List of nationally authorised medicinal products

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1 06 July 2017 EMA/436040/2017 Human Medicines Evaluation Division Active substance: 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 Member where MOTENS 4 mg Filmtabletten MOTENS 4 mg Filmtabletten sécable sécable sécable sécable not available BE SCS BOEHRINGER INGELHEIM not available 632/02/09/7775 SCS BOEHRINGER INGELHEIM not available BOEHRINGER INGELHEIM not available BOEHRINGER INGELHEIM not available BOEHRINGER INGELHEIM not available BOEHRINGER INGELHEIM not available BOEHRINGER INGELHEIM not available BOEHRINGER INGELHEIM not available BOEHRINGER INGELHEIM not available BOEHRINGER INGELHEIM not available BOEHRINGER INGELHEIM not available BOEHRINGER INGELHEIM not available BOEHRINGER INGELHEIM not available BOEHRINGER INGELHEIM BE LU EMA/436040/2017 Page 2/7

3 Member where sécable sécable sécable sécable Motens 4 mg comprimés s Motens 4 mg filmomhulde tabletten Motens 4 mg comprimés s Motens 2, omhulde tabletten 2 mg Motens 4, omhulde tabletten 4 mg not available BOEHRINGER INGELHEIM not available BOEHRINGER INGELHEIM not available BOEHRINGER INGELHEIM not available BOEHRINGER INGELHEIM not available BE SCS BOEHRINGER INGELHEIM BE not available BE SCS BOEHRINGER INGELHEIM BE not available 632/02/09/7775 SCS BOEHRINGER INGELHEIM LU not available RVG BOEHRINGER INGELHEIM B.V. NL not available RVG BOEHRINGER INGELHEIM B.V. NL Motens not available BOEHRINGER INGELHEIM GR ELLAS AE Lacirex 4 mg compresse not available LABORATORI GUIDOTTI S.P.A. IT Lacirex 6 mg compresse not available LABORATORI GUIDOTTI S.P.A. IT Lacirex 6 mg compresse not available LABORATORI GUIDOTTI S.P.A. IT VIAPRES 6 mg compresse not available CRINOS S.P.A. IT EMA/436040/2017 Page 3/7

4 Member where VIAPRES 6 mg compresse not available CRINOS S.P.A. IT VIAPRES 6 mg compresse not available CRINOS S.P.A. IT VIAPRES 4 mg compresse not available CRINOS S.P.A. IT VIAPRES 4 mg compresse not available CRINOS S.P.A. IT Lacimen 4 mg not available GLAXOSMITHKLINE S.A. ES comprimidos recubiertos con película Motens 2 mg Tablets not available PL 19494/0254 GLAXOSMITHKLINE UK UK LIMITED Motens 4 mg Tablets. not available PL 19494/0255 GLAXOSMITHKLINE UK UK LIMITED LACIPIL 4 mg filmsko not available H/04/00866/001 GLAXOSMITHKLINE D.O.O. SI obložene tablete Lacitens not available 41680/ GLAXOSMITHKLINE AEBE GR Lacipil 4 mg plėvele Lacipil 6 mg plėvele Lacipil 4 mg plėvele Lacipil 6 mg comprimidos not available LT/1/95/0724/001 UAB GLAXOSMITHKLINE not available LT/1/95/0724/003 UAB GLAXOSMITHKLINE not available LT/1/95/0724/002 UAB GLAXOSMITHKLINE not available GLAXO WELLCOME LT LT LT EMA/436040/2017 Page 4/7

5 Member where Lacipil 4 mg, comprimate not available 615/2008/03 GLAXO WELLCOME UK LIMITED RO filmate Lacipil 4 mg comprimidos not available GLAXOSMITHKLINE S.A. ES recubiertos con película Lacipil 4 mg comprimidos not available GLAXO WELLCOME Lacipil 4 mg comprimidos not available GLAXO WELLCOME Lacipil 4 mg comprimidos not available GLAXO WELLCOME ЛАСИПИЛ 4 mg not available GLAXO GROUP LIMITED BG филмирани таблетки Lacitens not available GLAXOSMITHKLINE AEBE GR Lacipil not available GLAXOSMITHKLINE AEBE GR Lacipil not available GLAXOSMITHKLINE AEBE GR LACIPIL 4 mg apvalkotās tabletes LACIPIL 6 mg apvalkotās tabletes Lacipil 2 mg potahované tablety Lacipil 4 mg, comprimate filmate Lacipil 4 mg tabletki powlekane not available GLAXOSMITHKLINE LATVIA SIA LV not available GLAXOSMITHKLINE LATVIA LV SIA not available 83/791/92-A/C GLAXO GROUP LIMITED CZ not available 615/2008/01 GLAXO WELLCOME UK LIMITED RO not available R/6506 GLAXOSMITHKLINE EXPORT PL LTD EMA/436040/2017 Page 5/7

6 Member where Lacipil, 6 mg, tabletki not available GLAXOSMITHKLINE EXPORT PL powlekane LTD Lacipil 4 mg potahované not available 83/791/92-B/C GLAXO GROUP LIMITED CZ tablety Lacipil 6 mg, õhukese not available GLAXOSMITHKLINE S.P.A. EE polümeerikattega tabletid Lacipil, 4 mg õhukese not available GLAXO WELLCOME LTD EE polümeerikattega tabletid Lacipil 6 mg plėvele not available LT/1/95/0724/004 UAB GLAXOSMITHKLINE LT Lacipil 6 mg comprimidos not available GLAXO WELLCOME Lacipil 4 mg, comprimate not available 615/2008/02 GLAXO WELLCOME UK LIMITED RO filmate Lacipil 2 mg comprimidos not available GLAXOSMITHKLINE S.A. ES recubiertos con película Lacipil, 2 mg, tabletki not available R/6505 GLAXOSMITHKLINE EXPORT PL powlekane LTD Lacipil 4 mg filmtabletta not available OGYI-T-4146/03 GLAXOSMITHKLINE KFT. HU Lacipil 2 mg filmtabletta not available OGYI-T-4146/02 GLAXOSMITHKLINE KFT. HU LADIP 4 mg compresse LACIPIL 6 mg compresse LADIP 6 mg compresse not available GLAXOSMITHKLINE S.P.A. IT not available GLAXOSMITHKLINE S.P.A. IT not available GLAXOSMITHKLINE S.P.A. IT EMA/436040/2017 Page 6/7

7 Member where LACIPIL 4 mg compresse not available GLAXOSMITHKLINE S.P.A. IT Lacipil 2 mg not available 83/0791/92-S GLAXO GROUP LIMITED SK Lacipil 4 mg not available 83/0791/92-S GLAXO GROUP LIMITED SK Lacipil 6 mg not available 83/0007/05-S GLAXO GROUP LIMITED SK Lacipil 4 mg filmom obložene tablete Lacipil 6 mg filmom obložene tablete APONIL 6 mg compresse APONIL 4 mg compresse not available UP/I /11-02/82 GLAXOSMITHKLINE D.O.O. HR not available UP/I /11-02/83 GLAXOSMITHKLINE D.O.O. HR not available I.B.N. SAVIO S.R.L. IT not available I.B.N. SAVIO S.R.L. IT EMA/436040/2017 Page 7/7

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