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Tapentadol : List of nationally authorised medicinal products - PSUSA/00002849/202111 (PDF/938.11 KB)

authorised medicinal products - PSUSA/00002849/202111 … authorised medicinal products - PSUSA/00002849/202111 EMA/724645/2022 05/09/2022 … tapentadol Procedure No. PSUSA/00002849/202111 http://www.ema.europa.eu/how-to-find-us http://www.ema.europa.eu/contact …

Last updated: 05/09/2022
Active substance: tapentadol
Procedure number: PSUSA/00002849/202111
Regulatory outcome: Variation
List item

Tapentadol : Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s) - PSUSA/00002849/202111 (PDF/129.49 KB)

Marketing Authorisation(s) - PSUSA/00002849/202111 … Marketing Authorisation(s) - PSUSA/00002849/202111 Other languages: de el es …

Last updated: 05/09/2022
Active substance: tapentadol
Procedure number: PSUSA/00002849/202111
Regulatory outcome: Variation
Bulgarian
(PDF/160.45 KB)

Croatian
(PDF/163.05 KB)

Czech
(PDF/165.3 KB)

Danish
(PDF/133.55 KB)

Dutch
(PDF/137.75 KB)

Estonian
(PDF/188.37 KB)

Finnish
(PDF/142.79 KB)

French
(PDF/135.2 KB)

German
(PDF/174.37 KB)

Greek
(PDF/155.01 KB)

Hungarian
(PDF/188.93 KB)

Icelandic
(PDF/133.19 KB)

Irish
(PDF/125.42 KB)

Italian
(PDF/143.36 KB)

Latvian
(PDF/165.1 KB)

Lithuanian
(PDF/186.87 KB)

Maltese
(PDF/163.4 KB)

Norwegian
(PDF/132.57 KB)

Polish
(PDF/170.91 KB)

Portuguese
(PDF/138.17 KB)

Romanian
(PDF/161.28 KB)

Slovak
(PDF/165.63 KB)

Slovenian
(PDF/156.37 KB)

Spanish
(PDF/132.24 KB)

Swedish
(PDF/138.42 KB)
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Tapentadol : List of nationally authorised medicinal products - PSUSA/00002849/201711 (PDF/1.4 MB)

authorised medicinal products - PSUSA/00002849/201711 … authorised medicinal products - PSUSA/00002849/201711 EMA/607287/2018 07/09/2018 … tapentadol Procedure no.: PSUSA/00002849/201711 List of nationally …

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

Tapentadol: List of nationally authorised medicinal products - PSUSA/00002849/201411 (PDF/267.5 KB)

authorised medicinal products - PSUSA/00002849/201411 … authorised medicinal products - PSUSA/00002849/201411 EMA/448789/2015 16/07/2015 … tapentadol Procedure no.: PSUSA/00002849/201411 List of nationally …

Last updated: 19/10/2016
Active substance: tapentadol
Procedure number: PSUSA/00002849/201411
Regulatory outcome: Maintenance
List item

Tapentadol: List of nationally authorised medicinal products - PSUSA/00002849/201811 (PDF/1.25 MB)

authorised medicinal products - PSUSA/00002849/201811 … authorised medicinal products - PSUSA/00002849/201811 EMA/450564/2019 02/09/2019 …

Last updated: 02/09/2019
Active substance: tapentadol
Procedure number: PSUSA/00002849/201811
Regulatory outcome: Variation
List item

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)

for the implementation - PSUSA/00002849/201711 … for the implementation - PSUSA/00002849/201711 Other languages: bg es cs …

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)
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Tapentadol: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002849/201811 (PDF/38.61 KB)

for the implementation - PSUSA/00002849/201811 … for the implementation - PSUSA/00002849/201811 Other languages: is it lt …

Last updated: 02/09/2019
Active substance: tapentadol
Procedure number: PSUSA/00002849/201811
Regulatory outcome: Variation
Bulgarian
(PDF/129.13 KB)

Croatian
(PDF/101.9 KB)

Czech
(PDF/137.89 KB)

Danish
(PDF/45.75 KB)

Dutch
(PDF/45.26 KB)

Estonian
(PDF/38.76 KB)

Finnish
(PDF/41.87 KB)

French
(PDF/40.68 KB)

German
(PDF/40.06 KB)

Greek
(PDF/135.71 KB)

Hungarian
(PDF/103.94 KB)

Icelandic
(PDF/42.52 KB)

Italian
(PDF/38.85 KB)

Latvian
(PDF/131.3 KB)

Lithuanian
(PDF/110.84 KB)

Maltese
(PDF/137.76 KB)

Norwegian
(PDF/45.19 KB)

Polish
(PDF/144.58 KB)

Portuguese
(PDF/43.53 KB)

Romanian
(PDF/125.84 KB)

Slovak
(PDF/114.11 KB)

Slovenian
(PDF/111.03 KB)

Spanish
(PDF/41.41 KB)

Swedish
(PDF/44.95 KB)
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Quinine : List of nationally authorised medicinal products - PSUSA/00002598/202111 (PDF/128.93 KB)

authorised medicinal products - PSUSA/00002598/202111 … authorised medicinal products - PSUSA/00002598/202111 EMA/607700/2022 08/07/2022 … substance(s): quinine Procedure No. PSUSA/00002598/202111 http://www.ema.europa.eu/how-to-find-us http://www.ema.europa.eu/contact …

Last updated: 08/07/2022
Active substance: quinine
Procedure number: PSUSA/00002598/202111
Regulatory outcome: Maintenance
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Clevidipine : List of nationally authorised medicinal products - PSUSA/00010288/202111 (PDF/122.61 KB)

authorised medicinal products - PSUSA/00010288/202111 … authorised medicinal products - PSUSA/00010288/202111 EMA/PRAC/591770/2022 15/06/20 … clevidipine Procedure no.: PSUSA/00010288/202111 List of nationally …

Last updated: 15/06/2022
Active substance: clevidipine
Procedure number: PSUSA/00010288/202111
Regulatory outcome: Maintenance
List item

Drospirenone : List of nationally authorised medicinal products - PSUSA/00010853/202111 (PDF/146.68 KB)

authorised medicinal products - PSUSA/00010853/202111 … authorised medicinal products - PSUSA/00010853/202111 EMA/585891/2022 13/06/2022 … drospirenone Procedure no.: PSUSA/00010853/202111 List of nationally …

Last updated: 13/06/2022
Active substance: drospirenone
Procedure number: PSUSA/00010853/202111
Regulatory outcome: Maintenance
List item

Cefazolin : List of nationally authorised medicinal products - PSUSA/00000589/202111 (PDF/171.7 KB)

authorised medicinal products - PSUSA/00000589/202111 … authorised medicinal products - PSUSA/00000589/202111 EMA/607701/2022 08/07/2022 … cefazolin Procedure No. PSUSA/00000589/202111 http://www.ema.europa.eu/how-to-find-us http://www.ema.europa.eu/contact …

Last updated: 08/07/2022
Active substance: cefazolin
Procedure number: PSUSA/00000589/202111
Regulatory outcome: Maintenance
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Ceftobiprole : List of nationally authorised medicinal products - PSUSA/00010734/202111 (PDF/159.23 KB)

authorised medicinal products - PSUSA/00010734/202111 … authorised medicinal products - PSUSA/00010734/202111 EMA/607705/2022 08/07/2022 … ceftobiprole Procedure No. PSUSA/00010734/202111 http://www.ema.europa.eu/how-to-find-us http://www.ema.europa.eu/contact …

Last updated: 08/07/2022
Active substance: ceftobiprole
Procedure number: PSUSA/00010734/202111
Regulatory outcome: Maintenance
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Metoclopramide : List of nationally authorised medicinal products - PSUSA/00002036/202111 (PDF/216.7 KB)

authorised medicinal products - PSUSA/00002036/202111 … authorised medicinal products - PSUSA/00002036/202111 EMA/PRAC/633711/2022 08/07/20 … metoclopramide Procedure No.: PSUSA/00002036/202111 http://www.ema.europa.eu/how-to-find-us http://www.ema.europa.eu/contact …

Last updated: 08/07/2022
Active substance: metoclopramide
Procedure number: PSUSA/00002036/202111
Regulatory outcome: Maintenance
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Donepezil : List of nationally authorised medicinal products - PSUSA/00001160/202111 (PDF/282.97 KB)

authorised medicinal products - PSUSA/00001160/202111 … authorised medicinal products - PSUSA/00001160/202111 EMA/CMDh/800411/2022 05/10/20 … donepezil Procedure No. PSUSA/00001160/202111 http://www.ema.europa.eu/how-to-find-us http://www.ema.europa.eu/contact …

Last updated: 05/10/2022
Active substance: donepezil
Procedure number: PSUSA/00001160/202111
Regulatory outcome: Variation
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Dextromethorphan : List of nationally authorised medicinal products - PSUSA/00001009/202111 (PDF/385.63 KB)

authorised medicinal products - PSUSA/00001009/202111 … authorised medicinal products - PSUSA/00001009/202111 EMA/585273/2022 13/06/2022 … dextromethorphan Procedure No. PSUSA/00001009/202111 http://www.ema.europa.eu/how-to-find-us http://www.ema.europa.eu/contact …

Last updated: 13/06/2022
Active substance: dextromethorphan
Procedure number: PSUSA/00001009/202111
Regulatory outcome: Maintenance
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teicoplanin : List of nationally authorised medicinal products - PSUSA/00002878/202111 (PDF/318.51 KB)

authorised medicinal products - PSUSA/00002878/202111 … authorised medicinal products - PSUSA/00002878/202111 EMA/75555/2022 05/08/2022 … teicoplanin Procedure No. PSUSA/00002878/202111 http://www.ema.europa.eu/how-to-find-us http://www.ema.europa.eu/contact …

Last updated: 05/08/2022
Active substance: Teicoplanin
Procedure number: PSUSA/00002878/202111
Regulatory outcome: Variation
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Hydromorphone : List of nationally authorised medicinal products - PSUSA/00001686/202111 (PDF/373.39 KB)

authorised medicinal products - PSUSA/00001686/202111 … authorised medicinal products - PSUSA/00001686/202111 EMA/270645/2015 07/09/2022 … hydromorphone Procedure no.: PSUSA/00001686/202111 List of nationally …

Last updated: 07/09/2022
Active substance: hydromorphone
Procedure number: PSUSA/00001686/202111
Regulatory outcome: Variation
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Bisoprolol / hydrochlorothiazide : List of nationally authorised medicinal products - PSUSA/00000420/202111 (PDF/220.18 KB)

authorised medicinal products - PSUSA/00000420/202111 … authorised medicinal products - PSUSA/00000420/202111 EMA/640852/2022 12/07/2022 … hydrochlorothiazide Procedure no.: PSUSA/00000420/202111 List of nationally …

Last updated: 13/07/2022
Active substance: bisoprolol, hydrochlorothiazide
Procedure number: PSUSA/00000420/202111
Regulatory outcome: Maintenance
List item

Acetylsalicylic acid / bisoprolol : List of nationally authorised medicinal products - PSUSA/00010287/202111 (PDF/137.14 KB)

authorised medicinal products - PSUSA/00010287/202111 … authorised medicinal products - PSUSA/00010287/202111 PSUSA/00010287/202111 13/06/2022 … bisoprolol Procedure no.: PSUSA/00010287/202111 List of nationally …

Last updated: 13/06/2022
Active substance: acetylsalicylic acid, bisoprolol
Procedure number: PSUSA/00010287/202111
Regulatory outcome: Maintenance
List item

indapamide / perindopril : List of nationally authorised medicinal products - PSUSA/00010230/202111 (PDF/550.01 KB)

authorised medicinal products - PSUSA/00010230/202111 … authorised medicinal products - PSUSA/00010230/202111 … perindopril Procedure no.: PSUSA/00010230/202111 List of nationally …

Last updated: 13/07/2022
Active substance: indapamide, perindopril
Procedure number: PSUSA/00010230/202111
Regulatory outcome: Maintenance
List item

Caffeine / ergotamine : List of nationally authorised medicinal products - PSUSA/00000485/202111 (PDF/120.06 KB)

authorised medicinal products - PSUSA/00000485/202111 … authorised medicinal products - PSUSA/00000485/202111 EMA/642802/2022 13/07/2022 … ergotamine Procedure no.: PSUSA/00000485/202111 List of nationally …

Last updated: 13/07/2022
Active substance: Caffeine, ergotamine
Procedure number: PSUSA/00000485/202111
Regulatory outcome: Maintenance
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chlormadinone acetate / ethinylestradiol : List of nationally authorised medicinal products - PSUSA/00000679/202111 (PDF/151.3 KB)

authorised medicinal products - PSUSA/00000679/202111 … authorised medicinal products - PSUSA/00000679/202111 EMA/726018/2022 05/09/2022 … ethinylestradiol Procedure no.: PSUSA/00000679/202111 List of nationally …

Last updated: 05/09/2022
Active substance: chlormadinone acetate, ethinylestradiol
Procedure number: PSUSA/00000679/202111
Regulatory outcome: Variation
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Benzalkonium chloride / chlorhexidine digluconate : List of nationally authorised medicinal products - PSUSA/00010070/202111 (PDF/102.43 KB)

authorised medicinal products - PSUSA/00010070/202111 … authorised medicinal products - PSUSA/00010070/202111 EMA/95628/2022 05/07/2022 … digluconate Procedure no.: PSUSA/00010070/202111 List of nationally …

Last updated: 05/07/2022
Active substance: benzalkonium chloride, chlorhexidine digluconate
Procedure number: PSUSA/00010070/202111
Regulatory outcome: Maintenance
List item

Teicoplanin : Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s) - PSUSA/00002878/202111 (PDF/121.18 KB)

Marketing Authorisation(s) - PSUSA/00002878/202111 … Marketing Authorisation(s) - PSUSA/00002878/202111 Other languages: de el es …

Last updated: 05/08/2022
Active substance: Teicoplanin
Procedure number: PSUSA/00002878/202111
Regulatory outcome: Variation
Bulgarian
(PDF/169.48 KB)

Croatian
(PDF/138.6 KB)

Czech
(PDF/50.65 KB)

Danish
(PDF/86.37 KB)

Dutch
(PDF/67.47 KB)

Estonian
(PDF/120.26 KB)

Finnish
(PDF/45.94 KB)

French
(PDF/85.44 KB)

German
(PDF/79.17 KB)

Greek
(PDF/185.73 KB)

Hungarian
(PDF/208.89 KB)

Irish
(PDF/121.81 KB)

Italian
(PDF/178.51 KB)

Latvian
(PDF/155.42 KB)

Lithuanian
(PDF/152.97 KB)

Maltese
(PDF/146.99 KB)

Polish
(PDF/129.04 KB)

Portuguese
(PDF/136.39 KB)

Romanian
(PDF/224.88 KB)

Slovak
(PDF/182.35 KB)

Slovenian
(PDF/70.41 KB)

Spanish
(PDF/185.92 KB)

Swedish
(PDF/49.06 KB)
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chlormadinone acetate / ethinylestradiol : Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s) - PSUSA/00000679/202111 (PDF/115.7 KB)

Marketing Authorisation(s) - PSUSA/00000679/202111 … Marketing Authorisation(s) - PSUSA/00000679/202111 Other languages: es et fi …

Last updated: 05/09/2022
Active substance: chlormadinone acetate, ethinylestradiol
Procedure number: PSUSA/00000679/202111
Regulatory outcome: Variation
Bulgarian
(PDF/154.15 KB)

Croatian
(PDF/137.79 KB)

Czech
(PDF/145.27 KB)

Danish
(PDF/88.65 KB)

Dutch
(PDF/146.11 KB)

Estonian
(PDF/140.23 KB)

Finnish
(PDF/84.29 KB)

French
(PDF/132.1 KB)

German
(PDF/186.68 KB)

Greek
(PDF/86.92 KB)

Hungarian
(PDF/158.92 KB)

Icelandic
(PDF/161.68 KB)

Italian
(PDF/146.38 KB)

Latvian
(PDF/182.14 KB)

Lithuanian
(PDF/147.67 KB)

Maltese
(PDF/124.46 KB)

Norwegian
(PDF/158.24 KB)

Polish
(PDF/141 KB)

Portuguese
(PDF/84.33 KB)

Romanian
(PDF/139.57 KB)

Slovak
(PDF/182.8 KB)

Slovenian
(PDF/133.57 KB)

Spanish
(PDF/163.98 KB)

Swedish
(PDF/83.07 KB)

2355 results

Tapentadol : List of nationally authorised medicinal products - PSUSA/00002849/202111 (PDF/938.11 KB)

Tapentadol : Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s) - PSUSA/00002849/202111 (PDF/129.49 KB)

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

Tapentadol: List of nationally authorised medicinal products - PSUSA/00002849/201411 (PDF/267.5 KB)

Tapentadol: List of nationally authorised medicinal products - PSUSA/00002849/201811 (PDF/1.25 MB)

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: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002849/201811 (PDF/38.61 KB)

Quinine : List of nationally authorised medicinal products - PSUSA/00002598/202111 (PDF/128.93 KB)

Clevidipine : List of nationally authorised medicinal products - PSUSA/00010288/202111 (PDF/122.61 KB)

Drospirenone : List of nationally authorised medicinal products - PSUSA/00010853/202111 (PDF/146.68 KB)

Cefazolin : List of nationally authorised medicinal products - PSUSA/00000589/202111 (PDF/171.7 KB)

Ceftobiprole : List of nationally authorised medicinal products - PSUSA/00010734/202111 (PDF/159.23 KB)

Metoclopramide : List of nationally authorised medicinal products - PSUSA/00002036/202111 (PDF/216.7 KB)

Donepezil : List of nationally authorised medicinal products - PSUSA/00001160/202111 (PDF/282.97 KB)

Dextromethorphan : List of nationally authorised medicinal products - PSUSA/00001009/202111 (PDF/385.63 KB)

teicoplanin : List of nationally authorised medicinal products - PSUSA/00002878/202111 (PDF/318.51 KB)

Hydromorphone : List of nationally authorised medicinal products - PSUSA/00001686/202111 (PDF/373.39 KB)

Bisoprolol / hydrochlorothiazide : List of nationally authorised medicinal products - PSUSA/00000420/202111 (PDF/220.18 KB)

Acetylsalicylic acid / bisoprolol : List of nationally authorised medicinal products - PSUSA/00010287/202111 (PDF/137.14 KB)

indapamide / perindopril : List of nationally authorised medicinal products - PSUSA/00010230/202111 (PDF/550.01 KB)

Caffeine / ergotamine : List of nationally authorised medicinal products - PSUSA/00000485/202111 (PDF/120.06 KB)

chlormadinone acetate / ethinylestradiol : List of nationally authorised medicinal products - PSUSA/00000679/202111 (PDF/151.3 KB)

Benzalkonium chloride / chlorhexidine digluconate : List of nationally authorised medicinal products - PSUSA/00010070/202111 (PDF/102.43 KB)

Teicoplanin : Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s) - PSUSA/00002878/202111 (PDF/121.18 KB)

chlormadinone acetate / ethinylestradiol : Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s) - PSUSA/00000679/202111 (PDF/115.7 KB)