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Rocuronium : List of nationally authorised medicinal products - PSUSA/00002656/201902 (PDF/317.01 KB)

authorised medicinal products - PSUSA/00002656/201902 … authorised medicinal products - PSUSA/00002656/201902 EMA/80538/2020 14/02/2020 …

Last updated: 14/02/2020
Active substance: rocuronium
Procedure number: PSUSA/00002656/201902
Regulatory outcome: Variation
List item

Rocuronium : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002656/201902 (PDF/112.99 KB)

for the implementation - PSUSA/00002656/201902 … for the implementation - PSUSA/00002656/201902 Other languages: cs da de …

Last updated: 14/02/2020
Active substance: rocuronium
Procedure number: PSUSA/00002656/201902
Regulatory outcome: Variation
Bulgarian
(PDF/134.21 KB)

Croatian
(PDF/121.91 KB)

Czech
(PDF/106.52 KB)

Danish
(PDF/129.92 KB)

Dutch
(PDF/135.44 KB)

Finnish
(PDF/104.34 KB)

French
(PDF/120.82 KB)

German
(PDF/124.68 KB)

Greek
(PDF/124.9 KB)

Hungarian
(PDF/119.32 KB)

Icelandic
(PDF/134.51 KB)

Italian
(PDF/126.55 KB)

Latvian
(PDF/139.36 KB)

Lithuanian
(PDF/126.28 KB)

Norwegian
(PDF/119.75 KB)

Polish
(PDF/101.31 KB)

Portuguese
(PDF/137.51 KB)

Romanian
(PDF/120.74 KB)

Slovak
(PDF/112.71 KB)

Slovenian
(PDF/107.6 KB)

Spanish
(PDF/109.88 KB)

Swedish
(PDF/104.18 KB)
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Rocuronium: List of nationally authorised medicinal products - PSUSA/00002656/201602 (PDF/152.91 KB)

authorised medicinal products - PSUSA/00002656/201602 … authorised medicinal products - PSUSA/00002656/201602 EMA/735249/2016 08/11/2016 … rocuronium Procedure no.: PSUSA/00002656/201602 List of nationally …

Last updated: 08/11/2016
Active substance: rocuronium
Procedure number: PSUSA/00002656/201602
Regulatory outcome: Maintenance
List item

Rocuronium - List of nationally authorised medicinal products - PSUSA-00002656-202202 (PDF/385.59 KB)

authorised medicinal products - PSUSA-00002656-202202 … authorised medicinal products - PSUSA-00002656-202202 EMA/855258/2022 27/10/2022 … rocuronium Procedure No. PSUSA-00002656-202202 http://www.ema.europa.eu/how-to-find-us http://www.ema.europa.eu/contact …

Last updated: 27/10/2022
Active substance: rocuronium
Procedure number: PSUSA-00002656-202202
Regulatory outcome: Maintenance
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Landiolol: List of nationally authorised medicinal products - PSUSA/00010570/201902 (PDF/134.08 KB)

authorised medicinal products - PSUSA/00010570/201902 … authorised medicinal products - PSUSA/00010570/201902 EMA/483140/2019 09/09/2019 …

Last updated: 09/09/2019
Active substance: landiolol
Procedure number: PSUSA/00010570/201902
Regulatory outcome: Maintenance
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Cilostazol: List of nationally authorised medicinal products - PSUSA/00010209/201902 (PDF/75.53 KB)

authorised medicinal products - PSUSA/00010209/201902 … authorised medicinal products - PSUSA/00010209/201902 EMA/550753/2019 09/10/2019 …

Last updated: 09/10/2019
Active substance: cilostazol
Procedure number: PSUSA/00010209/201902
Regulatory outcome: Maintenance
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Trandolapril: List of nationally authorised medicinal products - PSUSA/00003004/201902 (PDF/161.09 KB)

authorised medicinal products - PSUSA/00003004/201902 … authorised medicinal products - PSUSA/00003004/201902 EMA/552278/2019 10/10/2019 …

Last updated: 10/10/2019
Active substance: trandolapril
Procedure number: PSUSA/00003004/201902
Regulatory outcome: Maintenance
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Gabapentin: List of nationally authorised medicinal products - PSUSA/00001499/201902 (PDF/276.78 KB)

authorised medicinal products - PSUSA/00001499/201902 … authorised medicinal products - PSUSA/00001499/201902 EMA/556780/2019 15/10/2019 …

Last updated: 15/10/2019
Active substance: gabapentin
Procedure number: PSUSA/00001499/201902
Regulatory outcome: Maintenance
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Nicorandil : List of nationally authorised medicinal products - PSUSA-00002152-201902 (PDF/108.4 KB)

authorised medicinal products - PSUSA-00002152-201902 … authorised medicinal products - PSUSA-00002152-201902 EMA/597965/2019 05/11/2019 …

Last updated: 05/11/2019
Active substance: nicorandil
Procedure number: PSUSA-00002152-201902
Regulatory outcome: Maintenance
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Dorzolamide: List of nationally authorised medicinal products - PSUSA/00003168/201902 (PDF/242.22 KB)

authorised medicinal products - PSUSA/00003168/201902 … authorised medicinal products - PSUSA/00003168/201902 EMA/635720/2019 25/11/2019 …

Last updated: 25/11/2019
Active substance: dorzolamide
Procedure number: PSUSA/00003168/201902
Regulatory outcome: Variation
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Lisdexamfetamine: List of nationally authorised medicinal products - PSUSA/00010289/201902 (PDF/147.79 KB)

authorised medicinal products - PSUSA/00010289/201902 … authorised medicinal products - PSUSA/00010289/201902 EMA/270645/2019 14/01/2020 …

Last updated: 14/01/2020
Active substance: lisdexamfetamine
Procedure number: PSUSA/00010289/201902
Regulatory outcome: Variation
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Amitriptyline hydrochloride / chlordiazepoxide: List of nationally authorised medicinal products - PSUSA/00000171/201902 (PDF/61.93 KB)

authorised medicinal products - PSUSA/00000171/201902 … authorised medicinal products - PSUSA/00000171/201902 EMA/548242/2019 09/10/2019 …

Last updated: 09/10/2019
Active substance: amitriptyline hydrochloride, chlordiazepoxide
Procedure number: PSUSA/00000171/201902
Regulatory outcome: Maintenance
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Ethanol-orthophenylphenol: List of nationally authorised medicinal products - PSUSA/00010416/201902 (PDF/67.86 KB)

authorised medicinal products - PSUSA/00010416/201902 … authorised medicinal products - PSUSA/00010416/201902 EMA/542694/2019 09/10/2019 …

Last updated: 09/10/2019
Active substance: Ethanol, orthophenylphenol
Procedure number: PSUSA/00010416/201902
Regulatory outcome: Maintenance
List item

Dorzolamide / timolol: List of nationally authorised medicinal products - PSUSA/00001166/201902 (PDF/355.43 KB)

authorised medicinal products - PSUSA/00001166/201902 … authorised medicinal products - PSUSA/00001166/201902 EMA/382258/2015 09/10/2019 …

Last updated: 09/10/2019
Active substance: dorzolamide, timolol
Procedure number: PSUSA/00001166/201902
Regulatory outcome: Maintenance
List item

Acetylsalicylic acid: List of nationally authorised medicinal products - PSUSA/00000039/201902 (PDF/483.75 KB)

authorised medicinal products - PSUSA/00000039/201902 … authorised medicinal products - PSUSA/00000039/201902 EMA/631752/2019 21/11/2019 …

Last updated: 21/11/2019
Active substance: acetylsalicylic acid
Procedure number: PSUSA/00000039/201902
Regulatory outcome: Variation
List item

Acetylsalicylic acid: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000039/201902 (PDF/135.49 KB)

for the implementation - PSUSA/00000039/201902 … for the implementation - PSUSA/00000039/201902 Other languages: de el bg …

Last updated: 21/11/2019
Active substance: acetylsalicylic acid
Procedure number: PSUSA/00000039/201902
Regulatory outcome: Variation
Bulgarian
(PDF/205.24 KB)

Croatian
(PDF/218.24 KB)

Czech
(PDF/120.6 KB)

Danish
(PDF/150.2 KB)

Dutch
(PDF/133.52 KB)

Estonian
(PDF/132.04 KB)

Finnish
(PDF/126.13 KB)

French
(PDF/137.79 KB)

German
(PDF/141 KB)

Greek
(PDF/161.53 KB)

Hungarian
(PDF/210.09 KB)

Icelandic
(PDF/133.46 KB)

Italian
(PDF/188.79 KB)

Latvian
(PDF/201.35 KB)

Lithuanian
(PDF/271.82 KB)

Maltese
(PDF/197.4 KB)

Norwegian
(PDF/140.5 KB)

Polish
(PDF/197.8 KB)

Portuguese
(PDF/160.04 KB)

Romanian
(PDF/201.26 KB)

Slovak
(PDF/188.25 KB)

Slovenian
(PDF/196.25 KB)

Spanish
(PDF/156.69 KB)

Swedish
(PDF/151.46 KB)
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Dorzolamide: CMDh Scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00003168/201902 (PDF/17.97 KB)

for the implementation - PSUSA/00003168/201902 … for the implementation - PSUSA/00003168/201902 Other languages: nl no pl …

Last updated: 25/11/2019
Active substance: dorzolamide
Procedure number: PSUSA/00003168/201902
Regulatory outcome: Variation
Bulgarian
(PDF/109.19 KB)

Croatian
(PDF/85.71 KB)

Czech
(PDF/48.03 KB)

Danish
(PDF/22.05 KB)

Dutch
(PDF/21.17 KB)

Estonian
(PDF/22.29 KB)

Finnish
(PDF/25.78 KB)

French
(PDF/138.57 KB)

German
(PDF/19.3 KB)

Greek
(PDF/88.25 KB)

Hungarian
(PDF/89.8 KB)

Icelandic
(PDF/18.33 KB)

Italian
(PDF/27.64 KB)

Latvian
(PDF/100.77 KB)

Lithuanian
(PDF/91.02 KB)

Maltese
(PDF/50.81 KB)

Norwegian
(PDF/21.02 KB)

Polish
(PDF/94.79 KB)

Portuguese
(PDF/23.14 KB)

Romanian
(PDF/101.98 KB)

Slovak
(PDF/86.99 KB)

Slovenian
(PDF/90.12 KB)

Spanish
(PDF/27.52 KB)

Swedish
(PDF/22 KB)
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Lisdexamfetamine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010289/201902 (PDF/89.62 KB)

for the implementation - PSUSA/00010289/201902 … for the implementation - PSUSA/00010289/201902 Other languages: bg cs da …

Last updated: 14/01/2020
Active substance: lisdexamfetamine
Procedure number: PSUSA/00010289/201902
Regulatory outcome: Variation
Bulgarian
(PDF/103.64 KB)

Croatian
(PDF/95.66 KB)

Czech
(PDF/94.71 KB)

Danish
(PDF/96.64 KB)

Dutch
(PDF/96.05 KB)

Estonian
(PDF/95.85 KB)

Finnish
(PDF/92.7 KB)

French
(PDF/170.02 KB)

German
(PDF/104.19 KB)

Greek
(PDF/103.33 KB)

Hungarian
(PDF/99.68 KB)

Icelandic
(PDF/103.04 KB)

Italian
(PDF/104.99 KB)

Latvian
(PDF/110.54 KB)

Lithuanian
(PDF/139.24 KB)

Maltese
(PDF/117.65 KB)

Norwegian
(PDF/97.94 KB)

Polish
(PDF/102.35 KB)

Portuguese
(PDF/99.1 KB)

Romanian
(PDF/97.64 KB)

Slovak
(PDF/97.63 KB)

Slovenian
(PDF/92.48 KB)

Spanish
(PDF/98.62 KB)

Swedish
(PDF/96.08 KB)
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Tramadol: List of nationally authorised medicinal products - PSUSA/00003002/202005 (PDF/2.3 MB)

authorised medicinal products - PSUSA/00003002/202005 … authorised medicinal products - PSUSA/00003002/202005 EMA/270645/2015 10/03/2021 … tramadol Procedure no.: PSUSA/00003002/202005 List of nationally …

Last updated: 24/03/2021
Active substance: Tramadol
Procedure number: PSUSA/00003002/202005
Regulatory outcome: Variation
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Atorvastatin: List of nationally authorised medicinal products - PSUSA/00010347/201710 (PDF/885.03 KB)

authorised medicinal products - PSUSA/00010347/201710 … authorised medicinal products - PSUSA/00010347/201710 … atorvastatin Procedure No.: PSUSA/00010347/201710 EMA/PRAC/384956/2018 …

Last updated: 13/08/2018
Active substance: atorvastatin
Procedure number: PSUSA/00010347/201710
Regulatory outcome: Variation
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Levobupivacaine: List of nationally authorised medicinal products - PSUSA/00001848/201712 (PDF/254.62 KB)

authorised medicinal products - PSUSA/00001848/201712 … authorised medicinal products - PSUSA/00001848/201712 EMA/620439/2018 17/09/2018 … levobupivacaine Procedure no.: PSUSA/00001848/201712 List of nationally …

Last updated: 17/09/2018
Active substance: levobupivacaine
Procedure number: PSUSA/00001848/201712
Regulatory outcome: Maintenance
List item

Lamotrigine : List of nationally authorised medicinal products - PSUSA/00001825/201711 (PDF/639.41 KB)

authorised medicinal products - PSUSA/00001825/201711 … authorised medicinal products - PSUSA/00001825/201711 EMA/600046/2018 10/09/2018 … lamotrigine Procedure no.: PSUSA/00001825/201711 List of nationally …

Last updated: 10/09/2018
Active substance: lamotrigine
Procedure number: PSUSA/00001825/201711
Regulatory outcome: Variation
List item

Landiolol: List of nationally authorised medicinal products - PSUSA/00010570/201802 (PDF/122.96 KB)

authorised medicinal products - PSUSA/00010570/201802 … authorised medicinal products - PSUSA/00010570/201802 EMA/622806/2018 14/09/2018 … landiolol Procedure no.: PSUSA/00010570/201802 List of nationally …

Last updated: 14/09/2018
Active substance: landiolol
Procedure number: PSUSA/00010570/201802
Regulatory outcome: Maintenance
List item

Sertindole: List of nationally authorised medicinal products - PSUSA/00002695/201801 (PDF/105.81 KB)

authorised medicinal products - PSUSA/00002695/201801 … authorised medicinal products - PSUSA/00002695/201801 EMA/615366/2018 13/09/2018 … sertindole Procedure no.: PSUSA/00002695/201801 …

Last updated: 13/09/2018
Active substance: sertindole
Procedure number: PSUSA/00002695/201801
Regulatory outcome: Maintenance
List item

Cefprozil: List of nationally authorised medicinal products - PSUSA/00000605/201712 (PDF/84.44 KB)

authorised medicinal products - PSUSA/00000605/201712 … authorised medicinal products - PSUSA/00000605/201712 EMA/613929/2018 13/09/2018 … cefprozil Procedure no.: PSUSA/00000605/201712 …

Last updated: 13/09/2018
Active substance: cefprozil
Procedure number: PSUSA/00000605/201712
Regulatory outcome: Maintenance

3496 results

Rocuronium : List of nationally authorised medicinal products - PSUSA/00002656/201902 (PDF/317.01 KB)

Rocuronium : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002656/201902 (PDF/112.99 KB)

Rocuronium: List of nationally authorised medicinal products - PSUSA/00002656/201602 (PDF/152.91 KB)

Rocuronium - List of nationally authorised medicinal products - PSUSA-00002656-202202 (PDF/385.59 KB)

Landiolol: List of nationally authorised medicinal products - PSUSA/00010570/201902 (PDF/134.08 KB)

Cilostazol: List of nationally authorised medicinal products - PSUSA/00010209/201902 (PDF/75.53 KB)

Trandolapril: List of nationally authorised medicinal products - PSUSA/00003004/201902 (PDF/161.09 KB)

Gabapentin: List of nationally authorised medicinal products - PSUSA/00001499/201902 (PDF/276.78 KB)

Nicorandil : List of nationally authorised medicinal products - PSUSA-00002152-201902 (PDF/108.4 KB)

Dorzolamide: List of nationally authorised medicinal products - PSUSA/00003168/201902 (PDF/242.22 KB)

Lisdexamfetamine: List of nationally authorised medicinal products - PSUSA/00010289/201902 (PDF/147.79 KB)

Amitriptyline hydrochloride / chlordiazepoxide: List of nationally authorised medicinal products - PSUSA/00000171/201902 (PDF/61.93 KB)

Ethanol-orthophenylphenol: List of nationally authorised medicinal products - PSUSA/00010416/201902 (PDF/67.86 KB)

Dorzolamide / timolol: List of nationally authorised medicinal products - PSUSA/00001166/201902 (PDF/355.43 KB)

Acetylsalicylic acid: List of nationally authorised medicinal products - PSUSA/00000039/201902 (PDF/483.75 KB)

Acetylsalicylic acid: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000039/201902 (PDF/135.49 KB)

Dorzolamide: CMDh Scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00003168/201902 (PDF/17.97 KB)

Lisdexamfetamine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010289/201902 (PDF/89.62 KB)

Tramadol: List of nationally authorised medicinal products - PSUSA/00003002/202005 (PDF/2.3 MB)

Atorvastatin: List of nationally authorised medicinal products - PSUSA/00010347/201710 (PDF/885.03 KB)

Levobupivacaine: List of nationally authorised medicinal products - PSUSA/00001848/201712 (PDF/254.62 KB)

Lamotrigine : List of nationally authorised medicinal products - PSUSA/00001825/201711 (PDF/639.41 KB)

Landiolol: List of nationally authorised medicinal products - PSUSA/00010570/201802 (PDF/122.96 KB)

Sertindole: List of nationally authorised medicinal products - PSUSA/00002695/201801 (PDF/105.81 KB)

Cefprozil: List of nationally authorised medicinal products - PSUSA/00000605/201712 (PDF/84.44 KB)