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Isotretinoin (oral formulations) - List of the nationally authorised medicinal products - PSUSA/00010488/202005 (PDF/446.99 KB)

authorised medicinal products - PSUSA/00010488/202005 … authorised medicinal products - PSUSA/00010488/202005 EMA/353110/2021 22/06/2021 … formulations) Procedure No: PSUSA/00010488/202005 …

Last updated: 22/06/2021
Active substance: isotretinoin (oral formulations)
Procedure number: PSUSA/00010488/202005
Regulatory outcome: Maintenance
List item

Misoprostol (gynaecological indication - termination of pregnancy) : List of nationally authorised medicinal products - PSUSA/00010354/202005 (PDF/280.86 KB)

authorised medicinal products - PSUSA/00010354/202005 … authorised medicinal products - PSUSA/00010354/202005 EMA/706074/2020 05/05/2021 … pregnancy) Procedure No.: PSUSA/00010354/202005 List of nationally …

Last updated: 05/05/2021
Active substance: misoprostol
Procedure number: PSUSA/00010354/202005
Regulatory outcome: Maintenance
List item

Tramadol: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00003002/202005 (PDF/199.01 KB)

for the implementation - PSUSA/00003002/202005 … for the implementation - PSUSA/00003002/202005 Other languages: el bg cs …

Last updated: 24/03/2021
Active substance: Tramadol
Procedure number: PSUSA/00003002/202005
Regulatory outcome: Variation
Bulgarian
(PDF/228.07 KB)

Croatian
(PDF/247.66 KB)

Czech
(PDF/282.64 KB)

Danish
(PDF/178.93 KB)

Dutch
(PDF/189.31 KB)

Estonian
(PDF/196.26 KB)

Finnish
(PDF/195.52 KB)

French
(PDF/105.6 KB)

German
(PDF/203.88 KB)

Greek
(PDF/255.31 KB)

Greek
(PDF/255.31 KB)

Hungarian
(PDF/269.79 KB)

Icelandic
(PDF/213.74 KB)

Italian
(PDF/220.66 KB)

Latvian
(PDF/246.72 KB)

Lithuanian
(PDF/244.77 KB)

Maltese
(PDF/283.18 KB)

Norwegian
(PDF/208.41 KB)

Polish
(PDF/241.34 KB)

Portuguese
(PDF/183.34 KB)

Romanian
(PDF/220.02 KB)

Slovak
(PDF/248.59 KB)

Slovenian
(PDF/241.04 KB)

Spanish
(PDF/214.08 KB)

Swedish
(PDF/171.02 KB)
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Clotiazepam: CMDh Scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00000827/202005 (PDF/78.38 KB)

for the implementation - PSUSA/00000827/202005 … for the implementation - PSUSA/00000827/202005 Other languages: bg cs da …

Last updated: 18/03/2021
Active substance: clotiazepam
Procedure number: PSUSA/00000827/202005
Regulatory outcome: Variation
Bulgarian
(PDF/75.4 KB)

Croatian
(PDF/75.55 KB)

Czech
(PDF/75.11 KB)

Danish
(PDF/76.78 KB)

Dutch
(PDF/77.34 KB)

Estonian
(PDF/70.1 KB)

Finnish
(PDF/74.58 KB)

French
(PDF/76.05 KB)

German
(PDF/81.6 KB)

Greek
(PDF/72.65 KB)

Hungarian
(PDF/75.72 KB)

Icelandic
(PDF/81.68 KB)

Italian
(PDF/89.86 KB)

Latvian
(PDF/92.68 KB)

Lithuanian
(PDF/85.51 KB)

Maltese
(PDF/91.41 KB)

Norwegian
(PDF/76.67 KB)

Polish
(PDF/77.75 KB)

Portuguese
(PDF/76.2 KB)

Romanian
(PDF/73.92 KB)

Slovak
(PDF/80.29 KB)

Slovenian
(PDF/73.79 KB)

Spanish
(PDF/77.72 KB)

Swedish
(PDF/78.51 KB)
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Xylometazoline: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00003134/202005 (PDF/42.04 KB)

for the implementation - PSUSA/00003134/202005 … for the implementation - PSUSA/00003134/202005 Other languages: bg cs da …

Last updated: 16/03/2021
Active substance: xylometazoline
Procedure number: PSUSA/00003134/202005
Regulatory outcome: Variation
Bulgarian
(PDF/113.17 KB)

Croatian
(PDF/104.92 KB)

Czech
(PDF/132.01 KB)

Danish
(PDF/44.97 KB)

Dutch
(PDF/31.83 KB)

Estonian
(PDF/40.32 KB)

Finnish
(PDF/42.64 KB)

French
(PDF/38.16 KB)

German
(PDF/44.27 KB)

Greek
(PDF/107.29 KB)

Hungarian
(PDF/106.63 KB)

Icelandic
(PDF/33.25 KB)

Italian
(PDF/38.38 KB)

Latvian
(PDF/96.84 KB)

Lithuanian
(PDF/103.3 KB)

Maltese
(PDF/103.29 KB)

Norwegian
(PDF/37.75 KB)

Polish
(PDF/98.43 KB)

Portuguese
(PDF/37.94 KB)

Romanian
(PDF/95.73 KB)

Slovak
(PDF/101 KB)

Slovenian
(PDF/99.79 KB)

Spanish
(PDF/38.26 KB)

Swedish
(PDF/37.57 KB)
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Mifepristone: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002060/202005 (PDF/76.09 KB)

for the implementation - PSUSA/00002060/202005 … for the implementation - PSUSA/00002060/202005 Other languages: bg cs da …

Last updated: 30/04/2021
Active substance: mifepristone
Procedure number: PSUSA/00002060/202005
Regulatory outcome: Variation
(PDF/114.26 KB)

Bulgarian
(PDF/184.11 KB)

Croatian
(PDF/197.12 KB)

Czech
(PDF/110.91 KB)

Danish
(PDF/135.63 KB)

Dutch
(PDF/122.68 KB)

Finnish
(PDF/117.37 KB)

French
(PDF/138.71 KB)

German
(PDF/127.38 KB)

Greek
(PDF/163.47 KB)

Hungarian
(PDF/141.85 KB)

Icelandic
(PDF/121.76 KB)

Italian
(PDF/140.98 KB)

Latvian
(PDF/176.01 KB)

Lithuanian
(PDF/142.36 KB)

Maltese
(PDF/142.69 KB)

Norwegian
(PDF/120.96 KB)

Polish
(PDF/142.51 KB)

Portuguese
(PDF/132.64 KB)

Romanian
(PDF/164.65 KB)

Slovak
(PDF/131.55 KB)

Slovenian
(PDF/148.36 KB)

Spanish
(PDF/140.75 KB)

Swedish
(PDF/132.49 KB)
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Meloxicam : List of nationally authorised medicinal products - PSUSA/00010474/202207 (PDF/303.26 KB) (updated)

authorised medicinal products - PSUSA/00010474/202207 … authorised medicinal products - PSUSA/00010474/202207 EMA/215601/2023 11/05/2023 … meloxicam Procedure No. PSUSA/00010474/202207 http://www.ema.europa.eu/how-to-find-us http://www.ema.europa.eu/contact …

Last updated: 02/06/2023
Active substance: meloxicam
Procedure number: PSUSA/00010474/202207
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
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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
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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
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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
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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
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Acebutolol: List of nationally authorised medicinal products - PSUSA/00000018/201712 (PDF/68.24 KB)

authorised medicinal products - PSUSA/00000018/201712 … authorised medicinal products - PSUSA/00000018/201712 EMA/612663/2018 11/09/2018 … acebutolol Procedure no.: PSUSA/00000018/201712 …

Last updated: 11/09/2018
Active substance: acebutolol
Procedure number: PSUSA/00000018/201712
Regulatory outcome: Maintenance
List item

Ibutilide: List of nationally authorised medicinal products - PSUSA/00001713/201712 (PDF/80.23 KB)

authorised medicinal products - PSUSA/00001713/201712 … authorised medicinal products - PSUSA/00001713/201712 EMA/PRAC/607905/2018 10/09/2018 … ibutilide Procedure no.: PSUSA/00001713/201712 List of nationally …

Last updated: 10/09/2018
Active substance: ibutilide
Procedure number: PSUSA/00001713/201712
Regulatory outcome: Maintenance
List item

Felodipine: List of nationally authorised medicinal products - PSUSA/00001356/201712 (PDF/179.53 KB)

authorised medicinal products - PSUSA/00001356/201712 … authorised medicinal products - PSUSA/00001356/201712 EMA/609153/2018 11/09/2018 … felodipine Procedure no.: PSUSA/00001356/201712 List of nationally …

Last updated: 11/09/2018
Active substance: felodipine
Procedure number: PSUSA/00001356/201712
Regulatory outcome: Maintenance
List item

Betahistine: List of nationally authorised medicinal products - PSUSA/00000389/201712 (PDF/217.94 KB)

authorised medicinal products - PSUSA/00000389/201712 … authorised medicinal products - PSUSA/00000389/201712 EMA/608492/2018 10/09/2018 … betahistine Procedure no.: PSUSA/00000389/201712 List of nationally …

Last updated: 10/09/2018
Active substance: betahistine
Procedure number: PSUSA/00000389/201712
Regulatory outcome: Maintenance
List item

Furosemide: List of nationally authorised medicinal products - PSUSA/00001491/201801 (PDF/184.36 KB)

authorised medicinal products - PSUSA/00001491/201801 … authorised medicinal products - PSUSA/00001491/201801 EMA/608623/2018 10/09/2018 … furosemide Procedure no.: PSUSA/00001491/201801 List of nationally …

Last updated: 10/09/2018
Active substance: Furosemide
Procedure number: PSUSA/00001491/201801
Regulatory outcome: Maintenance
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Azelastine: List of nationally authorised medicinal products - PSUSA/00000277/201712 (PDF/220.2 KB)

authorised medicinal products - PSUSA/00000277/201712 … authorised medicinal products - PSUSA/00000277/201712 EMA/612350/2018 10/09/2018 … azelastine Procedure no.: PSUSA/00000277/201712 List of nationally …

Last updated: 10/09/2018
Active substance: azelastine
Procedure number: PSUSA/00000277/201712
Regulatory outcome: Maintenance
List item

Propofol: List of nationally authorised medicinal products - PSUSA/00002555/201711 (PDF/516.62 KB)

authorised medicinal products - PSUSA/00002555/201711 … authorised medicinal products - PSUSA/00002555/201711 EMA/475638/2018 13/09/2018 … propofol Procedure No.: PSUSA/00002555/201711 List of nationally …

Last updated: 13/09/2018
Active substance: propofol
Procedure number: PSUSA/00002555/201711
Regulatory outcome: Variation
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Paroxetine: List of nationally authorised medicinal products - PSUSA/00002319/201712 (PDF/348.11 KB)

authorised medicinal products - PSUSA/00002319/201712 … authorised medicinal products - PSUSA/00002319/201712 EMA/612747/2018 11/09/2018 … paroxetine Procedure no.: PSUSA/00002319/201712 …

Last updated: 11/09/2018
Active substance: paroxetine
Procedure number: PSUSA/00002319/201712
Regulatory outcome: Variation

3546 results

Isotretinoin (oral formulations) - List of the nationally authorised medicinal products - PSUSA/00010488/202005 (PDF/446.99 KB)

Misoprostol (gynaecological indication - termination of pregnancy) : List of nationally authorised medicinal products - PSUSA/00010354/202005 (PDF/280.86 KB)

Tramadol: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00003002/202005 (PDF/199.01 KB)

Clotiazepam: CMDh Scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00000827/202005 (PDF/78.38 KB)

Xylometazoline: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00003134/202005 (PDF/42.04 KB)

Mifepristone: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002060/202005 (PDF/76.09 KB)

Meloxicam : List of nationally authorised medicinal products - PSUSA/00010474/202207 (PDF/303.26 KB) (updated)

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)

Acebutolol: List of nationally authorised medicinal products - PSUSA/00000018/201712 (PDF/68.24 KB)

Ibutilide: List of nationally authorised medicinal products - PSUSA/00001713/201712 (PDF/80.23 KB)

Felodipine: List of nationally authorised medicinal products - PSUSA/00001356/201712 (PDF/179.53 KB)

Betahistine: List of nationally authorised medicinal products - PSUSA/00000389/201712 (PDF/217.94 KB)

Furosemide: List of nationally authorised medicinal products - PSUSA/00001491/201801 (PDF/184.36 KB)

Azelastine: List of nationally authorised medicinal products - PSUSA/00000277/201712 (PDF/220.2 KB)

Propofol: List of nationally authorised medicinal products - PSUSA/00002555/201711 (PDF/516.62 KB)

Paroxetine: List of nationally authorised medicinal products - PSUSA/00002319/201712 (PDF/348.11 KB)