List of nationally authorised medicinal products
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1 28 September 2017 EMA/639167/2017 Human Medicines Evaluation Division Active substance: zanamivir 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 Relenza SE/H/0180/ GLAXOSMITHKLINE PHARMA A/S DK not available 537/2008/01 GLAXO GROUP LIMITED RO not available 537/2008/02 GLAXO GROUP LIMITED RO not available 537/2008/01 GLAXO GROUP LIMITED RO not available 537/2008/02 GLAXO GROUP LIMITED RO Relenza 5 mg/ deva, dozets inhalacijas pulveris Relenza 5 mg/adag, adagolt inhalációs por SE/H/0180/ GLAXOSMITHKLINE LATVIA LV SIA SE/H/0180/001 OGYI-T-20325/01 GLAXOSMITHKLINE KFT. HU Relenza 5 mg/annos inhalaatiojauhe, annosteltu Relenza 5 mg/davka upraveny inhalacny prasok Relenza 5 mg/dos, inhalationspulver, avdelad dos SE/H/0180/ GLAXOSMITHKLINE OY FI SE/H/0180/001 42/0084/07-S GLAXOSMITHKLINE SK SLOVAKIA S.R.O. SE/H/0180/ GLAXOSMITHKLINE OY FI EMA/639167/2017 Page 2/6
3 Relenza 5 mg/dos, inhalationspulver, avdelad dos Relenza 5 mg/dose inhalasjonspulver, dosedispensert RELENZA 5 mg/dose polvere per inalazione in contenitore monodose RELENZA 5 mg/dose polvere per inalazione in contenitore monodose. Relenza 5 mg/dose, pó para inalação, em recipiente unidose. Relenza 5 mg/dose, pó para inalação, em recipiente unidose. RELENZA 5 mg/dose, poudre pour inhalation en récipient unidose RELENZA 5 mg/dose, poudre pour inhalation en récipient unidose RELENZA 5 mg/dose, poudre pour inhalation en récipient unidose National Number SE/H/0180/ GLAXOSMITHKLINE AB SE SE/H/0180/ GLAXOSMITHKLINE AS NO SE/H/0180/ GLAXOSMITHKLINE S.P.A. IT SE/H/0180/ GLAXOSMITHKLINE S.P.A. IT SE/H/0180/ GLAXO WELLCOME FARMACÊUTICA, LDA SE/H/0180/ GLAXO WELLCOME FARMACÊUTICA, LDA SE/H/0180/001 BE GLAXOSMITHKLINE SE/H/180/001 NL24551 LABORATOIRE GLAXOSMITHKLINE S.A.S. SE/H/0180/ /09/10/0597 GLAXOSMITHKLINE PT PT BE FR LU EMA/639167/2017 Page 3/6
4 RELENZA 5 mg/dosis, RELENZA 5 mg/dosis, RELENZA 5 mg/dosis, inhalatiepoeder, voorverdeeld RELENZA 5 mg/dosis, inhalatiepoeder, voorverdeeld Relenza 5 mg/dosis, inhalatiepoeder, voorverdeeld. Relenza 5 mg/dosis, polvo para inhalación, pre-dispensado Relenza 5 mg/dozėje dozuoti įkvepiamieji milteliai Relenza 5 mg/dozėje dozuoti įkvepiamieji milteliai Relenza 5 mg/dozi, prašak inhalata, dozirani National Number SE/H/0180/001 BE GLAXOSMITHKLINE SE/H/0180/ /09/10/0597 GLAXOSMITHKLINE SE/H/0180/001 BE GLAXOSMITHKLINE SE/H/0180/ /09/10/0597 GLAXOSMITHKLINE SE/H/0180/001 RVG GLAXOSMITHKLINE B.V. NL SE/H/0180/ GLAXOSMITHKLINE S.A. ES SE/H/0180/001 LT/1/07/0769/001 GLAXOSMITHKLINE LIETUVA UAB SE/H/0180/001 LT/1/07/0769/002 GLAXOSMITHKLINE LIETUVA UAB not available UP/I /12-02/64 GLAXOSMITHKLINE D.O.O. HR BE LU BE LU LT LT EMA/639167/2017 Page 4/6
5 Relenza 5 mg/odmerek, odmerjeni prašek za inhaliranje Relenza 5 mg/odmerek, odmerjeni prašek za inhaliranje Relenza 5 mg/skammt innöndunarduft, afmældir skammtar Relenza 5 mg/δόση, κόνις για εισπνοή, σε δόσεις National Number SE/H/0180/001 H/00/01329/002 GLAXOSMITHKLINE D.O.O. SI SE/H/0180/001 H/00/01329/001 GLAXOSMITHKLINE D.O.O. SI SE/H/0180/ GLAXOSMITHKLINE PHARMA A/S SE/H/0180/ GLAXO GROUP LIMITED GR IS Relenza 5mg/dose, inhalation powder, predispensed Relenza 5mg/dose, inhalation powder, predispensed Relenza 5mg/dose, inhalation powder, predispensed Relenza Rotadisks 5 mg/dosis Relenza, 5 mg/annuses, annustatud inhaleeritav pulber SE/H/0180/001 PA 1077/11/1 GLAXOSMITHKLINE (IRELAND) LIMITED SE/H/0180/001 MA 167/01601 GLAXO WELLCOME UK LTD TRADING AS GLAXOSMITHKLINE UK SE/H/0180/001 PL 10949/0327 GLAXO WELLCOME UK LTD TRADING AS GLAXOSMITHKLINE UK SE/H/0180/ GLAXOSMITHKLINE PHARMA GMBH. SE/H/0180/ GLAXOSMITHKLINE EESTI OÜ IE MT UK AT EE EMA/639167/2017 Page 5/6
6 Relenza, 5 mg/dávka, dávkovaný prášek k inhalaci Relenza, 5 mg/dawke proszek do inhalacji, podzielony RelenzaTM 5 mg/dosis, Реленца 5 mg/доза, прах за инхалация, предварително дозиран National Number SE/H/0180/001 42/445/00-C GLAXO GROUP LIMITED CZ SE/H/0180/ GLAXOSMITHKLINE EXPORT LTD SE/H/0180/ GLAXOSMITHKLINE GMBH & CO. KG not available GLAXO GROUP LIMITED BG PL DE EMA/639167/2017 Page 6/6
List of nationally authorised medicinal products
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
More informationList of nationally authorised medicinal products
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
More informationList 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
More informationList of nationally authorised medicinal products
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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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
More informationList 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
More informationList of nationally authorised medicinal products
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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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
More informationList of nationally authorised medicinal products
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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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
More informationList of nationally authorised medicinal products
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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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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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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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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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
More informationList of nationally authorised medicinal products
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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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
More informationList of nationally authorised medicinal products
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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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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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
More informationList of nationally authorised medicinal products
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
More informationList of nationally authorised medicinal products
28 September EMA/662335/2017 Human Medicines Evaluation Division List of nationally authorised medicinal products Active substance(s): levosalbutamol, salbutamol Procedure No.: PSUSA/00010330/201701 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
More informationList of nationally authorised medicinal products
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
More informationList of nationally authorised medicinal products
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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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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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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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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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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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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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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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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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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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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6 September 2018 EMA/619619/2018 Human Medicines Evaluation Division Active substance: haemophilus influenzae / klebsiella ozaenae / klebsiella pneumoniae / moraxella catarrhalis / staphylococcus aureus
More informationList of nationally authorised medicinal products
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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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
More informationList of nationally authorised medicinal products
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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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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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
More informationList of nationally authorised medicinal products
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
More informationList of nationally authorised medicinal products
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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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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