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Diltiazem - List of nationally authorised medicinal products - PSUSA/00001084/202205 (PDF/384.17 KB)

authorised medicinal products - PSUSA/00001084/202205 … authorised medicinal products - PSUSA/00001084/202205 EMA/134593/2023 22/03/2023 … diltiazem Procedure no.: PSUSA/00001084/202205 http://www.ema.europa.eu/how-to-find-us http://www.ema.europa.eu/contact …

Last updated: 22/03/2023
Active substance: diltiazem
Procedure number: PSUSA/00001084/202205
Regulatory outcome: Variation
List item

Diltiazem - CMDh Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation - PSUSA/00001084/202205 (PDF/115.73 KB)

Marketing Authorisation - PSUSA/00001084/202205 … Marketing Authorisation - PSUSA/00001084/202205 Other languages: bg sv sl …

Last updated: 22/03/2023
Active substance: diltiazem
Procedure number: PSUSA/00001084/202205
Regulatory outcome: Variation
Bulgarian
(PDF/252.02 KB)

Croatian
(PDF/157.38 KB)

Czech
(PDF/132.9 KB)

Danish
(PDF/200.08 KB)

Dutch
(PDF/128.07 KB)

Estonian
(PDF/54.47 KB)

Finnish
(PDF/168.84 KB)

French
(PDF/112.08 KB)

German
(PDF/145.18 KB)

Greek
(PDF/128.4 KB)

Hungarian
(PDF/59.49 KB)

Icelandic
(PDF/143.47 KB)

Italian
(PDF/200.5 KB)

Latvian
(PDF/132.05 KB)

Lithuanian
(PDF/131.56 KB)

Maltese
(PDF/241.65 KB)

Norwegian
(PDF/99.24 KB)

Polish
(PDF/221.08 KB)

Portuguese
(PDF/189.86 KB)

Romanian
(PDF/220.28 KB)

Slovak
(PDF/111.97 KB)

Slovenian
(PDF/98.21 KB)

Spanish
(PDF/198.75 KB)

Swedish
(PDF/121.92 KB)
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Diltiazem: List of nationally authorised medicinal products - PSUSA/00001084/201705 (PDF/287.21 KB)

authorised medicinal products - PSUSA/00001084/201705 … authorised medicinal products - PSUSA/00001084/201705 EMA/10900/2018 17/01/2018 … authorised medicinal products - PSUSA/00001084/201705 30 Churchill Place …

Last updated: 17/01/2018
Active substance: diltiazem
Procedure number: PSUSA/00001084/201705
Regulatory outcome: Maintenance
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Ozenoxacin : List of nationally authorised medicinal products - PSUSA/00010651/202205 (PDF/123.82 KB)

authorised medicinal products - PSUSA/00010651/202205 … authorised medicinal products - PSUSA/00010651/202205 EMA/794448/2022 01/12/2022 … ozenoxacin Procedure No. PSUSA/00010651/202205 http://www.ema.europa.eu/how-to-find-us http://www.ema.europa.eu/contact …

Last updated: 01/12/2022
Active substance: Ozenoxacin
Procedure number: PSUSA/00010651/202205
Regulatory outcome: Maintenance
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Olsalazine - List of nationally authorised medicinal products - PSUSA/00002213/202205 (PDF/179.85 KB)

authorised medicinal products - PSUSA/00002213/202205 … authorised medicinal products - PSUSA/00002213/202205 EMA/33067/2023 19/01/2023 … olsalazine Procedure No. PSUSA/00002213/202205 http://www.ema.europa.eu/how-to-find-us http://www.ema.europa.eu/contact …

Last updated: 19/01/2023
Active substance: olsalazine
Procedure number: PSUSA/00002213/202205
Regulatory outcome: Variation
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Methoxyflurane : List of nationally authorised medicinal products - PSUSA/00010484/202205 (PDF/149.32 KB)

authorised medicinal products - PSUSA/00010484/202205 … authorised medicinal products - PSUSA/00010484/202205 EMA/270645/2015 31/01/2023 … methoxyflurane Procedure no.: PSUSA/00010484/202205 List of nationally …

Last updated: 31/01/2023
Active substance: Methoxyflurane
Procedure number: PSUSA/00010484/202205
Regulatory outcome: Variation
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Betaxolol : List of nationally authorised medicinal products - PSUSA/00000401/202205 (PDF/196.52 KB)

authorised medicinal products - PSUSA/00000401/202205 … authorised medicinal products - PSUSA/00000401/202205 EMA/60182/2023 07/02/2023 … betaxolol Procedure No.: PSUSA/00000401/202205 http://www.ema.europa.eu/how-to-find-us http://www.ema.europa.eu/contact …

Last updated: 07/02/2023
Active substance: betaxolol
Procedure number: PSUSA/00000401/202205
Regulatory outcome: Maintenance
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Tirofiban : List of nationally authorised medicinal products - PSUSA/00002974/202205 (PDF/123.99 KB)

authorised medicinal products - PSUSA/00002974/202205 … authorised medicinal products - PSUSA/00002974/202205 EMA/30527/2023 18/01/2023 … tirofiban Procedure no.: PSUSA/00002974/202205 List of nationally authorised …

Last updated: 18/01/2023
Active substance: tirofiban
Procedure number: PSUSA/00002974/202205
Regulatory outcome: Maintenance
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Lanreotide : List of nationally authorised medicinal products - PSUSA/00001826/202205 (PDF/206.91 KB)

authorised medicinal products - PSUSA/00001826/202205 … authorised medicinal products - PSUSA/00001826/202205 EMA/37767/2023 24/01/2023 … lanreotide Procedure no.: PSUSA/00001826/202205 List of nationally …

Last updated: 24/01/2023
Active substance: lanreotide
Procedure number: PSUSA/00001826/202205
Regulatory outcome: Maintenance
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Methadone - List of nationally authorised medicinal products - PSUSA/00002004/202205 (PDF/225.23 KB)

authorised medicinal products - PSUSA/00002004/202205 … authorised medicinal products - PSUSA/00002004/202205 EMA/99341/2023 06/03/2023 … methadone Procedure No. PSUSA/00002004/202205 http://www.ema.europa.eu/how-to-find-us http://www.ema.europa.eu/contact …

Last updated: 06/03/2023
Active substance: methadone
Procedure number: PSUSA/00002004/202205
Regulatory outcome: Variation
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Alteplase - List of nationally authorised medicinal products - PSUSA/00000112/202205 (PDF/207.53 KB)

authorised medicinal products - PSUSA/00000112/202205 … authorised medicinal products - PSUSA/00000112/202205 EMA/27316/2023 17/01/2023 … alteplase Procedure no.: PSUSA/00000112/202205 List of nationally …

Last updated: 17/01/2023
Active substance: alteplase
Procedure number: PSUSA/00000112/202205
Regulatory outcome: Maintenance
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Levomethadone - List of nationally authorised medicinal products - PSUSA/00001855/202205 (PDF/234.65 KB)

authorised medicinal products - PSUSA/00001855/202205 … authorised medicinal products - PSUSA/00001855/202205 EMA/101192/2023 06/03/2023 … levomethadone Procedure no.: PSUSA/00001855/202205 List of nationally …

Last updated: 06/03/2023
Active substance: levomethadone
Procedure number: PSUSA/00001855/202205
Regulatory outcome: Variation
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Risperidone : List of nationally authorised medicinal products - PSUSA/00002649/202205 (PDF/504.27 KB)

authorised medicinal products - PSUSA/00002649/202205 … authorised medicinal products - PSUSA/00002649/202205 EMA/21406/2023 13/01/2023 … risperidone Procedure No. PSUSA/00002649/202205 http://www.ema.europa.eu/how-to-find-us http://www.ema.europa.eu/contact …

Last updated: 13/01/2023
Active substance: Risperidone
Procedure number: PSUSA/00002649/202205
Regulatory outcome: Maintenance
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Venlafaxine : List of nationally authorised medicinal products - PSUSA/00003104/202205 (PDF/948.12 KB)

authorised medicinal products - PSUSA/00003104/202205 … authorised medicinal products - PSUSA/00003104/202205 EMA/115290/2023 10/03/2023 … venlafaxine Procedure No. PSUSA/00003104/202205 http://www.ema.europa.eu/how-to-find-us http://www.ema.europa.eu/contact …

Last updated: 10/03/2023
Active substance: venlafaxine
Procedure number: PSUSA/00003104/202205
Regulatory outcome: Variation
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Procyanidolic oligomers - List of nationally authorised medicinal products - PSUSA/00002537/202205 (PDF/133.07 KB)

authorised medicinal products - PSUSA/00002537/202205 … authorised medicinal products - PSUSA/00002537/202205 EMA/163351/2023 11/04/2023 … oligomers Procedure no.: PSUSA/00002537/202205 List of nationally …

Last updated: 11/04/2023
Active substance: Procyanidolic oligomers
Procedure number: PSUSA/00002537/202205
Regulatory outcome: Maintenance
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Macrogol 3350 : List of nationally authorised medicinal products - PSUSA/00001924/202205 (PDF/154.24 KB)

authorised medicinal products - PSUSA/00001924/202205 … authorised medicinal products - PSUSA/00001924/202205 EMA/20257/2023 13/01/2023 … macrogol 3350 Procedure No. PSUSA/00001924/202205 http://www.ema.europa.eu/how-to-find-us http://www.ema.europa.eu/contact …

Last updated: 13/01/2023
Active substance: Macrogol 3350
Procedure number: PSUSA/00001924/202205
Regulatory outcome: Maintenance
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Fusidic acid (systemic use) - List of nationally authorised medicinal products - PSUSA/00010226/202205 (PDF/149.07 KB)

authorised medicinal products - PSUSA/00010226/202205 … authorised medicinal products - PSUSA/00010226/202205 EMA/20644/2023 13/01/2023 … systemic use) Procedure No. PSUSA/00010226/202205 http://www.ema.europa.eu/how-to-find-us http://www.ema.europa.eu/contact …

Last updated: 13/01/2023
Active substance: fusidic acid
Procedure number: PSUSA/00010226/202205
Regulatory outcome: Maintenance
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Levonorgestrel (for emergency contraception only) : List of nationally authorised medicinal products - PSUSA/00010827/202205 (PDF/191.22 KB)

authorised medicinal products - PSUSA/00010827/202205 … authorised medicinal products - PSUSA/00010827/202205 EMA/60229/2023 07/02/2023 … contraception only) Procedure No. PSUSA/00010827/202205 http://www.ema.europa.eu/how-to-find-us http://www.ema.europa.eu/contact …

Last updated: 07/02/2023
Active substance: levonorgestrel
Procedure number: PSUSA/00010827/202205
Regulatory outcome: Maintenance
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Macrogol 4000, macrogol 4000 combinations (oral use) : List of nationally authorised medicinal products - PSUSA/00010392/202205 (PDF/299.35 KB)

authorised medicinal products - PSUSA/00010392/202205 … authorised medicinal products - PSUSA/00010392/202205 EMA/20274/2023 13/01/2023 … oral use) Procedure No. PSUSA/00010392/202205 http://www.ema.europa.eu/how-to-find-us http://www.ema.europa.eu/contact …

Last updated: 13/01/2023
Active substance: macrogol 4000, macrogol 4000 combinations
Procedure number: PSUSA/00010392/202205
Regulatory outcome: Maintenance
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Isotretinoin (oral formulations) : List of nationally authorised medicinal products - PSUSA/00010488/202205 (PDF/426.43 KB)

authorised medicinal products - PSUSA/00010488/202205 … authorised medicinal products - PSUSA/00010488/202205 EMA/894509/2022 01/12/2022 … formulations) Procedure No: PSUSA/00010488/202205 http://www.ema.europa.eu/how-to-find-us http://www.ema.europa.eu/contact …

Last updated: 01/12/2022
Active substance: isotretinoin (oral formulations)
Procedure number: PSUSA/00010488/202205
Regulatory outcome: Maintenance
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Levomethadone - CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001855/202205 (PDF/171.84 KB)

for the implementation - PSUSA/00001855/202205 … for the implementation - PSUSA/00001855/202205 Other languages: bg cs da … As part of the parallel PSUSA procedure and in line with …

Last updated: 06/03/2023
Active substance: levomethadone
Procedure number: PSUSA/00001855/202205
Regulatory outcome: Variation
Bulgarian
(PDF/154.56 KB)

Croatian
(PDF/145.77 KB)

Czech
(PDF/154.17 KB)

Danish
(PDF/152.64 KB)

Dutch
(PDF/139.93 KB)

Finnish
(PDF/151.83 KB)

French
(PDF/155.9 KB)

German
(PDF/202.03 KB)

Greek
(PDF/190.6 KB)

Hungarian
(PDF/229.36 KB)

Icelandic
(PDF/136.14 KB)

Italian
(PDF/155 KB)

Latvian
(PDF/172.4 KB)

Lithuanian
(PDF/227.89 KB)

Maltese
(PDF/185.5 KB)

Norwegian
(PDF/119.21 KB)

Polish
(PDF/157.07 KB)

Portuguese
(PDF/153.6 KB)

Romanian
(PDF/169.41 KB)

Slovak
(PDF/219.35 KB)

Slovenian
(PDF/195.39 KB)

Spanish
(PDF/132.11 KB)

Swedish
(PDF/136.74 KB)
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Venlafaxine : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00003104/202205 (PDF/34.55 KB)

for the implementation - PSUSA/00003104/202205 … for the implementation - PSUSA/00003104/202205 Other languages: es et fi … reported data within this PSUSA. This includes that a proportion …

Last updated: 10/03/2023
Active substance: venlafaxine
Procedure number: PSUSA/00003104/202205
Regulatory outcome: Variation
Bulgarian
(PDF/210.27 KB)

Croatian
(PDF/119.76 KB)

Czech
(PDF/136.62 KB)

Danish
(PDF/105.94 KB)

Dutch
(PDF/111 KB)

Estonian
(PDF/104.85 KB)

Finnish
(PDF/87.01 KB)

French
(PDF/109.26 KB)

German
(PDF/110.09 KB)

Greek
(PDF/126.63 KB)

Hungarian
(PDF/140.57 KB)

Icelandic
(PDF/105.37 KB)

Italian
(PDF/107.3 KB)

Latvian
(PDF/146.5 KB)

Lithuanian
(PDF/144.81 KB)

Maltese
(PDF/147.59 KB)

Norwegian
(PDF/105.23 KB)

Polish
(PDF/143.22 KB)

Portuguese
(PDF/107.04 KB)

Romanian
(PDF/143.34 KB)

Slovak
(PDF/128.91 KB)

Slovenian
(PDF/125.7 KB)

Spanish
(PDF/106.31 KB)

Swedish
(PDF/103.78 KB)
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Methadone - CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002004/202205 (PDF/127.46 KB)

for the implementation - PSUSA/00002004/202205 … for the implementation - PSUSA/00002004/202205 Other languages: bg cs da … assessments of other opioids PSUSAs, the PRAC considers that the …

Last updated: 06/03/2023
Active substance: methadone
Procedure number: PSUSA/00002004/202205
Regulatory outcome: Variation
Bulgarian
(PDF/181.26 KB)

Croatian
(PDF/195.99 KB)

Czech
(PDF/153.01 KB)

Danish
(PDF/119.74 KB)

Dutch
(PDF/107.69 KB)

Estonian
(PDF/150.6 KB)

Finnish
(PDF/113.91 KB)

French
(PDF/116.42 KB)

German
(PDF/151 KB)

Greek
(PDF/188.11 KB)

Hungarian
(PDF/160.5 KB)

Icelandic
(PDF/105.84 KB)

Italian
(PDF/150.61 KB)

Latvian
(PDF/171 KB)

Lithuanian
(PDF/152.11 KB)

Maltese
(PDF/185.1 KB)

Norwegian
(PDF/118.93 KB)

Polish
(PDF/156.88 KB)

Portuguese
(PDF/149.73 KB)

Romanian
(PDF/170.12 KB)

Slovak
(PDF/218.45 KB)

Slovenian
(PDF/145.15 KB)

Spanish
(PDF/130.58 KB)

Swedish
(PDF/133.36 KB)
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Methoxyflurane : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010484/202205 (PDF/51.13 KB)

for the implementation - PSUSA/00010484/202205 … for the implementation - PSUSA/00010484/202205 Other languages: nl mt lv …

Last updated: 31/01/2023
Active substance: Methoxyflurane
Procedure number: PSUSA/00010484/202205
Regulatory outcome: Variation
Bulgarian
(PDF/92.42 KB)

Croatian
(PDF/97.21 KB)

Czech
(PDF/93.73 KB)

Danish
(PDF/26.57 KB)

Dutch
(PDF/28.4 KB)

Estonian
(PDF/86.91 KB)

Finnish
(PDF/24.95 KB)

French
(PDF/36.69 KB)

German
(PDF/56.46 KB)

Greek
(PDF/91.93 KB)

Hungarian
(PDF/94.88 KB)

Icelandic
(PDF/27.26 KB)

Irish
(PDF/25.12 KB)

Italian
(PDF/27.09 KB)

Latvian
(PDF/178.79 KB)

Lithuanian
(PDF/140.1 KB)

Maltese
(PDF/136.41 KB)

Norwegian
(PDF/87.4 KB)

Polish
(PDF/94.78 KB)

Portuguese
(PDF/29.59 KB)

Romanian
(PDF/94.75 KB)

Slovak
(PDF/98.5 KB)

Slovenian
(PDF/106.36 KB)

Spanish
(PDF/87.07 KB)

Swedish
(PDF/22.13 KB)
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Iodixanol: List of nationally authorised medicinal products - PSUSA/00001766/202004 (PDF/327.83 KB)

authorised medicinal products - PSUSA/00001766/202004 … authorised medicinal products - PSUSA/00001766/202004 EMA/21300/2021 16/03/2021 … iodixanol Procedure no.: PSUSA/00001766/202004 List of nationally …

Last updated: 10/10/2023
Active substance: iodixanol
Procedure number: PSUSA/00001766/202004
Regulatory outcome: Variation

3701 results

Diltiazem - List of nationally authorised medicinal products - PSUSA/00001084/202205 (PDF/384.17 KB)

Diltiazem - CMDh Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation - PSUSA/00001084/202205 (PDF/115.73 KB)

Diltiazem: List of nationally authorised medicinal products - PSUSA/00001084/201705 (PDF/287.21 KB)

Ozenoxacin : List of nationally authorised medicinal products - PSUSA/00010651/202205 (PDF/123.82 KB)

Olsalazine - List of nationally authorised medicinal products - PSUSA/00002213/202205 (PDF/179.85 KB)

Methoxyflurane : List of nationally authorised medicinal products - PSUSA/00010484/202205 (PDF/149.32 KB)

Betaxolol : List of nationally authorised medicinal products - PSUSA/00000401/202205 (PDF/196.52 KB)

Tirofiban : List of nationally authorised medicinal products - PSUSA/00002974/202205 (PDF/123.99 KB)

Lanreotide : List of nationally authorised medicinal products - PSUSA/00001826/202205 (PDF/206.91 KB)

Methadone - List of nationally authorised medicinal products - PSUSA/00002004/202205 (PDF/225.23 KB)

Alteplase - List of nationally authorised medicinal products - PSUSA/00000112/202205 (PDF/207.53 KB)

Levomethadone - List of nationally authorised medicinal products - PSUSA/00001855/202205 (PDF/234.65 KB)

Risperidone : List of nationally authorised medicinal products - PSUSA/00002649/202205 (PDF/504.27 KB)

Venlafaxine : List of nationally authorised medicinal products - PSUSA/00003104/202205 (PDF/948.12 KB)

Procyanidolic oligomers - List of nationally authorised medicinal products - PSUSA/00002537/202205 (PDF/133.07 KB)

Macrogol 3350 : List of nationally authorised medicinal products - PSUSA/00001924/202205 (PDF/154.24 KB)

Fusidic acid (systemic use) - List of nationally authorised medicinal products - PSUSA/00010226/202205 (PDF/149.07 KB)

Levonorgestrel (for emergency contraception only) : List of nationally authorised medicinal products - PSUSA/00010827/202205 (PDF/191.22 KB)

Macrogol 4000, macrogol 4000 combinations (oral use) : List of nationally authorised medicinal products - PSUSA/00010392/202205 (PDF/299.35 KB)

Isotretinoin (oral formulations) : List of nationally authorised medicinal products - PSUSA/00010488/202205 (PDF/426.43 KB)

Levomethadone - CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001855/202205 (PDF/171.84 KB)

Venlafaxine : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00003104/202205 (PDF/34.55 KB)

Methadone - CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002004/202205 (PDF/127.46 KB)

Methoxyflurane : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010484/202205 (PDF/51.13 KB)

Iodixanol: List of nationally authorised medicinal products - PSUSA/00001766/202004 (PDF/327.83 KB)