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Ezetimibe / rosuvastatin: List of nationally authorised medicinal products - PSUSA/00010271/202007 (PDF/904.23 KB)

authorised medicinal products - PSUSA/00010271/202007 … authorised medicinal products - PSUSA/00010271/202007 EMA/259778/2021 11/05/2021 … rosuvastatin Procedure No.: PSUSA/00010271/202007 EMA/259778/2021 …

Last updated: 11/05/2021
Active substance: Ezetimibe, Rosuvastatin
Procedure number: PSUSA/00010271/202007
Regulatory outcome: Variation
List item

Ezetimibe / rosuvastatin: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010271/202007 (PDF/128.84 KB)

for the implementation - PSUSA/00010271/202007 … for the implementation - PSUSA/00010271/202007 Other languages: bg cs da …

Last updated: 11/05/2021
Active substance: Ezetimibe, Rosuvastatin
Procedure number: PSUSA/00010271/202007
Regulatory outcome: Variation
Bulgarian
(PDF/111.32 KB)

Croatian
(PDF/193.12 KB)

Czech
(PDF/151.95 KB)

Danish
(PDF/188.71 KB)

Dutch
(PDF/136.03 KB)

Estonian
(PDF/65.76 KB)

Finnish
(PDF/182.32 KB)

French
(PDF/102.93 KB)

German
(PDF/227.67 KB)

Greek
(PDF/257.75 KB)

Hungarian
(PDF/51.68 KB)

Italian
(PDF/23.21 KB)

Latvian
(PDF/126.73 KB)

Lithuanian
(PDF/143.8 KB)

Maltese
(PDF/272.11 KB)

Norwegian
(PDF/48.06 KB)

Polish
(PDF/226.61 KB)

Portuguese
(PDF/121.92 KB)

Romanian
(PDF/139.38 KB)

Slovak
(PDF/146 KB)

Slovenian
(PDF/107.72 KB)

Spanish
(PDF/50.96 KB)

Swedish
(PDF/51.31 KB)
List item

Ezetimibe / rosuvastatin: List of nationally authorised medicinal products - PSUSA/00010271/201707 (PDF/157.54 KB)

authorised medicinal products - PSUSA/00010271/201707 … authorised medicinal products - PSUSA/00010271/201707 EMA/267099/2018 02/05/2018 … authorised medicinal products - PSUSA/00010271/201707 30 Churchill Place …

Last updated: 02/05/2018
Active substance: Ezetimibe, Rosuvastatin
Procedure number: PSUSA/00010271/201707
Regulatory outcome: Variation
List item

Ezetimibe / rosuvastatin: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010271/201707 (PDF/93.23 KB)

for the implementation - PSUSA/00010271/201707 … for the implementation - PSUSA/00010271/201707 Other languages: bg es cs … for the implementation - PSUSA/00010271/201707 1 …

Last updated: 07/05/2018
Active substance: Ezetimibe, Rosuvastatin
Procedure number: PSUSA/00010271/201707
Regulatory outcome: Variation
Bulgarian
(PDF/97.5 KB)

Croatian
(PDF/93.27 KB)

Czech
(PDF/89.84 KB)

Danish
(PDF/94.33 KB)

Dutch
(PDF/102.39 KB)

Estonian
(PDF/90.85 KB)

Finnish
(PDF/93.81 KB)

French
(PDF/95.96 KB)

German
(PDF/97.27 KB)

Greek
(PDF/98.22 KB)

Hungarian
(PDF/100.66 KB)

Italian
(PDF/92.1 KB)

Latvian
(PDF/124.32 KB)

Lithuanian
(PDF/123.87 KB)

Maltese
(PDF/104.44 KB)

Norwegian
(PDF/92.67 KB)

Polish
(PDF/103.37 KB)

Portuguese
(PDF/94.88 KB)

Romanian
(PDF/92.09 KB)

Slovak
(PDF/95.41 KB)

Slovenian
(PDF/94.25 KB)

Spanish
(PDF/121.03 KB)

Swedish
(PDF/92.89 KB)
List item

Epinephrine: List of nationally authorised medicinal products - PSUSA/00001232/202007 (PDF/304.96 KB)

authorised medicinal products - PSUSA/00001232/202007 … authorised medicinal products - PSUSA/00001232/202007 30/04/2021 List of nationally … epinephrine Procedure no.: PSUSA/00001232/202007 List of nationally …

Last updated: 30/04/2021
Active substance: epinephrine
Procedure number: PSUSA/00001232/202007
Regulatory outcome: Maintenance
List item

Imipramine : List of nationally authorised medicinal products - PSUSA/00001728/202007 (PDF/114.08 KB)

authorised medicinal products - PSUSA/00001728/202007 … authorised medicinal products - PSUSA/00001728/202007 EMA/146463/2021 15/03/2021 … Imipramine Procedure no.: PSUSA/00001728/202007 List of nationally …

Last updated: 15/03/2021
Active substance: imipramine
Procedure number: PSUSA/00001728/202007
Regulatory outcome: Maintenance
List item

Ziprasidone: List of nationally authorised medicinal products - PSUSA/00003146/202007 (PDF/258.44 KB)

authorised medicinal products - PSUSA/00003146/202007 … authorised medicinal products - PSUSA/00003146/202007 EMA/166520/2021 18/03/2021 … ziprasidone Procedure no.: PSUSA/00003146/202007 List of nationally …

Last updated: 18/03/2021
Active substance: ziprasidone
Procedure number: PSUSA/00003146/202007
Regulatory outcome: Maintenance
List item

Fenofibrate : List of nationally authorised medicinal products - PSUSA/00001362/202007 (PDF/239.43 KB)

authorised medicinal products - PSUSA/00001362/202007 … authorised medicinal products - PSUSA/00001362/202007 EMA/353788/2021Adopted 23/06 … fenofibrate Procedure no.: PSUSA/00001362/202007 List of nationally …

Last updated: 23/06/2021
Active substance: fenofibrate
Procedure number: PSUSA/00001362/202007
Regulatory outcome: Maintenance
List item

Octenidine: List of nationally authorised medicinal products - PSUSA/00010748/202007 (PDF/122.55 KB)

authorised medicinal products - PSUSA/00010748/202007 … authorised medicinal products - PSUSA/00010748/202007 EMA/101365/2021 19/02/2021 … octenidine Procedure no.: PSUSA/00010748/202007 List of nationally …

Last updated: 19/02/2021
Active substance: octenidine
Procedure number: PSUSA/00010748/202007
Regulatory outcome: Maintenance
List item

Indometacin: List of nationally authorised medicinal products - PSUSA/00001738/202007 (PDF/154.88 KB)

authorised medicinal products - PSUSA/00001738/202007 … authorised medicinal products - PSUSA/00001738/202007 EMA/146401/2021 16/03/2021 … indometacin Procedure no.: PSUSA/00001738/202007 List of nationally …

Last updated: 16/03/2021
Active substance: indometacin
Procedure number: PSUSA/00001738/202007
Regulatory outcome: Maintenance
List item

Ifosfamide: List of nationally authorised medicinal products - PSUSA/00001723/202007 (PDF/171.47 KB)

authorised medicinal products - PSUSA/00001723/202007 … authorised medicinal products - PSUSA/00001723/202007 EMA/156149/2021 16/03/2021 … ifosfamide Procedure no.: PSUSA/00001723/202007 List of nationally …

Last updated: 16/03/2021
Active substance: ifosfamide
Procedure number: PSUSA/00001723/202007
Regulatory outcome: Maintenance
List item

Cisatracurium: List of nationally authorised medicinal products - PSUSA/00000777/202007 (PDF/380.03 KB)

authorised medicinal products - PSUSA/00000777/202007 … authorised medicinal products - PSUSA/00000777/202007 EMA/145847/2021 30/04/2021 … cisatracurium Procedure no.: PSUSA/00000777/202007 List of nationally …

Last updated: 30/04/2021
Active substance: cisatracurium
Procedure number: PSUSA/00000777/202007
Regulatory outcome: Variation
List item

Dexamfetamine: List of nationally authorised medicinal products - PSUSA/00001307/202007 (PDF/122.74 KB)

authorised medicinal products - PSUSA/00001307/202007 … authorised medicinal products - PSUSA/00001307/202007 EMA/214158/2021 19/04/2021 … dexamfetamine Procedure no.: PSUSA/00000986/202009 List of nationally …

Last updated: 19/04/2021
Active substance: dexamfetamine
Procedure number: PSUSA/00000986/202009
Regulatory outcome: Maintenance
List item

Lidocaine hydrochloride / phenylephrine hydrochloride / tropicamide: List of nationally authorised medicinal products - PSUSA/00010390/202007 (PDF/151.62 KB)

authorised medicinal products - PSUSA/00010390/202007 … authorised medicinal products - PSUSA/00010390/202007 … tropicamide Procedure no.: PSUSA/00010390/202007 List of nationally …

Last updated: 07/04/2021
Active substance: lidocaine hydrochloride, phenylephrine hydrochloride, Tropicamide
Procedure number: PSUSA/00010390/202007
Regulatory outcome: Variation
List item

Dimetindene / phenylephrine: List of nationally authorised medicinal products - PSUSA/00001102/202007 (PDF/209.07 KB)

authorised medicinal products - PSUSA/00001102/202007 … authorised medicinal products - PSUSA/00001102/202007 30/04/2021 List of nationally … phenylephrine Procedure no.: PSUSA/00001102/202007 List of nationally …

Last updated: 30/04/2021
Active substance: Dimetindene, phenylephrine
Procedure number: PSUSA/00001102/202007
Regulatory outcome: Maintenance
List item

Betula verrucosa: List of nationally authorised medicinal products - PSUSA/00010815/202007 (PDF/177.57 KB)

authorised medicinal products - PSUSA/00010815/202007 … authorised medicinal products - PSUSA/00010815/202007 30/04/2021 … tablet) Procedure no.: PSUSA/00010815/202007 List of nationally …

Last updated: 30/04/2021
Active substance: Betula verrucosa
Procedure number: PSUSA/00010815/202007
Regulatory outcome: Maintenance
List item

Escherichia coli lysate : List of nationally authorised medicinal products - PSUSA/00001263/202007 (PDF/176.54 KB)

authorised medicinal products - PSUSA/00001263/202007 … authorised medicinal products - PSUSA/00001263/202007 EMA/45518/2021 15/03/2021 … coli lysate Procedure no.: PSUSA/00001263/202007 List of nationally …

Last updated: 15/03/2021
Active substance: escherichia coli lysate
Procedure number: PSUSA/00001263/202007
Regulatory outcome: Maintenance
List item

Aciclovir / hydrocortisone: List of nationally authorised medicinal products - PSUSA/00009004/202007 (PDF/115.57 KB)

authorised medicinal products - PSUSA/00009004/202007 … authorised medicinal products - PSUSA/00009004/202007 EMA/260351/2021 11/05/2021 … hydrocortisone Procedure no.: PSUSA/00009004/202007 List of nationally …

Last updated: 11/05/2021
Active substance: Aciclovir, hydrocortisone
Procedure number: PSUSA/00009004/202007
Regulatory outcome: Maintenance
List item

Indium (111In) pentetate : List of nationally authorised medicinal products - PSUSA/00009191/202007 (PDF/122.34 KB)

authorised medicinal products - PSUSA/00009191/202007 … authorised medicinal products - PSUSA/00009191/202007 EMA/159423/2021 15/03/2021 … pentetate Procedure no.: PSUSA/00009191/202007 List of nationally …

Last updated: 15/03/2021
Active substance: indium (111In) pentetate
Procedure number: PSUSA/00009191/202007
Regulatory outcome: Maintenance
List item

Ibuprofen / levomenthol: List of nationally authorised medicinal products - PSUSA/00001708/202007 (PDF/126.99 KB)

authorised medicinal products - PSUSA/00001708/202007 … authorised medicinal products - PSUSA/00001708/202007 EMA/252267/2021 05/05/2021 … levomenthol Procedure no.: PSUSA/00001708/202007 List of nationally …

Last updated: 05/05/2021
Active substance: Ibuprofen, Levomenthol
Procedure number: PSUSA/00001708/202007
Regulatory outcome: Variation
List item

Indium (111In) pentetreotide: List of nationally authorised medicinal products - PSUSA/00009192/202007 (PDF/120.61 KB)

authorised medicinal products - PSUSA/00009192/202007 … authorised medicinal products - PSUSA/00009192/202007 EMA/145095/2021 17/03/2021 … pentetreotide Procedure no.: PSUSA/00009192/202007 List of nationally …

Last updated: 17/03/2021
Active substance: indium (111In) pentetreotide
Procedure number: PSUSA/00009192/202007
Regulatory outcome: Maintenance
List item

Ethinylestradiol / etonogestrel: List of nationally authorised medicinal products - PSUSA/00001307/202007 (PDF/172.01 KB)

authorised medicinal products - PSUSA/00001307/202007 … authorised medicinal products - PSUSA/00001307/202007 EMA/211776/2021 15/04/2021 … etonogestrel Procedure No.: PSUSA/00001307/202007 EMA/211776/2021 …

Last updated: 15/04/2021
Active substance: ethinylestradiol, etonogestrel
Procedure number: PSUSA/00001307/202007
Regulatory outcome: Variation
List item

Ibuprofen / pseudoephedrine: List of nationally authorised medicinal products - PSUSA/00001711/202007 (PDF/405.14 KB)

authorised medicinal products - PSUSA/00001711/202007 … authorised medicinal products - PSUSA/00001711/202007 EMA/96159/2021 17/02/2021 … pseudoephedrine Procedure no.: PSUSA/00001711/202007 List of nationally …

Last updated: 17/02/2021
Active substance: Ibuprofen, pseudoephedrine
Procedure number: PSUSA/00001711/202007
Regulatory outcome: Maintenance
List item

Glyceryl trinitrate : List of nationally authorised medicinal products - PSUSA/00001552/202007 (PDF/325.73 KB)

authorised medicinal products - PSUSA/00001552/202007 … authorised medicinal products - PSUSA/00001552/202007 EMA/158016/2021 15/03/2021 … trinitrate Procedure no.: PSUSA/00001552/202007 List of nationally …

Last updated: 15/03/2021
Active substance: glyceryl trinitrate
Procedure number: PSUSA/00001552/202007
Regulatory outcome: Maintenance
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)

for the implementation - PSUSA/00010390/202007 … for the implementation - PSUSA/00010390/202007 …

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)

3691 results

Ezetimibe / rosuvastatin: List of nationally authorised medicinal products - PSUSA/00010271/202007 (PDF/904.23 KB)

Ezetimibe / rosuvastatin: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010271/202007 (PDF/128.84 KB)

Ezetimibe / rosuvastatin: List of nationally authorised medicinal products - PSUSA/00010271/201707 (PDF/157.54 KB)

Ezetimibe / rosuvastatin: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010271/201707 (PDF/93.23 KB)

Epinephrine: List of nationally authorised medicinal products - PSUSA/00001232/202007 (PDF/304.96 KB)

Imipramine : List of nationally authorised medicinal products - PSUSA/00001728/202007 (PDF/114.08 KB)

Ziprasidone: List of nationally authorised medicinal products - PSUSA/00003146/202007 (PDF/258.44 KB)

Fenofibrate : List of nationally authorised medicinal products - PSUSA/00001362/202007 (PDF/239.43 KB)

Octenidine: List of nationally authorised medicinal products - PSUSA/00010748/202007 (PDF/122.55 KB)

Indometacin: List of nationally authorised medicinal products - PSUSA/00001738/202007 (PDF/154.88 KB)

Ifosfamide: List of nationally authorised medicinal products - PSUSA/00001723/202007 (PDF/171.47 KB)

Cisatracurium: List of nationally authorised medicinal products - PSUSA/00000777/202007 (PDF/380.03 KB)

Dexamfetamine: List of nationally authorised medicinal products - PSUSA/00001307/202007 (PDF/122.74 KB)

Lidocaine hydrochloride / phenylephrine hydrochloride / tropicamide: List of nationally authorised medicinal products - PSUSA/00010390/202007 (PDF/151.62 KB)

Dimetindene / phenylephrine: List of nationally authorised medicinal products - PSUSA/00001102/202007 (PDF/209.07 KB)

Betula verrucosa: List of nationally authorised medicinal products - PSUSA/00010815/202007 (PDF/177.57 KB)

Escherichia coli lysate : List of nationally authorised medicinal products - PSUSA/00001263/202007 (PDF/176.54 KB)

Aciclovir / hydrocortisone: List of nationally authorised medicinal products - PSUSA/00009004/202007 (PDF/115.57 KB)

Indium (111In) pentetate : List of nationally authorised medicinal products - PSUSA/00009191/202007 (PDF/122.34 KB)

Ibuprofen / levomenthol: List of nationally authorised medicinal products - PSUSA/00001708/202007 (PDF/126.99 KB)

Indium (111In) pentetreotide: List of nationally authorised medicinal products - PSUSA/00009192/202007 (PDF/120.61 KB)

Ethinylestradiol / etonogestrel: List of nationally authorised medicinal products - PSUSA/00001307/202007 (PDF/172.01 KB)

Ibuprofen / pseudoephedrine: List of nationally authorised medicinal products - PSUSA/00001711/202007 (PDF/405.14 KB)

Glyceryl trinitrate : List of nationally authorised medicinal products - PSUSA/00001552/202007 (PDF/325.73 KB)

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)