List of nationally authorised medicinal products
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1 28 September 2017 EMA/658449/2017 Human Medicines Evaluation Division Active substance: olodaterol 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 is authorised provided the source is acknowledged.
2 National Number mikrogram ionsvätska, lösning mikrogramov, inhalačný roztok, 2,5 mikrogrammi sioonilahus microgramos, solución para inhalación mikrogramów/dawkę dostarczaną, roztwór do inhalacji microgramas, solução para inalação mikrogramov/vdih raztopina za inhaliranje NL/H/2498/ BOEHRINGER INGELHEIM NL/H/2498/001 14/0394/13-S BOEHRINGER INGELHEIM NL/H/2498/ BOEHRINGER INGELHEIM NL/H/2498/ BOEHRINGER INGELHEIM NL/H/2498/ BOEHRINGER INGELHEIM NL/H/2498/ BOEHRINGER INGELHEIM NL/H/2498/ I-369/14 BOEHRINGER INGELHEIM NL/H/2498/ BOEHRINGER INGELHEIM NL/H/2498/ BOEHRINGER INGELHEIM NL/H/2498/ BOEHRINGER INGELHEIM NL/H/2498/ BOEHRINGER INGELHEIM SE SK EE ES PL PT SI AT EMA/658449/2017 Page 2/6
3 National Number mikrogram, ionsvätska, lösning μικρογραμμάρια, εισπνεόμενο διάλυμα mikrogramu roztok k inhalaci NL/H/2498/ BOEHRINGER INGELHEIM NL/H/2498/ BOEHRINGER INGELHEIM NL/H/2498/ BOEHRINGER INGELHEIM NL/H/2498/001 14/111/14-C BOEHRINGER INGELHEIM NL/H/2498/ BOEHRINGER INGELHEIM NL/H/2498/ BOEHRINGER INGELHEIM NL/H/2498/ BOEHRINGER INGELHEIM NL/H/2498/ BOEHRINGER INGELHEIM NL/H/2498/ /2014/04 BOEHRINGER INGELHEIM NL/H/2498/ /2014/03 BOEHRINGER INGELHEIM NL/H/2498/ /2014/02 BOEHRINGER INGELHEIM FI GR CZ EMA/658449/2017 Page 3/6
4 National Number μικρογραμμάρια, εισπνεόμενο διάλυμα microgrammes/dose, solution à inhaler microgram, ieoplossing microgram, ieoplossing Стриверди Респимат 2,5 микрограма, разтвор за инхалация, ionsvæske, opløsning NL/H/2498/ /2014/01 BOEHRINGER INGELHEIM NL/H/2498/ BOEHRINGER INGELHEIM NL/H/2498/ BOEHRINGER INGELHEIM NL/H/2498/ BOEHRINGER INGELHEIM NL/H/2498/001 BE BOEHRINGER INGELHEIM NL/H/2498/001 BE BOEHRINGER INGELHEIM NL/H/2498/001 RVG BOEHRINGER INGELHEIM NL/H/2498/ BOEHRINGER INGELHEIM NL/H/2498/ BOEHRINGER INGELHEIM NL/H/2498/001 OGYI-T-22563/02 BOEHRINGER INGELHEIM NL/H/2498/001 OGYI-T-22563/04 BOEHRINGER INGELHEIM CY LU LU BE BE NL BG DK EMA/658449/2017 Page 4/6
5 National Number Striverdi Respimat 2,5 Mikrogramm/Hub Lösung mikrogrami šķīdums inhalācijām mikrog, inhalaationeste, liuos míkrógrömm, innöndunarlausn microgrammes, solution à inhaler Striverdi 2,5 mikrogram, inhalasjonsvæske, oppløsning 2.5 microgram, ion solution 2.5 microgram, ion solution NL/H/2498/ BOEHRINGER INGELHEIM NL/H/2498/ BOEHRINGER INGELHEIM NL/H/2498/ BOEHRINGER INGELHEIM NL/H/2498/ BOEHRINGER INGELHEIM NL/H/2498/001 OGYI-T-22563/01 BOEHRINGER INGELHEIM NL/H/2498/001 OGYI-T-22563/03 BOEHRINGER INGELHEIM NL/H/2498/001 IS/1/13/083/01 BOEHRINGER INGELHEIM NL/H/2498/001 BE BOEHRINGER INGELHEIM NL/H/2498/ BOEHRINGER INGELHEIM NL/H/2498/001 MA 211/00401 BOEHRINGER INGELHEIM NL/H/2498/001 PA 775/6/1 BOEHRINGER INGELHEIM LI DE LV FI IS BE NO MT IE EMA/658449/2017 Page 5/6
6 National Number 2.5 microgram, ion solution NL/H/2498/001 PL 14598/0093 BOEHRINGER INGELHEIM NL/H/2498/001 /1/13/3429/001 BOEHRINGER INGELHEIM NL/H/2498/001 /1/13/3429/002 BOEHRINGER INGELHEIM NL/H/2498/001 /1/13/3429/003 BOEHRINGER INGELHEIM NL/H/2498/001 /1/13/3429/004 BOEHRINGER INGELHEIM UK EMA/658449/2017 Page 6/6
List of nationally authorised medicinal products
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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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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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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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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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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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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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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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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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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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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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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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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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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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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11 September 2017 EMA/604559/2017 Human Medicines Evaluation Division Active substance: iron / parenteral preparations Procedure no.: PSUSA/00010236/201701 30 Churchill Place Canary Wharf London E14 5EU
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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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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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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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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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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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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/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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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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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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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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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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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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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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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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30 November 2017 EMA/812360/2017 Human Medicines Evaluation Division Active substance(s): mupirocin Procedure No.: PSUSA/00002096/201703 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
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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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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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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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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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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 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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