List of nationally authorised medicinal products
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1 1 December 2016 EMA/750653/2016 Human Medicines Evaluation Division Active substance: valganciclovir 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 Ro, comprimé pelliculé NL/H/323/ ROCHE FR RoValcyte 50 mg/ml pó para solução oral NL/H/0323/ ROCHE FARMACÊUTICA QUÍMICA, LDA. PT RoValcyte 50 mg/ml, poudre pour solution buvable RoValcyte, 450 mg, comprimidos revestidos por película Valcyte 450 mg επικαλυμμένα με λεπτό υμένιο δισκία Valcyte 450 mg επικαλυμμένα με λεπτό υμένιο δισκία VALCYTE 50 mg/ml κόνις για πόσιμο διάλυμα VALCYTE 50 mg/ml κόνις για πόσιμο διάλυμα - - apvalkotās tabletes compresse rivestite con film comprimate filmate NL/H/0323/ ROCHE FR NL/H/323/ ROCHE FARMACÊUTICA QUÍMICA, LDA. NL/H/0323/ G.A. STAMATIS & CO LTD CY NL/H/0323/ / ROCHE (HELLAS) SA GR NL/H/0323/ G.A. STAMATIS & CO LTD CY NL/H/0323/ / ROCHE (HELLAS) SA GR NL/H/0323/ ROCHE AUSTRIA GMBH AT NL/H/0323/ ROCHE AUSTRIA GMBH LI NL/H/0323/ ROCHE LATVIJA SIA LV NL/H/0323/ ROCHE S.P.A. IT NL/H/0323/ /2014/01 ROCHE ROMANIA SRL RO PT EMA/750653/2016 Page 2/7
3 comprimés pelliculés comprimés pelliculés comprimidos recubiertos con película Film-coated Tablets Film-coated Tablets film-coated tablets filmdragerade tabletter filmdragerade tabletter filmom obalené tablety filmom obložene tablete filmomhulde tabletten filmomhulde tabletten NL/H/0323/001 BE N.V. ROCHE S.A. BE NL/H/0323/ N.V. ROCHE S.A. LU NL/H/0323/ ROCHE FARMA, S.A. ES NL/H/323/001 PA 50/150/1 ROCHE PRODUCTS LTD IE NL/H/0323/001 MA060/01501 ROCHE PRODUCTS LTD MT NL/H/0323/001 PL00031/0599 ROCHE PRODUCTS LTD UK NL/H/323/ ROCHE OY FI NL/H/0323/ ROCHE AB SE NL/H/0323/001 42/0131/05-S ROCHE SLOVENSKO S.R.O. SK NL/H/0323/001 UP/I /13-01/49 ROCHE D.O.O. HR NL/H/0323/001 BE N.V. ROCHE S.A. BE NL/H/0323/001 RVG25992 ROCHE NEDERLAND B.V. NL filmsko obložene tablete NL/H/0323/001 H/14/01593/001 ROCHE FARMACEVTSKA DRUŽBA D.O.O. SI filmtabletta NL/H/0323/001 OGYI-T-9016/01 ROCHE (MAGYARORSZÁG) KFT HU EMA/750653/2016 Page 3/7
4 filmuhúðaðar töflur plėvele dengtos tabletės potahované tablety tabletter, filmdrasjerte tabletti, kalvopäällysteinen Valcyte 50 mg/ml - Pulver Valcyte 50 mg/ml - Pulver Valcyte 50 mg/ml jauhe oraaliliuosta varten Valcyte 50 mg/ml milteliai geriamajam tirpalui Valcyte 50 mg/ml mixtúruduft, lausn Valcyte 50 mg/ml poeder voor drank NL/H/323/01 BE N.V. ROCHE S.A. BE NL/H/0323/ N.V. ROCHE S.A. LU NL/H/0323/001 IS/1/02/007/01 ROCHE A/S IS NL/H/0323/001 LT/1/05/0386/001 UAB "ROCHE LIETUVA" LT NL/H/0323/001 42/122/03-C ROCHE S.R.O. CZ NL/H/0323/ ROCHE NORGE AS, NORWAY NO NL/H/0323/ ROCHE OY FI NL/H/0323/ ROCHE AUSTRIA GMBH AT NL/H/0323/ ROCHE AUSTRIA GMBH LI NL/H/0323/ ROCHE OY FI NL/H/0323/002 LT/1/08/1131/001 UAB "ROCHE LIETUVA" LT NL/H/0323/002 IS/1/07/009/01 ROCHE A/S IS NL/H/0323/002 BE N.V. ROCHE S.A. BE EMA/750653/2016 Page 4/7
5 Valcyte 50 mg/ml polvere per soluzione orale Valcyte 50 mg/ml polvo para solución oral NL/H/0323/ ROCHE S.P.A. IT NL/H/0323/ ROCHE FARMA, S.A. ES Valcyte 50 mg/ml por belsőleges oldathoz NL/H/0323/002 OGYI-T-9016/02 ROCHE (MAGYARORSZÁG) KFT HU Valcyte 50 mg/ml poudre pour solution buvable Valcyte 50 mg/ml poudre pour solution buvable Valcyte 50 mg/ml Powder for Oral Solution Valcyte 50 mg/ml powder for oral solution Valcyte 50 mg/ml Powder for oral solution Valcyte 50 mg/ml prašak za oralnu otopinu NL/H/0323/002 BE N.V. ROCHE S.A. BE NL/H/0323/ N.V. ROCHE S.A. LU NL/H/0323/002 PA 50/150/2 ROCHE PRODUCTS LTD IE NL/H/0323/002 MA060/01502 ROCHE PRODUCTS LTD MT NL/H/0323/002 PL00031/0829 ROCHE PRODUCTS LTD UK NL/H/0323/002 UP/I /13-01/48 ROCHE D.O.O. HR Valcyte 50 mg/ml prašek za peroralno raztopino NL/H/0323/002 H/14/01593/002 ROCHE FARMACEVTSKA DRUŽBA D.O.O. SI Valcyte 50 mg/ml prášok na perorálny roztok Valcyte 50 mg/ml pulbere pentru soluţie orală Valcyte 50 mg/ml pulver til mikstur, oppløsning Valcyte 50 mg/ml pulver till oral lösning NL/H/0323/002 42/0177/08-S ROCHE SLOVENSKO S.R.O. SK NL/H/0323/ /2014/01 ROCHE ROMANIA SRL RO NL/H/0323/ ROCHE NORGE AS, NORWAY NO NL/H/323/ ROCHE OY FI EMA/750653/2016 Page 5/7
6 Valcyte 50 mg/ml pulver till oral lösning Valcyte 50 mg/ml Pulver zur Herstellung einer Lösung VALCYTE 50 mg/ml Pulver Valcyte 50 mg/ml pulveris iekšķīgi lietojama šķīduma pagatavošanai Valcyte 50 mg/ml, poeder voor drank Valcyte 50 mg/ml, prášek pro perorální roztok Valcyte, 450 mg õhukese polümeerikattega tabletid Valcyte, 450 mg, tabletki powlekane VALCYTE, 50 mg/ml suukaudse lahuse pulber Valcyte, 50 mg/ml, proszek do sporządzania roztworu doustnego Valcyte, filmovertrukne tabletter Valcyte, pulver til oral opløsning Valcyte 450 mg NL/H/0323/ ROCHE AB SE NL/H/323/02 BE N.V. ROCHE S.A. BE NL/H/0323/ N.V. ROCHE S.A. LU NL/H/0323/ ROCHE LATVIJA SIA LV NL/H/0323/002 RVG ROCHE NEDERLAND B.V. NL NL/H/0323/002 42/302/08-C ROCHE S.R.O. CZ NL/H/0323/ ROCHE EESTI OÜ EE NL/H/0323/ ROCHE POLSKA SP.O.O. PL NL/H/0323/ ROCHE EESTI OÜ EE NL/H/0323/ ROCHE POLSKA SP.O.O. PL NL/H/0323/ ROCHE A/S DK NL/H/0323/ ROCHE A/S DK NL/H/0323/ ROCHE PHARMA AG DE EMA/750653/2016 Page 6/7
7 Valcyte 50 mg/ml Pulver Валцит 450 mg филмирани таблетки ВАЛЦИТ 50 mg/ml прах за перорален разтвор NL/H/0323/ ROCHE PHARMA AG DE NL/H/0323/ ROCHE BULGARIA EOOD BG NL/H/0323/ ROCHE BULGARIA EOOD BG EMA/750653/2016 Page 7/7
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 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
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
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
(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
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
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
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
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
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
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
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
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
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
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
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
6 September 2018 EMA/619619/2018 Human Medicines Evaluation Division Active substance: haemophilus influenzae / klebsiella ozaenae / klebsiella pneumoniae / moraxella catarrhalis / staphylococcus aureus
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
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
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
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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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
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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
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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List of nationally authorised medicinal products
12 April 2018 EMA/227889/2018 Human Medicines Evaluation Division Active substance(s): typhoid polysaccharide vaccine Procedure No.: PSUSA/00003065/201708 30 Churchill Place Canary Wharf London E14 5EU
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