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Extraordinary meeting of the Pharmacovigilance Risk Assessment Committee (PRAC): 20 April 2021 (new)

Virtual meeting, 20/04/2021, Last updated: 20/04/2021
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Dexamfetamine: List of nationally authorised medicinal products - PSUSA/00001307/202007 (PDF/122.74 KB) (new)

Last updated: 19/04/2021
Active substance: dexamfetamine
Procedure number: PSUSA/00000986/202009
Regulatory outcome: Maintenance
List item

Agenda - CHMP agenda of the 19-22 April 2021 meeting (PDF/766.06 KB) (new)

First published: 19/04/2021
EMA/CHMP/220334/2021
List item

Kesimpta : EPAR - Public assessment report (PDF/6.16 MB) (new)

Adopted
First published: 16/04/2021
EMA/160608/2021
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COVID-19 vaccine safety update for Vaxzevria (previously COVID-19 Vaccine AstraZeneca): 14 April 2021 (PDF/101.03 KB) (new)

Adopted
First published: 16/04/2021
List item

Prevexxion RN+HVT+IBD : EPAR - Procedural steps taken and scienfitic after authorisation (new)

First published: 15/04/2021
List item

Prevexxion RN+HVT+IBD : EPAR - Public assessment report (PDF/422.19 KB) (new)

Adopted
First published: 15/04/2021
EMA/321394/2020
List item

Prevexxion RN+HVT+IBD : EPAR - All authorised presentations (PDF/31.86 KB) (new)

First published: 15/04/2021
Bulgarian
(PDF/69.51 KB)

Croatian
(PDF/66.76 KB)

Czech
(PDF/80.34 KB)

Danish
(PDF/27.84 KB)

Dutch
(PDF/26.83 KB)

Estonian
(PDF/42.06 KB)

Finnish
(PDF/42.58 KB)

French
(PDF/40.69 KB)

German
(PDF/27.9 KB)

Greek
(PDF/81.13 KB)

Hungarian
(PDF/68.42 KB)

Icelandic
(PDF/40.2 KB)

Italian
(PDF/40.47 KB)

Latvian
(PDF/80.78 KB)

Lithuanian
(PDF/63.62 KB)

Maltese
(PDF/66.01 KB)

Norwegian
(PDF/27.82 KB)

Polish
(PDF/66.28 KB)

Portuguese
(PDF/26.92 KB)

Romanian
(PDF/71.81 KB)

Slovak
(PDF/82.13 KB)

Slovenian
(PDF/66.19 KB)

Spanish
(PDF/27.76 KB)

Swedish
(PDF/40.24 KB)
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Prevexxion RN+HVT+IBD : EPAR - Product information (PDF/364.05 KB) (new)

First published: 15/04/2021
Bulgarian
(PDF/340.52 KB)

Croatian
(PDF/323.99 KB)

Czech
(PDF/311.35 KB)

Danish
(PDF/216.59 KB)

Dutch
(PDF/232.81 KB)

Estonian
(PDF/230.63 KB)

Finnish
(PDF/224.67 KB)

French
(PDF/233.53 KB)

German
(PDF/367.59 KB)

Greek
(PDF/342.67 KB)

Hungarian
(PDF/545.51 KB)

Icelandic
(PDF/167.83 KB)

Italian
(PDF/219.88 KB)

Latvian
(PDF/304.79 KB)

Lithuanian
(PDF/400.09 KB)

Maltese
(PDF/348.3 KB)

Norwegian
(PDF/249.29 KB)

Polish
(PDF/404.79 KB)

Portuguese
(PDF/202.21 KB)

Romanian
(PDF/319.8 KB)

Slovak
(PDF/288.31 KB)

Slovenian
(PDF/281.13 KB)

Spanish
(PDF/337.24 KB)

Swedish
(PDF/329.02 KB)
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Prevexxion RN+HVT+IBD : EPAR - Medicine overview (PDF/141.77 KB) (new)

First published: 15/04/2021
Bulgarian
(PDF/170.99 KB)

Croatian
(PDF/178.39 KB)

Czech
(PDF/166.72 KB)

Danish
(PDF/146.11 KB)

Dutch
(PDF/145.94 KB)

Estonian
(PDF/144.65 KB)

Finnish
(PDF/144.35 KB)

French
(PDF/147.16 KB)

German
(PDF/149.29 KB)

Greek
(PDF/173.95 KB)

Hungarian
(PDF/181.45 KB)

Italian
(PDF/144.43 KB)

Latvian
(PDF/185.98 KB)

Lithuanian
(PDF/180.16 KB)

Maltese
(PDF/179.69 KB)

Polish
(PDF/171.4 KB)

Portuguese
(PDF/146.9 KB)

Romanian
(PDF/168.47 KB)

Slovak
(PDF/168.78 KB)

Slovenian
(PDF/176.92 KB)

Spanish
(PDF/146.22 KB)

Swedish
(PDF/145.75 KB)
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Suxamethonium: List of nationally authorised medicinal products - PSUSA/00002834/202008 (PDF/114.46 KB) (new)

Last updated: 15/04/2021
Active substance: suxamethonium
Procedure number: PSUSA/00002834/202008
Regulatory outcome: Maintenance
List item

Ethinylestradiol / etonogestrel: List of nationally authorised medicinal products - PSUSA/00001307/202007 (PDF/172.01 KB) (new)

Last updated: 15/04/2021
Active substance: ethinylestradiol, etonogestrel
Procedure number: PSUSA/00001307/202007
Regulatory outcome: Variation
List item

Ethinylestradiol / etonogestrel: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001307/202007 (PDF/79.07 KB) (new)

Last updated: 15/04/2021
Active substance: ethinylestradiol, etonogestrel
Procedure number: PSUSA/00001307/202007
Regulatory outcome: Variation
(PDF/187.55 KB)

Bulgarian
(PDF/195.66 KB)

Croatian
(PDF/188.57 KB)

Danish
(PDF/150.48 KB)

Dutch
(PDF/103.07 KB)

Estonian
(PDF/159.66 KB)

Finnish
(PDF/76.84 KB)

French
(PDF/132.04 KB)

German
(PDF/138.21 KB)

Greek
(PDF/183.14 KB)

Hungarian
(PDF/208.57 KB)

Icelandic
(PDF/117.32 KB)

Italian
(PDF/159.84 KB)

Latvian
(PDF/198.18 KB)

Lithuanian
(PDF/141.75 KB)

Maltese
(PDF/91.7 KB)

Norwegian
(PDF/132.82 KB)

Polish
(PDF/143.97 KB)

Portuguese
(PDF/153.04 KB)

Romanian
(PDF/197.82 KB)

Slovak
(PDF/180.76 KB)

Slovenian
(PDF/213.62 KB)

Spanish
(PDF/158.64 KB)

Swedish
(PDF/149.29 KB)
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Oyavas : EPAR - Public assessment report (PDF/3.64 MB) (new)

Adopted
First published: 15/04/2021
EMA/197736/2021
List item

Sogroya : EPAR - Product information (PDF/539.77 KB) (new)

First published: 15/04/2021
Bulgarian
(PDF/620.34 KB)

Croatian
(PDF/734.27 KB)

Czech
(PDF/659.63 KB)

Danish
(PDF/658.84 KB)

Dutch
(PDF/659.28 KB)

Estonian
(PDF/625.66 KB)

Finnish
(PDF/664.33 KB)

French
(PDF/685.5 KB)

German
(PDF/649.15 KB)

Greek
(PDF/1.05 MB)

Hungarian
(PDF/638.73 KB)

Icelandic
(PDF/626.89 KB)

Italian
(PDF/506.96 KB)

Latvian
(PDF/757.56 KB)

Lithuanian
(PDF/798.33 KB)

Maltese
(PDF/677.93 KB)

Norwegian
(PDF/622.44 KB)

Polish
(PDF/646.82 KB)

Portuguese
(PDF/608.67 KB)

Romanian
(PDF/667.89 KB)

Slovak
(PDF/767.16 KB)

Slovenian
(PDF/609.76 KB)

Spanish
(PDF/526.18 KB)

Swedish
(PDF/636.72 KB)
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Sogroya : EPAR - Public assessment report (PDF/2.29 MB) (new)

Adopted
First published: 15/04/2021
EMA/95144/2021
List item

Sogroya : EPAR - All authorised presentations (PDF/47.44 KB) (new)

First published: 15/04/2021
Bulgarian
(PDF/54.25 KB)

Croatian
(PDF/49.12 KB)

Czech
(PDF/54.41 KB)

Danish
(PDF/26.89 KB)

Dutch
(PDF/30.47 KB)

Estonian
(PDF/30.28 KB)

Finnish
(PDF/22.53 KB)

French
(PDF/30.7 KB)

German
(PDF/30.75 KB)

Greek
(PDF/53.56 KB)

Hungarian
(PDF/66.57 KB)

Icelandic
(PDF/30.48 KB)

Italian
(PDF/30.04 KB)

Latvian
(PDF/55.6 KB)

Lithuanian
(PDF/50.87 KB)

Maltese
(PDF/35.01 KB)

Norwegian
(PDF/28.12 KB)

Polish
(PDF/53.64 KB)

Portuguese
(PDF/13.82 KB)

Romanian
(PDF/53.24 KB)

Slovak
(PDF/54.31 KB)

Slovenian
(PDF/50.14 KB)

Spanish
(PDF/30.35 KB)

Swedish
(PDF/28.4 KB)
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Sogroya : EPAR - Medicine overview (PDF/120.2 KB) (new)

First published: 15/04/2021
EMA/69287/2021
Bulgarian
(PDF/143.99 KB)

Croatian
(PDF/140.73 KB)

Czech
(PDF/140.23 KB)

Danish
(PDF/118.88 KB)

Dutch
(PDF/120.65 KB)

Estonian
(PDF/107.87 KB)

Finnish
(PDF/117.15 KB)

French
(PDF/122.2 KB)

German
(PDF/123.78 KB)

Greek
(PDF/144.66 KB)

Hungarian
(PDF/141.73 KB)

Italian
(PDF/119.6 KB)

Latvian
(PDF/155.34 KB)

Lithuanian
(PDF/141.12 KB)

Maltese
(PDF/143.1 KB)

Polish
(PDF/143.13 KB)

Portuguese
(PDF/121.84 KB)

Romanian
(PDF/140.83 KB)

Slovak
(PDF/140.16 KB)

Slovenian
(PDF/139.33 KB)

Spanish
(PDF/120.66 KB)

Swedish
(PDF/118.54 KB)
List item

News: EMA starts review of VIR-7831 for treating patients with COVID-19 (new)

CHMP, Last updated: 15/04/2021
List item

Octreotide: List of nationally authorised medicinal products - PSUSA/00002201/202006 (PDF/436.27 KB) (new)

Last updated: 15/04/2021
Active substance: octreotide
Procedure number: PSUSA/00002201/202006
Regulatory outcome: Variation
List item

Octreotide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002201/202006 (PDF/147.2 KB) (new)

Last updated: 15/04/2021
Active substance: octreotide
Procedure number: PSUSA/00002201/202006
Regulatory outcome: Variation
Bulgarian
(PDF/143.08 KB)

Croatian
(PDF/143.58 KB)

Czech
(PDF/151.07 KB)

Danish
(PDF/128.92 KB)

Dutch
(PDF/60.75 KB)

Estonian
(PDF/124.28 KB)

Finnish
(PDF/127.15 KB)

French
(PDF/113.21 KB)

German
(PDF/69.11 KB)

Greek
(PDF/151.23 KB)

Hungarian
(PDF/151.09 KB)

Icelandic
(PDF/130.56 KB)

Italian
(PDF/77.31 KB)

Latvian
(PDF/182.26 KB)

Lithuanian
(PDF/148.87 KB)

Maltese
(PDF/147.53 KB)

Norwegian
(PDF/129.01 KB)

Polish
(PDF/149.71 KB)

Portuguese
(PDF/138.2 KB)

Romanian
(PDF/156.75 KB)

Slovak
(PDF/150.5 KB)

Slovenian
(PDF/141.89 KB)

Spanish
(PDF/128.14 KB)

Swedish
(PDF/128.52 KB)
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Direct healthcare professional communication (DHPC): Eylea 40 mg/mL (aflibercept solution for intravitreal injection): Higher risk of intraocular pressure increase with the pre-filled syringe (PDF/293.79 KB) (new)

First published: 15/04/2021
List item

List of withdrawn medicinal products in accordance with Art. 123(4) of the Directive (XLSX/748.34 KB) (new)

First published: 15/04/2021
EMA/42215/2021
List item

BroPair Spiromax : EPAR - Product information (PDF/949.22 KB) (new)

First published: 14/04/2021
Bulgarian
(PDF/1.13 MB)

Croatian
(PDF/1.19 MB)

Czech
(PDF/804.84 KB)

Danish
(PDF/1.02 MB)

Dutch
(PDF/1.02 MB)

Estonian
(PDF/1.01 MB)

Finnish
(PDF/1 MB)

French
(PDF/1.15 MB)

German
(PDF/1.03 MB)

Greek
(PDF/864.94 KB)

Hungarian
(PDF/815.09 KB)

Icelandic
(PDF/1 MB)

Italian
(PDF/1.03 MB)

Latvian
(PDF/1.11 MB)

Lithuanian
(PDF/1.11 MB)

Maltese
(PDF/1.31 MB)

Norwegian
(PDF/1.02 MB)

Polish
(PDF/1.16 MB)

Portuguese
(PDF/1.03 MB)

Romanian
(PDF/1.13 MB)

Slovak
(PDF/1.09 MB)

Slovenian
(PDF/766.44 KB)

Spanish
(PDF/1.02 MB)

Swedish
(PDF/1.01 MB)
List item

BroPair Spiromax : EPAR - Medicine overview (PDF/148.31 KB) (new)

First published: 14/04/2021
EMA/111494/2021
Bulgarian
(PDF/148.31 KB)

Croatian
(PDF/144.02 KB)

Czech
(PDF/145.08 KB)

Danish
(PDF/122.04 KB)

Dutch
(PDF/123.1 KB)

Estonian
(PDF/122.65 KB)

Finnish
(PDF/121.85 KB)

French
(PDF/124.47 KB)

German
(PDF/126.08 KB)

Greek
(PDF/146.91 KB)

Hungarian
(PDF/146.48 KB)

Italian
(PDF/134.45 KB)

Latvian
(PDF/153.6 KB)

Lithuanian
(PDF/146.23 KB)

Maltese
(PDF/148.47 KB)

Polish
(PDF/148.57 KB)

Portuguese
(PDF/124.07 KB)

Romanian
(PDF/142.75 KB)

Slovak
(PDF/145.56 KB)

Slovenian
(PDF/142.52 KB)

Spanish
(PDF/123.48 KB)

Swedish
(PDF/121.24 KB)

19798 results

Extraordinary meeting of the Pharmacovigilance Risk Assessment Committee (PRAC): 20 April 2021 (new)

Dexamfetamine: List of nationally authorised medicinal products - PSUSA/00001307/202007 (PDF/122.74 KB) (new)

Agenda - CHMP agenda of the 19-22 April 2021 meeting (PDF/766.06 KB) (new)

Kesimpta : EPAR - Public assessment report (PDF/6.16 MB) (new)

COVID-19 vaccine safety update for Vaxzevria (previously COVID-19 Vaccine AstraZeneca): 14 April 2021 (PDF/101.03 KB) (new)

Prevexxion RN+HVT+IBD : EPAR - Procedural steps taken and scienfitic after authorisation (new)

Prevexxion RN+HVT+IBD : EPAR - Public assessment report (PDF/422.19 KB) (new)

Prevexxion RN+HVT+IBD : EPAR - All authorised presentations (PDF/31.86 KB) (new)

Prevexxion RN+HVT+IBD : EPAR - Product information (PDF/364.05 KB) (new)

Prevexxion RN+HVT+IBD : EPAR - Medicine overview (PDF/141.77 KB) (new)

Suxamethonium: List of nationally authorised medicinal products - PSUSA/00002834/202008 (PDF/114.46 KB) (new)

Ethinylestradiol / etonogestrel: List of nationally authorised medicinal products - PSUSA/00001307/202007 (PDF/172.01 KB) (new)

Ethinylestradiol / etonogestrel: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001307/202007 (PDF/79.07 KB) (new)

Oyavas : EPAR - Public assessment report (PDF/3.64 MB) (new)

Sogroya : EPAR - Product information (PDF/539.77 KB) (new)

Sogroya : EPAR - Public assessment report (PDF/2.29 MB) (new)

Sogroya : EPAR - All authorised presentations (PDF/47.44 KB) (new)

Sogroya : EPAR - Medicine overview (PDF/120.2 KB) (new)

News: EMA starts review of VIR-7831 for treating patients with COVID-19 (new)

Octreotide: List of nationally authorised medicinal products - PSUSA/00002201/202006 (PDF/436.27 KB) (new)

Octreotide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002201/202006 (PDF/147.2 KB) (new)

Direct healthcare professional communication (DHPC): Eylea 40 mg/mL (aflibercept solution for intravitreal injection): Higher risk of intraocular pressure increase with the pre-filled syringe (PDF/293.79 KB) (new)

List of withdrawn medicinal products in accordance with Art. 123(4) of the Directive (XLSX/748.34 KB) (new)

BroPair Spiromax : EPAR - Product information (PDF/949.22 KB) (new)

BroPair Spiromax : EPAR - Medicine overview (PDF/148.31 KB) (new)