List of nationally authorised medicinal products
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1 30 November 2017 EMA/806818/2017 Human Medicines Evaluation Division Active substance: pravastatin Procedure no.: PSUSA/ / Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0) Facsimile +44 (0) Send a question via our website An agency of the European Union European Medicines Agency, Reproduction is authorised provided the source is acknowledged.
2 PRAVASINE 10 mg, tabletten PRAVASINE 20 mg, tabletten PRAVASINE 40 mg, tabletten PRAVASINE 10 mg, PRAVASINE 20 mg, PRAVASINE 40 mg, Pravastatine Sandoz 30 mg tabletten FR/H/0252/001 BE BRISTOL-MYERS SQUIBB BELGIUM NV BE FR/H/0252/002 BE BRISTOL-MYERS SQUIBB BE BELGIUM NV FR/H/0252/003 BE BRISTOL-MYERS SQUIBB BE BELGIUM NV FR/H/0252/001 BE BRISTOL-MYERS SQUIBB BE BELGIUM. FR/H/0252/002 BE BRISTOL-MYERS SQUIBB BE BELGIUM. FR/H/0252/003 BE BRISTOL-MYERS SQUIBB BE BELGIUM. DK/H/0603/004 BE SANDOZ N.V. BE Pravalam 30 mg tabletten /H/3406/003 BE SANDOZ N.V. BE Pravalam 30 mg tabletten /H/3406/003 BE SANDOZ N.V. BE Pravalam 30 mg tabletten /H/3406/003 BE SANDOZ N.V. BE PRAREDUCT 10mg, tabletten not available BE DAIICHI SANKYO BELGIUM BE PRAREDUCT 20mg, tabletten not available BE DAIICHI SANKYO BELGIUM BE PRAREDUCT 40mg, tabletten not available BE DAIICHI SANKYO BELGIUM BE PRAREDUCT 10mg, not available BE DAIICHI SANKYO BELGIUM BE PRAREDUCT 20mg, not available BE DAIICHI SANKYO BELGIUM BE PRAREDUCT 40mg, not available BE DAIICHI SANKYO BELGIUM BE PravaLich 40 mg Tabletten DE/H/0547/ WINTHROP ARZNEIMTEL DE PravaLich 40 mg Tabletten DE/H/0547/ WINTHROP ARZNEIMTEL DE PravaLich 40 mg Tabletten DE/H/0547/ WINTHROP ARZNEIMTEL DE PravaLich 40 mg Tabletten DE/H/0547/ WINTHROP ARZNEIMTEL DE where EMA/806818/2017 Page 2/10
3 PravaLich 10 mg Tabletten DE/H/0547/ WINTHROP ARZNEIMTEL DE PravaLich 20 mg Tabletten DE/H/0547/ WINTHROP ARZNEIMTEL DE PravaLich 10 mg Tabletten DE/H/0547/ WINTHROP ARZNEIMTEL DE PravaLich 20 mg Tabletten DE/H/0547/ WINTHROP ARZNEIMTEL DE PravaLich 20 mg Tabletten DE/H/0547/ WINTHROP ARZNEIMTEL DE PravaLich 20 mg Tabletten DE/H/0547/ WINTHROP ARZNEIMTEL DE PravaLich 10 mg Tabletten DE/H/0547/ WINTHROP ARZNEIMTEL DE PravaLich 10 mg Tabletten DE/H/0547/ WINTHROP ARZNEIMTEL DE Pravasin protect 10 mg, FR/H/0252/ BRISTOL-MYERS SQUIBB DE Tabletten & CO. KGAA Pravasin protect 20 mg, FR/H/0252/ BRISTOL-MYERS SQUIBB DE Tabletten & CO. KGAA Pravasin protect 40 mg, FR/H/0252/ BRISTOL-MYERS SQUIBB DE Tabletten & CO. KGAA Mevalotin protect 20 mg, not available DAIICHI SANKYO EUROPE DE Tabletten Mevalotin protect 40 mg, not available DAIICHI SANKYO EUROPE DE Tabletten Pravastatin "Sandoz" DK/H/0603/ SANDOZ A/S DK LIPLAT 10 mg not available LABORATORIOS DR. ESTEVE ES. LIPLAT 20 mg not available LABORATORIOS DR. ESTEVE ES. LIPLAT 40 mg not available LABORATORIOS DR. ESTEVE ES. LIPEMOL 40 mg FR/H/0252/ BRISTOL-MYERS SQUIBB SA ES where EMA/806818/2017 Page 3/10
4 LIPEMOL 20 mg BRISTACOL 10 mg BRISTACOL 20mg BRISTACOL 40mg BRISTACOL 20mg Minuscol 40 mg Minuscol 10 mg Minuscol 20 mg PRAREDUCT 20 mg PRAREDUCT 40 mg ELISOR 10 mg, comprimé ELISOR 10 mg, comprimé PRAVASTATINE TEVA 40 mg, comprimé e FR/H/0252/ BRISTOL-MYERS SQUIBB SA ES not available EXELTIS HEALTHCARE S.L ES not available EXELTIS HEALTHCARE S.L ES not available EXELTIS HEALTHCARE S.L ES not available EXELTIS HEALTHCARE S.L ES not available TEVA PHARMA S.L.U ES not available TEVA PHARMA S.L.U ES not available TEVA PHARMA S.L.U ES not available DAIICHI SANKYO ESPAÑA,. ES not available DAIICHI SANKYO ESPAÑA, ES. FR/H/0252/ BRISTOL-MYERS SQUIBB FR FR/H/0252/ BRISTOL-MYERS SQUIBB FR NL/H/543/003 NL30679 TEVA SANTÉ FR not available SANOFI-AVENTIS FRANCE FR not available SANOFI-AVENTIS FRANCE FR not available SANOFI-AVENTIS FRANCE FR not available SANOFI-AVENTIS FRANCE FR not available SANOFI-AVENTIS FRANCE FR where EMA/806818/2017 Page 4/10
5 not available SANOFI-AVENTIS FRANCE FR not available SANOFI-AVENTIS FRANCE FR not available SANOFI-AVENTIS FRANCE FR not available SANOFI-AVENTIS FRANCE FR not available SANOFI-AVENTIS FRANCE FR not available SANOFI-AVENTIS FRANCE FR not available SANOFI-AVENTIS FRANCE FR not available SANOFI-AVENTIS FRANCE FR not available SANOFI-AVENTIS FRANCE FR not available SANOFI-AVENTIS FRANCE FR not available SANOFI-AVENTIS FRANCE FR not available SANOFI-AVENTIS FRANCE FR not available SANOFI-AVENTIS FRANCE FR not available SANOFI-AVENTIS FRANCE FR not available SANOFI-AVENTIS FRANCE FR not available SANOFI-AVENTIS FRANCE FR VASTEN 40 mg, comprimé not available SANOFI-AVENTIS FRANCE FR VASTEN 40 mg, comprimé not available SANOFI-AVENTIS FRANCE FR VASTEN 10 mg, comprimé not available SANOFI-AVENTIS FRANCE FR where EMA/806818/2017 Page 5/10
6 PRAVASTATINE ZENTIVA 10 PRAVASTATINE ZENTIVA 10 not available SANOFI-AVENTIS FRANCE FR not available SANOFI-AVENTIS FRANCE FR not available SANOFI-AVENTIS FRANCE FR not available SANOFI-AVENTIS FRANCE FR not available SANOFI-AVENTIS FRANCE FR not available SANOFI-AVENTIS FRANCE FR not available SANOFI-AVENTIS FRANCE FR not available SANOFI-AVENTIS FRANCE FR VASTEN 40 not available SANOFI-AVENTIS FRANCE FR VASTEN 40 not available SANOFI-AVENTIS FRANCE FR VASTEN 40 not available SANOFI-AVENTIS FRANCE FR VASTEN 40 not available SANOFI-AVENTIS FRANCE FR PRAVACHOL 20 mg δισκία FR/H/0252/ / BRISTOL-MYERS SQUIBB GR Α.Ε. PRAVACHOL 40 mg δισκία FR/H/0252/ / BRISTOL-MYERS SQUIBB GR Α.Ε. MAXUDIN 20 mg δισκία not available A. MENARINI - INDUSTRIE GR FARMACEUTICHE RIUNE - MAXUDIN 10 mg δισκία not available 4502 A. MENARINI - INDUSTRIE GR FARMACEUTICHE RIUNE - MAXUDIN 20 mg δισκία not available 4501 A. MENARINI - INDUSTRIE GR FARMACEUTICHE RIUNE - MAXUDIN 40 mg δισκία not available A. MENARINI - INDUSTRIE FARMACEUTICHE RIUNE - GR where EMA/806818/2017 Page 6/10
7 Lipostat 40mg tablets FR/H/0252/003 PA 2/55/6 BRISTOL-MYERS SQUIBB PHARMACEUTICALS LIMED Lipostat 10mg tablets FR/H/0252/001 PA 2/55/4 BRISTOL-MYERS SQUIBB PHARMACEUTICALS LIMED Lipostat 20mg tablets FR/H/0252/002 PA 2/55/5 BRISTOL-MYERS SQUIBB PHARMACEUTICALS LIMED SELECTIN 40 mg FR/H/0252/ BRISTOL-MYERS SQUIBB SELECTIN 20 mg FR/H/0252/ BRISTOL-MYERS SQUIBB SELECTIN 10 mg FR/H/0252/ BRISTOL-MYERS SQUIBB APLACTIN 20 mg not available FABBRICA ALIANA RROVATI MEDICINALI ED AFFINI F.I.R.M.A. - S.P.A. PRAVASELECT 20 mg not available A. MENARINI - INDUSTRIE FARMACEUTICHE RIUNE - PRAVASELECT 40 mg not available A. MENARINI - INDUSTRIE FARMACEUTICHE RIUNE - APLACTIN 40 mg not available FABBRICA ALIANA RROVATI MEDICINALI ED AFFINI F.I.R.M.A. - S.P.A. PRASTEROL 40 mg not available ISTUTO LUSO FARMACO D'ALIA S.P.A. PRASTEROL 20 mg not available ISTUTO LUSO FARMACO D'ALIA S.P.A. SANAPRAV 10 mg not available DAIICHI SANKYO ALIA S.P.A SANAPRAV 20 mg not available DAIICHI SANKYO ALIA S.P.A SANAPRAV 40 mg not available DAIICHI SANKYO ALIA S.P.A PRAREDUCT 10mg, not available 1851/ DAIICHI SANKYO BELGIUM where IE IE IE LU EMA/806818/2017 Page 7/10
8 PRAREDUCT 20mg, PRAREDUCT 40mg, not available 1851/ DAIICHI SANKYO BELGIUM LU not available 1851/ DAIICHI SANKYO BELGIUM LU Selektine 10 mg, tabletten FR/H/0252/001 RVG BRISTOL-MYERS SQUIBB NL B.V. Selektine 20 mg, tabletten FR/H/0252/002 RVG BRISTOL-MYERS SQUIBB NL B.V. Selektine 40 mg, tabletten FR/H/0252/003 RVG BRISTOL-MYERS SQUIBB NL B.V. Pravachol 20 mg tabletter FR/H/0252/ BRISTOL-MYERS SQUIBB AB NO Pravachol 40 mg tabletter FR/H/0252/ BRISTOL-MYERS SQUIBB AB NO Pravastatin Teva 10 mg NL/H/0543/ TEVA SWEDEN AB NO tabletter Pravacol 20 mg FR/H/0252/ BRISTOL-MYERS SQUIBB Pravacol 20 mg FR/H/0252/ BRISTOL-MYERS SQUIBB Pravacol 20 mg FR/H/0252/ BRISTOL-MYERS SQUIBB Pravacol 40 mg FR/H/0252/ BRISTOL-MYERS SQUIBB Pravacol 20 mg FR/H/0252/ BRISTOL-MYERS SQUIBB Pravacol 40 mg FR/H/0252/ BRISTOL-MYERS SQUIBB Pravacol 40 mg FR/H/0252/ BRISTOL-MYERS SQUIBB where EMA/806818/2017 Page 8/10
9 Pravacol 40 mg FR/H/0252/ BRISTOL-MYERS SQUIBB Pravacol 40 mg FR/H/0252/ BRISTOL-MYERS SQUIBB Sanaprav 10 mg not available DAIICHI SANKYO PORTUGAL,LDA Sanaprav 10 mg not available DAIICHI SANKYO PORTUGAL,LDA Sanaprav 20 mg not available DAIICHI SANKYO PORTUGAL,LDA Sanaprav 40 mg not available DAIICHI SANKYO PORTUGAL,LDA Pravastatin sodium 10mg not available PL 20416/0356 CRESCENT PHARMA LIMED Pravastatin sodium 20mg not available PL 20416/0357 CRESCENT PHARMA LIMED Pravastatin sodium 40mg not available PL 20416/0358 CRESCENT PHARMA LIMED Pravastatin sodium 10mg not available PL 21880/0047 MEDREICH PLC Pravastatin sodium 20mg not available PL 21880/0048 MEDREICH PLC Pravastatin sodium 40mg not available PL 21880/0049 MEDREICH PLC Pravastatin Sodium 30mg not available PL 11311/0497 TILLOMED LABORATORIES LTD Pravastatin Sodium 40 mg DK/H/0603/003 PL 04416/0806 SANDOZ LTD Pravastatin Sodium 40mg not available PL 04416/0601 SANDOZ LTD Pravastatin Sodium 10mg not available PL 04416/0599 SANDOZ LTD Pravastatin Sodium 20mg not available PL 04416/0600 SANDOZ LTD where EMA/806818/2017 Page 9/10
10 Pravastatin Sodium 10mg Pravastatin sodium 20mg Pravastatin Sodium 40mg not available PL 11311/0495 TILLOMED LABORATORIES LTD not available PL 11311/0496 TILLOMED LABORATORIES LTD not available PL 11311/0498 TILLOMED LABORATORIES LTD where EMA/806818/2017 Page 10/10
List of nationally authorised medicinal products
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