1 December 2016 EMA/848467/2016 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: mycophenolic acid (apart from mycophenolate mofetil)

Procedure no.: PSUSA/00010243/201605

30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5525 Send a question via our website www.ema.europa.eu/contact

An agency of the European Union

© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

Product Name (in

MRP/DCP

authorisation country)

Authorisation

National Authorisation Number

MAH of product in the

Member State where

member state

product is authorised

number Myfortic 180 mg

FR/H/0239/001

2004030120

NOVARTIS PHARMA N.V.

LU

FR/H/0239/002

2004030119

NOVARTIS PHARMA N.V.

LU

FR/H/0239/001

2004030120

NOVARTIS PHARMA N.V.

LU

FR/H/0239/002

2004030119

NOVARTIS PHARMA N.V.

LU

FR/H/0239/001

BE272054

NOVARTIS PHARMA N.V.

BE

FR/H/0239/002

BE272063

NOVARTIS PHARMA N.V.

BE

FR/H/0239/001

H/05/01070/001

NOVARTIS PHARMA GMBH

SI

FR/H/0239/001

H/05/01070/002

NOVARTIS PHARMA GMBH

SI

FR/H/0239/001

H/05/01070/003

NOVARTIS PHARMA GMBH

SI

comprimés gastrorésistants Myfortic 360 mg comprimés gastrorésistants Myfortic 180 mg magensaftresistente Tabletten Myfortic 360 mg magensaftresistente Tabletten Myfortic 180 mg magensaftresistente Tabletten Myfortic 360 mg magensaftresistente Tabletten Myfortic 180 mg gastrorezistentne tablete Myfortic 180 mg gastrorezistentne tablete Myfortic 180 mg gastrorezistentne tablete

List of nationally authorised medicinal products EMA/848467/2016

Page 2/15

Product Name (in

MRP/DCP

authorisation country)

Authorisation

National Authorisation Number

MAH of product in the

Member State where

member state

product is authorised

number Myfortic 180 mg

FR/H/0239/001

H/05/01070/004

NOVARTIS PHARMA GMBH

SI

FR/H/0239/001

H/05/01070/005

NOVARTIS PHARMA GMBH

SI

FR/H/0239/002

H/05/01070/006

NOVARTIS PHARMA GMBH

SI

FR/H/0239/002

H/05/01070/007

NOVARTIS PHARMA GMBH

SI

FR/H/0239/002

H/05/01070/008

NOVARTIS PHARMA GMBH

SI

FR/H/0239/002

H/05/01070/009

NOVARTIS PHARMA GMBH

SI

not available

HR-H-505070647

NOVARTIS HRVATSKA

HR

gastrorezistentne tablete Myfortic 180 mg gastrorezistentne tablete Myfortic 360 mg gastrorezistentne tablete Myfortic 360 mg gastrorezistentne tablete Myfortic 360 mg gastrorezistentne tablete Myfortic 360 mg gastrorezistentne tablete Myfortic 180 mg želučanootporne tablete Myfortic 360 mg

D.O.O. not available

HR-H-950094160

želučanootporne tablete MYFORTIC 180 mg

NOVARTIS HRVATSKA

HR

D.O.O. not available

8649/2016/01

NOVARTIS PHARMA GMBH

RO

not available

8649/2016/02

NOVARTIS PHARMA GMBH

RO

comprimate gastrorezistente MYFORTIC 180 mg comprimate gastrorezistente

List of nationally authorised medicinal products EMA/848467/2016

Page 3/15

Product Name (in

MRP/DCP

authorisation country)

Authorisation

National Authorisation Number

MAH of product in the

Member State where

member state

product is authorised

number MYFORTIC 180 mg

not available

8649/2016/03

NOVARTIS PHARMA GMBH

RO

not available

8649/2016/04

NOVARTIS PHARMA GMBH

RO

not available

8650/2016/01

NOVARTIS PHARMA GMBH

RO

not available

8650/2016/02

NOVARTIS PHARMA GMBH

RO

not available

8650/2016/03

NOVARTIS PHARMA GMBH

RO

not available

8650/2016/04

NOVARTIS PHARMA GMBH

RO

FR/H/0239/001

262810101

NOVARTIS (HELLAS)

GR

comprimate gastrorezistente MYFORTIC 180 mg comprimate gastrorezistente MYFORTIC 360 mg comprimate gastrorezistente MYFORTIC 360 mg comprimate gastrorezistente MYFORTIC 360 mg comprimate gastrorezistente MYFORTIC 360 mg comprimate gastrorezistente Myfortic 180 mg γαστροανθεκτικά δισκία Myfortic 180 mg

S.A.C.I. FR/H/0239/001

γαστροανθεκτικά δισκία

List of nationally authorised medicinal products EMA/848467/2016

262810102

NOVARTIS (HELLAS)

GR

S.A.C.I.

Page 4/15

Product Name (in

MRP/DCP

authorisation country)

Authorisation

National Authorisation Number

MAH of product in the

Member State where

member state

product is authorised

NOVARTIS (HELLAS)

GR

number Myfortic 180 mg

FR/H/0239/001

262810103

γαστροανθεκτικά δισκία Myfortic 180 mg

S.A.C.I. FR/H/0239/001

262810104

γαστροανθεκτικά δισκία Myfortic 180 mg

FR/H/0239/001

262810105

FR/H/0239/001

262810106

FR/H/0239/002

262810201

FR/H/0239/002

262810202

FR/H/0239/002

262810203

FR/H/0239/002

262810204

GR

NOVARTIS (HELLAS)

GR

NOVARTIS (HELLAS)

GR

NOVARTIS (HELLAS)

GR

S.A.C.I. FR/H/0239/002

262810205

γαστροανθεκτικά δισκία MYFORTIC 180 mg

NOVARTIS (HELLAS)

S.A.C.I.

γαστροανθεκτικά δισκία Myfortic 360 mg

GR

S.A.C.I.

γαστροανθεκτικά δισκία Myfortic 360 mg

NOVARTIS (HELLAS)

S.A.C.I.

γαστροανθεκτικά δισκία Myfortic 360 mg

GR

S.A.C.I.

γαστροανθεκτικά δισκία Myfortic 360 mg

NOVARTIS (HELLAS) S.A.C.I.

γαστροανθεκτικά δισκία Myfortic 360 mg

GR

S.A.C.I.

γαστροανθεκτικά δισκία Myfortic 180 mg

NOVARTIS (HELLAS)

NOVARTIS (HELLAS)

GR

S.A.C.I. FR/H/0239/001

036511018

NOVARTIS FARMA S.P.A.

IT

compresse gastroresistenti

List of nationally authorised medicinal products EMA/848467/2016

Page 5/15

Product Name (in

MRP/DCP

authorisation country)

Authorisation

National Authorisation Number

MAH of product in the

Member State where

member state

product is authorised

number MYFORTIC 180 mg

FR/H/0239/001

036511020

NOVARTIS FARMA S.P.A.

IT

FR/H/0239/001

036511032

NOVARTIS FARMA S.P.A.

IT

FR/H/0239/001

036511044

NOVARTIS FARMA S.P.A.

IT

FR/H/0239/001

036511057

NOVARTIS FARMA S.P.A.

IT

FR/H/0239/001

5051883

NOVARTIS FARMA -

PT

compresse gastroresistenti MYFORTIC 180 mg compresse gastroresistenti MYFORTIC 180 mg compresse gastroresistenti MYFORTIC 180 mg compresse gastroresistenti Myfortic 180 mg Comprimidos

PRODUTOS

gastrorresistentes

FARMACÊUTICOS S.A.

Myfortic 180 mg

FR/H/0239/001

5051982

NOVARTIS FARMA -

Comprimidos

PRODUTOS

gastrorresistentes

FARMACÊUTICOS S.A.

Myfortic 180 mg

FR/H/0239/001

5052089

NOVARTIS FARMA -

Comprimidos

PRODUTOS

gastrorresistentes

FARMACÊUTICOS S.A.

List of nationally authorised medicinal products EMA/848467/2016

PT

PT

Page 6/15

Product Name (in

MRP/DCP

authorisation country)

Authorisation

National Authorisation Number

MAH of product in the

Member State where

member state

product is authorised

number MYFORTIC 360 mg

FR/H/0239/002

036511069

NOVARTIS FARMA S.P.A.

IT

FR/H/0239/002

036511071

NOVARTIS FARMA S.P.A.

IT

FR/H/0239/002

036511083

NOVARTIS FARMA S.P.A.

IT

FR/H/0239/002

036511095

NOVARTIS FARMA S.P.A.

IT

FR/H/0239/002

5052188

NOVARTIS FARMA -

PT

compresse gastroresistenti MYFORTIC 360 mg compresse gastroresistenti MYFORTIC 360 mg compresse gastroresistenti MYFORTIC 360 mg compresse gastroresistenti Myfortic 360 mg Comprimidos

PRODUTOS

gastrorresistentes

FARMACÊUTICOS S.A.

Myfortic 360 mg

FR/H/0239/002

5052287

NOVARTIS FARMA -

Comprimidos

PRODUTOS

gastrorresistentes

FARMACÊUTICOS S.A.

MYFORTIC 180 mg

FR/H/0239/001

66140

comprimidos

NOVARTIS FARMACÉUTICA

PT

ES

S.A.

gastrorresistentes Myfortic 180 mg

FR/H/0239/001

18944

NOVARTIS FINLAND OY

FI

enterotabletti

List of nationally authorised medicinal products EMA/848467/2016

Page 7/15

Product Name (in

MRP/DCP

authorisation country)

Authorisation

National Authorisation Number

MAH of product in the

Member State where

member state

product is authorised

number Myfortic, 180 mg

FR/H/0239/001

469105

NOVARTIS FINLAND OY

EE

FR/H/0239/001

LT/1/05/0288/001

NOVARTIS FINLAND OY

LT

FR/H/0239/001

LT/1/05/0288/002

NOVARTIS FINLAND OY

LT

FR/H/0239/001

LT/1/05/0288/003

NOVARTIS FINLAND OY

LT

FR/H/0239/001

LT/1/05/0288/004

NOVARTIS FINLAND OY

LT

FR/H/0239/001

LT/1/05/0288/005

NOVARTIS FINLAND OY

LT

FR/H/0239/001

18944

NOVARTIS FINLAND OY

FI

FR/H/0239/002

66141

NOVARTIS FARMACÉUTICA

ES

gastroresistentsed tabletid Myfortic 180 mg skrandyje neirios tabletės Myfortic 180 mg skrandyje neirios tabletės Myfortic 180 mg skrandyje neirios tabletės Myfortic 180 mg skrandyje neirios tabletės Myfortic 180 mg skrandyje neirios tabletės Myfortic 180 mg enterotabletter MYFORTIC 360 mg comprimidos

S.A.

gastrorresistentes

List of nationally authorised medicinal products EMA/848467/2016

Page 8/15

Product Name (in

MRP/DCP

authorisation country)

Authorisation

National Authorisation Number

MAH of product in the

Member State where

member state

product is authorised

number Myfortic 360 mg

FR/H/0239/002

18945

NOVARTIS FINLAND OY

FI

FR/H/0239/002

469205

NOVARTIS FINLAND OY

EE

FR/H/0239/002

05-0270

NOVARTIS FINLAND OY

LV

FR/H/0239/002

18945

NOVARTIS FINLAND OY

FI

Myfortic

FR/H/0239/001

35821

NOVARTIS HEALTHCARE A/S

DK

Myfortic

FR/H/0239/002

35822

NOVARTIS HEALTHCARE A/S

DK

Myfortic 180 mg,

FR/H/0239/001

RVG 30202

NOVARTIS PHARMA B.V.

NL

not available

20050056

NOVARTIS PHARMA GMBH

BG

FR/H/0239/001

OGYI-T-10075/02

NOVARTIS HUNGÁRIA KFT.

HU

enterotabletti Myfortic, 360 mg gastroresistentsed tabletid Myfortic 360 mg zarnās šķīstošās tabletes Myfortic 360 mg enterotabletter

maagsapresistente tablet MИФОРТИК 180 MG СТОМАШНОУСТОЙЧИВИ ТАБЛЕТКИ Myfortic 180 mg gyomornedv-ellenálló

PHARMA

tabletta Myfortic® 180 mg

FR/H/0239/001

58399.00.00

NOVARTIS PHARMA GMBH

DE

magensaftresistente Tabletten

List of nationally authorised medicinal products EMA/848467/2016

Page 9/15

Product Name (in

MRP/DCP

authorisation country)

Authorisation

National Authorisation Number

MAH of product in the

Member State where

member state

product is authorised

NOVARTIS POLAND SP. Z O.

PL

number Myfortic 180 mg tabletki

FR/H/0239/001

11469

dojelitowe Myfortic 360 mg,

O. FR/H/0239/002

RVG 30203

NOVARTIS PHARMA B.V.

NL

not available

20050057

NOVARTIS PHARMA GMBH

BG

FR/H/0239/002

OGYI-T-10075/01

NOVARTIS HUNGÁRIA KFT.

HU

maagsapresistente tablet MИФОРТИК 360 MG СТОМАШНОУСТОЙЧИВИ ТАБЛЕТКИ Myfortic 360 mg gyomornedv-ellenálló

PHARMA

tabletta Myfortic® 360 mg

FR/H/0239/002

58399.01.00

NOVARTIS PHARMA GMBH

DE

FR/H/0239/002

11452

NOVARTIS POLAND SP. Z O.

PL

magensaftresistente Tabletten Myfortic 360 mg tabletki dojelitowe MYFORTIC 180 MG

O. FR/H/0239/001

PL 00101/0664

NOVARTIS

GASTRO-RESISTANT

PHARMACEUTICALS UK

TABLETS

LIMITED

MYFORTIC 360 MG

FR/H/0239/002

PL 00101/0665

NOVARTIS

GASTRO-RESISTANT

PHARMACEUTICALS UK

TABLETS

LIMITED

Myfortic 180 mg

FR/H/0239/001

59/111/05-C

NOVARTIS, S.R.O.

UK

UK

CZ

enterosolventní tablety

List of nationally authorised medicinal products EMA/848467/2016

Page 10/15

Product Name (in

MRP/DCP

authorisation country)

Authorisation

National Authorisation Number

MAH of product in the

Member State where

member state

product is authorised

number MYFORTIC 180 MG –

FR/H/0239/001

1-25367

NOVARTIS PHARMA GMBH

AT

FR/H/0239/001

3400936308428

NOVARTIS PHARMA S.A.S.

FR

FR/H/0239/001

3400936308596

NOVARTIS PHARMA S.A.S.

FR

FR/H/0239/001

3400936308657

NOVARTIS PHARMA S.A.S.

FR

FR/H/0239/001

3400936308718

NOVARTIS PHARMA S.A.S.

FR

FR/H/0239/001

3400936308886

NOVARTIS PHARMA S.A.S.

FR

FR/H/0239/001

20225

NOVARTIS SVERIGE AB

SE

FR/H/0239/001

PA 13/115/1

NOVARTIS

IE

MAGENSAFTRESISTENTE TABLETTEN MYFORTIC 180 mg comprimé gastrorésistant MYFORTIC 180 mg comprimé gastrorésistant MYFORTIC 180 mg comprimé gastrorésistant MYFORTIC 180 mg comprimé gastrorésistant MYFORTIC 180 mg comprimé gastrorésistant Myfortic 180 mg enterotablett Myfortic 180 mg gastroresistant tablets

PHARMACEUTICALS UK LIMITED

List of nationally authorised medicinal products EMA/848467/2016

Page 11/15

Product Name (in

MRP/DCP

authorisation country)

Authorisation

National Authorisation Number

MAH of product in the

Member State where

member state

product is authorised

number Myfortic 180 mg

FR/H/0239/001

59/0073/05-S

NOVARTIS, S.R.O.

SK

FR/H/0239/001

088/04901

NOVARTIS

MT

gastrorezistentné tablety Myfortic 180 mg gastro-

PHARMACEUTICALS UK

resistant tablets

LIMITED Myfortic 360 mg

FR/H/0239/002

59/112/05-C

NOVARTIS, S.R.O.

CZ

FR/H/0239/002

1-25368

NOVARTIS PHARMA GMBH

AT

FR/H/0239/002

3400936308947

NOVARTIS PHARMA S.A.S.

FR

FR/H/0239/002

3400936309029

NOVARTIS PHARMA S.A.S.

FR

FR/H/0239/002

3400936309197

NOVARTIS PHARMA S.A.S.

FR

FR/H/0239/002

3400936309258

NOVARTIS PHARMA S.A.S.

FR

enterosolventní tablety MYFORTIC 360 MG – MAGENSAFTRESISTENTE TABLETTEN MYFORTIC 360 mg comprimé gastrorésistant MYFORTIC 360 mg comprimé gastrorésistant MYFORTIC 360 mg comprimé gastrorésistant MYFORTIC 360 mg comprimé gastrorésistant

List of nationally authorised medicinal products EMA/848467/2016

Page 12/15

Product Name (in

MRP/DCP

authorisation country)

Authorisation

National Authorisation Number

MAH of product in the

Member State where

member state

product is authorised

number Myfortic 360 mg

FR/H/0239/002

BE272063

NOVARTIS PHARMA N.V.

BE

FR/H/0239/002

20226

NOVARTIS SVERIGE AB

SE

FR/H/0239/002

PA 13/115/2

NOVARTIS

IE

comprimés gastrorésistants Myfortic 360 mg enterotablett Myfortic 360 mg gastro-

PHARMACEUTICALS UK

resistant tablets

LIMITED Myfortic 360 mg

FR/H/0239/002

59/0074/05-S

NOVARTIS, S.R.O.

SK

FR/H/0239/002

088/04902

NOVARTIS

MT

gastrorezistentné tablety Myfortic 360 mg gastro-

PHARMACEUTICALS UK

resistant tablets

LIMITED Myfortic 360 mg

FR/H/0239/002

BE272063

NOVARTIS PHARMA N.V.

BE

FR/H/0239/001

19691

NOVARTIS

CY

maagsapresistente tabletten Myfortic® 180 mg

PHARMACEUTICALS UK

γαστροανθεκτικό δισκίο

LIMITED Myfortic 360mg

FR/H/0239/002

γαστροανθεκτικό δισκίο

19692

NOVARTIS

CY

PHARMACEUTICALS UK LIMITED

List of nationally authorised medicinal products EMA/848467/2016

Page 13/15

Product Name (in

MRP/DCP

authorisation country)

Authorisation

National Authorisation Number

MAH of product in the

Member State where

member state

product is authorised

number Myfortic 180 mg

FR/H/0239/001

BE272054

NOVARTIS PHARMA N.V.

BE

FR/H/0239/001

BE272054

NOVARTIS PHARMA N.V.

BE

FR/H/0239/002

LT/1/05/0288/007

NOVARTIS FINLAND OY

LT

FR/H/0239/002

LT/1/05/0288/008

NOVARTIS FINLAND OY

LT

FR/H/0239/002

LT/1/05/0288/009

NOVARTIS FINLAND OY

LT

FR/H/0239/002

LT/1/05/0288/010

NOVARTIS FINLAND OY

LT

FR/H/0239/001

IS/1/04/003/01

NOVARTIS HEALTHCARE A/S

IS

FR/H/0239/002

IS/1/04/003/02

NOVARTIS HEALTHCARE A/S

IS

comprimés gastrorésistants Myfortic 180 mg, maagsapresistente tabletten Myfortic 360 mg skrandyje neirios tabletės Myfortic 360 mg skrandyje neirios tabletės Myfortic 360 mg skrandyje neirios tabletės Myfortic 360 mg skrandyje neirios tabletės Myfortic 180 mg magasýruþolnar töflur Myfortic 360 mg magasýruþolnar töflur

List of nationally authorised medicinal products EMA/848467/2016

Page 14/15

Product Name (in

MRP/DCP

authorisation country)

Authorisation

National Authorisation Number

MAH of product in the

Member State where

member state

product is authorised

number MYFORTIC 180 mg

FR/H/0239/001

03-2258

NOVARTIS NORGE AS

NO

FR/H/0239/002

03-2259

NOVARTIS NORGE AS

NO

enterotabletter MYFORTIC 360 mg enterotabletter

List of nationally authorised medicinal products EMA/848467/2016

Page 15/15

Mycophenolic acid - European Medicines Agency - Europa EU

Dec 1, 2016 - Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5525. Send a question via our ... List of nationally authorised medicinal products.

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