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

authorised medicinal products - EMEA/H/N/PSR/S/0035 … authorised medicinal products - EMEA/H/N/PSR/S/0035 EMA/559241/2022 30/05/2022 … tramadol Procedure no.: EMEA/H/N/PSR/S/0035 List of nationally …

Last updated: 30/05/2022
Active substance: dexketoprofen, Tramadol
Procedure number: EMEA/H/N/PSR/S/0035
Regulatory outcome: Variation
List item

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)

for the implementation - EMEA/H/N/PSR/S/0035 … for the implementation - EMEA/H/N/PSR/S/0035 Other languages: ro el fr …

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)
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Cyproterone/ethinylestradiol: List of nationally authorised medicinal products - EMEA/H/N/PSR/J/0003; EMEA/H/N/PSR/J/0005; EMEA/H/N/PSR/J/0006 (PDF/123.83 KB)

authorised medicinal products - EMEA/H/N/PSR/J/0003; EMEA/H/N/PSR/J/0005; EMEA/H/N/PSR/J/0006 … authorised medicinal products - EMEA/H/N/PSR/J/0003; EMEA/H/N/PSR/J/0005; EMEA/H/N/PSR/J/0006 EMA/68246/2017 23/02/2017 …

Last updated: 23/02/2017
Active substance: cyproterone, ethinylestradiol
Procedure number: EMEA/H/N/PSR/J/0003
Regulatory outcome: Variation
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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)

implementation timetable - EMEA/H/N/PSR/0001 and EMEA/H/N/PSR/J/0002 … implementation timetable - EMEA/H/N/PSR/0001 and EMEA/H/N/PSR/J/0002 EMA/283107/2016 04/10/2016 … trimetazidine Procedure no.: EMEA/H/N/PSR/0001 & EMEA/H/N/PSR/J/0002 …

Last updated: 04/10/2016
Active substance: trimetazidine
Procedure number: EMEA/H/N/PSR/0001
Regulatory outcome: Variation
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Thiocolchicoside: List of nationally authorised medicinal products - EMEA/H/N/PSR/J/0008 (PDF/787.76 KB)

authorised medicinal products - EMEA/H/N/PSR/J/0008 … authorised medicinal products - EMEA/H/N/PSR/J/0008 EMA/224020/2018 10/04/2018 … Thiocolchicoside Procedure no.: EMEA-H-N-PSR-J-0008 List of nationally …

Last updated: 26/06/2018
Active substance: thiocolchicoside
Procedure number: EMEA-H-N-PSR-J-0008
Regulatory outcome: Variation
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Trimetazidine: List of nationally authorised medicinal products - EMEA/H/N/PSR/J/0003 (PDF/123.98 KB)

authorised medicinal products - EMEA/H/N/PSR/J/0003 … authorised medicinal products - EMEA/H/N/PSR/J/0003 EMA/68246/2017 01/02/2017 … for the implementation - EMEA/H/N/PSR/J/0003 30 Churchill Place …

Last updated: 01/02/2017
Active substance: trimetazidine
Procedure number: EMEA/H/N/PSR/J/0003
Regulatory outcome: Variation
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Trimetazidine: List of nationally authorised medicinal products - EMEA/H/N/PSR/0001 (PDF/238.84 KB)

authorised medicinal products - EMEA/H/N/PSR/0001 … authorised medicinal products - EMEA/H/N/PSR/0001 EMA/283098/2016 04/10/2016 … trimetazidine Procedure no.: EMEA/H/N/PSR/0001 List of nationally …

Last updated: 04/10/2016
Active substance: trimetazidine
Procedure number: EMEA/H/N/PSR/0001
Regulatory outcome: Variation
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Trimetazidine: List of nationally authorised medicinal products - EMEA/H/N/PSR/J/0002 (PDF/749.78 KB)

authorised medicinal products - EMEA/H/N/PSR/J/0002 … authorised medicinal products - EMEA/H/N/PSR/J/0002 EMA/637689/2016 04/10/2016 … trimetazidine Procedure no.: EMEA/H/N/PSR/J/0002 List of nationally …

Last updated: 04/10/2016
Active substance: trimetazidine
Procedure number: EMEA/H/N/PSR/J/0002
Regulatory outcome: Variation
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Numeta: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0017 (PDF/69.04 KB)

authorised medicinal products - EMEA/H/N/PSR/S/0017 … authorised medicinal products - EMEA/H/N/PSR/S/0017 …

Last updated: 10/12/2018
Active substance: alanine, arginine, aspartic acid, cysteine, glucose, glutamic acid, glycine, histidine, isoleucine, leucine, lysine monohydrate, methionine, ornithine hydrochloride, phenylalanine, proline, serine, taurine, threonine, tryptophan, tyrosine, valine, calcium chloride, magnesium acetate, potassium acetate, sodium chloride, sodium glycerophosphate, olive oil, Soybean oil
Procedure number: EMEA/H/N/PSR/S/0017
Regulatory outcome: Variation
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Hydroxyethyl starch : CMDh Divergent position - EMEA/H/N/PSR/J/0031 (PDF/62.69 KB)

CMDh Divergent position - EMEA/H/N/PSR/J/0031 … CMDh Divergent position - EMEA/H/N/PSR/J/0031 24/06/2022 … POSITION Procedure No: EMEA/H/N/PSR/J/0031 hydroxyethyl starch (HES …

Last updated: 24/06/2022
Active substance: hydroxyethyl starch
Procedure number: EMEA/H/N/PSR/J/0031
Regulatory outcome: Suspension
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Teicoplanin : List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0025 (PDF/120.29 KB)

authorised medicinal products - EMEA/H/N/PSR/S/0025 … authorised medicinal products - EMEA/H/N/PSR/S/0025 EMA/33992/2021 18/01/2021 … teicoplanin Procedure no.: EMEA/H/N/PSR/S/0025 List of nationally …

Last updated: 18/01/2021
Active substance: Teicoplanin
Procedure number: EMEA/H/N/PSR/S/0025
Regulatory outcome: Variation
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Dexamfetamine: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0028 (PDF/185.65 KB)

authorised medicinal products - EMEA/H/N/PSR/S/0028 … authorised medicinal products - EMEA/H/N/PSR/S/0028 EMA/619644/2021 19/11/2021 … dexamfetamine Procedure no.: EMEA/H/N/PSR/S/0028 List of nationally …

Last updated: 19/11/2021
Active substance: dexamfetamine
Procedure number: EMEA/H/N/PSR/S/0028
Regulatory outcome: Variation
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Dexamfetamine: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0029 (PDF/221.14 KB)

authorised medicinal products - EMEA/H/N/PSR/S/0029 … authorised medicinal products - EMEA/H/N/PSR/S/0029 EMA/619644/2021 19/11/2021 … dexamfetamine Procedure no.: EMEA/H/N/PSR/S/0029 List of nationally …

Last updated: 19/11/2021
Active substance: dexamfetamine
Procedure number: EMEA/H/N/PSR/S/0029
Regulatory outcome: Variation
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Thiocolcicoside: List of nationally authorised medicinal products - EMEA/H/N/PSR/J/0023 (PDF/313.6 KB)

authorised medicinal products - EMEA/H/N/PSR/J/0023 … authorised medicinal products - EMEA/H/N/PSR/J/0023 EMA/230507/2020 28/04/2020 …

Last updated: 28/04/2020
Active substance: thiocolchicoside
Procedure number: EMEA/H/N/PSR/J/0023
Regulatory outcome: Variation
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Domperidone: List of nationally authorised medicinal products - EMEA/H/N/PSR/J/0015 (PDF/289.49 KB)

authorised medicinal products - EMEA/H/N/PSR/J/0015 … authorised medicinal products - EMEA/H/N/PSR/J/0015 EMA/185142/2019 20/03/2019 …

Last updated: 20/03/2019
Active substance: domperidone
Procedure number: EMEA/H/N/PSR/J/0015
Regulatory outcome: Variation
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Poly (o-2-hydroxyethyl) starch: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0009 (PDF/148.61 KB)

authorised medicinal products - EMEA/H/N/PSR/S/0009 … authorised medicinal products - EMEA/H/N/PSR/S/0009 EMA/723696/2017 30/10/2017 … o-2-hydroxyethyl) Starch EMEA-H-N-PSR-S-0009 30 Churchill Place …

Last updated: 30/10/2017
Active substance: poly (o-2-hydroxyethyl) starch
Procedure number: EMEA/H/N/PSR/S/0009
Regulatory outcome: Variation
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Cyproterone/ethinylestradiol: PRAC non-interventional imposed PASS final study report assessment report - EMEA/H/N/PSR/J/0005 (PDF/129.08 KB)

report assessment report - EMEA/H/N/PSR/J/0005 … report assessment report - EMEA/H/N/PSR/J/0005 EMA/101726/2017 23/02/2017 … for the implementation - EMEA/H/N/PSR/J/0005 30 Churchill Place …

Last updated: 23/02/2017
Active substance: cyproterone, ethinylestradiol
Procedure number: EMEA/H/N/PSR/J/0005
Regulatory outcome: Variation
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Cyproterone/ethinylestradiol: PRAC non-interventional imposed PASS final study report assessment report - EMEA/H/N/PSR/J/0003 (PDF/129.78 KB)

report assessment report - EMEA/H/N/PSR/J/0003 … report assessment report - EMEA/H/N/PSR/J/0003 EMA/101714/2017 23/02/2017 … for the implementation - EMEA/H/N/PSR/J/0003 30 Churchill Place …

Last updated: 23/02/2017
Active substance: cyproterone, ethinylestradiol
Procedure number: EMEA/H/N/PSR/J/0003
Regulatory outcome: Variation
List item

Cyproterone/ethinylestradiol: PRAC non-interventional imposed PASS final study report assessment report - EMEA/H/N/PSR/J/0006 (PDF/156.64 KB)

report assessment report - EMEA/H/N/PSR/J/0006 … report assessment report - EMEA/H/N/PSR/J/0006 EMA/101741/2017 23/02/2017 … for the implementation - EMEA/H/N/PSR/J/0006 30 Churchill Place …

Last updated: 23/02/2017
Active substance: cyproterone, ethinylestradiol
Procedure number: EMEA/H/N/PSR/J/0006
Regulatory outcome: Variation
List item

Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0005 (PDF/26.44 KB)

implementation timetable - EMEA/H/N/PSR/J/0005 … implementation timetable - EMEA/H/N/PSR/J/0005 Other languages: bg es cs … for the implementation - EMEA/H/N/PSR/J/0005 …

Last updated: 23/02/2017
Active substance: cyproterone, ethinylestradiol
Procedure number: EMEA/H/N/PSR/J/0005
Regulatory outcome: Variation
Bulgarian
(PDF/62.63 KB)

Croatian
(PDF/58.95 KB)

Czech
(PDF/61.48 KB)

Danish
(PDF/28.61 KB)

Dutch
(PDF/29.35 KB)

Estonian
(PDF/26.13 KB)

Finnish
(PDF/26.27 KB)

French
(PDF/30.1 KB)

German
(PDF/29.45 KB)

Greek
(PDF/68.98 KB)

Hungarian
(PDF/60.35 KB)

Icelandic
(PDF/28.43 KB)

Italian
(PDF/32.08 KB)

Latvian
(PDF/60.11 KB)

Lithuanian
(PDF/63.7 KB)

Maltese
(PDF/64.69 KB)

Norwegian
(PDF/28.11 KB)

Polish
(PDF/71.94 KB)

Portuguese
(PDF/40.79 KB)

Romanian
(PDF/67.7 KB)

Slovak
(PDF/62.62 KB)

Slovenian
(PDF/57.42 KB)

Spanish
(PDF/28.41 KB)

Swedish
(PDF/30.1 KB)
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Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0003 (PDF/20.53 KB)

implementation timetable - EMEA/H/N/PSR/J/0003 … implementation timetable - EMEA/H/N/PSR/J/0003 Other languages: bg es cs … for the implementation - EMEA/H/N/PSR/J/0003 …

Last updated: 23/02/2017
Active substance: cyproterone, ethinylestradiol
Procedure number: EMEA/H/N/PSR/J/0003
Regulatory outcome: Variation
Bulgarian
(PDF/62.51 KB)

Croatian
(PDF/66.33 KB)

Czech
(PDF/70.27 KB)

Danish
(PDF/28.65 KB)

Dutch
(PDF/29.39 KB)

Estonian
(PDF/26.3 KB)

Finnish
(PDF/26.37 KB)

French
(PDF/30.23 KB)

German
(PDF/29.51 KB)

Greek
(PDF/65.11 KB)

Hungarian
(PDF/60.4 KB)

Icelandic
(PDF/28.63 KB)

Italian
(PDF/32.15 KB)

Latvian
(PDF/63.23 KB)

Lithuanian
(PDF/64.02 KB)

Maltese
(PDF/62.05 KB)

Norwegian
(PDF/28.04 KB)

Polish
(PDF/63.04 KB)

Portuguese
(PDF/42.42 KB)

Romanian
(PDF/71.7 KB)

Slovak
(PDF/62.81 KB)

Slovenian
(PDF/57.54 KB)

Spanish
(PDF/28.67 KB)

Swedish
(PDF/30.56 KB)
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Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0006 (PDF/25.74 KB)

implementation timetable - EMEA/H/N/PSR/J/0006 … implementation timetable - EMEA/H/N/PSR/J/0006 Other languages: bg es cs … for the implementation - EMEA/H/N/PSR/J/0006 …

Last updated: 23/02/2017
Active substance: cyproterone, ethinylestradiol
Procedure number: EMEA/H/N/PSR/J/0006
Regulatory outcome: Variation
Bulgarian
(PDF/61.15 KB)

Croatian
(PDF/65.7 KB)

Czech
(PDF/59.72 KB)

Danish
(PDF/27.61 KB)

Estonian
(PDF/25.77 KB)

Finnish
(PDF/25.62 KB)

French
(PDF/29.36 KB)

German
(PDF/30 KB)

Greek
(PDF/61.32 KB)

Hungarian
(PDF/58.56 KB)

Icelandic
(PDF/27.61 KB)

Italian
(PDF/31.13 KB)

Latvian
(PDF/60.28 KB)

Lithuanian
(PDF/62.31 KB)

Polish
(PDF/71.25 KB)

Romanian
(PDF/57.33 KB)

Slovak
(PDF/73.02 KB)

Slovenian
(PDF/55.28 KB)

Spanish
(PDF/27.61 KB)

Swedish
(PDF/29.41 KB)
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Hydroxyethyl starch : PRAC non-interventional imposed PASS final study report assessment report - EMEA/H/N/PSR/J/0031 (PDF/412.3 KB)

report assessment report - EMEA/H/N/PSR/J/0031 … report assessment report - EMEA/H/N/PSR/J/0031 EMA/596511/2022Adopted 24/06 … starch Procedure no.: EMEA/H/N/PSR/J/0031 Note Assessment …

Last updated: 24/06/2022
Active substance: hydroxyethyl starch
Procedure number: EMEA/H/N/PSR/J/0031
Regulatory outcome: Suspension
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Lisdexamfetamine dimesylate : List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0033 (PDF/181.32 KB)

authorised medicinal products - EMEA/H/N/PSR/S/0033 … authorised medicinal products - EMEA/H/N/PSR/S/0033 EMA/619644/2021 03/11/2021 … dimesylate Procedure no.: EMEA/H/N/PSR/S/0033 List of nationally …

Last updated: 03/11/2021
Active substance: lisdexamfetamine dimesylate
Procedure number: EMEA/H/N/PSR/S/0033
Regulatory outcome: Variation
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Intravenous iron: List of nationally authorised medicinal products - EMEA/H/N/PSR/J/0026 (PDF/237.09 KB)

authorised medicinal products - EMEA/H/N/PSR/J/0026 … authorised medicinal products - EMEA/H/N/PSR/J/0026 EMA/607374/2021 26/10/2021 … intravenous iron Procedure no.: EMEA/H/N/PSR/J/0026 List of nationally …

Last updated: 26/10/2021
Active substance: intravenous iron
Procedure number: EMEA/H/N/PSR/J/0026
Regulatory outcome: Variation

80 results

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

Cyproterone/ethinylestradiol: List of nationally authorised medicinal products - EMEA/H/N/PSR/J/0003; EMEA/H/N/PSR/J/0005; EMEA/H/N/PSR/J/0006 (PDF/123.83 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)

Thiocolchicoside: List of nationally authorised medicinal products - EMEA/H/N/PSR/J/0008 (PDF/787.76 KB)

Trimetazidine: List of nationally authorised medicinal products - EMEA/H/N/PSR/J/0003 (PDF/123.98 KB)

Trimetazidine: List of nationally authorised medicinal products - EMEA/H/N/PSR/0001 (PDF/238.84 KB)

Trimetazidine: List of nationally authorised medicinal products - EMEA/H/N/PSR/J/0002 (PDF/749.78 KB)

Numeta: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0017 (PDF/69.04 KB)

Hydroxyethyl starch : CMDh Divergent position - EMEA/H/N/PSR/J/0031 (PDF/62.69 KB)

Teicoplanin : List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0025 (PDF/120.29 KB)

Dexamfetamine: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0028 (PDF/185.65 KB)

Dexamfetamine: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0029 (PDF/221.14 KB)

Thiocolcicoside: List of nationally authorised medicinal products - EMEA/H/N/PSR/J/0023 (PDF/313.6 KB)

Domperidone: List of nationally authorised medicinal products - EMEA/H/N/PSR/J/0015 (PDF/289.49 KB)

Poly (o-2-hydroxyethyl) starch: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0009 (PDF/148.61 KB)

Cyproterone/ethinylestradiol: PRAC non-interventional imposed PASS final study report assessment report - EMEA/H/N/PSR/J/0005 (PDF/129.08 KB)

Cyproterone/ethinylestradiol: PRAC non-interventional imposed PASS final study report assessment report - EMEA/H/N/PSR/J/0003 (PDF/129.78 KB)

Cyproterone/ethinylestradiol: PRAC non-interventional imposed PASS final study report assessment report - EMEA/H/N/PSR/J/0006 (PDF/156.64 KB)

Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0005 (PDF/26.44 KB)

Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0003 (PDF/20.53 KB)

Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0006 (PDF/25.74 KB)

Hydroxyethyl starch : PRAC non-interventional imposed PASS final study report assessment report - EMEA/H/N/PSR/J/0031 (PDF/412.3 KB)

Lisdexamfetamine dimesylate : List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0033 (PDF/181.32 KB)

Intravenous iron: List of nationally authorised medicinal products - EMEA/H/N/PSR/J/0026 (PDF/237.09 KB)