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Ibuprofen / levomenthol: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001708/202007 (PDF/87.19 KB)

for the implementation - PSUSA/00001708/202007 … for the implementation - PSUSA/00001708/202007 Other languages: bg cz da … relationship and conclusions from PSUSA-00010649- 202002 (regarding ibuprofen …

Last updated: 05/05/2021
Active substance: Ibuprofen, Levomenthol
Procedure number: PSUSA/00001708/202007
Regulatory outcome: Variation
(PDF/78.91 KB)

Bulgarian
(PDF/113.6 KB)

Croatian
(PDF/112.34 KB)

Danish
(PDF/120.43 KB)

Dutch
(PDF/72.59 KB)

Estonian
(PDF/130.83 KB)

Finnish
(PDF/83.88 KB)

French
(PDF/74.94 KB)

German
(PDF/91.77 KB)

Greek
(PDF/110.72 KB)

Hungarian
(PDF/120.66 KB)

Icelandic
(PDF/86.16 KB)

Italian
(PDF/101.53 KB)

Latvian
(PDF/116.5 KB)

Lithuanian
(PDF/105.87 KB)

Maltese
(PDF/117.16 KB)

Norwegian
(PDF/87.12 KB)

Polish
(PDF/81.26 KB)

Portuguese
(PDF/87.91 KB)

Romanian
(PDF/115.82 KB)

Slovak
(PDF/81.03 KB)

Slovenian
(PDF/113.79 KB)

Spanish
(PDF/87.6 KB)

Swedish
(PDF/86.53 KB)
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Ezetimibe / rosuvastatin: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010271/202007 (PDF/128.84 KB)

for the implementation - PSUSA/00010271/202007 … for the implementation - PSUSA/00010271/202007 Other languages: bg cs da …

Last updated: 11/05/2021
Active substance: Ezetimibe, Rosuvastatin
Procedure number: PSUSA/00010271/202007
Regulatory outcome: Variation
Bulgarian
(PDF/111.32 KB)

Croatian
(PDF/193.12 KB)

Czech
(PDF/151.95 KB)

Danish
(PDF/188.71 KB)

Dutch
(PDF/136.03 KB)

Estonian
(PDF/65.76 KB)

Finnish
(PDF/182.32 KB)

French
(PDF/102.93 KB)

German
(PDF/227.67 KB)

Greek
(PDF/257.75 KB)

Hungarian
(PDF/51.68 KB)

Italian
(PDF/23.21 KB)

Latvian
(PDF/126.73 KB)

Lithuanian
(PDF/143.8 KB)

Maltese
(PDF/272.11 KB)

Norwegian
(PDF/48.06 KB)

Polish
(PDF/226.61 KB)

Portuguese
(PDF/121.92 KB)

Romanian
(PDF/139.38 KB)

Slovak
(PDF/146 KB)

Slovenian
(PDF/107.72 KB)

Spanish
(PDF/50.96 KB)

Swedish
(PDF/51.31 KB)
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Ethinylestradiol / etonogestrel: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001307/202007 (PDF/79.07 KB)

for the implementation - PSUSA/00001307/202007 … for the implementation - PSUSA/00001307/202007 Other languages: bg cz da …

Last updated: 15/04/2021
Active substance: ethinylestradiol, etonogestrel
Procedure number: PSUSA/00001307/202007
Regulatory outcome: Variation
(PDF/187.55 KB)

Bulgarian
(PDF/195.66 KB)

Croatian
(PDF/188.57 KB)

Danish
(PDF/150.48 KB)

Dutch
(PDF/103.07 KB)

Estonian
(PDF/159.66 KB)

Finnish
(PDF/76.84 KB)

French
(PDF/132.04 KB)

German
(PDF/138.21 KB)

Greek
(PDF/183.14 KB)

Hungarian
(PDF/208.57 KB)

Icelandic
(PDF/117.32 KB)

Italian
(PDF/159.84 KB)

Latvian
(PDF/198.18 KB)

Lithuanian
(PDF/141.75 KB)

Maltese
(PDF/91.7 KB)

Norwegian
(PDF/132.82 KB)

Polish
(PDF/143.97 KB)

Portuguese
(PDF/153.04 KB)

Romanian
(PDF/197.82 KB)

Slovak
(PDF/180.76 KB)

Slovenian
(PDF/213.62 KB)

Spanish
(PDF/158.64 KB)

Swedish
(PDF/149.29 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
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
List item

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
List item

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
List item

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
List item

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
List item

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
List item

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
List item

Mizolastine: List of nationally authorised medicinal products - PSUSA/00002078/201711 (PDF/217.66 KB)

authorised medicinal products - PSUSA/00002078/201711 … authorised medicinal products - PSUSA/00002078/201711 EMA/595427/2018 05/09/2018 … mizolastine Procedure no.: PSUSA/00002078/201711 List of nationally …

Last updated: 05/09/2018
Active substance: mizolastine
Procedure number: PSUSA/00002078/201711
Regulatory outcome: Variation
List item

Hydroxycarbamide: List of nationally authorised medicinal products - PSUSA/00009182/201712 (PDF/94.52 KB)

authorised medicinal products - PSUSA/00009182/201712 … authorised medicinal products - PSUSA/00009182/201712 EMA/584534/2018 31/08/2018 … product) Procedure no.: PSUSA/00009182/201712 List of nationally …

Last updated: 31/08/2018
Active substance: hydroxycarbamide
Procedure number: PSUSA/00009182/201712
Regulatory outcome: Variation

3604 results

Ibuprofen / levomenthol: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001708/202007 (PDF/87.19 KB)

Ezetimibe / rosuvastatin: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010271/202007 (PDF/128.84 KB)

Ethinylestradiol / etonogestrel: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001307/202007 (PDF/79.07 KB)

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

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)

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)

Mizolastine: List of nationally authorised medicinal products - PSUSA/00002078/201711 (PDF/217.66 KB)

Hydroxycarbamide: List of nationally authorised medicinal products - PSUSA/00009182/201712 (PDF/94.52 KB)