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Simvastatin: List of nationally authorised medicinal products - PSUSA/00002709/202004 (PDF/286.06 KB) (new)

Last updated: 18/01/2021
Active substance: simvastatin
Procedure number: PSUSA/00002709/202004
Regulatory outcome: Maintenance
List item

Teicoplanin : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - EMEA/H/N/PSR/S/0025 (PDF/190.6 KB) (new)

Last updated: 18/01/2021
Active substance: Teicoplanin
Procedure number: EMEA/H/N/PSR/S/0025
Regulatory outcome: Variation
Bulgarian
(PDF/144.44 KB)

Croatian
(PDF/183.23 KB)

Czech
(PDF/110.83 KB)

Danish
(PDF/160.66 KB)

Dutch
(PDF/201.55 KB)

Finnish
(PDF/148.94 KB)

French
(PDF/113.79 KB)

German
(PDF/242.18 KB)

Greek
(PDF/218.62 KB)

Hungarian
(PDF/71.35 KB)

Italian
(PDF/237.87 KB)

Maltese
(PDF/269.46 KB)

Polish
(PDF/254.79 KB)

Romanian
(PDF/263.23 KB)

Slovak
(PDF/118.14 KB)

Slovenian
(PDF/115.39 KB)

Spanish
(PDF/234.82 KB)

Swedish
(PDF/69.31 KB)
List item

Teicoplanin : List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0025 (PDF/120.29 KB) (new)

Last updated: 18/01/2021
Active substance: Teicoplanin
Procedure number: EMEA/H/N/PSR/S/0025
Regulatory outcome: Variation
List item

Cyproterone / ethinylestradiol : List of nationally authorised medicinal products - PSUSA/00000906/202005 (PDF/151.58 KB) (new)

Last updated: 18/01/2021
Active substance: cyproterone, ethinylestradiol
Procedure number: PSUSA/00000906/202005
Regulatory outcome: Maintenance
List item

Ivabradine / metoprolol : List of nationally authorised medicinal products - PSUSA/00010381/202004 (PDF/223.63 KB) (new)

Last updated: 18/01/2021
Active substance: ivabradine, metoprolol
Procedure number: PSUSA/00010381/202004
Regulatory outcome: Maintenance
List item

Azithromycin: List of nationally authorised medicinal products - PSUSA/00010491/202004 (PDF/350.15 KB) (new)

Last updated: 18/01/2021
Active substance: Azithromycin
Procedure number: PSUSA/00010491/202004
Regulatory outcome: Maintenance
List item

Azithromycin: List of nationally authorised medicinal products - PSUSA/00010491/202004 (PDF/350.15 KB) (new)

Last updated: 18/01/2021
Active substance: Azithromycin
Procedure number: PSUSA/00010491/202004
Regulatory outcome: Maintenance
List item

Gadodiamide: List of nationally authorised medicinal products - PSUSA/00001503/202004 (PDF/335.61 KB) (new)

Last updated: 18/01/2021
Active substance: gadodiamide
Procedure number: PSUSA/00001503/202004
Regulatory outcome: Maintenance
List item

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

Last updated: 18/01/2021
Active substance: Captopril
Procedure number: PSUSA/00000535/202004
Regulatory outcome: Maintenance
List item

Ozenoxacin: List of nationally authorised medicinal products - PSUSA/00010651/202005 (PDF/104.73 KB) (new)

Last updated: 15/01/2021
Active substance: Ozenoxacin
Procedure number: PSUSA/00010651/202005
Regulatory outcome: Maintenance
List item

Flucloxacillin : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001402/202003 (PDF/120.73 KB) (new)

Last updated: 11/01/2021
Active substance: flucloxacillin
Procedure number: PSUSA/00001402/202003
Regulatory outcome: Variation
Bulgarian
(PDF/168.95 KB)

Croatian
(PDF/154.91 KB)

Czech
(PDF/162.85 KB)

Danish
(PDF/157.2 KB)

Dutch
(PDF/146.76 KB)

Estonian
(PDF/140.74 KB)

Finnish
(PDF/142.26 KB)

French
(PDF/139.26 KB)

German
(PDF/149.49 KB)

Greek
(PDF/157.12 KB)

Hungarian
(PDF/163.85 KB)

Icelandic
(PDF/159.27 KB)

Italian
(PDF/167.63 KB)

Latvian
(PDF/157.5 KB)

Lithuanian
(PDF/194.82 KB)

Maltese
(PDF/174.08 KB)

Polish
(PDF/155.21 KB)

Portuguese
(PDF/143.73 KB)

Romanian
(PDF/157.82 KB)

Slovak
(PDF/178.7 KB)

Slovenian
(PDF/94.69 KB)

Spanish
(PDF/143.17 KB)

Swedish
(PDF/142.44 KB)
List item

Flucloxacillin: List of nationally authorised medicinal products - PSUSA/00001402/202003 (PDF/295.42 KB) (new)

Last updated: 11/01/2021
Active substance: flucloxacillin
Procedure number: PSUSA/00001402/202003
Regulatory outcome: Variation
List item

Ethosuximide: List of nationally authorised medicinal products - PSUSA/00001316/202003 (PDF/128.93 KB) (new)

Last updated: 08/01/2021
Active substance: ethosuximide
Procedure number: PSUSA/00001316/202003
Regulatory outcome: Variation
List item

Trandolapril / verapamil : List of nationally authorised medicinal products - PSUSA/00003005/202003 (PDF/210.1 KB) (new)

Last updated: 22/12/2020
Active substance: trandolapril, verapamil
Procedure number: PSUSA/00003005/202003
Regulatory outcome: Maintenance
List item

Ascorbic acid / paracetamol / pheniramine maleate : List of nationally authorised medicinal products - PSUSA/00002368/202003 (PDF/152.64 KB) (new)

Last updated: 22/12/2020
Active substance: Ascorbic acid, Paracetamol, pheniramine maleate
Procedure number: PSUSA/00002368/202003
Regulatory outcome: Maintenance
List item

Estradiol, estradiol /prednisolone : List of nationally authorised medicinal products - PSUSA/00010441/202004 (PDF/130.29 KB) (new)

Last updated: 22/12/2020
Active substance: estradiol, estradiol /prednisolone
Procedure number: PSUSA/00010441/202004
Regulatory outcome: Maintenance
List item

Lisdexamfetamine : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010289/202002 (PDF/106.13 KB) (new)

Last updated: 22/12/2020
Active substance: lisdexamfetamine
Procedure number: PSUSA/00010289/202002
Regulatory outcome: Variation
Bulgarian
(PDF/114.07 KB)

Croatian
(PDF/131.7 KB)

Czech
(PDF/130.16 KB)

Danish
(PDF/119.79 KB)

Dutch
(PDF/117.37 KB)

Estonian
(PDF/104.27 KB)

Finnish
(PDF/103.65 KB)

French
(PDF/125.66 KB)

German
(PDF/110.96 KB)

Greek
(PDF/129.67 KB)

Hungarian
(PDF/143.43 KB)

Icelandic
(PDF/106.55 KB)

Italian
(PDF/125.58 KB)

Latvian
(PDF/135.18 KB)

Lithuanian
(PDF/133.02 KB)

Maltese
(PDF/134.85 KB)

Norwegian
(PDF/106.76 KB)

Polish
(PDF/146.21 KB)

Portuguese
(PDF/108.43 KB)

Romanian
(PDF/124.78 KB)

Slovak
(PDF/166.46 KB)

Slovenian
(PDF/127.01 KB)

Spanish
(PDF/125.28 KB)

Swedish
(PDF/98.43 KB)
List item

Lisdexamfetamine : List of nationally authorised medicinal products - PSUSA/00010289/202002 (PDF/152.75 KB) (new)

Last updated: 22/12/2020
Active substance: lisdexamfetamine
Procedure number: PSUSA/00010289/202002
Regulatory outcome: Variation
List item

Galantamine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001512/202003 (PDF/32.94 KB)

Last updated: 18/12/2020
Active substance: galantamine
Procedure number: PSUSA/00001512/202003
Regulatory outcome: Variation
Bulgarian
(PDF/106.75 KB)

Croatian
(PDF/102.28 KB)

Czech
(PDF/105.08 KB)

Danish
(PDF/36.48 KB)

Dutch
(PDF/37.23 KB)

Estonian
(PDF/35.04 KB)

Finnish
(PDF/33.87 KB)

French
(PDF/33.05 KB)

German
(PDF/34 KB)

Greek
(PDF/111.71 KB)

Hungarian
(PDF/105.02 KB)

Italian
(PDF/36.19 KB)

Latvian
(PDF/108.01 KB)

Lithuanian
(PDF/103.66 KB)

Maltese
(PDF/109.49 KB)

Norwegian
(PDF/33.92 KB)

Polish
(PDF/108.36 KB)

Portuguese
(PDF/34.27 KB)

Romanian
(PDF/100.43 KB)

Slovak
(PDF/109.9 KB)

Slovenian
(PDF/100.17 KB)

Spanish
(PDF/37.49 KB)

Swedish
(PDF/50.48 KB)
List item

Mesalazine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001990/202002 (PDF/108.72 KB)

Last updated: 15/12/2020
Active substance: Mesalazine
Procedure number: PSUSA/00001990/202002
Regulatory outcome: Variation
Bulgarian
(PDF/146.2 KB)

Croatian
(PDF/41.2 KB)

Czech
(PDF/151.32 KB)

Danish
(PDF/136.59 KB)

Dutch
(PDF/126.68 KB)

Estonian
(PDF/15.94 KB)

Finnish
(PDF/123.34 KB)

French
(PDF/127.46 KB)

German
(PDF/131.22 KB)

Greek
(PDF/146.82 KB)

Hungarian
(PDF/150.31 KB)

Icelandic
(PDF/128.36 KB)

Italian
(PDF/137.74 KB)

Latvian
(PDF/162.76 KB)

Lithuanian
(PDF/157.81 KB)

Maltese
(PDF/171.62 KB)

Norwegian
(PDF/127.06 KB)

Polish
(PDF/148.07 KB)

Portuguese
(PDF/136.2 KB)

Romanian
(PDF/147.24 KB)

Slovak
(PDF/149.72 KB)

Slovenian
(PDF/37.14 KB)

Spanish
(PDF/125.82 KB)

Swedish
(PDF/125.75 KB)
List item

Mesalazine: List of nationally authorised medicinal products - PSUSA/00001990/202002 (PDF/222.08 KB)

Last updated: 15/12/2020
Active substance: Mesalazine
Procedure number: PSUSA/00001990/202002
Regulatory outcome: Variation
List item

Potassium para aminobenzoate: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010130/202002 (PDF/51.08 KB)

Last updated: 10/12/2020
Active substance: potassium para aminobenzoate
Procedure number: PSUSA/00010130/202002
Regulatory outcome: Variation
Bulgarian
(PDF/275.2 KB)

Croatian
(PDF/218.44 KB)

Czech
(PDF/255.92 KB)

Danish
(PDF/133.34 KB)

Dutch
(PDF/215.81 KB)

Dutch
(PDF/67.66 KB)

Estonian
(PDF/184.6 KB)

Finnish
(PDF/68.27 KB)

French
(PDF/55.11 KB)

German
(PDF/58.11 KB)

Greek
(PDF/167.98 KB)

Hungarian
(PDF/221.84 KB)

Icelandic
(PDF/54.99 KB)

Italian
(PDF/212.62 KB)

Latvian
(PDF/257.67 KB)

Lithuanian
(PDF/260.86 KB)

Maltese
(PDF/187.5 KB)

Norwegian
(PDF/60.67 KB)

Polish
(PDF/202.8 KB)

Portuguese
(PDF/67.53 KB)

Romanian
(PDF/172.8 KB)

Slovak
(PDF/224.51 KB)

Slovenian
(PDF/158.2 KB)

Spanish
(PDF/58.06 KB)

Swedish
(PDF/213.69 KB)
List item

Potassium para aminobenzoate: List of nationally authorised medicinal products - PSUSA/00010130/202002 (PDF/102.78 KB)

Last updated: 10/12/2020
Active substance: potassium para aminobenzoate
Procedure number: PSUSA/00010130/202002
Regulatory outcome: Variation
List item

Reboxetine : List of nationally authorised medicinal products - PSUSA/00002615/202004 (PDF/140.14 KB)

Last updated: 07/12/2020
Active substance: reboxetine
Procedure number: PSUSA/00002615/202004
Regulatory outcome: Maintenance
List item

Phenol: List of nationally authorised medicinal products - PSUSA/00009256/202004 (PDF/137.73 KB)

Last updated: 04/12/2020
Active substance: phenol
Procedure number: PSUSA/00009256/202004
Regulatory outcome: Maintenance

626 results

Simvastatin: List of nationally authorised medicinal products - PSUSA/00002709/202004 (PDF/286.06 KB) (new)

Teicoplanin : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - EMEA/H/N/PSR/S/0025 (PDF/190.6 KB) (new)

Teicoplanin : List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0025 (PDF/120.29 KB) (new)

Cyproterone / ethinylestradiol : List of nationally authorised medicinal products - PSUSA/00000906/202005 (PDF/151.58 KB) (new)

Ivabradine / metoprolol : List of nationally authorised medicinal products - PSUSA/00010381/202004 (PDF/223.63 KB) (new)

Azithromycin: List of nationally authorised medicinal products - PSUSA/00010491/202004 (PDF/350.15 KB) (new)

Azithromycin: List of nationally authorised medicinal products - PSUSA/00010491/202004 (PDF/350.15 KB) (new)

Gadodiamide: List of nationally authorised medicinal products - PSUSA/00001503/202004 (PDF/335.61 KB) (new)

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

Ozenoxacin: List of nationally authorised medicinal products - PSUSA/00010651/202005 (PDF/104.73 KB) (new)

Flucloxacillin : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001402/202003 (PDF/120.73 KB) (new)

Flucloxacillin: List of nationally authorised medicinal products - PSUSA/00001402/202003 (PDF/295.42 KB) (new)

Ethosuximide: List of nationally authorised medicinal products - PSUSA/00001316/202003 (PDF/128.93 KB) (new)

Trandolapril / verapamil : List of nationally authorised medicinal products - PSUSA/00003005/202003 (PDF/210.1 KB) (new)

Ascorbic acid / paracetamol / pheniramine maleate : List of nationally authorised medicinal products - PSUSA/00002368/202003 (PDF/152.64 KB) (new)

Estradiol, estradiol /prednisolone : List of nationally authorised medicinal products - PSUSA/00010441/202004 (PDF/130.29 KB) (new)

Lisdexamfetamine : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010289/202002 (PDF/106.13 KB) (new)

Lisdexamfetamine : List of nationally authorised medicinal products - PSUSA/00010289/202002 (PDF/152.75 KB) (new)

Galantamine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001512/202003 (PDF/32.94 KB)

Mesalazine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001990/202002 (PDF/108.72 KB)

Mesalazine: List of nationally authorised medicinal products - PSUSA/00001990/202002 (PDF/222.08 KB)

Potassium para aminobenzoate: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010130/202002 (PDF/51.08 KB)

Potassium para aminobenzoate: List of nationally authorised medicinal products - PSUSA/00010130/202002 (PDF/102.78 KB)

Reboxetine : List of nationally authorised medicinal products - PSUSA/00002615/202004 (PDF/140.14 KB)

Phenol: List of nationally authorised medicinal products - PSUSA/00009256/202004 (PDF/137.73 KB)