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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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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

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

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
List item

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

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

Ampicillin / sulbactam: CMDh scientific conclusions and grounds for the variation, amendments to the product information, and timetable for the implementation - PSUSA/00000197/201502 (PDF/1.32 MB)

Last updated: 17/10/2016
Active substance: ampicillin, Sulbactam
Procedure number: PSUSA/00000197/201502
Regulatory outcome: Variation
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

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
List item

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
List item

Doxazosin: CMDh Scientific conclusions and grounds for the variation, amendments to the product information, and timetable for the implementation - PSUSA/00001169/201512 (PDF/677.58 KB)

Last updated: 19/10/2016
Active substance: doxazosin
Procedure number: PSUSA/00001169/201512
Regulatory outcome: Variation
List item

Bemetizide / triamterene: CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation - PSUSA/00009076/201506 (PDF/748.16 KB)

Last updated: 18/10/2016
Active substance: bemetizide, triamterene
Procedure number: PSUSA/00009076/201506
Regulatory outcome: Variation
List item

Dexamethasone (apart from centrally authorised products): List of nationally authorised medicinal products - PSUSA/00000973/201601 (PDF/137.26 KB)

Last updated: 30/11/2016
Active substance: dexamethasone
Procedure number: PSUSA/00000973/201601
Regulatory outcome: Variation
List item

Testosterone (all formulations apart from topical use and testosterone undecanoate injection): CMDh Scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementa... (PDF/38.69 KB)

Last updated: 07/11/2016
Active substance: Testosterone, testosterone undecanoate
Procedure number: PSUSA/00002907/201512
Regulatory outcome: Variation
Bulgarian
(PDF/175.11 KB)

Croatian
(PDF/170.83 KB)

Czech
(PDF/146.77 KB)

Danish
(PDF/168.39 KB)

Dutch
(PDF/45.27 KB)

Estonian
(PDF/45.39 KB)

Finnish
(PDF/164.47 KB)

French
(PDF/49.36 KB)

German
(PDF/45.11 KB)

Greek
(PDF/159.98 KB)

Hungarian
(PDF/147 KB)

Icelandic
(PDF/169.02 KB)

Italian
(PDF/168.98 KB)

Latvian
(PDF/176.27 KB)

Lithuanian
(PDF/181.62 KB)

Maltese
(PDF/176.37 KB)

Norwegian
(PDF/43.29 KB)

Polish
(PDF/176.17 KB)

Portuguese
(PDF/168.8 KB)

Romanian
(PDF/166.83 KB)

Slovak
(PDF/141.35 KB)

Slovenian
(PDF/146.61 KB)

Spanish
(PDF/45.38 KB)

Swedish
(PDF/164.62 KB)
List item

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
List item

Dextromethorphan: List of nationally authorised medicinal products - PSUSA/00001009/201511 (PDF/335.85 KB)

Last updated: 17/10/2016
Active substance: dextromethorphan
Procedure number: PSUSA/00001009/201511
Regulatory outcome: Variation
List item

Gabapentin: List of nationally authorised medicinal products - PSUSA/00001499/201602 (PDF/172.26 KB)

Last updated: 29/11/2016
Active substance: gabapentin
Procedure number: PSUSA/00001499/201602
Regulatory outcome: Variation
List item

Oxaliplatin: CMDh scientific conclusions and grounds for the variation, amendments to the product information, and timetable for the implementation - PSUSA/00002229/201504 (PDF/990.88 KB)

Last updated: 18/10/2016
Active substance: oxaliplatin
Procedure number: PSUSA/00002229/201504
Regulatory outcome: Variation
List item

Leuprorelin: List of nationally authorised medicinal products - PSUSA/00001844/201707 (PDF/482.37 KB)

Last updated: 04/06/2018
Active substance: leuprorelin
Procedure number: PSUSA/00001844/201707
Regulatory outcome: Variation
List item

Ipratropium/salbutamol : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA-00001781-201701 (PDF/39.88 KB)

Last updated: 20/12/2017
Active substance: salbutamol, ipratropium
Procedure number: PSUSA-00001781-201701
Regulatory outcome: Variation
Bulgarian
(PDF/74.78 KB)

Croatian
(PDF/80.67 KB)

Czech
(PDF/121.36 KB)

Danish
(PDF/24.05 KB)

Dutch
(PDF/38.22 KB)

Estonian
(PDF/127.89 KB)

Finnish
(PDF/40.44 KB)

French
(PDF/24.69 KB)

German
(PDF/24.88 KB)

Greek
(PDF/216.59 KB)

Hungarian
(PDF/120.31 KB)

Italian
(PDF/25.6 KB)

Latvian
(PDF/87.05 KB)

Lithuanian
(PDF/72.62 KB)

Maltese
(PDF/100.4 KB)

Polish
(PDF/72.92 KB)

Portuguese
(PDF/137.9 KB)

Romanian
(PDF/133.11 KB)

Slovak
(PDF/105.75 KB)

Slovenian
(PDF/67.38 KB)

Spanish
(PDF/24.49 KB)

Swedish
(PDF/24.58 KB)
List item

Paroxetine: List of nationally authorised medicinal products - PSUSA/00002319/201712 (PDF/348.11 KB)

Last updated: 11/09/2018
Active substance: paroxetine
Procedure number: PSUSA/00002319/201712
Regulatory outcome: Variation
List item

Prulifloxacin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002569/201710 (PDF/151.98 KB)

Last updated: 09/08/2018
Active substance: prulifloxacin
Procedure number: PSUSA/00002569/201710
Regulatory outcome: Variation
Bulgarian
(PDF/247.73 KB)

Croatian
(PDF/238.27 KB)

Czech
(PDF/248.81 KB)

Danish
(PDF/155.96 KB)

Dutch
(PDF/153.82 KB)

Estonian
(PDF/236.14 KB)

Finnish
(PDF/148.8 KB)

French
(PDF/241.51 KB)

German
(PDF/156.18 KB)

Greek
(PDF/252.05 KB)

Hungarian
(PDF/243.38 KB)

Italian
(PDF/240.9 KB)

Latvian
(PDF/322.46 KB)

Lithuanian
(PDF/244.11 KB)

Maltese
(PDF/250.95 KB)

Polish
(PDF/244.88 KB)

Portuguese
(PDF/150.89 KB)

Romanian
(PDF/238.03 KB)

Slovak
(PDF/247.77 KB)

Slovenian
(PDF/239.76 KB)

Spanish
(PDF/152.14 KB)

Swedish
(PDF/150.81 KB)
List item

Amitriptyline: CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation - PSUSA/00000168/201501 (PDF/661.57 KB)

Last updated: 17/10/2016
Active substance: amitriptyline
Procedure number: PSUSA/00000168/201501
Regulatory outcome: Variation
List item

Candesartan, candesartan / hydrochlorothiazide: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00000527/201704 (PDF/156.82 KB)

Last updated: 02/05/2018
Active substance: hydrochlorothiazide, Candesartan
Procedure number: PSUSA/00000527/201704
Regulatory outcome: Variation
Bulgarian
(PDF/67.28 KB)

Croatian
(PDF/61.92 KB)

Czech
(PDF/57.65 KB)

Danish
(PDF/32.78 KB)

Dutch
(PDF/200.05 KB)

Estonian
(PDF/38.45 KB)

Finnish
(PDF/31.27 KB)

French
(PDF/257.09 KB)

German
(PDF/79.83 KB)

Greek
(PDF/259.57 KB)

Hungarian
(PDF/62.63 KB)

Icelandic
(PDF/64.96 KB)

Italian
(PDF/166.8 KB)

Latvian
(PDF/54.6 KB)

Lithuanian
(PDF/71.57 KB)

Maltese
(PDF/66.63 KB)

Norwegian
(PDF/64.83 KB)

Polish
(PDF/42.72 KB)

Portuguese
(PDF/171 KB)

Romanian
(PDF/190.98 KB)

Slovak
(PDF/72.92 KB)

Slovenian
(PDF/38.29 KB)

Spanish
(PDF/74.15 KB)

Swedish
(PDF/38.68 KB)
List item

Cefuroxime sodium (except for intracameral use): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000615/201704 (PDF/43.59 KB)

Last updated: 26/01/2018
Active substance: cefuroxime sodium
Procedure number: PSUSA/00000615/201704
Regulatory outcome: Variation
Bulgarian
(PDF/138.72 KB)

Croatian
(PDF/100.4 KB)

Czech
(PDF/97.5 KB)

Danish
(PDF/211.58 KB)

Dutch
(PDF/23.65 KB)

Estonian
(PDF/174.12 KB)

Finnish
(PDF/27.67 KB)

French
(PDF/26.12 KB)

German
(PDF/33.19 KB)

Greek
(PDF/259.67 KB)

Hungarian
(PDF/100.03 KB)

Icelandic
(PDF/124.25 KB)

Italian
(PDF/33.6 KB)

Latvian
(PDF/104.03 KB)

Lithuanian
(PDF/210.96 KB)

Maltese
(PDF/268.9 KB)

Norwegian
(PDF/142.31 KB)

Polish
(PDF/249.64 KB)

Portuguese
(PDF/35.53 KB)

Romanian
(PDF/136.46 KB)

Slovak
(PDF/322.98 KB)

Slovenian
(PDF/98.93 KB)

Spanish
(PDF/125.2 KB)

Swedish
(PDF/21.62 KB)

697 results

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)

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)

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)

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

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

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

Ampicillin / sulbactam: CMDh scientific conclusions and grounds for the variation, amendments to the product information, and timetable for the implementation - PSUSA/00000197/201502 (PDF/1.32 MB)

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)

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

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

Doxazosin: CMDh Scientific conclusions and grounds for the variation, amendments to the product information, and timetable for the implementation - PSUSA/00001169/201512 (PDF/677.58 KB)

Bemetizide / triamterene: CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation - PSUSA/00009076/201506 (PDF/748.16 KB)

Dexamethasone (apart from centrally authorised products): List of nationally authorised medicinal products - PSUSA/00000973/201601 (PDF/137.26 KB)

Testosterone (all formulations apart from topical use and testosterone undecanoate injection): CMDh Scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementa... (PDF/38.69 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)

Dextromethorphan: List of nationally authorised medicinal products - PSUSA/00001009/201511 (PDF/335.85 KB)

Gabapentin: List of nationally authorised medicinal products - PSUSA/00001499/201602 (PDF/172.26 KB)

Oxaliplatin: CMDh scientific conclusions and grounds for the variation, amendments to the product information, and timetable for the implementation - PSUSA/00002229/201504 (PDF/990.88 KB)

Leuprorelin: List of nationally authorised medicinal products - PSUSA/00001844/201707 (PDF/482.37 KB)

Ipratropium/salbutamol : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA-00001781-201701 (PDF/39.88 KB)

Paroxetine: List of nationally authorised medicinal products - PSUSA/00002319/201712 (PDF/348.11 KB)

Prulifloxacin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002569/201710 (PDF/151.98 KB)

Amitriptyline: CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation - PSUSA/00000168/201501 (PDF/661.57 KB)

Candesartan, candesartan / hydrochlorothiazide: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00000527/201704 (PDF/156.82 KB)

Cefuroxime sodium (except for intracameral use): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000615/201704 (PDF/43.59 KB)