List of nationally authorised medicinal products

Size: px
Start display at page:

Download "List of nationally authorised medicinal products"

Transcription

1 01 December 2016 Human Medicines Evaluation Division Active substance: 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 where Accupril 10 mg Filmtabletten not available BE PFIZER S.A. (BELGIUM) BE Accupril 10 mg Filmtabletten not available PFIZER S.A. (BELGIUM) LU Accupril 20 mg Filmtabletten not available BE PFIZER S.A. (BELGIUM) BE Accupril 20 mg Filmtabletten not available PFIZER S.A. (BELGIUM) LU Accupril 40 mg Filmtabletten not available BE PFIZER S.A. (BELGIUM) BE Accupril 40 mg Filmtabletten not available PFIZER S.A. (BELGIUM) LU Accupril 5 mg Filmtabletten not available BE PFIZER S.A. (BELGIUM) BE Accupril 5 mg Filmtabletten not available PFIZER S.A. (BELGIUM) LU Accupril 10 mg Filmtabletten not available PFIZER PHARMA GMBH DE Page 2/13

3 where Accupril 20 mg Filmtabletten not available PFIZER PHARMA GMBH DE Accupril 5 mg Filmtabletten not available PFIZER PHARMA GMBH DE ACCUPRIN 10 mg compresse not available PFIZER ITALIA S.R.L. IT ACCUPRIN 20 mg compresse not available PFIZER ITALIA S.R.L. IT ACCUPRIN 20 mg compresse not available PFIZER ITALIA S.R.L. IT ACCUPRIN 40 mg compresse not available PFIZER ITALIA S.R.L. IT ACCUPRIN 5 mg compresse not available PFIZER ITALIA S.R.L. IT ACCUPRO 10 potahované tablety not available 58/312/91-B/C PFIZER, SPOL. S R.O. CZ ACCUPRO 10 Filmom obalené tablety not available 58/0312/91 C/S PFIZER LIMITED SK Page 3/13

4 where ACCUPRO 10 mg apvalkotās tabletes not available PFIZER LIMITED LV Accupro 10 mg comprimate filmate not available 7888/2006/01 PFIZER EUROPE MA EEIG RO Accupro 10 mg Film - Coated tablets not available PA 0822/007/002 PFIZER HEALTHCARE IRELAND IE Accupro 10 mg filmdragerade tabletter not available PFIZER OY FI Accupro 10 mg filmtabletta not available OGYI-T-4163/02 PFIZER KFT. HU Accupro 10 mg Filmtabletten not available PFIZER CORPORATION AT AUSTRIA GESELLSCHAFT M.B.H. ACCUPRO 10 mg plėvele not available LT/1/2000/0234/003 PFIZER LIMITED LT ACCUPRO 10 mg plėvele not available LT/1/2000/0234/004 PFIZER LIMITED LT ACCUPRO 10, 10 mg, tabletki powlekane not available R/7070 PFIZER EUROPE MA EEIG PL Page 4/13

5 where ACCUPRO 20 Filmom obalené tablety not available 58/0312/91 C/S PFIZER LIMITED SK ACCUPRO 20 mg apvalkotās tabletes not available PFIZER LIMITED LV Accupro 20 mg comprimate filmate not available 4506/2004/01 PFIZER EUROPE MA EEIG RO Accupro 20 mg Film - Coated tablets not available PA 0822/007/003 PFIZER HEALTHCARE IRELAND IE Accupro 20 mg filmdragerade tabletter not available PFIZER OY FI Accupro 20 mg filmtabletta not available OGYI-T-4163/03 PFIZER KFT. HU Accupro 20 mg Filmtabletten not available PFIZER CORPORATION AT AUSTRIA GESELLSCHAFT M.B.H. ACCUPRO 20 mg plėvele not available LT/1/2000/0234/006 PFIZER LIMITED LT ACCUPRO 20 mg plėvele not available LT/1/2000/0234/005 PFIZER LIMITED LT Page 5/13

6 where ACCUPRO 20 mg plėvele not available LT/1/2000/0234/007 PFIZER LIMITED LT ACCUPRO 20 potahované tablety not available 58/312/91-C/C PFIZER, SPOL. S R.O. CZ ACCUPRO 20, 20 mg, tabletki powlekane not available R/7071 PFIZER EUROPE MA EEIG PL ACCUPRO 40 mg apvalkotās tabletes not available PFIZER LIMITED LV Accupro 40 mg Film - Coated tablets not available PA 0822/007/004 PFIZER HEALTHCARE IRELAND IE ACCUPRO 40 mg plėvele not available LT/1/2000/0234/001 PFIZER LIMITED LT ACCUPRO 40, 40 mg, tabletki powlekane not available PFIZER EUROPE MA EEIG PL ACCUPRO 5 Filmom obalené tablet not available 58/0312/91 C/S PFIZER LIMITED SK Accupro 5 mg comprimate filmate not available 4505/2004/01 PFIZER EUROPE MA EEIG RO Page 6/13

7 where Accupro 5 mg Film - Coated tablets not available PA 0822/007/001 PFIZER HEALTHCARE IRELAND IE Accupro 5 mg filmdragerade tabletter not available PFIZER OY FI Accupro 5 mg filmtabletta not available OGYI-T-4163/01 PFIZER KFT. HU Accupro 5 mg Filmtabletten not available PFIZER CORPORATION AT AUSTRIA GESELLSCHAFT M.B.H. ACCUPRO 5 mg plėvele not available LT/1/2000/0234/002 PFIZER LIMITED LT ACCUPRO 5 potahované tablety not available 58/312/91-A/C PFIZER, SPOL. S R.O. CZ ACCUPRO 5, 5 mg, tabletki powlekane not available R/7069 PFIZER EUROPE MA EEIG PL Accupro Tablets 10 mg not available PL 00057/0515 PFIZER LIMITED UK Accupro Tablets 20 mg not available PL 00057/0516 PFIZER LIMITED UK Page 7/13

8 where Accupro Tablets 40 mg not available PL 00057/0517 PFIZER LIMITED UK Accupro Tablets 5 mg not available PL 00057/0514 PFIZER LIMITED UK Accupro, tabletter, filmovertrukne not available PFIZER APS DK Accupro, tabletter, filmovertrukne not available PFIZER APS DK Accupro, tabletter, filmovertrukne not available PFIZER APS DK Accupro mg Filmtabletten not available PFIZER PHARMA GMBH DE Accupro mg Filmtabletten not available PFIZER PHARMA GMBH DE Accupro 5 5 mg Filmtabletten not available PFIZER PHARMA GMBH DE ACCUPRON not available PFIZER HELLAS, A.E. CY Page 8/13

9 where ACCUPRON not available PFIZER HELLAS, A.E. CY ACCUPRON not available 41131/10/ PFIZER HELLAS, A.E. GR ACCUPRON not available 41129/10/ PFIZER HELLAS, A.E. GR ACCUPRON not available 41126/10/ PFIZER HELLAS, A.E. GR ACEQUIN 20 mg compresse ACEQUIN 20 mg compresse ACEQUIN 5 mg compresse ACUITEL 20 mg, comprimé not available RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S.P.A. not available RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S.P.A. not available RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S.P.A. not available PFIZER HOLDING ANCE IT IT IT ACUITEL 20 mg, comprimé not available PFIZER HOLDING ANCE Page 9/13

10 where ACUITEL 20 mg, comprimé not available PFIZER HOLDING ANCE ACUITEL 20 mg, comprimé not available PFIZER HOLDING ANCE ACUITEL 20 mg, comprimé not available PFIZER HOLDING ANCE ACUITEL 5 mg, comprimé not available PFIZER HOLDING ANCE ACUITEL 5 mg, comprimé not available PFIZER HOLDING ANCE ACUITEL 5 mg, comprimé not available PFIZER HOLDING ANCE ACUITEL 5 mg, comprimé not available PFIZER HOLDING ANCE ACUITEL 5 mg, scored filmcoated tablets not available PFIZER HOLDING ANCE Acuprel 20 mg comprimidos recubiertos con película not available PARKE-DAVIS, S.L. ES Page 10/13

11 where Acuprel 40 mg comprimidos recubiertos con película not available PARKE-DAVIS, S.L. ES Acuprel 5 mg comprimidos recubiertos con película not available PARKE-DAVIS, S.L. ES Acupril 10, tabletten 10 mg not available RVG PFIZER B.V. NL Acupril 20 mg Comprimidos not available LABORATÓRIOS PFIZER, Acupril 20 mg Comprimidos not available LABORATÓRIOS PFIZER, Acupril 20, tabletten 20 mg not available RVG PFIZER B.V. NL Acupril 40 mg Comprimidos not available LABORATÓRIOS PFIZER, Acupril 40 mg Comprimidos not available LABORATÓRIOS PFIZER, Acupril 40, tabletten 40 mg not available RVG PFIZER B.V. NL Page 11/13

12 where Acupril 5 mg Comprimidos not available LABORATÓRIOS PFIZER, Acupril 5 mg Comprimidos not available LABORATÓRIOS PFIZER, Acupril 5 mg Comprimidos not available LABORATÓRIOS PFIZER, Acupril 5, tabletten 5 mg not available RVG PFIZER B.V. NL Ectren 20 mg comprimidos recubiertos con película not available LABORATORIOS MENARINI, S.A. ES Ectren 40 mg comprimidos recubiertos con película not available LABORATORIOS MENARINI, S.A. ES QUINAZIL 20 mg compresse QUINAZIL 20 mg compresse QUINAZIL 5 mg compresse not available MALESCI ISTITUTO FARMACOBIOLOGICO - S.P.A. not available MALESCI ISTITUTO FARMACOBIOLOGICO - S.P.A. not available MALESCI ISTITUTO FARMACOBIOLOGICO - S.P.A. IT IT IT Page 12/13

13 where Quinhexal 10 mg Film-coated Tablets UK/H/0660/002 PL 10880/0067 HEXAL AG UK Quinhexal 20 mg Film-coated Tablets UK/H/0660/003 PL 10880/0068 HEXAL AG UK Quinhexal 40 mg Film-coated Tablets UK/H/0660/004 PL 10880/0069 HEXAL AG UK Quinhexal 5 mg Film-coated Tablets UK/H/0660/001 PL 10880/0066 HEXAL AG UK Акупро 10 mg филмирани таблетки not available PFIZER EUROPE MA EEIG BG Акупро 20 mg филмирани таблетки not available PFIZER EUROPE MA EEIG BG Page 13/13

List of nationally authorised medicinal products

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

More information

List of nationally authorised medicinal products

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

More information

List of nationally authorised medicinal products

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

More information

List of nationally authorised medicinal products

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

More information

List of nationally authorised medicinal products

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

More information

List of nationally authorised medicinal products

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

More information

List of nationally authorised medicinal products

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

More information

List of nationally authorised medicinal products

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

More information

List of nationally authorised medicinal products

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

More information

List of nationally authorised medicinal products

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

More information

List of nationally authorised medicinal products

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

More information

List of nationally authorised medicinal products

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

More information

List of nationally authorised medicinal products

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

More information

List of nationally authorised medicinal products

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

More information

List of nationally authorised medicinal products

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

More information

List of nationally authorised medicinal products

List of nationally authorised medicinal products 21 February 2018 EMA/208334/2018 Human Medicines Evaluation Division Active substance: ibuprofen / pseudoephedrine Procedure no.: PSUSA/00001711/201707 30 Churchill Place Canary Wharf London E14 5EU United

More information

List of nationally authorised medicinal products

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

More information

List of nationally authorised medicinal products

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

More information

List of nationally authorised medicinal products

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

More information

List of nationally authorised medicinal products

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

More information

List of nationally authorised medicinal products

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

More information

List of nationally authorised medicinal products

List of nationally authorised medicinal products 12 April 2018 EMA/223740/2018 Human Medicines Evaluation Division Active substance: fludarabine Procedure no.: PSUSA/00001406/201708 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone

More information

List of nationally authorised medicinal products

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

More information

List of nationally authorised medicinal products

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

More information

List of nationally authorised medicinal products

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

More information

List of nationally authorised medicinal products

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

More information

List of nationally authorised medicinal products

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

More information

List of nationally authorised medicinal products

List of nationally authorised medicinal products 30 November 2017 EMA/806830/2017 Human Medicines Evaluation Division Active substance: piroxicam Procedure no.: PSUSA/00002438/201704 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone

More information

List of nationally authorised medicinal products

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

More information

List of nationally authorised medicinal products

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

More information

List of nationally authorised medicinal products

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

More information

List of nationally authorised medicinal products

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 information

List of nationally authorised medicinal products

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

More information

List of nationally authorised medicinal products

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

More information

List of nationally authorised medicinal products

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

More information

List of nationally authorised medicinal products

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

More information

Annex I. List of nationally authorised medicinal products and marketing authorisation applications

Annex I. List of nationally authorised medicinal products and marketing authorisation applications Annex I List of nationally authorised medicinal products and marketing authorisation applications 1 Annex IA: Medicinal products recommended for maintenance and marketing authorisation applications for

More information

List of nationally authorised medicinal products

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

More information

Package leaflet: Information for the patient. Levocetirizine Krka 5 mg film-coated tablets Levocetirizine dihydrochloride

Package leaflet: Information for the patient. Levocetirizine Krka 5 mg film-coated tablets Levocetirizine dihydrochloride Package leaflet: Information for the patient Levocetirizine Krka 5 mg film-coated tablets Levocetirizine dihydrochloride Read all of this leaflet carefully before you start taking this medicine because

More information

PACKAGE LEAFLET: INFORMATION FOR THE USER. Metformin HCl Aurobindo 500 mg/ 850 mg/ 1000 mg, film-coated tablets metformin hydrochloride

PACKAGE LEAFLET: INFORMATION FOR THE USER. Metformin HCl Aurobindo 500 mg/ 850 mg/ 1000 mg, film-coated tablets metformin hydrochloride PACKAGE LEAFLET: INFORMATION FOR THE USER Metfmin HCl Aurobindo 500 mg/ 850 mg/ 1000 mg, film-coated tablets metfmin hydrochlide Read all of this leaflet carefully befe you start taking this medicine.

More information

PACKAGE LEAFLET: INFORMATION FOR THE USER. Metformin HCl Bluefish 500 mg/ 850 mg/ 1000 mg, film-coated tablets metformin hydrochloride

PACKAGE LEAFLET: INFORMATION FOR THE USER. Metformin HCl Bluefish 500 mg/ 850 mg/ 1000 mg, film-coated tablets metformin hydrochloride PACKAGE LEAFLET: INFORMATION FOR THE USER Metformin HCl Bluefish 500 mg/ 850 mg/ 1000 mg, film-coated tablets metformin hydrochloride Read all of this leaflet carefully before you start taking this medicine

More information

PACKAGE LEAFLET: INFORMATION FOR THE USER. Metformin HCl Mylan 500 mg/ 850 mg/ 1000 mg, film-coated tablets metformin hydrochloride

PACKAGE LEAFLET: INFORMATION FOR THE USER. Metformin HCl Mylan 500 mg/ 850 mg/ 1000 mg, film-coated tablets metformin hydrochloride PACKAGE LEAFLET: INFORMATION FOR THE USER Metformin HCl Mylan 500 mg/ 850 mg/ 1000 mg, film-coated tablets metformin hydrochloride Read all of this leaflet carefully before you start taking this medicine.

More information

List of nationally authorised medicinal products

List of nationally authorised medicinal products 24 January 2018 EMA/270645/2015 Human Medicines Evaluation Division Active substance: azithromycin (systemic use formulations) Procedure no.: PSUSA/00010491/201704 30 Churchill Place Canary Wharf London

More information

List of nationally authorised medicinal products

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

More information

BIJSLUITER: INFORMATIE VOOR DE PATIËNT

BIJSLUITER: INFORMATIE VOOR DE PATIËNT BIJSLUITER: INFORMATIE VOOR DE PATIËNT Sitagliptine Teva 25 mg, filmomhulde tabletten Sitagliptine Teva 50 mg, filmomhulde tabletten Sitagliptine Teva 100 mg, filmomhulde tabletten Sitagliptin Read all

More information

(Invented) Name. Crestor 5 mg Filmtabletten. Filmtabletten. Filmtabletten. Filmtabletten. Crestor 5 mg Film coated tablets Oral use

(Invented) Name. Crestor 5 mg Filmtabletten. Filmtabletten. Filmtabletten. Filmtabletten. Crestor 5 mg Film coated tablets Oral use Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, route of and marketing authorisation holders in the Member s 1 Austria Austria Austria Austria Belgium Belgium Belgium

More information

(Invented) Name Strength Pharmaceutical Form. 3 mg/3 ml Solution for injection. Kytril 2 mg - Filmtabletten 2 mg Film-coated tablet Oral use

(Invented) Name Strength Pharmaceutical Form. 3 mg/3 ml Solution for injection. Kytril 2 mg - Filmtabletten 2 mg Film-coated tablet Oral use ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES 1 Austria Austria Bulgaria Bulgaria

More information

List of nationally authorised medicinal products

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

More information

List of nationally authorised medicinal products

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

More information

List of nationally authorised medicinal products

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

More information

List of nationally authorised medicinal products

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

More information

EUROPEAN MEDICINES AGENCY DECISION. of 20 July 2008

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

More information

Package leaflet: Information for the user. Clopidogrel 75 mg film-coated tablets. Clopidogrel

Package leaflet: Information for the user. Clopidogrel 75 mg film-coated tablets. Clopidogrel Package leaflet: Information for the user Clopidogrel 75 mg film-coated tablets Clopidogrel Read all of this leaflet carefully before you start taking this medicine because it contains important information

More information

List of nationally authorised medicinal products

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

More information

PACKAGE LEAFLET: INFORMATION FOR THE USER

PACKAGE LEAFLET: INFORMATION FOR THE USER PACKAGE LEAFLET: INFORMATION FOR THE USER Simvastatin Aurobindo 5 mg film-coated tablets Simvastatin Aurobindo 10 mg film-coated tablets Simvastatin Aurobindo 20 mg film-coated tablets Simvastatin Aurobindo

More information

List of nationally authorised medicinal products

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

More information

Annex I. List of nationally authorised medicinal products and marketing authorisation applications

Annex I. List of nationally authorised medicinal products and marketing authorisation applications Annex I List of nationally authorised medicinal products and marketing authorisation applications 1 Annex IA: Medicinal products recommended for maintenance and marketing authorisation applications for

More information

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 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'

More information

PACKAGE LEAFLET: INFORMATION FOR THE USER

PACKAGE LEAFLET: INFORMATION FOR THE USER PACKAGE LEAFLET: INFORMATION FOR THE USER Simvastatin Bluefish 10 mg film-coated tablets Simvastatin Bluefish 20 mg film-coated tablets Simvastatin Bluefish 40 mg film-coated tablets Simvastatin Bluefish

More information

European Medicines Agency decision

European Medicines Agency decision EMA/75416/2018 European Medicines Agency decision P/0042/2018 of 16 February 2018 on the acceptance of a modification of an agreed paediatric investigation plan for dasatinib (Sprycel), (EMEA-000567-PIP01-09-M05)

More information

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 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

More information

Please note that this draft Annex I will be updated to amend information on concerned products/mahs

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

More information

PACKAGE LEAFLET: INFORMATION FOR THE USER. Etoricoxib

PACKAGE LEAFLET: INFORMATION FOR THE USER. Etoricoxib PACKAGE LEAFLET: INFORMATION FOR THE USER ARCOXIA 30 mg film-coated tablets ARCOXIA 60 mg film-coated tablets ARCOXIA 90 mg film-coated tablets ARCOXIA 120 mg film-coated tablets Etoricoxib Read all of

More information

European Union herbal monograph on Pistacia lentiscus L., resin (mastix)

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

More information

MONTELAIR 10 mg film-coated tablets

MONTELAIR 10 mg film-coated tablets Package leaflet: Information for the user MONTELAIR 10 mg film-coated tablets For adolescents and adults from 15 years Montelukast Read all of this leaflet carefully before you start taking this medicine

More information

Prasugrel hydrochloride film-coated tablets 5 mg and 10 mg product-specific bioequivalence guidance

Prasugrel hydrochloride film-coated tablets 5 mg and 10 mg product-specific bioequivalence guidance 31 May 2018 EMA/CHMP/158772/2016/Rev.1 Committee for Medicinal Products for Human Use (CHMP) Prasugrel hydrochloride film-coated tablets 5 mg and 10 mg Draft Agreed by Pharmacokinetics Working Party April

More information

European Union herbal monograph on Eschscholzia californica Cham., herba

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

More information

VARIATIONS : IMPACT ON ADMINISTRATIVE BURDEN AND FEES. Rose-Marie Molina EMA Infoday London, 14th March 2014

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

More information

European Medicines Agency decision

European Medicines Agency decision EMA/848760/2017 European Medicines Agency decision P/0033/2018 of 30 January 2018 on the acceptance of a modification of an agreed paediatric investigation plan for sitagliptin (Januvia), (EMEA-000470-PIP01-08-M10)

More information

Interested parties (organisations or individuals) that commented on the draft document as released for consultation.

Interested parties (organisations or individuals) that commented on the draft document as released for consultation. 25 January 2018 EMA/CHMP/729976/2017 Committee for Medicinal Products for Human Use (CHMP) Overview of comments received on 'Paracetamol oral use, immediate release formulations product-specific bioequivalence

More information

European Medicines Agency decision

European Medicines Agency decision EMA/398442/2016 European Medicines Agency decision P/0191/2016 of 15 July 2016 on the acceptance of a modification of an agreed paediatric investigation plan for agomelatine (Valdoxan, Thymanax), (EMEA-001181-PIP01-11-M03)

More information

European Medicines Agency decision

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

More information

PACKAGE LEAFLET: INFORMATION FOR THE USER Arcoxia 60 mg Film coated Tablets Arcoxia 90 mg Film coated Tablets etoricoxib

PACKAGE LEAFLET: INFORMATION FOR THE USER Arcoxia 60 mg Film coated Tablets Arcoxia 90 mg Film coated Tablets etoricoxib PACKAGE LEAFLET: INFORMATION FOR THE USER Arcoxia 60 mg Film coated Tablets Arcoxia 90 mg Film coated Tablets etoricoxib Read all of this leaflet carefully before you start taking this medicine. Keep this

More information

Trends in injecting drug use in Europe

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

More information

European Medicines Agency decision

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)

More information

European Union herbal monograph on Peumus boldus Molina, folium

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

More information

Initial (Full) Marketing Authorisation application accelerated assessment timetables

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

More information

European Union herbal monograph on Glycine max (L.) Merr., lecithinum

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

More information

Package leaflet: Information for the user. Tadalafil teva 10 mg film-coated tablet Tadalafil teva 20 mg film-coated tablet tadalafil

Package leaflet: Information for the user. Tadalafil teva 10 mg film-coated tablet Tadalafil teva 20 mg film-coated tablet tadalafil Package leaflet: Information for the user Tadalafil teva 10 mg film-coated tablet Tadalafil teva 20 mg film-coated tablet tadalafil Read all of this leaflet carefully before you start taking this medicine

More information

Package leaflet: information for the user

Package leaflet: information for the user Package leaflet: information for the user Rosuvastatin 5 mg film-coated tablets Rosuvastatin 10 mg film-coated tablets Rosuvastatin 20 mg film-coated tablets Rosuvastatin 40 mg film-coated tablets rosuvastatin

More information

Package leaflet: Information for the patient

Package leaflet: Information for the patient Package leaflet: Information for the patient Atorvastatin 10 mg Film-coated Tablets Atorvastatin 20 mg Film-coated Tablets Atorvastatin 40 mg Film-coated Tablets Atorvastatin 80 mg Film-coated Tablets

More information

European Medicines Agency decision

European Medicines Agency decision EMA/155875/2015 European Medicines Agency decision P/0062/2015 of 1 April 2015 on the acceptance of a modification of an agreed paediatric investigation plan for sitagliptin (Januvia), (EMEA-000470-PIP01-08-M09)

More information

List of nationally authorised medicinal products

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

More information

Package Leaflet: Information for the user. Tadalafil 10 mg film-coated tablets Tadalafil

Package Leaflet: Information for the user. Tadalafil 10 mg film-coated tablets Tadalafil Package Leaflet: Information for the user Tadalafil 10 mg film-coated tablets Tadalafil Read all of this leaflet carefully before you start taking this medicine because it contains important information

More information

Screening programmes for Hepatitis B/C in Europe

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

More information

Valtan 80mg Film-coated Tablets

Valtan 80mg Film-coated Tablets Package leaflet: Information for the user Valtan 80mg Film-coated Tablets Valsartan Read all of this leaflet carefully before you start taking this medicine because it contains important information for

More information

European Union herbal monograph on Pelargonium sidoides DC and/or Pelargonium reniforme Curt., radix

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

More information

Finnish international trade 2017 Figures and diagrams. Finnish Customs Statistics

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

More information

Finnish international trade 2017 Figures and diagrams. Finnish Customs Statistics

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

More information

European Medicines Agency decision

European Medicines Agency decision EMA/761887/2015 European Medicines Agency decision P/0307/2015 of 21 December 2015 on the acceptance of a modification of an agreed paediatric investigation plan for odanacatib (EMEA- 001123-PIP01-11-M03)

More information

Draft Agreed by Pharmacokinetics Working Party February Adoption by CHMP for release for consultation 1 April 2016

Draft Agreed by Pharmacokinetics Working Party February Adoption by CHMP for release for consultation 1 April 2016 15 December 2016 Committee for Medicinal Products for Human Use (CHMP) Everolimus tablets 0.25 mg, 0.5 mg, 0.75 mg and 1 mg; 2.5 mg, 5 mg and 10 mg, dispersible tablets 0.1 mg and 0.25 mg; 2 mg, 3 mg and

More information

European Union herbal monograph on Epilobium angustifolium L. and/or Epilobium parviflorum Schreb., herba

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

More information

Package leaflet: Information for the user

Package leaflet: Information for the user Package leaflet: Information for the user Sevelamer Carbonate Rowex 800mg Film-coated tablets sevelamer carbonate Read all of this leaflet carefully before you start taking this medicine because it contains

More information

Package leaflet: Information for the user. Montelukast 10 mg film-coated tablets. Montelukast

Package leaflet: Information for the user. Montelukast 10 mg film-coated tablets. Montelukast Package leaflet: Information for the user Montelukast 10 mg film-coated tablets Montelukast Read all of this leaflet carefully before you start taking this medicine because it contains important information

More information

BIJSLUITER: INFORMATIE VOOR DE PATIËNT

BIJSLUITER: INFORMATIE VOOR DE PATIËNT PACKAGE LEAFLET 1 BIJSLUITER: INFORMATIE VOOR DE PATIËNT Cinacalcet 30 mg Teva, filmomhulde tabletten Cinacalcet 60 mg Teva, filmomhulde tabletten Cinacalcet 90 mg Teva, filmomhulde tabletten Cinacalcet

More information

European Medicines Agency decision

European Medicines Agency decision EMA/776083/2014 European Medicines Agency decision P/0001/2015 of 7 January 2015 on the acceptance of a modification of an agreed paediatric investigation plan for linagliptin (Trajenta) (EMEA-000498-PIP01-08-M04)

More information

EUROPEAN CITIZENS DIGITAL HEALTH LITERACY

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

More information

European Union herbal monograph on Symphytum officinale L., radix

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

More information

Package Leaflet: Information for the user. Tadalafil 20 mg film-coated tablets Tadalafil

Package Leaflet: Information for the user. Tadalafil 20 mg film-coated tablets Tadalafil Package Leaflet: Information for the user Tadalafil 20 mg film-coated tablets Tadalafil Read all of this leaflet carefully before you start taking this medicine because it contains important information

More information

Package leaflet: Information for the patient. Optinate Septimum 35 mg film-coated tablets risedronate sodium

Package leaflet: Information for the patient. Optinate Septimum 35 mg film-coated tablets risedronate sodium Package leaflet: Information for the patient Optinate Septimum 35 mg film-coated tablets risedronate sodium Read all of this leaflet carefully before you start taking this medicine because it contains

More information