Medicines

For help on how to get the results you want, see our search tips.

Search results

3550 results

Sort by

List item

N(2)-L-alanyl-L-glutamine : List of nationally authorised medicinal products - PSUSA/00003158/202103 (PDF/149.26 KB)

authorised medicinal products - PSUSA/00003158/202103 … authorised medicinal products - PSUSA/00003158/202103 EMA/734732/2021 08/12/2021 … N(2)-L-alanyl-L-glutamine Procedure no.: PSUSA/00003158/202103 List of nationally …

Last updated: 08/12/2021
Active substance: N(2)-L-alanyl-L-glutamine
Procedure number: PSUSA/00003158/202103
Regulatory outcome: Maintenance
List item

Influenza vaccine (surface antigen, inactivated) : List of nationally authorised medicinal products - PSUSA/00001744/202103 (PDF/141.43 KB)

authorised medicinal products - PSUSA/00001744/202103 … authorised medicinal products - PSUSA/00001744/202103 EMA/610630/2021 27/10/2021 … inactivated) Procedure no.: PSUSA/00001744/202103 List of nationally …

Last updated: 27/10/2021
Active substance: influenza vaccine (surface antigen, inactivated)
Procedure number: PSUSA/00001744/202103
Regulatory outcome: Maintenance
List item

Tobramycin (ophthalmic and otic use): List of nationally authorised medicinal products - PSUSA/00009317/202103 (PDF/175.88 KB)

authorised medicinal products - PSUSA/00009317/202103 … authorised medicinal products - PSUSA/00009317/202103 EMA/609316/2021 06/12/2021 … otic use) Procedure no.: PSUSA/00009317/202103 List of nationally …

Last updated: 06/12/2021
Active substance: Tobramycin
Procedure number: PSUSA/00009317/202103
Regulatory outcome: Maintenance
List item

Hydroxyethyl starch - List of nationally authorised medicinal products - PSUSA-00001694-202103 (PDF/310.93 KB)

authorised medicinal products - PSUSA-00001694-202103 … authorised medicinal products - PSUSA-00001694-202103 EMA/609295/2021Adopted 26/10 … hydroxyethyl starch Procedure no.: PSUSA/00001694/202103 List of nationally …

Last updated: 26/10/2021
Active substance: hydroxyethyl starch
Procedure number: PSUSA/00001694/202103
Regulatory outcome: Maintenance
List item

Influenza vaccine (split virion, inactivated) (non centrally authorised products) - List of nationally authorised medicinal products - PSUSA-00010298-202103 (PDF/477.74 KB)

authorised medicinal products - PSUSA-00010298-202103 … authorised medicinal products - PSUSA-00010298-202103 EMA/499957/2021Adopted 26/10 … products) Procedure no.: PSUSA/00010298/202103 List of nationally …

Last updated: 26/10/2021
Active substance: influenza vaccine (split virion, inactivated) (non centrally authorised products)
Procedure number: PSUSA/00010298/202103
Regulatory outcome: Maintenance
List item

Amlodipine besilate / ramipril, amlodipine / hydrochlorothiazide / ramipril, hydrochlorothiazide / ramipril : List of nationally authorised medicinal products - PSUSA/00010774/202103 (PDF/1.49 MB)

authorised medicinal products - PSUSA/00010774/202103 … authorised medicinal products - PSUSA/00010774/202103 EMA/731539/202121 08/12/2021 … ramipril Procedure no.: PSUSA/00010774/202103 List of nationally …

Last updated: 08/12/2021
Active substance: Amlodipine besilate, ramipril, amlodipine, hydrochlorothiazide, ramipril, hydrochlorothiazide, Ramipril
Procedure number: PSUSA/00010774/202103
Regulatory outcome: Maintenance
List item

Dobutamine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001151/202103 (PDF/91.49 KB)

for the implementation - PSUSA/00001151/202103 … for the implementation - PSUSA/00001151/202103 Other languages: bg cs da …

Last updated: 09/03/2022
Active substance: Dobutamine
Procedure number: PSUSA/00001151/202103
Regulatory outcome: Variation
Bulgarian
(PDF/175.59 KB)

Croatian
(PDF/181.04 KB)

Czech
(PDF/195.41 KB)

Danish
(PDF/143.34 KB)

Dutch
(PDF/153.59 KB)

Estonian
(PDF/145.68 KB)

Finnish
(PDF/138.67 KB)

French
(PDF/144.97 KB)

German
(PDF/158.06 KB)

Greek
(PDF/178.29 KB)

Hungarian
(PDF/187.06 KB)

Icelandic
(PDF/154.4 KB)

Italian
(PDF/152.06 KB)

Latvian
(PDF/188.95 KB)

Lithuanian
(PDF/181.58 KB)

Maltese
(PDF/190.13 KB)

Norwegian
(PDF/142.4 KB)

Polish
(PDF/187.4 KB)

Portuguese
(PDF/145.15 KB)

Romanian
(PDF/188.56 KB)

Slovak
(PDF/190.87 KB)

Slovenian
(PDF/178.39 KB)

Spanish
(PDF/146.18 KB)

Swedish
(PDF/142.39 KB)
List item

Bacterial lysate of haemophilus influenzae / klebsiella pneumoniae / moraxella catarrhalis / staphylococcus aureus / streptococcus mitis / strep. pneumoniae / strep. pyogenes : List of nationally authorised medicinal products - PSUSA/00002786/202103 (PDF/118.34 KB)

authorised medicinal products - PSUSA/00002786/202103 … authorised medicinal products - PSUSA/00002786/202103 EMA/689851/2021 17/01/2022 … streptococcus aga Procedure no.: PSUSA/00002786/202103 List of nationally …

Last updated: 17/01/2022
Active substance: bacterial lysate of haemophilus influenzae, klebsiella pneumoniae, moraxella catarrhalis, staphylococcus aureus, streptococcus mitis, streptococcus pneumoniae, streptococcus pyogenes, bacterial lysate of haemophilus influenzae, klebsiella pneumoniae, moraxella catarrhalis, staphylococcus aureus, streptococcus pneumoniae, streptococcus pyogenes, streptococcus pneumoniae, streptococcus aga
Procedure number: PSUSA/00002786/202103
Regulatory outcome: Maintenance
List item

Lanthanum : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00003175/202103 (PDF/116.89 KB)

for the implementation - PSUSA/00003175/202103 … for the implementation - PSUSA/00003175/202103 Other languages: it is hu …

Last updated: 26/11/2021
Active substance: lanthanum
Procedure number: PSUSA/00003175/202103
Regulatory outcome: Variation
Bulgarian
(PDF/140.57 KB)

Croatian
(PDF/105.42 KB)

Czech
(PDF/174.15 KB)

Danish
(PDF/195.86 KB)

Dutch
(PDF/178.21 KB)

Estonian
(PDF/88.76 KB)

Finnish
(PDF/139.44 KB)

French
(PDF/99 KB)

German
(PDF/99.38 KB)

Greek
(PDF/144.96 KB)

Hungarian
(PDF/276.44 KB)

Icelandic
(PDF/99.54 KB)

Italian
(PDF/128.53 KB)

Latvian
(PDF/353.84 KB)

Lithuanian
(PDF/241.62 KB)

Maltese
(PDF/251.56 KB)

Norwegian
(PDF/137.88 KB)

Polish
(PDF/139.51 KB)

Portuguese
(PDF/117.61 KB)

Romanian
(PDF/176.39 KB)

Slovak
(PDF/214.91 KB)

Slovenian
(PDF/158.76 KB)

Spanish
(PDF/93.63 KB)

Swedish
(PDF/191.77 KB)
List item

Metamizole : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001997/202103 (PDF/142.77 KB)

for the implementation - PSUSA/00001997/202103 … for the implementation - PSUSA/00001997/202103 Other languages: bg cs da …

Last updated: 13/12/2021
Active substance: metamizole
Procedure number: PSUSA/00001997/202103
Regulatory outcome: Variation
Bulgarian
(PDF/171.78 KB)

Croatian
(PDF/185.37 KB)

Czech
(PDF/245.6 KB)

Danish
(PDF/149.02 KB)

Dutch
(PDF/149.71 KB)

Estonian
(PDF/145.01 KB)

Finnish
(PDF/144.52 KB)

French
(PDF/148.59 KB)

German
(PDF/181.53 KB)

Greek
(PDF/174.43 KB)

Hungarian
(PDF/182.94 KB)

Italian
(PDF/147.1 KB)

Latvian
(PDF/181.38 KB)

Lithuanian
(PDF/187.65 KB)

Maltese
(PDF/192.4 KB)

Polish
(PDF/178.98 KB)

Portuguese
(PDF/148.77 KB)

Romanian
(PDF/173.77 KB)

Slovak
(PDF/175.63 KB)

Slovenian
(PDF/171.18 KB)

Spanish
(PDF/147.02 KB)

Swedish
(PDF/146.71 KB)
List item

Spironolactone: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002780/202103 (PDF/76.22 KB)

for the implementation - PSUSA/00002780/202103 … for the implementation - PSUSA/00002780/202103 Other languages: lv mt nl …

Last updated: 12/01/2022
Active substance: spironolactone
Procedure number: PSUSA/00002780/202103
Regulatory outcome: Variation
Bulgarian
(PDF/77.63 KB)

Croatian
(PDF/82.06 KB)

Czech
(PDF/75.79 KB)

Danish
(PDF/75.3 KB)

Dutch
(PDF/74.92 KB)

Estonian
(PDF/69.73 KB)

Finnish
(PDF/72.18 KB)

French
(PDF/85.33 KB)

German
(PDF/80.23 KB)

Greek
(PDF/76.05 KB)

Hungarian
(PDF/75.57 KB)

Icelandic
(PDF/77.65 KB)

Italian
(PDF/94.77 KB)

Latvian
(PDF/90.28 KB)

Lithuanian
(PDF/82.21 KB)

Maltese
(PDF/104.34 KB)

Norwegian
(PDF/75.24 KB)

Polish
(PDF/96.79 KB)

Portuguese
(PDF/94.5 KB)

Romanian
(PDF/72.88 KB)

Slovak
(PDF/77.79 KB)

Slovenian
(PDF/73.85 KB)

Spanish
(PDF/76.24 KB)

Swedish
(PDF/84.79 KB)
List item

Promestriene (cream and vaginal capsules) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00009271/202103 (PDF/84.34 KB)

for the implementation - PSUSA/00009271/202103 … for the implementation - PSUSA/00009271/202103 Other languages: es et fi …

Last updated: 31/01/2022
Active substance: promestriene
Procedure number: PSUSA/00009271/202103
Regulatory outcome: Variation
(PDF/102.13 KB)

Bulgarian
(PDF/95.55 KB)

Croatian
(PDF/213.09 KB)

Czech
(PDF/159.79 KB)

Danish
(PDF/95.66 KB)

Dutch
(PDF/86.76 KB)

Estonian
(PDF/146.98 KB)

Finnish
(PDF/82.21 KB)

French
(PDF/86.55 KB)

German
(PDF/88.44 KB)

Greek
(PDF/104.84 KB)

Hungarian
(PDF/107.53 KB)

Italian
(PDF/100.75 KB)

Latvian
(PDF/204.99 KB)

Lithuanian
(PDF/204.94 KB)

Maltese
(PDF/212.11 KB)

Polish
(PDF/128.11 KB)

Portuguese
(PDF/84.89 KB)

Romanian
(PDF/130.19 KB)

Slovak
(PDF/185.58 KB)

Spanish
(PDF/105.22 KB)

Swedish
(PDF/85.29 KB)
List item

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

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
List item

Cefprozil: List of nationally authorised medicinal products - PSUSA/00000605/201712 (PDF/84.44 KB)

authorised medicinal products - PSUSA/00000605/201712 … authorised medicinal products - PSUSA/00000605/201712 EMA/613929/2018 13/09/2018 … cefprozil Procedure no.: PSUSA/00000605/201712 …

Last updated: 13/09/2018
Active substance: cefprozil
Procedure number: PSUSA/00000605/201712
Regulatory outcome: Maintenance
List item

Amiodarone: List of nationally authorised medicinal products - PSUSA/00000166/201712 (PDF/141.23 KB)

authorised medicinal products - PSUSA/00000166/201712 … authorised medicinal products - PSUSA/00000166/201712 EMA/615607/2018 13/09/2018 … amiodarone Procedure no.: PSUSA/00000166/201712 List of nationally …

Last updated: 13/09/2018
Active substance: amiodarone
Procedure number: PSUSA/00000166/201712
Regulatory outcome: Maintenance
List item

Lubiprostone: List of nationally authorised medicinal products - PSUSA/00010290/201801 (PDF/95.2 KB)

authorised medicinal products - PSUSA/00010290/201801 … authorised medicinal products - PSUSA/00010290/201801 EMA/617522/2018 12/09/2018 … lubiprostone Procedure No.: PSUSA/00010290/201801 List of nationally …

Last updated: 12/09/2018
Active substance: Lubiprostone
Procedure number: PSUSA/00010290/201801
Regulatory outcome: Maintenance
List item

Celecoxib: List of nationally authorised medicinal products - PSUSA/00000616/201712 (PDF/173.46 KB)

authorised medicinal products - PSUSA/00000616/201712 … authorised medicinal products - PSUSA/00000616/201712 EMA/613929/2018 13/09/2018 … celecoxib Procedure no.: PSUSA/00000616/201712 …

Last updated: 13/09/2018
Active substance: Celecoxib
Procedure number: PSUSA/00000616/201712
Regulatory outcome: Maintenance
List item

Cyproheptadine: List of nationally authorised medicinal products - PSUSA/00000902/201712 (PDF/56.47 KB)

authorised medicinal products - PSUSA/00000902/201712 … authorised medicinal products - PSUSA/00000902/201712 EMA/613960/2018 11/09/2018 … cyproheptadine Procedure no.: PSUSA/00000902/201712 …

Last updated: 11/09/2018
Active substance: cyproheptadine
Procedure number: PSUSA/00000902/201712
Regulatory outcome: Maintenance
List item

Acebutolol: List of nationally authorised medicinal products - PSUSA/00000018/201712 (PDF/68.24 KB)

authorised medicinal products - PSUSA/00000018/201712 … authorised medicinal products - PSUSA/00000018/201712 EMA/612663/2018 11/09/2018 … acebutolol Procedure no.: PSUSA/00000018/201712 …

Last updated: 11/09/2018
Active substance: acebutolol
Procedure number: PSUSA/00000018/201712
Regulatory outcome: Maintenance

3550 results

N(2)-L-alanyl-L-glutamine : List of nationally authorised medicinal products - PSUSA/00003158/202103 (PDF/149.26 KB)

Influenza vaccine (surface antigen, inactivated) : List of nationally authorised medicinal products - PSUSA/00001744/202103 (PDF/141.43 KB)

Tobramycin (ophthalmic and otic use): List of nationally authorised medicinal products - PSUSA/00009317/202103 (PDF/175.88 KB)

Hydroxyethyl starch - List of nationally authorised medicinal products - PSUSA-00001694-202103 (PDF/310.93 KB)

Influenza vaccine (split virion, inactivated) (non centrally authorised products) - List of nationally authorised medicinal products - PSUSA-00010298-202103 (PDF/477.74 KB)

Amlodipine besilate / ramipril, amlodipine / hydrochlorothiazide / ramipril, hydrochlorothiazide / ramipril : List of nationally authorised medicinal products - PSUSA/00010774/202103 (PDF/1.49 MB)

Dobutamine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001151/202103 (PDF/91.49 KB)

Bacterial lysate of haemophilus influenzae / klebsiella pneumoniae / moraxella catarrhalis / staphylococcus aureus / streptococcus mitis / strep. pneumoniae / strep. pyogenes : List of nationally authorised medicinal products - PSUSA/00002786/202103 (PDF/118.34 KB)

Lanthanum : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00003175/202103 (PDF/116.89 KB)

Metamizole : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001997/202103 (PDF/142.77 KB)

Spironolactone: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002780/202103 (PDF/76.22 KB)

Promestriene (cream and vaginal capsules) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00009271/202103 (PDF/84.34 KB)

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

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)

Cefprozil: List of nationally authorised medicinal products - PSUSA/00000605/201712 (PDF/84.44 KB)

Amiodarone: List of nationally authorised medicinal products - PSUSA/00000166/201712 (PDF/141.23 KB)

Lubiprostone: List of nationally authorised medicinal products - PSUSA/00010290/201801 (PDF/95.2 KB)

Celecoxib: List of nationally authorised medicinal products - PSUSA/00000616/201712 (PDF/173.46 KB)

Cyproheptadine: List of nationally authorised medicinal products - PSUSA/00000902/201712 (PDF/56.47 KB)

Acebutolol: List of nationally authorised medicinal products - PSUSA/00000018/201712 (PDF/68.24 KB)