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Ocrevus-H-C-PSUSA-00010662- 202003 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/131.32 KB) (new)

First published: 22/01/2021
EMA/668602/2020
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Dupixent-H-C-PSUSA-00010645-202009 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/89.89 KB) (new)

First published: 22/01/2021
EMA/43938/2021
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Dupixent-H-C-4390-II-0027 : EPAR - Assessment report - Variation (PDF/6.04 MB) (new)

Adopted
First published: 22/01/2021
EMA/640921/2020
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Captopril: List of nationally authorised medicinal products - PSUSA/00000535/202004 (PDF/123.38 KB) (new)

Last updated: 22/01/2021
Active substance: captopril
Procedure number: PSUSA/00000535/202004
Regulatory outcome: Maintenance
List item

Blincyto-H-C-3731-II-0030 : EPAR - Assessment report - Variation (PDF/4.39 MB) (new)

Adopted
First published: 22/01/2021
EMA/CHMP/37563/2021
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Deoxycholic acid: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010525/202004 (PDF/80.32 KB) (new)

Last updated: 22/01/2021
Active substance: Deoxycholic acid
Procedure number: PSUSA/00010525/202004
Regulatory outcome: Variation
Bulgarian
(PDF/183.85 KB)

Croatian
(PDF/180.89 KB)

Czech
(PDF/159.38 KB)

Danish
(PDF/80.18 KB)

Dutch
(PDF/82.96 KB)

Estonian
(PDF/83.96 KB)

Finnish
(PDF/81.72 KB)

French
(PDF/82.46 KB)

German
(PDF/83.22 KB)

Greek
(PDF/184.37 KB)

Hungarian
(PDF/154.09 KB)

Icelandic
(PDF/78.98 KB)

Italian
(PDF/83.23 KB)

Latvian
(PDF/177.4 KB)

Lithuanian
(PDF/177.24 KB)

Maltese
(PDF/183.81 KB)

Norwegian
(PDF/80.63 KB)

Polish
(PDF/181.13 KB)

Portuguese
(PDF/81.07 KB)

Romanian
(PDF/174.96 KB)

Slovak
(PDF/157.58 KB)

Slovenian
(PDF/124.25 KB)

Spanish
(PDF/82.34 KB)

Swedish
(PDF/81.75 KB)
List item

Deoxycholic acid: List of nationally authorised medicinal products - PSUSA/00010525/202004 (PDF/173.45 KB) (new)

Last updated: 22/01/2021
Active substance: Deoxycholic acid
Procedure number: PSUSA/00010525/202004
Regulatory outcome: Variation
List item

Xofluza : EPAR - Public assessment report (PDF/4.39 MB) (new)

Adopted
First published: 22/01/2021
EMA/CHMP/537088/2020
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Methoxyflurane: List of nationally authorised medicinal products - PSUSA/00010484/202005 (PDF/147.38 KB) (new)

Last updated: 22/01/2021
Active substance: Methoxyflurane
Procedure number: PSUSA/00010484/202005
Regulatory outcome: Maintenance
List item

Xofluza : EPAR - All authorised presentations (PDF/21.7 KB) (new)

First published: 22/01/2021
Bulgarian
(PDF/39.25 KB)

Croatian
(PDF/25.75 KB)

Czech
(PDF/28.98 KB)

Danish
(PDF/17.47 KB)

Dutch
(PDF/12.09 KB)

Estonian
(PDF/16.19 KB)

Finnish
(PDF/27.6 KB)

French
(PDF/27.72 KB)

German
(PDF/16.71 KB)

Greek
(PDF/40.92 KB)

Hungarian
(PDF/33.78 KB)

Icelandic
(PDF/14.22 KB)

Italian
(PDF/13.65 KB)

Latvian
(PDF/38.53 KB)

Lithuanian
(PDF/58.35 KB)

Maltese
(PDF/33.84 KB)

Norwegian
(PDF/17.86 KB)

Polish
(PDF/26.79 KB)

Portuguese
(PDF/17.13 KB)

Romanian
(PDF/32.73 KB)

Slovak
(PDF/26.36 KB)

Slovenian
(PDF/22.37 KB)

Spanish
(PDF/25.19 KB)

Swedish
(PDF/16.95 KB)
List item

Tremfya-H-C-4271-II-17 : EPAR - Assessment report - Variation (PDF/7.15 MB) (new)

Adopted
First published: 22/01/2021
EMA/600660/2020
List item

Formoterol : List of nationally authorised medicinal products - PSUSA/00001469/202005 (PDF/831.46 KB) (new)

Last updated: 22/01/2021
Active substance: formoterol
Procedure number: PSUSA/00001469/202005
Regulatory outcome: Maintenance
List item

Xofluza : EPAR - Product information (PDF/261.64 KB) (new)

First published: 22/01/2021
Bulgarian
(PDF/457.59 KB)

Croatian
(PDF/302.27 KB)

Czech
(PDF/345.58 KB)

Danish
(PDF/463.18 KB)

Dutch
(PDF/256.41 KB)

Estonian
(PDF/428.65 KB)

Finnish
(PDF/262.1 KB)

French
(PDF/309.26 KB)

German
(PDF/600.4 KB)

Greek
(PDF/481.13 KB)

Hungarian
(PDF/315.53 KB)

Icelandic
(PDF/255.45 KB)

Italian
(PDF/523 KB)

Latvian
(PDF/364.79 KB)

Lithuanian
(PDF/351.62 KB)

Maltese
(PDF/421.58 KB)

Norwegian
(PDF/251.21 KB)

Polish
(PDF/316.77 KB)

Portuguese
(PDF/376.44 KB)

Romanian
(PDF/323.39 KB)

Slovak
(PDF/438.12 KB)

Slovenian
(PDF/431.61 KB)

Spanish
(PDF/243.13 KB)

Swedish
(PDF/241.56 KB)
List item

Xofluza : EPAR - Medicine overview (PDF/119.99 KB) (new)

First published: 22/01/2021
EMA/648596/2020
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Tasigna-H-C-PSUSA-00002162-202001 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/129.46 KB) (new)

First published: 22/01/2021
EMA/37441/2021
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Kalydeco-H-C-2494-X-83-G: EPAR - Assessment Report - Variation (PDF/4.62 MB) (new)

Adopted
First published: 22/01/2021
EMA/628136/2020
List item

Mometasone: List of nationally authorised medicinal products - PSUSA/00002085/202005 (PDF/838.45 KB) (new)

Last updated: 21/01/2021
Active substance: mometasone
Procedure number: PSUSA/00002085/202005
Regulatory outcome: Maintenance
List item

Zebinix-H-C-988-P46-026 : EPAR - Assessment report (PDF/552.18 KB) (new)

Adopted
First published: 21/01/2021
EMA/42324/2021
List item

Misoprostol (gastrointestinal indication): List of nationally authorised medicinal products - PSUSA/00010291/202006 (PDF/156.89 KB) (new)

Last updated: 21/01/2021
Active substance: misoprostol
Procedure number: PSUSA/00010291/202006
Regulatory outcome: Maintenance
List item

Dexpanthenol xylometazoline: List of nationally authorised medicinal products - PSUSA/00010030/202005 (PDF/252.82 KB) (new)

Last updated: 21/01/2021
Active substance: dexpanthenol xylometazoline
Procedure number: PSUSA/00010030/202005
Regulatory outcome: Maintenance
List item

Peppermint oil: List of nationally authorised medicinal products - PSUSA/00010436/202005 (PDF/131.77 KB) (new)

Last updated: 21/01/2021
Active substance: peppermint oil
Procedure number: PSUSA/00010436/202005
Regulatory outcome: Maintenance
List item

Roclanda : EPAR - Public assessment report (PDF/2.99 MB) (new)

Adopted
First published: 21/01/2021
EMA/CHMP/637805/2020
List item

Roclanda : EPAR - Medicine overview (PDF/138.47 KB) (new)

First published: 21/01/2021
EMA/686057/2020
Bulgarian
(PDF/142.64 KB)

Croatian
(PDF/137.52 KB)

Czech
(PDF/138.75 KB)

Danish
(PDF/116.11 KB)

Dutch
(PDF/117.37 KB)

Estonian
(PDF/104.59 KB)

Finnish
(PDF/114.42 KB)

French
(PDF/119.06 KB)

German
(PDF/120.57 KB)

Greek
(PDF/138.91 KB)

Hungarian
(PDF/138.23 KB)

Italian
(PDF/115.99 KB)

Latvian
(PDF/146.81 KB)

Lithuanian
(PDF/137.9 KB)

Maltese
(PDF/139.91 KB)

Polish
(PDF/141.4 KB)

Portuguese
(PDF/118.38 KB)

Romanian
(PDF/136.79 KB)

Slovak
(PDF/137.47 KB)

Slovenian
(PDF/133.94 KB)

Spanish
(PDF/118.03 KB)

Swedish
(PDF/115.67 KB)
List item

Gadoteric acid (intra articular formulation): List of nationally authorised medicinal products - PSUSA/00001505/202004 (PDF/118.36 KB) (new)

Last updated: 21/01/2021
Active substance: gadoteric acid
Procedure number: PSUSA/00001505/202004
Regulatory outcome: Maintenance
List item

COVID-19 Vaccine Moderna : EPAR - Public assessment report (PDF/3.07 MB) (new)

Adopted
First published: 20/01/2021
EMA/15689/2021

19345 results

Ocrevus-H-C-PSUSA-00010662- 202003 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/131.32 KB) (new)

Dupixent-H-C-PSUSA-00010645-202009 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/89.89 KB) (new)

Dupixent-H-C-4390-II-0027 : EPAR - Assessment report - Variation (PDF/6.04 MB) (new)

Captopril: List of nationally authorised medicinal products - PSUSA/00000535/202004 (PDF/123.38 KB) (new)

Blincyto-H-C-3731-II-0030 : EPAR - Assessment report - Variation (PDF/4.39 MB) (new)

Deoxycholic acid: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010525/202004 (PDF/80.32 KB) (new)

Deoxycholic acid: List of nationally authorised medicinal products - PSUSA/00010525/202004 (PDF/173.45 KB) (new)

Xofluza : EPAR - Public assessment report (PDF/4.39 MB) (new)

Methoxyflurane: List of nationally authorised medicinal products - PSUSA/00010484/202005 (PDF/147.38 KB) (new)

Xofluza : EPAR - All authorised presentations (PDF/21.7 KB) (new)

Tremfya-H-C-4271-II-17 : EPAR - Assessment report - Variation (PDF/7.15 MB) (new)

Formoterol : List of nationally authorised medicinal products - PSUSA/00001469/202005 (PDF/831.46 KB) (new)

Xofluza : EPAR - Product information (PDF/261.64 KB) (new)

Xofluza : EPAR - Medicine overview (PDF/119.99 KB) (new)

Tasigna-H-C-PSUSA-00002162-202001 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/129.46 KB) (new)

Kalydeco-H-C-2494-X-83-G: EPAR - Assessment Report - Variation (PDF/4.62 MB) (new)

Mometasone: List of nationally authorised medicinal products - PSUSA/00002085/202005 (PDF/838.45 KB) (new)

Zebinix-H-C-988-P46-026 : EPAR - Assessment report (PDF/552.18 KB) (new)

Misoprostol (gastrointestinal indication): List of nationally authorised medicinal products - PSUSA/00010291/202006 (PDF/156.89 KB) (new)

Dexpanthenol xylometazoline: List of nationally authorised medicinal products - PSUSA/00010030/202005 (PDF/252.82 KB) (new)

Peppermint oil: List of nationally authorised medicinal products - PSUSA/00010436/202005 (PDF/131.77 KB) (new)

Roclanda : EPAR - Public assessment report (PDF/2.99 MB) (new)

Roclanda : EPAR - Medicine overview (PDF/138.47 KB) (new)

Gadoteric acid (intra articular formulation): List of nationally authorised medicinal products - PSUSA/00001505/202004 (PDF/118.36 KB) (new)

COVID-19 Vaccine Moderna : EPAR - Public assessment report (PDF/3.07 MB) (new)