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2219 results

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Hydrochlorothiazide / spironolactone : List of nationally authorised medicinal products - PSUSA/00001662/202101 (PDF/105.37 KB)

authorised medicinal products - PSUSA/00001662/202101 … authorised medicinal products - PSUSA/00001662/202101 EMA/619421/2021 03/11/2021 … spironolactone Procedure No.: PSUSA/00001662/202101 EMA/619421/2021 …

Last updated: 03/11/2021
Active substance: hydrochlorothiazide, spironolactone
Procedure number: PSUSA/00001662/202101
Regulatory outcome: Variation
List item

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)
List item

Hydrochlorothiazide / spironolactone: List of nationally authorised medicinal products - PSUSA/00001662/201801 (PDF/69.12 KB)

authorised medicinal products - PSUSA/00001662/201801 … authorised medicinal products - PSUSA/00001662/201801 EMA/619695/2018 13/09/2018 … spironolactone Procedure no.: PSUSA/00001662/201801 List of nationally …

Last updated: 13/09/2018
Active substance: spironolactone, hydrochlorothiazide
Procedure number: PSUSA/00001662/201801
Regulatory outcome: Maintenance
List item

Hydrochlorothiazide, spironolactone: List of nationally authorised medicinal products - PSUSA/00001662/201501 (PDF/63.12 KB)

authorised medicinal products - PSUSA/00001662/201501 … authorised medicinal products - PSUSA/00001662/201501 EMA/270645/2015 08/12/2015 … spironolactone Procedure no.: PSUSA/00001662/201501 Product Name …

Last updated: 17/10/2016
Active substance: hydrochlorothiazide, spironolactone
Procedure number: PSUSA/00001662/201501
Regulatory outcome: Variation
List item

Hydrochlorothiazide, spironolactone: CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable forthe implementation - PSUSA/00001662/201501 (PDF/1.53 MB)

timetable forthe implementation - PSUSA/00001662/201501 … timetable forthe implementation - PSUSA/00001662/201501 EMA/739537/2015 08/12/2015 … spironolactone Procedure no.: PSUSA/00001662/201501 …

Last updated: 17/10/2016
Active substance: hydrochlorothiazide, spironolactone
Procedure number: PSUSA/00001662/201501
Regulatory outcome: Variation
List item

Carboprost - List of nationally authorised medicinal products - PSUSA-0000560-202101 (PDF/123.23 KB)

authorised medicinal products - PSUSA-0000560-202101 … authorised medicinal products - PSUSA-0000560-202101 EMA/509535/2021 13/09/2021 … carboprost Procedure No.: PSUSA/00000560/202101 List of nationally …

Last updated: 13/09/2021
Active substance: carboprost
Procedure number: PSUSA-0000560-202101
Regulatory outcome: Maintenance
List item

Nomegestrol - List of nationally authorised medicinal products - PSUSA-00002181-202101 (PDF/116.5 KB)

authorised medicinal products - PSUSA-00002181-202101 … authorised medicinal products - PSUSA-00002181-202101 EMA/538762/2021 04/10/2021 … nomegestrol Procedure no.: PSUSA/00002181/202101 List of nationally …

Last updated: 04/10/2021
Active substance: nomegestrol
Procedure number: PSUSA/00002181/202101
Regulatory outcome: Maintenance
List item

Cefoperazone - List of nationally authorised medicinal products - PSUSA-00000597-202101 (PDF/128.73 KB)

authorised medicinal products - PSUSA-00000597-202101 … authorised medicinal products - PSUSA-00000597-202101 EMA/473765/2021Adopted 27/10 … cefoperazone Procedure no.: PSUSA/00000597/202101 List of nationally …

Last updated: 27/10/2021
Active substance: cefoperazone
Procedure number: PSUSA/00000597/202101
Regulatory outcome: Variation
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Argatroban : List of nationally authorised medicinal products - PSUSA/00009057/202101 (PDF/131.55 KB)

authorised medicinal products - PSUSA/00009057/202101 … authorised medicinal products - PSUSA/00009057/202101 EMA/656136/2021 12/11/2021 … argatroban Procedure no.: PSUSA/ 00009057 202101 …

Last updated: 12/11/2021
Active substance: argatroban
Procedure number: PSUSA/ 00009057/202101
Regulatory outcome: Maintenance
List item

Alizapride: List of nationally authorised medicinal products - PSUSA-00000091-202101 (PDF/162.98 KB)

authorised medicinal products - PSUSA-00000091-202101 … authorised medicinal products - PSUSA-00000091-202101 EMA/517927/2021 15/09/2021 … alizapride Procedure no.: PSUSA/00000091/202101 List of nationally …

Last updated: 15/09/2021
Active substance: alizapride
Procedure number: PSUSA/00000091/202101
Regulatory outcome: Maintenance
List item

Propafenone : List of nationally authorised medicinal products : PSUSA/00002550/202101 (PDF/191.13 KB)

authorised medicinal products : PSUSA/00002550/202101 … authorised medicinal products : PSUSA/00002550/202101 EMA/583331/2021 13/10/2021 … propafenone Procedure no.: PSUSA/00002550/202101 List of nationally …

Last updated: 13/10/2021
Active substance: propafenone
Procedure number: PSUSA/00002550/202101
Regulatory outcome: Maintenance
List item

Alendronate : List of nationally authorised medicinal products - PSUSA/00000078/202101 (PDF/187.74 KB)

authorised medicinal products - PSUSA/00000078/202101 … authorised medicinal products - PSUSA/00000078/202101 EMA/PRAC/468922/2021 15/03/20 … alendronate Procedure No.: PSUSA/00000078/202101 EMA/PRAC/468922/2021 …

Last updated: 15/03/2022
Active substance: alendronate
Procedure number: PSUSA/00000078/202101
Regulatory outcome: Maintenance
List item

Calcitriol - List of nationally authorised medicinal products - PSUSA/00000495/202101 (PDF/281.49 KB)

authorised medicinal products - PSUSA/00000495/202101 … authorised medicinal products - PSUSA/00000495/202101 EMA/294429/2021 21/01/2022 … calcitriol Procedure No.: PSUSA/00000495/202101 List of nationally …

Last updated: 21/01/2022
Active substance: calcitriol
Procedure number: PSUSA/00000495/202101
Regulatory outcome: Maintenance
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Betamethasone : List of nationally authorised medicinal products - PSUSA/00000391/202101 (PDF/403.76 KB)

authorised medicinal products - PSUSA/00000391/202101 … authorised medicinal products - PSUSA/00000391/202101 EMA/618045/2021 29/10/2021 … betamethasone Procedure no.: PSUSA/00000391/202101 List of nationally …

Last updated: 29/10/2021
Active substance: betamethasone
Procedure number: PSUSA/00000391/202101
Regulatory outcome: Variation
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Dexamethasone - List of nationally authorised medicinal products - PSUSA-00000973-202101 (PDF/392.14 KB)

authorised medicinal products - PSUSA-00000973-202101 … authorised medicinal products - PSUSA-00000973-202101 EMA/709165/2021 30/11/2021 … products) Procedure no.: PSUSA/00000973/202101 List of nationally …

Last updated: 30/11/2021
Active substance: dexamethasone
Procedure number: PSUSA/00000973/202101
Regulatory outcome: Variation
List item

Betamethasone valerate / clioquinol: List of nationally authorised medicinal products - PSUSA/00000398/202101 (PDF/95.06 KB)

authorised medicinal products - PSUSA/00000398/202101 … authorised medicinal products - PSUSA/00000398/202101 EMA/260265/2021 06/09/2021 … clioquinol Procedure no.: PSUSA/00000398/202101 List of nationally …

Last updated: 06/09/2021
Active substance: Betamethasone valerate, clioquinol
Procedure number: PSUSA/00000398/202101
Regulatory outcome: Maintenance
List item

Amitriptyline / perphenazine - List of nationally authorised medicinal products - PSUSA-00000170-202101 (PDF/92.73 KB)

authorised medicinal products - PSUSA-00000170-202101 … authorised medicinal products - PSUSA-00000170-202101 EMA/708781/2021Adopted 29/11 … perphenazine Procedure no.: PSUSA/00000170/202101 List of nationally …

Last updated: 29/11/2021
Active substance: amitriptyline, perphenazine
Procedure number: PSUSA/00000170/202101
Regulatory outcome: Variation
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Cefoperazone / sulbactam : List of nationally authorised medicinal products - PSUSA/00000598/202101 (PDF/130.3 KB)

authorised medicinal products - PSUSA/00000598/202101 … authorised medicinal products - PSUSA/00000598/202101 EMA/540538/2021 24/09/2021 … sulbactam Procedure no.: PSUSA/00000598/202101 List of nationally …

Last updated: 24/09/2021
Active substance: cefoperazone / sulbactam
Procedure number: PSUSA/00000598/202101
Regulatory outcome: Maintenance
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Levonorgestrel / ethinylestradiol, ethinylestradiol : List of nationally authorised medicinal products - PSUSA/00010442/202101 (PDF/138.88 KB)

authorised medicinal products - PSUSA/00010442/202101 … authorised medicinal products - PSUSA/00010442/202101 EMA/502098/2021 08/09/2021 … combination pack) Procedure no.: PSUSA/00010442/202101 List of nationally …

Last updated: 08/09/2021
Active substance: levonorgestrel/ethinylestradiol, ethinylestradiol (combination pack)
Procedure number: PSUSA/00010442/202101
Regulatory outcome: Maintenance
List item

Iron dextran : list of nationally authorised medicinal products - PSUSA/00010696/202101 (PDF/94.44 KB)

authorised medicinal products - PSUSA/00010696/202101 … authorised medicinal products - PSUSA/00010696/202101 EMA/540044/2021 24/09/2021 … dextran Procedure no.: PSUSA/00010696/202101 …

Last updated: 24/09/2021
Active substance: iron dextran
Procedure number: PSUSA/00010696/202101
Regulatory outcome: Maintenance
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Cytomegalovirus immunoglobulin - List of nationally authorised medicinal products - PSUSA-00000914-202101 (PDF/141.83 KB)

authorised medicinal products - PSUSA-00000914-202101 … authorised medicinal products - PSUSA-00000914-202101 EMA/382258/2015 04/10/2021 … immunoglobulin Procedure no.: PSUSA/00000914/202101 List of nationally …

Last updated: 04/10/2021
Active substance: cytomegalovirus immunoglobulin
Procedure number: PSUSA/00000914/202101
Regulatory outcome: Maintenance
List item

Altizide / spironolactone - List of nationally authorised medicinal products - PSUSA/00002781/202101 (PDF/194.21 KB)

authorised medicinal products - PSUSA/00002781/202101 … authorised medicinal products - PSUSA/00002781/202101 EMA/294429/2021 21/01/2022 … spironolactone Procedure No.: PSUSA/00002781/202101 List of nationally …

Last updated: 21/01/2022
Active substance: altizide, spironolactone
Procedure number: PSUSA/00002781/202101
Regulatory outcome: Maintenance
List item

Iron sucrose : List of nationally authorised medicinal products - PSUSA/00010864/202101 (PDF/143.57 KB)

authorised medicinal products - PSUSA/00010864/202101 … authorised medicinal products - PSUSA/00010864/202101 EMA/495002/2021 03/09/2021 … preparations) Procedure no.: PSUSA/00010864/202101 2 Product Name …

Last updated: 03/09/2021
Active substance: iron sucrose
Procedure number: PSUSA/00010864/202101
Regulatory outcome: Maintenance
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Alitretinoin (oral use) : List of nationally authorised medicinal products - PSUSA/00010710/202101 (PDF/142.76 KB)

authorised medicinal products - PSUSA/00010710/202101 … authorised medicinal products - PSUSA/00010710/202101 EMA/503442/2021 08/09/2021 … oral use) Procedure no.: PSUSA/00010710/202101 List of nationally …

Last updated: 08/09/2021
Active substance: alitretinoin
Procedure number: PSUSA/00010710/202101
Regulatory outcome: Maintenance
List item

Iron isomaltoside : List of nationally authorised medicinal products - PSUSA/00010866/202101 (PDF/204.6 KB)

authorised medicinal products - PSUSA/00010866/202101 … authorised medicinal products - PSUSA/00010866/202101 EMA/540123/2021 24/09/2021 … preparations) Procedure no.: PSUSA/00010866/202101 …

Last updated: 24/09/2021
Active substance: iron isomaltoside
Procedure number: PSUSA/00010866/202101
Regulatory outcome: Maintenance

2219 results

Hydrochlorothiazide / spironolactone : List of nationally authorised medicinal products - PSUSA/00001662/202101 (PDF/105.37 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)

Hydrochlorothiazide / spironolactone: List of nationally authorised medicinal products - PSUSA/00001662/201801 (PDF/69.12 KB)

Hydrochlorothiazide, spironolactone: List of nationally authorised medicinal products - PSUSA/00001662/201501 (PDF/63.12 KB)

Hydrochlorothiazide, spironolactone: CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable forthe implementation - PSUSA/00001662/201501 (PDF/1.53 MB)

Carboprost - List of nationally authorised medicinal products - PSUSA-0000560-202101 (PDF/123.23 KB)

Nomegestrol - List of nationally authorised medicinal products - PSUSA-00002181-202101 (PDF/116.5 KB)

Cefoperazone - List of nationally authorised medicinal products - PSUSA-00000597-202101 (PDF/128.73 KB)

Argatroban : List of nationally authorised medicinal products - PSUSA/00009057/202101 (PDF/131.55 KB)

Alizapride: List of nationally authorised medicinal products - PSUSA-00000091-202101 (PDF/162.98 KB)

Propafenone : List of nationally authorised medicinal products : PSUSA/00002550/202101 (PDF/191.13 KB)

Alendronate : List of nationally authorised medicinal products - PSUSA/00000078/202101 (PDF/187.74 KB)

Calcitriol - List of nationally authorised medicinal products - PSUSA/00000495/202101 (PDF/281.49 KB)

Betamethasone : List of nationally authorised medicinal products - PSUSA/00000391/202101 (PDF/403.76 KB)

Dexamethasone - List of nationally authorised medicinal products - PSUSA-00000973-202101 (PDF/392.14 KB)

Betamethasone valerate / clioquinol: List of nationally authorised medicinal products - PSUSA/00000398/202101 (PDF/95.06 KB)

Amitriptyline / perphenazine - List of nationally authorised medicinal products - PSUSA-00000170-202101 (PDF/92.73 KB)

Cefoperazone / sulbactam : List of nationally authorised medicinal products - PSUSA/00000598/202101 (PDF/130.3 KB)

Levonorgestrel / ethinylestradiol, ethinylestradiol : List of nationally authorised medicinal products - PSUSA/00010442/202101 (PDF/138.88 KB)

Iron dextran : list of nationally authorised medicinal products - PSUSA/00010696/202101 (PDF/94.44 KB)

Cytomegalovirus immunoglobulin - List of nationally authorised medicinal products - PSUSA-00000914-202101 (PDF/141.83 KB)

Altizide / spironolactone - List of nationally authorised medicinal products - PSUSA/00002781/202101 (PDF/194.21 KB)

Iron sucrose : List of nationally authorised medicinal products - PSUSA/00010864/202101 (PDF/143.57 KB)

Alitretinoin (oral use) : List of nationally authorised medicinal products - PSUSA/00010710/202101 (PDF/142.76 KB)

Iron isomaltoside : List of nationally authorised medicinal products - PSUSA/00010866/202101 (PDF/204.6 KB)