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Hydroxycarbamide : List of nationally authorised medicinal products - PSUSA/00009182/202012 (PDF/140.17 KB)

authorised medicinal products - PSUSA/00009182/202012 … authorised medicinal products - PSUSA/00009182/202012 EMA/494031/2021 03/09/2021 … product) Procedure no.: PSUSA/00009182/202012 List of nationally …

Last updated: 03/09/2021
Active substance: hydroxycarbamide
Procedure number: PSUSA/00009182/202012
Regulatory outcome: Variation
List item

Hydroxycarbamide : Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation, amendments to the Product Information and timetable for the implementation - PSUSA/00009182/202012 (PDF/93.78 KB)

for the implementation - PSUSA/00009182/202012 … for the implementation - PSUSA/00009182/202012 Other languages: bg cs da …

Last updated: 03/09/2021
Active substance: hydroxycarbamide
Procedure number: PSUSA/00009182/202012
Regulatory outcome: Variation
Bulgarian
(PDF/103.46 KB)

Croatian
(PDF/82.92 KB)

Czech
(PDF/80.66 KB)

Danish
(PDF/80.04 KB)

Dutch
(PDF/81.45 KB)

Estonian
(PDF/77.68 KB)

Finnish
(PDF/75.76 KB)

French
(PDF/84.36 KB)

German
(PDF/70.78 KB)

Greek
(PDF/87.45 KB)

Hungarian
(PDF/72.31 KB)

Icelandic
(PDF/100.9 KB)

Italian
(PDF/94.01 KB)

Latvian
(PDF/98.66 KB)

Lithuanian
(PDF/91.43 KB)

Maltese
(PDF/93.42 KB)

Norwegian
(PDF/69.06 KB)

Polish
(PDF/86.88 KB)

Portuguese
(PDF/79.74 KB)

Romanian
(PDF/136.62 KB)

Slovak
(PDF/72.9 KB)

Slovenian
(PDF/82.49 KB)

Spanish
(PDF/78.93 KB)

Swedish
(PDF/82.26 KB)
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Hydroxycarbamide: List of nationally authorised medicinal products - PSUSA/00009182/201712 (PDF/94.52 KB)

authorised medicinal products - PSUSA/00009182/201712 … authorised medicinal products - PSUSA/00009182/201712 EMA/584534/2018 31/08/2018 … product) Procedure no.: PSUSA/00009182/201712 List of nationally …

Last updated: 31/08/2018
Active substance: hydroxycarbamide
Procedure number: PSUSA/00009182/201712
Regulatory outcome: Variation
List item

Hydroxycarbamide: CMDh Scientific conclusions, amendments to product information and implementation timetable - PSUSA/00009182/201712 (PDF/564.02 KB)

implementation timetable - PSUSA/00009182/201712 … implementation timetable - PSUSA/00009182/201712 Other languages: bg es da …

Last updated: 31/08/2018
Active substance: hydroxycarbamide
Procedure number: PSUSA/00009182/201712
Regulatory outcome: Variation
Bulgarian
(PDF/608.55 KB)

Croatian
(PDF/631.22 KB)

Czech
(PDF/68.6 KB)

Danish
(PDF/562.93 KB)

Dutch
(PDF/567.72 KB)

Estonian
(PDF/578.35 KB)

Finnish
(PDF/560.58 KB)

French
(PDF/584.52 KB)

German
(PDF/571.24 KB)

Greek
(PDF/606.07 KB)

Hungarian
(PDF/613.33 KB)

Italian
(PDF/578.71 KB)

Latvian
(PDF/620.3 KB)

Lithuanian
(PDF/617.24 KB)

Maltese
(PDF/608.88 KB)

Polish
(PDF/599.63 KB)

Portuguese
(PDF/562.79 KB)

Romanian
(PDF/602.41 KB)

Slovak
(PDF/607.71 KB)

Slovenian
(PDF/593.54 KB)

Spanish
(PDF/578.99 KB)

Swedish
(PDF/562.95 KB)
List item

Hydroxycarbamide (except for centrally authorised product): List of nationally authorised medicinal products - PSUSA/00009182/201612 (PDF/99.16 KB)

authorised medicinal products - PSUSA/00009182/201612 … authorised medicinal products - PSUSA/00009182/201612 EMA/429979/2017 10/07/2017 … centrally authorised product); PSUSA/00009182/201612 30 Churchill Place …

Last updated: 10/07/2017
Active substance: hydroxycarbamide
Procedure number: PSUSA/00009182/201612
Regulatory outcome: Maintenance
List item

Hydroxycarbamide (except for centrally authorised product): List of nationally authorised medicinal products - PSUSA-00009182-201812 (PDF/92.3 KB)

authorised medicinal products - PSUSA-00009182-201812 … authorised medicinal products - PSUSA-00009182-201812 EMA/401819/2019 15/07/2019 …

Last updated: 15/07/2019
Active substance: hydroxycarbamide
Procedure number: PSUSA-00009182-201812
Regulatory outcome: Maintenance
List item

Lormetazepam : List of nationally authorised medicinal products - PSUSA/00001910/202012 (PDF/140.13 KB)

authorised medicinal products - PSUSA/00001910/202012 … authorised medicinal products - PSUSA/00001910/202012 EMA/507606/2021 09/09/2021 … lormetazepam Procedure no.: PSUSA/00001910/202012 List of nationally …

Last updated: 09/09/2021
Active substance: lormetazepam
Procedure number: PSUSA/00001910/202012
Regulatory outcome: Maintenance
List item

Betahistine : List of nationally authorised medicinal products - PSUSA/00000389/202012 (PDF/276.74 KB)

authorised medicinal products - PSUSA/00000389/202012 … authorised medicinal products - PSUSA/00000389/202012 09/09/2021 … betahistine Procedure no.: PSUSA/00000389/202012 List of nationally …

Last updated: 09/09/2021
Active substance: betahistine
Procedure number: PSUSA/00000389/202012
Regulatory outcome: Maintenance
List item

Famciclovir - List of nationally authorised medicinal products - PSUSA-00001349-202012 (PDF/143.32 KB)

authorised medicinal products - PSUSA-00001349-202012 … authorised medicinal products - PSUSA-00001349-202012 EMA/260273/2021Adopted 06/09 … famciclovir Procedure no.: PSUSA/00001349/202012 List of nationally …

Last updated: 06/09/2021
Active substance: famciclovir
Procedure number: PSUSA/00001349/202012
Regulatory outcome: Maintenance
List item

Doxazosin : List of nationally authorised medicinal products - PSUSA/00001169/202012 (PDF/189.96 KB)

authorised medicinal products - PSUSA/00001169/202012 … authorised medicinal products - PSUSA/00001169/202012 EMA/501908/2021 08/09/2021 … doxazosin Procedure no.: PSUSA/00001169/202012 List of nationally …

Last updated: 08/09/2021
Active substance: doxazosin
Procedure number: PSUSA/00001169/202012
Regulatory outcome: Maintenance
List item

Amiodarone - List of nationally authorised medicinal products - PSUSA-00000166-202012 (PDF/203.01 KB)

authorised medicinal products - PSUSA-00000166-202012 … authorised medicinal products - PSUSA-00000166-202012 EMA/606309/2021Adopted 26/10 … amiodarone Procedure no.: PSUSA/00000166/202012 List of nationally …

Last updated: 26/10/2021
Active substance: amiodarone
Procedure number: PSUSA/00000166/202012
Regulatory outcome: Variation
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Allopurinol : List of nationally authorised medicinal products - PSUSA/00000095/202012 (PDF/263.31 KB)

authorised medicinal products - PSUSA/00000095/202012 … authorised medicinal products - PSUSA/00000095/202012 EMA/617623/2021 29/10/2021 … allopurinol Procedure no.: PSUSA/00000095/202012 List of nationally …

Last updated: 29/10/2021
Active substance: allopurinol
Procedure number: PSUSA/00000095/202012
Regulatory outcome: Variation
List item

Celecoxib : List of nationally authorised medicinal products - PSUSA/00000616/202012 (PDF/301.62 KB)

authorised medicinal products - PSUSA/00000616/202012 … authorised medicinal products - PSUSA/00000616/202012 EMA/505439/2021 09/09/2021 … celecoxib Procedure no.: PSUSA/00000616/202012 List of nationally …

Last updated: 09/09/2021
Active substance: Celecoxib
Procedure number: PSUSA/00000616/202012
Regulatory outcome: Maintenance
List item

Carbamazepine - List of nationally authorised medicinal products - PSUSA-00000539-202012 (PDF/290.95 KB)

authorised medicinal products - PSUSA-00000539-202012 … authorised medicinal products - PSUSA-00000539-202012 EMA/398898/2015Adopted 27/10 … carbamazepine Procedure no.: PSUSA/00000539/202012 List of nationally …

Last updated: 27/10/2021
Active substance: Carbamazepine
Procedure number: PSUSA/00000539/202012
Regulatory outcome: Variation
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Desmopressin - List of nationally authorised medicinal products - PSUSA-00000964-202012 (PDF/451.34 KB)

authorised medicinal products - PSUSA-00000964-202012 … authorised medicinal products - PSUSA-00000964-202012 EMA/382258/2015 14/09/2021 … desmopressin Procedure no.: PSUSA/00000964/202012 List of nationally …

Last updated: 14/09/2021
Active substance: desmopressin
Procedure number: PSUSA/00000964/202012
Regulatory outcome: Maintenance
List item

Antithrombin iii - List of nationally authorised medicinal products - PSUSA-00003159-202012 (PDF/235.67 KB)

authorised medicinal products - PSUSA-00003159-202012 … authorised medicinal products - PSUSA-00003159-202012 15/09/2021 … antithrombin iii Procedure no.: PSUSA/00003159/202012 List of nationally …

Last updated: 15/09/2021
Active substance: antithrombin iii
Procedure number: PSUSA/00003159/202012
Regulatory outcome: Maintenance
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Cyproheptadine : List of the nationally authorised medicinal products - PSUSA/00000902/202012 (PDF/161.09 KB)

authorised medicinal products - PSUSA/00000902/202012 … authorised medicinal products - PSUSA/00000902/202012 EMA/473810/2021 03/09/2021 … cyproheptadine Procedure No: PSUSA/00000902/202012 …

Last updated: 03/09/2021
Active substance: cyproheptadine
Procedure number: PSUSA/00000902/202012
Regulatory outcome: Maintenance
List item

Anthrax vaccine : List of nationally authorised medicinal products - PSUSA/00010771/202012 (PDF/105.15 KB)

authorised medicinal products - PSUSA/00010771/202012 … authorised medicinal products - PSUSA/00010771/202012 EMA/PRAC/467975/2021 24/09/20 … vaccine Procedure no.: PSUSA/00010771/202012 List of nationally …

Last updated: 24/09/2021
Active substance: anthrax vaccine
Procedure number: PSUSA/00010771/202012
Regulatory outcome: Maintenance
List item

Pseudoephedrine / triprolidine : List of nationally authorised medicinal products - PSUSA/00003047/202012 (PDF/120.91 KB)

authorised medicinal products - PSUSA/00003047/202012 … authorised medicinal products - PSUSA/00003047/202012 EMA/502957/2021 08/09/2021 … triprolidine Procedure no.: PSUSA/00003047/202012 List of nationally …

Last updated: 08/09/2021
Active substance: pseudoephedrine, triprolidine
Procedure number: PSUSA/00003047/202012
Regulatory outcome: Maintenance
List item

Diacerin : List of the nationally authorised medicinal products - PSUSA/00001026/202012 (PDF/209.81 KB)

authorised medicinal products - PSUSA/00001026/202012 … authorised medicinal products - PSUSA/00001026/202012 EMA/474110/2021 03/09/2021 … diacerin Procedure No: PSUSA/00001026/202012 …

Last updated: 03/09/2021
Active substance: diacerin
Procedure number: PSUSA/00001026/202012
Regulatory outcome: Maintenance
List item

Tafluprost / timolol - List of nationally authorised medicinal products - PSUSA-00010324-202012 (PDF/201.46 KB)

authorised medicinal products - PSUSA-00010324-202012 … authorised medicinal products - PSUSA-00010324-202012 EMA/394630/2021 12/07/2021 … timolol Procedure no.: PSUSA/00010324/202012 List of nationally …

Last updated: 12/07/2021
Active substance: Tafluprost, timolol
Procedure number: PSUSA/00010324/202012
Regulatory outcome: Maintenance
List item

Dapoxetine : List of the nationally authorised medicinal products - PSUSA/00000928/202012 (PDF/260.85 KB)

authorised medicinal products - PSUSA/00000928/202012 … authorised medicinal products - PSUSA/00000928/202012 EMA/473995/2021 03/09/2021 … dapoxetine Procedure No: PSUSA/00000928/202012 …

Last updated: 03/09/2021
Active substance: dapoxetine
Procedure number: PSUSA/00000928/202012
Regulatory outcome: Maintenance
List item

Tobramycin (nebuliser solution) : List of nationally authorised medicinal products - PSUSA/00009316/202012 (PDF/204.1 KB)

authorised medicinal products - PSUSA/00009316/202012 … authorised medicinal products - PSUSA/00009316/202012 EMA/467432/2021 24/09/2021 … product) Procedure no.: PSUSA/00009316/202012 List of nationally …

Last updated: 24/09/2021
Active substance: Tobramycin
Procedure number: PSUSA/00009316/202012
Regulatory outcome: Maintenance
List item

Rupatadine : List of the nationally authorised medicinal products - PSUSA/00002673/202012 (PDF/299.86 KB)

authorised medicinal products - PSUSA/00002673/202012 … authorised medicinal products - PSUSA/00002673/202012 EMA/474309/2021 03/09/2021 … rupatadine Procedure No: PSUSA/00002673/202012 …

Last updated: 03/09/2021
Active substance: rupatadine
Procedure number: PSUSA/00002673/202012
Regulatory outcome: Maintenance
List item

Yellow fever vaccine (live) - List of nationally authorised medicinal products - PSUSA-00003135-202012 (PDF/228.18 KB)

authorised medicinal products - PSUSA-00003135-202012 … authorised medicinal products - PSUSA-00003135-202012 EMA/393892/2021 12/07/2021 … vaccine (live) Procedure no.: PSUSA/00003135/202012 List of nationally …

Last updated: 12/07/2021
Active substance: yellow fever vaccine (live)
Procedure number: PSUSA/00003135/202012
Regulatory outcome: Maintenance

2219 results

Hydroxycarbamide : List of nationally authorised medicinal products - PSUSA/00009182/202012 (PDF/140.17 KB)

Hydroxycarbamide : Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation, amendments to the Product Information and timetable for the implementation - PSUSA/00009182/202012 (PDF/93.78 KB)

Hydroxycarbamide: List of nationally authorised medicinal products - PSUSA/00009182/201712 (PDF/94.52 KB)

Hydroxycarbamide: CMDh Scientific conclusions, amendments to product information and implementation timetable - PSUSA/00009182/201712 (PDF/564.02 KB)

Hydroxycarbamide (except for centrally authorised product): List of nationally authorised medicinal products - PSUSA/00009182/201612 (PDF/99.16 KB)

Hydroxycarbamide (except for centrally authorised product): List of nationally authorised medicinal products - PSUSA-00009182-201812 (PDF/92.3 KB)

Lormetazepam : List of nationally authorised medicinal products - PSUSA/00001910/202012 (PDF/140.13 KB)

Betahistine : List of nationally authorised medicinal products - PSUSA/00000389/202012 (PDF/276.74 KB)

Famciclovir - List of nationally authorised medicinal products - PSUSA-00001349-202012 (PDF/143.32 KB)

Doxazosin : List of nationally authorised medicinal products - PSUSA/00001169/202012 (PDF/189.96 KB)

Amiodarone - List of nationally authorised medicinal products - PSUSA-00000166-202012 (PDF/203.01 KB)

Allopurinol : List of nationally authorised medicinal products - PSUSA/00000095/202012 (PDF/263.31 KB)

Celecoxib : List of nationally authorised medicinal products - PSUSA/00000616/202012 (PDF/301.62 KB)

Carbamazepine - List of nationally authorised medicinal products - PSUSA-00000539-202012 (PDF/290.95 KB)

Desmopressin - List of nationally authorised medicinal products - PSUSA-00000964-202012 (PDF/451.34 KB)

Antithrombin iii - List of nationally authorised medicinal products - PSUSA-00003159-202012 (PDF/235.67 KB)

Cyproheptadine : List of the nationally authorised medicinal products - PSUSA/00000902/202012 (PDF/161.09 KB)

Anthrax vaccine : List of nationally authorised medicinal products - PSUSA/00010771/202012 (PDF/105.15 KB)

Pseudoephedrine / triprolidine : List of nationally authorised medicinal products - PSUSA/00003047/202012 (PDF/120.91 KB)

Diacerin : List of the nationally authorised medicinal products - PSUSA/00001026/202012 (PDF/209.81 KB)

Tafluprost / timolol - List of nationally authorised medicinal products - PSUSA-00010324-202012 (PDF/201.46 KB)

Dapoxetine : List of the nationally authorised medicinal products - PSUSA/00000928/202012 (PDF/260.85 KB)

Tobramycin (nebuliser solution) : List of nationally authorised medicinal products - PSUSA/00009316/202012 (PDF/204.1 KB)

Rupatadine : List of the nationally authorised medicinal products - PSUSA/00002673/202012 (PDF/299.86 KB)

Yellow fever vaccine (live) - List of nationally authorised medicinal products - PSUSA-00003135-202012 (PDF/228.18 KB)