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Isotretinoin (oral formulations): List of nationally authorised medicinal products - PSUSA/00010488/201905 (PDF/376.77 KB)

authorised medicinal products - PSUSA/00010488/201905 … authorised medicinal products - PSUSA/00010488/201905 EMA/28890/2020 20/01/2020 …

Last updated: 20/01/2020
Active substance: isotretinoin
Procedure number: PSUSA/00010488/201905
Regulatory outcome: Variation
List item

Isotretinoin (oral formulations): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010488/201905 (PDF/33.27 KB)

for the implementation - PSUSA/00010488/201905 … for the implementation - PSUSA/00010488/201905 Other languages: pl bg cs …

Last updated: 20/01/2020
Active substance: isotretinoin
Procedure number: PSUSA/00010488/201905
Regulatory outcome: Variation
Bulgarian
(PDF/109.74 KB)

Croatian
(PDF/89.78 KB)

Czech
(PDF/95.99 KB)

Danish
(PDF/29.82 KB)

Dutch
(PDF/34.4 KB)

Estonian
(PDF/30.63 KB)

Finnish
(PDF/25.65 KB)

French
(PDF/35.4 KB)

German
(PDF/31.93 KB)

Greek
(PDF/83.53 KB)

Hungarian
(PDF/75.61 KB)

Icelandic
(PDF/27.23 KB)

Italian
(PDF/34.48 KB)

Latvian
(PDF/98.49 KB)

Lithuanian
(PDF/92.28 KB)

Maltese
(PDF/58.67 KB)

Norwegian
(PDF/31.59 KB)

Polish
(PDF/117.07 KB)

Portuguese
(PDF/33.58 KB)

Romanian
(PDF/63.38 KB)

Slovak
(PDF/107.12 KB)

Slovenian
(PDF/88.62 KB)

Spanish
(PDF/29.83 KB)

Swedish
(PDF/31.06 KB)
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Isotretinoin (oral formulations): List of nationally authorised medicinal products - PSUSA/00010488/201705 (PDF/283 KB)

authorised medicinal products - PSUSA/00010488/201705 … authorised medicinal products - PSUSA/00010488/201705 EMA/787886/2017 05/12/2017 … authorised medicinal products; PSUSA/00010488/201705 30 Churchill Place …

Last updated: 05/12/2017
Active substance: isotretinoin
Procedure number: PSUSA/00010488/201705
Regulatory outcome: Maintenance
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Isotretinoin (oral formulations): List of nationally authorised medicinal products - PSUSA/00010488/201611 (PDF/339.76 KB)

authorised medicinal products - PSUSA/00010488/201611 … authorised medicinal products - PSUSA/00010488/201611 EMA/574447/2017 31/08/2017 … authorised medicinal products - PSUSA/00010488/201611 30 Churchill Place …

Last updated: 31/08/2017
Active substance: isotretinoin
Procedure number: PSUSA/00010488/201611
Regulatory outcome: Variation
List item

Isotretinoin (oral formulations) : List of nationally authorised medicinal products - PSUSA/00010488/202105 (PDF/560.7 KB)

authorised medicinal products - PSUSA/00010488/202105 … authorised medicinal products - PSUSA/00010488/202105 EMA/46466/2022 24/01/2022 … formulations) Procedure no.: PSUSA/00010488/202105 List of nationally …

Last updated: 24/01/2022
Active substance: isotretinoin (oral formulations)
Procedure number: PSUSA/00010488/202105
Regulatory outcome: Variation
List item

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

Isotretinoin (oral formulations): List of nationally authorised medicinal products - PSUSA/00010488/201805 (PDF/356.23 KB)

authorised medicinal products - PSUSA/00010488/201805 … authorised medicinal products - PSUSA/00010488/201805 22/01/2019 …

Last updated: 22/01/2019
Active substance: isotretinoin
Procedure number: PSUSA/00010488/201805
Regulatory outcome: Variation
List item

Isotretinoin (oral formulations) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010488/202105 (PDF/172.42 KB)

for the implementation - PSUSA/00010488/202105 … for the implementation - PSUSA/00010488/202105 Other languages: hr hu is …

Last updated: 31/05/2022
Active substance: isotretinoin (oral formulations)
Procedure number: PSUSA/00010488/202105
Regulatory outcome: Variation
Bulgarian
(PDF/269.83 KB)

Croatian
(PDF/39.8 KB)

Czech
(PDF/178.5 KB)

Danish
(PDF/168.46 KB)

Dutch
(PDF/193.1 KB)

Estonian
(PDF/243.64 KB)

Finnish
(PDF/158.17 KB)

French
(PDF/38.02 KB)

German
(PDF/227.2 KB)

Greek
(PDF/342.74 KB)

Hungarian
(PDF/122.72 KB)

Icelandic
(PDF/156.29 KB)

Italian
(PDF/181.64 KB)

Latvian
(PDF/331.18 KB)

Lithuanian
(PDF/132.27 KB)

Maltese
(PDF/182.37 KB)

Norwegian
(PDF/113.01 KB)

Polish
(PDF/258.27 KB)

Portuguese
(PDF/131.59 KB)

Romanian
(PDF/254.52 KB)

Slovak
(PDF/183.34 KB)

Slovenian
(PDF/307.82 KB)

Spanish
(PDF/166.42 KB)

Swedish
(PDF/173.38 KB)
List item

Isotretinoin (oral formulations): CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010488/201611 (PDF/44.58 KB)

for the implementation - PSUSA/00010488/201611 … for the implementation - PSUSA/00010488/201611 Other languages: bg es cs … for the implementation - PSUSA/00010488/201611 1 …

Last updated: 31/08/2017
Active substance: isotretinoin
Procedure number: PSUSA/00010488/201611
Regulatory outcome: Variation
Bulgarian
(PDF/115.4 KB)

Croatian
(PDF/75.94 KB)

Czech
(PDF/111.66 KB)

Danish
(PDF/40.08 KB)

Dutch
(PDF/40.58 KB)

Estonian
(PDF/40.26 KB)

Finnish
(PDF/34.13 KB)

French
(PDF/50.58 KB)

German
(PDF/46.92 KB)

Greek
(PDF/79.26 KB)

Hungarian
(PDF/69.88 KB)

Icelandic
(PDF/35.98 KB)

Italian
(PDF/45.25 KB)

Latvian
(PDF/108.94 KB)

Lithuanian
(PDF/133.34 KB)

Maltese
(PDF/77.56 KB)

Norwegian
(PDF/39.66 KB)

Polish
(PDF/115.66 KB)

Portuguese
(PDF/39.15 KB)

Romanian
(PDF/130.05 KB)

Slovak
(PDF/95.23 KB)

Slovenian
(PDF/108.4 KB)

Spanish
(PDF/40.66 KB)

Swedish
(PDF/40.6 KB)
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Isotretinoin (oral formulations): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00010488/201805 (PDF/87.05 KB)

for the implementation - PSUSA/00010488/201805 … for the implementation - PSUSA/00010488/201805 Other languages: cs da de …

Last updated: 22/01/2019
Active substance: isotretinoin
Procedure number: PSUSA/00010488/201805
Regulatory outcome: Variation
Bulgarian
(PDF/176.82 KB)

Croatian
(PDF/148.32 KB)

Czech
(PDF/150.79 KB)

Danish
(PDF/98.2 KB)

Dutch
(PDF/99.83 KB)

Estonian
(PDF/83.74 KB)

Finnish
(PDF/83.06 KB)

French
(PDF/138.08 KB)

German
(PDF/99.87 KB)

Greek
(PDF/152.31 KB)

Hungarian
(PDF/150.58 KB)

Icelandic
(PDF/90.52 KB)

Italian
(PDF/174.54 KB)

Latvian
(PDF/220.51 KB)

Lithuanian
(PDF/137.64 KB)

Maltese
(PDF/144.62 KB)

Norwegian
(PDF/98.27 KB)

Polish
(PDF/141.6 KB)

Portuguese
(PDF/86.87 KB)

Romanian
(PDF/150.45 KB)

Slovak
(PDF/140.07 KB)

Slovenian
(PDF/135.95 KB)

Spanish
(PDF/27.91 KB)

Swedish
(PDF/97.33 KB)
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Tirofiban: List of nationally authorised medicinal products - PSUSA/00002974/201905 (PDF/153.94 KB)

authorised medicinal products - PSUSA/00002974/201905 … authorised medicinal products - PSUSA/00002974/201905 EMA/2341/2020 17/01/2020 …

Last updated: 17/01/2020
Active substance: tirofiban
Procedure number: PSUSA/00002974/201905
Regulatory outcome: Maintenance
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Yohimbine: List of nationally authorised medicinal products - PSUSA/00003136/201905 (PDF/102.12 KB)

authorised medicinal products - PSUSA/00003136/201905 … authorised medicinal products - PSUSA/00003136/201905 EMA/33967/2020 22/01/2020 …

Last updated: 22/01/2020
Active substance: yohimbine
Procedure number: PSUSA/00003136/201905
Regulatory outcome: Maintenance
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Clevidipine: List of nationally authorised medicinal products - PSUSA/00010288/201905 (PDF/111.95 KB)

authorised medicinal products - PSUSA/00010288/201905 … authorised medicinal products - PSUSA/00010288/201905 EMA/628079/2019 23/01/2020 …

Last updated: 23/01/2020
Active substance: clevidipine
Procedure number: PSUSA/00010288/201905
Regulatory outcome: Maintenance
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Ozenoxacin: List of nationally authorised medicinal products - PSUSA/00010651/201905 (PDF/113.11 KB)

authorised medicinal products - PSUSA/00010651/201905 … authorised medicinal products - PSUSA/00010651/201905 EMA/34676/2020 23/01/2020 …

Last updated: 23/01/2020
Active substance: Ozenoxacin
Procedure number: PSUSA/00010651/201905
Regulatory outcome: Maintenance
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Treprostinil: List of nationally authorised medicinal products - PSUSA/00003013/201905 (PDF/198.05 KB)

authorised medicinal products - PSUSA/00003013/201905 … authorised medicinal products - PSUSA/00003013/201905 EMA/40234/2020 24/01/2020 …

Last updated: 24/01/2020
Active substance: Treprostinil
Procedure number: PSUSA/00003013/201905
Regulatory outcome: Maintenance
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Methoxyflurane: List of nationally authorised medicinal products - PSUSA/00010484/201905 (PDF/159.18 KB)

authorised medicinal products - PSUSA/00010484/201905 … authorised medicinal products - PSUSA/00010484/201905 EMA/40500/2020 24/01/2020 …

Last updated: 24/01/2020
Active substance: Methoxyflurane
Procedure number: PSUSA/00010484/201905
Regulatory outcome: Maintenance
List item

Nicardipine: List of nationally authorised medicinal products - PSUSA/00002149/201905 (PDF/192.13 KB)

authorised medicinal products - PSUSA/00002149/201905 … authorised medicinal products - PSUSA/00002149/201905 EMA/34502/2020 27/01/2020 …

Last updated: 27/01/2020
Active substance: nicardipine
Procedure number: PSUSA/00002149/201905
Regulatory outcome: Maintenance
List item

Levonorgestrel: List of nationally authorised medicinal products - PSUSA/00001856/201905 (PDF/301.96 KB)

authorised medicinal products - PSUSA/00001856/201905 … authorised medicinal products - PSUSA/00001856/201905 EMA/117021/2020 10/03/2020 …

Last updated: 10/03/2020
Active substance: levonorgestrel
Procedure number: PSUSA/00001856/201905
Regulatory outcome: Variation
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Levomethadone: List of nationally authorised medicinal products - PSUSA/00001855/201905 (PDF/339.96 KB)

authorised medicinal products - PSUSA/00001855/201905 … authorised medicinal products - PSUSA/00001855/201905 EMA/270645/2015 12/03/2020 …

Last updated: 12/03/2020
Active substance: levomethadone
Procedure number: PSUSA/00001855/201905
Regulatory outcome: Variation
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Methadone: List of nationally authorised medicinal products - PSUSA/00002004/201905 (PDF/173.45 KB)

authorised medicinal products - PSUSA/00002004/201905 … authorised medicinal products - PSUSA/00002004/201905 EMA/139738/2020 17/03/2020 …

Last updated: 17/03/2020
Active substance: methadone
Procedure number: PSUSA/00002004/201905
Regulatory outcome: Variation
List item

Pholcodine: List of nationally authorised medicinal products - PSUSA/00002396/201905 (PDF/121.58 KB)

authorised medicinal products - PSUSA/00002396/201905 … authorised medicinal products - PSUSA/00002396/201905 EMA/178348/2020 03/04/2020 …

Last updated: 03/04/2020
Active substance: pholcodine
Procedure number: PSUSA/00002396/201905
Regulatory outcome: Variation
List item

Methoxyflurane: List of nationally authorised medicinal products - PSUSA/00010484/201905 (PDF/129.27 KB)

authorised medicinal products - PSUSA/00010484/201905 … authorised medicinal products - PSUSA/00010484/201905 EMA/331322/2020 18/06/2020 …

Last updated: 18/06/2020
Active substance: Methoxyflurane
Procedure number: PSUSA/00010484/201905
Regulatory outcome: Maintenance
List item

Macrogol 3350: List of nationally authorised medicinal products - PSUSA/0001924/201905 (PDF/122.76 KB)

authorised medicinal products - PSUSA/0001924/201905 … authorised medicinal products - PSUSA/0001924/201905 EMA/39495/2020 23/01/2020 …

Last updated: 23/01/2020
Active substance: Macrogol 3350
Procedure number: PSUSA/00001924/201905
Regulatory outcome: Maintenance
List item

Isoniazide / rifampicin: List of nationally authorised medicinal products - PSUSA/00001792/201905 (PDF/123.59 KB)

authorised medicinal products - PSUSA/00001792/201905 … authorised medicinal products - PSUSA/00001792/201905 EMA/31710/2020 23/01/2020 …

Last updated: 23/01/2020
Active substance: rifampicin, isoniazid
Procedure number: PSUSA/00010651/201905
Regulatory outcome: Maintenance
List item

Moxifloxacin (systemic use): List of nationally authorised medicinal products - PSUSA/00009231/201905 (PDF/241.13 KB)

authorised medicinal products - PSUSA/00009231/201905 … authorised medicinal products - PSUSA/00009231/201905 EMA/123159/2020 10/03/2020 …

Last updated: 10/03/2020
Active substance: moxifloxacin
Procedure number: PSUSA/00009231/201905
Regulatory outcome: Variation

2192 results

Isotretinoin (oral formulations): List of nationally authorised medicinal products - PSUSA/00010488/201905 (PDF/376.77 KB)

Isotretinoin (oral formulations): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010488/201905 (PDF/33.27 KB)

Isotretinoin (oral formulations): List of nationally authorised medicinal products - PSUSA/00010488/201705 (PDF/283 KB)

Isotretinoin (oral formulations): List of nationally authorised medicinal products - PSUSA/00010488/201611 (PDF/339.76 KB)

Isotretinoin (oral formulations) : List of nationally authorised medicinal products - PSUSA/00010488/202105 (PDF/560.7 KB)

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

Isotretinoin (oral formulations): List of nationally authorised medicinal products - PSUSA/00010488/201805 (PDF/356.23 KB)

Isotretinoin (oral formulations) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010488/202105 (PDF/172.42 KB)

Isotretinoin (oral formulations): CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010488/201611 (PDF/44.58 KB)

Isotretinoin (oral formulations): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00010488/201805 (PDF/87.05 KB)

Tirofiban: List of nationally authorised medicinal products - PSUSA/00002974/201905 (PDF/153.94 KB)

Yohimbine: List of nationally authorised medicinal products - PSUSA/00003136/201905 (PDF/102.12 KB)

Clevidipine: List of nationally authorised medicinal products - PSUSA/00010288/201905 (PDF/111.95 KB)

Ozenoxacin: List of nationally authorised medicinal products - PSUSA/00010651/201905 (PDF/113.11 KB)

Treprostinil: List of nationally authorised medicinal products - PSUSA/00003013/201905 (PDF/198.05 KB)

Methoxyflurane: List of nationally authorised medicinal products - PSUSA/00010484/201905 (PDF/159.18 KB)

Nicardipine: List of nationally authorised medicinal products - PSUSA/00002149/201905 (PDF/192.13 KB)

Levonorgestrel: List of nationally authorised medicinal products - PSUSA/00001856/201905 (PDF/301.96 KB)

Levomethadone: List of nationally authorised medicinal products - PSUSA/00001855/201905 (PDF/339.96 KB)

Methadone: List of nationally authorised medicinal products - PSUSA/00002004/201905 (PDF/173.45 KB)

Pholcodine: List of nationally authorised medicinal products - PSUSA/00002396/201905 (PDF/121.58 KB)

Methoxyflurane: List of nationally authorised medicinal products - PSUSA/00010484/201905 (PDF/129.27 KB)

Macrogol 3350: List of nationally authorised medicinal products - PSUSA/0001924/201905 (PDF/122.76 KB)

Isoniazide / rifampicin: List of nationally authorised medicinal products - PSUSA/00001792/201905 (PDF/123.59 KB)

Moxifloxacin (systemic use): List of nationally authorised medicinal products - PSUSA/00009231/201905 (PDF/241.13 KB)