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Dexketoprofen : List of nationally authorised medicinal products - PSUSA/00000997/202110 (PDF/528.86 KB)

authorised medicinal products - PSUSA/00000997/202110 … authorised medicinal products - PSUSA/00000997/202110 EMA/669920/2022 01/08/2022 … dexketoprofen Procedure no.: PSUSA/00000997/202110 List of nationally …

Last updated: 01/08/2022
Active substance: dexketoprofen
Procedure number: PSUSA/00000997/202110
Regulatory outcome: Variation
List item

Dexketoprofen : Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s) - PSUSA/00000997/202110 (PDF/63.45 KB)

Marketing Authorisation(s) - PSUSA/00000997/202110 … Marketing Authorisation(s) - PSUSA/00000997/202110 Other languages: de el es …

Last updated: 01/08/2022
Active substance: dexketoprofen
Procedure number: PSUSA/00000997/202110
Regulatory outcome: Variation
Bulgarian
(PDF/99.18 KB)

Croatian
(PDF/158.53 KB)

Czech
(PDF/143.37 KB)

Danish
(PDF/63.01 KB)

Dutch
(PDF/64.66 KB)

Estonian
(PDF/61.88 KB)

Finnish
(PDF/61.38 KB)

French
(PDF/91.76 KB)

German
(PDF/67.48 KB)

Greek
(PDF/101.45 KB)

Hungarian
(PDF/114.87 KB)

Italian
(PDF/81.34 KB)

Latvian
(PDF/160.12 KB)

Lithuanian
(PDF/163.53 KB)

Maltese
(PDF/120.91 KB)

Polish
(PDF/122.32 KB)

Portuguese
(PDF/81.31 KB)

Romanian
(PDF/118.16 KB)

Slovak
(PDF/145.32 KB)

Slovenian
(PDF/143.41 KB)

Spanish
(PDF/64.24 KB)

Swedish
(PDF/64.55 KB)
List item

Dexketoprofen: List of nationally authorised medicinal products - PSUSA/00000997/201510 (PDF/472.98 KB)

authorised medicinal products - PSUSA/00000997/201510 … authorised medicinal products - PSUSA/00000997/201510 EMA/184638/2017 17/03/2017 … authorised medicinal products - PSUSA00000997/201510 7 July 2016 EMA/184638/2017 …

Last updated: 17/03/2017
Active substance: dexketoprofen
Procedure number: PSUSA/00000997/201510
Regulatory outcome: Maintenance
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Acitretin : List of nationally authorised medicinal products - PSUSA/00000051/202110 (PDF/178.19 KB)

authorised medicinal products - PSUSA/00000051/202110 … authorised medicinal products - PSUSA/00000051/202110 EMA/584914/2022 13/06/2022 … Risk Assessment Committee PSUSA/00000051/202110 List of nationally authorised …

Last updated: 13/06/2022
Active substance: acitretin
Procedure number: PSUSA/00000051/202110
Regulatory outcome: Maintenance
List item

Piretanide : List of nationally authorised medicinal products - PSUSA/00002433/202110 (PDF/92.46 KB)

authorised medicinal products - PSUSA/00002433/202110 … authorised medicinal products - PSUSA/00002433/202110 21/06/2022 … piretanide Procedure no.: PSUSA/00002433/202110 List of nationally …

Last updated: 21/06/2022
Active substance: piretanide
Procedure number: PSUSA/00002433/202110
Regulatory outcome: Maintenance
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Milrinone : List of nationally authorised medicinal products - PSUSA/00002064/202110 (PDF/129.51 KB)

authorised medicinal products - PSUSA/00002064/202110 … authorised medicinal products - PSUSA/00002064/202110 EMA/596955/2022 21/06/2022 … milrinone Procedure no.: PSUSA/00002064/202110 List of nationally …

Last updated: 21/06/2022
Active substance: milrinone
Procedure number: PSUSA/00002064/202110
Regulatory outcome: Maintenance
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Lacidipine : List of nationally authorised medicinal products - PSUSA/00001815/202110 (PDF/132.02 KB)

authorised medicinal products - PSUSA/00001815/202110 … authorised medicinal products - PSUSA/00001815/202110 EMA/PRAC/591665/2022 15/06/20 … lacidipine Procedure no.: PSUSA/00001815/202110 List of nationally …

Last updated: 15/06/2022
Active substance: lacidipine
Procedure number: PSUSA/00001815/202110
Regulatory outcome: Maintenance
List item

Letrozole : List of nationally authorised medicinal products - PSUSA/00001842/202110 (PDF/186.65 KB)

authorised medicinal products - PSUSA/00001842/202110 … authorised medicinal products - PSUSA/00001842/202110 EMA/589094/2022 14/06/2022 … letrozole Procedure No. PSUSA/00001842/202110 http://www.ema.europa.eu/how-to-find-us http://www.ema.europa.eu/contact …

Last updated: 14/06/2022
Active substance: letrozole
Procedure number: PSUSA/00001842/202110
Regulatory outcome: Maintenance
List item

Rabeprazole : List of nationally authorised medicinal products - PSUSA/00002601/202110 (PDF/172.27 KB)

authorised medicinal products - PSUSA/00002601/202110 … authorised medicinal products - PSUSA/00002601/202110 EMA/270645/2015 01/08/2022 … rabeprazole Procedure no.: PSUSA/00002601/202110 List of nationally …

Last updated: 01/08/2022
Active substance: Rabeprazole
Procedure number: PSUSA/00002601/202110
Regulatory outcome: Variation
List item

Clindamycin : List of nationally authorised medicinal products - PSUSA/00000795/202110 (PDF/315.98 KB)

authorised medicinal products - PSUSA/00000795/202110 … authorised medicinal products - PSUSA/00000795/202110 EMA/75532/2022 05/07/2022 … clindamycin Procedure no.: PSUSA/00000795/202110 List of …

Last updated: 05/07/2022
Active substance: clindamycin
Procedure number: PSUSA/00000795/202110
Regulatory outcome: Maintenance
List item

Olmesartan : List of nationally authorised medicinal products - PSUSA/00002207/202110 (PDF/383.21 KB)

authorised medicinal products - PSUSA/00002207/202110 … authorised medicinal products - PSUSA/00002207/202110 EMA/586078/2022 13/06/2022 … olmesartan Procedure no.: PSUSA/00002207/202110 List of nationally …

Last updated: 13/06/2022
Active substance: olmesartan
Procedure number: PSUSA/00002207/202110
Regulatory outcome: Maintenance
List item

Benzydamine: List of nationally authorised medicinal products - PSUSA/00000375/202110 (PDF/396.42 KB)

authorised medicinal products - PSUSA/00000375/202110 … authorised medicinal products - PSUSA/00000375/202110 EMA/591676/2022 21/06/2022 … benzydamine Procedure no.: PSUSA/00000375/202110 http://www.ema.europa.eu/how-to-find-us http://www.ema.europa.eu/contact …

Last updated: 21/06/2022
Active substance: benzydamine
Procedure number: PSUSA/00000375/202110
Regulatory outcome: Maintenance
List item

Tiotropium : List of nationally authorised medicinal products - PSUSA/00002972/202110 (PDF/473.01 KB)

authorised medicinal products - PSUSA/00002972/202110 … authorised medicinal products - PSUSA/00002972/202110 EMA/581555/2022 13/06/2022 … Tiotropium Procedure no.: PSUSA/00002972/202110 List of nationally …

Last updated: 13/06/2022
Active substance: tiotropium
Procedure number: PSUSA/00002972/202110
Regulatory outcome: Maintenance
List item

methylphenidate : List of nationally authorised medicinal products - PSUSA/00002024/202110 (PDF/902.29 KB)

authorised medicinal products - PSUSA/00002024/202110 … authorised medicinal products - PSUSA/00002024/202110 05/08/2022 … methylphenidate Procedure No. PSUSA/00002024/202110 http://www.ema.europa.eu/how-to-find-us http://www.ema.europa.eu/contact …

Last updated: 05/08/2022
Active substance: methylphenidate
Procedure number: PSUSA/00002024/202110
Regulatory outcome: Variation
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Amlodipine / perindopril : List of nationally authorised medicinal products - PSUSA/00000179/202110 (PDF/848.27 KB)

authorised medicinal products - PSUSA/00000179/202110 … authorised medicinal products - PSUSA/00000179/202110 … perindopril Procedure no.: PSUSA/00000179/202110 List of nationally …

Last updated: 16/06/2022
Active substance: amlodipine, perindopril
Procedure number: PSUSA/00000179/202110
Regulatory outcome: Maintenance
List item

13C-methacetin : List of nationally authorised medicinal products - PSUSA/00010846/202110 (PDF/127.47 KB)

authorised medicinal products - PSUSA/00010846/202110 … authorised medicinal products - PSUSA/00010846/202110 EMA/579312/2022 13/06/2022 … 13C-methacetin Procedure No. PSUSA/00010846/202110 http://www.ema.europa.eu/how-to-find-us http://www.ema.europa.eu/contact …

Last updated: 13/06/2022
Active substance: 13C-methacetin
Procedure number: PSUSA/00010846/202110
Regulatory outcome: Maintenance
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Erythromycin / tretinoin : List of nationally authorised medicinal products - PSUSA/00001259/202110 (PDF/115.13 KB)

authorised medicinal products - PSUSA/00001259/202110 … authorised medicinal products - PSUSA/00001259/202110 EMA/585845/2022 13/06/2022 … tretinoin Procedure No.: PSUSA/00001259/202110 http://www.ema.europa.eu/how-to-find-us http://www.ema.europa.eu/contact …

Last updated: 13/06/2022
Active substance: erythromycin, Tretinoin
Procedure number: PSUSA/00001259/202110
Regulatory outcome: Maintenance
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Ethinylestradiol / norgestimate : List of nationally authorised medicinal products - PSUSA/00001313/202110 (PDF/114.65 KB)

authorised medicinal products - PSUSA/00001313/202110 … authorised medicinal products - PSUSA/00001313/202110 EMA/PRAC/586129/2022 13/06/20 … norgestimate Procedure no.: PSUSA/00001313/202110 List of nationally …

Last updated: 13/06/2022
Active substance: ethinylestradiol, norgestimate
Procedure number: PSUSA/00001313/202110
Regulatory outcome: Maintenance
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Magnesium hydroxide : List of nationally authorised medicinal products - PSUSA/00001926/202110 (PDF/192.01 KB)

authorised medicinal products - PSUSA/00001926/202110 … authorised medicinal products - PSUSA/00001926/202110 EMA/584575/2022 13/06/2022 … hydroxide Procedure no.: PSUSA/00001926/202110 List of nationally …

Last updated: 13/06/2022
Active substance: magnesium hydroxide
Procedure number: PSUSA/00001926/202110
Regulatory outcome: Maintenance
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Polystyrene sulfonate : List of nationally authorised medicinal products - PSUSA/00002472/202110 (PDF/224.96 KB)

authorised medicinal products - PSUSA/00002472/202110 … authorised medicinal products - PSUSA/00002472/202110 EMA/584606/2022 13/06/2022 … sulfonate Procedure no.: PSUSA/00002472/202110 List of nationally …

Last updated: 13/06/2022
Active substance: polystyrene sulfonate
Procedure number: PSUSA/00002472/202110
Regulatory outcome: Maintenance
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Azelastine / fluticasone : List of nationally authorised medicinal products - PSUSA/00010067/202110 (PDF/276.55 KB)

authorised medicinal products - PSUSA/00010067/202110 … authorised medicinal products - PSUSA/00010067/202110 EMA/579324/2022 13/06/2022 … fluticasone Procedure no.: PSUSA/00010067/202110 List of nationally …

Last updated: 13/06/2022
Active substance: azelastine, fluticasone
Procedure number: PSUSA/00010067/202110
Regulatory outcome: Maintenance
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Rubidium chloride RB-82 : List of nationally authorised medicinal products - PSUSA/00010806/202110 (PDF/104.96 KB)

authorised medicinal products - PSUSA/00010806/202110 … authorised medicinal products - PSUSA/00010806/202110 EMA/587449/20222 14/06/2022 … chloride RB-82 Procedure no.: PSUSA/00010806/202110 List of nationally …

Last updated: 14/06/2022
Active substance: rubidium chloride RB-82
Procedure number: PSUSA/00010806/202110
Regulatory outcome: Maintenance
List item

Sodium oxybate (intravenous use) : List of nationally authorised medicinal products - PSUSA/0010613/202110 (PDF/113.55 KB)

authorised medicinal products - PSUSA/0010613/202110 … authorised medicinal products - PSUSA/0010613/202110 EMA/382258/2015 13/07/2022 … intravenous use) Procedure no.: PSUSA/00010613/202110 List of nationally …

Last updated: 13/07/2022
Active substance: sodium oxybate
Procedure number: PSUSA/0010613/202110
Regulatory outcome: Maintenance
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Soybean phospholipids (oral use) : List of nationally authorised medicinal products - PSUSA/00010707/202110 (PDF/167.82 KB)

authorised medicinal products - PSUSA/00010707/202110 … authorised medicinal products - PSUSA/00010707/202110 EMA/665634/2022 01/08/2022 … oral use) Procedure No. PSUSA/00010707/202110 http://www.ema.europa.eu/how-to-find-us http://www.ema.europa.eu/contact …

Last updated: 01/08/2022
Active substance: Soybean phospholipids (oral use)
Procedure number: PSUSA/00010707/202110
Regulatory outcome: Variation
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Hydrochlorothiazide / olmesartan : List of nationally authorised medicinal products - PSUSA/00002209/202110 (PDF/396.22 KB)

authorised medicinal products - PSUSA/00002209/202110 … authorised medicinal products - PSUSA/00002209/202110 EMA/PRAC/594307/2022 16/06/20 … olmesartan Procedure no.: PSUSA/00002209/202110 List of nationally …

Last updated: 16/06/2022
Active substance: hydrochlorothiazide, olmesartan
Procedure number: PSUSA/00002209/202110
Regulatory outcome: Maintenance

2355 results

Dexketoprofen : List of nationally authorised medicinal products - PSUSA/00000997/202110 (PDF/528.86 KB)

Dexketoprofen : Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s) - PSUSA/00000997/202110 (PDF/63.45 KB)

Dexketoprofen: List of nationally authorised medicinal products - PSUSA/00000997/201510 (PDF/472.98 KB)

Acitretin : List of nationally authorised medicinal products - PSUSA/00000051/202110 (PDF/178.19 KB)

Piretanide : List of nationally authorised medicinal products - PSUSA/00002433/202110 (PDF/92.46 KB)

Milrinone : List of nationally authorised medicinal products - PSUSA/00002064/202110 (PDF/129.51 KB)

Lacidipine : List of nationally authorised medicinal products - PSUSA/00001815/202110 (PDF/132.02 KB)

Letrozole : List of nationally authorised medicinal products - PSUSA/00001842/202110 (PDF/186.65 KB)

Rabeprazole : List of nationally authorised medicinal products - PSUSA/00002601/202110 (PDF/172.27 KB)

Clindamycin : List of nationally authorised medicinal products - PSUSA/00000795/202110 (PDF/315.98 KB)

Olmesartan : List of nationally authorised medicinal products - PSUSA/00002207/202110 (PDF/383.21 KB)

Benzydamine: List of nationally authorised medicinal products - PSUSA/00000375/202110 (PDF/396.42 KB)

Tiotropium : List of nationally authorised medicinal products - PSUSA/00002972/202110 (PDF/473.01 KB)

methylphenidate : List of nationally authorised medicinal products - PSUSA/00002024/202110 (PDF/902.29 KB)

Amlodipine / perindopril : List of nationally authorised medicinal products - PSUSA/00000179/202110 (PDF/848.27 KB)

13C-methacetin : List of nationally authorised medicinal products - PSUSA/00010846/202110 (PDF/127.47 KB)

Erythromycin / tretinoin : List of nationally authorised medicinal products - PSUSA/00001259/202110 (PDF/115.13 KB)

Ethinylestradiol / norgestimate : List of nationally authorised medicinal products - PSUSA/00001313/202110 (PDF/114.65 KB)

Magnesium hydroxide : List of nationally authorised medicinal products - PSUSA/00001926/202110 (PDF/192.01 KB)

Polystyrene sulfonate : List of nationally authorised medicinal products - PSUSA/00002472/202110 (PDF/224.96 KB)

Azelastine / fluticasone : List of nationally authorised medicinal products - PSUSA/00010067/202110 (PDF/276.55 KB)

Rubidium chloride RB-82 : List of nationally authorised medicinal products - PSUSA/00010806/202110 (PDF/104.96 KB)

Sodium oxybate (intravenous use) : List of nationally authorised medicinal products - PSUSA/0010613/202110 (PDF/113.55 KB)

Soybean phospholipids (oral use) : List of nationally authorised medicinal products - PSUSA/00010707/202110 (PDF/167.82 KB)

Hydrochlorothiazide / olmesartan : List of nationally authorised medicinal products - PSUSA/00002209/202110 (PDF/396.22 KB)