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Fentanyl (transdermal patches, solution for injection - nationally authorised product only) : List of nationally authorised medicinal products - PSUSA/00001370/202104 (PDF/310.82 KB)

authorised medicinal products - PSUSA/00001370/202104 … authorised medicinal products - PSUSA/00001370/202104 EMA/51965/2022 26/01/2022 … product only) Procedure no.: PSUSA/00001370/202104 List of nationally …

Last updated: 26/01/2022
Active substance: fentanyl (transdermal patches, solution for injection - nationally authorised product only)
Procedure number: PSUSA/00001370/202104
Regulatory outcome: Variation
List item

Fentanyl (transdermal patches, solution for injection....) - CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001370/202104 (PDF/215.41 KB)

for the implementation - PSUSA/00001370/202104 … for the implementation - PSUSA/00001370/202104 Other languages: hr hu is …

Last updated: 26/01/2022
Active substance: fentanyl (transdermal patches, solution for injection - nationally authorised product only)
Procedure number: PSUSA/00001370/202104
Regulatory outcome: Variation
Bulgarian
(PDF/236.63 KB)

Croatian
(PDF/214.06 KB)

Czech
(PDF/224.68 KB)

Danish
(PDF/49.59 KB)

Dutch
(PDF/185.23 KB)

Estonian
(PDF/213.86 KB)

Finnish
(PDF/54.37 KB)

French
(PDF/227.04 KB)

German
(PDF/240.61 KB)

Greek
(PDF/209.71 KB)

Hungarian
(PDF/223.22 KB)

Icelandic
(PDF/42.06 KB)

Italian
(PDF/202.33 KB)

Latvian
(PDF/229.23 KB)

Lithuanian
(PDF/219.9 KB)

Maltese
(PDF/233.64 KB)

Norwegian
(PDF/45.02 KB)

Polish
(PDF/214.03 KB)

Portuguese
(PDF/42.96 KB)

Romanian
(PDF/214.59 KB)

Slovak
(PDF/220.72 KB)

Slovenian
(PDF/215.2 KB)

Spanish
(PDF/177.54 KB)

Swedish
(PDF/45.27 KB)
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Fentanyl (transdermal patches, solution for injection): List of nationally authorised medicinal products - PSUSA/00001370/201504 (PDF/138.24 KB)

authorised medicinal products - PSUSA/00001370/201504 … authorised medicinal products - PSUSA/00001370/201504 EMA/230161/2016 31/03/2016 … injection) Procedure no.: PSUSA/00001370/201504 List of nationally …

Last updated: 18/10/2016
Active substance: fentanyl
Procedure number: PSUSA/00001370/201504
Regulatory outcome: Maintenance
List item

Fentanyl (transdermal patches, solution for injection - nationally authorised product only) - List of nationally authorised medicinal products - PSUSA/00001370/202204 (PDF/348.07 KB) (new)

authorised medicinal products - PSUSA/00001370/202204 … authorised medicinal products - PSUSA/00001370/202204 EMA/37490/2023 23/01/2023 … product only) Procedure no.: PSUSA/00001370/202204 http://www.ema.europa.eu/how-to-find-us http://www.ema.europa.eu/contact …

Last updated: 23/01/2023
Active substance: fentanyl
Procedure number: PSUSA/00001370/202204
Regulatory outcome: Variation
List item

Fentanyl (transdermal patches, solution for injection - nationally authorised product only): List of nationally authorised medicinal products - PSUSA/00001370/201804 (PDF/221.7 KB)

authorised medicinal products - PSUSA/00001370/201804 … authorised medicinal products - PSUSA/00001370/201804 EMA/170921/2019 19/03/2019 …

Last updated: 19/03/2019
Active substance: fentanyl
Procedure number: PSUSA/00001370/201804
Regulatory outcome: Variation
List item

Fentanyl (transdermal patches, solution for injection - nationally authorised product only) - CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001370/202204 (PDF/168.84 KB) (new)

for the implementation - PSUSA/00001370/202204 … for the implementation - PSUSA/00001370/202204 Other languages: sv bg cs … products covered by this PSUSA, amendment of SmPC section …

Last updated: 23/01/2023
Active substance: fentanyl
Procedure number: PSUSA/00001370/202204
Regulatory outcome: Variation
Bulgarian
(PDF/220.08 KB)

Croatian
(PDF/220.52 KB)

Czech
(PDF/224.94 KB)

Danish
(PDF/171.77 KB)

Dutch
(PDF/173.39 KB)

Estonian
(PDF/165.82 KB)

Finnish
(PDF/165.03 KB)

French
(PDF/178.18 KB)

German
(PDF/183.64 KB)

Greek
(PDF/213.96 KB)

Hungarian
(PDF/226.63 KB)

Icelandic
(PDF/177.64 KB)

Italian
(PDF/170.87 KB)

Latvian
(PDF/208.94 KB)

Lithuanian
(PDF/218.24 KB)

Maltese
(PDF/223.36 KB)

Norwegian
(PDF/169.55 KB)

Polish
(PDF/224.68 KB)

Portuguese
(PDF/175.16 KB)

Romanian
(PDF/214.75 KB)

Slovak
(PDF/216.32 KB)

Slovenian
(PDF/209.12 KB)

Spanish
(PDF/172.23 KB)

Swedish
(PDF/169.61 KB)
List item

Fentanyl (transdermal patches, solution for injection - nationally authorised product only): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001370/201804 (PDF/41.27 KB)

for the implementation - PSUSA/00001370/201804 … for the implementation - PSUSA/00001370/201804 Other languages: bg cs da …

Last updated: 19/03/2019
Active substance: fentanyl
Procedure number: PSUSA/00001370/201804
Regulatory outcome: Variation
Bulgarian
(PDF/120.84 KB)

Croatian
(PDF/101.01 KB)

Czech
(PDF/110.05 KB)

Danish
(PDF/54.63 KB)

Dutch
(PDF/41.24 KB)

Estonian
(PDF/42.79 KB)

Finnish
(PDF/40.59 KB)

French
(PDF/49.95 KB)

German
(PDF/44.57 KB)

Greek
(PDF/103.66 KB)

Hungarian
(PDF/103.71 KB)

Icelandic
(PDF/44.72 KB)

Italian
(PDF/52.07 KB)

Latvian
(PDF/109.99 KB)

Lithuanian
(PDF/104.96 KB)

Maltese
(PDF/115.93 KB)

Norwegian
(PDF/43.13 KB)

Polish
(PDF/111.05 KB)

Portuguese
(PDF/44.12 KB)

Romanian
(PDF/100.83 KB)

Slovak
(PDF/108.14 KB)

Slovenian
(PDF/100.22 KB)

Spanish
(PDF/41.49 KB)

Swedish
(PDF/41.16 KB)
List item

Carmustine: List of nationally authorised medicinal products - PSUSA/00010349/202104 (PDF/90.22 KB)

authorised medicinal products - PSUSA/00010349/202104 … authorised medicinal products - PSUSA/00010349/202104 EMA/772526/2021 05/01/2022 … infusion) Procedure no.: PSUSA/00010349/202104 …

Last updated: 05/01/2022
Active substance: carmustine
Procedure number: PSUSA/00010349/202104
Regulatory outcome: Maintenance
List item

Chloroquine : List of nationally authorised medicinal products - PSUSA/00000685/202104 (PDF/90.63 KB)

authorised medicinal products - PSUSA/00000685/202104 … authorised medicinal products - PSUSA/00000685/202104 EMA/502656/2021 20/01/2022 … chloroquine Procedure no.: PSUSA/00000685/202104 List of nationally …

Last updated: 20/01/2022
Active substance: Chloroquine
Procedure number: PSUSA/00000685/202104
Regulatory outcome: Variation
List item

Dihydroergotamine: List of nationally authorised medicinal products - PSUSA/00001075/202104 (PDF/139.11 KB)

authorised medicinal products - PSUSA/00001075/202104 … authorised medicinal products - PSUSA/00001075/202104 EMA/724961/2021 07/12/2021 … dihydroergotamine Procedure no.: PSUSA/00001075/202104 List of nationally …

Last updated: 07/12/2021
Active substance: dihydroergotamine
Procedure number: PSUSA/00001075/202104
Regulatory outcome: Maintenance
List item

Docosanol : List of nationally authorised medicinal products - PSUSA/00010092/202104 (PDF/118.33 KB)

authorised medicinal products - PSUSA/00010092/202104 … authorised medicinal products - PSUSA/00010092/202104 EMA/690088/2021 17/01/2022 … docosanol Procedure no.: PSUSA/00010092/202104 List of nationally …

Last updated: 17/01/2022
Active substance: docosanol
Procedure number: PSUSA/00010092/202104
Regulatory outcome: Maintenance
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Ivermectin: List of nationally authorised medicinal products - PSUSA/00010376/202104 (PDF/178.09 KB)

authorised medicinal products - PSUSA/00010376/202104 … authorised medicinal products - PSUSA/00010376/202104 EMA/756742/2021 16/12/2021 … topical use) Procedure no.: PSUSA/00010376/202104 List of nationally …

Last updated: 16/12/2021
Active substance: Ivermectin
Procedure number: PSUSA/00010376/202104
Regulatory outcome: Maintenance
List item

Milnalcipran : List of nationally authorised medicinal products - PSUSA/00002063/202104 (PDF/140.47 KB)

authorised medicinal products - PSUSA/00002063/202104 … authorised medicinal products - PSUSA/00002063/202104 EMA/25995/2022 14/01/2022 … milnalcipran Procedure no.: PSUSA/00002063/202104 List of nationally …

Last updated: 14/01/2022
Active substance: milnalcipran
Procedure number: PSUSA/00002063/202104
Regulatory outcome: Maintenance
List item

Hydroxychloroquine : List of nationally authorised medicinal products - PSUSA/00001693/202104 (PDF/131.71 KB)

authorised medicinal products - PSUSA/00001693/202104 … authorised medicinal products - PSUSA/00001693/202104 EMA/502667/2021 24/01/2022 … hydroxychloroquine Procedure no.: PSUSA/00001693/202104 List of nationally …

Last updated: 24/01/2022
Active substance: Hydroxychloroquine
Procedure number: PSUSA/00001693/202104
Regulatory outcome: Variation
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Terlipressin: List of nationally authorised medicinal products - PSUSA/00002905/202104 (PDF/179.51 KB)

authorised medicinal products - PSUSA/00002905/202104 … authorised medicinal products - PSUSA/00002905/202104 EMA/757577/2021 15/12/2021 … terlipressin Procedure no.: PSUSA/00002905/202104 List of nationally …

Last updated: 15/12/2021
Active substance: terlipressin
Procedure number: EMA/757577/2021
Regulatory outcome: Maintenance
List item

Tafluprost: List of nationally authorised medicinal products - PSUSA/00002843/202104 (PDF/201.99 KB)

authorised medicinal products - PSUSA/00002843/202104 … authorised medicinal products - PSUSA/00002843/202104 EMA/721991/2021 06/12/2021 … tafluprost Procedure no.: PSUSA/00002843/202104 List of nationally …

Last updated: 06/12/2021
Active substance: Tafluprost
Procedure number: PSUSA/00002843/202104
Regulatory outcome: Maintenance
List item

Quinapril : List of nationally authorised medicinal products - PSUSA/00002591/202104 (PDF/133.94 KB)

authorised medicinal products - PSUSA/00002591/202104 … authorised medicinal products - PSUSA/00002591/202104 EMA/76805/2022 08/02/2022 … quinapril Procedure No.: PSUSA/00002591/202104 EMA/76805/2022 …

Last updated: 08/02/2022
Active substance: quinapril
Procedure number: PSUSA/00002591/202104
Regulatory outcome: Variation
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Metformin : List of nationally authorised medicinal products - PSUSA/00002001/202104 (PDF/408.73 KB)

authorised medicinal products - PSUSA/00002001/202104 … authorised medicinal products - PSUSA/00002001/202104 EMA/731509/2021 08/12/2021 … metformin Procedure no.: PSUSA/00002001/202104 List of nationally …

Last updated: 08/12/2021
Active substance: Metformin
Procedure number: PSUSA/00002001/202104
Regulatory outcome: Maintenance
List item

Oxaliplatin - List of nationally authorised medicinal products - PSUSA/00002229/202104 (PDF/355.4 KB)

authorised medicinal products - PSUSA/00002229/202104 … authorised medicinal products - PSUSA/00002229/202104 EMA/719030/2021 03/12/2021 … oxaliplatin Procedure no.: PSUSA/00002229/202104 List of nationally …

Last updated: 03/12/2021
Active substance: oxaliplatin
Procedure number: PSUSA/00002229/202104
Regulatory outcome: Maintenance
List item

Oxycodone : List of nationally authorised medicinal products - PSUSA/00002254/202104 (PDF/510.16 KB)

authorised medicinal products - PSUSA/00002254/202104 … authorised medicinal products - PSUSA/00002254/202104 EMA/46766/2022 25/01/2022 … oxycodone Procedure no.: PSUSA/00002254/202104 List of nationally …

Last updated: 25/01/2022
Active substance: oxycodone
Procedure number: PSUSA/00002254/202104
Regulatory outcome: Variation
List item

Budesonide: List of nationally authorised medicinal products - PSUSA/00000449/202104 (PDF/732.33 KB)

authorised medicinal products - PSUSA/00000449/202104 … authorised medicinal products - PSUSA/00000449/202104 EMA/695847/2021 06/12/2021 … budesonide Procedure No: PSUSA/00000449/202104 List of the nationally …

Last updated: 06/12/2021
Active substance: budesonide
Procedure number: PSUSA/00000449/202104
Regulatory outcome: Maintenance
List item

Plasma protein fraction: List of nationally authorised medicinal products - PSUSA/00002449/202104 (PDF/101.34 KB)

authorised medicinal products - PSUSA/00002449/202104 … authorised medicinal products - PSUSA/00002449/202104 EMA/717468/2021 06/12/2021 … fraction Procedure No.: PSUSA/00002449/202104 List of nationally …

Last updated: 06/12/2021
Active substance: plasma protein fraction
Procedure number: PSUSA/00002449/202104
Regulatory outcome: Maintenance
List item

Captopril / hydrochlorothiazide : List of nationally authorised medicinal products - PSUSA/00000536/202104 (PDF/156.05 KB)

authorised medicinal products - PSUSA/00000536/202104 … authorised medicinal products - PSUSA/00000536/202104 EMA/294429/2021 13/01/2022 … hydrochlorothiazide Procedure No.: PSUSA/00000536/202104 List of nationally …

Last updated: 13/01/2022
Active substance: captopril, hydrochlorothiazide
Procedure number: PSUSA/00000536/202104
Regulatory outcome: Maintenance
List item

Praziquantel : List of the nationally authorised medicinal products - PSUSA/00002503/202104 (PDF/124.54 KB)

authorised medicinal products - PSUSA/00002503/202104 … authorised medicinal products - PSUSA/00002503/202104 EMA/37314/2022 20/01/2022 … praziquantel Procedure No: PSUSA/00002503/202104 …

Last updated: 20/01/2022
Active substance: praziquantel
Procedure number: PSUSA/00002503/202104
Regulatory outcome: Variation
List item

Dexamethasone / netilmicin: List of nationally authorised medicinal products - PSUSA/00010854/202104 (PDF/174.08 KB)

authorised medicinal products - PSUSA/00010854/202104 … authorised medicinal products - PSUSA/00010854/202104 EMA/724898/2021 07/12/2021 … netilmicin Procedure no.: PSUSA/00010854/202104 List of nationally …

Last updated: 07/12/2021
Active substance: dexamethasone, netilmicin
Procedure number: PSUSA/00010854/202104
Regulatory outcome: Maintenance

2355 results

Fentanyl (transdermal patches, solution for injection - nationally authorised product only) : List of nationally authorised medicinal products - PSUSA/00001370/202104 (PDF/310.82 KB)

Fentanyl (transdermal patches, solution for injection....) - CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001370/202104 (PDF/215.41 KB)

Fentanyl (transdermal patches, solution for injection): List of nationally authorised medicinal products - PSUSA/00001370/201504 (PDF/138.24 KB)

Fentanyl (transdermal patches, solution for injection - nationally authorised product only) - List of nationally authorised medicinal products - PSUSA/00001370/202204 (PDF/348.07 KB) (new)

Fentanyl (transdermal patches, solution for injection - nationally authorised product only): List of nationally authorised medicinal products - PSUSA/00001370/201804 (PDF/221.7 KB)

Fentanyl (transdermal patches, solution for injection - nationally authorised product only) - CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001370/202204 (PDF/168.84 KB) (new)

Fentanyl (transdermal patches, solution for injection - nationally authorised product only): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001370/201804 (PDF/41.27 KB)

Carmustine: List of nationally authorised medicinal products - PSUSA/00010349/202104 (PDF/90.22 KB)

Chloroquine : List of nationally authorised medicinal products - PSUSA/00000685/202104 (PDF/90.63 KB)

Dihydroergotamine: List of nationally authorised medicinal products - PSUSA/00001075/202104 (PDF/139.11 KB)

Docosanol : List of nationally authorised medicinal products - PSUSA/00010092/202104 (PDF/118.33 KB)

Ivermectin: List of nationally authorised medicinal products - PSUSA/00010376/202104 (PDF/178.09 KB)

Milnalcipran : List of nationally authorised medicinal products - PSUSA/00002063/202104 (PDF/140.47 KB)

Hydroxychloroquine : List of nationally authorised medicinal products - PSUSA/00001693/202104 (PDF/131.71 KB)

Terlipressin: List of nationally authorised medicinal products - PSUSA/00002905/202104 (PDF/179.51 KB)

Tafluprost: List of nationally authorised medicinal products - PSUSA/00002843/202104 (PDF/201.99 KB)

Quinapril : List of nationally authorised medicinal products - PSUSA/00002591/202104 (PDF/133.94 KB)

Metformin : List of nationally authorised medicinal products - PSUSA/00002001/202104 (PDF/408.73 KB)

Oxaliplatin - List of nationally authorised medicinal products - PSUSA/00002229/202104 (PDF/355.4 KB)

Oxycodone : List of nationally authorised medicinal products - PSUSA/00002254/202104 (PDF/510.16 KB)

Budesonide: List of nationally authorised medicinal products - PSUSA/00000449/202104 (PDF/732.33 KB)

Plasma protein fraction: List of nationally authorised medicinal products - PSUSA/00002449/202104 (PDF/101.34 KB)

Captopril / hydrochlorothiazide : List of nationally authorised medicinal products - PSUSA/00000536/202104 (PDF/156.05 KB)

Praziquantel : List of the nationally authorised medicinal products - PSUSA/00002503/202104 (PDF/124.54 KB)

Dexamethasone / netilmicin: List of nationally authorised medicinal products - PSUSA/00010854/202104 (PDF/174.08 KB)