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© European Medicines Agency, 2019. Reproduction is authorised provided the source is acknowledged.
31 October 2019 EMA/591990/2019 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: alprazolam
Procedure no.: PSUSA/00000109/201903
List of nationally authorised medicinal products EMA/591990/2019 Page 2/25
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
XANAX 0,25 mg tablety not available 70/214/85-A/C PFIZER, SPOL. S R.O. CZ
XANAX 0,5 mg tablety not available 70/214/85-B/C PFIZER, SPOL. S R.O. CZ
XANAX 1 mg tablety not available 70/214/85-C/C PFIZER, SPOL. S R.O. CZ
XANAX 2 mg tablety not available 70/214/85-D/C PFIZER, SPOL. S R.O. CZ
Tafil® 1,0 mg Tabletten not available 29946.01.00 PFIZER PHARMA PFE GMBH DE
Tafil® 0,5 mg Tabletten not available 29946.00.00 PFIZER PHARMA PFE GMBH DE
Zomiren 2 mg modifikuoto atpalaidavimo tabletės not available LT/1/08/1222/009 KRKA, D.D., NOVO MESTO LT
Zomiren 2 mg modifikuoto atpalaidavimo tabletės not available LT/1/08/1222/010 KRKA, D.D., NOVO MESTO LT
Zomiren 2 mg modifikuoto atpalaidavimo tabletės not available LT/1/08/1222/011 KRKA, D.D., NOVO MESTO LT
Zomiren 2 mg modifikuoto atpalaidavimo tabletės not available LT/1/08/1222/012 KRKA, D.D., NOVO MESTO LT
Xanax SR, 1 mg, tabletki o przedłużonym uwalnianiu not available 7942 PFIZER EUROPE MA EEIG PL
Xanax SR, 0,5 mg, tabletki o przedłużonym uwalnianiu not available 7939 PFIZER EUROPE MA EEIG PL
Xanax SR, 2 mg, tabletki o przedłużonym uwalnianiu not available 7940 PFIZER EUROPE MA EEIG PL
List of nationally authorised medicinal products EMA/591990/2019 Page 3/25
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
Xanax SR 1 mg tablete s podaljšanim sproščanjem not available H/92/01672/005 PFIZER LUXEMBOURG SARL SI
Xanax SR 2 mg tablete s podaljšanim sproščanjem not available H/92/01672/006 PFIZER LUXEMBOURG SARL SI
Xanax SR 0,5 mg tablete s podaljšanim sproščanjem not available H/92/01672/004 PFIZER LUXEMBOURG SARL SI
Tafil Retard 1 mg forðatöflur not available 940123 PFIZER APS IS
Tafil Retard 0,5 mg forðatöflur not available 940124 PFIZER APS IS
Tafil Retard 3 mg forðatöflur not available 940121 PFIZER APS IS
Tafil Retard 2 mg forðatöflur not available 940122 PFIZER APS IS
Xanax 0,5, tabletten 0,5 mg not available RVG 14410 PFIZER B.V. NL
Xanax 0,25, tabletten 0,25 mg not available RVG 14409 PFIZER B.V. NL
Alprazolam "Pfizer", tabletter not available 14214 PFIZER APS DK
Alprazolam "Pfizer", tabletter not available 14630 PFIZER APS DK
Alprazolam "Pfizer", tabletter not available 14213 PFIZER APS DK
Xanax 0,5 mg tabletid not available 239398 PFIZER EUROPE MA EEIG EE
List of nationally authorised medicinal products EMA/591990/2019 Page 4/25
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
Xanax 1 mg tabletid not available 239498 PFIZER EUROPE MA EEIG EE
Xanax 0,25 mg tabletid not available 205998 PFIZER EUROPE MA EEIG EE
XANAX 0,25 mg Tabletten not available BE120994 PFIZER S.A. (BELGIUM) BE
XANAX 0,5 mg Tabletten not available BE120933 PFIZER S.A. (BELGIUM) BE
XANAX 2 mg Tabletten not available BE147576 PFIZER S.A. (BELGIUM) BE
XANAX 1 mg Tabletten not available BE135046 PFIZER S.A. (BELGIUM) BE XANAX 0,75 mg/ml Tropfen zum Einnehmen, Lösung not available BE187311 PFIZER S.A. (BELGIUM) BE
XANAX 0,5 mg comprimés not available BE120933 PFIZER S.A. (BELGIUM) BE XANAX 0,75 mg/ml solution buvable en gouttes not available BE187311 PFIZER S.A. (BELGIUM) BE
XANAX 1 mg comprimés not available BE135046 PFIZER S.A. (BELGIUM) BE
XANAX 0,25 mg comprimés not available BE120994 PFIZER S.A. (BELGIUM) BE
XANAX 2 mg comprimés not available BE147576 PFIZER S.A. (BELGIUM) BE
List of nationally authorised medicinal products EMA/591990/2019 Page 5/25
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
XANAX 0,75 mg/ml druppels voor oraal gebruik, oplossing not available BE187311 PFIZER S.A. (BELGIUM) BE
XANAX 0,5 mg tabletten not available BE120933 PFIZER S.A. (BELGIUM) BE
XANAX 1 mg tabletten not available BE135046 PFIZER S.A. (BELGIUM) BE
XANAX 2 mg tabletten not available BE147576 PFIZER S.A. (BELGIUM) BE
XANAX 0,25 mg tabletten not available BE120994 PFIZER S.A. (BELGIUM) BE
Xanor 1 mg tabletter not available 9657 PFIZER OY FI
Xanor 0,5 mg tabletter not available 9385 PFIZER OY FI
Xanor 0,25 mg tabletter not available 9384 PFIZER OY FI
Xanor 2 mg tabletter not available 10729 PFIZER OY FI
XANOR 0,25 mg tabletti not available 9384 PFIZER OY FI
XANOR 0,5 mg tabletti not available 9385 PFIZER OY FI
XANOR 2 mg tabletti not available 10729 PFIZER OY FI
XANOR 1 mg tabletti not available 9657 PFIZER OY FI
List of nationally authorised medicinal products EMA/591990/2019 Page 6/25
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
Xanor® 0,5 mg – Tabletten not available 1-18639
PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. AT
Xanor® 1 mg – Tabletten not available 1-18638
PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. AT
TRANKIMAZIN 0,50 mg comprimidos not available 56026 PFIZER, S.L. ES
TRANKIMAZIN 0,25 mg comprimidos not available 56027 PFIZER, S.L. ES
TRANKIMAZIN 2 mg comprimidos not available 58784 PFIZER, S.L. ES
TRANKIMAZIN 0,75 mg/ml gotas orales en solución not available 64079 PFIZER, S.L. ES
TRANKIMAZIN 1 mg comprimidos not available 56025 PFIZER, S.L. ES
Alpraz 0,5 mg comprimés not available BE165751 LABORATOIRES SMB S.A. BE
Alpraz 0,5 mg tabletten not available BE165751 LABORATOIRES SMB S.A. BE
Alpraz 0,5 mg Tabletten not available BE165751 LABORATOIRES SMB S.A. BE
Alpraz 1 mg comprimés not available BE 165767 LABORATOIRES SMB S.A. BE
Alpraz 1 mg tabletten not available BE165767 LABORATOIRES SMB S.A. BE
List of nationally authorised medicinal products EMA/591990/2019 Page 7/25
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
Alpraz 1 mg Tabletten not available BE165767 LABORATOIRES SMB S.A. BE
Alpraz 0,5 mg comprimés not available 1994120670 LABORATOIRES SMB S.A. LU
Alpraz 0,5 mg Tabletten not available 1994120670 LABORATOIRES SMB S.A. LU
Alpraz 1 mg comprimés not available 1994120671 LABORATOIRES SMB S.A. LU
Alpraz 1 mg Tabletten not available 1994120671 LABORATOIRES SMB S.A. LU
Xanor Depot 1 mg depottabletter not available 11535 PFIZER OY FI
Xanor Depot 2 mg depottabletter not available 11536 PFIZER OY FI
Xanor Depot 0,5 mg depottabletter not available 11534 PFIZER OY FI
XANOR DEPOT 0,5 mg depottabletti not available 11534 PFIZER OY FI
XANOR DEPOT 2 mg depottabletti not available 11536 PFIZER OY FI
XANOR DEPOT 1 mg depottabletti not available 11535 PFIZER OY FI XANAX SR 2 mg tablety s prodlouženým uvolňováním not available 70/735/95-C/C PFIZER, SPOL. S R.O. CZ
List of nationally authorised medicinal products EMA/591990/2019 Page 8/25
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
XANAX SR 1 mg tablety s prodlouženým uvolňováním not available 70/735/95-B/C PFIZER, SPOL. S R.O. CZ XANAX SR 0,5 mg tablety s prodlouženým uvolňováním not available 70/735/95-A/C PFIZER, SPOL. S R.O. CZ
Xanax, 2 mg, tabletki not available R/0367 PFIZER EUROPE MA EEIG PL
Xanax, 0,25 mg, tabletki not available R/0364 PFIZER EUROPE MA EEIG PL
Xanax, 1 mg, tabletki not available R/0366 PFIZER EUROPE MA EEIG PL
Xanax, 0,5 mg, tabletki not available R/0365 PFIZER EUROPE MA EEIG PL
VALEANS® 0,25 mg capsule rigide not available 025941 028 VALEAS S.P.A. IT
VALEANS® 0,50 mg capsule rigide not available 025941 016 VALEAS S.P.A. IT
VALEANS® 1 mg capsule rigide not available 025941042 VALEAS S.P.A. IT
VALEANS® 0,75 mg/ml gocce orali, soluzione not available 025941 055 VALEAS S.P.A. IT
XANAX 0,25 mg tabletta not available OGYI-T-4617/04 PFIZER KFT. HU
XANAX 1 mg tabletta not available OGYI-T-4617/08 PFIZER KFT. HU
List of nationally authorised medicinal products EMA/591990/2019 Page 9/25
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
XANAX 0,5 mg tabletta not available OGYI-T-4617/06 PFIZER KFT. HU
XANAX 0,25 mg tabletta not available OGYI-T-4617/05 PFIZER KFT. HU
XANAX 0,5 mg tabletta not available OGYI-T-4617/07 PFIZER KFT. HU
XANAX Sublingualis 0,5 mg nyelvalatti tabletta not available OGYI-T-4617/09 PFIZER KFT. HU
XANAX Sublingualis 0,5 mg nyelvalatti tabletta not available OGYI-T-4617/12 PFIZER KFT. HU
XANAX Sublingualis 0,5 mg nyelvalatti tabletta not available OGYI-T-4617/13 PFIZER KFT. HU
XANAX Sublingualis 0,5 mg nyelvalatti tabletta not available OGYI-T-4617/10 PFIZER KFT. HU
XANAX Sublingualis 0,5 mg nyelvalatti tabletta not available OGYI-T-4617/11 PFIZER KFT. HU
Alprazolam AbZ 0,25 mg Tabletten NL/H/0338/001 54833.00.00 ABZ-PHARMA GMBH DE
XANAX 0,25 mg tabletės not available LT/1/96/2950/002 PFIZER EUROPE MA EEIG LT
XANAX 1 mg tabletės not available LT/1/96/2950/006 PFIZER EUROPE MA EEIG LT
XANAX 0,5 mg tabletės not available LT/1/96/2950/004 PFIZER EUROPE MA EEIG LT
XANAX 0,5 mg tabletės not available LT/1/96/2950/003 PFIZER EUROPE MA EEIG LT
List of nationally authorised medicinal products EMA/591990/2019 Page 10/25
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
XANAX 1 mg tabletės not available LT/1/96/2950/005 PFIZER EUROPE MA EEIG LT
XANAX 0,25 mg tabletės not available LT/1/96/2950/001 PFIZER EUROPE MA EEIG LT
Xanax 500 microgram Tablets not available PL 00057/1059 PFIZER LIMITED UK
Xanax 250 microgram Tablets not available PL 00057/1058 PFIZER LIMITED UK
XANAX not available 23877/26.06.95 PFIZER HELLAS, A.E. GR
XANAX not available 23876/26.06.95 PFIZER HELLAS, A.E. GR
XANAX not available 40778/22.12.97 PFIZER HELLAS, A.E. GR
XANAX not available 23875/26.06.95 PFIZER HELLAS, A.E. GR
Tafil, tabletter not available 10404 PFIZER APS DK
Tafil, tabletter not available 10403 PFIZER APS DK
Tafil, tabletter not available 10405 PFIZER APS DK
Tafil, tabletter not available 13776 PFIZER APS DK
Xanor 1 mg tabletter not available 9657 PFIZER OY FI
List of nationally authorised medicinal products EMA/591990/2019 Page 11/25
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
Xanor 0,5 mg tabletter not available 9385 PFIZER OY FI
Xanor 0,25 mg tabletter not available 9384 PFIZER OY FI
Xanor 2 mg tabletter not available 10729 PFIZER OY FI
XANOR 0,25 mg tabletti not available 9384 PFIZER OY FI
XANOR 0,5 mg tabletti not available 9385 PFIZER OY FI
XANOR 2 mg tabletti not available 10729 PFIZER OY FI
XANOR 1 mg tabletti not available 9657 PFIZER OY FI
Xanax 250 microgram Tablets not available 505/01701 PFIZER HELLAS, A.E. MT
Xanax 500 microgram Tablets not available 505/01702 PFIZER HELLAS, A.E. MT
Xanax 500 microgram Tablets not available PL 00057/1059 PFIZER LIMITED UK
Xanax 250 microgram Tablets not available PL 00057/1058 PFIZER LIMITED UK
XANAX 1 mg compresse a rilascio prolungato not available 025980210 PFIZER ITALIA S.R.L. IT
XANAX 2 mg compresse a rilascio prolungato not available 025980273 PFIZER ITALIA S.R.L. IT
List of nationally authorised medicinal products EMA/591990/2019 Page 12/25
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
XANAX 0,5 mg compresse a rilascio prolungato not available 025980172 PFIZER ITALIA S.R.L. IT
XANAX 1 mg compresse not available 025980071 PFIZER ITALIA S.R.L. IT
XANAX 0,5 mg compresse a rilascio prolungato not available 025980145 PFIZER ITALIA S.R.L. IT
XANAX 0,25 mg compresse not available 025980057 PFIZER ITALIA S.R.L. IT
XANAX 0,5 mg compresse a rilascio prolungato not available 025980133 PFIZER ITALIA S.R.L. IT
XANAX 0,5 mg compresse a rilascio prolungato not available 025980158 PFIZER ITALIA S.R.L. IT
XANAX 0,50 mg compresse not available 025980069 PFIZER ITALIA S.R.L. IT
XANAX 2 mg compresse a rilascio prolungato not available 025980261 PFIZER ITALIA S.R.L. IT
XANAX 2 mg compresse a rilascio prolungato not available 025980297 PFIZER ITALIA S.R.L. IT
XANAX 2 mg compresse a rilascio prolungato not available 025980259 PFIZER ITALIA S.R.L. IT
XANAX 0,5 mg compresse a rilascio prolungato not available 025980160 PFIZER ITALIA S.R.L. IT
XANAX 2 mg compresse a rilascio prolungato not available 025980285 PFIZER ITALIA S.R.L. IT
XANAX 3 mg compresse a rilascio prolungato not available 025980323 PFIZER ITALIA S.R.L. IT
List of nationally authorised medicinal products EMA/591990/2019 Page 13/25
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
XANAX 1 mg compresse a rilascio prolungato not available 025980196 PFIZER ITALIA S.R.L. IT
XANAX 1 mg compresse a rilascio prolungato not available 025980246 PFIZER ITALIA S.R.L. IT
XANAX 1 mg compresse a rilascio prolungato not available 025980184 PFIZER ITALIA S.R.L. IT
XANAX 3 mg compresse a rilascio prolungato not available 025980311 PFIZER ITALIA S.R.L. IT
XANAX 1 mg compresse a rilascio prolungato not available 025980234 PFIZER ITALIA S.R.L. IT
XANAX 3 mg compresse a rilascio prolungato not available 025980335 PFIZER ITALIA S.R.L. IT
XANAX 1 mg compresse a rilascio prolungato not available 025980208 PFIZER ITALIA S.R.L. IT
XANAX 3 mg compresse a rilascio prolungato not available 025980309 PFIZER ITALIA S.R.L. IT
XANAX 3 mg compresse a rilascio prolungato not available 025980347 PFIZER ITALIA S.R.L. IT
XANAX 1 mg compresse a rilascio prolungato not available 025980222 PFIZER ITALIA S.R.L. IT
XANAX 0,75 mg/ml gocce orali, soluzione not available 025980083 PFIZER ITALIA S.R.L. IT Xanax XR 1 mg toimeainet prolongeeritult vabastavad tabletid not available 239698 PFIZER EUROPE MA EEIG EE
List of nationally authorised medicinal products EMA/591990/2019 Page 14/25
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
Xanax XR 0,5 mg toimeainet prolongeeritult vabastavad tabletid not available 239798 PFIZER EUROPE MA EEIG EE XANAX 0,75 mg/ml Tropfen zum Einnehmen, Lösung not available 2007079356 PFIZER S.A. (BELGIUM) LU
XANAX Retard 2 mg Retardtabletten not available 2007079363 PFIZER S.A. (BELGIUM) LU
XANAX Retard 1 mg Retardtabletten not available 2007079362 PFIZER S.A. (BELGIUM) LU
XANAX 0,5 mg Tabletten Alprazolam not available 2007079358 PFIZER S.A. (BELGIUM) LU
XANAX Retard 0,5 mg Retardtabletten not available 2007079361 PFIZER S.A. (BELGIUM) LU
XANAX 0,25 mg Tabletten not available 2007079357 PFIZER S.A. (BELGIUM) LU
XANAX 1 mg Tabletten not available 2007079359 PFIZER S.A. (BELGIUM) LU
XANAX 2 mg Tabletten not available 2007079360 PFIZER S.A. (BELGIUM) LU
XANAX Retard 3 mg Retardtabletten not available 2007079364 PFIZER S.A. (BELGIUM) LU
Xanax 0,5 mg comprimate not available 7759/2015/01 PFIZER EUROPE MA EEIG RO
Xanax 1 mg comprimate not available 7760/2015/01 PFIZER EUROPE MA EEIG RO
List of nationally authorised medicinal products EMA/591990/2019 Page 15/25
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
Xanax 0,25 mg comprimate not available 7758/2015/01 PFIZER EUROPE MA EEIG RO
Xanax 2 mg comprimate not available 7761/2015/01 PFIZER EUROPE MA EEIG RO XANAX Retard 0,5 mg comprimés à libération prolongée not available 2007079361 PFIZER S.A. (BELGIUM) LU XANAX Retard 2 mg comprimés à libération prolongée not available 2007079363 PFIZER S.A. (BELGIUM) LU XANAX Retard 1 mg comprimés à libération prolongée not available 2007079362 PFIZER S.A. (BELGIUM) LU XANAX Retard 3 mg comprimés à libération prolongée not available 2007079364 PFIZER S.A. (BELGIUM) LU
XANAX 0,25 mg comprimés not available 2007079357 PFIZER S.A. (BELGIUM) LU XANAX 0,75 mg/ml solution buvable en gouttes not available 2007079356 PFIZER S.A. (BELGIUM) LU
XANAX 0,5 mg comprimés not available 2007079358 PFIZER S.A. (BELGIUM) LU
XANAX 2 mg comprimés not available 2007079360 PFIZER S.A. (BELGIUM) LU
XANAX 1 mg comprimés not available 2007079359 PFIZER S.A. (BELGIUM) LU
Tafil 0,25 mg töflur not available 802634 PFIZER APS IS
List of nationally authorised medicinal products EMA/591990/2019 Page 16/25
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
Tafil 1 mg töflur not available 880115 PFIZER APS IS
Tafil 0,5 mg töflur not available 802633 PFIZER APS IS
КСАНАКС 0,25 mg таблетки not available 20020166 PFIZER EUROPE MA EEIG BG
КСАНАКС 0,5 mg таблетки not available 20020165 PFIZER EUROPE MA EEIG BG
XANAX Retard 0,5 mg Retardtabletten not available BE173223 PFIZER S.A. (BELGIUM) BE
XANAX Retard 3 mg Retardtabletten not available BE173257 PFIZER S.A. (BELGIUM) BE
XANAX Retard 2 mg Retardtabletten not available BE173241 PFIZER S.A. (BELGIUM) BE
XANAX Retard 1 mg Retardtabletten not available BE173232 PFIZER S.A. (BELGIUM) BE XANAX Retard 3 mg comprimés à libération prolongée not available BE173257 PFIZER S.A. (BELGIUM) BE XANAX Retard 1 mg comprimés à libération prolongée not available BE173232 PFIZER S.A. (BELGIUM) BE XANAX Retard 0,5 mg comprimés à libération prolongée not available BE173223 PFIZER S.A. (BELGIUM) BE XANAX Retard 2 mg comprimés à libération prolongée not available BE173241 PFIZER S.A. (BELGIUM) BE
List of nationally authorised medicinal products EMA/591990/2019 Page 17/25
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
XANAX Retard 0,5 mg tabletten met verlengde afgifte not available BE173223 PFIZER S.A. (BELGIUM) BE XANAX Retard 1 mg tabletten met verlengde afgifte not available BE173232 PFIZER S.A. (BELGIUM) BE XANAX Retard 2 mg tabletten met verlengde afgifte not available BE173241 PFIZER S.A. (BELGIUM) BE XANAX Retard 3 mg tabletten met verlengde afgifte not available BE173257 PFIZER S.A. (BELGIUM) BE
Xanax 500 microgram Tablets not available PA 822/141/3 PFIZER HEALTHCARE IRELAND IE
Xanax 250 microgram Tablets not available PA 822/141/2 PFIZER HEALTHCARE IRELAND IE
Xanax 1 mg Tablets not available PA 822/141/1 PFIZER HEALTHCARE IRELAND IE
XANAX SR 1 mg tablete s produljenim oslobađanjem not available HR-H-466930724 PFIZER CROATIA D.O.O. HR
XANAX SR 2 mg tablete s produljenim oslobađanjem not available HR-H-020745058 PFIZER CROATIA D.O.O. HR XANAX SR 0,5 mg tablete s produljenim oslobađanjem not available HR-H-219339638 PFIZER CROATIA D.O.O. HR Xanax Retard 2, tabletten met gereguleerde afgifte 2 mg not available RVG 19888 PFIZER B.V. NL Xanax Retard 1, tabletten met gereguleerde afgifte 1 mg not available RVG 19887 PFIZER B.V. NL
List of nationally authorised medicinal products EMA/591990/2019 Page 18/25
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
Xanax Retard 0,5, tabletten met gereguleerde afgifte 0,5 mg not available RVG 19886 PFIZER B.V. NL
Xanor Depot 0,5 mg depottabletter not available 95-2110 PFIZER AS NO
Xanor Depot 3 mg depottabletter not available 95-2113 PFIZER AS NO
XANAX 0,25 mg, comprimé sécable not available 34009 554 218 3 2 PFIZER HOLDING FRANCE FR
XANAX 0,50 mg, comprimé sécable not available 34009 326 445 5 1 PFIZER HOLDING FRANCE FR
XANAX 0,25 mg, comprimé sécable not available 34009 326 444 9 0 PFIZER HOLDING FRANCE FR
XANAX 1 mg, comprimé sécable not available 34009 325 582 9 2 PFIZER HOLDING FRANCE FR
XANAX 0,50 mg, comprimé sécable not available 34009 554 220 8 2 PFIZER HOLDING FRANCE FR
XANAX 1 mg, comprimé sécable not available 34009 554 221 4 3 PFIZER HOLDING FRANCE FR
Xanax 0,25 mg tablete not available HR-H-204001816 PFIZER CROATIA D.O.O. HR
Xanax 0,5 mg tablete not available HR-H-365377512 PFIZER CROATIA D.O.O. HR
XANAX 1 mg tabletes not available 97- 0165 PFIZER EUROPE MA EEIG LV
List of nationally authorised medicinal products EMA/591990/2019 Page 19/25
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
XANAX 0,5 mg tabletes not available 97-0166 PFIZER EUROPE MA EEIG LV
Tafil 0,25 mg töflur not available 802634 PFIZER APS IS
Tafil 1 mg töflur not available 880115 PFIZER APS IS
Tafil 0,5 mg töflur not available 802633 PFIZER APS IS
TRANKIMAZIN Retard 3 mg comprimidos not available 61154 PFIZER, S.L. ES
TRANKIMAZIN Retard 1 mg comprimidos not available 61151 PFIZER, S.L. ES
TRANKIMAZIN Retard 2 mg comprimidos not available 61153 PFIZER, S.L. ES
TRANKIMAZIN Retard 0,5 mg comprimidos not available 61152 PFIZER, S.L. ES
XANAX 0,25 mg tablety not available 70/0214/85-CS PFIZER EUROPE MA EEIG SK
XANAX 2 mg tablety not available 70/0053/17-S PFIZER EUROPE MA EEIG SK
XANAX 1 mg tablety not available 70/0052/17-S PFIZER EUROPE MA EEIG SK
XANAX 0,5 mg tablety not available 70/0051/17-S PFIZER EUROPE MA EEIG SK
Xanor Depot 2 mg depottabletter not available 12759 PFIZER AB SE
List of nationally authorised medicinal products EMA/591990/2019 Page 20/25
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
Xanor Depot 3 mg depottabletter not available 12760 PFIZER AB SE
Xanor Depot 0,5 mg depottabletter not available 12757 PFIZER AB SE
Xanor Depot 1 mg depottabletter not available 12758 PFIZER AB SE
Xanor 0,5 mg tabletter not available 10177 PFIZER AB SE
Xanor 0,25 mg tabletter not available 10176 PFIZER AB SE
Xanor 1 mg tabletter not available 10382 PFIZER AB SE
Xanor 2 mg tabletter not available 11424 PFIZER AB SE
XANAX SR 3 mg tablety s predĺženým uvoľňovaním not available 70/0056/17-S PFIZER EUROPE MA EEIG SK
XANAX SR 1 mg tablety s predĺženým uvoľňovaním not available 70/0054/17-S PFIZER EUROPE MA EEIG SK
XANAX SR 2 mg tablety s predĺženým uvoľňovaním not available 70/0055/17-S PFIZER EUROPE MA EEIG SK
XANAX SR 0,5 mg tablety s predĺženým uvoľňovaním not available 70/0132/95-S PFIZER EUROPE MA EEIG SK
Xanax 1 mg tablete not available H/92/01672/003 PFIZER LUXEMBOURG SARL SI
Xanax 0,25 mg tablete not available H/92/01672/001 PFIZER LUXEMBOURG SARL SI
List of nationally authorised medicinal products EMA/591990/2019 Page 21/25
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
Xanax 0,5 mg tablete not available H/92/01672/002 PFIZER LUXEMBOURG SARL SI
Xanor Depot 0,5 mg depottabletter not available 95-2110 PFIZER AS NO
Xanor Depot 3 mg depottabletter not available 95-2113 PFIZER AS NO Xanax XR 0,5 mg Comprimidos de libertação modificada not available 2381085 LABORATÓRIOS PFIZER, LDA. PT Xanax XR 1 mg Comprimidos de libertação modificada not available 2381184 LABORATÓRIOS PFIZER, LDA. PT Xanax XR 3 mg Comprimidos de libertação modificada not available 2381382 LABORATÓRIOS PFIZER, LDA. PT Xanax XR 2 mg Comprimidos de libertação modificada not available 2381283 LABORATÓRIOS PFIZER, LDA. PT Xanax XR 2 mg Comprimidos de libertação modificada not available 4579785 LABORATÓRIOS PFIZER, LDA. PT Xanax XR 0,5 mg Comprimidos de libertação modificada not available 4579280 LABORATÓRIOS PFIZER, LDA. PT Xanax XR 1 mg Comprimidos de libertação modificada not available 4579587 LABORATÓRIOS PFIZER, LDA. PT Xanax XR 3 mg Comprimidos de libertação modificada not available 4579983 LABORATÓRIOS PFIZER, LDA. PT
List of nationally authorised medicinal products EMA/591990/2019 Page 22/25
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
Xanax XR 2 mg Comprimidos de libertação modificada not available 5816285 LABORATÓRIOS PFIZER, LDA. PT Xanax XR 0,5 mg Comprimidos de libertação modificada not available 4579389 LABORATÓRIOS PFIZER, LDA. PT Xanax XR 3 mg Comprimidos de libertação modificada not available 5816384 LABORATÓRIOS PFIZER, LDA. PT Xanax XR 2 mg Comprimidos de libertação modificada not available 4579686 LABORATÓRIOS PFIZER, LDA. PT Xanax XR 1 mg Comprimidos de libertação modificada not available 4579488 LABORATÓRIOS PFIZER, LDA. PT Xanax XR 0,5 mg Comprimidos de libertação modificada not available 5816087 LABORATÓRIOS PFIZER, LDA. PT Xanax XR 3 mg Comprimidos de libertação modificada not available 4579884 LABORATÓRIOS PFIZER, LDA. PT Xanax XR 1 mg Comprimidos de libertação modificada not available 5816186 LABORATÓRIOS PFIZER, LDA. PT
Xanax 0,25 mg comprimidos not available 9573345 LABORATÓRIOS PFIZER, LDA. PT
Xanax 0,5 mg comprimidos not available 4578993 LABORATÓRIOS PFIZER, LDA. PT
Xanax 0,5 mg comprimidos not available 4578894 LABORATÓRIOS PFIZER, LDA. PT
List of nationally authorised medicinal products EMA/591990/2019 Page 23/25
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
Xanax 0,25 mg comprimidos not available 4578795 LABORATÓRIOS PFIZER, LDA. PT
Xanax 1 mg comprimidos not available 4579199 LABORATÓRIOS PFIZER, LDA. PT
Xanax 1 mg comprimidos not available 4579090 LABORATÓRIOS PFIZER, LDA. PT
Xanax 0,5 mg comprimidos not available 5787791 LABORATÓRIOS PFIZER, LDA. PT
Xanax 1 mg comprimidos not available 5787890 LABORATÓRIOS PFIZER, LDA. PT
Xanax 1 mg comprimidos not available 4579181 LABORATÓRIOS PFIZER, LDA. PT
Xanax 0,5 mg comprimidos not available 4578886 LABORATÓRIOS PFIZER, LDA. PT
Xanax 0,5 mg comprimidos not available 4578985 LABORATÓRIOS PFIZER, LDA. PT
Xanax 0,25 mg comprimidos not available 4578787 LABORATÓRIOS PFIZER, LDA. PT
Xanax 0,25 mg comprimidos not available 5787692 LABORATÓRIOS PFIZER, LDA. PT
Xanax 0,25 mg comprimidos not available 8573345 LABORATÓRIOS PFIZER, LDA. PT
Xanax 1 mg comprimidos not available 4579082 LABORATÓRIOS PFIZER, LDA. PT
Xanor 2 mg tabletter not available 8029 PFIZER AS NO
List of nationally authorised medicinal products EMA/591990/2019 Page 24/25
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
Xanor 0,5 mg tabletter not available 8027 PFIZER AS NO
Xanor 1 mg tabletter not available 8028 PFIZER AS NO
Xanor 0,25 mg tabletter not available 8026 PFIZER AS NO
ALPRASOX 0,75 mg/ml gocce orali, soluzione not available 028644084 MYLAN ITALIA S.R.L. IT
ALPRASOX 0,25 mg compresse not available 028644019 MYLAN ITALIA S.R.L. IT
ALPRASOX 0,50 mg compresse not available 028644021 MYLAN ITALIA S.R.L. IT
ALPRASOX 1 mg compresse not available 028644033 MYLAN ITALIA S.R.L. IT XANAX XR 0,5 mg pailginto atpalaidavimo tabletės not available LT/1/96/2951/001 PFIZER EUROPE MA EEIG LT
XANAX XR 1 mg pailginto atpalaidavimo tabletės not available LT/1/96/2951/002 PFIZER EUROPE MA EEIG LT
Tafil Retard, depottabletter not available 15827 PFIZER APS DK
Tafil Retard, depottabletter not available 15825 PFIZER APS DK
Tafil Retard, depottabletter not available 15828 PFIZER APS DK
Tafil Retard, depottabletter not available 15826 PFIZER APS DK
List of nationally authorised medicinal products EMA/591990/2019 Page 25/25
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
XANAX SR 2 mg retard tabletta not available OGYI-T-4617/03 PFIZER KFT. HU
XANAX SR 0,5 mg retard tabletta not available OGYI-T-4617/01 PFIZER KFT. HU
XANAX SR 1 mg retard tabletta not available OGYI-T-4617/02 PFIZER KFT. HU
