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Perindopril - List of nationally authorised medicinal products - PSUSA-00002354-202010 (PDF/519.57 KB)

authorised medicinal products - PSUSA-00002354-202010 … authorised medicinal products - PSUSA-00002354-202010 … perindopril Procedure no.: PSUSA/00002354/202010 List of nationally …

Last updated: 03/08/2021
Active substance: perindopril
Procedure number: PSUSA/00002354/202010
Regulatory outcome: Variation
List item

Perindopril - Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation - PSUSA-00002354-202010 (PDF/140.61 KB)

Marketing Authorisation - PSUSA-00002354-202010 … Marketing Authorisation - PSUSA-00002354-202010 …

Last updated: 03/08/2021
Active substance: perindopril
Procedure number: PSUSA/00002354/202010
Regulatory outcome: Variation
Bulgarian
(PDF/514.06 KB)

Croatian
(PDF/153.44 KB)

Czech
(PDF/91.23 KB)

Danish
(PDF/166.57 KB)

Dutch
(PDF/35.84 KB)

Estonian
(PDF/135.47 KB)

Finnish
(PDF/138.55 KB)

French
(PDF/148.58 KB)

German
(PDF/123.74 KB)

Greek
(PDF/191.39 KB)

Hungarian
(PDF/229.7 KB)

Icelandic
(PDF/45.68 KB)

Italian
(PDF/45.41 KB)

Latvian
(PDF/108.53 KB)

Lithuanian
(PDF/122.26 KB)

Maltese
(PDF/68.28 KB)

Norwegian
(PDF/162.45 KB)

Polish
(PDF/208.2 KB)

Portuguese
(PDF/121.45 KB)

Romanian
(PDF/218.41 KB)

Slovak
(PDF/225.95 KB)

Slovenian
(PDF/160.87 KB)

Spanish
(PDF/117.59 KB)

Swedish
(PDF/161.05 KB)
List item

Perindopril: List of nationally authorised medicinal products - PSUSA/00002354/201510 (PDF/439.31 KB)

authorised medicinal products - PSUSA/00002354/201510 … authorised medicinal products - PSUSA/00002354/201510 … perindopril Procedure no.: PSUSA/00002354/201510 List of nationally …

Last updated: 17/10/2016
Active substance: perindopril
Procedure number: PSUSA/00002354/201510
Regulatory outcome: Variation
List item

Perindopril: CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation - PSUSA/00002354/201510 (PDF/812.41 KB)

for the implementation - PSUSA/00002354/201510 … for the implementation - PSUSA/00002354/201510 … perindopril Procedure no.: PSUSA/00002354/201510 1 …

Last updated: 17/10/2016
Active substance: perindopril
Procedure number: PSUSA/00002354/201510
Regulatory outcome: Variation
List item

Tetrabenazine: List of nationally authorised medicinal products - PSUSA/00002911/202010 (PDF/136.21 KB)

authorised medicinal products - PSUSA/00002911/202010 … authorised medicinal products - PSUSA/00002911/202010 … tetrabenazine Procedure no.: PSUSA/00002911/202010 List of nationally …

Last updated: 28/06/2021
Active substance: tetrabenazine
Procedure number: PSUSA/00002911/202010
Regulatory outcome: Maintenance
List item

Bisoprolol / perindopril : List of nationally authorised medicines - PSUSA/00010462/202010 (PDF/326.82 KB)

nationally authorised medicines - PSUSA/00010462/202010 … nationally authorised medicines - PSUSA/00010462/202010 …

Last updated: 16/06/2021
Active substance: bisoprolol, perindopril
Procedure number: PSUSA/00010462/202010
Regulatory outcome: Maintenance
List item

Beractant : List of nationally authorised medicines - PSUSA/00000384/202010 (PDF/148.85 KB)

nationally authorised medicines - PSUSA/00000384/202010 … nationally authorised medicines - PSUSA/00000384/202010 EMA/382258/2015 16/06/2021 … beractant Procedure no.: PSUSA/00000384/202010 List of nationally …

Last updated: 16/06/2021
Active substance: beractant
Procedure number: PSUSA/00000384/202010
Regulatory outcome: Maintenance
List item

Etifoxine : List of nationally authorised medicinal products - PSUSA/00001321/202010 (PDF/128.21 KB)

authorised medicinal products - PSUSA/00001321/202010 … authorised medicinal products - PSUSA/00001321/202010 EMA/344705/2021 17/06/2021 … etifoxine Procedure no.: PSUSA/00001321/202010 List of nationally …

Last updated: 17/06/2021
Active substance: etifoxine
Procedure number: PSUSA/00001321/202010
Regulatory outcome: Maintenance
List item

Ketotifen : List of nationally authorised medicines - PSUSA/00001813/202010 (PDF/168.87 KB)

nationally authorised medicines - PSUSA/00001813/202010 … nationally authorised medicines - PSUSA/00001813/202010 EMA/343291/2021 16/06/2021 … formulations) Procedure No: PSUSA/00001813/202010 …

Last updated: 16/06/2021
Active substance: ketotifen
Procedure number: PSUSA/00001813/202010
Regulatory outcome: Maintenance
List item

Prulifloxacin : List of nationally authorised medicinal products - PSUSA/00002569/202010 (PDF/156.94 KB)

authorised medicinal products - PSUSA/00002569/202010 … authorised medicinal products - PSUSA/00002569/202010 EMA/356899/2021 23/06/2021 … prulifloxacin Procedure no.: PSUSA/00002569/202010 List of nationally …

Last updated: 23/06/2021
Active substance: prulifloxacin
Procedure number: PSUSA/00002569/202010
Regulatory outcome: Maintenance
List item

Acitretin : List of nationally authorised medicinal products - PSUSA/00000051/202010 (PDF/256.26 KB)

authorised medicinal products - PSUSA/00000051/202010 … authorised medicinal products - PSUSA/00000051/202010 EMA/382258/2015 16/06/2021 … acitretin Procedure no.: PSUSA/00000051/202010 List of nationally …

Last updated: 16/06/2021
Active substance: acitretin
Procedure number: PSUSA/00000051/202010
Regulatory outcome: Maintenance
List item

Salmeterol : List of nationally authorised medicines - PSUSA/00002681/202010 (PDF/219.17 KB)

nationally authorised medicines - PSUSA/00002681/202010 … nationally authorised medicines - PSUSA/00002681/202010 EMA/338746/2021 16/06/2021 … salmeterol Procedure no.: PSUSA/00002681/202010 List of nationally …

Last updated: 16/06/2021
Active substance: salmeterol
Procedure number: PSUSA/00002681/202010
Regulatory outcome: Maintenance
List item

Minoxidil : List of nationally authorised medicines - PSUSA-00002067-202010 (PDF/351.94 KB)

nationally authorised medicines - PSUSA-00002067-202010 … nationally authorised medicines - PSUSA-00002067-202010 EMA/343225/2021 16/06/2021 … formulation) Procedure No: PSUSA/00002067/202010 …

Last updated: 16/06/2021
Active substance: minoxidil
Procedure number: PSUSA-00002067-202010
Regulatory outcome: Maintenance
List item

Atorvastatin / perindopril - List of nationally authorised medicinal products - PSUSA/00010679/202010 (PDF/386.57 KB)

authorised medicinal products - PSUSA/00010679/202010 … authorised medicinal products - PSUSA/00010679/202010 … perindopril Procedure No.: PSUSA/00010679/202010 List of nationally …

Last updated: 21/01/2022
Active substance: atorvastatin, perindopril
Procedure number: PSUSA/00010679/202010
Regulatory outcome: Maintenance
List item

Amlodipine / atorvastatin / perindopril - List of nationally authorised medicinal products - PSUSA/00010431/202010 (PDF/300.67 KB)

authorised medicinal products - PSUSA/00010431/202010 … authorised medicinal products - PSUSA/00010431/202010 … perindopril Procedure no.: PSUSA/00010431/202010 List of nationally …

Last updated: 15/06/2021
Active substance: amlodipine, atorvastatin, perindopril
Procedure number: PSUSA/00010431/202010
Regulatory outcome: Maintenance
List item

13C-methacetin : List of nationally authorised medicinal products - PSUSA/00010846/202010 (PDF/102.38 KB)

authorised medicinal products - PSUSA/00010846/202010 … authorised medicinal products - PSUSA/00010846/202010 EMA/346670/2021 18/06/2021 … 13C-methacetin Procedure no.: PSUSA/00010846/202010 List of nationally …

Last updated: 18/06/2021
Active substance: methacetin (13C)
Procedure number: PSUSA/00010846/202010
Regulatory outcome: Maintenance
List item

Polystyrene sulfonate - List of nationally authorised medicinal products - PSUSA-00002472-202010 (PDF/124.87 KB)

authorised medicinal products - PSUSA-00002472-202010 … authorised medicinal products - PSUSA-00002472-202010 EMA/420759/2021 03/08/2021 … sulfonate Procedure no.: PSUSA/00002472/202010 List of nationally …

Last updated: 03/08/2021
Active substance: polystyrene sulfonate
Procedure number: PSUSA/00002472/202010
Regulatory outcome: Variation
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Rubidium chloride RB-82 - List of nationally authorised medicinal products - PSUSA-00010806-202010 (PDF/104.25 KB)

authorised medicinal products - PSUSA-00010806-202010 … authorised medicinal products - PSUSA-00010806-202010 EMA/301053/2021 15/06/2021 … chloride RB-82 Procedure no.: PSUSA/00010806/202010 List of nationally …

Last updated: 15/06/2021
Active substance: Rubidium (82Rb) chloride
Procedure number: PSUSA-00010806-202010
Regulatory outcome: Maintenance
List item

Minoxidil (non-topical formulations) : List of nationally authorised medicinal products - PSUSA/00002066/202010 (PDF/88.75 KB)

authorised medicinal products - PSUSA/00002066/202010 … authorised medicinal products - PSUSA/00002066/202010 EMA/PRAC/308836/2021 11/03/20 … formulations) Procedure No.: PSUSA/00002066/202010 EMA/PRAC/308836/2021 …

Last updated: 11/03/2022
Active substance: minoxidil
Procedure number: PSUSA/00002066/202010
Regulatory outcome: Maintenance
List item

Polystyrene sulfonate - Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation - PSUSA-00002472-202010 (PDF/145.36 KB)

Marketing Authorisation - PSUSA-00002472-202010 … Marketing Authorisation - PSUSA-00002472-202010 Other languages: bg cs da …

Last updated: 03/08/2021
Active substance: polystyrene sulfonate
Procedure number: PSUSA/00002472/202010
Regulatory outcome: Variation
Bulgarian
(PDF/128.78 KB)

Croatian
(PDF/210.57 KB)

Czech
(PDF/684.58 KB)

Danish
(PDF/167.5 KB)

Dutch
(PDF/170.82 KB)

Estonian
(PDF/153.3 KB)

Finnish
(PDF/167.76 KB)

French
(PDF/163.92 KB)

German
(PDF/167.03 KB)

Greek
(PDF/217.51 KB)

Hungarian
(PDF/53.23 KB)

Italian
(PDF/194.71 KB)

Latvian
(PDF/227.34 KB)

Lithuanian
(PDF/100.36 KB)

Maltese
(PDF/247.71 KB)

Norwegian
(PDF/82.64 KB)

Polish
(PDF/245.16 KB)

Portuguese
(PDF/134.9 KB)

Romanian
(PDF/108.3 KB)

Slovak
(PDF/164.11 KB)

Slovenian
(PDF/142.93 KB)

Spanish
(PDF/200.54 KB)

Swedish
(PDF/91.93 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
List item

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

2355 results

Perindopril - List of nationally authorised medicinal products - PSUSA-00002354-202010 (PDF/519.57 KB)

Perindopril - Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation - PSUSA-00002354-202010 (PDF/140.61 KB)

Perindopril: List of nationally authorised medicinal products - PSUSA/00002354/201510 (PDF/439.31 KB)

Perindopril: CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation - PSUSA/00002354/201510 (PDF/812.41 KB)

Tetrabenazine: List of nationally authorised medicinal products - PSUSA/00002911/202010 (PDF/136.21 KB)

Bisoprolol / perindopril : List of nationally authorised medicines - PSUSA/00010462/202010 (PDF/326.82 KB)

Beractant : List of nationally authorised medicines - PSUSA/00000384/202010 (PDF/148.85 KB)

Etifoxine : List of nationally authorised medicinal products - PSUSA/00001321/202010 (PDF/128.21 KB)

Ketotifen : List of nationally authorised medicines - PSUSA/00001813/202010 (PDF/168.87 KB)

Prulifloxacin : List of nationally authorised medicinal products - PSUSA/00002569/202010 (PDF/156.94 KB)

Acitretin : List of nationally authorised medicinal products - PSUSA/00000051/202010 (PDF/256.26 KB)

Salmeterol : List of nationally authorised medicines - PSUSA/00002681/202010 (PDF/219.17 KB)

Minoxidil : List of nationally authorised medicines - PSUSA-00002067-202010 (PDF/351.94 KB)

Atorvastatin / perindopril - List of nationally authorised medicinal products - PSUSA/00010679/202010 (PDF/386.57 KB)

Amlodipine / atorvastatin / perindopril - List of nationally authorised medicinal products - PSUSA/00010431/202010 (PDF/300.67 KB)

13C-methacetin : List of nationally authorised medicinal products - PSUSA/00010846/202010 (PDF/102.38 KB)

Polystyrene sulfonate - List of nationally authorised medicinal products - PSUSA-00002472-202010 (PDF/124.87 KB)

Rubidium chloride RB-82 - List of nationally authorised medicinal products - PSUSA-00010806-202010 (PDF/104.25 KB)

Minoxidil (non-topical formulations) : List of nationally authorised medicinal products - PSUSA/00002066/202010 (PDF/88.75 KB)

Polystyrene sulfonate - Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation - PSUSA-00002472-202010 (PDF/145.36 KB)

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