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  • Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands

    An agency of the European Union Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000

    © 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

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