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Deproteinised hemoderivative of calf blood.... : List of nationally authorised medicinal products - PSUSA/00010600/202303 (PDF/173.21 KB) (new)

Last updated: 01/12/2023
Active substance: deproteinised hemoderivative of calf blood
Procedure number: PSUSA/00010600/202303
Regulatory outcome: Maintenance
List item

Hydroxyethyl starch : List of nationally authorised medicinal products - PSUSA/00001694/202303 (PDF/389.05 KB) (new)

Last updated: 01/12/2023
Active substance: hydroxyethyl starch
Procedure number: PSUSA/00001694/202303
Regulatory outcome: Maintenance
List item

Furosemide : List of nationally authorised medicinal products - PSUSA/00001491/202301 (PDF/341.6 KB) (new)

Last updated: 01/12/2023
Active substance: Furosemide
Procedure number: PSUSA/00001491/202301
Regulatory outcome: Maintenance
List item

Analapril / nitrendipine : List of nationally authorised medicinal products - PSUSA/00001213/202301 (PDF/152.89 KB) (new)

Last updated: 01/12/2023
Active substance: enalapril, nitrendipine
Procedure number: PSUSA/00001213/202301
Regulatory outcome: Maintenance
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Drospirenone : List of nationally authorised medicinal products - PSUSA/00010853/202211 (PDF/162.83 KB) (new)

Last updated: 01/12/2023
Active substance: drospirenone
Procedure number: PSUSA/00010853/202211
Regulatory outcome: Maintenance
List item

Ciprofloxacin (systemic use) : List of nationally authorised medicinal products - PSUSA/00000775/202304 (PDF/274.95 KB) (new)

Last updated: 01/12/2023
Active substance: Ciprofloxacin
Procedure number: PSUSA/00000775/202304
Regulatory outcome: Maintenance
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BCG (bacillus calmette-guérin) for Immunotherapy : List of nationally authorised medicinal products - PSUSA/00000303/202303 (PDF/191.76 KB) (new)

Last updated: 01/12/2023
Active substance: BCG (bacillus calmette-guérin)
Procedure number: PSUSA/00000303/202303
Regulatory outcome: Maintenance
List item

Direct healthcare professional communication (DHPC): Omega-3-acid ethyl ester medicines: dose-dependent increased risk of atrial fibrillation in patients with established cardiovascular diseases or cardiovascular risk factors (updated)

Active substance: Omega-3 fatty acid ethyl esters, DHPC type: Adverse event, Last updated: 01/12/2023
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Direct healthcare professional communication (DHPC): Ozempic (semaglutide) and Victoza (liraglutide): Supply shortage (updated)

Active substance: semaglutide, liraglutide, DHPC type: Medicine shortage, Last updated: 01/12/2023
List item

Direct healthcare professional communication (DHPC): Integrilin (eptifibatide): Discontinuation of manufacturing of Integrilin (updated)

Active substance: eptifibatide, DHPC type: Medicine shortage, Last updated: 01/12/2023
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Oral retinoids: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0040 (PDF/40.51 KB) (new)

Last updated: 30/11/2023
Active substance: Oral retinoids: (Acitretin, Alitretinoin, Isotretinoin)
Bulgarian
(PDF/197.55 KB)

Croatian
(PDF/111.02 KB)

Czech
(PDF/66.27 KB)

Danish
(PDF/40.56 KB)

Dutch
(PDF/158.66 KB)

Estonian
(PDF/33.09 KB)

Finnish
(PDF/145.7 KB)

French
(PDF/143.67 KB)

German
(PDF/47.92 KB)

Greek
(PDF/173.59 KB)

Hungarian
(PDF/212.83 KB)

Icelandic
(PDF/35.93 KB)

Irish
(PDF/39.78 KB)

Italian
(PDF/137.84 KB)

Latvian
(PDF/455.26 KB)

Lithuanian
(PDF/73.59 KB)

Maltese
(PDF/143.41 KB)

Norwegian
(PDF/42.34 KB)

Polish
(PDF/199.92 KB)

Portuguese
(PDF/74.55 KB)

Romanian
(PDF/62.54 KB)

Slovak
(PDF/204.89 KB)

Slovenian
(PDF/64.49 KB)

Spanish
(PDF/157.37 KB)

Swedish
(PDF/42.13 KB)
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Oral retinoids: List of nationally authorised medicinal products - EMEA/H/N/PSR/J/0002 (PDF/393.75 KB) (new)

Last updated: 30/11/2023
Active substance: Oral retinoids: (Acitretin, Alitretinoin, Isotretinoin)
Regulatory outcome: Variation
List item

Omega-3-acid ethyl esters : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010312/202301 (PDF/132.88 KB) (new)

Last updated: 30/11/2023
Active substance: omega-3-acid-ethyl esters
Procedure number: PSUSA/00010312/202301
Regulatory outcome: Variation
(PDF/143.37 KB)

Bulgarian
(PDF/216.53 KB)

Croatian
(PDF/223.47 KB)

Czech
(PDF/204.12 KB)

Dutch
(PDF/145.64 KB)

Estonian
(PDF/155.02 KB)

Finnish
(PDF/137.21 KB)

French
(PDF/147.26 KB)

German
(PDF/158.26 KB)

Greek
(PDF/171.24 KB)

Hungarian
(PDF/241.68 KB)

Irish
(PDF/141.7 KB)

Italian
(PDF/185.06 KB)

Latvian
(PDF/212.04 KB)

Lithuanian
(PDF/233.01 KB)

Maltese
(PDF/192.28 KB)

Norwegian
(PDF/141.73 KB)

Polish
(PDF/211.04 KB)

Portuguese
(PDF/161.14 KB)

Romanian
(PDF/208.16 KB)

Slovak
(PDF/192.37 KB)

Slovenian
(PDF/199.07 KB)

Spanish
(PDF/161.08 KB)

Swedish
(PDF/114.08 KB)
List item

Omega-3-acid ethyl esters : List of nationally authorised medicinal products - PSUSA-00010312-202301 (PDF/158.73 KB) (new)

Last updated: 30/11/2023
Active substance: omega-3-acid ethyl esters 90
Procedure number: PSUSA/00010312/202301
Regulatory outcome: Variation
List item

ibuprofen, ibuprofen lysine (not indicated in ductus arteriosus), ibuprofen / caffeine : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010649/202302 (PDF/198.25 KB) (new)

Last updated: 29/11/2023
Active substance: Ibuprofen, ibuprofen lysine (not indicated in ductus arteriosus), ibuprofen / caffeine
Regulatory outcome: Variation
Bulgarian
(PDF/278.07 KB)

Croatian
(PDF/250.73 KB)

Czech
(PDF/257.73 KB)

Danish
(PDF/197.85 KB)

Dutch
(PDF/205.38 KB)

Estonian
(PDF/199.3 KB)

Finnish
(PDF/208.54 KB)

French
(PDF/204.08 KB)

German
(PDF/227.84 KB)

Greek
(PDF/252.04 KB)

Hungarian
(PDF/194.35 KB)

Icelandic
(PDF/195.28 KB)

Italian
(PDF/221.52 KB)

Latvian
(PDF/265.98 KB)

Lithuanian
(PDF/241.75 KB)

Maltese
(PDF/288.77 KB)

Norwegian
(PDF/180.08 KB)

Polish
(PDF/248.52 KB)

Portuguese
(PDF/182.57 KB)

Romanian
(PDF/249.2 KB)

Slovak
(PDF/257.01 KB)

Slovenian
(PDF/241.01 KB)

Spanish
(PDF/214.61 KB)

Swedish
(PDF/184.07 KB)
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ibuprofen, ibuprofen lysine (not indicated in ductus arteriosus), ibuprofen / caffeine : List of nationally authorised medicinal products - PSUSA/00010649/202302 (PDF/3.11 MB) (new)

Last updated: 29/11/2023
Active substance: Ibuprofen, ibuprofen lysine (not indicated in ductus arteriosus), ibuprofen / caffeine
Procedure number: PSUSA/00010649/202302
Regulatory outcome: Variation
List item

Etoposide : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001333/202302 (PDF/169.49 KB) (new)

Last updated: 29/11/2023
Active substance: etoposide
Regulatory outcome: Variation
Bulgarian
(PDF/205 KB)

Croatian
(PDF/206.42 KB)

Czech
(PDF/219.8 KB)

Danish
(PDF/169.8 KB)

Dutch
(PDF/171.09 KB)

Estonian
(PDF/165.88 KB)

Finnish
(PDF/166.48 KB)

French
(PDF/172.36 KB)

German
(PDF/179.66 KB)

Greek
(PDF/200.02 KB)

Hungarian
(PDF/224.19 KB)

Icelandic
(PDF/172.3 KB)

Irish
(PDF/150.32 KB)

Italian
(PDF/173.38 KB)

Latvian
(PDF/212.46 KB)

Lithuanian
(PDF/210.55 KB)

Maltese
(PDF/212.38 KB)

Norwegian
(PDF/169.52 KB)

Polish
(PDF/217.62 KB)

Portuguese
(PDF/171.83 KB)

Romanian
(PDF/219.79 KB)

Slovak
(PDF/217.23 KB)

Slovenian
(PDF/207.01 KB)

Spanish
(PDF/171.89 KB)

Swedish
(PDF/172.27 KB)
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Etoposide : List of nationally authorised medicinal products - PSUSA/00001333/202302 (PDF/160.66 KB) (new)

Last updated: 29/11/2023
Active substance: etoposide
Procedure number: PSUSA/00001333/202302
Regulatory outcome: Variation
List item

Beta-alanine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/10510/202301 (PDF/93.76 KB) (new)

Last updated: 29/11/2023
Active substance: beta-alanine
Procedure number: PSUSA/10510/202301
Regulatory outcome: Variation
Bulgarian
(PDF/157.1 KB)

Croatian
(PDF/198.3 KB)

Czech
(PDF/115.9 KB)

Danish
(PDF/94.07 KB)

Dutch
(PDF/94.31 KB)

Estonian
(PDF/97 KB)

Finnish
(PDF/92.32 KB)

French
(PDF/100.84 KB)

German
(PDF/86.32 KB)

Greek
(PDF/112.17 KB)

Hungarian
(PDF/115.75 KB)

Italian
(PDF/104.74 KB)

Latvian
(PDF/120.21 KB)

Lithuanian
(PDF/121.41 KB)

Maltese
(PDF/121.03 KB)

Polish
(PDF/113.46 KB)

Portuguese
(PDF/94.54 KB)

Romanian
(PDF/113.06 KB)

Slovak
(PDF/113.54 KB)

Slovenian
(PDF/107.92 KB)

Spanish
(PDF/94.54 KB)

Swedish
(PDF/93.54 KB)
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Beta-alanine : List of nationally authorised medicinal products - PSUSA/10510/202301 (PDF/132.26 KB) (new)

Last updated: 29/11/2023
Active substance: beta-alanine
Procedure number: PSUSA/10510/202301
Regulatory outcome: Variation
List item

levosalbutamol, salbutamol : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010330/202301 (PDF/134.07 KB) (new)

Last updated: 28/11/2023
Active substance: levosalbutamol, salbutamol
Procedure number: PSUSA/00010330/202301
Regulatory outcome: Variation
Bulgarian
(PDF/224.66 KB)

Croatian
(PDF/241.06 KB)

Czech
(PDF/232.11 KB)

Danish
(PDF/191.02 KB)

Dutch
(PDF/117.77 KB)

Estonian
(PDF/210.4 KB)

Finnish
(PDF/186.92 KB)

French
(PDF/143.02 KB)

German
(PDF/186.14 KB)

Greek
(PDF/129.17 KB)

Hungarian
(PDF/162.14 KB)

Icelandic
(PDF/176.69 KB)

Italian
(PDF/112.86 KB)

Latvian
(PDF/143.02 KB)

Lithuanian
(PDF/215.92 KB)

Maltese
(PDF/137.15 KB)

Norwegian
(PDF/198.92 KB)

Polish
(PDF/218.13 KB)

Portuguese
(PDF/189.07 KB)

Romanian
(PDF/257.04 KB)

Slovak
(PDF/241.93 KB)

Slovenian
(PDF/252.71 KB)

Spanish
(PDF/192.94 KB)

Swedish
(PDF/183.82 KB)
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Levosalbutamol, salbutamol : List of nationally authorised medicinal products - PSUSA/000010330/202301 (PDF/330.05 KB) (new)

Last updated: 28/11/2023
Active substance: levosalbutamol, salbutamol
Procedure number: PSUSA/00010330/202301
Regulatory outcome: Variation
List item

Lomustine : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001902/202301 (PDF/72.49 KB) (new)

Last updated: 28/11/2023
Active substance: lomustine
Procedure number: PSUSA/00001902/202301
Regulatory outcome: Variation
Bulgarian
(PDF/134.32 KB)

Croatian
(PDF/124.21 KB)

Czech
(PDF/139.93 KB)

Danish
(PDF/45.7 KB)

Dutch
(PDF/45.67 KB)

Estonian
(PDF/45.03 KB)

Finnish
(PDF/43.2 KB)

French
(PDF/44.77 KB)

German
(PDF/39.9 KB)

Greek
(PDF/131.11 KB)

Hungarian
(PDF/128.93 KB)

Irish
(PDF/44.75 KB)

Italian
(PDF/59.77 KB)

Latvian
(PDF/135.07 KB)

Lithuanian
(PDF/130.25 KB)

Maltese
(PDF/138.97 KB)

Polish
(PDF/133.97 KB)

Portuguese
(PDF/44.52 KB)

Romanian
(PDF/133.27 KB)

Slovak
(PDF/139.76 KB)

Slovenian
(PDF/131.64 KB)

Spanish
(PDF/43.36 KB)

Swedish
(PDF/35.91 KB)
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Lomustine : List of nationally authorised medicinal products - PSUSA/00001902/202301 (PDF/114.23 KB) (new)

Last updated: 28/11/2023
Active substance: lomustine
Procedure number: PSUSA/00001902/202301
Regulatory outcome: Variation
List item

Bicalutamide : List of nationally authorised medicinal products - PSUSA/00000407/202302 (PDF/172.23 KB) (new)

Last updated: 28/11/2023
Active substance: bicalutamide
Procedure number: PSUSA/00000407/202302
Regulatory outcome: Maintenance

2731 results

Deproteinised hemoderivative of calf blood.... : List of nationally authorised medicinal products - PSUSA/00010600/202303 (PDF/173.21 KB) (new)

Hydroxyethyl starch : List of nationally authorised medicinal products - PSUSA/00001694/202303 (PDF/389.05 KB) (new)

Furosemide : List of nationally authorised medicinal products - PSUSA/00001491/202301 (PDF/341.6 KB) (new)

Analapril / nitrendipine : List of nationally authorised medicinal products - PSUSA/00001213/202301 (PDF/152.89 KB) (new)

Drospirenone : List of nationally authorised medicinal products - PSUSA/00010853/202211 (PDF/162.83 KB) (new)

Ciprofloxacin (systemic use) : List of nationally authorised medicinal products - PSUSA/00000775/202304 (PDF/274.95 KB) (new)

BCG (bacillus calmette-guérin) for Immunotherapy : List of nationally authorised medicinal products - PSUSA/00000303/202303 (PDF/191.76 KB) (new)

Direct healthcare professional communication (DHPC): Omega-3-acid ethyl ester medicines: dose-dependent increased risk of atrial fibrillation in patients with established cardiovascular diseases or cardiovascular risk factors (updated)

Direct healthcare professional communication (DHPC): Ozempic (semaglutide) and Victoza (liraglutide): Supply shortage (updated)

Direct healthcare professional communication (DHPC): Integrilin (eptifibatide): Discontinuation of manufacturing of Integrilin (updated)

Oral retinoids: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0040 (PDF/40.51 KB) (new)

Oral retinoids: List of nationally authorised medicinal products - EMEA/H/N/PSR/J/0002 (PDF/393.75 KB) (new)

Omega-3-acid ethyl esters : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010312/202301 (PDF/132.88 KB) (new)

Omega-3-acid ethyl esters : List of nationally authorised medicinal products - PSUSA-00010312-202301 (PDF/158.73 KB) (new)

ibuprofen, ibuprofen lysine (not indicated in ductus arteriosus), ibuprofen / caffeine : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010649/202302 (PDF/198.25 KB) (new)

ibuprofen, ibuprofen lysine (not indicated in ductus arteriosus), ibuprofen / caffeine : List of nationally authorised medicinal products - PSUSA/00010649/202302 (PDF/3.11 MB) (new)

Etoposide : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001333/202302 (PDF/169.49 KB) (new)

Etoposide : List of nationally authorised medicinal products - PSUSA/00001333/202302 (PDF/160.66 KB) (new)

Beta-alanine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/10510/202301 (PDF/93.76 KB) (new)

Beta-alanine : List of nationally authorised medicinal products - PSUSA/10510/202301 (PDF/132.26 KB) (new)

levosalbutamol, salbutamol : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010330/202301 (PDF/134.07 KB) (new)

Levosalbutamol, salbutamol : List of nationally authorised medicinal products - PSUSA/000010330/202301 (PDF/330.05 KB) (new)

Lomustine : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001902/202301 (PDF/72.49 KB) (new)

Lomustine : List of nationally authorised medicinal products - PSUSA/00001902/202301 (PDF/114.23 KB) (new)

Bicalutamide : List of nationally authorised medicinal products - PSUSA/00000407/202302 (PDF/172.23 KB) (new)