List of nationally authorised medicinal products

Transkript

1 7 July 2016 EMA/270645/2015 Procedure Management and Committees Support Active substance: mycophenolic acid (apart from mycophenolate mofetil) 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 magensaftresistente Tabletten magensaftresistente Tabletten MYFORTIC 180 MG ΓΑΣΤΡΟΑΝΘΕΚΤΙΚΆ ΔΙΣΚΊΑ MYFORTIC 360 MG ΓΑΣΤΡΟΑΝΘΕΚΤΙΚΆ ΔΙΣΚΊΑ National Number /H/0239/ NOVARTIS PHARMA N.V. /H/0239/ NOVARTIS PHARMA N.V. /H/0239/ NOVARTIS (HELLAS) S.A.C.I. /H/0239/ NOVARTIS (HELLAS) S.A.C.I. /H/0239/ NOVARTIS FARMA S.P.A. /H/0239/ NOVARTIS FARMA S.P.A. /H/0239/ NOVARTIS FARMA S.P.A. /H/0239/ NOVARTIS FARMA S.P.A. LU LU GR GR EMA/478377/2016 Page 2/12

3 Comprimidos Comprimidos Comprimidos National Number /H/0239/ NOVARTIS FARMA S.P.A. /H/0239/ NOVARTIS FARMA - PRODUTOS FARMACÊUTICOS S.A. ART57 /H/0239/ NOVARTIS FARMA - PRODUTOS FARMACÊUTICOS S.A. ART57 /H/0239/ NOVARTIS FARMA - PRODUTOS FARMACÊUTICOS S.A. ART57 /H/0239/ NOVARTIS FARMA S.P.A. /H/0239/ NOVARTIS FARMA S.P.A. /H/0239/ NOVARTIS FARMA S.P.A. /H/0239/ NOVARTIS FARMA S.P.A. PT PT PT EMA/478377/2016 Page 3/12

4 Comprimidos Comprimidos comprimidos enterotabletti National Number /H/0239/ NOVARTIS FARMA - PRODUTOS FARMACÊUTICOS S.A. ART57 /H/0239/ NOVARTIS FARMA - PRODUTOS FARMACÊUTICOS S.A. ART57 /H/0239/ NOVARTIS FARMACÉUTICA S.A. /H/0239/ NOVARTIS FINLAND OY PT PT ES FI MYFORTIC, 180 MG GASTRORESISTENTSED TABLETID /H/0239/ NOVARTIS FINLAND OY /H/0239/001 /1/05/0288/001 NOVARTIS FINLAND OY EE /H/0239/001 /1/05/0288/002 NOVARTIS FINLAND OY /H/0239/001 /1/05/0288/003 NOVARTIS FINLAND OY EMA/478377/2016 Page 4/12

5 National Number /H/0239/001 /1/05/0288/004 NOVARTIS FINLAND OY /H/0239/001 /1/05/0288/005 NOVARTIS FINLAND OY zarnās šķīstošās tabletes /H/0239/ NOVARTIS FINLAND OY LV comprimidos enterotabletti /H/0239/ NOVARTIS FARMACÉUTICA S.A. /H/0239/ NOVARTIS FINLAND OY ES FI MYFORTIC, 360 MG GASTRORESISTENTSED TABLETID MYFORTIC 360 MG ZARNĀS ŠĶĪSTOŠĀS TABLETES /H/0239/ NOVARTIS FINLAND OY /H/0239/ NOVARTIS FINLAND OY EE LV Myfortic /H/0239/ NOVARTIS HEAHCARE A/S DK EMA/478377/2016 Page 5/12

6 National Number Myfortic /H/0239/ NOVARTIS HEAHCARE A/S DK comprimate filmate gastrorezistente filmomhulde maagsapresistente tablet MИФОРТИК 180 MG СТОМАШНО-УСТОЙЧИВИ ТАБЛЕТКИ gastrorezistentne tablete not available 5599/2005/04 NOVARTIS PHARMA GMBH /H/0239/001 RVG NOVARTIS PHARMA B.V. not available NOVARTIS PHARMA GMBH /H/0239/001 H/05/01070/001 NOVARTIS PHARMA GMBH RO NL BG SI gyomornedv-ellenálló tabletta MYFORTIC 180 MG MAGENSAFTRESISTENTE TABLETTEN tabletki dojelitowe /H/0239/001 OGYI-T-10075/02 NOVARTIS HUNGÁRIA KFT. PHARMA /H/0239/ NOVARTIS PHARMA GMBH /H/0239/ NOVARTIS POLAND SP. Z O. O. HU DE PL EMA/478377/2016 Page 6/12

7 filmomhulde maagsapresistente tablet MИФОРТИК 360 MG СТОМАШНО-УСТОЙЧИВИ ТАБЛЕТКИ gastrorezistentne tablete National Number /H/0239/002 RVG NOVARTIS PHARMA B.V. not available NOVARTIS PHARMA GMBH /H/0239/002 H/05/01070/006 NOVARTIS PHARMA GMBH NL BG SI gyomornedv-ellenálló tabletta MYFORTIC 360 MG MAGENSAFTRESISTENTE TABLETTEN tabletki dojelitowe /H/0239/002 OGYI-T-10075/01 NOVARTIS HUNGÁRIA KFT. PHARMA /H/0239/ NOVARTIS PHARMA GMBH /H/0239/ NOVARTIS POLAND SP. Z O. O. HU DE PL, comprimate filmate gastrorezistente MYFORTIC 180 MG GASTRO-RESISTANT TABLETS not available 5600/2005/04 NOVARTIS PHARMA GMBH /H/0239/001 PL 00101/0664 NOVARTIS LIMED RO UK EMA/478377/2016 Page 7/12

8 MYFORTIC 360 MG GASTRO-RESISTANT TABLETS National Number /H/0239/002 PL 00101/0665 NOVARTIS LIMED UK MYFORTIC 180 MG ENTEROSOLVENTNÍ TABLETY /H/0239/001 59/111/05-C NOVARTIS, S.R.O. CZ MYFORTIC 180 MG MAGENSAFTRESISTENTE TABLETTEN /H/0239/ NOVARTIS PHARMA GMBH /H/0239/ NOVARTIS PHARMA S.A.S. /H/0239/ NOVARTIS PHARMA S.A.S. /H/0239/ NOVARTIS PHARMA S.A.S. /H/0239/ NOVARTIS PHARMA S.A.S. /H/0239/ NOVARTIS PHARMA S.A.S. AT EMA/478377/2016 Page 8/12

9 enterotablett National Number /H/0239/ NOVARTIS SVERIGE AB SE MYFORTIC 180 MG GASTRO-RESISTANT TABLETS /H/0239/001 PA 13/115/1 NOVARTIS LIMED IE filmom obalená gastrorezistentná tableta /H/0239/001 59/0073/05-S NOVARTIS, S.R.O. SK MYFORTIC 180 MG GASTRO-RESISTANT TABLETS /H/0239/ /04901 NOVARTIS LIMED MT MYFORTIC 360 MG ENTEROSOLVENTNÍ TABLETY /H/0239/002 59/112/05-C NOVARTIS, S.R.O. CZ MYFORTIC 360 MG MAGENSAFTRESISTENTE TABLETTEN /H/0239/ NOVARTIS PHARMA GMBH /H/0239/ NOVARTIS PHARMA S.A.S. /H/0239/ NOVARTIS PHARMA S.A.S. AT EMA/478377/2016 Page 9/12

10 enterotablett National Number /H/0239/ NOVARTIS PHARMA S.A.S. /H/0239/ NOVARTIS PHARMA S.A.S. /H/0239/ NOVARTIS SVERIGE AB SE MYFORTIC 360 MG GASTRO-RESISTANT TABLETS /H/0239/002 PA 13/115/2 NOVARTIS LIMED IE filmom obalená gastrorezistentná tableta /H/0239/002 59/0074/05-S NOVARTIS, S.R.O. SK MYFORTIC 360 MG GASTRO-RESISTANT TABLETS MYFORTIC 360 MG MAAGSAPRESISTENTE TABLETTEN MYFORTIC 180 MG ΕΠΙΚΑΛΥΜΜΈΝΟ ΜΕ ΛΕΠΤΌ ΥΜΈΝΙΟ ΓΑΣΤΡΟΑΝΘΕΚΤΙΚΌ /H/0239/ /04902 NOVARTIS LIMED /H/0239/002 BE NOVARTIS PHARMA N.V. /H/0239/ NOVARTIS LIMED MT BE CY EMA/478377/2016 Page 10/12

11 ΔΙΣΚΊΟ National Number MYFORTIC 360MG ΕΠΙΚΑΛΥΜΜΈΝΟ ΜΕ ΛΕΠΤΌ ΥΜΈΝΙΟ ΓΑΣΤΡΟΑΝΘΕΚΤΙΚΌ ΔΙΣΚΊΟ, maagsapresistente tabletten /H/0239/ NOVARTIS LIMED /H/0239/001 BE NOVARTIS PHARMA N.V. /H/0239/002 /1/05/0288/007 NOVARTIS FINLAND OY CY BE /H/0239/002 /1/05/0288/008 NOVARTIS FINLAND OY /H/0239/002 /1/05/0288/009 NOVARTIS FINLAND OY /H/0239/002 /1/05/0288/010 NOVARTIS FINLAND OY EMA/478377/2016 Page 11/12

12 filmuhúðuð sýruþolin tafla filmuhúðuð sýruþolin tafla enterotabletter National Number /H/0239/001 IS/1/04/003/01 NOVARTIS HEAHCARE A/S /H/0239/002 IS/1/04/003/02 NOVARTIS HEAHCARE A/S /H/0239/ NOVARTIS NORGE AS IS IS NO enterotabletter /H/0239/ NOVARTIS NORGE AS NO zelucanootporne tablete not available UP/I /10-01/618 NOVARTIS HRVATSKA D.O.O. HR zelucanootporne tablete not available UP/I /10-02/89 NOVARTIS HRVATSKA D.O.O. HR EMA/478377/2016 Page 12/12