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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
List item

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)
List item

Tapentadol : List of nationally authorised medicinal products - PSUSA/00002849/201711 (PDF/1.4 MB)

Last updated: 07/09/2018
Active substance: tapentadol
Procedure number: PSUSA/00002849/201711
Regulatory outcome: Variation
List item

Mizolastine: List of nationally authorised medicinal products - PSUSA/00002078/201711 (PDF/217.66 KB)

Last updated: 05/09/2018
Active substance: mizolastine
Procedure number: PSUSA/00002078/201711
Regulatory outcome: Variation
List item

Mizolastine: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002078/201711 (PDF/34.31 KB)

Last updated: 05/09/2018
Active substance: mizolastine
Procedure number: PSUSA/00002078/201711
Regulatory outcome: Variation
Bulgarian
(PDF/75.12 KB)

Croatian
(PDF/85.88 KB)

Czech
(PDF/102.28 KB)

Danish
(PDF/37.78 KB)

Dutch
(PDF/31.89 KB)

Estonian
(PDF/29.12 KB)

Finnish
(PDF/33.46 KB)

French
(PDF/36.38 KB)

German
(PDF/36.61 KB)

Greek
(PDF/106.58 KB)

Hungarian
(PDF/92.45 KB)

Icelandic
(PDF/29.15 KB)

Italian
(PDF/39.66 KB)

Latvian
(PDF/100.51 KB)

Lithuanian
(PDF/97.19 KB)

Maltese
(PDF/66.19 KB)

Norwegian
(PDF/31.99 KB)

Polish
(PDF/103.47 KB)

Portuguese
(PDF/57.32 KB)

Romanian
(PDF/83.3 KB)

Slovak
(PDF/94.36 KB)

Slovenian
(PDF/63.65 KB)

Spanish
(PDF/39.48 KB)

Swedish
(PDF/32.81 KB)
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Hydroxycarbamide: List of nationally authorised medicinal products - PSUSA/00009182/201712 (PDF/94.52 KB)

Last updated: 31/08/2018
Active substance: hydroxycarbamide
Procedure number: PSUSA/00009182/201712
Regulatory outcome: Variation
List item

Hydroxycarbamide: CMDh Scientific conclusions, amendments to product information and implementation timetable - PSUSA/00009182/201712

Last updated: 31/08/2018
Active substance: hydroxycarbamide
Procedure number: PSUSA/00009182/201712
Regulatory outcome: Variation
Bulgarian
(PDF/608.55 KB)

Croatian
(PDF/631.22 KB)

Czech
(PDF/68.6 KB)

Danish
(PDF/562.93 KB)

Dutch
(PDF/567.72 KB)

Estonian
(PDF/578.35 KB)

Finnish
(PDF/560.58 KB)

French
(PDF/584.52 KB)

German
(PDF/571.24 KB)

Greek
(PDF/606.07 KB)

Hungarian
(PDF/613.33 KB)

Italian
(PDF/578.71 KB)

Latvian
(PDF/620.3 KB)

Lithuanian
(PDF/617.24 KB)

Maltese
(PDF/608.88 KB)

Polish
(PDF/599.63 KB)

Portuguese
(PDF/562.79 KB)

Romanian
(PDF/602.41 KB)

Slovak
(PDF/607.71 KB)

Slovenian
(PDF/593.54 KB)

Spanish
(PDF/578.99 KB)

Swedish
(PDF/562.95 KB)
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Rosuvastatin: List of nationally authorised medicinal products - PSUSA/00002664/201711 (PDF/710.43 KB)

Last updated: 31/08/2018
Active substance: Rosuvastatin
Procedure number: PSUSA/00002664/201711
Regulatory outcome: Variation
List item

Rosuvastatin: CMDh Scientific conclusions, amendments to product information and implementation timetable - PSUSA/00002664/201711 (PDF/347.92 KB)

Last updated: 31/08/2018
Active substance: Rosuvastatin
Procedure number: PSUSA/00002664/201711
Regulatory outcome: Variation
Bulgarian
(PDF/176.2 KB)

Croatian
(PDF/400.54 KB)

Czech
(PDF/415.09 KB)

Danish
(PDF/408.38 KB)

Dutch
(PDF/175.7 KB)

Estonian
(PDF/307.82 KB)

Finnish
(PDF/373.06 KB)

French
(PDF/422.15 KB)

German
(PDF/119.68 KB)

Greek
(PDF/478.82 KB)

Hungarian
(PDF/73.31 KB)

Icelandic
(PDF/421.74 KB)

Italian
(PDF/378.85 KB)

Latvian
(PDF/114.81 KB)

Lithuanian
(PDF/71.17 KB)

Maltese
(PDF/354.48 KB)

Norwegian
(PDF/335.96 KB)

Polish
(PDF/454.07 KB)

Portuguese
(PDF/110.9 KB)

Romanian
(PDF/335.66 KB)

Slovak
(PDF/75.77 KB)

Slovenian
(PDF/268.19 KB)

Spanish
(PDF/146.26 KB)

Swedish
(PDF/415.95 KB)
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Atorvastatin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010347/201710 (PDF/52.49 KB)

Last updated: 24/08/2018
Active substance: Atorvastatin
Procedure number: PSUSA/00010347/201710
Regulatory outcome: Variation
Bulgarian
(PDF/159.88 KB)

Croatian
(PDF/111.08 KB)

Czech
(PDF/150.73 KB)

Danish
(PDF/53.21 KB)

Dutch
(PDF/57.08 KB)

Estonian
(PDF/55.09 KB)

Finnish
(PDF/55.02 KB)

French
(PDF/55.51 KB)

German
(PDF/56.22 KB)

Greek
(PDF/156.96 KB)

Hungarian
(PDF/113.47 KB)

Icelandic
(PDF/50.27 KB)

Italian
(PDF/54.12 KB)

Latvian
(PDF/153.58 KB)

Lithuanian
(PDF/133.54 KB)

Maltese
(PDF/143.63 KB)

Norwegian
(PDF/56.02 KB)

Polish
(PDF/146.92 KB)

Portuguese
(PDF/55.19 KB)

Romanian
(PDF/136.51 KB)

Slovak
(PDF/115.05 KB)

Slovenian
(PDF/129.32 KB)

Spanish
(PDF/55.45 KB)

Swedish
(PDF/53.02 KB)
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Adapalene / benzoyl peroxide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000059/201709 (PDF/104.04 KB)

Last updated: 16/08/2018
Active substance: benzoyl peroxide, adapalene
Procedure number: PSUSA/00000059/201709
Regulatory outcome: Variation
Bulgarian
(PDF/125.22 KB)

Croatian
(PDF/131.65 KB)

Danish
(PDF/115.01 KB)

Dutch
(PDF/112.88 KB)

Finnish
(PDF/96.79 KB)

French
(PDF/25.55 KB)

German
(PDF/109.39 KB)

Greek
(PDF/108.93 KB)

Hungarian
(PDF/105.09 KB)

Icelandic
(PDF/105.83 KB)

Italian
(PDF/122.22 KB)

Latvian
(PDF/126.62 KB)

Lithuanian
(PDF/103.96 KB)

Maltese
(PDF/104.53 KB)

Norwegian
(PDF/102.08 KB)

Polish
(PDF/105.34 KB)

Portuguese
(PDF/103.29 KB)

Romanian
(PDF/101.45 KB)

Slovak
(PDF/106.19 KB)

Slovenian
(PDF/102.33 KB)

Spanish
(PDF/93.63 KB)

Swedish
(PDF/116.31 KB)
List item

Epinastine: List of nationally authorised medicinal products - PSUSA/00001231/201710 (PDF/130.86 KB)

Last updated: 14/08/2018
Active substance: epinastine
Procedure number: PSUSA/00001231/201710
Regulatory outcome: Variation
List item

Epinastine: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001231/201710 (PDF/41.37 KB)

Last updated: 14/08/2018
Active substance: epinastine
Procedure number: PSUSA/00001231/201710
Regulatory outcome: Variation
Bulgarian
(PDF/101.72 KB)

Croatian
(PDF/102.13 KB)

Czech
(PDF/99.94 KB)

Danish
(PDF/38.07 KB)

Dutch
(PDF/39.09 KB)

Estonian
(PDF/38.72 KB)

Finnish
(PDF/38.41 KB)

French
(PDF/40.04 KB)

German
(PDF/39.09 KB)

Greek
(PDF/99.3 KB)

Hungarian
(PDF/102.98 KB)

Italian
(PDF/39.43 KB)

Latvian
(PDF/105.6 KB)

Lithuanian
(PDF/98.26 KB)

Maltese
(PDF/106.75 KB)

Polish
(PDF/102.78 KB)

Portuguese
(PDF/38.88 KB)

Romanian
(PDF/97.63 KB)

Slovak
(PDF/103.86 KB)

Slovenian
(PDF/96.23 KB)

Spanish
(PDF/39.6 KB)

Swedish
(PDF/37.46 KB)
List item

Deoxycholic acid: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010525/201710 (PDF/218.35 KB)

Last updated: 14/08/2018
Active substance: Deoxycholic acid
Procedure number: PSUSA/00010525/201710
Regulatory outcome: Variation
Bulgarian
(PDF/390.85 KB)

Croatian
(PDF/302.5 KB)

Czech
(PDF/391.89 KB)

Danish
(PDF/221.13 KB)

Dutch
(PDF/219.82 KB)

Estonian
(PDF/213.82 KB)

Finnish
(PDF/210.2 KB)

French
(PDF/222.17 KB)

German
(PDF/190.18 KB)

Greek
(PDF/350.53 KB)

Hungarian
(PDF/314.68 KB)

Icelandic
(PDF/220.35 KB)

Italian
(PDF/217.72 KB)

Latvian
(PDF/392.57 KB)

Lithuanian
(PDF/387.24 KB)

Maltese
(PDF/394.42 KB)

Norwegian
(PDF/216.64 KB)

Polish
(PDF/392.85 KB)

Portuguese
(PDF/219.74 KB)

Romanian
(PDF/382.08 KB)

Slovak
(PDF/451.87 KB)

Slovenian
(PDF/388.38 KB)

Spanish
(PDF/248.31 KB)

Swedish
(PDF/218.08 KB)

691 results

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)

Tapentadol : List of nationally authorised medicinal products - PSUSA/00002849/201711 (PDF/1.4 MB)

Mizolastine: List of nationally authorised medicinal products - PSUSA/00002078/201711 (PDF/217.66 KB)

Mizolastine: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002078/201711 (PDF/34.31 KB)

Hydroxycarbamide: List of nationally authorised medicinal products - PSUSA/00009182/201712 (PDF/94.52 KB)

Hydroxycarbamide: CMDh Scientific conclusions, amendments to product information and implementation timetable - PSUSA/00009182/201712

Rosuvastatin: List of nationally authorised medicinal products - PSUSA/00002664/201711 (PDF/710.43 KB)

Rosuvastatin: CMDh Scientific conclusions, amendments to product information and implementation timetable - PSUSA/00002664/201711 (PDF/347.92 KB)

Atorvastatin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010347/201710 (PDF/52.49 KB)

Adapalene / benzoyl peroxide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000059/201709 (PDF/104.04 KB)

Epinastine: List of nationally authorised medicinal products - PSUSA/00001231/201710 (PDF/130.86 KB)

Epinastine: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001231/201710 (PDF/41.37 KB)

Deoxycholic acid: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010525/201710 (PDF/218.35 KB)