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Fluconazole: List of nationally authorised medicinal products - PSUSA/00001404/202003 (PDF/476.81 KB)

authorised medicinal products - PSUSA/00001404/202003 … authorised medicinal products - PSUSA/00001404/202003 EMA/698316/2020 21/12/2020 … Active substance: Fluconazole PSUSA/00001404/202003 Procedure no PSUSA/00001404/202003 List of nationally …

Last updated: 21/12/2020
Active substance: fluconazole
Procedure number: PSUSA/00001404/202003
Regulatory outcome: Variation
List item

Fluconazole: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001404/202003 (PDF/117.21 KB)

for the implementation - PSUSA/00001404/202003 … for the implementation - PSUSA/00001404/202003 Other languages: bg cs da …

Last updated: 21/12/2020
Active substance: fluconazole
Procedure number: PSUSA/00001404/202003
Regulatory outcome: Variation
Bulgarian
(PDF/130.16 KB)

Croatian
(PDF/121.13 KB)

Czech
(PDF/119.4 KB)

Danish
(PDF/117.66 KB)

Dutch
(PDF/123.74 KB)

Estonian
(PDF/117.61 KB)

Finnish
(PDF/115.73 KB)

French
(PDF/123.5 KB)

German
(PDF/125.43 KB)

Greek
(PDF/133.01 KB)

Hungarian
(PDF/120.62 KB)

Icelandic
(PDF/122.57 KB)

Italian
(PDF/122.47 KB)

Latvian
(PDF/128.58 KB)

Lithuanian
(PDF/129.16 KB)

Maltese
(PDF/130.1 KB)

Norwegian
(PDF/117.98 KB)

Polish
(PDF/127.56 KB)

Portuguese
(PDF/122.2 KB)

Romanian
(PDF/117.25 KB)

Slovak
(PDF/126.34 KB)

Slovenian
(PDF/125.92 KB)

Spanish
(PDF/119.67 KB)

Swedish
(PDF/118.59 KB)
List item

Fluconazole: List of nationally authorised medicinal products - PSUSA/00001404/201703 (PDF/487.17 KB)

authorised medicinal products - PSUSA/00001404/201703 … authorised medicinal products - PSUSA/00001404/201703 EMA/716513/2017 26/10/2017 … authorised medicinal products - PSUSA/00001404/201703 30 Churchill Place …

Last updated: 26/10/2017
Active substance: fluconazole
Procedure number: PSUSA/00001404/201703
Regulatory outcome: Maintenance
List item

Metamizole: List of nationally authorised medicinal products - PSUSA/00001997/202003 (PDF/162.1 KB)

authorised medicinal products - PSUSA/00001997/202003 … authorised medicinal products - PSUSA/00001997/202003 EMA/270645/2015 18/12/2020 … metamizole Procedure no.: PSUSA/00001997/202003 List of nationally …

Last updated: 18/12/2020
Active substance: metamizole
Procedure number: PSUSA/00001997/202003
Regulatory outcome: Variation
List item

Galantamine: List of nationally authorised medicinal products - PSUSA/00001512/202003 (PDF/214.5 KB)

authorised medicinal products - PSUSA/00001512/202003 … authorised medicinal products - PSUSA/00001512/202003 EMA/270645/2015 18/12/2020 … galantamine Procedure no.: PSUSA/00001512/202003 List of nationally …

Last updated: 18/12/2020
Active substance: galantamine
Procedure number: PSUSA/00001512/202003
Regulatory outcome: Variation
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Ethosuximide: List of nationally authorised medicinal products - PSUSA/00001316/202003 (PDF/128.93 KB)

authorised medicinal products - PSUSA/00001316/202003 … authorised medicinal products - PSUSA/00001316/202003 EMA/10382/2021 08/01/2021 … ethosuximide Procedure no.: PSUSA/00001316/202003 List of nationally …

Last updated: 08/01/2021
Active substance: ethosuximide
Procedure number: PSUSA/00001316/202003
Regulatory outcome: Variation
List item

Piribedil: List of nationally authorised medicinal products - PSUSA/00002436/202003 (PDF/135 KB)

authorised medicinal products - PSUSA/00002436/202003 … authorised medicinal products - PSUSA/00002436/202003 EMA/646822/2020 04/12/2020 … piribedil Procedure no.: PSUSA/00002436/202003 List of nationally …

Last updated: 04/12/2020
Active substance: piribedil
Procedure number: PSUSA/00002436/202003
Regulatory outcome: Maintenance
List item

Aceclofenac: List of nationally authorised medicinal products - PSUSA/00000022/202003 (PDF/158.47 KB)

authorised medicinal products - PSUSA/00000022/202003 … authorised medicinal products - PSUSA/00000022/202003 EMA/646694/2020 04/12/2020 … aceclofenac Procedure no.: PSUSA/00000022/202003 List of nationally …

Last updated: 04/12/2020
Active substance: aceclofenac
Procedure number: PSUSA/00000022/202003
Regulatory outcome: Maintenance
List item

Flucloxacillin: List of nationally authorised medicinal products - PSUSA/00001402/202003 (PDF/295.42 KB)

authorised medicinal products - PSUSA/00001402/202003 … authorised medicinal products - PSUSA/00001402/202003 EMA/14202/2021 11/01/2021 … flucloxacillin Procedure no.: PSUSA/00001402/202003 List of nationally …

Last updated: 11/01/2021
Active substance: flucloxacillin
Procedure number: PSUSA/00001402/202003
Regulatory outcome: Variation
List item

Gentamicin : List of nationally authorised medicinal products - PSUSA/00009159/202003 (PDF/272.25 KB)

authorised medicinal products - PSUSA/00009159/202003 … authorised medicinal products - PSUSA/00009159/202003 EMA/640938/2020 01/12/2020 …

Last updated: 01/12/2020
Active substance: gentamicin
Procedure number: PSUSA/00009159/202003
Regulatory outcome: Maintenance
List item

Pravastatin : List of nationally authorised medicinal products - PSUSA/00002500/202003 (PDF/178.57 KB)

authorised medicinal products - PSUSA/00002500/202003 … authorised medicinal products - PSUSA/00002500/202003 EMA/646100/2020 02/12/2020 …

Last updated: 02/12/2020
Active substance: Pravastatin
Procedure number: PSUSA/00002500/202003
Regulatory outcome: Maintenance
List item

Racecadotril : List of nationally authorised medicinal products - PSUSA/00002602/202003 (PDF/365.46 KB)

authorised medicinal products - PSUSA/00002602/202003 … authorised medicinal products - PSUSA/00002602/202003 EMA/646224/2020 03/12/2020 …

Last updated: 03/12/2020
Active substance: racecadotril
Procedure number: PSUSA/00002602/202003
Regulatory outcome: Maintenance
List item

Ascorbic acid / paracetamol / pheniramine maleate : List of nationally authorised medicinal products - PSUSA/00002368/202003 (PDF/152.64 KB)

authorised medicinal products - PSUSA/00002368/202003 … authorised medicinal products - PSUSA/00002368/202003 … maleate Procedure No.: PSUSA/00002368/202003 EMA/700848/2020 …

Last updated: 22/12/2020
Active substance: ascorbic acid, paracetamol, pheniramine maleate
Procedure number: PSUSA/00002368/202003
Regulatory outcome: Maintenance
List item

Influenza vaccine (surface antigen, inactivated, adjuvanted) : List of nationally authorised medicinal products - PSUSA/00010300/202003 (PDF/128.12 KB)

authorised medicinal products - PSUSA/00010300/202003 … authorised medicinal products - PSUSA/00010300/202003 …

Last updated: 19/10/2020
Active substance: influenza vaccine (surface antigen, inactivated, adjuvanted)
Procedure number: PSUSA/00010300/202003
Regulatory outcome: Maintenance
List item

Influenza vaccine (surface antigen, inactivated) : List of nationally authorised medicinal products - PSUSA/00001744/202003 (PDF/166.73 KB)

authorised medicinal products - PSUSA/00001744/202003 … authorised medicinal products - PSUSA/00001744/202003 …

Last updated: 19/10/2020
Active substance: influenza vaccine (surface antigen, inactivated)
Procedure number: PSUSA/00001744/202003
Regulatory outcome: Maintenance
List item

Trandolapril / verapamil : List of nationally authorised medicinal products - PSUSA/00003005/202003 (PDF/210.1 KB)

authorised medicinal products - PSUSA/00003005/202003 … authorised medicinal products - PSUSA/00003005/202003 EMA/700852/2020 22/12/2020 … verapamil Procedure No.: PSUSA/00003005/202003 EMA/700852/2020 …

Last updated: 22/12/2020
Active substance: trandolapril, verapamil
Procedure number: PSUSA/00003005/202003
Regulatory outcome: Maintenance
List item

Lamivudine / tenofovir disoproxil: List of nationally authorised medicinal products - PSUSA/00010751/202003 (PDF/114.81 KB)

authorised medicinal products - PSUSA/00010751/202003 … authorised medicinal products - PSUSA/00010751/202003 EMA/634109/2020 30/11/2020 …

Last updated: 30/11/2020
Active substance: lamivudine, tenofovir disoproxil
Procedure number: PSUSA/00010751/202003
Regulatory outcome: Variation
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Hydroxyethyl starch : List of nationally authorised medicinal products - PSUSA/00001694/202003 (PDF/347.23 KB)

authorised medicinal products - PSUSA/00001694/202003 … authorised medicinal products - PSUSA/00001694/202003 EMA/646222/2020 03/12/2020 …

Last updated: 03/12/2020
Active substance: hydroxyethyl starch
Procedure number: PSUSA/00001694/202003
Regulatory outcome: Maintenance
List item

Influenza vaccine (split virion, inactivated, prepared in cell cultures) : List of nationally authorised medicinal products - PSUSA/00010299/202003 (PDF/105.97 KB)

authorised medicinal products - PSUSA/00010299/202003 … authorised medicinal products - PSUSA/00010299/202003 …

Last updated: 19/10/2020
Active substance: Influenza vaccine (split virion, inactivated, prepared in cell cultures)
Procedure number: PSUSA/00010299/202003
Regulatory outcome: Maintenance
List item

Influenza vaccine (split virion, inactivated) (non centrally authorised products): List of nationally authorised medicinal products - PSUSA/00010298/202003 (PDF/301.29 KB)

authorised medicinal products - PSUSA/00010298/202003 … authorised medicinal products - PSUSA/00010298/202003 …

Last updated: 19/10/2020
Active substance: influenza vaccine (split virion, inactivated)
Procedure number: PSUSA/00010298/202003
Regulatory outcome: Maintenance
List item

Galantamine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001512/202003 (PDF/32.94 KB)

for the implementation - PSUSA/00001512/202003 … for the implementation - PSUSA/00001512/202003 Other languages: bg cs da …

Last updated: 18/12/2020
Active substance: galantamine
Procedure number: PSUSA/00001512/202003
Regulatory outcome: Variation
Bulgarian
(PDF/106.75 KB)

Croatian
(PDF/102.28 KB)

Czech
(PDF/105.08 KB)

Danish
(PDF/36.48 KB)

Dutch
(PDF/37.23 KB)

Estonian
(PDF/35.04 KB)

Finnish
(PDF/33.87 KB)

French
(PDF/33.05 KB)

German
(PDF/34 KB)

Greek
(PDF/111.71 KB)

Hungarian
(PDF/105.02 KB)

Italian
(PDF/36.19 KB)

Latvian
(PDF/108.01 KB)

Lithuanian
(PDF/103.66 KB)

Maltese
(PDF/109.49 KB)

Norwegian
(PDF/33.92 KB)

Polish
(PDF/108.36 KB)

Portuguese
(PDF/34.27 KB)

Romanian
(PDF/100.43 KB)

Slovak
(PDF/109.9 KB)

Slovenian
(PDF/100.17 KB)

Spanish
(PDF/37.49 KB)

Swedish
(PDF/50.48 KB)
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Metamizole: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001997/202003 (PDF/153.93 KB)

for the implementation - PSUSA/00001997/202003 … for the implementation - PSUSA/00001997/202003 Other languages: bg cz da …

Last updated: 18/12/2020
Active substance: metamizole
Procedure number: PSUSA/00001997/202003
Regulatory outcome: Variation
(PDF/186.62 KB)

Bulgarian
(PDF/199.2 KB)

Croatian
(PDF/176.96 KB)

Danish
(PDF/158.48 KB)

Dutch
(PDF/115.56 KB)

Estonian
(PDF/157.86 KB)

Finnish
(PDF/157.08 KB)

French
(PDF/175.53 KB)

German
(PDF/232.71 KB)

Greek
(PDF/176.46 KB)

Hungarian
(PDF/64.54 KB)

Italian
(PDF/231.39 KB)

Latvian
(PDF/187.47 KB)

Lithuanian
(PDF/192.47 KB)

Maltese
(PDF/190.82 KB)

Polish
(PDF/192.48 KB)

Portuguese
(PDF/159.83 KB)

Romanian
(PDF/163.62 KB)

Slovak
(PDF/215.8 KB)

Slovenian
(PDF/182.66 KB)

Spanish
(PDF/56.59 KB)

Swedish
(PDF/158.64 KB)
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Flucloxacillin : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001402/202003 (PDF/120.73 KB)

for the implementation - PSUSA/00001402/202003 … for the implementation - PSUSA/00001402/202003 Other languages: bg cs da …

Last updated: 11/01/2021
Active substance: flucloxacillin
Procedure number: PSUSA/00001402/202003
Regulatory outcome: Variation
Bulgarian
(PDF/168.95 KB)

Croatian
(PDF/154.91 KB)

Czech
(PDF/162.85 KB)

Danish
(PDF/157.2 KB)

Dutch
(PDF/146.76 KB)

Estonian
(PDF/140.74 KB)

Finnish
(PDF/142.26 KB)

French
(PDF/139.26 KB)

German
(PDF/149.49 KB)

Greek
(PDF/157.12 KB)

Hungarian
(PDF/163.85 KB)

Icelandic
(PDF/159.27 KB)

Italian
(PDF/167.63 KB)

Latvian
(PDF/157.5 KB)

Lithuanian
(PDF/194.82 KB)

Maltese
(PDF/174.08 KB)

Polish
(PDF/155.21 KB)

Portuguese
(PDF/143.73 KB)

Romanian
(PDF/157.82 KB)

Slovak
(PDF/178.7 KB)

Slovenian
(PDF/94.69 KB)

Spanish
(PDF/143.17 KB)

Swedish
(PDF/142.44 KB)
List item

Ethosuximide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementatio - PSUSA/00001316/202003 (PDF/115.33 KB)

timetable for the implementatio - PSUSA/00001316/202003 … timetable for the implementatio - PSUSA/00001316/202003 Other languages: bg cs da …

Last updated: 08/01/2021
Active substance: ethosuximide
Procedure number: PSUSA/00001316/202003
Regulatory outcome: Variation
Bulgarian
(PDF/242.91 KB)

Croatian
(PDF/253.03 KB)

Czech
(PDF/166.53 KB)

Danish
(PDF/201.35 KB)

Dutch
(PDF/174.67 KB)

Estonian
(PDF/203.84 KB)

Finnish
(PDF/173.18 KB)

French
(PDF/183.31 KB)

German
(PDF/189.18 KB)

Greek
(PDF/129.55 KB)

Hungarian
(PDF/213.81 KB)

Icelandic
(PDF/183.39 KB)

Italian
(PDF/232.51 KB)

Latvian
(PDF/150.36 KB)

Lithuanian
(PDF/290.68 KB)

Maltese
(PDF/276.37 KB)

Norwegian
(PDF/180.79 KB)

Polish
(PDF/283.95 KB)

Portuguese
(PDF/199.31 KB)

Romanian
(PDF/283.28 KB)

Slovak
(PDF/261.36 KB)

Slovenian
(PDF/257.15 KB)

Spanish
(PDF/116.86 KB)

Swedish
(PDF/189.81 KB)
List item

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

3498 results

Fluconazole: List of nationally authorised medicinal products - PSUSA/00001404/202003 (PDF/476.81 KB)

Fluconazole: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001404/202003 (PDF/117.21 KB)

Fluconazole: List of nationally authorised medicinal products - PSUSA/00001404/201703 (PDF/487.17 KB)

Metamizole: List of nationally authorised medicinal products - PSUSA/00001997/202003 (PDF/162.1 KB)

Galantamine: List of nationally authorised medicinal products - PSUSA/00001512/202003 (PDF/214.5 KB)

Ethosuximide: List of nationally authorised medicinal products - PSUSA/00001316/202003 (PDF/128.93 KB)

Piribedil: List of nationally authorised medicinal products - PSUSA/00002436/202003 (PDF/135 KB)

Aceclofenac: List of nationally authorised medicinal products - PSUSA/00000022/202003 (PDF/158.47 KB)

Flucloxacillin: List of nationally authorised medicinal products - PSUSA/00001402/202003 (PDF/295.42 KB)

Gentamicin : List of nationally authorised medicinal products - PSUSA/00009159/202003 (PDF/272.25 KB)

Pravastatin : List of nationally authorised medicinal products - PSUSA/00002500/202003 (PDF/178.57 KB)

Racecadotril : List of nationally authorised medicinal products - PSUSA/00002602/202003 (PDF/365.46 KB)

Ascorbic acid / paracetamol / pheniramine maleate : List of nationally authorised medicinal products - PSUSA/00002368/202003 (PDF/152.64 KB)

Influenza vaccine (surface antigen, inactivated, adjuvanted) : List of nationally authorised medicinal products - PSUSA/00010300/202003 (PDF/128.12 KB)

Influenza vaccine (surface antigen, inactivated) : List of nationally authorised medicinal products - PSUSA/00001744/202003 (PDF/166.73 KB)

Trandolapril / verapamil : List of nationally authorised medicinal products - PSUSA/00003005/202003 (PDF/210.1 KB)

Lamivudine / tenofovir disoproxil: List of nationally authorised medicinal products - PSUSA/00010751/202003 (PDF/114.81 KB)

Hydroxyethyl starch : List of nationally authorised medicinal products - PSUSA/00001694/202003 (PDF/347.23 KB)

Influenza vaccine (split virion, inactivated, prepared in cell cultures) : List of nationally authorised medicinal products - PSUSA/00010299/202003 (PDF/105.97 KB)

Influenza vaccine (split virion, inactivated) (non centrally authorised products): List of nationally authorised medicinal products - PSUSA/00010298/202003 (PDF/301.29 KB)

Galantamine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001512/202003 (PDF/32.94 KB)

Metamizole: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001997/202003 (PDF/153.93 KB)

Flucloxacillin : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001402/202003 (PDF/120.73 KB)

Ethosuximide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementatio - PSUSA/00001316/202003 (PDF/115.33 KB)

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