8 February 2018 EMA/85572/2018 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: pitavastatin

Procedure no.: PSUSA/00010502/201707

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, 2018. Reproduction is authorised provided the source is acknowledged.

Product Name (in authorisation country)

MRP/DCP Authorisation number UK/H/1555/001

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

ZUL.NR.: 1-30154

AT

UK/H/1555/002

ZUL.NR.: 1-30155

UK/H/1555/003

ZUL.NR.: 1-30156

UK/H/1555/001

75160.00.00

Livazo 4 mg Filmtabletten

UK/H/1555/002

75161.00.00

Livazo 1 mg Filmtabletten

UK/H/1555/003

79602.00.00

Livazo 2mg comprimidos recubiertos con película Livazo 4mg comprimidos recubiertos con película Alipza 1mg comprimidos recubiertos con película Alipza 4mg comprimidos recubiertos con película Alipza 2mg comprimidos recubiertos con película Livazo 1mg comprimidos recubiertos con película Livazo 2mg tabletti, kalvopäällysteinen Livazo 4mg tabletti, kalvopäällysteinen Livazo 1mg tabletti, kalvopäällysteinen TROLISE 2 mg, comprimé pelliculé TROLISE 4 mg, comprimé pelliculé Lippiza 1 mg, comprimé pelliculé Lippiza 4 mg, comprimé pelliculé

UK/H/1555/01/DC

73.038

UK/H/1555/002

73.039

UK/H/1556/03/DC

73058

UK/H/1556/002

73040

UK/H/1556/001

73041

UK/H/1555/03/DC

73.037

UK/H/1555/01/DC

MTNR:25467

UK/H/1555/002

MTNR:25468

UK/H/1555/003

MTNR: 28478

UK/H/1555/001

NL36650

UK/H/1555/002

NL36651

UK/H/1556/003

NL39485

UK/H/1556/002

NL36653

KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD

Trolise 2 mg Filmtabletten Trolise 4 mg Filmtabletten Trolise 1 mg Filmtabletten Livazo 2 mg Filmtabletten

List of nationally authorised medicinal products

AT AT DE DE DE ES ES ES ES ES ES FI FI FI FR FR FR FR

Page 2/6

Product Name (in authorisation country) LIPPIZA 2 mg, comprimé pelliculé TROLISE 1 mg, comprimé pelliculé Livazo 2 mg δισκία επικαλυμμένα με λεπτό υμένιο Livazo 4 mg δισκία επικαλυμμένα με λεπτό υμένιο Pitava 1 mg δισκία επικαλυμμένα με λεπτό υμένιο Pitava 4 mg δισκία επικαλυμμένα με λεπτό υμένιο Pitava 2 mg δισκία επικαλυμμένα με λεπτό υμένιο Livazo 1 mg δισκία επικαλυμμένα με λεπτό υμένιο Livazo 2mg film-coated tablets. Livazo 4mg film-coated tablets. Livazo 1mg film-coated tablets. Livazo 2mg compresse rivestite con film Livazo 2mg compresse rivestite con film Livazo 2mg compresse rivestite con film Livazo 2mg compresse rivestite con film

MRP/DCP Authorisation number UK/H/1556/001

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

NL36652

FR

UK/H/1555/003

NL39484

UK/H/1555/001

19212/15-03-2011

KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD

UK/H/1555/002

19213/15-03-2011

KOWA PHARMACEUTICAL EUROPE CO. LTD

GR

UK/H/1556/003

14087/23-02-2012

KOWA PHARMACEUTICAL EUROPE CO. LTD

GR

UK/H/1556/002

14086/23-02-2012

KOWA PHARMACEUTICAL EUROPE CO. LTD

GR

UK/H/1556/001

14085/23-02-2012

KOWA PHARMACEUTICAL EUROPE CO. LTD

GR

UK/H/1555/003

10786/10/15-03-2011

KOWA PHARMACEUTICAL EUROPE CO. LTD

GR

UK/H/1555/001

PA 1532/001/001

IE

UK/H/1555/002

PA 1532/001/002

UK/H/1555/03/DC

PA 1532/001/003

UK/H/1555/001

040363020

UK/H/1555/001

040363032

UK/H/1555/001

040363119

UK/H/1555/001

040363044

KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD

List of nationally authorised medicinal products EMA/173192/2017

FR GR

IE IE IT IT IT IT

Page 3/6

Product Name (in authorisation country) Livazo 2mg compresse rivestite con film Livazo 4mg compresse rivestite con film Livazo 4mg compresse rivestite con film Livazo 4mg compresse rivestite con film Alipza 1mg compresse rivestite con film Alipza 1mg compresse rivestite con film Alipza 1mg compresse rivestite con film Alipza 1mg compresse rivestite con film Alipza 1mg compresse rivestite con film Alipza 4mg compresse rivestite con film Alipza 4mg compresse rivestite con film Alipza 4mg compresse rivestite con film Alipza 2mg compresse rivestite con film Alipza 2mg compresse rivestite con film Alipza 2mg compresse rivestite con film Alipza 2mg compresse rivestite con film Alipza 2mg compresse rivestite con film Livazo 1mg compresse rivestite con film

MRP/DCP Authorisation number UK/H/1555/01/DC

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

040363018/

IT

UK/H/1555/002

040363069

UK/H/1555/002

040363071

UK/H/1555/02/DC

040363057/

UK/H/1556/003

040322099

UK/H/1556/003

040322101

UK/H/1556/003

040322125

UK/H/1556/003

040322137

UK/H/1556/03/DC

040322087/

UK/H/1556/002

040322063

UK/H/1556/002

040322075

UK/H/1556/02/DC

040322051/

UK/H/1556/001

040322024

UK/H/1556/001

040322036

UK/H/1556/001

040322113

UK/H/1556/001

040322048

UK/H/1556/01/DC

040322012/

UK/H/1555/003

040363095

KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD

List of nationally authorised medicinal products EMA/173192/2017

IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT

Page 4/6

Product Name (in authorisation country) Livazo 1mg compresse rivestite con film Livazo 1mg compresse rivestite con film Livazo 1mg compresse rivestite con film Livazo 1mg compresse rivestite con film Livazo 2mg filmomhulde tabletten Livazo 4mg filmomhulde tabletten Livazo 1mg filmomhulde tabletten Livazo 2 mg tablett, filmdrasjert Livazo 4 mg tablett, filmdrasjert Livazo 1 mg tablett, filmdrasjert Livazo, 2 mg, tabletki powlekane Livazo, 4 mg, tabletki powlekane Livazo, 1 mg, tabletki powlekane Livazo 2mg comprimidos revestidos por película Livazo 2mg comprimidos revestidos por película Livazo 4mg comprimidos revestidos por película Alipza 1mg comprimidos revestidos por película Alipza 1mg comprimidos revestidos por película

MRP/DCP Authorisation number UK/H/1555/003

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

040363107

IT

UK/H/1555/003

040363121

UK/H/1555/003

040363133

UK/H/1555/03/DC

040363083/

UK/H/1555/001

RVG 103768

UK/H/1555/002

RVG 103769

UK/H/1555/003

RVG 106928

UK/H/1555/001

08-6220

UK/H/1555/002

08-6221

UK/H/1555/003

10-7330

UK/H/1555/001

18362

UK/H/1555/002

18363

UK/H/1555/03/DC

18361

UK/H/1555/001

5324553

UK/H/1555/01/DC

5324546

UK/H/1555/002

5324561

UK/H/1556/003

5324603

UK/H/1556/003

5324579

KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD

List of nationally authorised medicinal products EMA/173192/2017

IT IT IT NL NL NL NO NO NO PL PL PL PT PT PT PT PT

Page 5/6

Product Name (in authorisation country) Alipza 4mg comprimidos revestidos por película Alipza 2mg comprimidos revestidos por película Alipza 2mg comprimidos revestidos por película Livazo 1mg comprimidos revestidos por película Livazo 1mg comprimidos revestidos por película Livazo 2 mg filmdragerade tabletter Livazo 4 mg filmdragerade tabletter Livazo 1 mg filmdragerade tabletter Livazo 2mg film-coated tablets Livazo 4mg film-coated tablets Alipza 1mg film-coated tablets Alipza 4mg film-coated tablets Alipza 2mg film-coated tablets Livazo 1mg film-coated tablets

MRP/DCP Authorisation number UK/H/1556/002

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

5324637

PT

UK/H/1556/001

5324629

UK/H/1556/001

5324611

UK/H/1555/003

5324538

UK/H/1555/003

5324520

UK/H/1555/001

28030

UK/H/1555/002

28031

UK/H/1555/003

43753

UK/H/1555/001

PL 32363/0001

UK/H/1555/002

PL 32363/0002

UK/H/1556/003

PL 32363/0012

UK/H/1556/002

PL 32363/0004

UK/H/1556/001

PL 32363/0003

UK/H/1555/003

PL 32363/0011

KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD KOWA PHARMACEUTICAL EUROPE CO. LTD

List of nationally authorised medicinal products EMA/173192/2017

PT PT PT PT SE SE SE UK UK UK UK UK UK

Page 6/6

pitavastatin - European Medicines Agency - Europa EU

Feb 8, 2018 - List of nationally authorised medicinal products. Page 2/6. 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. Trolise 2 mg. Filmtabletten. UK/H/1555/001. ZUL.NR.
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