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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
List item

Hydroxychloroquine : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001693/202104 (PDF/109.26 KB)

for the implementation - PSUSA/00001693/202104 … for the implementation - PSUSA/00001693/202104 Other languages: hr hu is …

Last updated: 24/01/2022
Active substance: Hydroxychloroquine
Procedure number: PSUSA/00001693/202104
Regulatory outcome: Variation
Bulgarian
(PDF/123.2 KB)

Croatian
(PDF/121.54 KB)

Czech
(PDF/401.98 KB)

Danish
(PDF/234.94 KB)

Dutch
(PDF/134.22 KB)

Estonian
(PDF/182.6 KB)

Finnish
(PDF/101.66 KB)

French
(PDF/149.65 KB)

German
(PDF/218.41 KB)

Greek
(PDF/90.08 KB)

Hungarian
(PDF/179.68 KB)

Icelandic
(PDF/134.54 KB)

Irish
(PDF/109.99 KB)

Italian
(PDF/139.43 KB)

Latvian
(PDF/253.91 KB)

Lithuanian
(PDF/274.46 KB)

Maltese
(PDF/190 KB)

Norwegian
(PDF/129.92 KB)

Polish
(PDF/122.49 KB)

Portuguese
(PDF/113.86 KB)

Romanian
(PDF/229.61 KB)

Slovak
(PDF/228.57 KB)

Slovenian
(PDF/109.34 KB)

Spanish
(PDF/107.67 KB)

Swedish
(PDF/141.59 KB)
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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Deoxycholic acid : List of nationally authorised medicinal products - PSUSA/00010525/202104 (PDF/147.8 KB)

authorised medicinal products - PSUSA/00010525/202104 … authorised medicinal products - PSUSA/00010525/202104 EMA/751094/2021 14/12/2021 … deoxycholic acid Procedure no.: PSUSA/00010525/202104 List of nationally …

Last updated: 14/12/2021
Active substance: Deoxycholic acid
Procedure number: PSUSA/00010525/202104
Regulatory outcome: Maintenance
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Hydrochlorothiazide / quinapril : List of nationally authorised medicinal products - PSUSA/00002592/202104 (PDF/132.81 KB)

authorised medicinal products - PSUSA/00002592/202104 … authorised medicinal products - PSUSA/00002592/202104 EMA/76996/2022 08/02/2022 … quinapril Procedure No.: PSUSA/00002592/202104 EMA/76996/2022 …

Last updated: 08/02/2022
Active substance: hydrochlorothiazide, quinapril
Procedure number: PSUSA/00002592/202104
Regulatory outcome: Variation
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Human prothrombin complex : List of nationally authorised medicinal products - PSUSA/00001638/202104 (PDF/196.57 KB)

authorised medicinal products - PSUSA/00001638/202104 … authorised medicinal products - PSUSA/00001638/202104 EMA/15908/2022 14/01/2022 … complex Procedure No.: PSUSA/00001638/202104 List of …

Last updated: 14/01/2022
Active substance: human prothrombin complex
Procedure number: PSUSA/00001638/202104
Regulatory outcome: Maintenance
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Ofloxacin (systemic use) - List of nationally authorised medicinal products - PSUSA/00002203/202104 (PDF/213.56 KB)

authorised medicinal products - PSUSA/00002203/202104 … authorised medicinal products - PSUSA/00002203/202104 EMA/502701/2021 17/01/2022 … systemic use) Procedure no.: PSUSA/00002203/202104 List of nationally …

Last updated: 17/01/2022
Active substance: ofloxacin (systemic use)
Procedure number: PSUSA/00002203/202104
Regulatory outcome: Variation
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Ofloxacin (systemic use) - List of nationally authorised medicinal products - PSUSA/00002203/202104 (PDF/213.56 KB)

authorised medicinal products - PSUSA/00002203/202104 … authorised medicinal products - PSUSA/00002203/202104 EMA/502701/2021 21/01/2022 … systemic use) Procedure no.: PSUSA/00002203/202104 List of nationally …

Last updated: 21/01/2022
Active substance: ofloxacin (systemic use)
Procedure number: PSUSA/00002203/202104
Regulatory outcome: Variation
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Ofloxacin (topical use) : List of nationally authorised medicinal products - PSUSA/00002204/202104 (PDF/299.33 KB)

authorised medicinal products - PSUSA/00002204/202104 … authorised medicinal products - PSUSA/00002204/202104 EMA/788063/2022 28/09/2022 … topical use) Procedure no.: PSUSA/00002204/202104 List of nationally …

Last updated: 28/09/2022
Active substance: Ofloxacin (topical use)
Procedure number: PSUSA/00002204/202104
Regulatory outcome: Maintenance

2359 results

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

Hydroxychloroquine : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001693/202104 (PDF/109.26 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)

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)

Deoxycholic acid : List of nationally authorised medicinal products - PSUSA/00010525/202104 (PDF/147.8 KB)

Hydrochlorothiazide / quinapril : List of nationally authorised medicinal products - PSUSA/00002592/202104 (PDF/132.81 KB)

Human prothrombin complex : List of nationally authorised medicinal products - PSUSA/00001638/202104 (PDF/196.57 KB)

Ofloxacin (systemic use) - List of nationally authorised medicinal products - PSUSA/00002203/202104 (PDF/213.56 KB)

Ofloxacin (systemic use) - List of nationally authorised medicinal products - PSUSA/00002203/202104 (PDF/213.56 KB)

Ofloxacin (topical use) : List of nationally authorised medicinal products - PSUSA/00002204/202104 (PDF/299.33 KB)