List of nationally authorised medicinal products

Transcription

1 21 February 2018 EMA/208334/2018 Human Medicines Evaluation Division Active substance: ibuprofen / pseudoephedrine 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 BoxaGrippal 200 mg/30 mg - Dolorflu akut 200 mg/30 mg - Ibuduo, 200 mg/30 mg film-coated tablets WICK DayMed Duo 200mg/30mg HCl Pfizer 200 mg/30 mg comprimés enrobés HCl Pfizer 200 mg/30 mg omhulde tabletten HCl Pfizer 200mg/30 mg überzogene Tabletten hydrochloride Boehringer Ingelheim 200 mg/30 mg hydrochloride Boehringer Ingelheim 200 mg/30 mg filmomhulde tabletten IBUPFEN/PSEUDOEPHED RINE HYDCHLORI SANOFI 200 mg/30 mg Ibuprofen/pseudoephedrine hydrochloride Sanofi 200 mg/30 mg filmomhulde tabletten /H/4352/ SANOFI-AVENTIS AT OSTERREICH /H/4184/ SANDOZ AT AT/H/0614/ ORIFARM GENERICS A/S AT IT/H/0331/ RATIOPHARM ARZNEIMITTEL VERTRBS- AT /H/0420/001 BE PFIZER B.V. BE /H/0420/001 BE PFIZER B.V. BE /H/0420/001 BE PFIZER B.V. BE /H/4352/001 BE BOEHRINGER INGELHEIM INTERNATIONAL /H/4352/001 BE BOEHRINGER INGELHEIM INTERNATIONAL /H/4352/001 BE SANOFI BELGIUM BE /H/4352/001 BE SANOFI BELGIUM BE BE BE EMA/208334/2018 Page 2/18

3 Ibuprofen/pseudoephedrine hydrochloride Sanofi 200 mg/30 mg filmomhulde tabletten filmomhulde tabletten filmomhulde tabletten filmomhulde tabletten ЕКСТРАЛГИН КОЛД 200 mg/30 mg филмирани таблетки ЕКСТРАЛГИН КОЛД 200 mg/30 mg филмирани таблетки ЕКСТРАЛГИН КОЛД 200 mg/30 mg филмирани таблетки /H/4352/001 BE SANOFI BELGIUM BE not available ZENTIVA, K.S. BG not available ZENTIVA, K.S. BG not available ZENTIVA, K.S. BG EMA/208334/2018 Page 3/18

4 ЕКСТРАЛГИН КОЛД 200 mg/30 mg филмирани таблетки Ибупром Синус 200 mg/30 mg обвити таблетки Мукогрип 200 mg/30 mg филмирани таблетки Нурофен Стопколд 200 mg/30 mg филмирани таблетки Олитабс 200 mg/30 mg филмирани таблетки Олитабс 200 mg/30 mg филмирани таблетки Олитабс 200 mg/30 mg филмирани таблетки Олитабс 200 mg/30 mg филмирани таблетки Hexatab Headcold Relief 200 mg/30 mg, Hexatab Headcold Relief 200 mg/30 mg, Hexatab Headcold Relief 200 mg/30 mg, Hexatab Headcold Relief 200 mg/30 mg, not available ZENTIVA, K.S. BG not available US PHARMACIA SP. Z O.O. BG /H/4352/ BOEHRINGER INGELHEIM INTERNATIONAL not available RECKITT BENCKISER INTERNATIONAL /H/4183/001/DC MCNEIL PDUCTS /H/4183/001/DC MCNEIL PDUCTS /H/4183/001/DC MCNEIL PDUCTS /H/4183/001/DC MCNEIL PDUCTS /H/4183/ JOHNSON & JOHNSON HELLAS CONSUMER AE /H/4183/ JOHNSON & JOHNSON HELLAS CONSUMER AE /H/4183/ JOHNSON & JOHNSON HELLAS CONSUMER AE /H/4183/ JOHNSON & JOHNSON HELLAS CONSUMER AE BG BG BG BG BG BG CY CY CY CY EMA/208334/2018 Page 4/18

5 Mucocold 200mg/30mg /H/4352/ BOEHRINGER INGELHEIM INTERNATIONAL NUFEN Cold & Flu not available RECKITT BENCKISER CY HELLAS CHEMICALS ABEE Grippecton 200 mg/30 mg /H/4188/001 07/155/16-C KREWEL MEUSELBACH CZ potahované tablety Modafen potahované not available 07/136/98-C ZENTIVA, K.S. CZ tablety Modafen potahované not available 07/136/98-C ZENTIVA, K.S. CZ tablety Modafen potahované not available 07/136/98-C ZENTIVA, K.S. CZ tablety Modafen potahované not available 07/136/98-C ZENTIVA, K.S. CZ tablety Nurofen StopGrip potahované tablety not available 07/612/96-C RECKITT BENCKISER INTERNATIONAL CZ Robicold 200 mg/30 mg obalené tablety BoxaGrippal Erkältungssaft 200 mg/10 ml + 30 mg/10 ml Suspension zum Einnehmen BoxaGrippal Erkältungstabletten 200 mg / 30 mg Dolormin Grippal 200 mg/30 mg Dolormin Grippal 200 mg/30 mg Dolormin Grippal 200 mg/30 mg GRIPOMED 200 mg/30 mg /H/0420/001 07/040/15-C PFIZER CORPORATION /H/5545/ SANOFI-AVENTIS UTSCHLAND /H/4352/ SANOFI-AVENTIS UTSCHLAND /H/4182/001/DC JOHNSON & JOHNSON /H/4182/001/DC JOHNSON & JOHNSON /H/4182/001/DC JOHNSON & JOHNSON /H/4185/ PHARMASWISS ČESKÁ REPUBLIKA S.R.O. CY CZ EMA/208334/2018 Page 5/18

6 IbuHEXAL Grippal 200 mg/30 mg Ibuprofen/Pseudoephedrinh ydrochlorid Angelini 200 mg/30 mg Ibuprofen/Pseudoephedrinh ydrochlorid Krewel 200 mg/30 mg IbuSinex 200 mg/30 mg ratiogrippal 200 mg/30 mg Spalt Effekt 30mg/200 mg überzogene Tabletten SpaltGrippal 200 mg/30 mg Weichkapseln WICK DuoGrippal 200 mg/30 mg Febrilek 200 mg / 30 mg õhukese polümeerikattega tabletid Bisolfren 200 mg/30 mg comprimidos recubiertos con película /H/4184/ HEXAL AG /H/4186/ AZN CHIMICHE RIUNITE ANGELINI FRANCESCO - A.C.R.A.F. S.P.A. /H/4188/ KREWEL MEUSELBACH /H/4187/ DIAPHARM & CO. KG /H/4183/001/DC JOHNSON & JOHNSON /H/4183/001/DC JOHNSON & JOHNSON /H/4183/001/DC JOHNSON & JOHNSON /H/4183/001/DC JOHNSON & JOHNSON not available RATIOPHARM FR/H/0238/ PFIZER CONSUMER /H/5671/ PFIZER CONSUMER IT/H/0331/ WICK PHARMA ZWEIGNRLASSUNG R PCTER & GAMBLE /H/4185/ PHARMASWISS ČESKÁ REPUBLIKA S.R.O. /H/4352/ BOEHRINGER INGELHEIM INTERNATIONAL EE ES EMA/208334/2018 Page 6/18

7 Gripaduo 200 mg/30 mg comprimidos recubiertos con película NUFEN RHUME, comprimé pelliculé RHINADVIL RHUME IBUPFENE/PSEUDOEPHE DRINE, comprimé enrobé RHINUREFLEX, comprimé pelliculé Gripomed 200 mg/30 mg Hexatab Headcold Relief 200 mg/30 mg, Hexatab Headcold Relief 200 mg/30 mg, Hexatab Headcold Relief 200 mg/30 mg, Hexatab Headcold Relief 200 mg/30 mg, Mucocold 200mg/30mg IT/H/0331/ LABORATORIOS VICKS, S.L. not available RECKITT BENCKISER FRANCE FR/H/0238/ PFIZER SANTE FAMILIALE SAS not available RECKITT BENCKISER FRANCE /H/4185/ /14/ PHARMASWISS ČESKÁ REPUBLIKA S.R.O. /H/4183/001/DC 70000/ JOHNSON & JOHNSON HELLAS CONSUMER AE /H/4183/001/DC 70000/ JOHNSON & JOHNSON HELLAS CONSUMER AE /H/4183/001/DC 70000/ JOHNSON & JOHNSON HELLAS CONSUMER AE /H/4183/001/DC 70000/ JOHNSON & JOHNSON HELLAS CONSUMER AE /H/4352/ BOEHRINGER INGELHEIM INTERNATIONAL NUFEN Cold & Flu not available 44616/10 RECKITT BENCKISER GR HELLAS CHEMICALS ABEE Fidiprofen flu 200 mg+ 30 mg tablete not available UP/I /11-01/363 FIDIFARM D.O.O. HR ES FR FR FR GR GR GR GR GR GR EMA/208334/2018 Page 7/18

8 Ibutren Flu 200 mg/30 mg filmom obložene tablete Nurofen Cold and Flu 200 mg + 30 mg filmom obložene tablete filmom obložene tablete filmom obložene tablete filmom obložene tablete filmom obložene tablete RHINORELF 200 mg + 30 mg tablete Advil Cold 200 mg/30 mg bevont tabletta Advil Cold 200 mg/30 mg bevont tabletta Advil Cold Rapid 200 mg/30 mg lágy kapszula Advil Cold Rapid 200 mg/30 mg lágy kapszula Advil Cold Rapid 200 mg/30 mg lágy kapszula Advil Cold Rapid 200 mg/30 mg lágy kapszula ALGOFLEX COLD 200 mg/30 mg filmtabletta /H/4184/001 HR-H SANDOZ D.O.O. HR not available UP/I /11-02/20 RECKITT BENCKISER (CATIA) D.O.O. /H/4183/001/DC HR-H JOHNSON & JOHNSON S.E.D.O.O. HR /H/4183/001/DC HR-H JOHNSON & JOHNSON HR S.E.D.O.O. /H/4183/001/DC HR-H JOHNSON & JOHNSON HR S.E.D.O.O. /H/4183/001/DC HR-H JOHNSON & JOHNSON HR S.E.D.O.O. not available UP/I /11-01/379 JADRAN-GALENSKI HR LABORATORIJ D.D. /H/0420/001 OGYI-T-22705/02 PFIZER CORPORATION HU /H/0420/001 OGYI-T-22705/01 PFIZER CORPORATION HU /H/5670/001 OGYI-T-22705/05 PFIZER CORPORATION HU /H/5670/001 OGYI-T-22705/03 PFIZER CORPORATION HU /H/5670/001 OGYI-T-22705/06 PFIZER CORPORATION HU /H/5670/001 OGYI-T-22705/04 PFIZER CORPORATION HU not available OGYI-T-22831/01 SANOFI-AVENTIS ZRT HU HR EMA/208334/2018 Page 8/18

9 ALGOFLEX COLD 200 mg/30 mg filmtabletta ALGOFLEX COLD 200 mg/30 mg filmtabletta Ibuprofen/Pszeudoefedrin Wick 200 mg/30 mg filmtabletta Ibuprofen/Pszeudoefedrin Wick 200 mg/30 mg filmtabletta Ibuprofen/Pszeudoefedrin Wick 200 mg/30 mg filmtabletta Nurofen Cold and Flu 200 mg/30 mg filmtabletta Nurofen Cold and Flu 200 mg/30 mg filmtabletta Advil Cold & Flu Coated Tablets Ibuprofen 200 mg Pseudoephedrine Hydrochloride 30 mg Advil Sinus Relief Soft Capsules Ibuprofen 200 mg Pseudoephedrine hydrochloride 30 mg Hydrochloride 200mg/30mg film coated tablets Hydrochloride 200mg/30mg film coated tablets not available OGYI-T-22831/03 SANOFI-AVENTIS ZRT HU not available OGYI-T-22831/02 SANOFI-AVENTIS ZRT HU IT/H0331/001 OGYI-T-22836/01 WICK PHARMA ZWEIGNRLASSUNG R PCTER & GAMBLE IT/H/0331/001 OGYI-T-22836/02 WICK PHARMA ZWEIGNRLASSUNG R PCTER & GAMBLE IT/H/0331/001 OGYI-T-22836/03 WICK PHARMA ZWEIGNRLASSUNG R PCTER & GAMBLE not available OGYI-T-6797/02 RECKITT BENCKISER INTERNATIONAL not available OGYI-T-6797/01 RECKITT BENCKISER INTERNATIONAL /H/0420/001 PA 0822/164/001 PFIZER IRELAND /H/5670/001 PA 822/164/002 PFIZER IRELAND /H/4182/001/DC PA823/067/001 MCNEIL (IRELAND) /H/4182/001/DC PA823/067/001 MCNEIL (IRELAND) HU HU HU HU HU EMA/208334/2018 Page 9/18

10 Hydrochloride 200mg/30mg film coated tablets Hydrochloride 200mg/30mg film coated tablets Non-Drowsy Sudapro Head Cold 200mg / 30mg Filmcoated Tablets Non-Drowsy Sudapro Head Cold 200mg / 30mg Filmcoated Tablets Non-Drowsy Sudapro Head Cold 200mg / 30mg Filmcoated Tablets Non-Drowsy Sudapro Head Cold 200mg / 30mg Filmcoated Tablets Nurofen Cold & Flu Filmcoated Tablets, Ibuprofen 200mg, Pseduoephedrine Hydrochloride 30mg Nurofen Sinus and Pain Film-Coated Tablets Ibuprofen 200mg Pseudoephedrine Hydrochloride 30mg Nurofen Sinus and Pain Film-Coated Tablets Ibuprofen 200mg Pseudoephedrine Hydrochloride 30mg ACTISINU 200 mg/30 mg, ACTISINU 200 mg/30 mg, /H/4182/001/DC PA823/067/001 MCNEIL (IRELAND) /H/4182/001/DC PA823/067/001 MCNEIL (IRELAND) /H/4183/001/DC PA 823/68/1 MCNEIL (IRELAND) /H/4183/001/DC PA 823/68/1 MCNEIL (IRELAND) /H/4183/001/DC PA 823/68/1 MCNEIL (IRELAND) /H/4183/001/DC PA 823/68/1 MCNEIL (IRELAND) not available PA 979/33/1 RECKITT BENCKISER IRELAND LTD. not available PA 979/65/1 RECKITT BENCKISER IRELAND LTD. not available PA 979/65/1 RECKITT BENCKISER IRELAND LTD. /H/4183/001/DC JOHNSON & JOHNSON S.P.A. /H/4183/001/DC JOHNSON & JOHNSON S.P.A. IT IT EMA/208334/2018 Page 10/18

11 ACTISINU 200 mg/30 mg, ACTISINU 200 mg/30 mg, Momenxsin 200 mg/30 mg Momenxsin 200 mg/30 mg Momenxsin 200 mg/30 mg Momenxsin 200 mg/30 mg NUFEN INFLUENZA E RAFFREDDORE 200 mg + 30 mg Compresse Rivestite NUFEN INFLUENZA E RAFFREDDORE 200 mg + 30 mg Compresse Rivestite Vicks Flu Action 200 mg/30 mg compresse rivestite con film Vicks Flu Action 200 mg/30 mg compresse rivestite con film Vicks Flu Action 200 mg/30 mg compresse rivestite con film /H/4183/001/DC JOHNSON & JOHNSON S.P.A. IT /H/4183/001/DC JOHNSON & JOHNSON IT S.P.A. /H/4186/ AZN CHIMICHE IT RIUNITE ANGELINI FRANCESCO - A.C.R.A.F. S.P.A. /H/4186/ AZN CHIMICHE IT RIUNITE ANGELINI FRANCESCO - A.C.R.A.F. S.P.A. /H/4186/ AZN CHIMICHE IT RIUNITE ANGELINI FRANCESCO - A.C.R.A.F. S.P.A. /H/4186/ AZN CHIMICHE IT RIUNITE ANGELINI FRANCESCO - A.C.R.A.F. S.P.A. not available RECKITT BENCKISER IT INTERNATIONAL not available RECKITT BENCKISER IT INTERNATIONAL IT/H/0331/ PCTER & GAMBLE S.R.L IT IT/H/0331/ PCTER & GAMBLE S.R.L IT IT/H/0331/ PCTER & GAMBLE S.R.L IT EMA/208334/2018 Page 11/18

12 ZerinoDek 200 mg/30 mg ZerinoDek 200 mg/30 mg Daikol 200 mg/30 mg plėvele dengtos tabletės ILOXEN 200 mg/30 mg plėvele dengtos tabletės ILOXEN 200 mg/30 mg plėvele dengtos tabletės ILOXEN 200 mg/30 mg plėvele dengtos tabletės ILOXEN 200 mg/30 mg plėvele dengtos tabletės HCl Pfizer 200 mg / 30 mg Comprimés enrobé IBUPFEN/PSEUDOEPHED RINE HYDCHLORI SANOFI 200 mg/30 mg hydrochloride Sanofi 200 mg/30 mg IbuSinex 200 mg/30 mg comprimé pelliculé ILOXEN 200 mg/30 mg apvalkotās tabletes /H/4352/ SANOFI SPA IT /H/4352/ SANOFI SPA IT not available LT/1/16/3982/001 SIA INGEN PHARMA LT /H/4185/001 LT/1/16/3881/001 PHARMASWISS ČESKÁ REPUBLIKA S.R.O. LT /H/4185/001 LT/1/16/3881/002 PHARMASWISS ČESKÁ LT REPUBLIKA S.R.O. /H/4185/001 LT/1/16/3881/003 PHARMASWISS ČESKÁ LT REPUBLIKA S.R.O. /H/4185/001 LT/1/16/3881/004 PHARMASWISS ČESKÁ LT REPUBLIKA S.R.O. /H/0420/ PFIZER B.V. LU /H/4352/ SANOFI BELGIUM LU /H/4352/ SANOFI BELGIUM LU /H/4187/ DIAPHARM & CO. KG LU /H/4183/001/DC JOHNSON & JOHNSON /H/4183/001/DC JOHNSON & JOHNSON /H/4183/001/DC JOHNSON & JOHNSON /H/4183/001/DC JOHNSON & JOHNSON /H/4185/ PHARMASWISS ČESKÁ REPUBLIKA S.R.O. LU LU LU LU LV EMA/208334/2018 Page 12/18

13 Nurofen Antigrip 200 mg/30 not available RECKITT BENCKISER LV mg apvalkotās tabletes (POLAND) S.A. Advil Cold & Flu Coated not available MA 969/00201 PFIZER CONSUMER MT Tablets LTD. Advil Cold & Flu Coated not available MA 969/00201 PFIZER CONSUMER MT Tablets LTD. Advil Sinus Relief Soft /H/5670/001 MA969/00202 PFIZER CORPORATION MT Capsules Ibuprofen 200 mg Pseudoephedrine hydrochloride 30 mg Nurofen Cold & Flu not available MA 190/00404 RECKITT BENCKISER MT INTERNATIONAL Acatar Zatoki, 200 mg + 30 mg, tabletki powlekane not available US PHARMACIA SP. Z O.O. PL Advil Zatoki, 200 mg + 30 mg, tabletki powlekane /H/0420/ PFIZER CORPORATION PL /H/4185/ PHARMASWISS ČESKÁ PL REPUBLIKA S.R.O. not available HASCO-LEK PL Efedoxin, 200 mg + 30 mg, tabletki powlekane IBUM GRIP, 200 mg + 30 mg, tabletki powlekane Ibum Zatoki Max, 400 mg + not available HASCO-LEK PL 60 mg, tabletki powlekane Ibum Zatoki, 200 mg + 30 not available HASCO-LEK PL mg, tabletki powlekane /H/4188/ KREWEL MEUSELBACH PL hydrochloride Krewel, 200 mg + 30 mg, tabletki powlekane IBUPM ZATOKI, 200 mg not available 9650 US PHARMACIA SP. Z O.O. PL + 30 mg, tabletki powlekane Infex Zatoki IT-H DC TEVA PHARMACEUTICALS PL POLSKA SP. Z O.O. EMA/208334/2018 Page 13/18

14 Laboratoria PolfaŁódź ZATOKI, 200 mg + 30 mg, tabletki Metafen ZATOKI, 200 mg + 30 mg, tabletki Metafen ZATOKI, 200 mg + 30 mg, tabletki MODAFEN EXTRA GRIP, 200 mg + 30 mg, tabletki powlekane MODAFEN EXTRA GRIP, 200 mg + 30 mg, tabletki powlekane MODAFEN EXTRA GRIP, 200 mg + 30 mg, tabletki powlekane Nurofen Zatoki, 200 mg + 30 mg, tabletki powlekane Sudafed Extra, 200 mg + 30 mg, tabletki powlekane Sudafed Extra, 200 mg + 30 mg, tabletki powlekane Sudafed Extra, 200 mg + 30 mg, tabletki powlekane Sudafed Extra, 200 mg + 30 mg, tabletki powlekane Bisolpront 200 mg + 30 mg comprimidos revestidos por película Bisolpront 200 mg + 30 mg comprimidos revestidos por película not available BIO PFIL POLSKA SP Z OO not available ZAKLADY FARMACEUTYCZNE "POLPHARMA" SPOLKA AKCYJNA PL not available ZAKLADY PL FARMACEUTYCZNE "POLPHARMA" SPOLKA AKCYJNA not available 9603 ZENTIVA, K.S. PL not available 9603 ZENTIVA, K.S. PL not available 9603 ZENTIVA, K.S. PL not available 7787 RECKITT BENCKISER (POLAND) S.A. /H/4183/001/DC MCNEIL PDUCTS /H/4183/001/DC MCNEIL PDUCTS /H/4183/001/DC MCNEIL PDUCTS /H/4183/001/DC MCNEIL PDUCTS /H/4352/ SANOFI - PDUTOS FARMACEUTICOS LDA /H/4352/ SANOFI - PDUTOS FARMACEUTICOS LDA PL PL PL PL PL PL PT PT EMA/208334/2018 Page 14/18

15 Larofen Plus 200mg/30mg Modafen 200 mg/30 mg Modafen 200 mg/30 mg Modafen 200 mg/30 mg Modafen 200 mg/30 mg Nurofen Răceală şi Gripă 200 mg/30 mg comprimate filmate Nurofen Răceală şi Gripă 200 mg/30 mg comprimate filmate not available 9424/2016/01 LAPHARM SRL not available 480/2007/02 ZENTIVA, K.S. not available 480/2007/03 ZENTIVA, K.S. not available 480/2007/04 ZENTIVA, K.S. not available 480/2007/01 ZENTIVA, K.S. not available 4144/2011/02 RECKITT BENCKISER INTERNATIONAL not available 4144/2011/01 RECKITT BENCKISER INTERNATIONAL /H/4183/001/DC 8529/2016/03 MCNEIL PDUCTS /H/4183/001/DC 8529/2016/01 MCNEIL PDUCTS /H/4183/001/DC 8529/2016/04 MCNEIL PDUCTS /H/4183/001/DC 8529/2016/02 MCNEIL PDUCTS /H/5670/ /2016/01 PFIZER CORPORATION /H/5670/ /2016/02 PFIZER CORPORATION /H/5670/ /2016/08 PFIZER CORPORATION /H/5670/ /2016/14 PFIZER CORPORATION EMA/208334/2018 Page 15/18

16 /H/5670/ /2016/12 PFIZER CORPORATION /H/5670/ /2016/03 PFIZER CORPORATION /H/5670/ /2016/10 PFIZER CORPORATION /H/5670/ /2016/06 PFIZER CORPORATION /H/5670/ /2016/04 PFIZER CORPORATION /H/5670/ /2016/16 PFIZER CORPORATION /H/5670/ /2016/05 PFIZER CORPORATION /H/5670/ /2016/13 PFIZER CORPORATION /H/5670/ /2016/07 PFIZER CORPORATION /H/5670/ /2016/11 PFIZER CORPORATION /H/5670/ /2016/09 PFIZER CORPORATION /H/5670/ /2016/15 PFIZER CORPORATION EMA/208334/2018 Page 16/18

17 TEDOLFEN 200mg/30mg IT/H/0331/ /2014/01-04 TEVA PHARMACEUTICALS S.R.L Ibuseu, 200 mg/30 mg AT/H/0614/ ORIFARM GENERICS A/S SE filmdragerade tabletter /H/4183/001/DC H/16/02163/004 MCNEIL PDUCTS SI filmsko obložene tablete /H/4183/001/DC H/16/02163/002 MCNEIL PDUCTS SI filmsko obložene tablete /H/4183/001/DC H/16/02163/001 MCNEIL PDUCTS SI filmsko obložene tablete /H/4183/001/DC H/16/02163/003 MCNEIL PDUCTS SI filmsko obložene tablete Grippecton 200 mg/30 mg /H/4188/001 07/0143/16-S KREWEL MEUSELBACH SK filmom obalené tablety MODAFEN 200 mg/30 mg not available 07/0263/01-S ZENTIVA, K.S. SK filmom obalené tablety MODAFEN 200 mg/30 mg not available 07/0263/01-S ZENTIVA, K.S. SK filmom obalené tablety MODAFEN 200 mg/30 mg not available 07/0263/01-S ZENTIVA, K.S. SK filmom obalené tablety NUFEN STOPGRIP not available 07/0662/96-S RECKITT BENCKISER SK INTERNATIONAL Robicold 200 mg/30 mg obalené tablety /H/0420/001 07/0264/14-S PFIZER CORPORATION SK Robicold Rapid 200 mg/30 mg mäkké kapsuly Boots Cold & Flu Relief with Ibuprofen Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/30mg Capsules /H/5670/001 07/0235/16-S PFIZER CORPORATION SK not available 00014/0600 THE BOOTS COMPANY PLC /H/5671/001 PL 00165/0389 PFIZER CONSUMER LTD. EMA/208334/2018 Page 17/18

18 Nurofen Sinus Pressure & Headache Relief 200mg/30mg Tablets not available PL 00063/0718 RECKITT BENCKISER () Nurofen Cold & Flu not available PL 00063/0375 RECKITT BENCKISER () Nurofen Sinus Relief not available PL 00063/0375 RECKITT BENCKISER () RobiCold Cold & Flu Relief /H/5670/001 PL 00165/0388 PFIZER CONSUMER 200 mg / 30 mg Soft LTD. Capsules RobiCold Sinus Relief 200 /H/0420/001 PL 00165/0391 PFIZER CONSUMER mg, 30 mg Tablets LTD. Sudafed Sinus Pressure & Pain 200mg/30mg filmcoated tablets Sudafed Sinus Pressure & Pain 200mg/30mg filmcoated tablets Sudafed Sinus Pressure & Pain 200mg/30mg filmcoated tablets Sudafed Sinus Pressure & Pain 200mg/30mg filmcoated tablets Sudafed Sinus Pressure & Pain Tablets Sudafed Sinus Pressure & Pain Tablets Sudafed Sinus Pressure & Pain Tablets Sudafed Sinus Pressure & Pain Tablets /H/4183/001 PL 15513/0396 MCNEIL PDUCTS /H/4183/001 PL 15513/0396 MCNEIL PDUCTS /H/4183/001 PL 15513/0396 MCNEIL PDUCTS /H/4183/001 PL 15513/0396 MCNEIL PDUCTS not available PL 15513/0126 MCNEIL PDUCTS not available PL 15513/0126 MCNEIL PDUCTS not available PL 15513/0126 MCNEIL PDUCTS not available PL 15513/0126 MCNEIL PDUCTS EMA/208334/2018 Page 18/18