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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
List item

Betamethasone : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000391/202101 (PDF/156.56 KB)

for the implementation - PSUSA/00000391/202101 … for the implementation - PSUSA/00000391/202101 Other languages: bg cs da …

Last updated: 18/10/2022
Active substance: betamethasone
Procedure number: PSUSA/00000391/202101
Regulatory outcome: Variation
Bulgarian
(PDF/126.38 KB)

Croatian
(PDF/218.18 KB)

Czech
(PDF/411.72 KB)

Danish
(PDF/156.89 KB)

Dutch
(PDF/135.15 KB)

Estonian
(PDF/150.55 KB)

Finnish
(PDF/113.87 KB)

French
(PDF/192.49 KB)

German
(PDF/107.8 KB)

Greek
(PDF/126.78 KB)

Hungarian
(PDF/215.99 KB)

Icelandic
(PDF/125.77 KB)

Italian
(PDF/123.46 KB)

Latvian
(PDF/165.6 KB)

Lithuanian
(PDF/429.9 KB)

Maltese
(PDF/90.56 KB)

Norwegian
(PDF/182.53 KB)

Polish
(PDF/206.42 KB)

Portuguese
(PDF/156.53 KB)

Romanian
(PDF/130.4 KB)

Slovak
(PDF/125.51 KB)

Slovenian
(PDF/198.26 KB)

Spanish
(PDF/157.21 KB)

Swedish
(PDF/175.82 KB)
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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
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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
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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
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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
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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
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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
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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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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
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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
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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
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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
List item

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
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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
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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
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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
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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
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Caffeine / drotaverine hydrochloride / metamizol sodium : List of nationally authorised medicinal products - PSUSA/00001996/202101 (PDF/112.62 KB)

authorised medicinal products - PSUSA/00001996/202101 … authorised medicinal products - PSUSA/00001996/202101 EMA/505443/2021 09/09/2021 … metamizol sodium Procedure no.: PSUSA/00001996/202101 List of nationally …

Last updated: 09/09/2021
Active substance: Caffeine, drotaverine hydrochloride, metamizol sodium
Procedure number: PSUSA/00001996/202101
Regulatory outcome: Maintenance
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Sodium iron gluconate (parenteral preparations) - List of nationally authorised medicinal products - PSUSA-00010867-202101 (PDF/121.43 KB)

authorised medicinal products - PSUSA-00010867-202101 … authorised medicinal products - PSUSA-00010867-202101 EMA/520175/2021 15/09/2021 … preparations) Procedure no.: PSUSA/00010867/202101 List of nationally …

Last updated: 15/09/2021
Active substance: sodium iron gluconate (parenteral preparations)
Procedure number: PSUSA/00010867/202101
Regulatory outcome: Maintenance
List item

Betamethasone dipropionate clotrimazole - List of nationally authorised medicinal products - PSUSA-00000394-202101 (PDF/104.33 KB)

authorised medicinal products - PSUSA-00000394-202101 … authorised medicinal products - PSUSA-00000394-202101 EMA/260262/2021Adopted 06/09 … clotrimazole Procedure no.: PSUSA/00000394/202101 List of nationally …

Last updated: 06/09/2021
Active substance: betamethasone dipropionate clotrimazole
Procedure number: PSUSA/00000394/202101
Regulatory outcome: Maintenance

3485 results

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

Betamethasone : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000391/202101 (PDF/156.56 KB)

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)

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)

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

Caffeine / drotaverine hydrochloride / metamizol sodium : List of nationally authorised medicinal products - PSUSA/00001996/202101 (PDF/112.62 KB)

Sodium iron gluconate (parenteral preparations) - List of nationally authorised medicinal products - PSUSA-00010867-202101 (PDF/121.43 KB)

Betamethasone dipropionate clotrimazole - List of nationally authorised medicinal products - PSUSA-00000394-202101 (PDF/104.33 KB)