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Naftifine: List of nationally authorised medicinal products - PSUSA/00002109/202008 (PDF/115.84 KB)

authorised medicinal products - PSUSA/00002109/202008 … authorised medicinal products - PSUSA/00002109/202008 EMA/127237/2021 03/06/2021 … naftifine Procedure no.: PSUSA/00002109/202008 List of nationally …

Last updated: 03/06/2021
Active substance: naftifine
Procedure number: PSUSA/00002109/202008
Regulatory outcome: Variation
List item

Naftifine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002109/202008 (PDF/85.84 KB)

for the implementation - PSUSA/00002109/202008 … for the implementation - PSUSA/00002109/202008 Other languages: bg cs da …

Last updated: 03/06/2021
Active substance: naftifine
Procedure number: PSUSA/00002109/202008
Regulatory outcome: Variation
Bulgarian
(PDF/86.72 KB)

Croatian
(PDF/126.64 KB)

Czech
(PDF/96.84 KB)

Danish
(PDF/100.06 KB)

Dutch
(PDF/113.31 KB)

Estonian
(PDF/109.25 KB)

Finnish
(PDF/109.15 KB)

French
(PDF/112 KB)

German
(PDF/103.79 KB)

Greek
(PDF/115.51 KB)

Hungarian
(PDF/132.55 KB)

Italian
(PDF/115.67 KB)

Latvian
(PDF/100.72 KB)

Lithuanian
(PDF/119.66 KB)

Maltese
(PDF/132 KB)

Polish
(PDF/96.7 KB)

Portuguese
(PDF/112.54 KB)

Romanian
(PDF/130.38 KB)

Slovak
(PDF/119.95 KB)

Slovenian
(PDF/126.81 KB)

Spanish
(PDF/78.97 KB)

Swedish
(PDF/111.69 KB)
List item

Pethidine: List of nationally authorised medicinal products - PSUSA/00002357/202008 (PDF/115.25 KB)

authorised medicinal products - PSUSA/00002357/202008 … authorised medicinal products - PSUSA/00002357/202008 EMA/162181/2021 16/03/2021 … pethidine Procedure no.: PSUSA/00002357/202008 List of nationally …

Last updated: 16/03/2021
Active substance: pethidine
Procedure number: PSUSA/00002357/202008
Regulatory outcome: Maintenance
List item

Pefloxacin: List of nationally authorised medicinal products - PSUSA/00002322/202008 (PDF/113.89 KB)

authorised medicinal products - PSUSA/00002322/202008 … authorised medicinal products - PSUSA/00002322/202008 EMA/116496/2021 14/04/2021 … pefloxacin Procedure no.: PSUSA/00002322/202008 List of nationally …

Last updated: 14/04/2021
Active substance: pefloxacin
Procedure number: PSUSA/00002322/202008
Regulatory outcome: Maintenance
List item

Permethrin: List of nationally authorised medicinal products - PSUSA/00002355/202008 (PDF/122.96 KB)

authorised medicinal products - PSUSA/00002355/202008 … authorised medicinal products - PSUSA/00002355/202008 EMA/210511/2021 14/04/2021 … permethrin Procedure no.: PSUSA/00002355/202008 List of nationally …

Last updated: 14/04/2021
Active substance: permethrin
Procedure number: PSUSA/00002355/202008
Regulatory outcome: Maintenance
List item

Nifedipine: List of nationally authorised medicinal products - PSUSA/00002156/202008 (PDF/176.96 KB)

authorised medicinal products - PSUSA/00002156/202008 … authorised medicinal products - PSUSA/00002156/202008 EMA/210716/2021 15/04/2021 … nifedipine Procedure no.: PSUSA/00002156/202008 List of nationally …

Last updated: 15/04/2021
Active substance: Nifedipine
Procedure number: PSUSA/00002156/202008
Regulatory outcome: Maintenance
List item

Oxymetazoline: List of nationally authorised medicinal products - PSUSA/00002258/202008 (PDF/264.12 KB)

authorised medicinal products - PSUSA/00002258/202008 … authorised medicinal products - PSUSA/00002258/202008 EMA/164735/2021 18/03/2021 … oxymetazoline Procedure no.: PSUSA/00002258/202008 List of nationally …

Last updated: 18/03/2021
Active substance: oxymetazoline
Procedure number: PSUSA/00002258/202008
Regulatory outcome: Maintenance
List item

Niclosamide: List of nationally authorised medicinal products - PSUSA/00002151/202008 (PDF/103.36 KB)

authorised medicinal products - PSUSA/00002151/202008 … authorised medicinal products - PSUSA/00002151/202008 EMA/19912/2021 15/03/2021 … niclosamide Procedure no.: PSUSA/00002151/202008 List of nationally …

Last updated: 15/03/2021
Active substance: niclosamide
Procedure number: PSUSA/00002151/202008
Regulatory outcome: Maintenance
List item

Modafinil : List of nationally authorised medicinal products - PSUSA/00010242/202008 (PDF/145.14 KB)

authorised medicinal products - PSUSA/00010242/202008 … authorised medicinal products - PSUSA/00010242/202008 EMA/PRAC/222466/2021 21/04/2021 … modafinil Procedure no.: PSUSA/00010242/202008 List of nationally …

Last updated: 21/04/2021
Active substance: modafinil
Procedure number: PSUSA/00010242/202008
Regulatory outcome: Maintenance
List item

Suxamethonium: List of nationally authorised medicinal products - PSUSA/00002834/202008 (PDF/114.46 KB)

authorised medicinal products - PSUSA/00002834/202008 … authorised medicinal products - PSUSA/00002834/202008 EMA/212240/2021 15/04/2021 … suxamethonium Procedure no.: PSUSA/00002834/202008 List of nationally …

Last updated: 15/04/2021
Active substance: suxamethonium
Procedure number: PSUSA/00002834/202008
Regulatory outcome: Maintenance
List item

Bromazepam: List of nationally authorised medicinal products - PSUSA/00000435/202008 (PDF/150.88 KB)

authorised medicinal products - PSUSA/00000435/202008 … authorised medicinal products - PSUSA/00000435/202008 EMA/183024/2021 30/04/2021 … bromazepam Procedure no.: PSUSA/00000435/202008 List of nationally …

Last updated: 30/04/2021
Active substance: bromazepam
Procedure number: PSUSA/00000435/202008
Regulatory outcome: Maintenance
List item

Fosphenytoin: List of nationally authorised medicinal products - PSUSA/00001476/202008 (PDF/131.13 KB)

authorised medicinal products - PSUSA/00001476/202008 … authorised medicinal products - PSUSA/00001476/202008 EMA/246760/2021 30/04/2021 … fosphenytoin Procedure no.: PSUSA/00001476/202008 List of nationally …

Last updated: 30/04/2021
Active substance: fosphenytoin
Procedure number: PSUSA/00001476/202008
Regulatory outcome: Variation
List item

Phenytoin: List of nationally authorised medicinal products - PSUSA/00002392/202008 (PDF/146.64 KB)

authorised medicinal products - PSUSA/00002392/202008 … authorised medicinal products - PSUSA/00002392/202008 EMA/305569/2021 01/06/2021 … phenytoin Procedure no.: PSUSA/00002392/202008 List of nationally …

Last updated: 01/06/2021
Active substance: phenytoin
Procedure number: PSUSA/00002392/202008
Regulatory outcome: Variation
List item

Dexibuprofen: List of nationally authorised medicinal products - PSUSA/00000996/202008 (PDF/220 KB)

authorised medicinal products - PSUSA/00000996/202008 … authorised medicinal products - PSUSA/00000996/202008 EMA/179938/2021 30/04/2021 … dexibuprofen Procedure no.: PSUSA/00000996/202008 List of nationally …

Last updated: 30/04/2021
Active substance: dexibuprofen
Procedure number: PSUSA/00000996/202008
Regulatory outcome: Maintenance
List item

Trimetazidine: List of nationally authorised medicinal products - PSUSA/00003043/202008 (PDF/284.51 KB)

authorised medicinal products - PSUSA/00003043/202008 … authorised medicinal products - PSUSA/00003043/202008 EMA/78560/2021 30/04/2021 … trimetazidine Procedure No.: PSUSA/00003043/202008 List of nationally …

Last updated: 30/04/2021
Active substance: trimetazidine
Procedure number: PSUSA/00003043/202008
Regulatory outcome: Maintenance
List item

Naproxen: List of nationally authorised medicinal products - PSUSA/00002125/202008 (PDF/279.99 KB)

authorised medicinal products - PSUSA/00002125/202008 … authorised medicinal products - PSUSA/00002125/202008 EMA/165987/2021 18/03/2021 … naproxen Procedure no.: PSUSA/00002125/202008 List of nationally …

Last updated: 18/03/2021
Active substance: naproxen
Procedure number: PSUSA/00002125/202008
Regulatory outcome: Maintenance
List item

Oxcarbazepine : List of nationally authorised medicinal products - PSUSA/00002235/202008 (PDF/359.7 KB)

authorised medicinal products - PSUSA/00002235/202008 … authorised medicinal products - PSUSA/00002235/202008 EMA/PRAC/222202/2021 21/04/2021 … oxcarbazepine Procedure no.: PSUSA/00002235/202008 List of nationally …

Last updated: 21/04/2021
Active substance: oxcarbazepine
Procedure number: PSUSA/00002235/202008
Regulatory outcome: Maintenance
List item

Hexoprenaline sulfate: List of nationally authorised medicinal products - PSUSA/00003170/202008 (PDF/161.39 KB)

authorised medicinal products - PSUSA/00003170/202008 … authorised medicinal products - PSUSA/00003170/202008 EMA/213490/2021 19/04/2021 … sulfate Procedure no.: PSUSA/00003170/202008 List of nationally …

Last updated: 19/04/2021
Active substance: hexoprenaline sulfate
Procedure number: PSUSA/00003170/202008
Regulatory outcome: Maintenance
List item

Fluocinolone acetonide: List of nationally authorised medicinal products - PSUSA/00010224/202008 (PDF/120.32 KB)

authorised medicinal products - PSUSA/00010224/202008 … authorised medicinal products - PSUSA/00010224/202008 EMA/255019/2021 12/05/2021 … applicator) Procedure no.: PSUSA/00010224/202008 List of nationally …

Last updated: 12/05/2021
Active substance: Fluocinolone acetonide
Procedure number: PSUSA/00010224/202008
Regulatory outcome: Variation
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Typhoid polysaccharide vaccine : List of nationally authorised medicinal products - PSUSA/00003065/202008 (PDF/174.06 KB)

authorised medicinal products - PSUSA/00003065/202008 … authorised medicinal products - PSUSA/00003065/202008 EMA/131553/2021 16/03/2021 … vaccine Procedure no.: PSUSA/00003065/202008 List of nationally …

Last updated: 16/03/2021
Active substance: typhoid polysaccharide vaccine
Procedure number: PSUSA/00003065/202008
Regulatory outcome: Maintenance
List item

Lidocaine hydrochloride/methylprednisolone acetate: List of nationally authorised medicinal products - PSUSA/00001879/202008 (PDF/183.83 KB)

authorised medicinal products - PSUSA/00001879/202008 … authorised medicinal products - PSUSA/00001879/202008 EMA/164837/2021 24/03/2021 … acetate Procedure no.: PSUSA/00001879/202008 List of nationally …

Last updated: 24/03/2021
Active substance: lidocaine hydrochloride, methylprednisolone acetate
Procedure number: PSUSA/00001879/202008
Regulatory outcome: Maintenance
List item

Dalteparin sodium: List of nationally authorised medicinal products - PSUSA/00000922/202008 (PDF/344.2 KB)

authorised medicinal products - PSUSA/00000922/202008 … authorised medicinal products - PSUSA/00000922/202008 EMA/211175/2021 20/04/2021 … dalteparin sodium Procedure No.: PSUSA/00000922/202008 List of nationally …

Last updated: 20/04/2021
Active substance: dalteparin sodium
Procedure number: PSUSA/00000922/202008
Regulatory outcome: Maintenance
List item

Fluocinolone acetonide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010224/202008 (PDF/29.91 KB)

for the implementation - PSUSA/00010224/202008 … for the implementation - PSUSA/00010224/202008 Other languages: lv es fi …

Last updated: 12/05/2021
Active substance: Fluocinolone acetonide
Procedure number: PSUSA/00010224/202008
Regulatory outcome: Variation
Bulgarian
(PDF/117.01 KB)

Croatian
(PDF/51.06 KB)

Czech
(PDF/210.22 KB)

Danish
(PDF/171.33 KB)

Dutch
(PDF/160.88 KB)

Estonian
(PDF/29.38 KB)

Finnish
(PDF/133.8 KB)

French
(PDF/153.61 KB)

German
(PDF/165.68 KB)

Greek
(PDF/61.54 KB)

Hungarian
(PDF/51.24 KB)

Italian
(PDF/165.11 KB)

Latvian
(PDF/57.36 KB)

Lithuanian
(PDF/57.8 KB)

Maltese
(PDF/54.99 KB)

Norwegian
(PDF/159.85 KB)

Polish
(PDF/194.75 KB)

Portuguese
(PDF/165.81 KB)

Romanian
(PDF/54.08 KB)

Slovak
(PDF/53.07 KB)

Slovenian
(PDF/50.62 KB)

Spanish
(PDF/166.01 KB)

Swedish
(PDF/159.8 KB)
List item

Fosphenytoin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001476/202008 (PDF/83.3 KB)

for the implementation - PSUSA/00001476/202008 … for the implementation - PSUSA/00001476/202008 Other languages: bg cs da …

Last updated: 30/04/2021
Active substance: fosphenytoin
Procedure number: PSUSA/00001476/202008
Regulatory outcome: Variation
Bulgarian
(PDF/92.57 KB)

Croatian
(PDF/92.49 KB)

Czech
(PDF/85.68 KB)

Danish
(PDF/102.76 KB)

Dutch
(PDF/87.27 KB)

Estonian
(PDF/80.26 KB)

Finnish
(PDF/79.76 KB)

French
(PDF/86.2 KB)

German
(PDF/89.88 KB)

Greek
(PDF/91.59 KB)

Hungarian
(PDF/91.22 KB)

Icelandic
(PDF/86.03 KB)

Italian
(PDF/102.98 KB)

Latvian
(PDF/97.99 KB)

Lithuanian
(PDF/92.08 KB)

Maltese
(PDF/101.02 KB)

Norwegian
(PDF/83.1 KB)

Polish
(PDF/95.54 KB)

Portuguese
(PDF/93.34 KB)

Romanian
(PDF/83.33 KB)

Slovak
(PDF/87.69 KB)

Slovenian
(PDF/90.9 KB)

Spanish
(PDF/83.32 KB)

Swedish
(PDF/84.46 KB)
List item

Phenytoin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002392/202008 (PDF/130.15 KB)

for the implementation - PSUSA/00002392/202008 … for the implementation - PSUSA/00002392/202008 Other languages: bg cs da …

Last updated: 01/06/2021
Active substance: phenytoin
Procedure number: PSUSA/00002392/202008
Regulatory outcome: Variation
Bulgarian
(PDF/135.61 KB)

Croatian
(PDF/141.43 KB)

Czech
(PDF/134.46 KB)

Danish
(PDF/136.96 KB)

Dutch
(PDF/155.15 KB)

Estonian
(PDF/108.9 KB)

Finnish
(PDF/129.67 KB)

French
(PDF/129.75 KB)

German
(PDF/142.7 KB)

Greek
(PDF/136.33 KB)

Hungarian
(PDF/133.66 KB)

Italian
(PDF/151.1 KB)

Latvian
(PDF/134.12 KB)

Lithuanian
(PDF/133.37 KB)

Maltese
(PDF/142.15 KB)

Norwegian
(PDF/129.5 KB)

Polish
(PDF/133.74 KB)

Portuguese
(PDF/138 KB)

Romanian
(PDF/137.51 KB)

Slovak
(PDF/140.17 KB)

Slovenian
(PDF/135.18 KB)

Spanish
(PDF/123.18 KB)

Swedish
(PDF/130.52 KB)

3496 results

Naftifine: List of nationally authorised medicinal products - PSUSA/00002109/202008 (PDF/115.84 KB)

Naftifine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002109/202008 (PDF/85.84 KB)

Pethidine: List of nationally authorised medicinal products - PSUSA/00002357/202008 (PDF/115.25 KB)

Pefloxacin: List of nationally authorised medicinal products - PSUSA/00002322/202008 (PDF/113.89 KB)

Permethrin: List of nationally authorised medicinal products - PSUSA/00002355/202008 (PDF/122.96 KB)

Nifedipine: List of nationally authorised medicinal products - PSUSA/00002156/202008 (PDF/176.96 KB)

Oxymetazoline: List of nationally authorised medicinal products - PSUSA/00002258/202008 (PDF/264.12 KB)

Niclosamide: List of nationally authorised medicinal products - PSUSA/00002151/202008 (PDF/103.36 KB)

Modafinil : List of nationally authorised medicinal products - PSUSA/00010242/202008 (PDF/145.14 KB)

Suxamethonium: List of nationally authorised medicinal products - PSUSA/00002834/202008 (PDF/114.46 KB)

Bromazepam: List of nationally authorised medicinal products - PSUSA/00000435/202008 (PDF/150.88 KB)

Fosphenytoin: List of nationally authorised medicinal products - PSUSA/00001476/202008 (PDF/131.13 KB)

Phenytoin: List of nationally authorised medicinal products - PSUSA/00002392/202008 (PDF/146.64 KB)

Dexibuprofen: List of nationally authorised medicinal products - PSUSA/00000996/202008 (PDF/220 KB)

Trimetazidine: List of nationally authorised medicinal products - PSUSA/00003043/202008 (PDF/284.51 KB)

Naproxen: List of nationally authorised medicinal products - PSUSA/00002125/202008 (PDF/279.99 KB)

Oxcarbazepine : List of nationally authorised medicinal products - PSUSA/00002235/202008 (PDF/359.7 KB)

Hexoprenaline sulfate: List of nationally authorised medicinal products - PSUSA/00003170/202008 (PDF/161.39 KB)

Fluocinolone acetonide: List of nationally authorised medicinal products - PSUSA/00010224/202008 (PDF/120.32 KB)

Typhoid polysaccharide vaccine : List of nationally authorised medicinal products - PSUSA/00003065/202008 (PDF/174.06 KB)

Lidocaine hydrochloride/methylprednisolone acetate: List of nationally authorised medicinal products - PSUSA/00001879/202008 (PDF/183.83 KB)

Dalteparin sodium: List of nationally authorised medicinal products - PSUSA/00000922/202008 (PDF/344.2 KB)

Fluocinolone acetonide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010224/202008 (PDF/29.91 KB)

Fosphenytoin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001476/202008 (PDF/83.3 KB)

Phenytoin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002392/202008 (PDF/130.15 KB)