Medicines

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Fluocinolone acetonide (intravitreal implant in applicator): List of nationally authorised medicinal products - PSUSA/00010224/201508 (PDF/83.47 KB)

Last updated: 18/10/2016
Active substance: Fluocinolone acetonide
Procedure number: PSUSA/00010224/201508
Regulatory outcome: Maintenance
List item

Gadodiamide: List of nationally authorised medicinal products - PSUSA/00001503/201504 (PDF/86.84 KB)

Last updated: 19/10/2016
Active substance: gadodiamide
Procedure number: PSUSA/00001503/201504
Regulatory outcome: Variation
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Methylphenidate: List of nationally authorised medicinal products - PSUSA/00002024/201710 (PDF/639.97 KB)

Last updated: 19/06/2018
Active substance: methylphenidate
Procedure number: PSUSA/00002024/201710
Regulatory outcome: Maintenance
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Lactitol: List of nationally authorised medicinal products - PSUSA/00001819/201509 (PDF/80.68 KB)

Last updated: 17/10/2016
Active substance: lactitol
Procedure number: PSUSA/00001819/201509
Regulatory outcome: Maintenance
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Ropinirole : List of nationally authorised medicinal products - PSUSA/00002661/201607 (PDF/303.11 KB)

Last updated: 03/05/2017
Active substance: ropinirole
Procedure number: PSUSA/00002661/201607
Regulatory outcome: Variation
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Terbinafine: List of nationally authorised medicinal products - PSUSA/00002896/201709 (PDF/247.53 KB)

Last updated: 18/05/2018
Active substance: terbinafine
Procedure number: PSUSA/00002896/201709
Regulatory outcome: Maintenance
List item

Fluocinolone acetonide (intravitreal implant in applicator): List of nationally authorised medicinal products - PSUSA/00010224/201502 (PDF/72.49 KB)

Last updated: 18/10/2016
Active substance: Fluocinolone acetonide
Procedure number: PSUSA/00010224/201502
Regulatory outcome: Maintenance
List item

Aceclofenac : List of nationally authorised medicinal products - PSUSA/00000022/201703 (PDF/118.21 KB)

Last updated: 01/12/2017
Active substance: aceclofenac
Procedure number: PSUSA/00000022/201703
Regulatory outcome: Maintenance
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Famotidine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001350/201709 (PDF/33.87 KB)

Last updated: 12/07/2018
Active substance: Famotidine
Procedure number: PSUSA/00001350/201709
Regulatory outcome: Variation
Bulgarian
(PDF/61.7 KB)

Croatian
(PDF/55.46 KB)

Czech
(PDF/59.26 KB)

Danish
(PDF/33.34 KB)

Dutch
(PDF/34.04 KB)

Estonian
(PDF/33.54 KB)

Finnish
(PDF/33.34 KB)

French
(PDF/33.93 KB)

German
(PDF/34.26 KB)

Greek
(PDF/62.66 KB)

Hungarian
(PDF/71.05 KB)

Italian
(PDF/34.45 KB)

Latvian
(PDF/58.96 KB)

Lithuanian
(PDF/59.88 KB)

Maltese
(PDF/60.5 KB)

Polish
(PDF/61.2 KB)

Portuguese
(PDF/33.55 KB)

Romanian
(PDF/57.35 KB)

Slovak
(PDF/59.48 KB)

Slovenian
(PDF/57.29 KB)

Spanish
(PDF/33.83 KB)

Swedish
(PDF/31 KB)
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Trimetazidine: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/0001 and EMEA/H/N/PSR/J/0002 (PDF/1.26 MB)

Last updated: 04/10/2016
Active substance: trimetazidine
Procedure number: EMEA/H/N/PSR/0001
Regulatory outcome: Variation
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Amitriptyline / perphenazine: List of nationally authorised medicinal products - PSUSA/00000170/201501 (PDF/118.31 KB)

Last updated: 17/10/2016
Active substance: amitriptyline, perphenazine
Procedure number: PSUSA/00000170/201501
Regulatory outcome: Variation
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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

Benserazide / levodopa: List of nationally authorised medicinal products - PSUSA/00000330/201706 (PDF/182.3 KB)

Last updated: 09/02/2018
Active substance: benserazide, levodopa
Procedure number: PSUSA/00000330/201706
Regulatory outcome: Maintenance
List item

Mycophenolic acid (apart from mycophenolate mofetil): List of nationally authorised medicinal products - PSUSA/00010243/201605 (PDF/168.49 KB)

Last updated: 12/12/2016
Active substance: mycophenolic acid
Procedure number: PSUSA/00010243/201605
Regulatory outcome: Maintenance
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Paricalcitol: List of nationally authorised medicinal products - PSUSA/00002316/201608 (PDF/130 KB)

Last updated: 10/04/2017
Active substance: paricalcitol
Procedure number: PSUSA/00002316/201608
Regulatory outcome: Maintenance
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Daunorubicin: List of nationally authorised medicinal products - PSUSA/00000936/201506 (PDF/75.82 KB)

Last updated: 17/10/2016
Active substance: daunorubicin
Procedure number: PSUSA/00000936/201506
Regulatory outcome: Variation
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Everolimus (indicated for rejection of transplanted organs): List of nationally authorised medicinal products - PSUSA/00010269/201507 (PDF/258.4 KB)

Last updated: 18/10/2016
Active substance: everolimus
Procedure number: PSUSA/00010269/201507
Regulatory outcome: Variation
List item

Calcium carbonate / famotidine / magnesium hydroxide: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001351/201409 (PDF/574.01 KB)

Last updated: 18/10/2016
Active substance: calcium carbonate, Famotidine, magnesium hydroxide
Procedure number: PSUSA/00001351/201409
Regulatory outcome: Variation
List item

Methysergide: List of nationally authorised medicinal products -PSUSA/00002030/201502 (PDF/65.04 KB)

Last updated: 18/10/2016
Active substance: methysergide
Procedure number: PSUSA/00002030/201502
Regulatory outcome: Maintenance
List item

Human coagulation factor VIII (inhibitor bypassing fraction): List of nationally authorised medicinal products - PSUSA/00009174/201702 (PDF/131.91 KB)

Last updated: 05/10/2017
Active substance: Human coagulation factor VIII
Procedure number: PSUSA/00009174/201702
Regulatory outcome: Maintenance
List item

Gadoxetic acid disodium: CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation - PSUSA/00001509/201504 (PDF/687.1 KB)

Last updated: 18/10/2016
Active substance: gadoxetic acid disodium
Procedure number: PSUSA/00001509/201504
Regulatory outcome: Variation
List item

Betahistine: List of nationally authorised medicinal products - PSUSA/00000389/201712 (PDF/217.94 KB)

Last updated: 10/09/2018
Active substance: betahistine
Procedure number: PSUSA/00000389/201712
Regulatory outcome: Maintenance
List item

Alprostadil (indicated in peripheral arterial occlusive diseases): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000111/201707 (PDF/103.08 KB)

Last updated: 04/06/2018
Active substance: alprostadil
Procedure number: PSUSA/00000111/201707
Regulatory outcome: Variation
Bulgarian
(PDF/158.26 KB)

Croatian
(PDF/61.35 KB)

Czech
(PDF/114.27 KB)

Danish
(PDF/39.12 KB)

Dutch
(PDF/39.4 KB)

Estonian
(PDF/39.12 KB)

Finnish
(PDF/39.08 KB)

French
(PDF/39.93 KB)

German
(PDF/120.89 KB)

Greek
(PDF/69.38 KB)

Hungarian
(PDF/62.96 KB)

Italian
(PDF/39.8 KB)

Latvian
(PDF/64.52 KB)

Lithuanian
(PDF/68.03 KB)

Maltese
(PDF/66.63 KB)

Polish
(PDF/127.59 KB)

Portuguese
(PDF/116.24 KB)

Romanian
(PDF/120.81 KB)

Slovak
(PDF/125.98 KB)

Slovenian
(PDF/65.3 KB)

Spanish
(PDF/39.46 KB)

Swedish
(PDF/39.26 KB)
List item

Alprostadil (erectile dysfunction): List of nationally authorised medicinal products - PSUSA/00000110/201601 (PDF/273.81 KB)

Last updated: 18/11/2016
Active substance: alprostadil
Procedure number: PSUSA/00000110/201601
Regulatory outcome: Variation
List item

Omeprazole: List of nationally authorised medicinal products - PSUSA/00002215/201704 (PDF/362.06 KB)

Last updated: 08/12/2017
Active substance: omeprazole
Procedure number: PSUSA/00002215/201704
Regulatory outcome: Maintenance

2592 results

Fluocinolone acetonide (intravitreal implant in applicator): List of nationally authorised medicinal products - PSUSA/00010224/201508 (PDF/83.47 KB)

Gadodiamide: List of nationally authorised medicinal products - PSUSA/00001503/201504 (PDF/86.84 KB)

Methylphenidate: List of nationally authorised medicinal products - PSUSA/00002024/201710 (PDF/639.97 KB)

Lactitol: List of nationally authorised medicinal products - PSUSA/00001819/201509 (PDF/80.68 KB)

Ropinirole : List of nationally authorised medicinal products - PSUSA/00002661/201607 (PDF/303.11 KB)

Terbinafine: List of nationally authorised medicinal products - PSUSA/00002896/201709 (PDF/247.53 KB)

Fluocinolone acetonide (intravitreal implant in applicator): List of nationally authorised medicinal products - PSUSA/00010224/201502 (PDF/72.49 KB)

Aceclofenac : List of nationally authorised medicinal products - PSUSA/00000022/201703 (PDF/118.21 KB)

Famotidine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001350/201709 (PDF/33.87 KB)

Trimetazidine: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/0001 and EMEA/H/N/PSR/J/0002 (PDF/1.26 MB)

Amitriptyline / perphenazine: List of nationally authorised medicinal products - PSUSA/00000170/201501 (PDF/118.31 KB)

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

Benserazide / levodopa: List of nationally authorised medicinal products - PSUSA/00000330/201706 (PDF/182.3 KB)

Mycophenolic acid (apart from mycophenolate mofetil): List of nationally authorised medicinal products - PSUSA/00010243/201605 (PDF/168.49 KB)

Paricalcitol: List of nationally authorised medicinal products - PSUSA/00002316/201608 (PDF/130 KB)

Daunorubicin: List of nationally authorised medicinal products - PSUSA/00000936/201506 (PDF/75.82 KB)

Everolimus (indicated for rejection of transplanted organs): List of nationally authorised medicinal products - PSUSA/00010269/201507 (PDF/258.4 KB)

Calcium carbonate / famotidine / magnesium hydroxide: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001351/201409 (PDF/574.01 KB)

Methysergide: List of nationally authorised medicinal products -PSUSA/00002030/201502 (PDF/65.04 KB)

Human coagulation factor VIII (inhibitor bypassing fraction): List of nationally authorised medicinal products - PSUSA/00009174/201702 (PDF/131.91 KB)

Gadoxetic acid disodium: CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation - PSUSA/00001509/201504 (PDF/687.1 KB)

Betahistine: List of nationally authorised medicinal products - PSUSA/00000389/201712 (PDF/217.94 KB)

Alprostadil (indicated in peripheral arterial occlusive diseases): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000111/201707 (PDF/103.08 KB)

Alprostadil (erectile dysfunction): List of nationally authorised medicinal products - PSUSA/00000110/201601 (PDF/273.81 KB)

Omeprazole: List of nationally authorised medicinal products - PSUSA/00002215/201704 (PDF/362.06 KB)