List of nationally authorised medicinal products
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- Regina Maud Greer
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1 8 March 2018 EMA/182668/2018 Human Medicines Evaluation Division Active substance(s): triamcinolone (topical and nasal formulations) 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 AFTAB 0,025 mg not available MEDA PHARMA GMBH & CO. Hafttabletten KG AFTAB 25 microgrammi not available ROTTAPHARM S.P.A. IT compresse buccali mucoadesive Aftab 25 mikrog not available MEDA OY FI bukkaalitabletti Aftab 25 mikrogram not available MEDA OY FI buckaltablett Aftach not available ANGELINI FARMACÊUTICA, PT LDA Aftach not available ANGELINI FARMACÊUTICA, PT LDA Allegra nasal 55 UK/H/4484/001 BE SANOFI BELGIUM BE microgrammes/dose Allegra nasal 55 UK/H/4484/001 BE SANOFI BELGIUM BE microgrammes/dose Allegra nasal 55 UK/H/4484/ SANOFI BELGIUM LU microgrammes/dose Allegra nasal 55 UK/H/4484/ SANOFI BELGIUM LU microgrammes/dose Allegra nasal, 55 UK/H/4484/001 BE SANOFI BELGIUM BE microgram/dosis Allegra nasal, 55 microgram/dosis UK/H/4484/001 BE SANOFI BELGIUM BE EMA/182668/2018 Page 2/9
3 National Number FTOROCORT 1 mg/g not available GEON RICHTER PLC. LV ziede FTOROCORT 0,1 % NULL LT/1/94/0978/001 GEON RICHTER PLC. LT tepalas FTOROCORT, 1 mg/g not available GEON RICHTER PLC. EE salv NASACORT not available SANOFI-AVENTIS CYPRUS CY LTD NASACORT not available SANOFI-AVENTIS CYPRUS CY LTD NASACORT UK/H/0189/ SANOFI-AVENTIS NMARK DK A/S NASACORT UK/H/0189/ SANOFI-AVENTIS NMARK DK A/S NASACORT UK/H/0189/ SANOFI-AVENTIS AEBE GR NASACORT UK/H/0189/ SANOFI-AVENTIS AEBE GR NASACORT not available MA082/01701 SANOFI MALTA LTD MT NASACORT not available MA082/01701 SANOFI MALTA LTD MT NASACORT UK/H/0189/ SANOFI - PRODUTOS PT FARMACEUTICOS LDA UK/H/0189/001 BE SANOFI BELGIUM BE microgram/dosis, UK/H/0189/001 BE SANOFI BELGIUM BE microgram/dosis, micrograme/doză spray nazal suspensie UK/H/0189/ /2015/01 SANOFI-AVENTIS ROMANIA SRL RO micrograme/doză spray nazal suspensie MICROGRAMMES/DOSE, SUSPENSION POUR UK/H/0189/ /2015/02 SANOFI-AVENTIS ROMANIA SRL not available SANOFI-AVENTIS FRANCE FR EMA/182668/2018 Page 3/9 RO
4 National Number PULVERISATION NASALE microgrammes/dose, microgrammes/dose, microgrammes/dose, microgrammi/dose, spray nasale, sospensione microgrammi/dose, spray nasale, sospensione microgramos/dosis, suspensión para pulverización nasal microgramos/dosis, suspensión para pulverización nasal MICROGRAMS/DOSE, NASAL SPRAY, SUSPENSION MICROGRAMS/DOSE, UK/H/0189/001 BE SANOFI BELGIUM BE UK/H/0189/001 BE SANOFI BELGIUM BE UK/H/0189/ SANOFI BELGIUM LU UK/H/0189/ SANOFI SPA IT UK/H/0189/ SANOFI SPA IT UK/H/0189/ SANOFI-AVENTIS, S.A. ES UK/H/0189/ SANOFI-AVENTIS, S.A. ES not available SANOFI-AVENTIS NORGE AS IS not available SANOFI-AVENTIS NORGE AS IS EMA/182668/2018 Page 4/9
5 National Number NASAL SPRAY, SUSPENSION micrograms/dose, nasal spray, suspension micrograms/dose, nasal spray, suspension MIKROGRAM/DOS, NASSPRAY, SUSPENSION MIKROGRAM/DOS, NASSPRAY, SUSPENSION mikrogrami/devā deguna aerosols, suspensija mikrogrami/devā deguna aerosols, suspensija mikrogramm/adag szuszpenziós orrspray mikrogramm/adag szuszpenziós orrspray UK/H/0189/001 PL 04425/0287 AVENTIS PHARMA LTD UK UK/H/0189/001 PL 04425/0287 AVENTIS PHARMA LTD UK UK/H/0189/ SANOFI AB SE UK/H/0189/ SANOFI AB SE UK/H/0189/ SANOFI-AVENTIS LATVIA SIA UK/H/0189/ SANOFI-AVENTIS LATVIA SIA UK/H/0189/001 OGYI-T-22852/02 SANOFI-AVENTIS ZRT HU UK/H/0189/001 OGYI-T-22852/01 SANOFI-AVENTIS ZRT HU UK/H/0189/ SANOFI BULGARIA EOOD BG UK/H/0189/ SANOFI BULGARIA EOOD BG UK/H/0189/ SANOFI-AVENTIS UK/H/0189/ SANOFI-AVENTIS UK/H/0189/ SANOFI OY FI LV LV EMA/182668/2018 Page 5/9
6 National Number mikrogrammaa/annos nenäsumute, suspensio mikrogrammaa/annos nenäsumute, suspensio mikrogramov /odmerek pršilo za nos mikrogramov /odmerek pršilo za nos mikrogramov/dávka mikrogramov/dávka NASACORT 55 micrograms/dose, nasal spray, suspension NASACORT 55 micrograms/dose, nasal spray, suspension UK/H/0189/ SANOFI OY FI UK/H/0189/001 H/16/02186/001 SANOFI-AVENTIS D.O.O. SI UK/H/0189/001 H/16/02186/002 SANOFI-AVENTIS D.O.O. SI UK/H/0189/001 69/0207/15-S SANOFI-AVENTIS SLOVAKIA SRO UK/H/0189/001 69/0207/15-S SANOFI-AVENTIS SLOVAKIA SRO UK/H/0189/001 PA 540/11/1 SANOFI-AVENTIS IRELAND LTD. T/A SANOFI UK/H/0189/001 PA 540/11/1 SANOFI-AVENTIS IRELAND LTD. T/A SANOFI NASACORT ALLERGY UK/H/4484/ / SANOFI-AVENTIS AEBE GR NASACORT ALLERGY UK/H/4484/ / SANOFI-AVENTIS AEBE GR NASACORT ALLERGY UK/H/4484/001 PA 540/11/2 SANOFI-AVENTIS IRELAND IE LTD. T/A SANOFI NASACORT ALLERGY UK/H/4484/001 PA 540/11/2 SANOFI-AVENTIS IRELAND IE LTD. T/A SANOFI NASACORT ALLERGY not available PL 04425/0605 AVENTIS PHARMA LTD UK Nasacort nesespray, not available SANOFI-AVENTIS NORGE AS NO suspensjon Nasacort nesespray, not available SANOFI-AVENTIS NORGE AS NO suspensjon NASACORT SANOFI- AVENTIS 55 MIKROGRAMM/SPRUHST UK/H/4484/ SANOFI-AVENTIS EMA/182668/2018 Page 6/9 SK SK IE IE
7 National Number OSS NASENSPRAY, SUSPENSION NASACORT SANOFI- AVENTIS 55 MIKROGRAMM/SPRUHST OSS NASENSPRAY, SUSPENSION microgram/verstuiving mikrogrammi/pihustuses, ninasprei, suspensioon mikrogrammi/pihustuses, ninasprei, suspensioon mikrogramów/dawkę, aerozol do nosa, zawiesina mikrogramów/dawkę, aerozol do nosa, zawiesina RHINISAN 55 RHINISAN 55 Triamcinolon Teva 1 mg/g kožní emulze Triamcinolon/acetonide zalf Triamcinolona Sanofi 55 microgramas/dose, suspensão para UK/H/4484/ SANOFI-AVENTIS UK/H/0189/001 RGV SANOFI-AVENTIS NETHERLANDS B.V. UK/H/0189/ SANOFI-AVENTIS ESTONIA OÜ UK/H/0189/ SANOFI-AVENTIS ESTONIA OÜ UK/H/0189/ AVENTIS PHARMA LTD PL UK/H/0189/ AVENTIS PHARMA LTD PL not available SANOFI-AVENTIS not available SANOFI-AVENTIS not available 46/219/74-C TEVA CZECH INDUSTRIES S.R.O not available RVG BASIC PHARMA MANUFACTURING BV UK/H/4484/ SANOFI - PRODUTOS FARMACEUTICOS LDA NL EE EE CZ NL PT EMA/182668/2018 Page 7/9
8 National Number pulverização nasal Triamcinolona Sanofi 55 microgramas/dose, suspensão para pulverização nasal Triamcinolonacetonid sa nofi-aventis Triamcinolonacetonid sa nofi-aventis Triamcinolonacetonide hydrofiele crème 1 mg/g Triamcinolonacetonide hydrofiele crème Basic Pharma 1 mg/g Triamcinolonacetonide hydrofiele crème Basic Pharma 1 mg/g Triamcinolone acetonide 55 micrograms/dose, nasal spray, suspension Triamcinolone acetonide 55 micrograms/dose, nasal spray, suspension Triamcinolone acetonide Sanofi 55 micrograms/dose, nasal spray, suspension Triamcinolone acetonide Sanofi 55 micrograms/dose, nasal spray, suspension TRIAMCINOLONE SANOFI 55 MIKGROGRAMŮ/DÁVKA UK/H/4484/ SANOFI - PRODUTOS FARMACEUTICOS LDA UK/H/4484/ SANOFI-AVENTIS NMARK A/S DK UK/H/4484/ SANOFI-AVENTIS NMARK DK A/S not available RVG BASIC PHARMA NL MANUFACTURING BV not available RVG 19042=51893 APOTEX EUROPE B.V. NL not available RVG BASIC PHARMA MANUFACTURING BV UK/H/4484/001 PL 04425/0669 AVENTIS PHARMA LTD UK UK/H/4484/001 PL 04425/0669 AVENTIS PHARMA LTD UK UK/H/0189/001 LT/1/15/3760/001 UAB SANOFI-AVENTIS LIETUVA UK/H/0189/001 LT/1/15/3760/002 UAB SANOFI-AVENTIS LIETUVA UK/H/0189/001 69/324/15-C SANOFI-AVENTIS SRO CZ TRIAMCINOLONE UK/H/0189/001 69/324/15-C SANOFI-AVENTIS SRO CZ PT NL LT LT EMA/182668/2018 Page 8/9
9 National Number SANOFI 55 MIKGROGRAMŮ/DÁVKA EMA/182668/2018 Page 9/9
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
List of nationally authorised medicinal products
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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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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List of nationally authorised medicinal products
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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
List 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
List of nationally authorised medicinal products
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
List of nationally authorised medicinal products
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
List 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
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
List 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
List of nationally authorised medicinal products
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
List of nationally authorised medicinal products
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
List of nationally authorised medicinal products
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
List 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
List 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
List of nationally authorised medicinal products
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
List of nationally authorised medicinal products
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
List of nationally authorised medicinal products
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
List of nationally authorised medicinal products
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List of nationally authorised medicinal products
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List of nationally authorised medicinal products
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List of nationally authorised medicinal products
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List of nationally authorised medicinal products
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List of nationally authorised medicinal products
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List of nationally authorised medicinal products
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
List of nationally authorised medicinal products
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