28 September 2017 EMA/639185/2017 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: lisdexamfetamine

Procedure no.: PSUSA/00010289/201702

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 (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Aduvanz, hårde kapsler

UK/H/5567/001

53795

SHIRE PHARMACEUTICAL

DK

CONTRACTS LIMITED Aduvanz, hårde kapsler

UK/H/5567/001

53795

SHIRE PHARMACEUTICAL

DK

CONTRACTS LIMITED Aduvanz, hårde kapsler

UK/H/5567/002

53796

SHIRE PHARMACEUTICAL

DK

CONTRACTS LIMITED Aduvanz, hårde kapsler

UK/H/5567/002

53796

SHIRE PHARMACEUTICAL

DK

CONTRACTS LIMITED Aduvanz, hårde kapsler

UK/H/5567/003

53797

SHIRE PHARMACEUTICAL

DK

CONTRACTS LIMITED Aduvanz, hårde kapsler

UK/H/5567/003

53797

SHIRE PHARMACEUTICAL

DK

CONTRACTS LIMITED Elvanse 20 mg capsules,

UK/H/3326/004

PL 08081/0062

hard Elvanse 20 mg capsules,

UK/H/3326/004

PL 08081/0062

SHIRE PHARMACEUTICAL

UK

CONTRACTS LIMITED UK/H/3326/004

93471.00.00

Hartkapseln Elvanse 20 mg

UK

CONTRACTS LIMITED

hard Elvanse 20 mg

SHIRE PHARMACEUTICAL

SHIRE PHARMACEUTICAL

DE

CONTRACTS LIMITED UK/H/3326/004

Hartkapseln

List of nationally authorised medicinal products EMA/639185/2017

93471.00.00

SHIRE PHARMACEUTICAL

DE

CONTRACTS LIMITED

Page 2/17

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Elvanse 20 mg kapselit,

UK/H/3326/004

32537

SHIRE PHARMACEUTICAL

FI

kovat Elvanse 20 mg kapselit,

CONTRACTS LIMITED UK/H/3326/004

32537

kovat Elvanse 20 mg kapslar,

UK/H/3326/004

32537

UK/H/3326/004

32537

UK/H/3326/004

51596

UK/H/3326/004

51596

UK/H/3326/004

14-10265

SHIRE PHARMACEUTICAL

SE

SHIRE PHARMACEUTICAL

SE

SHIRE PHARMACEUTICAL

NO

CONTRACTS LIMITED UK/H/3326/004

14-10265

harde Elvanse 20 mg kapsler,

FI

CONTRACTS LIMITED

harde Elvanse 20 mg kapsler,

SHIRE PHARMACEUTICAL

CONTRACTS LIMITED

hårda Elvanse 20 mg kapsler,

FI

CONTRACTS LIMITED

hårda Elvanse 20 mg kapslar,

SHIRE PHARMACEUTICAL CONTRACTS LIMITED

hårda Elvanse 20 mg kapslar,

FI

CONTRACTS LIMITED

hårda Elvanse 20 mg kapslar,

SHIRE PHARMACEUTICAL

SHIRE PHARMACEUTICAL

NO

CONTRACTS LIMITED UK/H/3326/004

hårde

List of nationally authorised medicinal products EMA/639185/2017

54624

SHIRE PHARMACEUTICAL

DK

CONTRACTS LIMITED

Page 3/17

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Elvanse 20 mg kapsler,

UK/H/3326/004

54624

SHIRE PHARMACEUTICAL

DK

hårde Elvanse 30 mg cápsulas

CONTRACTS LIMITED UK/H/3326/001

5674726

SHIRE PHARMACEUTICAL

PT

CONTRACTS LIMITED Elvanse 30 mg cápsulas

UK/H/3326/001

5674734

SHIRE PHARMACEUTICAL

PT

CONTRACTS LIMITED Elvanse 30 mg cápsulas

UK/H/3326/001

77642

duras Elvanse 30 mg cápsulas

UK/H/3326/001

77642

UK/H/3326/001

PL 08081/0050

UK/H/3326/001

PL 08081/0050

SHIRE PHARMACEUTICAL

UK

SHIRE PHARMACEUTICAL

UK

CONTRACTS LIMITED UK/H/3326/001

136851

Hartkapseln Elvanse 30 mg

ES

CONTRACTS LIMITED

hard Elvanse 30 mg

SHIRE PHARMACEUTICAL CONTRACTS LIMITED

hard Elvanse 30 mg capsules,

ES

CONTRACTS LIMITED

duras Elvanse 30 mg capsules,

SHIRE PHARMACEUTICAL

SHIRE PHARMACEUTICAL

AT

CONTRACTS LIMITED UK/H/3326/001

Hartkapseln

List of nationally authorised medicinal products EMA/639185/2017

136851

SHIRE PHARMACEUTICAL

AT

CONTRACTS LIMITED

Page 4/17

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Elvanse 30 mg

UK/H/3326/001

86155.00.00

SHIRE PHARMACEUTICAL

DE

Hartkapseln Elvanse 30 mg

CONTRACTS LIMITED UK/H/3326/001

86155.00.00

Hartkapseln Elvanse 30 mg kapselit,

UK/H/3326/001

30382

UK/H/3326/001

30382

UK/H/3326/001

30382

UK/H/3326/001

30382

UK/H/3326/001

47382

SHIRE PHARMACEUTICAL

FI

SHIRE PHARMACEUTICAL

FI

SHIRE PHARMACEUTICAL

SE

CONTRACTS LIMITED UK/H/3326/001

47382

hårda Elvanse 30 mg kapsler,

FI

CONTRACTS LIMITED

hårda Elvanse 30 mg kapslar,

SHIRE PHARMACEUTICAL

CONTRACTS LIMITED

hårda Elvanse 30 mg kapslar,

FI

CONTRACTS LIMITED

hårda Elvanse 30 mg kapslar,

SHIRE PHARMACEUTICAL CONTRACTS LIMITED

kovat Elvanse 30 mg kapslar,

DE

CONTRACTS LIMITED

kovat Elvanse 30 mg kapselit,

SHIRE PHARMACEUTICAL

SHIRE PHARMACEUTICAL

SE

CONTRACTS LIMITED UK/H/3326/001

harde

List of nationally authorised medicinal products EMA/639185/2017

11-8762

SHIRE PHARMACEUTICAL

NO

CONTRACTS LIMITED

Page 5/17

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Elvanse 30 mg kapsler,

UK/H/3326/001

11-8762

SHIRE PHARMACEUTICAL

NO

harde Elvanse 30 mg kapsler,

CONTRACTS LIMITED UK/H/3326/001

49980

hårde Elvanse 30 mg kapsler,

UK/H/3326/001

49980

UK/H/3326/001

06/082/16-C

UK/H/3326/001

06/082/16-C

UK/H/3326/005

PL 08081/0063

UK/H/3326/005

PL 08081/0063

SHIRE PHARMACEUTICAL

CZ

SHIRE PHARMACEUTICAL

UK

SHIRE PHARMACEUTICAL

UK

CONTRACTS LIMITED UK/H/3326/005

93472.00.00

Hartkapseln Elvanse 40 mg

CZ

CONTRACTS LIMITED

hard Elvanse 40 mg

SHIRE PHARMACEUTICAL

CONTRACTS LIMITED

hard Elvanse 40 mg capsules,

DK

CONTRACTS LIMITED

tobolky Elvanse 40 mg capsules,

SHIRE PHARMACEUTICAL CONTRACTS LIMITED

tobolky Elvanse 30 mg tvrdé

DK

CONTRACTS LIMITED

hårde Elvanse 30 mg tvrdé

SHIRE PHARMACEUTICAL

SHIRE PHARMACEUTICAL

DE

CONTRACTS LIMITED UK/H/3326/005

Hartkapseln

List of nationally authorised medicinal products EMA/639185/2017

93472.00.00

SHIRE PHARMACEUTICAL

DE

CONTRACTS LIMITED

Page 6/17

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Elvanse 40 mg kapselit

UK/H/3326/005

32538

SHIRE PHARMACEUTICAL

FI

kovat Elvanse 40 mg kapselit

CONTRACTS LIMITED UK/H/3326/005

32538

kovat Elvanse 40 mg kapslar,

UK/H/3326/005

32538

UK/H/3326/005

32538

UK/H/3326/005

51597

UK/H/3326/005

51597

UK/H/3326/005

14-10266

SHIRE PHARMACEUTICAL

SE

SHIRE PHARMACEUTICAL

SE

SHIRE PHARMACEUTICAL

NO

CONTRACTS LIMITED UK/H/3326/005

14-10266

harde Elvanse 40 mg kapsler,

FI

CONTRACTS LIMITED

harde Elvanse 40 mg kapsler,

SHIRE PHARMACEUTICAL

CONTRACTS LIMITED

hårda Elvanse 40 mg kapsler,

FI

CONTRACTS LIMITED

hårda Elvanse 40 mg kapslar,

SHIRE PHARMACEUTICAL CONTRACTS LIMITED

hårda Elvanse 40 mg kapslar,

FI

CONTRACTS LIMITED

hårda Elvanse 40 mg kapslar,

SHIRE PHARMACEUTICAL

SHIRE PHARMACEUTICAL

NO

CONTRACTS LIMITED UK/H/3326/005

hårde

List of nationally authorised medicinal products EMA/639185/2017

54625

SHIRE PHARMACEUTICAL

DK

CONTRACTS LIMITED

Page 7/17

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Elvanse 40 mg kapsler,

UK/H/3326/005

54625

SHIRE PHARMACEUTICAL

DK

hårde Elvanse 50 mg cápsulas

CONTRACTS LIMITED UK/H/3326/002

5674700

SHIRE PHARMACEUTICAL

PT

CONTRACTS LIMITED Elvanse 50 mg cápsulas

UK/H/3326/002

5674718

SHIRE PHARMACEUTICAL

PT

CONTRACTS LIMITED Elvanse 50 mg cápsulas

UK/H/3326/002

77643

duras Elvanse 50 mg cápsulas

UK/H/3326/002

77643

UK/H/3326/002

PL 08081/0051

UK/H/3326/002

PL 08081/0051

SHIRE PHARMACEUTICAL

UK

SHIRE PHARMACEUTICAL

UK

CONTRACTS LIMITED UK/H/3326/002

136852

Hartkapseln Elvanse 50 mg

ES

CONTRACTS LIMITED

hard Elvanse 50 mg

SHIRE PHARMACEUTICAL CONTRACTS LIMITED

hard Elvanse 50 mg capsules,

ES

CONTRACTS LIMITED

duras Elvanse 50 mg capsules,

SHIRE PHARMACEUTICAL

SHIRE PHARMACEUTICAL

AT

CONTRACTS LIMITED UK/H/3326/002

Hartkapseln

List of nationally authorised medicinal products EMA/639185/2017

136852

SHIRE PHARMACEUTICAL

AT

CONTRACTS LIMITED

Page 8/17

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Elvanse 50 mg

UK/H/3326/002

86156.00.00

SHIRE PHARMACEUTICAL

DE

Hartkapseln Elvanse 50 mg

CONTRACTS LIMITED UK/H/3326/002

86156.00.00

Hartkapseln Elvanse 50 mg kapselit,

UK/H/3326/002

30383

UK/H/3326/002

30383

UK/H/3326/002

30383

UK/H/3326/002

30383

UK/H/3326/002

47383

SHIRE PHARMACEUTICAL

FI

SHIRE PHARMACEUTICAL

FI

SHIRE PHARMACEUTICAL

SE

CONTRACTS LIMITED UK/H/3326/002

47383

hårda Elvanse 50 mg kapsler,

FI

CONTRACTS LIMITED

hårda Elvanse 50 mg kapslar,

SHIRE PHARMACEUTICAL

CONTRACTS LIMITED

hårda Elvanse 50 mg kapslar,

FI

CONTRACTS LIMITED

hårda Elvanse 50 mg kapslar,

SHIRE PHARMACEUTICAL CONTRACTS LIMITED

kovat Elvanse 50 mg kapslar,

DE

CONTRACTS LIMITED

kovat Elvanse 50 mg kapselit,

SHIRE PHARMACEUTICAL

SHIRE PHARMACEUTICAL

SE

CONTRACTS LIMITED UK/H/3326/002

harde

List of nationally authorised medicinal products EMA/639185/2017

11-8763

SHIRE PHARMACEUTICAL

NO

CONTRACTS LIMITED

Page 9/17

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Elvanse 50 mg kapsler,

UK/H/3326/002

11-8763

SHIRE PHARMACEUTICAL

NO

harde Elvanse 50 mg kapsler,

CONTRACTS LIMITED UK/H/3326/002

49981

hårde Elvanse 50 mg kapsler,

UK/H/3326/002

49981

UK/H/3326/002

06/083/16-C

UK/H/3326/002

06/083/16-C

UK/H/3326/006

PL 08081/0064

UK/H/3326/006

PL 08081/0064

SHIRE PHARMACEUTICAL

CZ

SHIRE PHARMACEUTICAL

UK

SHIRE PHARMACEUTICAL

UK

CONTRACTS LIMITED UK/H/3326/006

93473.00.00

Hartkapseln Elvanse 60 mg

CZ

CONTRACTS LIMITED

hard Elvanse 60 mg

SHIRE PHARMACEUTICAL

CONTRACTS LIMITED

hard Elvanse 60 mg capsules,

DK

CONTRACTS LIMITED

tobolky Elvanse 60 mg capsules,

SHIRE PHARMACEUTICAL CONTRACTS LIMITED

tobolky Elvanse 50 mg tvrdé

DK

CONTRACTS LIMITED

hårde Elvanse 50 mg tvrdé

SHIRE PHARMACEUTICAL

SHIRE PHARMACEUTICAL

DE

CONTRACTS LIMITED UK/H/3326/006

Hartkapseln

List of nationally authorised medicinal products EMA/639185/2017

93473.00.00

SHIRE PHARMACEUTICAL

DE

CONTRACTS LIMITED

Page 10/17

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Elvanse 60 mg kapselit

UK/H/3326/006

32539

SHIRE PHARMACEUTICAL

FI

kovat Elvanse 60 mg kapselit

CONTRACTS LIMITED UK/H/3326/006

32539

kovat Elvanse 60 mg kapslar,

UK/H/3326/006

32539

UK/H/3326/006

32539

UK/H/3326/006

51598

UK/H/3326/006

51598

UK/H/3326/006

14-10267

SHIRE PHARMACEUTICAL

SE

SHIRE PHARMACEUTICAL

SE

SHIRE PHARMACEUTICAL

NO

CONTRACTS LIMITED UK/H/3326/006

14-10267

harde Elvanse 60 mg kapsler,

FI

CONTRACTS LIMITED

harde Elvanse 60 mg kapsler,

SHIRE PHARMACEUTICAL

CONTRACTS LIMITED

hårda Elvanse 60 mg kapsler,

FI

CONTRACTS LIMITED

hårda Elvanse 60 mg kapslar,

SHIRE PHARMACEUTICAL CONTRACTS LIMITED

hårda Elvanse 60 mg kapslar,

FI

CONTRACTS LIMITED

hårda Elvanse 60 mg kapslar,

SHIRE PHARMACEUTICAL

SHIRE PHARMACEUTICAL

NO

CONTRACTS LIMITED UK/H/3326/006

hårde

List of nationally authorised medicinal products EMA/639185/2017

54626

SHIRE PHARMACEUTICAL

DK

CONTRACTS LIMITED

Page 11/17

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Elvanse 60 mg kapsler,

UK/H/3326/006

54626

SHIRE PHARMACEUTICAL

DK

hårde Elvanse 70 mg cápsulas

CONTRACTS LIMITED UK/H/3326/003

5674668

SHIRE PHARMACEUTICAL

PT

CONTRACTS LIMITED Elvanse 70 mg cápsulas

UK/H/3326/003

5674676

SHIRE PHARMACEUTICAL

PT

CONTRACTS LIMITED Elvanse 70 mg cápsulas

UK/H/3326/003

77644

duras Elvanse 70 mg cápsulas

UK/H/3326/003

77644

UK/H/3326/003

PL 08081/0052

UK/H/3326/003

PL 08081/0052

SHIRE PHARMACEUTICAL

UK

SHIRE PHARMACEUTICAL

UK

CONTRACTS LIMITED UK/H/3326/003

136853

Hartkapseln Elvanse 70 mg

ES

CONTRACTS LIMITED

hard Elvanse 70 mg

SHIRE PHARMACEUTICAL CONTRACTS LIMITED

hard Elvanse 70 mg capsules,

ES

CONTRACTS LIMITED

duras Elvanse 70 mg capsules,

SHIRE PHARMACEUTICAL

SHIRE PHARMACEUTICAL

AT

CONTRACTS LIMITED UK/H/3326/003

Hartkapseln

List of nationally authorised medicinal products EMA/639185/2017

136853

SHIRE PHARMACEUTICAL

AT

CONTRACTS LIMITED

Page 12/17

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Elvanse 70 mg

UK/H/3326/003

86157.00.00

SHIRE PHARMACEUTICAL

DE

Hartkapseln Elvanse 70 mg

CONTRACTS LIMITED UK/H/3326/003

86157.00.00

Hartkapseln Elvanse 70 mg kapselit,

UK/H/3326/003

30384

UK/H/3326/003

30384

UK/H/3326/003

30384

UK/H/3326/003

30384

UK/H/3326/003

47384

SHIRE PHARMACEUTICAL

FI

SHIRE PHARMACEUTICAL

FI

SHIRE PHARMACEUTICAL

SE

CONTRACTS LIMITED UK/H/3326/003

47384

hårda Elvanse 70 mg kapsler,

FI

CONTRACTS LIMITED

hårda Elvanse 70 mg kapslar,

SHIRE PHARMACEUTICAL

CONTRACTS LIMITED

kovat Elvanse 70 mg kapslar,

FI

CONTRACTS LIMITED

kovat Elvanse 70 mg kapselit,

SHIRE PHARMACEUTICAL CONTRACTS LIMITED

kovat Elvanse 70 mg kapselit,

DE

CONTRACTS LIMITED

kovat Elvanse 70 mg kapselit,

SHIRE PHARMACEUTICAL

SHIRE PHARMACEUTICAL

SE

CONTRACTS LIMITED UK/H/3326/003

harde

List of nationally authorised medicinal products EMA/639185/2017

11-8764

SHIRE PHARMACEUTICAL

NO

CONTRACTS LIMITED

Page 13/17

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Elvanse 70 mg kapsler,

UK/H/3326/003

11-8764

SHIRE PHARMACEUTICAL

NO

harde Elvanse 70 mg kapsler,

CONTRACTS LIMITED UK/H/3326/003

49982

hårde Elvanse 70 mg kapsler,

UK/H/3326/003

49982

UK/H/3326/003

06/084/16-C

UK/H/3326/003

06/084/16-C

UK/H/5567/001

PL 08081/0059

UK/H/5567/001

PL 08081/0059

SHIRE PHARMACEUTICAL

CZ

SHIRE PHARMACEUTICAL

UK

SHIRE PHARMACEUTICAL

UK

CONTRACTS LIMITED UK/H/5567/002

PL 08081/0060

capsules, hard Elvanse Adult 50mg

CZ

CONTRACTS LIMITED

capsules, hard. Elvanse Adult 50 mg

SHIRE PHARMACEUTICAL

CONTRACTS LIMITED

capsules, hard Elvanse Adult 30 mg

DK

CONTRACTS LIMITED

tobolky Elvanse Adult 30 mg

SHIRE PHARMACEUTICAL CONTRACTS LIMITED

tobolky Elvanse 70 mg tvrdé

DK

CONTRACTS LIMITED

hårde Elvanse 70 mg tvrdé

SHIRE PHARMACEUTICAL

SHIRE PHARMACEUTICAL

UK

CONTRACTS LIMITED UK/H/5567/002

capsules, hard

List of nationally authorised medicinal products EMA/639185/2017

PL 08081/0060

SHIRE PHARMACEUTICAL

UK

CONTRACTS LIMITED

Page 14/17

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Elvanse Adult 70 mg

UK/H/5567/003

PL 08081/0061

SHIRE PHARMACEUTICAL

UK

capsules, hard Elvanse Adult 70mg

CONTRACTS LIMITED UK/H/5567/003

PL 08081/0061

capsules, hard Elvanse Vuxen 30 mg

UK/H/5567/001

50796

UK/H/5567/001

50796

UK/H/5567/002

50797

UK/H/5567/002

50797

UK/H/5567/003

50798

SHIRE PHARMACEUTICAL

SE

SHIRE PHARMACEUTICAL

SE

SHIRE PHARMACEUTICAL

SE

CONTRACTS LIMITED UK/H/5567/003

50798

kapslar, hårda Tyvense 20 mg capsules,

SE

CONTRACTS LIMITED

kapslar, hårda Elvanse Vuxen 70 mg

SHIRE PHARMACEUTICAL

CONTRACTS LIMITED

kapslar, hårda Elvanse Vuxen 70 mg

SE

CONTRACTS LIMITED

kapslar, hårda Elvanse Vuxen 50 mg

SHIRE PHARMACEUTICAL CONTRACTS LIMITED

kapslar, hårda Elvanse Vuxen 50 mg

UK

CONTRACTS LIMITED

kapslar, hårda Elvanse Vuxen 30 mg

SHIRE PHARMACEUTICAL

SHIRE PHARMACEUTICAL

SE

CONTRACTS LIMITED UK/H/3326/004

hard

List of nationally authorised medicinal products EMA/639185/2017

PA 0689/006/004

SHIRE PHARMACEUTICAL

IE

CONTRACTS LIMITED

Page 15/17

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Tyvense 20 mg capsules,

UK/H/3326/004

PA 0689/006/004

SHIRE PHARMACEUTICAL

IE

hard Tyvense 30 mg capsules,

CONTRACTS LIMITED UK/H/3326/001

PA 689/6/1

hard Tyvense 30 mg capsules,

UK/H/3326/001

PA 689/6/1

UK/H/3326/005

PA 0689/006/005

UK/H/3326/005

PA 0689/006/005

UK/H/3326/002

PA 689/6/2

UK/H/3326/002

PA 689/6/2

SHIRE PHARMACEUTICAL

IE

SHIRE PHARMACEUTICAL

IE

SHIRE PHARMACEUTICAL

IE

CONTRACTS LIMITED UK/H/3326/006

PA 0689/006/006

hard Tyvense 60 mg capsules,

IE

CONTRACTS LIMITED

hard Tyvense 60 mg capsules,

SHIRE PHARMACEUTICAL

CONTRACTS LIMITED

hard Tyvense 50 mg capsules,

IE

CONTRACTS LIMITED

hard Tyvense 50 mg capsules,

SHIRE PHARMACEUTICAL CONTRACTS LIMITED

hard Tyvense 40 mg capsules,

IE

CONTRACTS LIMITED

hard Tyvense 40 mg capsules,

SHIRE PHARMACEUTICAL

SHIRE PHARMACEUTICAL

IE

CONTRACTS LIMITED UK/H/3326/006

hard

List of nationally authorised medicinal products EMA/639185/2017

PA 0689/006/006

SHIRE PHARMACEUTICAL

IE

CONTRACTS LIMITED

Page 16/17

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Tyvense 70 mg capsules,

UK/H/3326/003

PA 689/6/3

SHIRE PHARMACEUTICAL

IE

hard Tyvense 70 mg capsules,

CONTRACTS LIMITED UK/H/3326/003

hard

List of nationally authorised medicinal products EMA/639185/2017

PA 689/6/3

SHIRE PHARMACEUTICAL

IE

CONTRACTS LIMITED

Page 17/17