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Buprenorphine: List of nationally authorised medicinal products - PSUSA/00000459/201707 (PDF/864.92 KB)

Last updated: 19/04/2018
Active substance: buprenorphine
Procedure number: PSUSA/00000459/201707
Regulatory outcome: Maintenance
List item

Typhoid polysaccharide vaccine: List of nationally authorised medicinal products - PSUSA/00003065/201708 (PDF/151.64 KB)

Last updated: 19/04/2018
Active substance: typhoid polysaccharide vaccine
Procedure number: PSUSA/00003065/201708
Regulatory outcome: Maintenance
List item

Aciclovir / hydrocortisone: List of nationally authorised medicinal products - PSUSA/00003065/201708 (PDF/91.23 KB)

Last updated: 19/04/2018
Active substance: Aciclovir, hydrocortisone
Procedure number: PSUSA/00003065/201708
Regulatory outcome: Maintenance
List item

Fenspiride: List of nationally authorised medicinal products - PSUSA/00001368/201704 (PDF/102.69 KB)

Last updated: 12/12/2017
Active substance: fenspiride
Procedure number: PSUSA/00001368/201704
Regulatory outcome: Maintenance
List item

Saccharomyces boulardii : CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00009284/201702 (PDF/66.18 KB)

Last updated: 01/12/2017
Active substance: saccharomyces boulardii
Procedure number: PSUSA/00009284/201702
Regulatory outcome: Variation
Bulgarian
(PDF/323.24 KB)

Croatian
(PDF/273.28 KB)

Czech
(PDF/293.49 KB)

Danish
(PDF/207.2 KB)

Dutch
(PDF/144.18 KB)

Estonian
(PDF/180.69 KB)

Finnish
(PDF/178.37 KB)

French
(PDF/278.44 KB)

German
(PDF/186.9 KB)

Greek
(PDF/428.94 KB)

Hungarian
(PDF/341.69 KB)

Italian
(PDF/266.29 KB)

Latvian
(PDF/354.72 KB)

Lithuanian
(PDF/277.09 KB)

Maltese
(PDF/282.24 KB)

Norwegian
(PDF/182.52 KB)

Polish
(PDF/280.38 KB)

Portuguese
(PDF/141.95 KB)

Romanian
(PDF/279.31 KB)

Slovak
(PDF/279.63 KB)

Slovenian
(PDF/341.2 KB)

Spanish
(PDF/251.65 KB)

Swedish
(PDF/184.06 KB)
List item

Saccharomyces boulardii : List of nationally authorised medicinal products - PSUSA/00009284/201702 (PDF/192.73 KB)

Last updated: 20/11/2017
Active substance: saccharomyces boulardii
Procedure number: PSUSA/00009284/201702
Regulatory outcome: Variation
List item

Flubendazole: List of nationally authorised medicinal products - PSUSA/00001400/201702 (PDF/70.11 KB)

Last updated: 14/11/2017
Active substance: flubendazole
Procedure number: PSUSA/00001400/201702
Regulatory outcome: Variation
List item

Flubendazole: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001400/201702 (PDF/42.01 KB)

Last updated: 14/11/2017
Active substance: flubendazole
Procedure number: PSUSA/00001400/201702
Regulatory outcome: Variation
Bulgarian
(PDF/75.25 KB)

Croatian
(PDF/70.44 KB)

Czech
(PDF/74.21 KB)

Danish
(PDF/37.6 KB)

Dutch
(PDF/37.86 KB)

Estonian
(PDF/37.95 KB)

Finnish
(PDF/37.41 KB)

French
(PDF/36.49 KB)

German
(PDF/38.68 KB)

Greek
(PDF/74.82 KB)

Hungarian
(PDF/62.57 KB)

Italian
(PDF/36.94 KB)

Latvian
(PDF/70.99 KB)

Lithuanian
(PDF/75.53 KB)

Maltese
(PDF/71.76 KB)

Polish
(PDF/74.38 KB)

Portuguese
(PDF/36.46 KB)

Romanian
(PDF/68.48 KB)

Slovak
(PDF/72.55 KB)

Slovenian
(PDF/70.71 KB)

Spanish
(PDF/38.87 KB)

Swedish
(PDF/37.98 KB)
List item

Clodronic acid : List of nationally authorised medicinal products - PSUSA-00000804-201702 (PDF/133.13 KB)

Last updated: 31/10/2017
Active substance: clodronic acid
Procedure number: PSUSA/00000804/201702
Regulatory outcome: Maintenance
List item

Eplerenone : List of nationally authorised medicinal products - PSUSA-00001236-201703 (PDF/161.11 KB)

Last updated: 31/10/2017
Active substance: eplerenone
Procedure number: PSUSA/00001236/201703
Regulatory outcome: Maintenance
List item

Hydroquinidine : List of nationally authorised medicinal products - PSUSA/00001688/201703 (PDF/68.29 KB)

Last updated: 30/10/2017
Active substance: hydroquinidine
Procedure number: PSUSA/00001688/201703
Regulatory outcome: Maintenance
List item

Human plasma (pooled and treated for virus inactivation) : List of nationally authorised medicinal products - PSUSA/00001635/201702 (PDF/108.21 KB)

Last updated: 30/10/2017
Active substance: human plasma (pooled and treated for virus inactivation)
Procedure number: PSUSA/00001635/201702
Regulatory outcome: Maintenance
List item

Hydroxyethyl starch: List of nationally authorised medicinal products - PSUSA/00001694/201703 (PDF/288.77 KB)

Last updated: 04/10/2017
Active substance: hydroxyethyl starch
Procedure number: PSUSA/00001694/201703
Regulatory outcome: Maintenance
List item

Letrozole : CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001842/201610 (PDF/43.49 KB)

Last updated: 25/07/2017
Active substance: letrozole
Procedure number: PSUSA/00001842/201610
Regulatory outcome: Variation
Bulgarian
(PDF/70.99 KB)

Croatian
(PDF/66.82 KB)

Czech
(PDF/69.3 KB)

Danish
(PDF/39.97 KB)

Dutch
(PDF/40.47 KB)

Estonian
(PDF/40.19 KB)

Finnish
(PDF/62.4 KB)

French
(PDF/40.76 KB)

German
(PDF/40.68 KB)

Greek
(PDF/71.53 KB)

Hungarian
(PDF/66.73 KB)

Icelandic
(PDF/40.71 KB)

Italian
(PDF/40.96 KB)

Latvian
(PDF/67.98 KB)

Lithuanian
(PDF/70.7 KB)

Maltese
(PDF/71.65 KB)

Norwegian
(PDF/40.24 KB)

Polish
(PDF/71.19 KB)

Portuguese
(PDF/40.6 KB)

Romanian
(PDF/67.27 KB)

Slovak
(PDF/70.09 KB)

Slovenian
(PDF/68.09 KB)

Spanish
(PDF/40.97 KB)

Swedish
(PDF/40.5 KB)
List item

Letrozole : List of nationally authorised medicinal products - PSUSA/00001842/201610 (PDF/114.49 KB)

Last updated: 25/07/2017
Active substance: letrozole
Procedure number: PSUSA/00001842/201610
Regulatory outcome: Variation
List item

Chloroquine phosphate / proguanil hydrochloride: List of nationally authorised medicinal products - PSUSA/00010207/201611 (PDF/99.66 KB)

Last updated: 13/07/2017
Active substance: proguanil hydrochloride, chloroquine phosphate
Procedure number: PSUSA/00010207/201611
Regulatory outcome: Maintenance
List item

Teicoplanin: List of nationally authorised medicinal products - PSUSA/00002878/201611 (PDF/223.35 KB)

Last updated: 11/07/2017
Active substance: Teicoplanin
Procedure number: PSUSA/00002878/201611
Regulatory outcome: Maintenance
List item

Olmesartan: List of nationally authorised medicinal products - PSUSA/00002207/201610 (PDF/336.41 KB)

Last updated: 15/06/2017
Active substance: olmesartan
Procedure number: PSUSA/00002207/201610
Regulatory outcome: Maintenance
List item

Dinoprostone: List of nationally authorised medicinal products - PSUSA/00001104/201609 (PDF/133.4 KB)

Last updated: 15/06/2017
Active substance: dinoprostone
Procedure number: PSUSA/00001104/201609
Regulatory outcome: Maintenance
List item

Hydrochlorothiazide / olmesartan: List of nationally authorised medicinal products - PSUSA/00002209/201610 (PDF/473.23 KB)

Last updated: 15/06/2017
Active substance: olmesartan, hydrochlorothiazide
Procedure number: PSUSA/00002209/201610
Regulatory outcome: Maintenance
List item

Dexamethasone (apart from centrally authorised products): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000973/201601 (PDF/317.71 KB)

Last updated: 21/02/2017
Active substance: dexamethasone
Procedure number: PSUSA/00000973/201601
Regulatory outcome: Variation
Bulgarian
(PDF/319.02 KB)

Croatian
(PDF/294.92 KB)

Czech
(PDF/297.89 KB)

Danish
(PDF/245.6 KB)

Dutch
(PDF/248.24 KB)

Estonian
(PDF/170.84 KB)

Finnish
(PDF/112.81 KB)

French
(PDF/246.52 KB)

German
(PDF/73.13 KB)

Greek
(PDF/291.98 KB)

Hungarian
(PDF/294.31 KB)

Icelandic
(PDF/117.34 KB)

Italian
(PDF/246.62 KB)

Latvian
(PDF/286.35 KB)

Lithuanian
(PDF/298.31 KB)

Maltese
(PDF/304.1 KB)

Norwegian
(PDF/170.69 KB)

Polish
(PDF/294.75 KB)

Portuguese
(PDF/174.78 KB)

Romanian
(PDF/285.97 KB)

Slovak
(PDF/301.44 KB)

Slovenian
(PDF/242.66 KB)

Spanish
(PDF/118.16 KB)

Swedish
(PDF/169.75 KB)
List item

Bismuth subcitrate potassium / metronidazole / tetracycline: List of nationally authorised medicinal products - PSUSA/00010199/201605 (PDF/94.34 KB)

Last updated: 24/01/2017
Active substance: tetracycline, Metronidazole, Bismuth subcitrate potassium
Procedure number: PSUSA/00010199/201605
Regulatory outcome: Maintenance
List item

Docosanol: List of nationally authorised medicinal products - PSUSA/00010092/201604 (PDF/90.81 KB)

Last updated: 18/01/2017
Active substance: docosanol
Procedure number: PSUSA/00010092/201604
Regulatory outcome: Maintenance
List item

Carboplatin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000559/201601 (PDF/75.55 KB)

Last updated: 03/01/2017
Active substance: carboplatin
Procedure number: PSUSA/00000559/201601
Regulatory outcome: Variation
Bulgarian
(PDF/101.59 KB)

Croatian
(PDF/103.21 KB)

Czech
(PDF/296.34 KB)

Danish
(PDF/99.05 KB)

Dutch
(PDF/106.32 KB)

Estonian
(PDF/95.88 KB)

Finnish
(PDF/220.29 KB)

French
(PDF/103.89 KB)

German
(PDF/55.22 KB)

Greek
(PDF/99.68 KB)

Hungarian
(PDF/232.73 KB)

Icelandic
(PDF/104.75 KB)

Italian
(PDF/106.83 KB)

Latvian
(PDF/342.06 KB)

Lithuanian
(PDF/283.76 KB)

Maltese
(PDF/109.21 KB)

Norwegian
(PDF/102.23 KB)

Polish
(PDF/103.85 KB)

Portuguese
(PDF/99.2 KB)

Romanian
(PDF/99.56 KB)

Slovak
(PDF/104.73 KB)

Slovenian
(PDF/98.5 KB)

Spanish
(PDF/104.35 KB)

Swedish
(PDF/101.81 KB)
List item

Rabies vaccine : CMDh Scientific conclusions and grounds for the variation, amendments to the Product Information, and timetable for the implementation: PSUSA/00009277/201603 (PDF/31.69 KB)

Last updated: 19/12/2016
Active substance: rabies vaccine
Procedure number: PSUSA/00009277/201603
Regulatory outcome: Variation
Bulgarian
(PDF/114.05 KB)

Croatian
(PDF/131.34 KB)

Czech
(PDF/114.1 KB)

Danish
(PDF/34.49 KB)

Dutch
(PDF/34.67 KB)

Estonian
(PDF/35.18 KB)

Finnish
(PDF/39.52 KB)

French
(PDF/191.3 KB)

German
(PDF/39.47 KB)

Greek
(PDF/170.38 KB)

Hungarian
(PDF/109.31 KB)

Icelandic
(PDF/31.75 KB)

Italian
(PDF/188.4 KB)

Latvian
(PDF/114.17 KB)

Lithuanian
(PDF/109.66 KB)

Maltese
(PDF/113.97 KB)

Norwegian
(PDF/37.69 KB)

Polish
(PDF/118.38 KB)

Portuguese
(PDF/29.53 KB)

Romanian
(PDF/114.06 KB)

Slovak
(PDF/112.81 KB)

Slovenian
(PDF/111.73 KB)

Spanish
(PDF/39.63 KB)

Swedish
(PDF/39.76 KB)

64 results

Buprenorphine: List of nationally authorised medicinal products - PSUSA/00000459/201707 (PDF/864.92 KB)

Typhoid polysaccharide vaccine: List of nationally authorised medicinal products - PSUSA/00003065/201708 (PDF/151.64 KB)

Aciclovir / hydrocortisone: List of nationally authorised medicinal products - PSUSA/00003065/201708 (PDF/91.23 KB)

Fenspiride: List of nationally authorised medicinal products - PSUSA/00001368/201704 (PDF/102.69 KB)

Saccharomyces boulardii : CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00009284/201702 (PDF/66.18 KB)

Saccharomyces boulardii : List of nationally authorised medicinal products - PSUSA/00009284/201702 (PDF/192.73 KB)

Flubendazole: List of nationally authorised medicinal products - PSUSA/00001400/201702 (PDF/70.11 KB)

Flubendazole: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001400/201702 (PDF/42.01 KB)

Clodronic acid : List of nationally authorised medicinal products - PSUSA-00000804-201702 (PDF/133.13 KB)

Eplerenone : List of nationally authorised medicinal products - PSUSA-00001236-201703 (PDF/161.11 KB)

Hydroquinidine : List of nationally authorised medicinal products - PSUSA/00001688/201703 (PDF/68.29 KB)

Human plasma (pooled and treated for virus inactivation) : List of nationally authorised medicinal products - PSUSA/00001635/201702 (PDF/108.21 KB)

Hydroxyethyl starch: List of nationally authorised medicinal products - PSUSA/00001694/201703 (PDF/288.77 KB)

Letrozole : CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001842/201610 (PDF/43.49 KB)

Letrozole : List of nationally authorised medicinal products - PSUSA/00001842/201610 (PDF/114.49 KB)

Chloroquine phosphate / proguanil hydrochloride: List of nationally authorised medicinal products - PSUSA/00010207/201611 (PDF/99.66 KB)

Teicoplanin: List of nationally authorised medicinal products - PSUSA/00002878/201611 (PDF/223.35 KB)

Olmesartan: List of nationally authorised medicinal products - PSUSA/00002207/201610 (PDF/336.41 KB)

Dinoprostone: List of nationally authorised medicinal products - PSUSA/00001104/201609 (PDF/133.4 KB)

Hydrochlorothiazide / olmesartan: List of nationally authorised medicinal products - PSUSA/00002209/201610 (PDF/473.23 KB)

Dexamethasone (apart from centrally authorised products): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000973/201601 (PDF/317.71 KB)

Bismuth subcitrate potassium / metronidazole / tetracycline: List of nationally authorised medicinal products - PSUSA/00010199/201605 (PDF/94.34 KB)

Docosanol: List of nationally authorised medicinal products - PSUSA/00010092/201604 (PDF/90.81 KB)

Carboplatin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000559/201601 (PDF/75.55 KB)

Rabies vaccine : CMDh Scientific conclusions and grounds for the variation, amendments to the Product Information, and timetable for the implementation: PSUSA/00009277/201603 (PDF/31.69 KB)