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Dorzolamide : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00003168/202202 (PDF/36.95 KB)

Last updated: 25/11/2022
Active substance: dorzolamide
Procedure number: PSUSA/00003168/202202
Regulatory outcome: Variation
Bulgarian
(PDF/86.28 KB)

Croatian
(PDF/69.52 KB)

Czech
(PDF/81.98 KB)

Danish
(PDF/39.28 KB)

Dutch
(PDF/39.36 KB)

Estonian
(PDF/38.34 KB)

Finnish
(PDF/38.46 KB)

French
(PDF/40.04 KB)

German
(PDF/32.7 KB)

Greek
(PDF/89.72 KB)

Hungarian
(PDF/69.13 KB)

Icelandic
(PDF/42.28 KB)

Irish
(PDF/38.75 KB)

Italian
(PDF/42.01 KB)

Latvian
(PDF/80.69 KB)

Lithuanian
(PDF/84.38 KB)

Maltese
(PDF/82.53 KB)

Norwegian
(PDF/39.12 KB)

Polish
(PDF/84.34 KB)

Portuguese
(PDF/39.03 KB)

Romanian
(PDF/80.09 KB)

Slovak
(PDF/70.86 KB)

Slovenian
(PDF/76.3 KB)

Spanish
(PDF/39.52 KB)

Swedish
(PDF/40.2 KB)
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Betamethasone : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000391/202101 (PDF/156.56 KB)

Last updated: 18/10/2022
Active substance: betamethasone
Procedure number: PSUSA/00000391/202101
Regulatory outcome: Variation
Bulgarian
(PDF/126.38 KB)

Croatian
(PDF/218.18 KB)

Czech
(PDF/411.72 KB)

Danish
(PDF/156.89 KB)

Dutch
(PDF/135.15 KB)

Estonian
(PDF/150.55 KB)

Finnish
(PDF/113.87 KB)

French
(PDF/192.49 KB)

German
(PDF/107.8 KB)

Greek
(PDF/126.78 KB)

Hungarian
(PDF/215.99 KB)

Icelandic
(PDF/125.77 KB)

Italian
(PDF/123.46 KB)

Latvian
(PDF/165.6 KB)

Lithuanian
(PDF/429.9 KB)

Maltese
(PDF/90.56 KB)

Norwegian
(PDF/182.53 KB)

Polish
(PDF/206.42 KB)

Portuguese
(PDF/156.53 KB)

Romanian
(PDF/130.4 KB)

Slovak
(PDF/125.51 KB)

Slovenian
(PDF/198.26 KB)

Spanish
(PDF/157.21 KB)

Swedish
(PDF/175.82 KB)
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Isotretinoin (oral formulations) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010488/202105 (PDF/172.42 KB)

Last updated: 31/05/2022
Active substance: isotretinoin (oral formulations)
Procedure number: PSUSA/00010488/202105
Regulatory outcome: Variation
Bulgarian
(PDF/269.83 KB)

Croatian
(PDF/39.8 KB)

Czech
(PDF/178.5 KB)

Danish
(PDF/168.46 KB)

Dutch
(PDF/193.1 KB)

Estonian
(PDF/243.64 KB)

Finnish
(PDF/158.17 KB)

French
(PDF/38.02 KB)

German
(PDF/227.2 KB)

Greek
(PDF/342.74 KB)

Hungarian
(PDF/122.72 KB)

Icelandic
(PDF/156.29 KB)

Italian
(PDF/181.64 KB)

Latvian
(PDF/331.18 KB)

Lithuanian
(PDF/132.27 KB)

Maltese
(PDF/182.37 KB)

Norwegian
(PDF/113.01 KB)

Polish
(PDF/258.27 KB)

Portuguese
(PDF/131.59 KB)

Romanian
(PDF/254.52 KB)

Slovak
(PDF/183.34 KB)

Slovenian
(PDF/307.82 KB)

Spanish
(PDF/166.42 KB)

Swedish
(PDF/173.38 KB)
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Paracetamol (IV formulation) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002311/202105 (PDF/136.32 KB)

Last updated: 07/04/2022
Active substance: paracetamol (IV formulation)
Procedure number: PSUSA/00002311/202105
Regulatory outcome: Variation
Bulgarian
(PDF/192.3 KB)

Croatian
(PDF/195.36 KB)

Czech
(PDF/159.35 KB)

Danish
(PDF/162.18 KB)

Dutch
(PDF/140.68 KB)

Estonian
(PDF/92.08 KB)

Finnish
(PDF/136.2 KB)

French
(PDF/138.09 KB)

German
(PDF/143.47 KB)

Greek
(PDF/171.42 KB)

Hungarian
(PDF/219.74 KB)

Icelandic
(PDF/134.29 KB)

Italian
(PDF/182.7 KB)

Latvian
(PDF/125.25 KB)

Lithuanian
(PDF/120.98 KB)

Maltese
(PDF/120.5 KB)

Norwegian
(PDF/153.3 KB)

Polish
(PDF/204.5 KB)

Portuguese
(PDF/159.76 KB)

Romanian
(PDF/201.4 KB)

Slovak
(PDF/188.03 KB)

Slovenian
(PDF/230.38 KB)

Spanish
(PDF/154.91 KB)

Swedish
(PDF/172.08 KB)
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Remifentanil : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002617/202105 (PDF/147.75 KB)

Last updated: 06/04/2022
Active substance: remifentanil
Procedure number: PSUSA/00002617/202105
Regulatory outcome: Variation
Bulgarian
(PDF/337.89 KB)

Croatian
(PDF/268.55 KB)

Czech
(PDF/443.34 KB)

Danish
(PDF/388.37 KB)

Dutch
(PDF/328.14 KB)

Estonian
(PDF/271.48 KB)

Finnish
(PDF/321.82 KB)

French
(PDF/336.01 KB)

German
(PDF/330.82 KB)

Greek
(PDF/335.2 KB)

Hungarian
(PDF/468.29 KB)

Italian
(PDF/378.5 KB)

Latvian
(PDF/522.33 KB)

Lithuanian
(PDF/270.09 KB)

Maltese
(PDF/367.96 KB)

Norwegian
(PDF/325.44 KB)

Polish
(PDF/370.65 KB)

Portuguese
(PDF/370.07 KB)

Romanian
(PDF/331.4 KB)

Slovak
(PDF/277.26 KB)

Slovenian
(PDF/436.65 KB)

Spanish
(PDF/370.98 KB)

Swedish
(PDF/366.23 KB)
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Dobutamine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001151/202103 (PDF/91.49 KB)

Last updated: 09/03/2022
Active substance: Dobutamine
Procedure number: PSUSA/00001151/202103
Regulatory outcome: Variation
Bulgarian
(PDF/175.59 KB)

Croatian
(PDF/181.04 KB)

Czech
(PDF/195.41 KB)

Danish
(PDF/143.34 KB)

Dutch
(PDF/153.59 KB)

Estonian
(PDF/145.68 KB)

Finnish
(PDF/138.67 KB)

French
(PDF/144.97 KB)

German
(PDF/158.06 KB)

Greek
(PDF/178.29 KB)

Hungarian
(PDF/187.06 KB)

Icelandic
(PDF/154.4 KB)

Italian
(PDF/152.06 KB)

Latvian
(PDF/188.95 KB)

Lithuanian
(PDF/181.58 KB)

Maltese
(PDF/190.13 KB)

Norwegian
(PDF/142.4 KB)

Polish
(PDF/187.4 KB)

Portuguese
(PDF/145.15 KB)

Romanian
(PDF/188.56 KB)

Slovak
(PDF/190.87 KB)

Slovenian
(PDF/178.39 KB)

Spanish
(PDF/146.18 KB)

Swedish
(PDF/142.39 KB)
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Quinapril : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002591/202104 (PDF/80.07 KB)

Last updated: 15/02/2022
Active substance: quinapril
Procedure number: PSUSA/00002591/202104
Regulatory outcome: Variation
Bulgarian
(PDF/81.1 KB)

Croatian
(PDF/103.14 KB)

Czech
(PDF/82.44 KB)

Danish
(PDF/82.97 KB)

Dutch
(PDF/94.26 KB)

Estonian
(PDF/102.53 KB)

Finnish
(PDF/83.63 KB)

French
(PDF/82.76 KB)

German
(PDF/89.59 KB)

Greek
(PDF/80.16 KB)

Hungarian
(PDF/81.46 KB)

Italian
(PDF/101.42 KB)

Latvian
(PDF/112.01 KB)

Lithuanian
(PDF/88.64 KB)

Maltese
(PDF/110.28 KB)

Polish
(PDF/105.59 KB)

Portuguese
(PDF/91.38 KB)

Romanian
(PDF/80.24 KB)

Slovak
(PDF/84.34 KB)

Slovenian
(PDF/108.57 KB)

Spanish
(PDF/81.17 KB)

Swedish
(PDF/80.89 KB)
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Oxycodone : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002254/202104 (PDF/205.51 KB)

Last updated: 01/02/2022
Active substance: oxycodone
Procedure number: PSUSA/00002254/202104
Regulatory outcome: Variation
Bulgarian
(PDF/292.01 KB)

Croatian
(PDF/287.67 KB)

Czech
(PDF/161.83 KB)

Danish
(PDF/214.08 KB)

Dutch
(PDF/208.28 KB)

Estonian
(PDF/200.93 KB)

Finnish
(PDF/201.41 KB)

French
(PDF/227.02 KB)

German
(PDF/242.89 KB)

Greek
(PDF/268.51 KB)

Hungarian
(PDF/313.38 KB)

Icelandic
(PDF/213.35 KB)

Italian
(PDF/213.47 KB)

Latvian
(PDF/296.66 KB)

Lithuanian
(PDF/286.49 KB)

Maltese
(PDF/241.3 KB)

Norwegian
(PDF/204.07 KB)

Polish
(PDF/247.98 KB)

Portuguese
(PDF/311.01 KB)

Romanian
(PDF/390.27 KB)

Slovak
(PDF/287.18 KB)

Slovenian
(PDF/284.3 KB)

Spanish
(PDF/210.22 KB)

Swedish
(PDF/194.95 KB)
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Glatiramer - Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation - PSUSA-00001529-202011 (PDF/33.83 KB)

Last updated: 20/01/2022
Active substance: glatiramer
Regulatory outcome: Variation
Bulgarian
(PDF/80.29 KB)

Croatian
(PDF/73.59 KB)

Czech
(PDF/134.01 KB)

Danish
(PDF/34.48 KB)

Dutch
(PDF/36.33 KB)

Estonian
(PDF/30.2 KB)

Finnish
(PDF/86.42 KB)

French
(PDF/34.28 KB)

German
(PDF/155.78 KB)

Greek
(PDF/84.1 KB)

Hungarian
(PDF/153.76 KB)

Icelandic
(PDF/36.15 KB)

Italian
(PDF/36.54 KB)

Latvian
(PDF/76.32 KB)

Lithuanian
(PDF/77.31 KB)

Maltese
(PDF/78.4 KB)

Norwegian
(PDF/30.64 KB)

Polish
(PDF/80.05 KB)

Portuguese
(PDF/34.25 KB)

Romanian
(PDF/66.96 KB)

Slovak
(PDF/77.46 KB)

Slovenian
(PDF/66.22 KB)

Spanish
(PDF/35.56 KB)

Swedish
(PDF/34.46 KB)
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Nafarelin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002105/202102 (PDF/72.61 KB)

Last updated: 14/01/2022
Active substance: nafarelin
Procedure number: PSUSA/00002105/202102
Regulatory outcome: Variation
Bulgarian
(PDF/80.31 KB)

Croatian
(PDF/82.51 KB)

Czech
(PDF/209.8 KB)

Danish
(PDF/76.43 KB)

Dutch
(PDF/74.54 KB)

Estonian
(PDF/79.54 KB)

Finnish
(PDF/68.38 KB)

French
(PDF/82.06 KB)

German
(PDF/80.72 KB)

Greek
(PDF/72.09 KB)

Hungarian
(PDF/72.76 KB)

Icelandic
(PDF/74.93 KB)

Italian
(PDF/101.18 KB)

Latvian
(PDF/95.19 KB)

Lithuanian
(PDF/88.44 KB)

Maltese
(PDF/92.6 KB)

Norwegian
(PDF/71.68 KB)

Polish
(PDF/91.25 KB)

Portuguese
(PDF/90.53 KB)

Romanian
(PDF/79.05 KB)

Slovak
(PDF/83.76 KB)

Slovenian
(PDF/83.27 KB)

Spanish
(PDF/80.73 KB)

Swedish
(PDF/84.17 KB)
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Tramadol: List of nationally authorised medicinal products - PSUSA/00003002/202005 (PDF/2.3 MB)

Last updated: 24/03/2021
Active substance: Tramadol
Procedure number: PSUSA/00003002/202005
Regulatory outcome: Variation
List item

Tramadol: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00003002/202005 (PDF/199.01 KB)

Last updated: 24/03/2021
Active substance: Tramadol
Procedure number: PSUSA/00003002/202005
Regulatory outcome: Variation
Bulgarian
(PDF/228.07 KB)

Croatian
(PDF/247.66 KB)

Czech
(PDF/282.64 KB)

Danish
(PDF/178.93 KB)

Dutch
(PDF/189.31 KB)

Estonian
(PDF/196.26 KB)

Finnish
(PDF/195.52 KB)

French
(PDF/105.6 KB)

German
(PDF/203.88 KB)

Greek
(PDF/255.31 KB)

Greek
(PDF/255.31 KB)

Hungarian
(PDF/269.79 KB)

Icelandic
(PDF/213.74 KB)

Italian
(PDF/220.66 KB)

Latvian
(PDF/246.72 KB)

Lithuanian
(PDF/244.77 KB)

Maltese
(PDF/283.18 KB)

Norwegian
(PDF/208.41 KB)

Polish
(PDF/241.34 KB)

Portuguese
(PDF/183.34 KB)

Romanian
(PDF/220.02 KB)

Slovak
(PDF/248.59 KB)

Slovenian
(PDF/241.04 KB)

Spanish
(PDF/214.08 KB)

Swedish
(PDF/171.02 KB)
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Ciprofloxacin (systemic use): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00000775/201801 (PDF/53.12 KB)

Last updated: 03/10/2019
Active substance: Ciprofloxacin
Procedure number: PSUSA/00000775/201801
Regulatory outcome: Variation
Bulgarian
(PDF/91.98 KB)

Croatian
(PDF/77.13 KB)

Czech
(PDF/87.25 KB)

Danish
(PDF/50.56 KB)

Dutch
(PDF/51.17 KB)

Estonian
(PDF/45.67 KB)

Finnish
(PDF/49.17 KB)

French
(PDF/50.96 KB)

German
(PDF/52.64 KB)

Greek
(PDF/94.38 KB)

Hungarian
(PDF/79.87 KB)

Icelandic
(PDF/47.02 KB)

Italian
(PDF/52.77 KB)

Latvian
(PDF/88.52 KB)

Lithuanian
(PDF/77.1 KB)

Maltese
(PDF/115.63 KB)

Norwegian
(PDF/50.25 KB)

Polish
(PDF/90.63 KB)

Portuguese
(PDF/45.98 KB)

Romanian
(PDF/93.48 KB)

Slovak
(PDF/85.23 KB)

Slovenian
(PDF/81.33 KB)

Spanish
(PDF/65.36 KB)

Swedish
(PDF/50.93 KB)
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Everolimus (indicated for rejection of transplanted organs) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010269/201807 (PDF/27.04 KB)

Last updated: 17/06/2019
Active substance: everolimus
Procedure number: PSUSA/00010269/201807
Regulatory outcome: Variation
Bulgarian
(PDF/58.96 KB)

Croatian
(PDF/50.28 KB)

Czech
(PDF/53.92 KB)

Danish
(PDF/25.61 KB)

Dutch
(PDF/26.13 KB)

Estonian
(PDF/25.16 KB)

Finnish
(PDF/25.14 KB)

French
(PDF/26.08 KB)

German
(PDF/27.28 KB)

Greek
(PDF/59.4 KB)

Hungarian
(PDF/50.71 KB)

Icelandic
(PDF/27.46 KB)

Italian
(PDF/27.13 KB)

Latvian
(PDF/53.63 KB)

Lithuanian
(PDF/55.6 KB)

Maltese
(PDF/54.4 KB)

Norwegian
(PDF/25.09 KB)

Polish
(PDF/56.26 KB)

Portuguese
(PDF/25.77 KB)

Romanian
(PDF/52.72 KB)

Slovak
(PDF/54.21 KB)

Slovenian
(PDF/50.43 KB)

Spanish
(PDF/25.78 KB)

Swedish
(PDF/25.87 KB)
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Paracetamol / pseudoephedrine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002307/201806 (PDF/69.19 KB)

Last updated: 17/04/2019
Active substance: paracetamol, pseudoephedrine
Procedure number: PSUSA/00002307/201806
Regulatory outcome: Variation
(PDF/106.92 KB)

Bulgarian
(PDF/116.05 KB)

Croatian
(PDF/104.86 KB)

Czech
(PDF/112.31 KB)

Danish
(PDF/78.6 KB)

Dutch
(PDF/92.13 KB)

Estonian
(PDF/74.16 KB)

Finnish
(PDF/86.84 KB)

French
(PDF/96.05 KB)

German
(PDF/85.54 KB)

Greek
(PDF/96.37 KB)

Hungarian
(PDF/98.3 KB)

Italian
(PDF/134.96 KB)

Latvian
(PDF/110.71 KB)

Lithuanian
(PDF/86.4 KB)

Maltese
(PDF/92.16 KB)

Polish
(PDF/100.74 KB)

Portuguese
(PDF/68.89 KB)

Romanian
(PDF/108.41 KB)

Slovak
(PDF/114.92 KB)

Slovenian
(PDF/84.26 KB)

Spanish
(PDF/81.9 KB)

Swedish
(PDF/67.98 KB)
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Deoxycholic acid: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00010525/201804 (PDF/213.14 KB)

Last updated: 26/02/2019
Active substance: Deoxycholic acid
Procedure number: PSUSA/00010525/201804
Regulatory outcome: Variation
(PDF/212.44 KB)

Bulgarian
(PDF/224.87 KB)

Croatian
(PDF/218.08 KB)

Czech
(PDF/224.85 KB)

Danish
(PDF/258.51 KB)

Dutch
(PDF/216.5 KB)

Finnish
(PDF/207.09 KB)

French
(PDF/225.63 KB)

German
(PDF/238.95 KB)

Greek
(PDF/223.4 KB)

Hungarian
(PDF/447.46 KB)

Icelandic
(PDF/262.37 KB)

Italian
(PDF/298.96 KB)

Latvian
(PDF/288.44 KB)

Lithuanian
(PDF/144.59 KB)

Maltese
(PDF/230.19 KB)

Norwegian
(PDF/213.26 KB)

Polish
(PDF/197.11 KB)

Portuguese
(PDF/215.19 KB)

Romanian
(PDF/220.35 KB)

Slovak
(PDF/266.5 KB)

Slovenian
(PDF/217.57 KB)

Spanish
(PDF/214.75 KB)

Swedish
(PDF/213.9 KB)
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Propofol: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00002555/201711 (PDF/35.38 KB)

Last updated: 13/09/2018
Active substance: propofol
Procedure number: PSUSA/00002555/201711
Regulatory outcome: Variation
Bulgarian
(PDF/62.03 KB)

Croatian
(PDF/56.31 KB)

Czech
(PDF/76.89 KB)

Danish
(PDF/34.11 KB)

Dutch
(PDF/34.69 KB)

Estonian
(PDF/34.11 KB)

Finnish
(PDF/34.02 KB)

French
(PDF/34.98 KB)

German
(PDF/35.06 KB)

Greek
(PDF/61.81 KB)

Hungarian
(PDF/58.15 KB)

Icelandic
(PDF/34.47 KB)

Italian
(PDF/35.54 KB)

Latvian
(PDF/58.65 KB)

Lithuanian
(PDF/63.03 KB)

Maltese
(PDF/60.46 KB)

Norwegian
(PDF/34.07 KB)

Polish
(PDF/61.83 KB)

Portuguese
(PDF/34.1 KB)

Romanian
(PDF/56.9 KB)

Slovak
(PDF/59.23 KB)

Slovenian
(PDF/58.16 KB)

Spanish
(PDF/34.44 KB)

Swedish
(PDF/34.46 KB)
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Propofol: List of nationally authorised medicinal products - PSUSA/00002555/201711 (PDF/516.62 KB)

Last updated: 13/09/2018
Active substance: propofol
Procedure number: PSUSA/00002555/201711
Regulatory outcome: Variation
List item

Naproxen: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002125/201708 (PDF/32.74 KB)

Last updated: 13/09/2018
Active substance: naproxen
Procedure number: PSUSA/00002125/201708
Regulatory outcome: Variation
Bulgarian
(PDF/112.63 KB)

Croatian
(PDF/100.3 KB)

Czech
(PDF/89.6 KB)

Danish
(PDF/38.79 KB)

Dutch
(PDF/32.68 KB)

Estonian
(PDF/39.52 KB)

Finnish
(PDF/36.98 KB)

French
(PDF/58.73 KB)

German
(PDF/34.02 KB)

Greek
(PDF/94.01 KB)

Hungarian
(PDF/86.24 KB)

Icelandic
(PDF/35.57 KB)

Italian
(PDF/39.9 KB)

Latvian
(PDF/96.1 KB)

Lithuanian
(PDF/90.5 KB)

Maltese
(PDF/119.1 KB)

Norwegian
(PDF/34.49 KB)

Polish
(PDF/97.29 KB)

Portuguese
(PDF/38.87 KB)

Romanian
(PDF/90.29 KB)

Slovak
(PDF/95.88 KB)

Slovenian
(PDF/92.68 KB)

Spanish
(PDF/39.2 KB)

Swedish
(PDF/38.61 KB)
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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

Paroxetine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002319/201712 (PDF/45.82 KB)

Last updated: 11/09/2018
Active substance: paroxetine
Procedure number: PSUSA/00002319/201712
Regulatory outcome: Variation
Bulgarian
(PDF/194.76 KB)

Croatian
(PDF/76.64 KB)

Czech
(PDF/85.21 KB)

Danish
(PDF/60.1 KB)

Dutch
(PDF/32.46 KB)

Estonian
(PDF/160.5 KB)

Finnish
(PDF/86.04 KB)

French
(PDF/49.91 KB)

German
(PDF/58.14 KB)

Greek
(PDF/96.13 KB)

Hungarian
(PDF/85.51 KB)

Icelandic
(PDF/162.78 KB)

Italian
(PDF/177.21 KB)

Latvian
(PDF/107.22 KB)

Lithuanian
(PDF/155.93 KB)

Maltese
(PDF/90.85 KB)

Norwegian
(PDF/125.64 KB)

Polish
(PDF/171.82 KB)

Portuguese
(PDF/55.85 KB)

Romanian
(PDF/143.38 KB)

Slovak
(PDF/86.64 KB)

Slovenian
(PDF/81.83 KB)

Spanish
(PDF/115.7 KB)

Swedish
(PDF/50.36 KB)
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Lamotrigine : CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001825/201711 (PDF/98.15 KB)

Last updated: 10/09/2018
Active substance: lamotrigine
Procedure number: PSUSA/00001825/201711
Regulatory outcome: Variation
Bulgarian
(PDF/305.37 KB)

Croatian
(PDF/183.53 KB)

Czech
(PDF/211.83 KB)

Danish
(PDF/162.47 KB)

Dutch
(PDF/113.85 KB)

Estonian
(PDF/276.16 KB)

Finnish
(PDF/175.1 KB)

French
(PDF/169.48 KB)

German
(PDF/127.86 KB)

Greek
(PDF/356.94 KB)

Hungarian
(PDF/167.68 KB)

Icelandic
(PDF/266.57 KB)

Italian
(PDF/246.26 KB)

Latvian
(PDF/249.66 KB)

Lithuanian
(PDF/281.89 KB)

Maltese
(PDF/330.08 KB)

Norwegian
(PDF/312.69 KB)

Polish
(PDF/340.26 KB)

Portuguese
(PDF/125.86 KB)

Romanian
(PDF/261.2 KB)

Slovak
(PDF/250.45 KB)

Slovenian
(PDF/323.3 KB)

Spanish
(PDF/212.78 KB)

Swedish
(PDF/190.79 KB)
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Lamotrigine : List of nationally authorised medicinal products - PSUSA/00001825/201711 (PDF/639.41 KB)

Last updated: 10/09/2018
Active substance: lamotrigine
Procedure number: PSUSA/00001825/201711
Regulatory outcome: Variation
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Leuprorelin: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001844/201707 (PDF/31.71 KB)

Last updated: 10/09/2018
Active substance: leuprorelin
Procedure number: PSUSA/00001844/201707
Regulatory outcome: Variation
Bulgarian
(PDF/99.03 KB)

Croatian
(PDF/93.95 KB)

Czech
(PDF/121.91 KB)

Danish
(PDF/36.42 KB)

Dutch
(PDF/35.33 KB)

Estonian
(PDF/36.2 KB)

Finnish
(PDF/29.9 KB)

French
(PDF/35.75 KB)

German
(PDF/31.31 KB)

Greek
(PDF/104.04 KB)

Hungarian
(PDF/95.61 KB)

Icelandic
(PDF/30.14 KB)

Italian
(PDF/38.66 KB)

Latvian
(PDF/100.35 KB)

Lithuanian
(PDF/101.02 KB)

Maltese
(PDF/101.79 KB)

Norwegian
(PDF/27.21 KB)

Polish
(PDF/95.31 KB)

Portuguese
(PDF/32.58 KB)

Romanian
(PDF/100.31 KB)

Slovak
(PDF/98.74 KB)

Spanish
(PDF/37.09 KB)

Swedish
(PDF/33.33 KB)
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Tapentadol : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002849/201711 (PDF/52.62 KB)

Last updated: 07/09/2018
Active substance: tapentadol
Procedure number: PSUSA/00002849/201711
Regulatory outcome: Variation
Bulgarian
(PDF/146.74 KB)

Croatian
(PDF/141.58 KB)

Czech
(PDF/443.47 KB)

Danish
(PDF/54.31 KB)

Dutch
(PDF/53.74 KB)

Estonian
(PDF/425.24 KB)

Finnish
(PDF/54.08 KB)

French
(PDF/69.07 KB)

German
(PDF/56.58 KB)

Greek
(PDF/127.77 KB)

Hungarian
(PDF/124.58 KB)

Icelandic
(PDF/53.52 KB)

Italian
(PDF/55.5 KB)

Latvian
(PDF/129.88 KB)

Lithuanian
(PDF/127.91 KB)

Maltese
(PDF/504.58 KB)

Norwegian
(PDF/52.99 KB)

Polish
(PDF/133.05 KB)

Portuguese
(PDF/68.82 KB)

Romanian
(PDF/126.81 KB)

Slovak
(PDF/128.36 KB)

Slovenian
(PDF/430.96 KB)

Spanish
(PDF/53.35 KB)

Swedish
(PDF/74.28 KB)

960 results

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Betamethasone : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000391/202101 (PDF/156.56 KB)

Isotretinoin (oral formulations) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010488/202105 (PDF/172.42 KB)

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Remifentanil : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002617/202105 (PDF/147.75 KB)

Dobutamine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001151/202103 (PDF/91.49 KB)

Quinapril : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002591/202104 (PDF/80.07 KB)

Oxycodone : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002254/202104 (PDF/205.51 KB)

Glatiramer - Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation - PSUSA-00001529-202011 (PDF/33.83 KB)

Nafarelin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002105/202102 (PDF/72.61 KB)

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

Tramadol: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00003002/202005 (PDF/199.01 KB)

Ciprofloxacin (systemic use): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00000775/201801 (PDF/53.12 KB)

Everolimus (indicated for rejection of transplanted organs) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010269/201807 (PDF/27.04 KB)

Paracetamol / pseudoephedrine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002307/201806 (PDF/69.19 KB)

Deoxycholic acid: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00010525/201804 (PDF/213.14 KB)

Propofol: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00002555/201711 (PDF/35.38 KB)

Propofol: List of nationally authorised medicinal products - PSUSA/00002555/201711 (PDF/516.62 KB)

Naproxen: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002125/201708 (PDF/32.74 KB)

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

Paroxetine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002319/201712 (PDF/45.82 KB)

Lamotrigine : CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001825/201711 (PDF/98.15 KB)

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

Leuprorelin: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001844/201707 (PDF/31.71 KB)

Tapentadol : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002849/201711 (PDF/52.62 KB)