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Baclofen (intrathecal) - List of nationally authorised medicinal products - PSUSA/00000293/202101 (PDF/265.93 KB)

authorised medicinal products - PSUSA/00000293/202101 … authorised medicinal products - PSUSA/00000293/202101 EMA/382258/2015 05/10/2021 … intrathecal) Procedure no.: PSUSA/00000293/202101 List of nationally …

Last updated: 05/10/2021
Active substance: baclofen (intrathecal)
Procedure number: PSUSA/00000293/202101
Regulatory outcome: Maintenance
List item

Allergen for therapy: betula verrucosa (sublingual tablet) : List of nationally authorised medicinal products - PSUSA/00010815/202101 (PDF/123.29 KB)

authorised medicinal products - PSUSA/00010815/202101 … authorised medicinal products - PSUSA/00010815/202101 EMA/504007/2021 08/09/2021 … procedure Procedure no.: PSUSA/00010815/202101 List of nationally …

Last updated: 08/09/2021
Active substance: Betula verrucosa
Procedure number: PSUSA/00010815/202101
Regulatory outcome: Maintenance
List item

Iloprost (i.v. solution only) - List of nationally authorised medicinal products - PSUSA-00009190-202101 (PDF/149.23 KB)

authorised medicinal products - PSUSA-00009190-202101 … authorised medicinal products - PSUSA-00009190-202101 EMA/564487/2021 05/10/2021 … solution only) Procedure No.: PSUSA/00009190/202101 List of nationally …

Last updated: 05/10/2021
Active substance: iloprost (i.v. solution only)
Procedure number: PSUSA/00009190/202101
Regulatory outcome: Maintenance
List item

Betamethasone valerate / fusidic acid: List of nationally authorised medicinal products - PSUSA/00000399/202101 (PDF/145.72 KB)

authorised medicinal products - PSUSA/00000399/202101 … authorised medicinal products - PSUSA/00000399/202101 EMA/260271/2021 06/09/2021 … fusidic acid Procedure no.: PSUSA/00000399/202101 List of nationally …

Last updated: 06/09/2021
Active substance: betamethasone valerate, fusidic acid
Procedure number: PSUSA/00000399/202101
Regulatory outcome: Maintenance
List item

Amitriptyline, amitriptyline / amitriptylinoxide, amitriptylinoxide : List of nationally authorised medicinal products - PSUSA/00010374/202101 (PDF/166.81 KB)

authorised medicinal products - PSUSA/00010374/202101 … authorised medicinal products - PSUSA/00010374/202101 EMA/617089/2021 03/11/2021 … amitriptylinoxide Procedure no.: PSUSA/00010374/202101 List of nationally …

Last updated: 03/11/2021
Active substance: amitriptyline, amitriptyline, amitriptylinoxide, amitriptylinoxide
Procedure number: PSUSA/00010374/202101
Regulatory outcome: Variation
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Alprostadil (erectile dysfunction) : List of nationally authorised medicinal products - PSUSA/00000110/202101 (PDF/274.42 KB)

authorised medicinal products - PSUSA/00000110/202101 … authorised medicinal products - PSUSA/00000110/202101 EMA/PRAC/538498/2021 16/03/20 … dysfunction) Procedure No.: PSUSA/00000110/202101 EMA/PRAC/538498/2021 …

Last updated: 16/03/2022
Active substance: alprostadil
Procedure number: PSUSA/00000110/202101
Regulatory outcome: Maintenance
List item

Cefoperazone - Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation - PSUSA-00000597-202101 (PDF/74.61 KB)

Marketing Authorisation - PSUSA-00000597-202101 … Marketing Authorisation - PSUSA-00000597-202101 Other languages: sv bg cs …

Last updated: 27/10/2021
Active substance: cefoperazone
Procedure number: PSUSA/00000597/202101
Regulatory outcome: Variation
Bulgarian
(PDF/76.71 KB)

Croatian
(PDF/76.35 KB)

Czech
(PDF/79.76 KB)

Danish
(PDF/78.02 KB)

Dutch
(PDF/77.46 KB)

Estonian
(PDF/72.48 KB)

Finnish
(PDF/71.55 KB)

French
(PDF/77.33 KB)

German
(PDF/82.98 KB)

Greek
(PDF/71.97 KB)

Hungarian
(PDF/79.39 KB)

Icelandic
(PDF/80.06 KB)

Italian
(PDF/92.26 KB)

Latvian
(PDF/93.24 KB)

Lithuanian
(PDF/86.52 KB)

Maltese
(PDF/92.23 KB)

Norwegian
(PDF/76.63 KB)

Polish
(PDF/80.98 KB)

Portuguese
(PDF/78.02 KB)

Romanian
(PDF/76.01 KB)

Slovak
(PDF/77.64 KB)

Slovenian
(PDF/76.5 KB)

Spanish
(PDF/79.9 KB)

Swedish
(PDF/77.43 KB)
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Dexamethasone - Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA-00000973-202101 (PDF/119.33 KB)

for the implementation - PSUSA-00000973-202101 … for the implementation - PSUSA-00000973-202101 Other languages: sl sv bg …

Last updated: 30/11/2021
Active substance: dexamethasone
Procedure number: PSUSA/00000973/202101
Regulatory outcome: Variation
Bulgarian
(PDF/169.62 KB)

Croatian
(PDF/187.68 KB)

Czech
(PDF/193.22 KB)

Danish
(PDF/156.64 KB)

Dutch
(PDF/157.11 KB)

Estonian
(PDF/151.8 KB)

Finnish
(PDF/150.76 KB)

French
(PDF/157.17 KB)

German
(PDF/162.11 KB)

Greek
(PDF/177.73 KB)

Hungarian
(PDF/196.21 KB)

Icelandic
(PDF/156.85 KB)

Italian
(PDF/195.14 KB)

Latvian
(PDF/187.49 KB)

Lithuanian
(PDF/188.48 KB)

Maltese
(PDF/195.53 KB)

Norwegian
(PDF/137.41 KB)

Polish
(PDF/148.73 KB)

Portuguese
(PDF/226.72 KB)

Romanian
(PDF/191.68 KB)

Slovak
(PDF/193.9 KB)

Slovenian
(PDF/185.43 KB)

Spanish
(PDF/143.04 KB)

Swedish
(PDF/154.33 KB)
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valproic acid, sodium valproate, valproate pivoxil, valproate semisodium, valpriomide, valproate bismuth, calcium valproate, valproate magnesium - List of nationally authorised medicinal products - PSUSA-00003090-202101 (PDF/575.65 KB)

authorised medicinal products - PSUSA-00003090-202101 … authorised medicinal products - PSUSA-00003090-202101 EMA/700665/2021 29/11/2021 … magnesium Procedure no.: PSUSA/00003090/202101 List of nationally …

Last updated: 29/11/2021
Active substance: Valproic acid, Sodium valproate, valproate pivoxil, valproate semisodium, valproate bismuth, calcium valproate, valproate magnesium, valpriomide
Procedure number: PSUSA/00003090/202101
Regulatory outcome: Variation
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Amitriptyline, amitriptyline / amitriptylinoxide, amitriptylinoxide : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010374/202101 (PDF/155.83 KB)

for the implementation - PSUSA/00010374/202101 … for the implementation - PSUSA/00010374/202101 Other languages: mt lv lt …

Last updated: 03/11/2021
Active substance: amitriptyline, amitriptyline, amitriptylinoxide, amitriptylinoxide
Procedure number: PSUSA/00010374/202101
Regulatory outcome: Variation
Bulgarian
(PDF/268.24 KB)

Croatian
(PDF/276.3 KB)

Czech
(PDF/280.96 KB)

Danish
(PDF/223.99 KB)

Dutch
(PDF/212.68 KB)

Estonian
(PDF/214.13 KB)

Finnish
(PDF/207.83 KB)

French
(PDF/211.76 KB)

German
(PDF/216.77 KB)

Greek
(PDF/224.73 KB)

Hungarian
(PDF/285.5 KB)

Icelandic
(PDF/212.6 KB)

Italian
(PDF/217.23 KB)

Latvian
(PDF/242.01 KB)

Lithuanian
(PDF/271.93 KB)

Maltese
(PDF/268.8 KB)

Norwegian
(PDF/198.55 KB)

Polish
(PDF/282.87 KB)

Portuguese
(PDF/197.69 KB)

Romanian
(PDF/272.98 KB)

Slovak
(PDF/233.71 KB)

Slovenian
(PDF/252.9 KB)

Spanish
(PDF/191.99 KB)

Swedish
(PDF/245.29 KB)
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Hydrochlorothiazide / spironolactone : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001662/202101 (PDF/92.92 KB)

for the implementation - PSUSA/00001662/202101 … for the implementation - PSUSA/00001662/202101 Other languages: et fi fr …

Last updated: 03/11/2021
Active substance: hydrochlorothiazide, spironolactone
Procedure number: PSUSA/00001662/202101
Regulatory outcome: Variation
Bulgarian
(PDF/127.93 KB)

Croatian
(PDF/136.28 KB)

Czech
(PDF/135.54 KB)

Danish
(PDF/112.65 KB)

Dutch
(PDF/113.24 KB)

Estonian
(PDF/108.7 KB)

Finnish
(PDF/109.89 KB)

French
(PDF/112.74 KB)

German
(PDF/114.72 KB)

Greek
(PDF/127.65 KB)

Hungarian
(PDF/138.36 KB)

Italian
(PDF/135.27 KB)

Latvian
(PDF/138.76 KB)

Lithuanian
(PDF/111.54 KB)

Maltese
(PDF/153 KB)

Polish
(PDF/133.73 KB)

Portuguese
(PDF/121.82 KB)

Romanian
(PDF/131.7 KB)

Slovak
(PDF/132.81 KB)

Slovenian
(PDF/126.6 KB)

Spanish
(PDF/111.92 KB)

Swedish
(PDF/113.1 KB)
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Amitriptyline / perphenazine - Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA-00000170-202101 (PDF/149.32 KB)

for the implementation - PSUSA-00000170-202101 … for the implementation - PSUSA-00000170-202101 Other languages: sv bg cs …

Last updated: 29/11/2021
Active substance: amitriptyline, perphenazine
Procedure number: PSUSA/00000170/202101
Regulatory outcome: Variation
Bulgarian
(PDF/187.93 KB)

Croatian
(PDF/195.99 KB)

Czech
(PDF/241.05 KB)

Danish
(PDF/197.59 KB)

Dutch
(PDF/179.88 KB)

Estonian
(PDF/172.01 KB)

Finnish
(PDF/175.29 KB)

French
(PDF/179.59 KB)

German
(PDF/183.08 KB)

Greek
(PDF/191.44 KB)

Hungarian
(PDF/200.98 KB)

Italian
(PDF/184 KB)

Latvian
(PDF/243.42 KB)

Lithuanian
(PDF/252.13 KB)

Maltese
(PDF/226.58 KB)

Polish
(PDF/208.78 KB)

Portuguese
(PDF/176.21 KB)

Romanian
(PDF/211.93 KB)

Slovak
(PDF/202.61 KB)

Slovenian
(PDF/195.27 KB)

Spanish
(PDF/176.72 KB)

Swedish
(PDF/176.13 KB)
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valproic acid, sodium valproate, valproate pivoxil, valproate semisodium, valpriomide, valproate bismuth, calcium valproate, valproate magnesium - Scientific conclusions and grounds for variation, amendments to the Product Informat - PSUSA-00003090-202101 (PDF/121.24 KB)

to the Product Informat - PSUSA-00003090-202101 … to the Product Informat - PSUSA-00003090-202101 Other languages: sv bg cs …

Last updated: 29/11/2021
Active substance: Valproic acid, Sodium valproate, valproate pivoxil, valproate semisodium, valpriomide, valproate bismuth, calcium valproate, valproate magnesium
Procedure number: PSUSA/00003090/202101
Regulatory outcome: Variation
Bulgarian
(PDF/106.99 KB)

Croatian
(PDF/193.56 KB)

Czech
(PDF/172.76 KB)

Danish
(PDF/152.74 KB)

Dutch
(PDF/164.68 KB)

Estonian
(PDF/165.27 KB)

Finnish
(PDF/93.78 KB)

French
(PDF/239.36 KB)

German
(PDF/163.83 KB)

Greek
(PDF/190.71 KB)

Hungarian
(PDF/55.06 KB)

Icelandic
(PDF/149.41 KB)

Italian
(PDF/196.45 KB)

Latvian
(PDF/163.49 KB)

Lithuanian
(PDF/245.91 KB)

Maltese
(PDF/264.92 KB)

Norwegian
(PDF/50.83 KB)

Polish
(PDF/275.3 KB)

Portuguese
(PDF/399 KB)

Romanian
(PDF/268.74 KB)

Slovak
(PDF/203.42 KB)

Slovenian
(PDF/115.19 KB)

Spanish
(PDF/238.03 KB)

Swedish
(PDF/263.23 KB)
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Tramadol: List of nationally authorised medicinal products - PSUSA/00003002/202005 (PDF/2.3 MB)

authorised medicinal products - PSUSA/00003002/202005 … authorised medicinal products - PSUSA/00003002/202005 EMA/270645/2015 10/03/2021 … tramadol Procedure no.: PSUSA/00003002/202005 List of nationally …

Last updated: 24/03/2021
Active substance: Tramadol
Procedure number: PSUSA/00003002/202005
Regulatory outcome: Variation
List item

Tapentadol : List of nationally authorised medicinal products - PSUSA/00002849/201711 (PDF/1.4 MB)

authorised medicinal products - PSUSA/00002849/201711 … authorised medicinal products - PSUSA/00002849/201711 EMA/607287/2018 07/09/2018 … tapentadol Procedure no.: PSUSA/00002849/201711 List of nationally …

Last updated: 07/09/2018
Active substance: tapentadol
Procedure number: PSUSA/00002849/201711
Regulatory outcome: Variation
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Atorvastatin: List of nationally authorised medicinal products - PSUSA/00010347/201710 (PDF/885.03 KB)

authorised medicinal products - PSUSA/00010347/201710 … authorised medicinal products - PSUSA/00010347/201710 … atorvastatin Procedure No.: PSUSA/00010347/201710 EMA/PRAC/384956/2018 …

Last updated: 13/08/2018
Active substance: atorvastatin
Procedure number: PSUSA/00010347/201710
Regulatory outcome: Variation
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Levobupivacaine: List of nationally authorised medicinal products - PSUSA/00001848/201712 (PDF/254.62 KB)

authorised medicinal products - PSUSA/00001848/201712 … authorised medicinal products - PSUSA/00001848/201712 EMA/620439/2018 17/09/2018 … levobupivacaine Procedure no.: PSUSA/00001848/201712 List of nationally …

Last updated: 17/09/2018
Active substance: levobupivacaine
Procedure number: PSUSA/00001848/201712
Regulatory outcome: Maintenance
List item

Lamotrigine : List of nationally authorised medicinal products - PSUSA/00001825/201711 (PDF/639.41 KB)

authorised medicinal products - PSUSA/00001825/201711 … authorised medicinal products - PSUSA/00001825/201711 EMA/600046/2018 10/09/2018 … lamotrigine Procedure no.: PSUSA/00001825/201711 List of nationally …

Last updated: 10/09/2018
Active substance: lamotrigine
Procedure number: PSUSA/00001825/201711
Regulatory outcome: Variation
List item

Landiolol: List of nationally authorised medicinal products - PSUSA/00010570/201802 (PDF/122.96 KB)

authorised medicinal products - PSUSA/00010570/201802 … authorised medicinal products - PSUSA/00010570/201802 EMA/622806/2018 14/09/2018 … landiolol Procedure no.: PSUSA/00010570/201802 List of nationally …

Last updated: 14/09/2018
Active substance: landiolol
Procedure number: PSUSA/00010570/201802
Regulatory outcome: Maintenance
List item

Sertindole: List of nationally authorised medicinal products - PSUSA/00002695/201801 (PDF/105.81 KB)

authorised medicinal products - PSUSA/00002695/201801 … authorised medicinal products - PSUSA/00002695/201801 EMA/615366/2018 13/09/2018 … sertindole Procedure no.: PSUSA/00002695/201801 …

Last updated: 13/09/2018
Active substance: sertindole
Procedure number: PSUSA/00002695/201801
Regulatory outcome: Maintenance
List item

Cefprozil: List of nationally authorised medicinal products - PSUSA/00000605/201712 (PDF/84.44 KB)

authorised medicinal products - PSUSA/00000605/201712 … authorised medicinal products - PSUSA/00000605/201712 EMA/613929/2018 13/09/2018 … cefprozil Procedure no.: PSUSA/00000605/201712 …

Last updated: 13/09/2018
Active substance: cefprozil
Procedure number: PSUSA/00000605/201712
Regulatory outcome: Maintenance
List item

Amiodarone: List of nationally authorised medicinal products - PSUSA/00000166/201712 (PDF/141.23 KB)

authorised medicinal products - PSUSA/00000166/201712 … authorised medicinal products - PSUSA/00000166/201712 EMA/615607/2018 13/09/2018 … amiodarone Procedure no.: PSUSA/00000166/201712 List of nationally …

Last updated: 13/09/2018
Active substance: amiodarone
Procedure number: PSUSA/00000166/201712
Regulatory outcome: Maintenance
List item

Lubiprostone: List of nationally authorised medicinal products - PSUSA/00010290/201801 (PDF/95.2 KB)

authorised medicinal products - PSUSA/00010290/201801 … authorised medicinal products - PSUSA/00010290/201801 EMA/617522/2018 12/09/2018 … lubiprostone Procedure No.: PSUSA/00010290/201801 List of nationally …

Last updated: 12/09/2018
Active substance: Lubiprostone
Procedure number: PSUSA/00010290/201801
Regulatory outcome: Maintenance
List item

Celecoxib: List of nationally authorised medicinal products - PSUSA/00000616/201712 (PDF/173.46 KB)

authorised medicinal products - PSUSA/00000616/201712 … authorised medicinal products - PSUSA/00000616/201712 EMA/613929/2018 13/09/2018 … celecoxib Procedure no.: PSUSA/00000616/201712 …

Last updated: 13/09/2018
Active substance: Celecoxib
Procedure number: PSUSA/00000616/201712
Regulatory outcome: Maintenance
List item

Cyproheptadine: List of nationally authorised medicinal products - PSUSA/00000902/201712 (PDF/56.47 KB)

authorised medicinal products - PSUSA/00000902/201712 … authorised medicinal products - PSUSA/00000902/201712 EMA/613960/2018 11/09/2018 … cyproheptadine Procedure no.: PSUSA/00000902/201712 …

Last updated: 11/09/2018
Active substance: cyproheptadine
Procedure number: PSUSA/00000902/201712
Regulatory outcome: Maintenance

2416 results

Baclofen (intrathecal) - List of nationally authorised medicinal products - PSUSA/00000293/202101 (PDF/265.93 KB)

Allergen for therapy: betula verrucosa (sublingual tablet) : List of nationally authorised medicinal products - PSUSA/00010815/202101 (PDF/123.29 KB)

Iloprost (i.v. solution only) - List of nationally authorised medicinal products - PSUSA-00009190-202101 (PDF/149.23 KB)

Betamethasone valerate / fusidic acid: List of nationally authorised medicinal products - PSUSA/00000399/202101 (PDF/145.72 KB)

Amitriptyline, amitriptyline / amitriptylinoxide, amitriptylinoxide : List of nationally authorised medicinal products - PSUSA/00010374/202101 (PDF/166.81 KB)

Alprostadil (erectile dysfunction) : List of nationally authorised medicinal products - PSUSA/00000110/202101 (PDF/274.42 KB)

Cefoperazone - Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation - PSUSA-00000597-202101 (PDF/74.61 KB)

Dexamethasone - Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA-00000973-202101 (PDF/119.33 KB)

valproic acid, sodium valproate, valproate pivoxil, valproate semisodium, valpriomide, valproate bismuth, calcium valproate, valproate magnesium - List of nationally authorised medicinal products - PSUSA-00003090-202101 (PDF/575.65 KB)

Amitriptyline, amitriptyline / amitriptylinoxide, amitriptylinoxide : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010374/202101 (PDF/155.83 KB)

Hydrochlorothiazide / spironolactone : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001662/202101 (PDF/92.92 KB)

Amitriptyline / perphenazine - Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA-00000170-202101 (PDF/149.32 KB)

valproic acid, sodium valproate, valproate pivoxil, valproate semisodium, valpriomide, valproate bismuth, calcium valproate, valproate magnesium - Scientific conclusions and grounds for variation, amendments to the Product Informat - PSUSA-00003090-202101 (PDF/121.24 KB)

Tramadol: List of nationally authorised medicinal products - PSUSA/00003002/202005 (PDF/2.3 MB)

Tapentadol : List of nationally authorised medicinal products - PSUSA/00002849/201711 (PDF/1.4 MB)

Atorvastatin: List of nationally authorised medicinal products - PSUSA/00010347/201710 (PDF/885.03 KB)

Levobupivacaine: List of nationally authorised medicinal products - PSUSA/00001848/201712 (PDF/254.62 KB)

Lamotrigine : List of nationally authorised medicinal products - PSUSA/00001825/201711 (PDF/639.41 KB)

Landiolol: List of nationally authorised medicinal products - PSUSA/00010570/201802 (PDF/122.96 KB)

Sertindole: List of nationally authorised medicinal products - PSUSA/00002695/201801 (PDF/105.81 KB)

Cefprozil: List of nationally authorised medicinal products - PSUSA/00000605/201712 (PDF/84.44 KB)

Amiodarone: List of nationally authorised medicinal products - PSUSA/00000166/201712 (PDF/141.23 KB)

Lubiprostone: List of nationally authorised medicinal products - PSUSA/00010290/201801 (PDF/95.2 KB)

Celecoxib: List of nationally authorised medicinal products - PSUSA/00000616/201712 (PDF/173.46 KB)

Cyproheptadine: List of nationally authorised medicinal products - PSUSA/00000902/201712 (PDF/56.47 KB)