Search the website

Search results

324 results

Sort by

List item

Lidocaine hydrochloride / phenylephrine hydrochloride / tropicamide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010390/202007 (PDF/88.38 KB) (new)

Last updated: 07/04/2021
Active substance: lidocaine hydrochloride, Phenylephrine hydrochloride, Tropicamide
Procedure number: PSUSA/00010390/202007
Regulatory outcome: Variation
Bulgarian
(PDF/180.14 KB)

Croatian
(PDF/218.22 KB)

Czech
(PDF/174.59 KB)

Danish
(PDF/141.87 KB)

Dutch
(PDF/126.43 KB)

Estonian
(PDF/144.91 KB)

Finnish
(PDF/119.17 KB)

French
(PDF/125.9 KB)

German
(PDF/133.01 KB)

Greek
(PDF/151.5 KB)

Hungarian
(PDF/203.12 KB)

Icelandic
(PDF/120.42 KB)

Italian
(PDF/166.66 KB)

Latvian
(PDF/190.42 KB)

Lithuanian
(PDF/208.2 KB)

Maltese
(PDF/180.16 KB)

Norwegian
(PDF/126.34 KB)

Polish
(PDF/185.41 KB)

Portuguese
(PDF/148.73 KB)

Romanian
(PDF/190.16 KB)

Slovak
(PDF/173.9 KB)

Slovenian
(PDF/178.05 KB)

Spanish
(PDF/142.79 KB)

Swedish
(PDF/143.95 KB)
List item

Primidone: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002525/202006 (PDF/213.75 KB) (new)

Last updated: 07/04/2021
Active substance: primidone
Procedure number: PSUSA/00002525/202006
Regulatory outcome: Variation
(PDF/161.21 KB)

Bulgarian
(PDF/230.77 KB)

Croatian
(PDF/280.97 KB)

Czech
(PDF/221.6 KB)

Danish
(PDF/166.97 KB)

Dutch
(PDF/221.45 KB)

Finnish
(PDF/243.13 KB)

French
(PDF/290.07 KB)

German
(PDF/229.03 KB)

Greek
(PDF/225.66 KB)

Hungarian
(PDF/260.39 KB)

Italian
(PDF/237.73 KB)

Latvian
(PDF/337.12 KB)

Lithuanian
(PDF/258.56 KB)

Maltese
(PDF/287.82 KB)

Polish
(PDF/229.29 KB)

Portuguese
(PDF/217.32 KB)

Romanian
(PDF/218.08 KB)

Slovak
(PDF/223.83 KB)

Slovenian
(PDF/279.84 KB)

Spanish
(PDF/68.63 KB)

Swedish
(PDF/66.13 KB)
List item

Xylometazoline: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00003134/202005 (PDF/42.04 KB) (new)

Last updated: 16/03/2021
Active substance: xylometazoline
Procedure number: PSUSA/00003134/202005
Regulatory outcome: Variation
Bulgarian
(PDF/113.17 KB)

Croatian
(PDF/104.92 KB)

Czech
(PDF/132.01 KB)

Danish
(PDF/44.97 KB)

Dutch
(PDF/31.83 KB)

Estonian
(PDF/40.32 KB)

Finnish
(PDF/42.64 KB)

French
(PDF/38.16 KB)

German
(PDF/44.27 KB)

Greek
(PDF/107.29 KB)

Hungarian
(PDF/106.63 KB)

Icelandic
(PDF/33.25 KB)

Italian
(PDF/38.38 KB)

Latvian
(PDF/96.84 KB)

Lithuanian
(PDF/103.3 KB)

Maltese
(PDF/103.29 KB)

Norwegian
(PDF/37.75 KB)

Polish
(PDF/98.43 KB)

Portuguese
(PDF/37.94 KB)

Romanian
(PDF/95.73 KB)

Slovak
(PDF/101 KB)

Slovenian
(PDF/99.79 KB)

Spanish
(PDF/38.26 KB)

Swedish
(PDF/37.57 KB)
List item

Irinotecan (except for liposomal formulations): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001783/202005 (PDF/108.72 KB)

Last updated: 15/03/2021
Active substance: irinotecan
Procedure number: PSUSA/00001783/202005
Regulatory outcome: Variation
Bulgarian
(PDF/117.43 KB)

Croatian
(PDF/116.63 KB)

Czech
(PDF/115.87 KB)

Danish
(PDF/111.88 KB)

Dutch
(PDF/116.92 KB)

Estonian
(PDF/104.88 KB)

Finnish
(PDF/107.84 KB)

French
(PDF/110.04 KB)

German
(PDF/117 KB)

Greek
(PDF/117.23 KB)

Hungarian
(PDF/115.85 KB)

Icelandic
(PDF/115.78 KB)

Italian
(PDF/121.06 KB)

Latvian
(PDF/119.01 KB)

Lithuanian
(PDF/117.38 KB)

Maltese
(PDF/120.27 KB)

Norwegian
(PDF/111.22 KB)

Polish
(PDF/115.82 KB)

Portuguese
(PDF/113.34 KB)

Romanian
(PDF/113.25 KB)

Slovak
(PDF/117.78 KB)

Slovenian
(PDF/115.53 KB)

Spanish
(PDF/114.19 KB)

Swedish
(PDF/112.04 KB)
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) (updated)

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)
List item

Ethosuximide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementatio - PSUSA/00001316/202003 (PDF/115.33 KB)

Last updated: 08/01/2021
Active substance: ethosuximide
Procedure number: PSUSA/00001316/202003
Regulatory outcome: Variation
Bulgarian
(PDF/242.91 KB)

Croatian
(PDF/253.03 KB)

Czech
(PDF/166.53 KB)

Danish
(PDF/201.35 KB)

Dutch
(PDF/174.67 KB)

Estonian
(PDF/203.84 KB)

Finnish
(PDF/173.18 KB)

French
(PDF/183.31 KB)

German
(PDF/189.18 KB)

Greek
(PDF/129.55 KB)

Hungarian
(PDF/213.81 KB)

Icelandic
(PDF/183.39 KB)

Italian
(PDF/232.51 KB)

Latvian
(PDF/150.36 KB)

Lithuanian
(PDF/290.68 KB)

Maltese
(PDF/276.37 KB)

Norwegian
(PDF/180.79 KB)

Polish
(PDF/283.95 KB)

Portuguese
(PDF/199.31 KB)

Romanian
(PDF/283.28 KB)

Slovak
(PDF/261.36 KB)

Slovenian
(PDF/257.15 KB)

Spanish
(PDF/116.86 KB)

Swedish
(PDF/189.81 KB)
List item

Verapamil: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00003105/202001 (PDF/63.26 KB)

Last updated: 03/12/2020
Active substance: verapamil
Procedure number: PSUSA/00003105/202001
Regulatory outcome: Variation
Bulgarian
(PDF/106.65 KB)

Croatian
(PDF/93.32 KB)

Czech
(PDF/94.18 KB)

Danish
(PDF/28.68 KB)

Dutch
(PDF/27.89 KB)

Estonian
(PDF/28.12 KB)

Finnish
(PDF/23.12 KB)

French
(PDF/26.8 KB)

German
(PDF/137.53 KB)

Greek
(PDF/84.96 KB)

Hungarian
(PDF/212.32 KB)

Icelandic
(PDF/27.28 KB)

Italian
(PDF/30.77 KB)

Latvian
(PDF/87.22 KB)

Lithuanian
(PDF/94.3 KB)

Maltese
(PDF/104.07 KB)

Norwegian
(PDF/36 KB)

Polish
(PDF/93.49 KB)

Portuguese
(PDF/24.2 KB)

Romanian
(PDF/94.37 KB)

Slovak
(PDF/97.85 KB)

Slovenian
(PDF/94.08 KB)

Spanish
(PDF/23.53 KB)

Swedish
(PDF/22.93 KB)
List item

Clobetasol: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000799/202002 (PDF/182.55 KB)

Last updated: 26/11/2020
Active substance: clobetasol
Procedure number: PSUSA/00000799/202002
Regulatory outcome: Variation
Bulgarian
(PDF/245.73 KB)

Croatian
(PDF/239.5 KB)

Czech
(PDF/247.35 KB)

Danish
(PDF/184.16 KB)

Dutch
(PDF/182.02 KB)

Estonian
(PDF/182.49 KB)

Finnish
(PDF/175.87 KB)

French
(PDF/185.07 KB)

German
(PDF/171.6 KB)

Greek
(PDF/228.15 KB)

Hungarian
(PDF/247.59 KB)

Icelandic
(PDF/163.66 KB)

Italian
(PDF/191.08 KB)

Latvian
(PDF/244.39 KB)

Lithuanian
(PDF/236.65 KB)

Maltese
(PDF/267.25 KB)

Norwegian
(PDF/166.43 KB)

Polish
(PDF/226.13 KB)

Portuguese
(PDF/160.9 KB)

Romanian
(PDF/253.2 KB)

Slovak
(PDF/249.53 KB)

Slovenian
(PDF/222.54 KB)

Spanish
(PDF/167.35 KB)

Swedish
(PDF/179 KB)
List item

Codeine camphosulphonate / sodium benzoate, codeine camphosulphonate...:CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010542/201912 (PDF/104.05 KB)

Last updated: 10/11/2020
Active substance: codeine camphosulphonate / sodium benzoate, codeine camphosulphonate / sulfogaiacol / grindelia soft extract
Procedure number: PSUSA/00010542/201912
Regulatory outcome: Variation
Bulgarian
(PDF/142.59 KB)

Croatian
(PDF/141.71 KB)

Czech
(PDF/151.09 KB)

Danish
(PDF/128.1 KB)

Dutch
(PDF/129.26 KB)

Estonian
(PDF/125.02 KB)

Finnish
(PDF/125.17 KB)

French
(PDF/128.61 KB)

German
(PDF/131 KB)

Greek
(PDF/145.71 KB)

Hungarian
(PDF/174.58 KB)

Italian
(PDF/130.95 KB)

Latvian
(PDF/148.47 KB)

Lithuanian
(PDF/145.99 KB)

Maltese
(PDF/146.07 KB)

Polish
(PDF/147.63 KB)

Portuguese
(PDF/128.21 KB)

Romanian
(PDF/146.23 KB)

Slovak
(PDF/147.93 KB)

Slovenian
(PDF/141.11 KB)

Spanish
(PDF/127.25 KB)

Swedish
(PDF/127.75 KB)
List item

Bendamustine hydrochloride: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00003162/202001 (PDF/42.14 KB)

Last updated: 10/11/2020
Active substance: bendamustine hydrochloride
Procedure number: PSUSA/00003162/202001
Regulatory outcome: Variation
Bulgarian
(PDF/123.52 KB)

Croatian
(PDF/106.19 KB)

Czech
(PDF/113.58 KB)

Danish
(PDF/67.45 KB)

Dutch
(PDF/65.34 KB)

Estonian
(PDF/68.63 KB)

Finnish
(PDF/66.68 KB)

French
(PDF/40.58 KB)

German
(PDF/142.82 KB)

Greek
(PDF/115.48 KB)

Hungarian
(PDF/112.14 KB)

Icelandic
(PDF/72.12 KB)

Italian
(PDF/58.5 KB)

Latvian
(PDF/113.94 KB)

Lithuanian
(PDF/111.68 KB)

Maltese
(PDF/116.37 KB)

Norwegian
(PDF/64.61 KB)

Polish
(PDF/117.42 KB)

Portuguese
(PDF/67.77 KB)

Romanian
(PDF/109.59 KB)

Slovak
(PDF/112.15 KB)

Slovenian
(PDF/107.48 KB)

Spanish
(PDF/66.72 KB)

Swedish
(PDF/65.82 KB)
List item

Iopamidol: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001771/201912 (PDF/39.36 KB)

Last updated: 06/11/2020
Active substance: iopamidol
Procedure number: PSUSA/00001771/201912
Regulatory outcome: Variation
Bulgarian
(PDF/121.25 KB)

Croatian
(PDF/124.09 KB)

Czech
(PDF/112.55 KB)

Danish
(PDF/170.65 KB)

Dutch
(PDF/36.52 KB)

Estonian
(PDF/253.64 KB)

Finnish
(PDF/37.61 KB)

French
(PDF/38.57 KB)

German
(PDF/38.58 KB)

Greek
(PDF/168.8 KB)

Hungarian
(PDF/107.03 KB)

Italian
(PDF/41.45 KB)

Latvian
(PDF/111.56 KB)

Lithuanian
(PDF/111.63 KB)

Maltese
(PDF/114.97 KB)

Polish
(PDF/116.3 KB)

Portuguese
(PDF/37.42 KB)

Romanian
(PDF/110.41 KB)

Slovak
(PDF/108 KB)

Slovenian
(PDF/108.33 KB)

Spanish
(PDF/38.25 KB)

Swedish
(PDF/172.97 KB)
List item

Phenylephrine (ophthalmic formulations): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010402/202001 (PDF/80.73 KB)

Last updated: 05/11/2020
Active substance: phenylephrine (ophthalmic formulations)
Procedure number: PSUSA/00010402/202001
Regulatory outcome: Variation
(PDF/139.14 KB)

(PDF/83.47 KB)

Bulgarian
(PDF/183.66 KB)

Croatian
(PDF/173.49 KB)

Czech
(PDF/180.25 KB)

Dutch
(PDF/141.12 KB)

Finnish
(PDF/128.24 KB)

French
(PDF/174.93 KB)

German
(PDF/90.14 KB)

Greek
(PDF/179.34 KB)

Hungarian
(PDF/187.76 KB)

Icelandic
(PDF/87.23 KB)

Italian
(PDF/163.87 KB)

Latvian
(PDF/212.36 KB)

Lithuanian
(PDF/176.9 KB)

Maltese
(PDF/188.24 KB)

Norwegian
(PDF/88.27 KB)

Polish
(PDF/183.67 KB)

Portuguese
(PDF/88.96 KB)

Romanian
(PDF/171 KB)

Slovak
(PDF/165.32 KB)

Slovenian
(PDF/174.24 KB)

Spanish
(PDF/191.69 KB)

Swedish
(PDF/87.59 KB)
List item

Levonorgestrel/ethinylestradiol, ethinylestradiol (combination pack): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010442/202001 (PDF/235.48 KB)

Last updated: 04/11/2020
Active substance: levonorgestrel/ethinylestradiol, ethinylestradiol (combination pack)
Procedure number: PSUSA/00010442/202001
Regulatory outcome: Variation
(PDF/182.78 KB)

Bulgarian
(PDF/237.09 KB)

Croatian
(PDF/267.42 KB)

Czech
(PDF/214.41 KB)

Danish
(PDF/193.75 KB)

Dutch
(PDF/184.57 KB)

Estonian
(PDF/193.81 KB)

Finnish
(PDF/148.01 KB)

French
(PDF/201.14 KB)

German
(PDF/215.2 KB)

Greek
(PDF/239.28 KB)

Hungarian
(PDF/270.61 KB)

Italian
(PDF/200.26 KB)

Latvian
(PDF/248.32 KB)

Lithuanian
(PDF/256.13 KB)

Maltese
(PDF/301.16 KB)

Polish
(PDF/248.24 KB)

Portuguese
(PDF/198.75 KB)

Romanian
(PDF/253.09 KB)

Slovak
(PDF/193.08 KB)

Slovenian
(PDF/257.27 KB)

Spanish
(PDF/181.51 KB)
List item

Bacillus clausii multi-antibioresistant spores: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000284/201911 (PDF/95.16 KB)

Last updated: 11/09/2020
Active substance: bacillus clausii multi-antibioresistant spores
Procedure number: PSUSA/00000284/201911
Regulatory outcome: Variation
Bulgarian
(PDF/135.38 KB)

Croatian
(PDF/120.04 KB)

Czech
(PDF/132.37 KB)

Danish
(PDF/102.68 KB)

Dutch
(PDF/101.53 KB)

Estonian
(PDF/98.38 KB)

Finnish
(PDF/100.13 KB)

French
(PDF/102.62 KB)

German
(PDF/116.88 KB)

Greek
(PDF/126.84 KB)

Hungarian
(PDF/135.09 KB)

Italian
(PDF/92.22 KB)

Latvian
(PDF/123.2 KB)

Lithuanian
(PDF/123.72 KB)

Maltese
(PDF/92.65 KB)

Polish
(PDF/117.29 KB)

Portuguese
(PDF/102.92 KB)

Romanian
(PDF/121.72 KB)

Slovak
(PDF/0 bytes)

Slovenian
(PDF/0 bytes)

Spanish
(PDF/103.61 KB)

Swedish
(PDF/0 bytes)
List item

Iron (parenteral preparations, except for iron dextran): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010236/202001 (PDF/27.64 KB)

Last updated: 07/09/2020
Active substance: iron
Procedure number: PSUSA/00010236/202001
Regulatory outcome: Variation
Bulgarian
(PDF/76.13 KB)

Croatian
(PDF/65.09 KB)

Czech
(PDF/59.24 KB)

Danish
(PDF/27.87 KB)

Dutch
(PDF/28.21 KB)

Estonian
(PDF/27.8 KB)

Finnish
(PDF/26.7 KB)

French
(PDF/28.65 KB)

German
(PDF/29.5 KB)

Greek
(PDF/132.29 KB)

Hungarian
(PDF/57.1 KB)

Icelandic
(PDF/27.78 KB)

Italian
(PDF/28.84 KB)

Latvian
(PDF/81.43 KB)

Lithuanian
(PDF/74.33 KB)

Maltese
(PDF/70.47 KB)

Norwegian
(PDF/28.4 KB)

Polish
(PDF/61.32 KB)

Portuguese
(PDF/28.01 KB)

Romanian
(PDF/66.42 KB)

Slovak
(PDF/58.98 KB)

Slovenian
(PDF/65.5 KB)

Spanish
(PDF/28.52 KB)

Swedish
(PDF/27.31 KB)
List item

Opium: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010670/201909 (PDF/51.75 KB)

Last updated: 27/07/2020
Active substance: opium
Procedure number: PSUSA/00010670/201909
Regulatory outcome: Variation
Bulgarian
(PDF/185.71 KB)

Croatian
(PDF/182.64 KB)

Czech
(PDF/186.65 KB)

Danish
(PDF/171.84 KB)

Dutch
(PDF/170.74 KB)

Estonian
(PDF/175.76 KB)

Finnish
(PDF/69.45 KB)

French
(PDF/313.69 KB)

German
(PDF/173.3 KB)

Greek
(PDF/185.52 KB)

Hungarian
(PDF/184.75 KB)

Icelandic
(PDF/173.62 KB)

Italian
(PDF/248.27 KB)

Latvian
(PDF/66.66 KB)

Lithuanian
(PDF/183.75 KB)

Maltese
(PDF/282.14 KB)

Norwegian
(PDF/201.6 KB)

Polish
(PDF/186.25 KB)

Portuguese
(PDF/180.3 KB)

Romanian
(PDF/181.82 KB)

Slovak
(PDF/186.48 KB)

Slovenian
(PDF/179.82 KB)

Spanish
(PDF/179.9 KB)

Swedish
(PDF/69.86 KB)
List item

Pholcodine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002396/201905 (PDF/124.87 KB)

Last updated: 03/04/2020
Active substance: pholcodine
Procedure number: PSUSA/00002396/201905
Regulatory outcome: Variation
(PDF/98.03 KB)

Bulgarian
(PDF/142.38 KB)

Croatian
(PDF/139.94 KB)

Czech
(PDF/151.71 KB)

Danish
(PDF/100.77 KB)

Dutch
(PDF/100.84 KB)

Estonian
(PDF/96.25 KB)

Finnish
(PDF/96.86 KB)

French
(PDF/147.77 KB)

German
(PDF/103.8 KB)

Greek
(PDF/137.46 KB)

Hungarian
(PDF/143.03 KB)

Italian
(PDF/141.23 KB)

Latvian
(PDF/176.43 KB)

Lithuanian
(PDF/141.82 KB)

Maltese
(PDF/147.47 KB)

Polish
(PDF/144.58 KB)

Portuguese
(PDF/98.02 KB)

Romanian
(PDF/137.11 KB)

Slovak
(PDF/147.75 KB)

Slovenian
(PDF/136.05 KB)

Swedish
(PDF/98.22 KB)
List item

Methadone: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002004/201905 (PDF/874.74 KB)

Last updated: 17/03/2020
Active substance: methadone
Procedure number: PSUSA/00002004/201905
Regulatory outcome: Variation
(PDF/896.27 KB)

Bulgarian
(PDF/970.68 KB)

Croatian
(PDF/884.89 KB)

Danish
(PDF/882.99 KB)

Dutch
(PDF/896.23 KB)

Estonian
(PDF/899.15 KB)

Finnish
(PDF/868.54 KB)

French
(PDF/768.29 KB)

German
(PDF/896.19 KB)

Greek
(PDF/880.96 KB)

Hungarian
(PDF/1.02 MB)

Icelandic
(PDF/887.07 KB)

Italian
(PDF/877.03 KB)

Latvian
(PDF/978.01 KB)

Lithuanian
(PDF/890.31 KB)

Maltese
(PDF/203.23 KB)

Norwegian
(PDF/881.57 KB)

Polish
(PDF/844.65 KB)

Portuguese
(PDF/711.59 KB)

Romanian
(PDF/900.19 KB)

Slovak
(PDF/539.87 KB)

Slovenian
(PDF/891.92 KB)

Spanish
(PDF/876.84 KB)

Swedish
(PDF/871.65 KB)
List item

Levomethadone: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001855/201905 (PDF/173.35 KB)

Last updated: 12/03/2020
Active substance: levomethadone
Procedure number: PSUSA/00001855/201905
Regulatory outcome: Variation
Bulgarian
(PDF/211.15 KB)

Croatian
(PDF/146.38 KB)

Czech
(PDF/174.86 KB)

Danish
(PDF/149.81 KB)

Dutch
(PDF/201.83 KB)

Estonian
(PDF/80.37 KB)

Finnish
(PDF/122.48 KB)

French
(PDF/157.53 KB)

German
(PDF/213.2 KB)

Greek
(PDF/196.04 KB)

Hungarian
(PDF/70.5 KB)

Italian
(PDF/180.89 KB)

Latvian
(PDF/174.59 KB)

Lithuanian
(PDF/139.14 KB)

Maltese
(PDF/216.99 KB)

Norwegian
(PDF/111.58 KB)

Polish
(PDF/171.04 KB)

Portuguese
(PDF/187.54 KB)

Romanian
(PDF/299.18 KB)

Slovak
(PDF/211.76 KB)

Slovenian
(PDF/119.71 KB)

Spanish
(PDF/127.22 KB)

Swedish
(PDF/206.23 KB)
List item

Tolperisone: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002991/201906 (PDF/114.31 KB)

Last updated: 11/03/2020
Active substance: tolperisone
Procedure number: PSUSA/00002991/201906
Regulatory outcome: Variation
Bulgarian
(PDF/152.97 KB)

Croatian
(PDF/123.44 KB)

Czech
(PDF/153.98 KB)

Danish
(PDF/168.66 KB)

Dutch
(PDF/89.47 KB)

Estonian
(PDF/142.4 KB)

Finnish
(PDF/115.48 KB)

French
(PDF/154.62 KB)

German
(PDF/158.08 KB)

Greek
(PDF/116.17 KB)

Hungarian
(PDF/155.13 KB)

Italian
(PDF/86.1 KB)

Latvian
(PDF/162.96 KB)

Lithuanian
(PDF/148.93 KB)

Maltese
(PDF/189.77 KB)

Polish
(PDF/129.33 KB)

Portuguese
(PDF/132.98 KB)

Romanian
(PDF/125.1 KB)

Slovak
(PDF/156.63 KB)

Slovenian
(PDF/123.21 KB)

Spanish
(PDF/126.06 KB)

Swedish
(PDF/173.98 KB)
List item

Levonorgestrel: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001856/201905 (PDF/57.75 KB)

Last updated: 10/03/2020
Active substance: levonorgestrel
Procedure number: PSUSA/00001856/201905
Regulatory outcome: Variation
Bulgarian
(PDF/113.71 KB)

Croatian
(PDF/110.67 KB)

Czech
(PDF/112.51 KB)

Danish
(PDF/32.9 KB)

Dutch
(PDF/33.29 KB)

Estonian
(PDF/33.62 KB)

Finnish
(PDF/31.01 KB)

French
(PDF/32.52 KB)

German
(PDF/38.89 KB)

Greek
(PDF/105.06 KB)

Hungarian
(PDF/131.41 KB)

Icelandic
(PDF/30.65 KB)

Italian
(PDF/39.85 KB)

Latvian
(PDF/130.78 KB)

Lithuanian
(PDF/111.08 KB)

Maltese
(PDF/136.55 KB)

Norwegian
(PDF/33.28 KB)

Polish
(PDF/109.36 KB)

Portuguese
(PDF/63.38 KB)

Romanian
(PDF/104.27 KB)

Slovak
(PDF/113.2 KB)

Slovenian
(PDF/103.66 KB)

Spanish
(PDF/63.46 KB)

Swedish
(PDF/38.25 KB)
List item

Isotretinoin (oral formulations): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010488/201905 (PDF/33.27 KB)

Last updated: 20/01/2020
Active substance: isotretinoin
Procedure number: PSUSA/00010488/201905
Regulatory outcome: Variation
Bulgarian
(PDF/109.74 KB)

Croatian
(PDF/89.78 KB)

Czech
(PDF/95.99 KB)

Danish
(PDF/29.82 KB)

Dutch
(PDF/34.4 KB)

Estonian
(PDF/30.63 KB)

Finnish
(PDF/25.65 KB)

French
(PDF/35.4 KB)

German
(PDF/31.93 KB)

Greek
(PDF/83.53 KB)

Hungarian
(PDF/75.61 KB)

Icelandic
(PDF/27.23 KB)

Italian
(PDF/34.48 KB)

Latvian
(PDF/98.49 KB)

Lithuanian
(PDF/92.28 KB)

Maltese
(PDF/58.67 KB)

Norwegian
(PDF/31.59 KB)

Polish
(PDF/117.07 KB)

Portuguese
(PDF/33.58 KB)

Romanian
(PDF/63.38 KB)

Slovak
(PDF/107.12 KB)

Slovenian
(PDF/88.62 KB)

Spanish
(PDF/29.83 KB)

Swedish
(PDF/31.06 KB)
List item

Lisdexamfetamine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010289/201902 (PDF/89.62 KB)

Last updated: 14/01/2020
Active substance: lisdexamfetamine
Procedure number: PSUSA/00010289/201902
Regulatory outcome: Variation
Bulgarian
(PDF/103.64 KB)

Croatian
(PDF/95.66 KB)

Czech
(PDF/94.71 KB)

Danish
(PDF/96.64 KB)

Dutch
(PDF/96.05 KB)

Estonian
(PDF/95.85 KB)

Finnish
(PDF/92.7 KB)

French
(PDF/170.02 KB)

German
(PDF/104.19 KB)

Greek
(PDF/103.33 KB)

Hungarian
(PDF/99.68 KB)

Icelandic
(PDF/103.04 KB)

Italian
(PDF/104.99 KB)

Latvian
(PDF/110.54 KB)

Lithuanian
(PDF/139.24 KB)

Maltese
(PDF/117.65 KB)

Norwegian
(PDF/97.94 KB)

Polish
(PDF/102.35 KB)

Portuguese
(PDF/99.1 KB)

Romanian
(PDF/97.64 KB)

Slovak
(PDF/97.63 KB)

Slovenian
(PDF/92.48 KB)

Spanish
(PDF/98.62 KB)

Swedish
(PDF/96.08 KB)
List item

Erythromycin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001257/201903 (PDF/132.84 KB)

Last updated: 14/01/2020
Active substance: erythromycin
Procedure number: PSUSA/00001257/201903
Regulatory outcome: Variation
Bulgarian
(PDF/157.12 KB)

Croatian
(PDF/170.5 KB)

Czech
(PDF/182.36 KB)

Danish
(PDF/137.19 KB)

Dutch
(PDF/136.82 KB)

Estonian
(PDF/143.49 KB)

Finnish
(PDF/133.61 KB)

French
(PDF/137.98 KB)

German
(PDF/146.21 KB)

Greek
(PDF/155.66 KB)

Hungarian
(PDF/166.04 KB)

Icelandic
(PDF/136.15 KB)

Italian
(PDF/134.88 KB)

Latvian
(PDF/200.57 KB)

Lithuanian
(PDF/166.83 KB)

Maltese
(PDF/170.76 KB)

Norwegian
(PDF/203.85 KB)

Polish
(PDF/162.92 KB)

Portuguese
(PDF/133.56 KB)

Romanian
(PDF/157.35 KB)

Slovak
(PDF/160.3 KB)

Slovenian
(PDF/152.42 KB)

Spanish
(PDF/134.55 KB)

Swedish
(PDF/133.52 KB)
List item

Ezetimibe / simvastatin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001347/201903 (PDF/97.81 KB)

Last updated: 10/01/2020
Active substance: Ezetimibe, simvastatin
Procedure number: PSUSA/00001347/201903
Regulatory outcome: Variation
Bulgarian
(PDF/264.38 KB)

Croatian
(PDF/287.51 KB)

Czech
(PDF/268.23 KB)

Danish
(PDF/217.84 KB)

Dutch
(PDF/225.42 KB)

Estonian
(PDF/218.24 KB)

Finnish
(PDF/216.13 KB)

French
(PDF/231.27 KB)

German
(PDF/228.66 KB)

Greek
(PDF/292.93 KB)

Hungarian
(PDF/280.46 KB)

Icelandic
(PDF/214.75 KB)

Italian
(PDF/218.68 KB)

Latvian
(PDF/230.07 KB)

Lithuanian
(PDF/288.37 KB)

Maltese
(PDF/241.78 KB)

Norwegian
(PDF/196.66 KB)

Polish
(PDF/288.95 KB)

Portuguese
(PDF/219.33 KB)

Romanian
(PDF/308.54 KB)

Slovak
(PDF/275.41 KB)

Slovenian
(PDF/268.09 KB)

Spanish
(PDF/225.75 KB)

Swedish
(PDF/216.94 KB)

324 results

Lidocaine hydrochloride / phenylephrine hydrochloride / tropicamide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010390/202007 (PDF/88.38 KB) (new)

Primidone: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002525/202006 (PDF/213.75 KB) (new)

Xylometazoline: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00003134/202005 (PDF/42.04 KB) (new)

Irinotecan (except for liposomal formulations): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001783/202005 (PDF/108.72 KB)

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) (updated)

Ethosuximide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementatio - PSUSA/00001316/202003 (PDF/115.33 KB)

Verapamil: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00003105/202001 (PDF/63.26 KB)

Clobetasol: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000799/202002 (PDF/182.55 KB)

Codeine camphosulphonate / sodium benzoate, codeine camphosulphonate...:CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010542/201912 (PDF/104.05 KB)

Bendamustine hydrochloride: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00003162/202001 (PDF/42.14 KB)

Iopamidol: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001771/201912 (PDF/39.36 KB)

Phenylephrine (ophthalmic formulations): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010402/202001 (PDF/80.73 KB)

Levonorgestrel/ethinylestradiol, ethinylestradiol (combination pack): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010442/202001 (PDF/235.48 KB)

Bacillus clausii multi-antibioresistant spores: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000284/201911 (PDF/95.16 KB)

Iron (parenteral preparations, except for iron dextran): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010236/202001 (PDF/27.64 KB)

Opium: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010670/201909 (PDF/51.75 KB)

Pholcodine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002396/201905 (PDF/124.87 KB)

Methadone: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002004/201905 (PDF/874.74 KB)

Levomethadone: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001855/201905 (PDF/173.35 KB)

Tolperisone: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002991/201906 (PDF/114.31 KB)

Levonorgestrel: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001856/201905 (PDF/57.75 KB)

Isotretinoin (oral formulations): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010488/201905 (PDF/33.27 KB)

Lisdexamfetamine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010289/201902 (PDF/89.62 KB)

Erythromycin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001257/201903 (PDF/132.84 KB)

Ezetimibe / simvastatin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001347/201903 (PDF/97.81 KB)