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Ezetimibe / simvastatin: List of nationally authorised medicinal products - PSUSA/00001347/201903 (PDF/387.95 KB)

authorised medicinal products - PSUSA/00001347/201903 … authorised medicinal products - PSUSA/00001347/201903 EMA/694470/2019 10/01/2020 …

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

for the implementation - PSUSA/00001347/201903 … for the implementation - PSUSA/00001347/201903 Other languages: cs da de …

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)
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Alprazolam : List of nationally authorised medicinal products - PSUSA/00000109/201903 (PDF/256.07 KB)

authorised medicinal products - PSUSA/00000109/201903 … authorised medicinal products - PSUSA/00000109/201903 EMA/591990/2019 04/11/2019 …

Last updated: 04/11/2019
Active substance: alprazolam
Procedure number: PSUSA/00000109/201903
Regulatory outcome: Maintenance
List item

Cabergoline: List of nationally authorised medicinal products - PSUSA/00000477/201903 (PDF/142.53 KB)

authorised medicinal products - PSUSA/00000477/201903 … authorised medicinal products - PSUSA/00000477/201903 EMA/645069/2019 28/11/2019 …

Last updated: 28/11/2019
Active substance: cabergoline
Procedure number: PSUSA/00000477/201903
Regulatory outcome: Variation
List item

Nefopam: List of nationally authorised medicinal products - PSUSA/00002131/201903 (PDF/141.86 KB)

authorised medicinal products - PSUSA/00002131/201903 … authorised medicinal products - PSUSA/00002131/201903 EMA/653040/2019 02/12/2019 …

Last updated: 02/12/2019
Active substance: nefopam
Procedure number: PSUSA/00002131/201903
Regulatory outcome: Maintenance
List item

Carteolol: List of nationally authorised medicinal products - PSUSA/00000574/201903 (PDF/308.35 KB)

authorised medicinal products - PSUSA/00000574/201903 … authorised medicinal products - PSUSA/00000574/201903 EMA/637806/2019 03/12/2019 …

Last updated: 03/12/2019
Active substance: carteolol
Procedure number: PSUSA/00000574/201903
Regulatory outcome: Maintenance
List item

Erythromycin: List of nationally authorised medicinal products - PSUSA/00001257/201903 (PDF/275.98 KB)

authorised medicinal products - PSUSA/00001257/201903 … authorised medicinal products - PSUSA/00001257/201903 EMA/270645/2015 14/01/2020 …

Last updated: 14/01/2020
Active substance: erythromycin
Procedure number: PSUSA/00001257/201903
Regulatory outcome: Variation
List item

Hydroxyethyl starch: List of nationally authorised medicinal products - PSUSA/00001694/201903 (PDF/278.48 KB)

authorised medicinal products - PSUSA/00001694/201903 … authorised medicinal products - PSUSA/00001694/201903 EMA/553019/2019 10/10/2019 …

Last updated: 10/10/2019
Active substance: hydroxyethyl starch
Procedure number: PSUSA/00001694/201903
Regulatory outcome: Maintenance
List item

Triamcinolone (intraocular formulations): List of nationally authorised medicinal products - PSUSA/00010292/201903 (PDF/229.07 KB)

authorised medicinal products - PSUSA/00010292/201903 … authorised medicinal products - PSUSA/00010292/201903 EMA/628318/2019 29/11/2019 …

Last updated: 29/11/2019
Active substance: triamcinolone
Procedure number: PSUSA/00010292/201903
Regulatory outcome: Maintenance
List item

Varicella vaccine (live) : List of nationally authorised medicinal products - PSUSA/000010473/201903 (PDF/207.82 KB)

authorised medicinal products - PSUSA/000010473/201903 … authorised medicinal products - PSUSA/000010473/201903 EMA/650338/2019 02/12/2019 …

Last updated: 02/12/2019
Active substance: varicella vaccine (live)
Procedure number: PSUSA/00010473/201903
Regulatory outcome: Maintenance
List item

Influenza vaccine (surface antigen, inactivated, adjuvanted) : List of nationally authorised medicinal products - PSUSA/00010300/201903 (PDF/109.25 KB)

authorised medicinal products - PSUSA/00010300/201903 … authorised medicinal products - PSUSA/00010300/201903 EMA/601121/2019 08/11/2019 …

Last updated: 08/11/2019
Active substance: influenza vaccine (surface antigen, inactivated, adjuvanted)
Procedure number: PSUSA/00010300/201903
Regulatory outcome: Maintenance
List item

Influenza vaccine (surface antigen, inactivated) : List of nationally authorised medicinal products - PSUSA/00001744/201903 (PDF/157.5 KB)

authorised medicinal products - PSUSA/00001744/201903 … authorised medicinal products - PSUSA/00001744/201903 EMA/600346/2019 08/11/2019 …

Last updated: 08/11/2019
Active substance: influenza vaccine (surface antigen, inactivated)
Procedure number: PSUSA/00001744/201903
Regulatory outcome: Maintenance
List item

Influenza vaccine (split virion, inactivated, prepared in cell cultures) : List of nationally authorised medicinal products - PSUSA/00010299/201903 (PDF/87.8 KB)

authorised medicinal products - PSUSA/00010299/201903 … authorised medicinal products - PSUSA/00010299/201903 EMA/601087/2019 08/11/2019 …

Last updated: 08/11/2019
Active substance: Influenza vaccine (split virion, inactivated, prepared in cell cultures)
Procedure number: PSUSA/00010299/201903
Regulatory outcome: Maintenance
List item

Influenza vaccine (split virion, inactivated) (non centrally authorised products) : List of nationally authorised medicinal products - PSUSA/00010298/201903 (PDF/331.34 KB)

authorised medicinal products - PSUSA/00010298/201903 … authorised medicinal products - PSUSA/00010298/201903 EMA/600419/2019 08/11/2019 …

Last updated: 08/11/2019
Active substance: influenza vaccine (split virion, inactivated)
Procedure number: PSUSA/00010298/201903
Regulatory outcome: Maintenance
List item

Germanium (68Ge) chloride / gallium (68Ga) chloride : List of nationally authorised medicinal products - PSUSA/00010364/201903 (PDF/137.41 KB)

authorised medicinal products - PSUSA/00010364/201903 … authorised medicinal products - PSUSA/00010364/201903 EMA/593886/2019 19/11/2019 …

Last updated: 19/11/2019
Active substance: germanium (68Ge) chloride, gallium (68Ga) chloride
Procedure number: PSUSA/00010364/201903
Regulatory outcome: Maintenance
List item

Sulfametrole / trimethoprim, sulfadiazine / trimethoprim, sulfamethoxazole / trimethoprim (co-trimoxazole): List of nationally authorised medicinal products - PSUSA/00010593/201903 (PDF/210.96 KB)

authorised medicinal products - PSUSA/00010593/201903 … authorised medicinal products - PSUSA/00010593/201903 EMA/80054/2020 13/02/2020 …

Last updated: 13/02/2020
Active substance: sulfametrole, trimethoprim, sulfadiazine, Sulfamethoxazole
Procedure number: PSUSA/00010593/201903
Regulatory outcome: Variation
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)

for the implementation - PSUSA/00001257/201903 … for the implementation - PSUSA/00001257/201903 Other languages: bg cs da …

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

Sulfametrole / trimethoprim, sulfadiazine / trimethoprim, sulfamethoxazole / trimethoprim (co-trimoxazole): CMDh Scientific conclusions and grounds for variation, amendments to the product information and timetable for the implem - PSUSA/00010593/201903 (PDF/138.46 KB)

timetable for the implem - PSUSA/00010593/201903 … timetable for the implem - PSUSA/00010593/201903 Other languages: nl no pl …

Last updated: 13/02/2020
Active substance: sulfametrole, trimethoprim, sulfadiazine, Sulfamethoxazole
Procedure number: PSUSA/00010593/201903
Regulatory outcome: Variation
Bulgarian
(PDF/178.58 KB)

Croatian
(PDF/151.62 KB)

Czech
(PDF/80.88 KB)

Danish
(PDF/168.82 KB)

Dutch
(PDF/153.74 KB)

Estonian
(PDF/145.87 KB)

Finnish
(PDF/135.56 KB)

French
(PDF/138.86 KB)

German
(PDF/159.05 KB)

Greek
(PDF/180.12 KB)

Hungarian
(PDF/159.33 KB)

Icelandic
(PDF/139 KB)

Italian
(PDF/153 KB)

Latvian
(PDF/198.98 KB)

Lithuanian
(PDF/177.47 KB)

Maltese
(PDF/165.52 KB)

Norwegian
(PDF/152.27 KB)

Polish
(PDF/201.67 KB)

Portuguese
(PDF/147.36 KB)

Romanian
(PDF/155.9 KB)

Slovak
(PDF/167.08 KB)

Slovenian
(PDF/154.43 KB)

Spanish
(PDF/138.07 KB)

Swedish
(PDF/151.81 KB)
List item

Meloxicam : List of nationally authorised medicinal products - PSUSA/00010474/202207 (PDF/303.26 KB)

authorised medicinal products - PSUSA/00010474/202207 … authorised medicinal products - PSUSA/00010474/202207 EMA/215601/2023 11/05/2023 … meloxicam Procedure No. PSUSA/00010474/202207 http://www.ema.europa.eu/how-to-find-us http://www.ema.europa.eu/contact …

Last updated: 02/06/2023
Active substance: meloxicam
Procedure number: PSUSA/00010474/202207
Regulatory outcome: Variation
List item

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
List item

Levobupivacaine: List of nationally authorised medicinal products - PSUSA/00001848/201712 (PDF/254.62 KB)

authorised medicinal products - PSUSA/00001848/201712 … authorised medicinal products - PSUSA/00001848/201712 EMA/620439/2018 17/09/2018 … levobupivacaine Procedure no.: PSUSA/00001848/201712 List of nationally …

Last updated: 17/09/2018
Active substance: levobupivacaine
Procedure number: PSUSA/00001848/201712
Regulatory outcome: Maintenance
List item

Lamotrigine : List of nationally authorised medicinal products - PSUSA/00001825/201711 (PDF/639.41 KB)

authorised medicinal products - PSUSA/00001825/201711 … authorised medicinal products - PSUSA/00001825/201711 EMA/600046/2018 10/09/2018 … lamotrigine Procedure no.: PSUSA/00001825/201711 List of nationally …

Last updated: 10/09/2018
Active substance: lamotrigine
Procedure number: PSUSA/00001825/201711
Regulatory outcome: Variation
List item

Landiolol: List of nationally authorised medicinal products - PSUSA/00010570/201802 (PDF/122.96 KB)

authorised medicinal products - PSUSA/00010570/201802 … authorised medicinal products - PSUSA/00010570/201802 EMA/622806/2018 14/09/2018 … landiolol Procedure no.: PSUSA/00010570/201802 List of nationally …

Last updated: 14/09/2018
Active substance: landiolol
Procedure number: PSUSA/00010570/201802
Regulatory outcome: Maintenance
List item

Sertindole: List of nationally authorised medicinal products - PSUSA/00002695/201801 (PDF/105.81 KB)

authorised medicinal products - PSUSA/00002695/201801 … authorised medicinal products - PSUSA/00002695/201801 EMA/615366/2018 13/09/2018 … sertindole Procedure no.: PSUSA/00002695/201801 …

Last updated: 13/09/2018
Active substance: sertindole
Procedure number: PSUSA/00002695/201801
Regulatory outcome: Maintenance

2531 results

Ezetimibe / simvastatin: List of nationally authorised medicinal products - PSUSA/00001347/201903 (PDF/387.95 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)

Alprazolam : List of nationally authorised medicinal products - PSUSA/00000109/201903 (PDF/256.07 KB)

Cabergoline: List of nationally authorised medicinal products - PSUSA/00000477/201903 (PDF/142.53 KB)

Nefopam: List of nationally authorised medicinal products - PSUSA/00002131/201903 (PDF/141.86 KB)

Carteolol: List of nationally authorised medicinal products - PSUSA/00000574/201903 (PDF/308.35 KB)

Erythromycin: List of nationally authorised medicinal products - PSUSA/00001257/201903 (PDF/275.98 KB)

Hydroxyethyl starch: List of nationally authorised medicinal products - PSUSA/00001694/201903 (PDF/278.48 KB)

Triamcinolone (intraocular formulations): List of nationally authorised medicinal products - PSUSA/00010292/201903 (PDF/229.07 KB)

Varicella vaccine (live) : List of nationally authorised medicinal products - PSUSA/000010473/201903 (PDF/207.82 KB)

Influenza vaccine (surface antigen, inactivated, adjuvanted) : List of nationally authorised medicinal products - PSUSA/00010300/201903 (PDF/109.25 KB)

Influenza vaccine (surface antigen, inactivated) : List of nationally authorised medicinal products - PSUSA/00001744/201903 (PDF/157.5 KB)

Influenza vaccine (split virion, inactivated, prepared in cell cultures) : List of nationally authorised medicinal products - PSUSA/00010299/201903 (PDF/87.8 KB)

Influenza vaccine (split virion, inactivated) (non centrally authorised products) : List of nationally authorised medicinal products - PSUSA/00010298/201903 (PDF/331.34 KB)

Germanium (68Ge) chloride / gallium (68Ga) chloride : List of nationally authorised medicinal products - PSUSA/00010364/201903 (PDF/137.41 KB)

Sulfametrole / trimethoprim, sulfadiazine / trimethoprim, sulfamethoxazole / trimethoprim (co-trimoxazole): List of nationally authorised medicinal products - PSUSA/00010593/201903 (PDF/210.96 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)

Sulfametrole / trimethoprim, sulfadiazine / trimethoprim, sulfamethoxazole / trimethoprim (co-trimoxazole): CMDh Scientific conclusions and grounds for variation, amendments to the product information and timetable for the implem - PSUSA/00010593/201903 (PDF/138.46 KB)

Meloxicam : List of nationally authorised medicinal products - PSUSA/00010474/202207 (PDF/303.26 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)

Levobupivacaine: List of nationally authorised medicinal products - PSUSA/00001848/201712 (PDF/254.62 KB)

Lamotrigine : List of nationally authorised medicinal products - PSUSA/00001825/201711 (PDF/639.41 KB)

Landiolol: List of nationally authorised medicinal products - PSUSA/00010570/201802 (PDF/122.96 KB)

Sertindole: List of nationally authorised medicinal products - PSUSA/00002695/201801 (PDF/105.81 KB)