Transcription
29 September 2016EMA/646404/2016Human Medicines Evaluation DivisionList of nationally authorised medicinal productsActive substance: levothyroxineProcedure no.: PSUSA/00001860/20160130 Churchill Place Canary Wharf London E14 5EU United KingdomTelephone 44 (0)20 3660 6000 Facsimile 44 (0)20 3660 5525Send a question via our website www.ema.europa.eu/contactAn agency of the European Union European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.
Product Name (inauthorisation country)MRP/DCPAuthorisationnumberNational Authorisation NumberMAH of product in themember stateMember State whereproduct is authorisedSyntroxine 13DE/H/2580/001OGYI-T-21944/01IBSA FARMACEUTICI ITALIAHUDE/H/2580/001OGYI-T-21944/02IBSA FARMACEUTICI ITALIAHUDE/H/2580/001OGYI-T-21944/03IBSA FARMACEUTICI ITALIAHUDE/H/2580/002OGYI-T-21944/04IBSA FARMACEUTICI ITALIAHUDE/H/2580/002OGYI-T-21944/05IBSA FARMACEUTICI ITALIAHUDE/H/2580/002OGYI-T-21944/06IBSA FARMACEUTICI ITALIAHUDE/H/2580/005OGYI-T-21944/13IBSA FARMACEUTICI ITALIAHUDE/H/2580/005OGYI-T-21944/14IBSA FARMACEUTICI ITALIAHUDE/H/2580/005OGYI-T-21944/15IBSA FARMACEUTICI ITALIAHUDE/H/2580/007OGYI-T-21944/19IBSA FARMACEUTICI ITALIAHUmikrogramm lágykapszulaSyntroxine 13mikrogramm lágykapszulaSyntroxine 13mikrogramm lágykapszulaSyntroxine 25mikrogramm lágykapszulaSyntroxine 25mikrogramm lágykapszulaSyntroxine 25mikrogramm lágykapszulaSyntroxine 88mikrogramm lágykapszulaSyntroxine 88mikrogramm lágykapszulaSyntroxine 88mikrogramm lágykapszulaSyntroxine 112mikrogramm lágykapszulaList of nationally authorised medicinal productsEMA/646404/2016Page 2/108
Product Name (inauthorisation country)MRP/DCPAuthorisationnumberNational Authorisation NumberMAH of product in themember stateMember State whereproduct is authorisedSyntroxine 112DE/H/2580/007OGYI-T-21944/20IBSA FARMACEUTICI ITALIAHUDE/H/2580/007OGYI-T-21944/21IBSA FARMACEUTICI ITALIAHUDE/H/2580/009OGYI-T-21944/25IBSA FARMACEUTICI ITALIAHUDE/H/2580/009OGYI-T-21944/26IBSA FARMACEUTICI ITALIAHUDE/H/2580/009OGYI-T-21944/27IBSA FARMACEUTICI ITALIAHUDE/H/2580/012OGYI-T-21944/34IBSA FARMACEUTICI ITALIAHUDE/H/2580/012OGYI-T-21944/35IBSA FARMACEUTICI ITALIAHUDE/H/2580/012OGYI-T-21944/36IBSA FARMACEUTICI ITALIAHUnot available042508010IBSA FARMACEUTICI ITALIAITmikrogramm lágykapszulaSyntroxine 112mikrogramm lágykapszulaSyntroxine 137mikrogramm lágykapszulaSyntroxine 137mikrogramm lágykapszulaSyntroxine 137mikrogramm lágykapszulaSyntroxine 200mikrogramm lágykapszulaSyntroxine 200mikrogramm lágykapszulaSyntroxine 200mikrogramm lágykapszulaTICHE 13 microgrammicapsule molliList of nationally authorised medicinal productsEMA/646404/2016Page 3/108
Product Name (inauthorisation country)MRP/DCPAuthorisationnumberNational Authorisation NumberMAH of product in themember stateMember State whereproduct is authorisedTICHE 13 microgramminot available042508022IBSA FARMACEUTICI ITALIAITnot available042508034IBSA FARMACEUTICI ITALIAITnot available042508147IBSA FARMACEUTICI ITALIAITnot available042508150IBSA FARMACEUTICI ITALIAITnot available042508198IBSA FARMACEUTICI ITALIAITnot available042508212IBSA FARMACEUTICI ITALIAITnot available042508251IBSA FARMACEUTICI ITALIAITnot available042508263IBSA FARMACEUTICI ITALIAITnot available042508275IBSA FARMACEUTICI ITALIAITcapsule molliTICHE 13 microgrammicapsule molliTICHE 88 microgrammicapsule molliTICHE 88 microgrammicapsule molliTICHE 112 microgrammicapsule molliTICHE 112 microgrammicapsule molliTICHE 137 microgrammicapsule molliTICHE 137 microgrammicapsule molliTICHE 137 microgrammicapsule molliList of nationally authorised medicinal productsEMA/646404/2016Page 4/108
Product Name (inauthorisation country)MRP/DCPAuthorisationnumberNational Authorisation NumberMAH of product in themember stateMember State whereproduct is authorisedTirosint 100 microgramminot available034368062IBSA FARMACEUTICI ITALIAITnot available034368074IBSA FARMACEUTICI ITALIAITnot available034368086IBSA FARMACEUTICI ITALIAITnot available034368098IBSA FARMACEUTICI ITALIAITnot available034368100IBSA FARMACEUTICI ITALIAITTirosint 13 µgDE/H/2580/00156/0267/11-SIBSA FARMACEUTICI ITALIASKTirosint 88 µg mäkkéDE/H/2580/00556/0271/11-SIBSA FARMACEUTICI ITALIASKTirosint 112 µgDE/H/2580/00756/0273/11-SIBSA FARMACEUTICI ITALIASKTirosint 137 µgDE/H/2580/00956/0275/11-SIBSA FARMACEUTICI ITALIASK/ml gocce orali, soluzioneTirosint 25microgrammi/1 mlsoluzione oraleTirosint 50microgrammi/1 mlsoluzione oraleTirosint 75microgrammi/1 mlsoluzione oraleTirosint 100microgrammi/1 mlsoluzione oralekapsulyList of nationally authorised medicinal productsEMA/646404/2016Page 5/108
Product Name (inauthorisation country)MRP/DCPAuthorisationnumberNational Authorisation NumberMAH of product in themember stateMember State whereproduct is authorisedSyntroxine 13DE/H/2580041528011BRACCO SPAITDE/H/2580041528047BRACCO SPAITDE/H/2580041528074BRACCO SPAITDE/H/2580041528100BRACCO SPAITDE/H/2580041528136BRACCO SPAITDE/H/2580041528163BRACCO SPAITDE/H/2580041528199BRACCO SPAITDE/H/2580041528225BRACCO SPAITDE/H/2580/0011-30382IBSA FARMACEUTICI ITALIAATmicrogrammi capsulemolliSyntroxine 25microgrammi capsulemolliSyntroxine 50microgrammi capsulemolliSyntroxine 75microgrammi capsulemolliSyntroxine 88microgrammi capsulemolliSyntroxine 100microgrammi capsulemolliSyntroxine 112microgrammi capsulemolliSyntroxine 125microgrammi capsulemolliSyntroxine 13MikrogrammWeichkapselnList of nationally authorised medicinal productsEMA/646404/2016Page 6/108
Product Name (inauthorisation country)MRP/DCPAuthorisationnumberNational Authorisation NumberMAH of product in themember stateMember State whereproduct is authorisedSyntroxine 13DE/H/2580/001041528023BRACCO SPAITDE/H/2580/001041528035BRACCO SPAITDE/H/2580/002041528050BRACCO SPAITDE/H/2580/002041528062BRACCO SPAITDE/H/2580/003041528086BRACCO SPAITDE/H/2580/003041528098BRACCO SPAITDE/H/2580/004041528124BRACCO SPAITDE/H/2580/005041528148BRACCO SPAITDE/H/2580/005041528151BRACCO SPAITmicrogrammi capsulemolliSyntroxine 13microgrammi capsulemolliSyntroxine 25microgrammi capsulemolliSyntroxine 25microgrammi capsulemolliSyntroxine 50microgrammi capsulemolliSyntroxine 50microgrammi capsulemolliSyntroxine 75microgrammi capsulemolliSyntroxine 88microgrammi capsulemolliSyntroxine 88microgrammi capsulemolliList of nationally authorised medicinal productsEMA/646404/2016Page 7/108
Product Name (inauthorisation country)MRP/DCPAuthorisationnumberNational Authorisation NumberMAH of product in themember stateMember State whereproduct is authorisedSyntroxine 100DE/H/2580/006041528175BRACCO SPAITDE/H/2580/006041528187BRACCO SPAITDE/H/2580/007041528201BRACCO SPAITDE/H/2580/007041528213BRACCO SPAITDE/H/2580/008041528237BRACCO SPAITDE/H/2580/008041528249BRACCO SPAITDE/H/2580/009041528252BRACCO SPAITDE/H/2580/009041528264BRACCO SPAITDE/H/2580/009041528276BRACCO SPAITmicrogrammi capsulemolliSyntroxine 100microgrammi capsulemolliSyntroxine 112microgrammi capsulemolliSyntroxine 112microgrammi capsulemolliSyntroxine 125microgrammi capsulemolliSyntroxine 125microgrammi capsulemolliSyntroxine 137microgrammi capsulemolliSyntroxine 137microgrammi capsulemolliSyntroxine 137microgrammi capsulemolliList of nationally authorised medicinal productsEMA/646404/2016Page 8/108
Product Name (inauthorisation country)MRP/DCPAuthorisationnumberNational Authorisation NumberMAH of product in themember stateMember State whereproduct is authorisedSyntroxine 150DE/H/2580/010041528288BRACCO SPAITDE/H/2580/010041528290BRACCO SPAITDE/H/2580/010041528302BRACCO SPAITDE/H/2580/011041528314BRACCO SPAITDE/H/2580/011041528326BRACCO SPAITDE/H/2580/011041528338BRACCO SPAITDE/H/2580/012041528340BRACCO SPAITDE/H/2580/012041528353BRACCO SPAITDE/H/2580/012041528365BRACCO SPAITmicrogrammi capsulemolliSyntroxine 150microgrammi capsulemolliSyntroxine 150microgrammi capsulemolliSyntroxine 175microgrammi capsulemolliSyntroxine 175microgrammi capsulemolliSyntroxine 175microgrammi capsulemolliSyntroxine 200microgrammi capsulemolliSyntroxine 200microgrammi capsulemolliSyntroxine 200microgrammi capsulemolliList of nationally authorised medicinal productsEMA/646404/2016Page 9/108
Product Name (inauthorisation country)MRP/DCPAuthorisationnumberNational Authorisation NumberMAH of product in themember stateMember State whereproduct is authorisedSyntroxine 75DE/H/2580/004041528112BRACCO SPAITDE/H/2580/00156/388/11-CIBSA FARMACEUTICI ITALIACZDE/H/2580/00256/389/11-CIBSA FARMACEUTICI ITALIACZDE/H/2580/00556/392/11-CIBSA FARMACEUTICI ITALIACZDE/H/2580/00756/394/11-CIBSA FARMACEUTICI ITALIACZDE/H/2580/00956/396/11-CIBSA FARMACEUTICI ITALIACZDE/H/2580/01256/399/11-CIBSA FARMACEUTICI ITALIACZTirosintDE/H/2580/00146370IBSA FARMACEUTICI ITALIADKTirosint; bløde kapslerDE/H/2580/00546374IBSA FARMACEUTICI ITALIADKmicrogrammi capsulemolliSyntroxine 13mikrogramů měkkétobolkySyntroxine 25mikrogramů měkkétobolkySyntroxine 88mikrogramů měkkétobolkySyntroxine 112mikrogramů měkkétobolkySyntroxine 137mikrogramů měkkétobolkySyntroxine 200mikrogramů měkkétobolkyList of nationally authorised medicinal productsEMA/646404/2016Page 10/108
Product Name (inauthorisation country)MRP/DCPAuthorisationnumberNational Authorisation NumberMAH of product in themember stateMember State whereproduct is authorisedTirosint; bløde kapslerDE/H/2580/00746376IBSA FARMACEUTICI ITALIADKTirosint; bløde kapslerDE/H/2580/00946378IBSA FARMACEUTICI ITALIADKTirosint 13 MikrogrammDE/H/2580/00179650.00.00IBSA FARMACEUTICI ITALIADEDE/H/2580/001RVG 106848IBSA FARMACEUTICI ITALIANLnot available06-0014BERLIN-CHEMIE AGLVnot available06-0015BERLIN-CHEMIE AGLVnot availableOGYI-T-7546/05BERLIN-CHEMIE AGHUnot availableOGYI-T-7546/04BERLIN-CHEMIE AGHUnot availableOGYI-T-7546/06BERLIN-CHEMIE AGHUWeichkapselnTirosint 13 microgramzachte capsulesL-Thyroxin Berlin-Chemie75 mikrogramu tabletesL-Thyroxin Berlin-Chemie125 mikrogramu tabletesLetrox 75 mikrogrammtablettaLetrox 75 mikrogrammtablettaLetrox 75 mikrogrammtablettaList of nationally authorised medicinal productsEMA/646404/2016Page 11/108
Product Name (inauthorisation country)MRP/DCPAuthorisationnumberNational Authorisation NumberMAH of product in themember stateMember State whereproduct is authorisedLETROX 125not available21736BERLIN-CHEMIE AGPLnot available51838.01.00BERLIN-CHEMIE AGDEDE/H/2631/002PA 0749/143/002TEVA PHARMA B.V.IEDE/H/2631/001PA 0749/143/001TEVA PHARMA B.V.IEDE/H/2631/004II-23776TEVA PHARMACEUTICALSBGmikrogramów; 125mikrogramów (µg),tabletkiBerlthyrox 150 µg 150Mikrogramm, TablettenLevothyroxine Teva 50microgram TabletsLevothyroxine Teva 25microgram TabletsТеваТирокс 100микрограма таблеткиТеваТирокс 50BULGARIA EOODDE/H/2631/002II-23775микрограма таблеткиWolarex, 75BGBULGARIA EOODDE/H/2631/00321029mikrogramów, tabletkiLevotiroxina Teva 50TEVA PHARMACEUTICALSTEVA PHARMACEUTICALSPLPOLSKA SP. Z O.O.DE/H/2631/002040619367TEVA ITALIA S.R.L.ITDE/H/2631/004040619734TEVA ITALIA S.R.L.ITmicrogrammi compresseLevotiroxina Teva 100microgrammi compresseList of nationally authorised medicinal productsEMA/646404/2016Page 12/108
Product Name (inauthorisation country)MRP/DCPAuthorisationnumberNational Authorisation NumberMAH of product in themember stateMember State whereproduct is authorisedLevothyroxine Teva 100DE/H/2631/004PA 0749/143/003TEVA PHARMA B.V.IEDE/H/2631/004040619746TEVA ITALIA S.R.L.ITDE/H/2631/003040619470TEVA ITALIA S.R.L.ITDE/H/2631/00221028TEVA PHARMACEUTICALSPLmicrogram TabletsLevotiroxina Teva 100microgrammi compresseLevotiroxina Teva 75microgrammi compresseWolarex, 50mikrogramów, tabletkiLevotiroxina Teva 50POLSKA SP. Z O.O.DE/H/2631/002040619227TEVA ITALIA S.R.L.ITDE/H/2631/002040619316/MTEVA ITALIA S.R.L.ITDE/H/2631/001040619114TEVA ITALIA S.R.L.ITDE/H/2631/004040619660TEVA ITALIA S.R.L.ITDE/H/2631/005040620015TEVA ITALIA S.R.L.ITmicrogrammi compresseLevotiroxina Teva 50microgrammi compresseLevotiroxina Teva 25microgrammi compresseLevotiroxina Teva 100microgrammi compresseLevotiroxina Teva 125microgrammi compresseList of nationally authorised medicinal productsEMA/646404/2016Page 13/108
Product Name (inauthorisation country)MRP/DCPAuthorisationnumberNational Authorisation NumberMAH of product in themember stateMember State whereproduct is authorisedLevotiroxina Teva 125DE/H/2631/005040619936TEVA ITALIA S.R.L.ITDE/H/2631/003040619557TEVA ITALIA S.R.L.ITDE/H/2631/002040619239TEVA ITALIA S.R.L.ITDE/H/2631/003040619520TEVA ITALIA S.R.L.ITDE/H/2631/008040620496TEVA ITALIA S.R.L.ITD/H/2631/001040619049TEVA ITALIA S.R.L.ITDE/H/2631/008040620534TEVA ITALIA S.R.L.ITDE/H/2631/008040620546TEVA ITALIA S.R.L.ITDE/H/2631/003040619443TEVA ITALIA S.R.L.ITmicrogrammi compresseLevotiroxina Teva 75microgrammi compresseLevotiroxina Teva 50microgrammi compresseLevotiroxina Teva 75microgrammi compresseLevotiroxina Teva 200microgrammi compresseLevotiroxina Teva 25microgrammi compresseLevotiroxina Teva 200microgrammi compresseLevotiroxina Teva 200microgrammi compresseLevotiroxina Teva 75microgrammi compresseList of nationally authorised medicinal productsEMA/646404/2016Page 14/108
Product Name (inauthorisation country)MRP/DCPAuthorisationnumberNational Authorisation NumberMAH of product in themember stateMember State whereproduct is authorisedLevotiroxina Teva 125DE/H/2631/005040619874TEVA ITALIA S.R.L.ITDE/H/2631/005040619999/MTEVA ITALIA S.R.L.ITDE/H/2631/002040619292TEVA ITALIA S.R.L.ITDE/H/2631/00277.044TEVA PHARMA S.L.UESDE/H/2631/003040619544/MTEVA ITALIA S.R.L.ITDE/H/2631/005040619948TEVA ITALIA S.R.L.ITDE/H/2631/003040619532TEVA ITALIA S.R.L.ITDE/H/2631/008040620662TEVA ITALIA S.R.L.ITDE/H/2631/002040619355TEVA ITALIA S.R.L.ITmicrogrammi compresseLevotiroxina Teva 125microgrammi compresseLevotiroxina Teva 50microgrammi compresseLevotiroxina sódica Teva75 microgramoscomprimidos EFGLevotiroxina Teva 75microgrammi compresseLevotiroxina Teva 125microgrammi compresseLevotiroxina Teva 75microgrammi compresseLevotiroxina Teva 200microgrammi compresseLevotiroxina Teva 50
List of nationally authorised medicinal products . Active substance: levothyroxine . Procedure no.: PSUSA/00001860/201601 . List of nationally authorised medicinal products EMA/646404/2016 Page 2/108 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 Syntroxine 13 .
