2 September 2016 EMA/607581/2016 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: valaciclovir

Procedure no.: PSUSA/00003086/201512

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 TALAVIR 1000 mg compresse rivestite con film TALAVIR 250 mg compresse rivestite con film TALAVIR 500 mg compresse rivestite con film TALAVIR 500 mg compresse rivestite con film TALAVIR 500 mg compresse rivestite con film Valaciclovir ”Orion” Valaciclovir ”Orion” VALACICLOVIR ACTAVIS 1000 mg apvalkotās tabletes VALACICLOVIR ACTAVIS 1000 mg apvalkotās tabletes Valaciclovir Actavis 1000 mg filmom obalené tablety Valaciclovir Actavis 1000 mg filmom obalené tablety Valaciclovir Actavis 1000 mg plévele dengtos tabletés Valaciclovir Actavis 1000 mg plévele dengtos tabletés Valaciclovir Actavis 250 mg filmom obalené tablety Valaciclovir Actavis 250 mg

not available

029498021

not available

029498045

not available

029498019

not available

029498033

not available UK/H/2940/01/DC UK/H/2940/01/DC

029498058 44083 10/09/2020

SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A. SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A. SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A. SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A. SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A. ORION OYJ ORION OYJ

AT/H/0179/003

08-0350

ACTAVIS GROUP PTC EHF.

LV

AT/H/0179/003

08-0350

ACTAVIS GROUP PTC EHF.

LV

AT/H/0179/003

42/0626/08-S

ACTAVIS GROUP PTC EHF.

SK

AT/H/0179/003

42/0626/08-S

ACTAVIS GROUP PTC EHF.

SK

AT/H/0179/003

LT/1/09/1488/033-048

ACTAVIS GROUP PTC EHF.

LT

AT/H/0179/003

LT/1/09/1488/033-048

ACTAVIS GROUP PTC EHF.

LT

AT/H/0179/001 AT/H/0179/001

42/0624/08-S 42/0624/08-S

ACTAVIS GROUP PTC EHF. ACTAVIS GROUP PTC EHF.

SK SK

List of nationally authorised medicinal products EMA/607581/2016

IT IT IT IT IT DK DK

Page 2/8

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 filmom obalené tablety Valaciclovir Actavis 250 mg plévele dengtos tabletés AT/H/0179/001 Valaciclovir Actavis 250 mg plévele dengtos tabletés AT/H/0179/001 Valaciclovir Actavis, 1000 mg õhukese polümeerikattega tabletid AT/H/0179/003 Valaciclovir Apotex AT/H/0178/0011000 mg 003 Valaciclovir Apotex AT/H/0178/001250 mg 003 Valaciclovir Orion 1000 mg filmdragerade tabletter UK/H/2940/01/DC Valaciclovir Orion 500 mg tabletti, kalvopäällysteinen UK/H/2940/01/DC Valaciclovir Sandoz 1000 mg - Filmtabletten 936.023 Valaciclovir Sandoz 250 mg - Filmtabletten 942.392 Valaciclovir Sandoz 500 mg - Filmtabletten 936.022 VALACICLOVIR ZENTIVA 500 mg, comprimé pelliculé not available Valdacir 1000 mg filmsko obložene tablete AT/H/0179/003 Valdacir 250 mg filmsko obložene tablete AT/H/0179/001 Valtrex 1000 mg Filmtabletten SE/H/1041/003 Valtrex 500 mg Filmtabletten SE/H/1041/002 Valtrex 1.000 mg comprimidos recubiertos SE/H/1041/003

List of nationally authorised medicinal products EMA/607581/2016

LT/1/09/1488/001-016

ACTAVIS GROUP PTC EHF.

LT

LT/1/09/1488/001-016

ACTAVIS GROUP PTC EHF.

LT

609808 BE 329226 , 329235 BE 329183, 329192

ACTAVIS GROUP PTC EHF.

EE

Apotex NV/SA

BE

Apotex NV/SA

BE

13/02/1970

ORION OYJ

FI

25611

ORION OYJ

FI

1-21107

SANDOZ GMBH

AT

1-22633

SANDOZ GMBH

AT

1-21105

AT

NL35716

SANDOZ GMBH LABORATOIRE GLAXOSMITHKLINE S.A.S.

5363-I-1649/13

ACTAVIS GROUP PTC EHF.

SI

5363-I-1647/13

SI

1-21007

ACTAVIS GROUP PTC EHF. GLAXOSMITHKLINE PHARMA GMBH. GLAXOSMITHKLINE PHARMA GMBH.

61.241

GLAXOSMITHKLINE, S.A.

ES

1-21103

FR

AT AT

Page 3/8

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 con película Valtrex 1000 mg comprimidos revestidos por película SE/H/1041/003 Valtrex 1000 mg filmdragerade tabletter SE/H/1041/003 Valtrex 1000 mg filmdrasjerte tabletter SE/H/1041/003 Valtrex 1000 mg επικαλυμμένα με λεπτό υμένιο δισκία SE/H/1041/003 Valtrex 250 mg comprimidos revestidos por película SE/H/1041/001 Valtrex 250 mg comprimidos revestidos por película SE/H/1041/001 Valtrex 250 mg filmdragerade tabletter SE/H/1041/001 Valtrex 250 mg filmdrasjerte tabletter SE/H/1041/001 Valtrex 250 mg filmuhúðaðar töflur SE/H/1041/01 Valtrex 250 mg kalvopäällysteiset tabletit SE/H/1041/001 Valtrex 250 mg kalvopäällysteiset tabletit SE/H/1041/001 Valtrex 250 mg επικαλυμμένα με λεπτό υμένιο δισκία SE/H/1041/001 Valtrex 500 mg SE/H/1041/002 Valtrex 500 mg apvalkotas tabletes SE/H/1041/002 Valtrex 500 mg SE/H/1041/02 List of nationally authorised medicinal products EMA/607581/2016

2965986

LABORATORIOS WELLCOME DE PORTUGAL LIMITADA PT

12213

GLAXOSMITHKLINE AB

SE

94-1772

GLAXOSMITHKLINE AS

NO

8916/04-02-13

THE WELLCOME FOUNDATION LTD GR

2966083

LABORATORIOS WELLCOME DE PORTUGAL LIMITADA PT

3131786

LABORATORIOS WELLCOME DE PORTUGAL LIMITADA PT

13714

GLAXOSMITHKLINE AB

SE

97-2744

NO

990226(IS)

GLAXOSMITHKLINE AS GLAXOSMITHKLINE PHARMA A/S

12935

GLAXOSMITHKLINE OY

FI

12935

GLAXOSMITHKLINE OY

FI

8915/04-02-13 42/0222/99-S 99-0877 4643/2012/01

THE WELLCOME FOUNDATION LTD GLAXOSMITHKLINE SLOVAKIA S.R.O. GLAXOSMITHKLINE LATVIA SIA THE WELLCOME FOUNDATION

IS

GR SK LV RO

Page 4/8

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 comprimate filmate Valtrex 500 mg comprimate filmate SE/H/1041/02 Valtrex 500 mg comprimate filmate SE/H/1041/02 Valtrex 500 mg comprimate filmate SE/H/1041/02 Valtrex 500 mg comprimate filmate SE/H/1041/02 Valtrex 500 mg comprimate filmate SE/H/1041/02 Valtrex 500 mg comprimidos recubiertos con película SE/H/1041/002 Valtrex 500 mg comprimidos revestidos por película SE/H/1041/002 Valtrex 500 mg comprimidos revestidos por película SE/H/1041/002 Valtrex 500 mg comprimidos revestidos por película SE/H/1041/002 Valtrex 500 mg comprimidos revestidos por película SE/H/1041/002 Valtrex 500 mg film-coated tablets SE/H/1041/002 Valtrex 500 mg film-coated tablets SE/H/1041/002 Valtrex 500 mg filmdragerade tabletter SE/H/1041/002 Valtrex 500 mg filmdrasjerte tabletter SE/H/1041/002 VALTREX 500 mg filmsko SE/H/1041/002 List of nationally authorised medicinal products EMA/607581/2016

4643/2012/06

LTD THE LTD THE LTD THE LTD THE LTD THE LTD

61.240

GLAXOSMITHKLINE, S.A.

2965788

LABORATORIOS WELLCOME DE PORTUGAL LIMITADA PT

2965887

LABORATORIOS WELLCOME DE PORTUGAL LIMITADA PT

3131885

LABORATORIOS WELLCOME DE PORTUGAL LIMITADA PT

4643/2012/02 4643/2012/03 4643/2012/04 4643/2012/05

WELLCOME FOUNDATION WELLCOME FOUNDATION WELLCOME FOUNDATION WELLCOME FOUNDATION WELLCOME FOUNDATION

RO RO RO RO RO ES

PL 00003/0352

LABORATORIOS WELLCOME DE PORTUGAL LIMITADA PT THE WELLCOME FOUNDATION LTD MT THE WELLCOME FOUNDATION LTD UK

12212

GLAXOSMITHKLINE AB

SE

94-1771 H/99/01609/001

GLAXOSMITHKLINE AS GLAXOSMITHKLINE D.O.O.

NO SI

3872280 MA 168/01201

Page 5/8

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 obložene tablete VALTREX 500 mg filmsko obložene tablete VALTREX 500 mg filmsko obložene tablete VALTREX 500 mg filmsko obložene tablete VALTREX 500 mg filmsko obložene tablete VALTREX 500 mg filmsko obložene tablete Valtrex 500 mg filmuhúðaðar töflur Valtrex 500 mg kalvopäällysteiset tabletit Valtrex 500 mg kalvopäällysteiset tabletit Valtrex 500 mg plėvele dengtos tabletės Valtrex 500 mg plėvele dengtos tabletės Valtrex 500 mg plėvele dengtos tabletės Valtrex 500 mg plėvele dengtos tabletės Valtrex 500 mg plėvele dengtos tabletės Valtrex 500 mg plėvele dengtos tabletės Valtrex 500 mg επικαλυμμένα με λεπτό υμένιο δισκία Valtrex 500 mg επικαλυμμένα με λεπτό

SE/H/1041/002

H/99/01609/002

GLAXOSMITHKLINE D.O.O.

SI

SE/H/1041/002

H/99/01609/003

GLAXOSMITHKLINE D.O.O.

SI

SE/H/1041/002

H/99/01609/004

GLAXOSMITHKLINE D.O.O.

SI

SE/H/1041/002

H/99/01609/005

GLAXOSMITHKLINE D.O.O.

SI

SE/H/1041/002

H/99/01609/006

SI

SE/H/1041/02

940254

SE/H/1041/002

11839

SE/H/1041/002

11839

SE/H/1041/002

LT/1/96/2894/001

SE/H/1041/002

LT/1/96/2894/002

SE/H/1041/002

LT/1/96/2894/003

SE/H/1041/002

LT/1/96/2894/004

SE/H/1041/002

LT/1/96/2894/005

SE/H/1041/002

LT/1/96/2894/006

GLAXOSMITHKLINE D.O.O. GLAXOSMITHKLINE PHARMA A/S THE WELLCOME FOUNDATION LTD THE WELLCOME FOUNDATION LTD GLAXOSMITHKLINE LIETUVA UAB GLAXOSMITHKLINE LIETUVA UAB GLAXOSMITHKLINE LIETUVA UAB GLAXOSMITHKLINE LIETUVA UAB GLAXOSMITHKLINE LIETUVA UAB GLAXOSMITHKLINE LIETUVA UAB

SE/H/1041/02

16180

SE/H/1041/002

8914/04-02-13

List of nationally authorised medicinal products EMA/607581/2016

IS FI FI LT LT LT LT LT LT

GLAXO GROUP LIMITED CY THE WELLCOME FOUNDATION LTD GR

Page 6/8

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 υμένιο δισκία Valtrex 500 mg, potahované tablety SE/H/1041/002 Valtrex, 500 mg õhukese polümeerikattega tabletid SE/H/1041/002 Valtrex, 500 mg, tabletki powlekane SE/H/1041/02 Valtrex® 250 mg filmcoated tablets SE/H/1041/001 Valtrex® 500 mg Filmtabletten SE/H/1041/002 Valtrex™ 250 mg filmcoated tablets SE/H/1041/001 Valtrex™ 500 mg filmcoated tablets SE/H/1041/002 Zelitrex 1000 mg compresse rivestite con film SE/H/1041/003 Zelitrex 250 mg compresse rivestite con film SE/H/1041/001 Zelitrex 250 mg filmomhulde tabletten SE/H/1041/01 Zelitrex 500 mg compresse rivestite con film SE/H/1041/002 Zelitrex 500 mg compresse rivestite con film SE/H/1041/002 Zelitrex 500 mg comprimés pelliculés SE/H/1041/002 Zelitrex 500 mg comprimés pelliculés SE/H/1041/002 Zelitrex 500 mg filmomhulde tabletten SE/H/1041/002 Zelitrex 500 mg filmomhulde tabletten SE/H/1041/002

List of nationally authorised medicinal products EMA/607581/2016

42/384/96-C 141696

THE WELLCOME FOUNDATION LTD CZ EE

PA 1077/082/002

GLAXO WELLCOME LTD GLAXOSMITHKLINE EXPORT LTD THE WELLCOME FOUNDATION LTD GLAXOSMITHKLINE GMBH & CO. KG GLAXOSMITHKLINE (IRELAND) LIMITED GLAXOSMITHKLINE (IRELAND) LIMITED

029503024

GLAXOSMITHKLINE S.P.A.

IT

029503048

GLAXOSMITHKLINE S.P.A.

IT

RVG 21719

GLAXOSMITHKLINE B.V.

NL

029503012

GLAXOSMITHKLINE S.P.A.

IT

029503036

GLAXOSMITHKLINE S.P.A. GLAXOSMITHKLINE PHARMACEUTICALS SA GLAXOSMITHKLINE PHARMACEUTICALS SA GLAXOSMITHKLINE PHARMACEUTICALS SA GLAXOSMITHKLINE PHARMACEUTICALS SA

IT

7665 PL 00003/0371 33325.00.00 PA 1077/082/001

BE 181036 2003 07 7472 BE 181036 2003 07 7472

PL UK DE IE IE

BE LU BE LU

Page 7/8

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 Zelitrex 500 mg filmomhulde tabletten Zelitrex 500 mg Filmtabletten Zelitrex 500 mg Filmtabletten ZELITREX 500 mg, comprimé pelliculé Zelitrex, filmovertrukne tabletter Zelitrex, filmovertrukne tabletter Валтрекс 500 mg филмирани таблетки

SE/H/1041/02

RVG 18065

SE/H/1041/002

BE 181036

SE/H/1041/002

2003 07 7472

SE/H/1041/002

NL20459

SE/H/1041/001

19065

SE/H/1041/002 SE/H/1041/002

List of nationally authorised medicinal products EMA/607581/2016

NL

16801

GLAXOSMITHKLINE B.V. GLAXOSMITHKLINE PHARMACEUTICALS SA GLAXOSMITHKLINE PHARMACEUTICALS SA LABORATOIRE GLAXOSMITHKLINE GLAXOSMITHKLINE PHARMA A/S GLAXOSMITHKLINE PHARMA A/S

9700507

GLAXO GROUP LIMITED

BG

BE LU FR DK DK

Page 8/8

Active substance: valaciclovir Regulatory outcome - European ...

Sep 2, 2016 - THE WELLCOME FOUNDATION. LTD. GR. Valtrex 250 mg comprimidos revestidos por película. SE/H/1041/001. 2966083. LABORATORIOS WELLCOME DE. PORTUGAL LIMITADA. PT. Valtrex 250 mg comprimidos revestidos por película. SE/H/1041/001. 3131786. LABORATORIOS WELLCOME DE.
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