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Ethinylestradiol / levonorgestrel: List of nationally authorised medicinal products - PSUSA/00001309/201904 (PDF/208.54 KB)

authorised medicinal products - PSUSA/00001309/201904 … authorised medicinal products - PSUSA/00001309/201904 EMA/40774/2020 27/01/2020 …

Last updated: 27/01/2020
Active substance: ethinylestradiol, levonorgestrel
Procedure number: PSUSA/00001309/201904
Regulatory outcome: Variation
List item

Ethinylestradiol / levonorgestrel: CMDh Scientific conclusions, amendments to product information and implementation timetable - PSUSA/00001309/201904 (PDF/38.01 KB)

implementation timetable - PSUSA/00001309/201904 … implementation timetable - PSUSA/00001309/201904 Other languages: lv mt nl …

Last updated: 27/01/2020
Active substance: ethinylestradiol, levonorgestrel
Procedure number: PSUSA/00001309/201904
Regulatory outcome: Variation
Bulgarian
(PDF/169.45 KB)

Croatian
(PDF/146.74 KB)

Czech
(PDF/149.23 KB)

Danish
(PDF/43.07 KB)

Dutch
(PDF/49.84 KB)

Estonian
(PDF/47.54 KB)

Finnish
(PDF/45.37 KB)

French
(PDF/44.18 KB)

German
(PDF/41.76 KB)

Greek
(PDF/158.14 KB)

Hungarian
(PDF/120.48 KB)

Icelandic
(PDF/42.67 KB)

Italian
(PDF/50.19 KB)

Latvian
(PDF/147.01 KB)

Lithuanian
(PDF/141.53 KB)

Maltese
(PDF/148.07 KB)

Norwegian
(PDF/43.61 KB)

Polish
(PDF/155.93 KB)

Portuguese
(PDF/42.56 KB)

Romanian
(PDF/136.92 KB)

Slovak
(PDF/127.45 KB)

Slovenian
(PDF/145.8 KB)

Spanish
(PDF/42.21 KB)

Swedish
(PDF/51.94 KB)
List item

Ethinylestradiol / levonorgestrel: List of nationally authorised medicinal products - PSUSA/00001309/201604 (PDF/145.63 KB)

authorised medicinal products - PSUSA/00001309/201604 … authorised medicinal products - PSUSA/00001309/201604 EMA/858449/2016 14/12/2016 … authorised medicinal products - PSUSA/00001309/201604 30 Churchill Place …

Last updated: 14/12/2016
Active substance: ethinylestradiol, levonorgestrel
Procedure number: PSUSA/00001309/201604
Regulatory outcome: Maintenance
List item

Ethinylestradiol / levonorgestrel : List of nationally authorised medicinal products - PSUSA/00001309/202204 (PDF/181.2 KB)

authorised medicinal products - PSUSA/00001309/202204 … authorised medicinal products - PSUSA/00001309/202204 EMA/933038/2022 09/12/2022 … levonorgestrel Procedure no.: PSUSA/00001309/202204 List of nationally …

Last updated: 09/12/2022
Active substance: ethinylestradiol, levonorgestrel
Procedure number: PSUSA/00001309/202204
Regulatory outcome: Maintenance
List item

Bemiparin: List of nationally authorised medicinal products - PSUSA/00000312/201904 (PDF/581.04 KB)

authorised medicinal products - PSUSA/00000312/201904 … authorised medicinal products - PSUSA/00000312/201904 EMA/36860/2020 23/01/2020 …

Last updated: 23/01/2020
Active substance: bemiparin
Procedure number: PSUSA/00000312/201904
Regulatory outcome: Maintenance
List item

Iobitridol: List of nationally authorised medicinal products - PSUSA/00001761/201904 (PDF/382.03 KB)

authorised medicinal products - PSUSA/00001761/201904 … authorised medicinal products - PSUSA/00001761/201904 EMA/173989/2020 03/04/2020 …

Last updated: 03/04/2020
Active substance: iobitridol
Procedure number: PSUSA/00001761/201904
Regulatory outcome: Variation
List item

Carvedilol / ivabradine : List of nationally authorised medicinal products - PSUSA/00010586/201904 (PDF/294.08 KB)

authorised medicinal products - PSUSA/00010586/201904 … authorised medicinal products - PSUSA/00010586/201904 EMA/650666/2019 02/12/2019 …

Last updated: 02/12/2019
Active substance: Carvedilol, ivabradine
Procedure number: PSUSA/00010586/201904
Regulatory outcome: Maintenance
List item

Ivermectin (topical use): List of nationally authorised medicinal products - PSUSA/00010376/201904 (PDF/172.07 KB)

authorised medicinal products - PSUSA/00010376/201904 … authorised medicinal products - PSUSA/00010376/201904 EMA/664500/2019 05/12/2019 …

Last updated: 05/12/2019
Active substance: Ivermectin
Procedure number: PSUSA/00010376/201904
Regulatory outcome: Maintenance
List item

Ivermectin (systemic use): List of nationally authorised medicinal products - PSUSA/00010377/201904 (PDF/105.47 KB)

authorised medicinal products - PSUSA/00010377/201904 … authorised medicinal products - PSUSA/00010377/201904 EMA/664534/2019 05/12/2019 …

Last updated: 05/12/2019
Active substance: Ivermectin
Procedure number: PSUSA/00010377/201904
Regulatory outcome: Maintenance
List item

Enoxaparin (except for biosimilars) : List of nationally authorised medicinal products - PSUSA/00010560/201904 (PDF/292.29 KB)

authorised medicinal products - PSUSA/00010560/201904 … authorised medicinal products - PSUSA/00010560/201904 EMA/601977/2019 07/11/2019 …

Last updated: 07/11/2019
Active substance: enoxaparin
Procedure number: PSUSA/00010560/201904
Regulatory outcome: Maintenance
List item

Allergen for therapy: Ambrosia Artemisiifolia (302) (sublingual use, products authorised via decentralised procedure) : List of nationally authorised medicinal products - PSUSA/00010693/201904 (PDF/67.93 KB)

authorised medicinal products - PSUSA/00010693/201904 … authorised medicinal products - PSUSA/00010693/201904 EMA/596024/2019 05/11/2019 …

Last updated: 05/11/2019
Active substance: ASMF
Procedure number: PSUSA/00010693/201904
Regulatory outcome: Maintenance
List item

Iobitridol: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001761/201904 (PDF/183.73 KB)

for the implementation - PSUSA/00001761/201904 … for the implementation - PSUSA/00001761/201904 Other languages: hu is it …

Last updated: 03/04/2020
Active substance: iobitridol
Procedure number: PSUSA/00001761/201904
Regulatory outcome: Variation
Bulgarian
(PDF/268.18 KB)

Croatian
(PDF/252.01 KB)

Czech
(PDF/208.68 KB)

Danish
(PDF/178.19 KB)

Dutch
(PDF/180.34 KB)

Estonian
(PDF/157.98 KB)

Finnish
(PDF/156.85 KB)

German
(PDF/188.1 KB)

Greek
(PDF/170.04 KB)

Hungarian
(PDF/230.15 KB)

Icelandic
(PDF/166.49 KB)

Italian
(PDF/187.3 KB)

Latvian
(PDF/338.22 KB)

Lithuanian
(PDF/228.35 KB)

Maltese
(PDF/241.92 KB)

Norwegian
(PDF/180.4 KB)

Polish
(PDF/233.28 KB)

Portuguese
(PDF/190.26 KB)

Romanian
(PDF/242.3 KB)

Slovak
(PDF/166.89 KB)

Slovenian
(PDF/238.13 KB)

Spanish
(PDF/179.41 KB)

Swedish
(PDF/182.38 KB)
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

2422 results

Ethinylestradiol / levonorgestrel: List of nationally authorised medicinal products - PSUSA/00001309/201904 (PDF/208.54 KB)

Ethinylestradiol / levonorgestrel: CMDh Scientific conclusions, amendments to product information and implementation timetable - PSUSA/00001309/201904 (PDF/38.01 KB)

Ethinylestradiol / levonorgestrel: List of nationally authorised medicinal products - PSUSA/00001309/201604 (PDF/145.63 KB)

Ethinylestradiol / levonorgestrel : List of nationally authorised medicinal products - PSUSA/00001309/202204 (PDF/181.2 KB)

Bemiparin: List of nationally authorised medicinal products - PSUSA/00000312/201904 (PDF/581.04 KB)

Iobitridol: List of nationally authorised medicinal products - PSUSA/00001761/201904 (PDF/382.03 KB)

Carvedilol / ivabradine : List of nationally authorised medicinal products - PSUSA/00010586/201904 (PDF/294.08 KB)

Ivermectin (topical use): List of nationally authorised medicinal products - PSUSA/00010376/201904 (PDF/172.07 KB)

Ivermectin (systemic use): List of nationally authorised medicinal products - PSUSA/00010377/201904 (PDF/105.47 KB)

Enoxaparin (except for biosimilars) : List of nationally authorised medicinal products - PSUSA/00010560/201904 (PDF/292.29 KB)

Allergen for therapy: Ambrosia Artemisiifolia (302) (sublingual use, products authorised via decentralised procedure) : List of nationally authorised medicinal products - PSUSA/00010693/201904 (PDF/67.93 KB)

Iobitridol: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001761/201904 (PDF/183.73 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)

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)