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Diclofenac (systemic formulations) : List of nationally authorised medicinal products - PSUSA/00001048/202109 (PDF/605.95 KB)

authorised medicinal products - PSUSA/00001048/202109 … authorised medicinal products - PSUSA/00001048/202109 … formulations) Procedure No. PSUSA/00001048/202109 http://www.ema.europa.eu/how-to-find-us http://www.ema.europa.eu/contact …

Last updated: 08/08/2022
Active substance: diclofenac
Procedure number: PSUSA/00001048/202109
Regulatory outcome: Variation
List item

Diclofenac (systemic formulations) : Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s) - PSUSA/00001048/202109 (PDF/130.68 KB)

Marketing Authorisation(s) - PSUSA/00001048/202109 … Marketing Authorisation(s) - PSUSA/00001048/202109 …

Last updated: 08/08/2022
Active substance: diclofenac
Procedure number: PSUSA/00001048/202109
Regulatory outcome: Variation
Bulgarian
(PDF/150.99 KB)

Croatian
(PDF/153.41 KB)

Czech
(PDF/170.32 KB)

Danish
(PDF/123.31 KB)

Dutch
(PDF/114.2 KB)

Estonian
(PDF/121.81 KB)

Finnish
(PDF/111.8 KB)

French
(PDF/138.36 KB)

German
(PDF/128.04 KB)

Greek
(PDF/136.41 KB)

Hungarian
(PDF/150.82 KB)

Icelandic
(PDF/137.76 KB)

Italian
(PDF/171.11 KB)

Latvian
(PDF/174.83 KB)

Lithuanian
(PDF/153.2 KB)

Maltese
(PDF/143.1 KB)

Norwegian
(PDF/200.84 KB)

Polish
(PDF/155.97 KB)

Portuguese
(PDF/123.92 KB)

Romanian
(PDF/133.34 KB)

Slovak
(PDF/135.09 KB)

Slovenian
(PDF/151.41 KB)

Spanish
(PDF/132.78 KB)

Swedish
(PDF/112.59 KB)
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Diclofenac (systemic formulations): List of nationally authorised medicinal products - PSUSA/00001048/201509 (PDF/313.58 KB)

authorised medicinal products - PSUSA/00001048/201509 … authorised medicinal products - PSUSA/00001048/201509 … formulations) Procedure No.: PSUSA/00001048/201509 List of nationally …

Last updated: 17/10/2016
Active substance: diclofenac
Procedure number: PSUSA/00001048/201509
Regulatory outcome: Variation
List item

Diclofenac (systemic formulations): List of nationally authorised medicinal products - PSUSA/00001048/201809 (PDF/439.8 KB)

authorised medicinal products - PSUSA/00001048/201809 … authorised medicinal products - PSUSA/00001048/201809 …

Last updated: 31/07/2019
Active substance: diclofenac
Procedure number: PSUSA/00001048/201809
Regulatory outcome: Variation
List item

Diclofenac (systemic formulations): CMDh Scientific conclusions and grounds for the variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001048/201509 (PDF/941.82 KB)

for the implementation - PSUSA/00001048/201509 … for the implementation - PSUSA/00001048/201509 … formulations) Procedure No.: PSUSA/00001048/201509 2 …

Last updated: 17/10/2016
Active substance: diclofenac
Procedure number: PSUSA/00001048/201509
Regulatory outcome: Variation
List item

Diclofenac (systemic formulations): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001048/201809 (PDF/40.14 KB)

for the implementation - PSUSA/00001048/201809 … for the implementation - PSUSA/00001048/201809 …

Last updated: 31/07/2019
Active substance: diclofenac
Procedure number: PSUSA/00001048/201809
Regulatory outcome: Variation
Bulgarian
(PDF/71.99 KB)

Croatian
(PDF/63.74 KB)

Czech
(PDF/68.46 KB)

Danish
(PDF/37.41 KB)

Dutch
(PDF/38.54 KB)

Estonian
(PDF/37.77 KB)

Finnish
(PDF/37.7 KB)

French
(PDF/39.26 KB)

German
(PDF/39.79 KB)

Greek
(PDF/72.52 KB)

Hungarian
(PDF/63.94 KB)

Icelandic
(PDF/39.56 KB)

Italian
(PDF/39.03 KB)

Latvian
(PDF/66.35 KB)

Lithuanian
(PDF/68.72 KB)

Maltese
(PDF/70.43 KB)

Norwegian
(PDF/37.71 KB)

Polish
(PDF/69.95 KB)

Portuguese
(PDF/38.34 KB)

Romanian
(PDF/66.36 KB)

Slovak
(PDF/68.76 KB)

Slovenian
(PDF/64.81 KB)

Spanish
(PDF/38.38 KB)

Swedish
(PDF/37.91 KB)
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Zidovudine - List of nationally authorised medicinal products - PSUSA/00003143/202109 (PDF/105.83 KB)

authorised medicinal products - PSUSA/00003143/202109 … authorised medicinal products - PSUSA/00003143/202109 EMA/95633/2022 05/07/2022 … zidovudine Procedure no.: PSUSA/00003143/202109 List of nationally …

Last updated: 05/07/2022
Active substance: zidovudine
Procedure number: PSUSA/00003143/202109
Regulatory outcome: Maintenance
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Alfentanil : List of nationally authorised medicinal products - PSUSA/00000082/202109 (PDF/149.41 KB)

authorised medicinal products - PSUSA/00000082/202109 … authorised medicinal products - PSUSA/00000082/202109 EMA/PRAC/596144/2022 22/06/20 … alfentanil Procedure No. PSUSA/00000082/202109 http://www.ema.europa.eu/how-to-find-us http://www.ema.europa.eu/contact …

Last updated: 22/06/2022
Active substance: alfentanil
Procedure number: PSUSA/00000082/202109
Regulatory outcome: Variation
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Opium : List of nationally authorised medicinal products - PSUSA/00010670/202109 (PDF/133.03 KB)

authorised medicinal products - PSUSA/00010670/202109 … authorised medicinal products - PSUSA/00010670/202109 EMA/254662/2022 10/05/2022 … substance: opium Procedure no.: PSUSA/00010670/202109 List of nationally …

Last updated: 10/05/2022
Active substance: opium
Procedure number: PSUSA/00010670/202109
Regulatory outcome: Maintenance
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Dexamfetamine : List of nationally authorised medicinal products - PSUSA/00000986/202109 (PDF/157.25 KB)

authorised medicinal products - PSUSA/00000986/202109 … authorised medicinal products - PSUSA/00000986/202109 EMA/560257/2022 31/05/2022 … dexamfetamine Procedure No. PSUSA/00000986/202109 http://www.ema.europa.eu/how-to-find-us http://www.ema.europa.eu/contact …

Last updated: 31/05/2022
Active substance: dexamfetamine
Procedure number: PSUSA/00000986/202109
Regulatory outcome: Variation
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Etonogestrel : List of nationally authorised medicinal products - PSUSA/00001331/202109 (PDF/216.14 KB)

authorised medicinal products - PSUSA/00001331/202109 … authorised medicinal products - PSUSA/00001331/202109 EMA/569364/2022 07/06/2022 … etonogestrel Procedure no.: PSUSA/00001331/202109 List of nationally …

Last updated: 07/06/2022
Active substance: etonogestrel
Procedure number: PSUSA/00001331/202109
Regulatory outcome: Variation
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Diclofenac / omeprazole : List of nationally authorised medicinal products - PSUSA/00010461/202109 (PDF/176.47 KB)

authorised medicinal products - PSUSA/00010461/202109 … authorised medicinal products - PSUSA/00010461/202109 … omeprazole Procedure No. PSUSA/00010461/202109 http://www.ema.europa.eu/how-to-find-us http://www.ema.europa.eu/contact …

Last updated: 16/06/2022
Active substance: diclofenac, omeprazole
Procedure number: PSUSA/00010461/202109
Regulatory outcome: Maintenance
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Phloroglucinol, phloroglucinol/trimethylphloroglucinol : List of nationally authorised medicinal products - PSUSA/00010355/202109 (PDF/182.76 KB)

authorised medicinal products - PSUSA/00010355/202109 … authorised medicinal products - PSUSA/00010355/202109 EMA/579234/2022 13/06/2022 … phloroglucinol/trimethylphloroglucinol Procedure no.: PSUSA/00010355/202109 List of nationally …

Last updated: 13/06/2022
Active substance: phloroglucinol, trimethylphloroglucinol
Procedure number: PSUSA/00010355/202109
Regulatory outcome: Maintenance
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Carmustine (implant) : List of nationally authorised medicinal products - PSUSA/00010348/202109 (PDF/157.22 KB)

authorised medicinal products - PSUSA/00010348/202109 … authorised medicinal products - PSUSA/00010348/202109 EMA/382258/2015 12/07/2022 … implant) Procedure no.: PSUSA/00010348/202109 List of nationally …

Last updated: 12/07/2022
Active substance: carmustine
Procedure number: PSUSA/00010348/202109
Regulatory outcome: Maintenance
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Brimonidine/timolol : List of nationally authorised medicinal products - PSUSA/00000431/202109 (PDF/171.43 KB)

authorised medicinal products - PSUSA/00000431/202109 … authorised medicinal products - PSUSA/00000431/202109 EMA/591702/2022 16/06/2022 … brimonidine/timolol Procedure no.: PSUSA/00000431/202109 List of nationally …

Last updated: 16/06/2022
Active substance: brimonidine, timolol
Procedure number: PSUSA/00000431/202109
Regulatory outcome: Maintenance
List item

Isopropyl alcohol / propyl alcohol / mecetronium ethyl sulfate : List of nationally authorised medicinal products - PSUSA/00010108/202109 (PDF/101.54 KB)

authorised medicinal products - PSUSA/00010108/202109 … authorised medicinal products - PSUSA/00010108/202109 EMA/95623/2022 05/07/2022 … sulfate Procedure no.: PSUSA/00010108/202109 List of nationally …

Last updated: 05/07/2022
Active substance: isopropyl alcohol, propyl alcohol, mecetronium ethyl sulfate
Procedure number: PSUSA/00010108/202109
Regulatory outcome: Maintenance
List item

Tuberculin purified protein derivative : List of nationally authorised medicinal products - PSUSA/00003063/202109 (PDF/205.91 KB)

authorised medicinal products - PSUSA/00003063/202109 … authorised medicinal products - PSUSA/00003063/202109 EMA/75501/2022 20/04/2022 … derivative Procedure no.: PSUSA/00003063/202109 List of nationally …

Last updated: 20/04/2022
Active substance: Tuberculin purified protein derivative
Procedure number: PSUSA/00003063/202109
Regulatory outcome: Maintenance
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Brimonidine (except for the centrally authorised product) : List of nationally authorised medicinal products - PSUSA/00000430/202109 (PDF/327.04 KB)

authorised medicinal products - PSUSA/00000430/202109 … authorised medicinal products - PSUSA/00000430/202109 EMA/382258/2015 16/06/2022 … product) Procedure no.: PSUSA/00000430/202109 List of nationally …

Last updated: 16/06/2022
Active substance: brimonidine
Procedure number: PSUSA/00000430/202109
Regulatory outcome: Maintenance
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Tolterodine : List of nationally authorised medicinal products - PSUSA 00002993 202109 (PDF/607.83 KB)

authorised medicinal products - PSUSA 00002993 202109 … authorised medicinal products - PSUSA 00002993 202109 EMA/267394/2022 12/05/2022 … tolterodine Procedure no.: PSUSA 00002993 202109 List of nationally …

Last updated: 12/05/2022
Active substance: tolterodine
Procedure number: PSUSA-00002993-202109
Regulatory outcome: Maintenance
List item

Dexamfetamine : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000986/202109 (PDF/121.66 KB)

for the implementation - PSUSA/00000986/202109 … for the implementation - PSUSA/00000986/202109 Other languages: et fi fr … sk sl sv bg cs da de el es PSUSA/00000986/202109 31/05/2022 …

Last updated: 31/05/2022
Active substance: dexamfetamine
Procedure number: PSUSA/00000986/202109
Regulatory outcome: Variation
Bulgarian
(PDF/175.24 KB)

Croatian
(PDF/199.13 KB)

Czech
(PDF/205.72 KB)

Danish
(PDF/150.12 KB)

Dutch
(PDF/171.27 KB)

Estonian
(PDF/140.25 KB)

Finnish
(PDF/135.51 KB)

French
(PDF/138.65 KB)

German
(PDF/141.43 KB)

Greek
(PDF/166.86 KB)

Hungarian
(PDF/190.51 KB)

Icelandic
(PDF/225.94 KB)

Italian
(PDF/180.52 KB)

Latvian
(PDF/170.53 KB)

Lithuanian
(PDF/212.28 KB)

Maltese
(PDF/200.96 KB)

Norwegian
(PDF/206.6 KB)

Polish
(PDF/171.41 KB)

Portuguese
(PDF/154.54 KB)

Romanian
(PDF/214.82 KB)

Slovak
(PDF/182.94 KB)

Slovenian
(PDF/153.52 KB)

Spanish
(PDF/173.84 KB)

Swedish
(PDF/133.26 KB)
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Allergen for therapy: Dermatophagoides pteronyssinus / Dermatophagoides farina (oromucosal use, products authorised via mutually recognition procedure and decentralised procedure) : List of nationally authorised medicinal products - PSUSA/00010582/202109 (PDF/332.46 KB)

authorised medicinal products - PSUSA/00010582/202109 … authorised medicinal products - PSUSA/00010582/202109 EMA/210096/2022 07/04/2022 … procedure) Procedure no.: PSUSA/00010582/202109 List of nationally …

Last updated: 07/04/2022
Active substance: Dermatophagoides pteronyssinus, Dermatophagoides farina
Procedure number: PSUSA/00010582/202109
Regulatory outcome: Maintenance
List item

Etonogestrel : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001331/202109 (PDF/87.37 KB)

for the implementation - PSUSA/00001331/202109 … for the implementation - PSUSA/00001331/202109 Other languages: fr hr hu …

Last updated: 07/06/2022
Active substance: etonogestrel
Procedure number: PSUSA/00001331/202109
Regulatory outcome: Variation
Bulgarian
(PDF/140.19 KB)

Croatian
(PDF/148.38 KB)

Czech
(PDF/155.11 KB)

Danish
(PDF/142.29 KB)

Dutch
(PDF/130.5 KB)

Estonian
(PDF/140.01 KB)

Finnish
(PDF/47.08 KB)

French
(PDF/164.2 KB)

German
(PDF/62.34 KB)

Greek
(PDF/156.5 KB)

Hungarian
(PDF/133.55 KB)

Icelandic
(PDF/147.42 KB)

Italian
(PDF/128.27 KB)

Latvian
(PDF/192.43 KB)

Lithuanian
(PDF/175.7 KB)

Maltese
(PDF/128.25 KB)

Norwegian
(PDF/86.97 KB)

Polish
(PDF/125.04 KB)

Portuguese
(PDF/159.06 KB)

Romanian
(PDF/141.69 KB)

Slovak
(PDF/100.09 KB)

Slovenian
(PDF/192.25 KB)

Spanish
(PDF/123.82 KB)

Swedish
(PDF/122.86 KB)
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Alfentanil : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000082/202109 (PDF/141.59 KB)

for the implementation - PSUSA/00000082/202109 … for the implementation - PSUSA/00000082/202109 Other languages: nl lt bg …

Last updated: 22/06/2022
Active substance: alfentanil
Procedure number: PSUSA/00000082/202109
Regulatory outcome: Variation
Bulgarian
(PDF/208.54 KB)

Croatian
(PDF/217.81 KB)

Czech
(PDF/212.01 KB)

Danish
(PDF/188.47 KB)

Dutch
(PDF/192.33 KB)

Estonian
(PDF/186.23 KB)

Finnish
(PDF/188.67 KB)

French
(PDF/190.94 KB)

German
(PDF/193.93 KB)

Greek
(PDF/207.29 KB)

Hungarian
(PDF/212.23 KB)

Italian
(PDF/208.74 KB)

Latvian
(PDF/225.33 KB)

Lithuanian
(PDF/216.03 KB)

Maltese
(PDF/219.33 KB)

Norwegian
(PDF/188.41 KB)

Polish
(PDF/211.62 KB)

Portuguese
(PDF/189.34 KB)

Romanian
(PDF/209.38 KB)

Slovak
(PDF/210.45 KB)

Slovenian
(PDF/203.58 KB)

Spanish
(PDF/196.66 KB)

Swedish
(PDF/190.8 KB)
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Tramadol: List of nationally authorised medicinal products - PSUSA/00003002/202005 (PDF/2.3 MB)

authorised medicinal products - PSUSA/00003002/202005 … authorised medicinal products - PSUSA/00003002/202005 EMA/270645/2015 10/03/2021 … tramadol Procedure no.: PSUSA/00003002/202005 List of nationally …

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

Atorvastatin: List of nationally authorised medicinal products - PSUSA/00010347/201710 (PDF/885.03 KB)

authorised medicinal products - PSUSA/00010347/201710 … authorised medicinal products - PSUSA/00010347/201710 … atorvastatin Procedure No.: PSUSA/00010347/201710 EMA/PRAC/384956/2018 …

Last updated: 13/08/2018
Active substance: atorvastatin
Procedure number: PSUSA/00010347/201710
Regulatory outcome: Variation

2359 results

Diclofenac (systemic formulations) : List of nationally authorised medicinal products - PSUSA/00001048/202109 (PDF/605.95 KB)

Diclofenac (systemic formulations) : Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s) - PSUSA/00001048/202109 (PDF/130.68 KB)

Diclofenac (systemic formulations): List of nationally authorised medicinal products - PSUSA/00001048/201509 (PDF/313.58 KB)

Diclofenac (systemic formulations): List of nationally authorised medicinal products - PSUSA/00001048/201809 (PDF/439.8 KB)

Diclofenac (systemic formulations): CMDh Scientific conclusions and grounds for the variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001048/201509 (PDF/941.82 KB)

Diclofenac (systemic formulations): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001048/201809 (PDF/40.14 KB)

Zidovudine - List of nationally authorised medicinal products - PSUSA/00003143/202109 (PDF/105.83 KB)

Alfentanil : List of nationally authorised medicinal products - PSUSA/00000082/202109 (PDF/149.41 KB)

Opium : List of nationally authorised medicinal products - PSUSA/00010670/202109 (PDF/133.03 KB)

Dexamfetamine : List of nationally authorised medicinal products - PSUSA/00000986/202109 (PDF/157.25 KB)

Etonogestrel : List of nationally authorised medicinal products - PSUSA/00001331/202109 (PDF/216.14 KB)

Diclofenac / omeprazole : List of nationally authorised medicinal products - PSUSA/00010461/202109 (PDF/176.47 KB)

Phloroglucinol, phloroglucinol/trimethylphloroglucinol : List of nationally authorised medicinal products - PSUSA/00010355/202109 (PDF/182.76 KB)

Carmustine (implant) : List of nationally authorised medicinal products - PSUSA/00010348/202109 (PDF/157.22 KB)

Brimonidine/timolol : List of nationally authorised medicinal products - PSUSA/00000431/202109 (PDF/171.43 KB)

Isopropyl alcohol / propyl alcohol / mecetronium ethyl sulfate : List of nationally authorised medicinal products - PSUSA/00010108/202109 (PDF/101.54 KB)

Tuberculin purified protein derivative : List of nationally authorised medicinal products - PSUSA/00003063/202109 (PDF/205.91 KB)

Brimonidine (except for the centrally authorised product) : List of nationally authorised medicinal products - PSUSA/00000430/202109 (PDF/327.04 KB)

Tolterodine : List of nationally authorised medicinal products - PSUSA 00002993 202109 (PDF/607.83 KB)

Dexamfetamine : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000986/202109 (PDF/121.66 KB)

Allergen for therapy: Dermatophagoides pteronyssinus / Dermatophagoides farina (oromucosal use, products authorised via mutually recognition procedure and decentralised procedure) : List of nationally authorised medicinal products - PSUSA/00010582/202109 (PDF/332.46 KB)

Etonogestrel : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001331/202109 (PDF/87.37 KB)

Alfentanil : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000082/202109 (PDF/141.59 KB)

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

Atorvastatin: List of nationally authorised medicinal products - PSUSA/00010347/201710 (PDF/885.03 KB)