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Busulfan: List of nationally authorised medicinal products - PSUSA/0464/201907 (PDF/136.27 KB)

authorised medicinal products - PSUSA/0464/201907 … authorised medicinal products - PSUSA/0464/201907 EMA/270645/2015 19/05/2020 …

Last updated: 19/05/2020
Active substance: busulfan
Procedure number: PSUSA/0464/201907
Regulatory outcome: Variation
List item

Busulfan: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/0464/201907 (PDF/107.9 KB)

for the implementation - PSUSA/0464/201907 … for the implementation - PSUSA/0464/201907 Other languages: bg cs da …

Last updated: 19/05/2020
Active substance: busulfan
Procedure number: PSUSA/0464/201907
Regulatory outcome: Variation
Bulgarian
(PDF/122.54 KB)

Croatian
(PDF/223.11 KB)

Czech
(PDF/221.85 KB)

Danish
(PDF/109.73 KB)

Dutch
(PDF/96.17 KB)

Estonian
(PDF/105.2 KB)

Finnish
(PDF/109.72 KB)

French
(PDF/104.25 KB)

German
(PDF/99.6 KB)

Greek
(PDF/124.45 KB)

Hungarian
(PDF/113.66 KB)

Icelandic
(PDF/144.25 KB)

Italian
(PDF/96.76 KB)

Latvian
(PDF/119.89 KB)

Lithuanian
(PDF/197.33 KB)

Maltese
(PDF/113.95 KB)

Norwegian
(PDF/94.42 KB)

Polish
(PDF/118.16 KB)

Portuguese
(PDF/96.5 KB)

Romanian
(PDF/114.04 KB)

Slovak
(PDF/188.95 KB)

Slovenian
(PDF/110.45 KB)

Spanish
(PDF/96.96 KB)

Swedish
(PDF/97.18 KB)
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Pitavastatin: List of nationally authorised medicinal products - PSUSA/00010502/201907 (PDF/158.42 KB)

authorised medicinal products - PSUSA/00010502/201907 … authorised medicinal products - PSUSA/00010502/201907 EMA/185150/2020 07/04/2020 …

Last updated: 07/04/2020
Active substance: pitavastatin
Procedure number: PSUSA/00010502/201907
Regulatory outcome: Variation
List item

Brivudine: List of nationally authorised medicinal products - PSUSA/00000434/201907 (PDF/136.54 KB)

authorised medicinal products - PSUSA/00000434/201907 … authorised medicinal products - PSUSA/00000434/201907 EMA/246826/2020 08/05/2020 …

Last updated: 08/05/2020
Active substance: Brivudine
Procedure number: PSUSA/00000434/201907
Regulatory outcome: Variation
List item

Ibuprofen / pseudoephedrine: List of nationally authorised medicinal products - PSUSA/00001711/201907 (PDF/368.58 KB)

authorised medicinal products - PSUSA/00001711/201907 … authorised medicinal products - PSUSA/00001711/201907 EMA/180675/2020 07/04/2020 …

Last updated: 07/04/2020
Active substance: Ibuprofen, pseudoephedrine
Procedure number: PSUSA/00001711/201907
Regulatory outcome: Variation
List item

Pitavastatin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010502/201907 (PDF/141.12 KB)

for the implementation - PSUSA/00010502/201907 … for the implementation - PSUSA/00010502/201907 Other languages: bg cs da …

Last updated: 07/04/2020
Active substance: pitavastatin
Procedure number: PSUSA/00010502/201907
Regulatory outcome: Variation
Bulgarian
(PDF/145.97 KB)

Croatian
(PDF/133.19 KB)

Czech
(PDF/106 KB)

Danish
(PDF/126.7 KB)

Dutch
(PDF/153.88 KB)

Estonian
(PDF/85.68 KB)

Finnish
(PDF/120.21 KB)

French
(PDF/124.73 KB)

German
(PDF/126.1 KB)

Greek
(PDF/146.95 KB)

Hungarian
(PDF/145.53 KB)

Italian
(PDF/120.49 KB)

Latvian
(PDF/145.32 KB)

Lithuanian
(PDF/149.87 KB)

Maltese
(PDF/150.48 KB)

Norwegian
(PDF/120.16 KB)

Polish
(PDF/159.54 KB)

Portuguese
(PDF/118.85 KB)

Romanian
(PDF/138.09 KB)

Slovak
(PDF/157.6 KB)

Slovenian
(PDF/105.91 KB)

Spanish
(PDF/127.83 KB)

Swedish
(PDF/128.85 KB)
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Ibuprofen / pseudoephedrine: CMDh Scientific conclusions and grounds for variation, amendments to the product Information and timetable for the implementation - PSUSA/00001711/201907 (PDF/75.46 KB)

for the implementation - PSUSA/00001711/201907 … for the implementation - PSUSA/00001711/201907 Other languages: es et fi …

Last updated: 07/04/2020
Active substance: Ibuprofen, pseudoephedrine
Procedure number: PSUSA/00001711/201907
Regulatory outcome: Variation
Bulgarian
(PDF/71.28 KB)

Croatian
(PDF/78.08 KB)

Czech
(PDF/77.56 KB)

Danish
(PDF/76.94 KB)

Dutch
(PDF/76.14 KB)

Estonian
(PDF/67.37 KB)

Finnish
(PDF/68.49 KB)

French
(PDF/72.91 KB)

German
(PDF/82.49 KB)

Greek
(PDF/67.71 KB)

Hungarian
(PDF/76.21 KB)

Italian
(PDF/98.79 KB)

Latvian
(PDF/87.28 KB)

Lithuanian
(PDF/81.05 KB)

Maltese
(PDF/88.12 KB)

Polish
(PDF/73.46 KB)

Portuguese
(PDF/77.42 KB)

Romanian
(PDF/70.61 KB)

Slovak
(PDF/74.82 KB)

Slovenian
(PDF/98.79 KB)

Spanish
(PDF/74.28 KB)

Swedish
(PDF/71.78 KB)
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Brivudine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000434/201907 (PDF/340.59 KB)

for the implementation - PSUSA/00000434/201907 … for the implementation - PSUSA/00000434/201907 Other languages: bg cs da …

Last updated: 08/05/2020
Active substance: Brivudine
Procedure number: PSUSA/00000434/201907
Regulatory outcome: Variation
Bulgarian
(PDF/482.92 KB)

Croatian
(PDF/678.57 KB)

Czech
(PDF/545.33 KB)

Danish
(PDF/396.97 KB)

Dutch
(PDF/271.46 KB)

Estonian
(PDF/404.81 KB)

Finnish
(PDF/389.03 KB)

French
(PDF/366.22 KB)

German
(PDF/377.46 KB)

Greek
(PDF/566.89 KB)

Hungarian
(PDF/537.25 KB)

Italian
(PDF/193.78 KB)

Latvian
(PDF/568.68 KB)

Lithuanian
(PDF/604.61 KB)

Maltese
(PDF/563.71 KB)

Polish
(PDF/590.85 KB)

Portuguese
(PDF/349.08 KB)

Romanian
(PDF/532.33 KB)

Slovak
(PDF/487.51 KB)

Slovenian
(PDF/584.75 KB)

Spanish
(PDF/404.4 KB)

Swedish
(PDF/276.22 KB)
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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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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

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
List item

Tapentadol : List of nationally authorised medicinal products - PSUSA/00002849/201711 (PDF/1.4 MB)

authorised medicinal products - PSUSA/00002849/201711 … authorised medicinal products - PSUSA/00002849/201711 EMA/607287/2018 07/09/2018 … tapentadol Procedure no.: PSUSA/00002849/201711 List of nationally …

Last updated: 07/09/2018
Active substance: tapentadol
Procedure number: PSUSA/00002849/201711
Regulatory outcome: Variation
List item

Rosuvastatin: List of nationally authorised medicinal products - PSUSA/00002664/201711 (PDF/710.43 KB)

authorised medicinal products - PSUSA/00002664/201711 … authorised medicinal products - PSUSA/00002664/201711 EMA/270645/2015 31/08/2018 … rosuvastatin Procedure no.: PSUSA/00002664/201711 List of nationally …

Last updated: 31/08/2018
Active substance: Rosuvastatin
Procedure number: PSUSA/00002664/201711
Regulatory outcome: Variation
List item

Epinastine: List of nationally authorised medicinal products - PSUSA/00001231/201710 (PDF/130.86 KB)

authorised medicinal products - PSUSA/00001231/201710 … authorised medicinal products - PSUSA/00001231/201710 EMA/553008/2018 14/08/2018 … epinastine PSUSA/1231/201710 30 Churchill Place …

Last updated: 14/08/2018
Active substance: epinastine
Procedure number: PSUSA/00001231/201710
Regulatory outcome: Variation
List item

Deoxycholic acid: List of nationally authorised products - PSUSA/00010525/201710 (PDF/134.12 KB)

nationally authorised products - PSUSA/00010525/201710 … nationally authorised products - PSUSA/00010525/201710 EMA/PRAC/380270/2018 14/08/2018 … deoxycholic acid Procedure No.: PSUSA/00010525/201710 EMA/PRAC/384956/2018 …

Last updated: 14/08/2018
Active substance: Deoxycholic acid
Procedure number: PSUSA/00010525/201710
Regulatory outcome: Variation
List item

Prulifloxacin: List of nationally authorised medicinal products - PSUSA/00002569/201710 (PDF/101.7 KB)

authorised medicinal products - PSUSA/00002569/201710 … authorised medicinal products - PSUSA/00002569/201710 EMA/542253/2018 09/08/2018 … authorised medicinal products - PSUSA/00002569/201710 30 Churchill Place …

Last updated: 09/08/2018
Active substance: prulifloxacin
Procedure number: PSUSA/00002569/201710
Regulatory outcome: Variation
List item

Etomidate: List of nationally authorised medicinal products - PSUSA/00001330/20170 (PDF/82.09 KB)

authorised medicinal products - PSUSA/00001330/20170 … authorised medicinal products - PSUSA/00001330/20170 EMA/473178/2018 12/07/2018 … authorised medicinal products - PSUSA/00001330/201709 30 Churchill Place …

Last updated: 12/07/2018
Active substance: etomidate
Procedure number: PSUSA/00001330/20170
Regulatory outcome: Variation
List item

Famotidine: List of nationally authorised medicinal products - PSUSA/00001350/201709 (PDF/91.19 KB)

authorised medicinal products - PSUSA/00001350/201709 … authorised medicinal products - PSUSA/00001350/201709 EMA/475011/2018 12/07/2018 … famotidine PSUSA-00001350-201709 - variation 30 Churchill …

Last updated: 12/07/2018
Active substance: Famotidine
Procedure number: PSUSA/00001350/201709
Regulatory outcome: Variation
List item

Fluvastatin: List of nationally authorised medicinal products - PSUSA-00001457-201708 (PDF/319.58 KB)

authorised medicinal products - PSUSA-00001457-201708 … authorised medicinal products - PSUSA-00001457-201708 EMA/443956/2018 04/07/2018 … authorised medicinal products - PSUSA/00001457/201708 30 Churchill Place …

Last updated: 04/07/2018
Active substance: fluvastatin
Procedure number: PSUSA-00001457-201708
Regulatory outcome: Variation
List item

Treprostinil: List of nationally authorised medicinal products - PSUSA/00003013/201711 (PDF/139.8 KB)

authorised medicinal products - PSUSA/00003013/201711 … authorised medicinal products - PSUSA/00003013/201711 EMA/527312/2018 02/08/2018 …

Last updated: 02/08/2018
Active substance: Treprostinil
Procedure number: PSUSA/00003013/201711
Regulatory outcome: Variation
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Quetiapine: List of nationally authorised medicinal products - PSUSA/00002589/201707 (PDF/561.65 KB)

medicinal products - PSUSA/00002589/201707 … authorised medicinal products - PSUSA/00002589/201707 04/06/2018 15/06/2018 … authorised medicinal products - PSUSA-00002589-201707 30 Churchill Place …

Last updated: 15/06/2018
Active substance: quetiapine
Procedure number: PSUSA/00002589/201707
Regulatory outcome: Variation

910 results

Busulfan: List of nationally authorised medicinal products - PSUSA/0464/201907 (PDF/136.27 KB)

Busulfan: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/0464/201907 (PDF/107.9 KB)

Pitavastatin: List of nationally authorised medicinal products - PSUSA/00010502/201907 (PDF/158.42 KB)

Brivudine: List of nationally authorised medicinal products - PSUSA/00000434/201907 (PDF/136.54 KB)

Ibuprofen / pseudoephedrine: List of nationally authorised medicinal products - PSUSA/00001711/201907 (PDF/368.58 KB)

Pitavastatin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010502/201907 (PDF/141.12 KB)

Ibuprofen / pseudoephedrine: CMDh Scientific conclusions and grounds for variation, amendments to the product Information and timetable for the implementation - PSUSA/00001711/201907 (PDF/75.46 KB)

Brivudine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000434/201907 (PDF/340.59 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)

Lamotrigine : List of nationally authorised medicinal products - PSUSA/00001825/201711 (PDF/639.41 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)

Tapentadol : List of nationally authorised medicinal products - PSUSA/00002849/201711 (PDF/1.4 MB)

Rosuvastatin: List of nationally authorised medicinal products - PSUSA/00002664/201711 (PDF/710.43 KB)

Epinastine: List of nationally authorised medicinal products - PSUSA/00001231/201710 (PDF/130.86 KB)

Deoxycholic acid: List of nationally authorised products - PSUSA/00010525/201710 (PDF/134.12 KB)

Prulifloxacin: List of nationally authorised medicinal products - PSUSA/00002569/201710 (PDF/101.7 KB)

Etomidate: List of nationally authorised medicinal products - PSUSA/00001330/20170 (PDF/82.09 KB)

Famotidine: List of nationally authorised medicinal products - PSUSA/00001350/201709 (PDF/91.19 KB)

Fluvastatin: List of nationally authorised medicinal products - PSUSA-00001457-201708 (PDF/319.58 KB)

Treprostinil: List of nationally authorised medicinal products - PSUSA/00003013/201711 (PDF/139.8 KB)

Quetiapine: List of nationally authorised medicinal products - PSUSA/00002589/201707 (PDF/561.65 KB)