30 November 2017 EMA/787818/2017 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: Zidovudine

Procedure no.: PSUSA/00003143/201703

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© 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

Retrovir, 250 mg,

not available

R/2837

VIIV HEALTHCARE UK

PL

kapsułki twarde Retrovir, 100 mg,

LIMITED not available

R/3007

kapsulki twarde Retrovir 10 mg/ml,

VIIV HEALTHCARE UK

PL

LIMITED not available

7699

koncentrat do

VIIV HEALTHCARE UK

PL

LIMITED

sporzadzania roztworu do infuzji Retrovir, 50 mg/5ml,

not available

7698

roztwór doustny Retrovir 250 mg tvrdé

not available

42/151/88-C

not available

42/152/88-C

not available

42/367/92-C

UK/H/0022/008

026697134

CZ

VIIV HEALTHCARE UK

CZ

VIIV HEALTHCARE UK

IT

LIMITED UK/H/0022/008

026697058

soluzione orale Retrovir 10 mg/ml

VIIV HEALTHCARE UK

LIMITED

soluzione orale Retrovir 100 mg/10 ml

CZ

LIMITED

perorální roztok Retrovir 100 mg/10 ml

VIIV HEALTHCARE UK LIMITED

infuzní roztok Retrovir 50 mg/5 ml

PL

LIMITED

tobolky Retrovir Koncentrát pro

VIIV HEALTHCARE UK

VIIV HEALTHCARE UK

IT

LIMITED UK/H/0022/11

026697072

concentrato per soluzione

VIIV HEALTHCARE UK

IT

LIMITED

per infusione Retrovir 100 mg capsule

UK/H/0022/001

026697122

rigide Retrovir 100 mg capsule

IT

LIMITED UK/H/0022/001

026697146

rigide Retrovir 250 mg capsule

VIIV HEALTHCARE UK VIIV HEALTHCARE UK

IT

LIMITED UK/H/0022/002

rigide

List of nationally authorised medicinal products EMA/787818/2017

026697159

VIIV HEALTHCARE UK

IT

LIMITED

Page 2/8

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

Retrovir 100 mg, capsule

not available

2183/2009/01

VIIV HEALTHCARE UK

RO

LIMITED Retrovir 100 mg, capsule

not available

2183/2009/02

VIIV HEALTHCARE UK

RO

LIMITED Retrovir 100 mg, capsule

not available

2183/2009/03

VIIV HEALTHCARE UK

RO

LIMITED Retrovir 250 mg

not available

59/0151/88-C/S

VIIV HEALTHCARE UK

SK

LIMITED RETROVIR 100 mg/10 ml

UK/H/0022/008

0260/09/05/0307

UK/H/0022/001

0260/09/05/0305

drank Retrovir 100 mg

UK/H/0022/002

0260/09/05/0306

UK/H/0022/002

10417

VIIV HEALTHCARE UK

LU

VIIV HEALTHCARE UK

FI

LIMITED UK/H/0022/008

401602

suukaudne lahus RETROVIR 10 mg/ml I.V.

LU

LIMITED

kapseli, kova RETROVIR, 10 mg/ml

VIIV HEALTHCARE UK LIMITED

Hartkapseln Zidovudin RETROVIR 250 mg

LU

LIMITED

Hartkapseln Zidovudin Retrovir 250 mg

VIIV HEALTHCARE UK

VIIV HEALTHCARE UK

EE

LIMITED UK/H/0022/11

BE 177843

– solution à diluer pour

VIIV HEALTHCARE UK

BE

LIMITED

perfusion RETROVIR 10 mg/ml,

UK/H/0022/11

NL14792

solution à diluer pour

VIIV HEALTHCARE UK

FR

LIMITED

perfusion RETROVIR 10 mg/ml I.V.

UK/H/0022/11

– solution à diluer pour

2009 05 0309

VIIV HEALTHCARE UK

LU

LIMITED

perfusion

List of nationally authorised medicinal products EMA/787818/2017

Page 3/8

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

Retrovir® 10 mg/ml i.v.

UK/H/0022/11)

29682.00.00

VIIV HEALTHCARE UK

DE

Konzentrat zur

LIMITED

Herstellung einer Infusionslösung Retrovir 10 mg/ml IV

UK/H/0022/11

PA 1716/001/003

Concentrate for Solution

VIIV HEALTHCARE UK

IE

LIMITED

for Infusion Retrovir® 10 mg/ml IV

UK/H/0022/11

PL 35728/0005

Concentrate for Solution

VIIV HEALTHCARE UK

UK

LIMITED

for Infusion Retrovir 10 mg/ml Πυκνό

UK/H/0022/11

1960703

διάλυμα προς έγχυση Retrovir IV 10 mg/ml

VIIV HEALTHCARE UK

GR

LIMITED UK/H/0022/11

8739128

Concentrado para solução

VIIV HEALTHCARE UK

PT

LIMITED

para perfusão Retrovir Infuus 10 mg/ml

UK/H/0022/11

RVG 16389

concentraat voor

VIIV HEALTHCARE UK

NL

LIMITED

oplossing voor infusie Retrovir 10 mg/ml

UK/H/0022/11

11764

koncentrat till

VIIV HEALTHCARE UK

SE

LIMITED

infusionsvätska, lösning Retrovir 300 mg film

UK/H/0022/10

PL 35728/0003

UK/H/0022/010

NL20865

coated tablets RETROVIR 300 mg,

UK

LIMITED

comprimé pelliculé Retrovir® 100 mg

VIIV HEALTHCARE UK VIIV HEALTHCARE UK

FR

LIMITED UK/H/0022/001

capsules, hard

List of nationally authorised medicinal products EMA/787818/2017

PL 35728/0001

VIIV HEALTHCARE UK

UK

LIMITED

Page 4/8

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

Retrovir 100 mg

UK/H/0022/001

PA 1716/001/001

VIIV HEALTHCARE UK

IE

capsules, hard Retrovir 100 mg

LIMITED not available

MA990/00101

capsules, hard Retrovir 100 mg-Kapseln

VIIV HEALTHCARE UK

MT

LIMITED UK/H/0022/1

1-18276

VIIV HEALTHCARE UK

AT

LIMITED Retrovir® 100 mg

UK/H/0022/001

24229.00.00

Hartkapseln RETROVIR 100 mg

UK/H/0022/001

BE 333855

UK/H/0022/001

BE 137925

UK/H/0022/001

BE 333846

UK/H/0022/001

NL 14702

UK/H/0022/1

2009 05 0305

UK/H/0022/1

9460

UK/H/0022/001

1960701

BE

VIIV HEALTHCARE UK

FR

VIIV HEALTHCARE UK

LU

UK/H/0022/001

4030680

VIIV HEALTHCARE UK

FI

LIMITED

100 mg Retrovir 100 mg cápsulas

VIIV HEALTHCARE UK

LIMITED

kapseli, kova Retrovir καψάκια σκληρά

BE

LIMITED

gélules RETROVIR 100 mg

VIIV HEALTHCARE UK

LIMITED

gélule RETROVIR 100 mg

BE

LIMITED

gélules RETROVIR 100 mg,

VIIV HEALTHCARE UK LIMITED

gélules RETROVIR 100 mg

DE

LIMITED

gélules RETROVIR 100 mg

VIIV HEALTHCARE UK

VIIV HEALTHCARE UK

GR

LIMITED VIIV HEALTHCARE UK

PT

LIMITED Retrovir 100 mg cápsulas

UK/H/0022/001

8739102

VIIV HEALTHCARE UK

PT

LIMITED Retrovir 100 mg

UK/H/0022/1

capsules, hard

List of nationally authorised medicinal products EMA/787818/2017

RVG 12639

VIIV HEALTHCARE UK

NL

LIMITED

Page 5/8

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

Retrovir 100 mg, kapslar,

UK/H/0022/001

10588

VIIV HEALTHCARE UK

SE

hårda Retrovir® 250 mg

LIMITED UK/H/0022/2

PL 35728/0002

capsules, hard RETROVIR 250 mg

UK/H/0022/002

BE 137907

UK/H/0022/2

2009 05 0306

BE

VIIV HEALTHCARE UK

LU

LIMITED UK/H/0022/002

NL14703

UK/H/0022/2

1-18277

gélule Retrovir 250 mg-Kapseln

VIIV HEALTHCARE UK LIMITED

gélules RETROVIR 250 mg,

UK

LIMITED

gélules RETROVIR 250 mg

VIIV HEALTHCARE UK

VIIV HEALTHCARE UK

FR

LIMITED VIIV HEALTHCARE UK

AT

LIMITED Retrovir® 250 mg

UK/H/0022/002

24229.01.00

Hartkapseln Retrovir καψάκια σκληρά

DE

LIMITED UK/H/0022/2

1960702

250 mg Retrovir 250 mg cápsulas

VIIV HEALTHCARE UK VIIV HEALTHCARE UK

GR

LIMITED UK/H/0022/002

8739110

VIIV HEALTHCARE UK

PT

LIMITED Retrovir

UK/H/0022/2

12918

Retrovir 250 mg, kapslar,

UK/H/0022/2

10735

UK/H/0022/002

57.486

VIIV HEALTHCARE UK

DK

LIMITED hårda Retrovir 250 mg cápsulas

LABORATORIOS VIIV

ES

HEALTHCARE, S.L UK/H/0022/8

24229.00.01

Lösung zum Einnehmen Retrovir πόσιμο διάλυμα

SE

LIMITED

duras Retrovir 100 mg/10 ml

VIIV HEALTHCARE UK

VIIV HEALTHCARE UK

DE

LIMITED UK/H/0022/8

100 mg/ 10ml

List of nationally authorised medicinal products EMA/787818/2017

1960704

VIIV HEALTHCARE UK

GR

LIMITED

Page 6/8

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

RETROVIR 100 mg/10 ml

UK/H/0022/8

BE 161524

VIIV HEALTHCARE UK

BE

solution buvable RETROVIR 100 mg/10 ml,

LIMITED UK/H/0022/8

NL17450

solution buvable RETROVIR 100 mg/10 ml

UK/H/0022/8

2009 05 0307

UK/H/0022/008

11427 2165785

VIIV HEALTHCARE UK

UK/H/0022/008

5429683

VIIV HEALTHCARE UK

UK/H/0022/8

59.332

UK/H/0022/8

RVG 15118

UK/H/0022/008

PL 35728/0004

ES

VIIV HEALTHCARE UK

NL

VIIV HEALTHCARE UK

UK

LIMITED UK/H/0022/008

PA 1716/001/002

UK/H/0022/8

1-20397

UK/H/0022/8

14194

VIIV HEALTHCARE UK

IE

LIMITED

Saft Retrovir

LABORATORIOS VIIV

LIMITED

oral solution Retrovir 100 mg/10 ml-

PT

HEALTHCARE, S.L

oral solution Retrovir 100 mg/10 ml

PT

LIMITED

drank Retrovir® 100 mg/10 ml

SE

LIMITED

solución oral Retrovir 100 mg/10 ml

VIIV HEALTHCARE UK

UK/H/0022/008

solução oral Retrovir 100 mg/10 ml

LU

LIMITED

solução oral Retrovir 100 mg/10 ml

VIIV HEALTHCARE UK LIMITED

lösning Retrovir 100 mg/10 ml

FR

LIMITED

solution buvable Retrovir 10 mg/ml, oral

VIIV HEALTHCARE UK

VIIV HEALTHCARE UK

AT

LIMITED VIIV HEALTHCARE UK

DK

LIMITED Ретровир 100 mg

not available

20020588

капсули, твърди Ретровир 10 mg/ml

VIIV HEALTHCARE UK

BG

LIMITED not available

пероралeн разтвор

List of nationally authorised medicinal products EMA/787818/2017

20020587

VIIV HEALTHCARE UK

BG

LIMITED

Page 7/8

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

ZIDOVUDINA G.E.S. 2

not available

69184

G.E.S. GENÉRICOS

ES

mg/ml Solución para

ESPAÑOLES LABORATORIO,

perfusión

S.A.

ZIDOVUDINA G.E.S. 2

not available

69184

G.E.S. GENÉRICOS

mg/ml Solución para

ESPAÑOLES LABORATORIO,

perfusión

S.A.

List of nationally authorised medicinal products EMA/787818/2017

ES

Page 8/8