List of nationally authorised medicinal products
|
|
|
- Allan Todd
- 6 years ago
- Views:
Transcription
1 10 September 2015 EMA/622830/2015 Procedure Management and Committees Support Active substance: azelastine 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 Product Name (in authorisation country) MRP/DCP Authorisation number National Authorisation Number MAH of product in the member state Member State where product is authorised Afluon 33527/ Meda Pharmaceuticals S.A. GR Afluon Meda Pharma Gmbh & Co. Kg ES Afluon 64557/ Meda Pharmaceuticals S.A. GR Afluon S00794 Meda Pharmaceuticals S.A. CY Afluon Sucralosa UK/H/0256/ Meda Pharma S.A.U. ES Afluón UK/H/0256/001, Meda Pharma S.A.U. ES Alerdual Meda Pharma Sas FR Allergodil Meda Pharma Gmbh AT Allergodil Meda Pharma Gmbh AT Allergodil Meda Pharma Gmbh & Co. Kg PL Allergodil Meda As DK Allergodil Meda Pharma Gmbh & Co. Kg Allergodil Meda Pharma Sia EE Allergodil 2011/ S.A. Meda Pharma N.V. LU Allergodil 2011/ S.A. Meda Pharma N.V. LU Allergodil Meda Pharma Gmbh & Co. Kg Allergodil Meda Pharma Gmbh & Co. Kg Allergodil Meda Pharma Sia EE Allergodil 24/002/97-C Meda Pharma Gmbh & Co. Kg CZ Allergodil 24/0205/97-S Meda Pharma Gmbh & Co. Kg SK Allergodil 24/0206/97-S Meda Pharma Gmbh & Co. Kg SK Allergodil Meda Pharma Sas FR Allergodil Meda Pharma Sas FR Allergodil Meda Pharma Gmbh & Co. Kg Allergodil 5363-I-2537/10 Meda Pharma Gmbh & Co. Kg SI Allergodil 5416/2004/02 Meda Pharma Gmbh & Co. Kg RO Allergodil 64/0157/99-S Meda Pharma Gmbh & Co. Kg SK Allergodil 64/210/00-C Meda Pharma Gmbh & Co. Kg CZ Allergodil 7602 Meda Pharma Gmbh & Co. Kg PL Allergodil Meda Pharma Sia LV Allergodil Meda Pharma Sia LV Allergodil BE S.A. Meda Pharma N.V. BE Allergodil BE Meda Pharma N.V. BE Allergodil OGYI-T-4877/01 Meda Pharma Gmbh HU EMA/622830/2015 Page 2/7
3 Allergodil OGYI-T-4877/02 Meda Pharma Hungary Kft. HU Allergodil UP/I /10- Medical Intertrade D.O.O. HR 01/516 Allergodil UK/H/0256/ /M Meda Pharma S.P.A. IT Allergodil UK/H/0256/ /M Meda Pharma S.P.A. IT Allergodil UK/H/0256/ Meda Pharma Produtos Allergodil UK/H/0256/ Meda Pharma Produtos Allergodil UK/H/0256/ Meda As DK Allergodil UK/H/0256/ Meda Pharma Produtos Allergodil UK/H/0256/ Meda Pharma Gmbh & Co. Kg Allergodil UK/H/0256/001 RVG Meda Pharma B.V. NL Allergodil UK/H/0256/001/MR Meda Pharma Gmbh AT Allergodil UK/H/0256/ Meda Pharma Gmbh & Co. Kg Allergodil UK/H/0256/ Meda Pharma S.P.A. IT Allergodil UK/H/0256/ Meda Pharma S.P.A. IT Allergodil UK/H/0256/ Meda Pharma S.P.A. IT Allergodil UK/H/0256/004 RVG Meda Pharma B.V. NL Allergodil UK/H/0256/004/DC Meda Pharma Gmbh AT Allergodil UK/H/4326/ Meda Ab SE Allergodil UK/H/4327/ Meda Pharma Gmbh & Co. Kg Allergodil Akut Meda Pharma Gmbh & Co. Kg Allergodil Akut UK/H/0255/ Meda Pharma Gmbh & Co. Kg Allergodil Akut Duo Meda Pharma Gmbh & Co. Kg Allergodil Akut Duo Meda Pharma Gmbh & Co. Kg Allergodil Bid UK/H/0256/003/DC NJA Meda Pharma Produtos Allergodil Forte UK/H/4757/001/DC Meda As DK Allergodil Nasal UK/H/0256/003/DC Meda As DK Allergodil Nevel RVG Meda Pharma B.V. NL Allergodrop UK/H/0255/001/MR Meda Pharma Gmbh AT Allergospray Meda Pharma Gmbh AT Allergospray UK/H/0256/001/DC Meda Pharma Gmbh AT Allergospray Mit Sucralose UK/H/0256/ Meda Pharma Gmbh AT Allespray Meda Pharma S.P.A. IT EMA/622830/2015 Page 3/7
4 Astepro UK/H/0256/003 PA1332/039/001 Meda Health Sales Ireland Astepro UK/H/0256/003/DC Meda Oy FI Astepro UK/H/4757/ Meda Pharma S.P.A. IT Astepro UK/H/4757/ Meda Pharma S.P.A. IT Astepro UK/H/4757/ Meda Pharma S.P.A. IT Astepro UK/H/4757/ Meda Ab SE Astepro UK/H/4757/ Meda Pharma S.A.U. ES Astepro UK/H/4757/ Meda Pharma Gmbh & Co. Kg Astepro UK/H/4757/001 PA1332/39/2 Meda Health Sales Ireland Astepro UK/H/4757/001 PL 15142/0236 Meda Pharmaceuticals Ltd GB Astepro UK/H/4757/001 RVG Meda Pharma B.V. NL Astepro UK/H/4757/001/DC Meda Pharma Gmbh AT Astepro UK/H/4757/001/DC Meda As DK Astepro Forte UK/H/4757/001/DC Meda Oy FI Azela-Vision Md Sine SE/H/1183/01/DC Omnivision Gmbh AT Azela-Vision Md Sine SE/H/1183/01/DC Omnivision Gmbh Azela-Vision Sine /H/3852/001/DC FORMERLY Omnivision Gmbh AT SE/H/1105/001/DC Azela-Vision Sine /H/3852/001/DC FORMERLY Omnivision Gmbh SE/H/1105/001/DC Azelastin Meda Pharma UK/H/4329/001, Meda Pharma Gmbh & Co. Kg Azelastin-POS AT/H/0351/ URSAPHARM AT Azelastin-POS AT/H/0351/ URSAPHARM AT Azelastin-COMOD AT/H/0454/ URSAPHARM AT Azelastin-POS AT/H/0351/002 BE URSAPHARM Benelux B.V. BE Azelastin-COMOD AT/H/0454/001 BE URSAPHARM Benelux B.V. BE Azelastin-POS AT/H/0351/001 64/300/11-CZ URSAPHARM CZ Azelastin-COMOD AT/H/0454/001 64/057/13-C URSAPHARM CZ Azelastin-POS AT/H/0351/ URSAPHARM Arzneimittel Azelastin-COMOD AT/H/0454/ URSAPHARM Arzneimittel Azelastin-POS AT/H/0351/ URSAPHARM Arzneimittel Azelastin-POS AT/H/0351/ URSAPHARM Benelux B.V. LU EMA/622830/2015 Page 4/7
5 Azelastin-COMOD AT/H/0454/ URSAPHARM Benelux B.V. LU Azelastin-POS AT/H/0351/001 AA063/00701 URSAPHARM Arzneimittel MT Azelastin-POS AT/H/0351/002 RVG URSAPHARM Benelux B.V. NL Azelastin-POS AT/H/0351/001 RVG URSAPHARM Benelux B.V. NL Azelastin-COMOD AT/H/0454/001 RVG URSAPHARM Benelux B.V. NL Azelastin-POS AT/H/0351/ URSAPHARM Poland sp. z PL o.o. Azelastin-COMOD AT/H/0454/ URSAPHARM Poland sp. z PL o.o. Azelastin-POS AT/H/0351/ /08116_REG URSAPHARM Arzneimittel SK Azelastin-POS AT/H/0351/001 64/0380/11-S URSAPHARM Arzneimittel SK Azelastin-URSAPHARM AT/H/0454/001 64/0452/12-S URSAPHARM Arzneimittel SK Azelastine Meda Health UK/H/0255/001 PA 1332/010/001 Meda Health Sales Ireland Azelastine Omnivision SE/H/1183/01/DC Omnivision Gmbh SE Azelastinhydrochlorid /H/3273/ Stadapharm Gmbh Stadapharm Azep Meda Pharma Produtos Azep Meda Pharma Produtos Carelastin UK/H/4326/ Meda Pharma Gmbh & Co. Kg Corifina Meda Pharma S.A.U. ES Corifina UK/H/0255/ Meda Pharma S.A.U. ES Lasticom UK/H/0255/ /M Meda Pharma Gmbh IT Lastin Meda As NO Lastin Meda Oy FI Lastin Meda Ab SE Lastin (IS) Meda Ab IS Lastin Meda As NO Lastin UK/H/0256/ Meda Ab SE Lastin UK/H/0256/001/MR Meda Oy FI Lastinaz UK/H/0256/ Meda Ab SE Loxin UK/H/256/ Dr. Gerhard Mann Chem.- EMA/622830/2015 Page 5/7
6 Pharm. Fabrik Gmbh Oculastin UK/H/0255/ Meda Ab SE Oculastin UK/H/0255/ Meda Pharma Produtos Oculastin UK/H/0255/ Meda Pharma Produtos Oculastin UK/H/0255/ Meda Pharma Produtos Oculastin UK/H/0255/001 RVG Meda Pharma B.V. NL Oculastin UK/H/0255/001/MR Meda Oy FI Oculastin UK/H/0255/001/MR Meda As DK Optilast UK/H/0256/001 PA 1332/009/001 Meda Health Sales Ireland Otrivin Neusallergie RVG Novartis Consumer Health NL B.V. Proallergodil Meda Pharma Sas FR Rhinolast PA 1332/15/1 Meda Health Sales Ireland Rhinolast UK/H/0256/ Meda Pharma Gmbh & Co. Kg Rhinolast UK/H/0256/004/DC Meda Oy FI Rhinolast UK/H/4328/ Meda Pharma Gmbh & Co. Kg Rhinolast Hayfever PA1322/015/002 Meda Health Sales Ireland Rhinolast S UK/H/0256/004 PL 15142/0235 Meda Pharmaceuticals Ltd GB Rhinolast S UK/H/0256/004/DC PA 1332/15/4 Meda Health Sales Ireland Rhinolast S UK/H/4327/001/DC PA 1332/015/003 Meda Health Sales Ireland Rinelaz UK/H/0256/ Meda Ab SE Tebarat ES/H/0178/001/DC Laboratorios Salvat, S.A. IT Tebarat ES/H/0178/001/DC Laboratorios Salvat, S.A. IT Tebarat ES/H/0178/001/DC Laboratorios Salvat, S.A. IT Tebarat ES/H/0178/001/DC Laboratorios Salvat, S.A. Tebarat ES/H/0178/001/DC Laboratorios Salvat, S.A. Tebarat ES/H/0178/001/DC Laboratorios Salvat, S.A. Tebarat ES/H/0178/001/DC Laboratorios Salvat, S.A. ES Vividrin Akut Azelastin Antiallergische UK/H/255/ Dr. Gerhard Mann Chem.- Pharm. Fabrik Gmbh EMA/622830/2015 Page 6/7
7 Vividrin Akut Meda Pharma Gmbh & Co. Kg Vividrin Akut Meda Pharma Gmbh & Co. Kg алергодил Meda Pharma Gmbh & Co. Kg BG алергодил Meda Pharma Gmbh & Co. Kg BG EMA/622830/2015 Page 7/7
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
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
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
List of nationally authorised medicinal products
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
List of nationally authorised medicinal products
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
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
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
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
List of nationally authorised medicinal products
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
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
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
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
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
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
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
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
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
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
List of nationally authorised medicinal products
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
List 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
List of nationally authorised medicinal products
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
List of nationally authorised medicinal products
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
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
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
List of nationally authorised medicinal products
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
List 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
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
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
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
List of nationally authorised medicinal products
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
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
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
List 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
List of nationally authorised medicinal products
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
List of nationally authorised medicinal products
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
List 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
List of nationally authorised medicinal products
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
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/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
List of nationally authorised medicinal products
6 September 2018 EMA/619619/2018 Human Medicines Evaluation Division Active substance: haemophilus influenzae / klebsiella ozaenae / klebsiella pneumoniae / moraxella catarrhalis / staphylococcus aureus
Implementation Report on the patient safety Recommendation 2009/C 151/01. Healthcare Systems Unit DG SANCO
Implementation Report on the patient safety Recommendation 2009/C 151/01 Healthcare Systems Unit DG SANCO Published 15 November 2012 REPORT FROM THE COMMISSION TO THE COUNCIL on the basis of Member States'
Public administration reforms and public sector performance in Central and Eastern Europe EU member states: in EU perspective
Public administration reforms and public sector performance in Central and Eastern Europe EU member states: in EU perspective Prof. Ing. Juraj Nemec, CSc. Masaryk University, Czech Republic, Size of government
List 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
EUROPEAN MEDICINES AGENCY DECISION. of 20 July 2008
European Medicines Agency Doc. Ref. EMEA/357907/2008 P/53/2008 EUROPEAN MEDICINES AGENCY DECISION of 20 July 2008 on the application for agreement of a Paediatric Investigation Plan for Atorvastatin calcium
VARIATIONS : IMPACT ON ADMINISTRATIVE BURDEN AND FEES. Rose-Marie Molina EMA Infoday London, 14th March 2014
Rose-Marie Molina EMA Infoday London, 14th March 2014 Before 1234/2008 Regulation, variation procedures in the European Union for industry was synonymous of: - Lack of visibility about timelines - Lack
List of nationally authorised medicinal products
26 October 2017 EMA/663700/2017 Human Medicines Evaluation Division Active substance: cromoglicic acid Procedure no.: PSUSA/00000883/201702 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
Trends in injecting drug use in Europe
Trends in injecting drug use in Europe Linda Montanari, Bruno Guarita and Danica Thanki Annual Expert Meeting on Drug-Related Infectious Diseases Lisbon, 15-17 October Overview of the presentation 1) Information
Finnish international trade 2017 Figures and diagrams. Finnish Customs Statistics
Finnish international trade 217 Figures and diagrams Finnish Customs Statistics IMPORTS, EXPORTS AND TRADE BALANCE 199-217 Billion e 7 6 5 4 3 2 1-1 9 91 92 93 94 95 96 97 98 99 1 2 3 4 5 6 7 8 9 1 11
Finnish international trade 2017 Figures and diagrams. Finnish Customs Statistics
Finnish international trade 217 Figures and diagrams Finnish Customs Statistics IMPORTS, EXPORTS AND TRADE BALANCE 199-217 Billion e 7 6 5 4 3 2 1-1 9 91 92 93 94 95 96 97 98 99 1 2 3 4 5 6 7 8 9 1 11
Ensuring protection of public health and patients in member states: priorities, constraints, opportunities
Ensuring protection of public health and patients in member states: priorities, constraints, opportunities Dr. Christa Wirthumer-Hoche AGES Austrian Medicines and Medical Devices Agency Vienna, Austria
'SECTION B EU PARTY. The following abbreviations are used:
'SECTION B EU PARTY The following abbreviations are used: AT Austria BE Belgium BG Bulgaria CY Cyprus CZ Czech Republic DE Germany DK Denmark ES Spain EE Estonia EU European Union, including all its Member
European Medicines Agency decision
EMA/497687/2017 European Medicines Agency decision P/0245/2017 of 4 September 2017 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of a waiver for
Commission. Product. Notification. Decision. Issued 2 / affected 3 amended on 11/01/2019 PL
Procedural steps taken and scientific information after the authorisation Application Scope Opinion/ Commission Product Summary number Notification Decision Information 1 issued on Issued 2 / affected
Initial (Full) Marketing Authorisation application accelerated assessment timetables
30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact An agency of the European
List of nationally authorised medicinal products
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
European Union herbal monograph on Pistacia lentiscus L., resin (mastix)
7 July 2015 EMA/HMPC/46758/2015 Committee on Herbal Medicinal Products (HMPC) European Union herbal monograph on Pistacia lentiscus L., resin (mastix) Draft Discussion in Working Party on European Union
LIMITE EN COUNCIL OF THE EUROPEAN UNION. Brussels, 7 July /11 LIMITE ENFOPOL 228 DAPIX 81
COUNCIL OF THE EUROPEAN UNION Brussels, 7 July 2011 12390/11 LIMITE ENFOPOL 228 DAPIX 81 NOTE From: Presidency To: Law Enforcement Working Party No. prev. doc.: CM 1508/11 Subject: Results of the questionnaire
European Union herbal monograph on Eschscholzia californica Cham., herba
28 January 2015 EMA/HMPC/680372/2013 Committee on Herbal Medicinal Products (HMPC) European Union herbal monograph on Eschscholzia californica Cham., herba Final Discussion in Working Party on European
Consequence of the change in the definition of. an agricultural parcel
Ispra, 03-04 April 2008 Kick-off Meeting of the 2008 CwRS Campaign 1 Consequence of the change in the definition of Andrew ROWLANDS MARS-PAC, JRC Ispra an agricultural parcel Ispra, 03-04 April 2008 Kick-off
Pharmaceutical Pricing & Reimbursement Information. PPRI Project Co-ordination Sabine Vogler, Gesundheit Österreich GmbH
PPRI - Comparative Analysis PPRI Project Co-ordination Sabine Vogler, Gesundheit Österreich GmbH PPRI Conference Vienna, 29 June 2007 PPRI Conference, Vienna, 29 June 2007 1 Comparative Analysis - Outline
Transmission, processing and publication of HBS 2015 data
EUROPEAN COMMISSION EUROSTAT Directorate F: Social statistics Unit F-4: Income and living conditions; Quality of life Doc. LC-ILC/194/17/EN estat.f.4 (2017) WORKING GROUP ON INCOME AND LIVING CONDITIONS
Please note that this draft Annex I will be updated to amend information on concerned products/mahs
22 March 2018 EMA/197481/2018 Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of, applicants, marketing authorisation holders in the member states for for omega-3
European Medicines Agency decision
EMA/757980/2016 European Medicines Agency decision P/0313/2016 of 21 December 2016 on the agreement of a paediatric investigation plan for complex of povidone and iodine / dexamethasone (SHP640) (EMEA-001936-PIP01-16)
European Union herbal monograph on Peumus boldus Molina, folium
22 November 2016 EMA/HMPC/453725/2016 Committee on Herbal Medicinal Products (HMPC) European Union herbal monograph on Peumus boldus Molina, folium Final Initial assessment Discussion in Working Party
List of nationally authorised medicinal products
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
European Union herbal monograph on Glycine max (L.) Merr., lecithinum
31 January 2017 EMA/HMPC/220599/2016 Committee on Herbal Medicinal Products (HMPC) European Union herbal monograph on Glycine max (L.) Merr., lecithinum Final Discussion in Working Party on European Union
European Union herbal monograph on Ruscus aculeatus L. rhizoma
30 January 2018 EMA/188804/2017 Committee on Herbal Medicinal Products (HMPC) European Union herbal monograph on Ruscus aculeatus L. rhizoma Draft Initial assessment Discussion in Working Party on European
Patient reporting update
Patient reporting update François Houÿez Director of Treatment Information & Access, EURORDIS 8 th Pharmacovigilance stakeholders forum EMA, 15/06/2014 15/09/2014 eurordis.org 1 Spontaneous reporting in
CHMP List of questions
28 June 2018 EMA/CHMP/346196/2018 To be addressed by the marketing authorisation holders for bacterial lysatescontaining medicinal products for respiratory conditions Referral under Article 31 of Directive
Commission. Product. Notification. Decision. Issued 2 / affected 3 amended on
Procedural steps taken and scientific information after the authorisation Application Scope Opinion/ Commission Product Summary number Notification Decision Information 1 issued on Issued 2 / affected
European Medicines Agency decision
EMA/574564/2017 European Medicines Agency decision P/0278/2017 of 4 October 2017 on the acceptance of a modification of an agreed paediatric investigation plan for Japanese encephalitis vaccine (inactivated,
European Union herbal monograph on Pelargonium sidoides DC and/or Pelargonium reniforme Curt., radix
05 June 2018 EMA/HMPC/444244/2015 Committee on Herbal Medicinal Products (HMPC) European Union herbal monograph on Pelargonium sidoides DC and/or Pelargonium Final Initial assessment Discussion in Working
Annex I. Article 107i of Directive 2001/83/EC. Procedure number: EMEA/H/A-107i/ March 2013 EMA/147828/2013 Patient Health Protection
07 March 2013 EMA/147828/2013 Patient Health Protection Annex I List of the names, pharmaceutical s, strengths of the medicinal products, routes of, marketing authorisation holders in the member states
Palliative nursing care of children and young people across Europe
Palliative nursing care of children and young people across Europe Results of a postal survey in August 2016 Updated in April 2017 (presented at the 29th PNAE-meeting in Naples/Italy on 28th April 2017)
EU Market Situation for Poultry. Committee for the Common Organisation of the Agricultural Markets 20 April 2017
EU Market Situation for Poultry Committee for the Common Organisation of the Agricultural Markets 2 April 217 -9.% -11.% -5.% -.1% -.7% -2.2% 3.% 1.7% 1.2%.8%.6%.%.%.% 7.9% 7.% 6.4% 6.2% 6.% 5.5% 5.3%
European Union herbal monograph on Epilobium angustifolium L. and/or Epilobium parviflorum Schreb., herba
24 November 2015 EMA/HMPC/712511/2014 Committee on Herbal Medicinal Products (HMPC) European Union herbal monograph on Epilobium angustifolium L. and/or Epilobium parviflorum Schreb., herba Final Discussion
Variations & worksharing An industry perspective
Variations & worksharing An industry perspective Rémon van Aubel European Medicines Agency/IFAH-Europe Info Day 7-8 March 2013, London 1 Variations - Regulation Commission Regulation (EU) No 1234/2008
EUROPEAN CITIZENS DIGITAL HEALTH LITERACY
Flash Eurobarometer 404 EUROPEAN CITIZENS DIGITAL HEALTH LITERACY SUMMARY Fieldwork: September 2014 Publication: November 2014 This survey has been requested by the European Commission, Directorate-General
European Union herbal monograph on Symphytum officinale L., radix
5 May 2015 EMA/HMPC/572846/2009 Committee on Herbal Medicinal Products (HMPC) European Union herbal monograph on Symphytum officinale L., radix Final Discussion in Working Party on Community monographs
Screening programmes for Hepatitis B/C in Europe
Programme STI, HIV/AIDS and viral hepatitis Screening programmes for Hepatitis B/C in Europe Mika Salminen, Ph.D. European Centre for Disease Prevention and Control Why might screening be needed for hepatitis
European Union herbal monograph on Oenothera biennis L. or Oenothera lamarckiana L., oleum
5 June 2018 EMA/HMPC/753041/2017 Committee on Herbal Medicinal Products (HMPC) European Union herbal monograph on Oenothera biennis L. or Oenothera lamarckiana L., oleum Final Discussion in Working Party
Update on EEA s near real time air quality data exchange
Update on EEA s near real time air quality data exchange Jaume Targa (EEA ETC/ACC) Acknowledgement Thanks to all nrt data providers Currently there are 71 providers Latvian Environment, Geology and Name
Attention. Therefore, all the data and statements made in this presentation are preliminary and might change in the future.
Attention The aim of the Dose Datamed II workshop in Athens was to present preliminary data, collect feedback from the audience and to work towards final results and conclusions. Therefore, all the data
PRAC recommendations on signals
14 December 2017 EMA/PRAC/610978/2017 Pharmacovigilance Risk Assessment Committee (PRAC) Adopted at the 27-30 November 2017 PRAC meeting This document provides an overview of the recommendations adopted
European Medicines Agency decision
EMA/281879/2015 European Medicines Agency decision P/0097/2015 of 8 May 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for human
European Union herbal monograph on Agrimonia eupatoria L., herba
28 January 2015 EMA/HMPC/680597/2013 Committee on Herbal Medicinal Products (HMPC) European Union herbal monograph on Agrimonia eupatoria L., herba Final Discussion in Working Party on European Union monographs
European Medicines Agency decision
EMA/120432/2017 European Medicines Agency decision P/0069/2017 of 3 April 2017 on the acceptance of a modification of an agreed paediatric investigation plan for dupilumab (EMEA-001501-PIP01-13-M04) in
European Union herbal monograph on Helichrysum arenarium (L.) Moench, flos
29 September 2015 EMA/HMPC/41108/2015 Committee on Herbal Medicinal Products (HMPC) European Union herbal monograph on Helichrysum arenarium (L.) Moench, flos Draft Discussion in Working Party on European
Meeting report, September 2005
European Medicines Agency Post-authorisation Evaluation of Medicines for Human Use London, 24 October 2005 Doc. Ref. EMEA//322553/2005 COMMITTEE ON HERBAL MEDICINAL PRODUCTS () Meeting report, 19-20 September
European Medicines Agency decision
EMA/741983/2016 European Medicines Agency decision P/0324/2016 of 2 December 2016 on the acceptance of a modification of an agreed paediatric investigation plan for linagliptin (Trajenta), (EMEA-000498-PIP01-08-M06)
Non-reproductive tissues and cells
Colour key Minimum requirements as set out in Directive 2004/23/EC and its technical Directives (particularly 2006/17/EC) More stringent -legally binding, applies for all donations and all donor profiles
Q&A on Off-Label Use. EMA Industry Stakeholder Platform - Operation of EU Pharmacovigilance Legislation 12 January 2015
Proposal in response to EFPIA paper of 3 rd October 2014 EMA Industry Stakeholder Platform - Operation of EU Pharmacovigilance Legislation 12 January 2015 Presented by Sabine Brosch (EMA) and Anja van
Commission. Product. Notification. Decision. Issued 2 / affected 3 amended on 05/03/2018 PL
Procedural steps taken and scientific information after the authorisation Application Scope Opinion/ Commission Product Summary number Notification Decision Information 1 issued on Issued 2 / affected
September 2014 January 2015 March 2015 May 2015 Adoption by Committee on Herbal Medicinal Products (HMPC) for release for consultation
7 July 2015 EMA/HMPC/39453/2015 Committee on Herbal Medicinal Products (HMPC) European Union herbal monograph on Sideritis scardica Griseb.; Sideritis clandestina (Bory & Chaub.) Hayek; Sideritis Draft
European Medicines Agency decision
EMA/357972/2017 European Medicines Agency decision P/0173/2017 of 3 July 2017 on the acceptance of a modification of an agreed paediatric investigation plan for colistimethate sodium (Colobreathe), (EMEA-000176-PIP01-07-M05)
European Union herbal monograph on Hedera helix L., folium
21 November 2017 EMA/HMPC/325716/2017 Committee on Herbal Medicinal Products (HMPC) European Union herbal monograph on Hedera helix L., folium Final Initial assessment Discussion in Working Party on European
Review of Member State approaches to the Macrophyte and Phytobenthos Biological Quality Element in lakes
Review of Member State approaches to the Macrophyte and Phytobenthos Biological Quality Element in lakes Report to ECOSTAT Martyn Kelly (Bowburn Consultancy, UK) Sebastian Birk (University of Duisburg-Essen,
European Union herbal monograph on Curcuma longa L. (C. domestica Valeton), rhizoma
21 November 2017 EMA/HMPC/329755/2017 Committee on Herbal Medicinal Products (HMPC) European Union herbal monograph on Curcuma longa L. (C. domestica Valeton), Draft Initial assessment Discussion in Working
European Union herbal monograph on Melilotus officinalis (L.) Lam., herba
28 March 2017 EMA/HMPC/44166/2016 Committee on Herbal Medicinal Products (HMPC) European Union herbal monograph on Melilotus officinalis (L.) Lam., herba Draft Initial assessment Discussion in Working