26 October 2017 EMA/720706/2017 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: Acetyl salicylic acid / atorvastatin / ramipril

Procedure no.: PSUSA/00010280/201702

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, 2017. Reproduction is authorised provided the source is acknowledged.

Product Name

MRP/DCP Authorisation

National Authorisation

MAH of product in the

Member State where

(in authorisation country)

Number

Number

Member State

product is authorised

Sincronia 100 mg/20 mg/10

not available

80938

NEWLINE PHARMA S.L.

ES

not available

80939

NEWLINE PHARMA S.L.

ES

not available

80937

NEWLINE PHARMA S.L.

ES

ES/H/0241/006

BE505022

FERRER INTERNACIONAL,

BE

mg cápsulas duras Sincronia 100 mg/20 mg/5 mg cápsulas duras Sincronia 100 mg/20 mg/2,5 mg cápsulas duras Trinomia 100 mg/40 mg/10 mg harde capsules Trinomia 100 mg/40 mg/5 mg

S.A. ES/H/0241/005

BE505013

harde capsules Trinomia 100 mg/40 mg/2,5

ES/H/0241/004

BE505004

ES/H/0241/006/DC

II-36642

ES/H/0241/005/DC

II-36643

ES/H/0241/004/DC

II-36644

ES/H/0241/005

5704440

ES/H/0241/005

5704432

FERRER INTERNACIONAL, FERRER INTERNACIONAL,

5704457

ES/H/0241/004

5704416

BG PT PT

FERRER INTERNACIONAL, FERRER INTERNACIONAL,

ES/H/0241/004

5704408

FERRER INTERNACIONAL,

PT

S.A. PT

S.A.

2,5 mg cápsulas Trinomia 100 mg + 40 mg +

FERRER INTERNACIONAL,

ES/H/0241/005

2,5 mg cápsulas Trinomia 100 mg + 40 mg +

BG

S.A.

5 mg cápsulas Trinomia 100 mg + 40 mg +

FERRER INTERNACIONAL,

S.A.

5 mg cápsulas Trinomia 100 mg + 40 mg +

BG

S.A.

5 mg cápsulas Trinomia 100 mg + 40 mg +

FERRER INTERNACIONAL,

S.A.

mg твърди капсули Trinomia 100 mg + 40 mg +

BE

S.A.

mg твърди капсули Триномиа 100 mg/40 mg/2,5

FERRER INTERNACIONAL, S.A.

mg твърди капсули Триномиа 100 mg/40 mg/5

BE

S.A.

mg harde capsules Триномиа 100 mg/40 mg/10

FERRER INTERNACIONAL,

PT

S.A. ES/H/0241/004

List of nationally authorised medicinal products EMA/720706/2017

5704424

FERRER INTERNACIONAL,

PT

Page 2/8

Product Name

MRP/DCP Authorisation

National Authorisation

MAH of product in the

Member State where

(in authorisation country)

Number

Number

Member State

product is authorised

2,5 mg cápsulas Trinomia 100 mg + 40 mg +

S.A. ES/H/0241/006

5704721

10 mg cápsulas Trinomia 100 mg + 40 mg +

ES/H/0241/006

5704705

ES/H/0241/006

5704713

ES/H/0241/006

54440

ES/H/0241/004

54438

ES/H/0241/005

54439

ES/H/0241/004

6 154 240 7

ES/H/0241/005

6 451 898 4

ES/H/0241/006

6 272 093 0

ES/H/0241/001

78574

ES/H/0241/002

78575

ES/H/0241/003

78576

FERRER INTERNACIONAL,

FR

FERRER INTERNACIONAL,

FR

FERRER INTERNACIONAL,

FR

FERRER INTERNACIONAL,

ES

FERRER INTERNACIONAL,

ES

FERRER INTERNACIONAL,

ES

S.A. ES/H/0241/001

49331

mg kapslar, hårda Trinomia 100 mg/20 mg/5 mg

SE

S.A.

mg cápsulas duras Trinomia 100 mg/20 mg/2,5

FERRER INTERNACIONAL,

S.A.

cápsulas duras Trinomia 100 mg/20 mg/10

SE

S.A.

mg cápsulas duras Trinomia 100 mg/20 mg/5 mg

FERRER INTERNACIONAL,

S.A.

gélule Trinomia 100 mg/20 mg/2,5

SE

S.A.

gélule ILTRIA 100 mg/40 mg/10 mg,

FERRER INTERNACIONAL,

S.A.

mg, gélule ILTRIA 100 mg/40 mg/5 mg,

PT

S.A.

hårda kapslar ILTRIA 100 mg/40 mg/2,5

FERRER INTERNACIONAL,

S.A.

mg hårda kapslar Trinomia 100 mg/40 mg/5 mg

PT

S.A.

mg hårda kapslar Trinomia 100 mg/40 mg/2,5

FERRER INTERNACIONAL, S.A.

10 mg cápsulas Trinomia 100 mg/40 mg/10

PT

S.A.

10 mg cápsulas Trinomia 100 mg + 40 mg +

FERRER INTERNACIONAL,

FERRER INTERNACIONAL,

SE

S.A. ES/H/0241/002

kapslar, hårda List of nationally authorised medicinal products EMA/720706/2017

49332

FERRER INTERNACIONAL,

SE

S.A.

Page 3/8

Product Name

MRP/DCP Authorisation

National Authorisation

MAH of product in the

Member State where

(in authorisation country)

Number

Number

Member State

product is authorised

Trinomia 100 mg/20 mg/10

ES/H/0241/003

49333

FERRER INTERNACIONAL,

SE

mg kapslar, hårda Trinomia 100 mg/20 mg/2,5

S.A. ES/H/0241/001/DC

6486/2014/01-05

ES/H/0241/002/DC

6487/2014/01-05

ES/H/0241/003/DC

6488/2014/01-05

mg capsule Trinomia 100 mg/20 mg/5 mg

ES/H/0241/001

5627047

ES/H/0241/001

5627054

ES/H/0241/001

5627062

ES/H/0241/002

5627070

ES/H/0241/002

5627104

ES/H/0241/002

5627112

ES/H/0241/003

5627120

ES/H/0241/003

5627138

ES/H/0241/003

5627146

ES/H/0241/001

II-28096

FERRER INTERNACIONAL,

PT

FERRER INTERNACIONAL,

PT

FERRER INTERNACIONAL,

PT

FERRER INTERNACIONAL,

PT

FERRER INTERNACIONAL,

PT

FERRER INTERNACIONAL,

PT

S.A.

mg твърди капсули Триномиа 100 mg/20 mg/5

PT

S.A.

10 mg cápsulas Триномиа 100 mg/20 mg/2,5

FERRER INTERNACIONAL,

S.A.

10 mg cápsulas Trinomia 100 mg + 20 mg +

PT

S.A.

10 mg cápsulas Trinomia 100 mg + 20 mg +

FERRER INTERNACIONAL,

S.A.

5 mg cápsulas Trinomia 100 mg + 20 mg +

PT

S.A.

5 mg cápsulas Trinomia 100 mg + 20 mg +

FERRER INTERNACIONAL,

S.A.

5 mg cápsulas Trinomia 100 mg + 20 mg +

RO

S.A.

2,5 mg cápsulas Trinomia 100 mg + 20 mg +

FERRER INTERNACIONAL,

S.A.

2,5 mg cápsulas Trinomia 100 mg + 20 mg +

RO

S.A.

2,5 mg cápsulas Trinomia 100 mg + 20 mg +

FERRER INTERNACIONAL, S.A.

mg capsule Trinomia 100 mg + 20 mg +

RO

S.A.

capsule Trinomia 100 mg/20 mg/10

FERRER INTERNACIONAL,

FERRER INTERNACIONAL,

BG

S.A. ES/H/0241/002

List of nationally authorised medicinal products EMA/720706/2017

II-28097

FERRER INTERNACIONAL,

BG

Page 4/8

Product Name

MRP/DCP Authorisation

National Authorisation

MAH of product in the

Member State where

(in authorisation country)

Number

Number

Member State

product is authorised

mg твърди капсули Триномиа 100 mg/20 mg/10

S.A. ES/H/0241/003

II-28098

mg твърди капсули Trinomia 100 mg/20 mg/2.5

ES/H/0241/001

PA1744/002/001

ES/H/0241/002

PA1744/002/002

ES/H/0241/003

PA1744/002/003

ES/H/0241/001/E/001

BE469537

ES/H/0241/002/E/001

BE469546

ES/H/0241/003/E/001

BE469555

ES/H/0241/001

BE469537

ES/H/0241/002

BE469546

ES/H/0241/003

BE469555

ES/H/0241/001

BE469537

ES/H/0241/002

BE469546

FERRER INTERNACIONAL,

BE

FERRER INTERNACIONAL,

BE

FERRER INTERNACIONAL,

BE

FERRER INTERNACIONAL,

BE

FERRER INTERNACIONAL,

BE

FERRER INTERNACIONAL,

BE

S.A. ES/H/0241/003

BE469555

mg Hartkapseln Trinomia 100 mg/20 mg/10

BE

S.A.

Hartkapseln Trinomia 100 mg/20 mg/10

FERRER INTERNACIONAL,

S.A.

mg Hartkapseln Trinomia 100 mg/20 mg/5 mg

BE

S.A.

mg harde capsules Trinomia 100 mg/20 mg/2,5

FERRER INTERNACIONAL,

S.A.

harde capsules Trinomia 100 mg/20 mg/10

IE

S.A.

mg harde capsules Trinomia 100 mg/20 mg/5 mg

FERRER INTERNACIONAL,

S.A.

mg gélules Trinomia 100 mg/20 mg/2,5

IE

S.A.

gélules Trinomia 100 mg/20 mg/10

FERRER INTERNACIONAL,

S.A.

mg gélules Trinomia 100 mg/20 mg/5 mg

IE

S.A.

mg hard capsules Trinomia 100 mg/20 mg/2,5

FERRER INTERNACIONAL, S.A.

hard capsules Trinomia 100 mg/20 mg/10

BG

S.A.

mg hard capsules Trinomia 100 mg/20 mg/5 mg

FERRER INTERNACIONAL,

FERRER INTERNACIONAL,

BE

S.A. ES/H/0241/003

mg Hartkapseln List of nationally authorised medicinal products EMA/720706/2017

91938.00.00

FERRER INTERNACIONAL,

DE

S.A.

Page 5/8

Product Name

MRP/DCP Authorisation

National Authorisation

MAH of product in the

Member State where

(in authorisation country)

Number

Number

Member State

product is authorised

Trinomia 100 mg/20 mg/5 mg

ES/H/0241/002

91937.00.00

FERRER INTERNACIONAL,

DE

Hartkapseln Trinomia 100 mg/20 mg/2,5

S.A. ES/H/0241/001

91936.00.00

ES/H/0241/003

136165

ES/H/0241/002

136164

mg Hartkapseln Trinomia 100 mg/20 mg/10

ES/H/0241/001

136163

ES/H/0241/003

043397114

ES/H/0241/002

043397064

ES/H/0241/001

043397013

ES/H/0241/003

043397126

ES/H/0241/003

043397138

ES/H/0241/003

043397140

ES/H/0241/003

043397153

ES/H/0241/002

043397076

ES/H/0241/002

043397088

FERRER INTERNACIONAL,

IT

FERRER INTERNACIONAL,

IT

FERRER INTERNACIONAL,

IT

FERRER INTERNACIONAL,

IT

FERRER INTERNACIONAL,

IT

FERRER INTERNACIONAL,

IT

S.A.

capsule rigide Trinomia 100 mg/20 mg/5 mg

IT

S.A.

capsule rigide Trinomia 100 mg/20 mg/5 mg

FERRER INTERNACIONAL,

S.A.

mg capsule rigide Trinomia 100 mg/20 mg/5 mg

IT

S.A.

mg capsule rigide Trinomia 100 mg/20 mg/10

FERRER INTERNACIONAL,

S.A.

mg capsule rigide Trinomia 100 mg/20 mg/10

AT

S.A.

mg capsule rigide Trinomia 100 mg/20 mg/10

FERRER INTERNACIONAL,

S.A.

mg capsule rigide Trinomia 100 mg/20 mg/10

AT

S.A.

capsule rigide Trinomia 100 mg/20 mg/2,5

FERRER INTERNACIONAL,

S.A.

mg capsule rigide Trinomia 100 mg/20 mg/5 mg

AT

S.A.

mg Hartkapseln Trinomia 100 mg/20 mg/10

FERRER INTERNACIONAL, S.A.

Hartkapseln Trinomia 100 mg/20 mg/2,5

DE

S.A.

mg Hartkapseln Trinomia 100 mg/20 mg/5 mg

FERRER INTERNACIONAL,

FERRER INTERNACIONAL,

IT

S.A. ES/H/0241/002

List of nationally authorised medicinal products EMA/720706/2017

043397090

FERRER INTERNACIONAL,

IT

Page 6/8

Product Name

MRP/DCP Authorisation

National Authorisation

MAH of product in the

Member State where

(in authorisation country)

Number

Number

Member State

product is authorised

capsule rigide Trinomia 100 mg/20 mg/5 mg

S.A. ES/H/0241/002

043397102

capsule rigide Trinomia 100 mg/20 mg/2,5

ES/H/0241/001

043397025

ES/H/0241/001

043397037

ES/H/0241/001

043397049

ES/H/0241/001

043397052

ES/H/0241/001

41/050/15-C

ES/H/0241/002

41/049/15-C

ES/H/0241/003

41/048/15-C

ES/H/0241/003

34009 300 071 8 1

ES/H/0241/001

34009 300 071 6 7

ES/H/0241/002

34009 300 071 6 7

ES/H/0241/001

34009 550 026 3 5

FERRER INTERNACIONAL,

CZ

FERRER INTERNACIONAL,

CZ

FERRER INTERNACIONAL,

FR

FERRER INTERNACIONAL,

FR

FERRER INTERNACIONAL,

FR

FERRER INTERNACIONAL,

FR

S.A. ES/H/0241/002

34009 550 026 3 5

gélules Iltria 100 mg/20 mg/10 mg

CZ

S.A.

gélules Iltria 100 mg/20 mg/5 mg

FERRER INTERNACIONAL,

S.A.

gélules Iltria 100 mg/20 mg/2,5 mg

IT

S.A.

gélules Iltria 100 mg/20 mg/5 mg

FERRER INTERNACIONAL,

S.A.

gélules Iltria 100 mg/20 mg/2,5 mg

IT

S.A.

mg tvrdé tobolky Iltria 100 mg/20 mg/10 mg

FERRER INTERNACIONAL,

S.A.

tvrdé tobolky Trinomia 100 mg/20 mg/10

IT

S.A.

mg tvrdé tobolky Trinomia 100 mg/20 mg/5 mg

FERRER INTERNACIONAL,

S.A.

mg capsule rigide Trinomia 100 mg/20 mg/2,5

IT

S.A.

mg capsule rigide Trinomia 100 mg/20 mg/2,5

FERRER INTERNACIONAL, S.A.

mg capsule rigide Trinomia 100 mg/20 mg/2,5

IT

S.A.

mg capsule rigide Trinomia 100 mg/20 mg/2,5

FERRER INTERNACIONAL,

FERRER INTERNACIONAL,

FR

S.A. ES/H/0241/003

gélules List of nationally authorised medicinal products EMA/720706/2017

34009 550 026 5 9

FERRER INTERNACIONAL,

FR

S.A.

Page 7/8

Product Name

MRP/DCP Authorisation

National Authorisation

MAH of product in the

Member State where

(in authorisation country)

Number

Number

Member State

product is authorised

TRINOMIA 100 mg / 20 mg /

ES/H/0241/003

32223

FERRER INTERNACIONAL,

FI

10 mg kapseli, kova TRINOMIA 100 mg / 20 mg /

S.A. ES/H/0241/002

32222

ES/H/0241/001

32221

FERRER INTERNACIONAL,

ES/H/0241/001

12478/15/5-10-2016

FERRER-GALENICA S.A.

GR

ES/H/0241/003

12478/15/5-10-2016

FERRER-GALENICA S.A.

GR

ES/H/0241/002

12478/15/5-10-2016

FERRER-GALENICA S.A.

GR

not available

80938

NEWLINE PHARMA S.L.

ES

not available

80939

NEWLINE PHARMA S.L.

ES

not available

80937

NEWLINE PHARMA S.L.

ES

5 mg kapseli, kova TRINOMIA 100 mg / 20 mg /

FI

S.A.

2.5 mg kapseli, kova Trinomia 100 mg/20 mg/2,5

FERRER INTERNACIONAL,

FI

S.A.

mg καψάκια σκληρά Trinomia 100 mg/20 mg/10 mg καψάκια σκληρά Trinomia 100 mg/20 mg/5 mg καψάκια σκληρά Sincronia 100 mg/20 mg/10 mg cápsulas duras Sincronia 100 mg/20 mg/5 mg cápsulas duras Sincronia 100 mg/20 mg/2,5 mg cápsulas duras

List of nationally authorised medicinal products EMA/720706/2017

Page 8/8