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

Dexketoprofen : List of nationally authorised … Document details Dexketoprofen : List of nationally authorised … products Active substance: dexketoprofen Procedure no.: PSUSA/00000997/202110 …

Last updated: 01/08/2022
Active substance: dexketoprofen
Procedure number: PSUSA/00000997/202110
Regulatory outcome: Variation
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Dexketoprofen : Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s) - PSUSA/00000997/202110 (PDF/63.45 KB)

Dexketoprofen : Scientific conclusions … Document details Dexketoprofen : Scientific conclusions … Report on the PSUR(s) for dexketoprofen, the scientific conclusions …

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)
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Dexketoprofen and tramadol : List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0035 (PDF/167.44 KB)

Dexketoprofen and tramadol : List of nationally … Document details Dexketoprofen and tramadol : List of nationally … products Active substance: dexketoprofen and tramadol Procedure …

Last updated: 30/05/2022
Active substance: dexketoprofen, Tramadol
Procedure number: EMEA/H/N/PSR/S/0035
Regulatory outcome: Variation
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Dexketoprofen / tramadol - List of nationally authorised medicinal products - PSUSA/00010468/202201 (PDF/325.71 KB)

Dexketoprofen / tramadol - List of nationally … Document details Dexketoprofen / tramadol - List of nationally … products Active substance: dexketoprofen / tramadol Procedure no …

Last updated: 24/10/2022
Active substance: dexketoprofen, Tramadol
Procedure number: PSUSA/00010468/202201
Regulatory outcome: Variation
List item

Dexketoprofen / tramadol - Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s) - PSUSA/00010468/202201 (PDF/139.71 KB)

Dexketoprofen / tramadol - Scientific conclusions … Document details Dexketoprofen / tramadol - Scientific conclusions … Report on the PSUR(s) for dexketoprofen / tramadol the scientific …

Last updated: 24/10/2022
Active substance: dexketoprofen, Tramadol
Procedure number: PSUSA/00010468/202201
Regulatory outcome: Variation
(PDF/140.2 KB)

Bulgarian
(PDF/216.34 KB)

Croatian
(PDF/258.86 KB)

Czech
(PDF/246.22 KB)

Danish
(PDF/137.38 KB)

Dutch
(PDF/139.83 KB)

Estonian
(PDF/134.01 KB)

Finnish
(PDF/138.76 KB)

French
(PDF/168.31 KB)

German
(PDF/145.38 KB)

Greek
(PDF/215.74 KB)

Hungarian
(PDF/219.26 KB)

Italian
(PDF/159.9 KB)

Latvian
(PDF/279.82 KB)

Lithuanian
(PDF/284.42 KB)

Maltese
(PDF/241.9 KB)

Polish
(PDF/227.98 KB)

Portuguese
(PDF/142.78 KB)

Romanian
(PDF/225.22 KB)

Slovak
(PDF/250.38 KB)

Slovenian
(PDF/206.44 KB)

Spanish
(PDF/141.65 KB)

Swedish
(PDF/138.46 KB)
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Dexketoprofen and tramadol : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - EMEA/H/N/PSR/S/0035 (PDF/72.15 KB)

Dexketoprofen and tramadol : CMDh Scientific … Document details Dexketoprofen and tramadol : CMDh Scientific … containing the active substance dexketoprofen and tramadol (DKP-TRAM) and …

Last updated: 30/05/2022
Active substance: dexketoprofen, Tramadol
Procedure number: EMEA/H/N/PSR/S/0035
Regulatory outcome: Variation
(PDF/26.31 KB)

Bulgarian
(PDF/86.46 KB)

Croatian
(PDF/157.39 KB)

Czech
(PDF/132.25 KB)

Danish
(PDF/25.57 KB)

Dutch
(PDF/26.32 KB)

Estonian
(PDF/69.79 KB)

Finnish
(PDF/25.27 KB)

French
(PDF/97.61 KB)

German
(PDF/75.32 KB)

Greek
(PDF/101.49 KB)

Hungarian
(PDF/117.1 KB)

Italian
(PDF/91.18 KB)

Latvian
(PDF/144.79 KB)

Lithuanian
(PDF/162.34 KB)

Maltese
(PDF/139.99 KB)

Polish
(PDF/122.29 KB)

Portuguese
(PDF/72.96 KB)

Romanian
(PDF/116.94 KB)

Slovak
(PDF/132.17 KB)

Slovenian
(PDF/85.63 KB)

Spanish
(PDF/72.72 KB)

Swedish
(PDF/25.34 KB)

6 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 and tramadol : List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0035 (PDF/167.44 KB)

Dexketoprofen / tramadol - List of nationally authorised medicinal products - PSUSA/00010468/202201 (PDF/325.71 KB)

Dexketoprofen / tramadol - Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s) - PSUSA/00010468/202201 (PDF/139.71 KB)

Dexketoprofen and tramadol : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - EMEA/H/N/PSR/S/0035 (PDF/72.15 KB)