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Loperamide, loperamide / simeticone : List of nationally authorised medicinal products - PSUSA/00010665/202105 (PDF/228.94 KB)

authorised medicinal products - PSUSA/00010665/202105 … authorised medicinal products - PSUSA/00010665/202105 EMA/148029/2022 14/03/2022 … simeticone Procedure no.: PSUSA/00010665/202105 List of nationally authorised …

Last updated: 14/03/2022
Active substance: loperamide, simeticone
Procedure number: PSUSA/00010665/202105
Regulatory outcome: Variation
List item

Loperamide, loperamide / simeticone : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010665/202105 (PDF/27.38 KB)

for the implementation - PSUSA/00010665/202105 … for the implementation - PSUSA/00010665/202105 Other languages: lt it is …

Last updated: 14/03/2022
Active substance: loperamide, simeticone
Procedure number: PSUSA/00010665/202105
Regulatory outcome: Variation
Bulgarian
(PDF/53.31 KB)

Croatian
(PDF/47.29 KB)

Czech
(PDF/48.33 KB)

Danish
(PDF/25.34 KB)

Dutch
(PDF/25.97 KB)

Estonian
(PDF/24.72 KB)

Finnish
(PDF/24.87 KB)

French
(PDF/25.91 KB)

German
(PDF/25.76 KB)

Greek
(PDF/54.96 KB)

Hungarian
(PDF/45.65 KB)

Icelandic
(PDF/25.02 KB)

Italian
(PDF/27.51 KB)

Latvian
(PDF/50.9 KB)

Lithuanian
(PDF/76.61 KB)

Maltese
(PDF/51.45 KB)

Norwegian
(PDF/25.04 KB)

Polish
(PDF/50.44 KB)

Portuguese
(PDF/25.53 KB)

Romanian
(PDF/48.47 KB)

Slovak
(PDF/47.81 KB)

Slovenian
(PDF/45.82 KB)

Spanish
(PDF/25.91 KB)

Swedish
(PDF/25.28 KB)
List item

Loperamide, loperamide / simeticone: List of nationally authorised medicinal products - PSUSA/00010665/201805 (PDF/386.34 KB)

authorised medicinal products - PSUSA/00010665/201805 … authorised medicinal products - PSUSA/00010665/201805 EMA/172877/2019 13/03/2019 …

Last updated: 13/03/2019
Active substance: loperamide, simeticone
Procedure number: PSUSA/00010665/201805
Regulatory outcome: Variation
List item

Loperamide, loperamide / simeticone: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010665/201805 (PDF/98.38 KB)

for the implementation - PSUSA/00010665/201805 … for the implementation - PSUSA/00010665/201805 Other languages: pl pt ro …

Last updated: 13/03/2019
Active substance: loperamide, simeticone
Procedure number: PSUSA/00010665/201805
Regulatory outcome: Variation
Bulgarian
(PDF/121.35 KB)

Croatian
(PDF/110.39 KB)

Czech
(PDF/116.01 KB)

Danish
(PDF/96.69 KB)

Dutch
(PDF/88.13 KB)

Estonian
(PDF/94.39 KB)

Finnish
(PDF/94.33 KB)

French
(PDF/97.22 KB)

German
(PDF/93.15 KB)

Greek
(PDF/112.3 KB)

Hungarian
(PDF/116.4 KB)

Icelandic
(PDF/88.49 KB)

Italian
(PDF/107.12 KB)

Latvian
(PDF/122.39 KB)

Lithuanian
(PDF/140.04 KB)

Maltese
(PDF/120.37 KB)

Norwegian
(PDF/88.99 KB)

Polish
(PDF/122.76 KB)

Portuguese
(PDF/90.08 KB)

Romanian
(PDF/113.63 KB)

Slovak
(PDF/103.57 KB)

Slovenian
(PDF/102.89 KB)

Spanish
(PDF/105.88 KB)

Swedish
(PDF/97.53 KB)
List item

Ozenoxacin - List of nationally authorised medicinal products - PSUSA/00010651/202105 (PDF/95.21 KB)

authorised medicinal products - PSUSA/00010651/202105 … authorised medicinal products - PSUSA/00010651/202105 EMA/689651/2021 03/12/2021 … ozenoxacin Procedure no.: PSUSA/00010651/202105 List of …

Last updated: 03/12/2021
Active substance: Ozenoxacin
Procedure number: PSUSA/00010651/202105
Regulatory outcome: Maintenance
List item

Nadifloxacin : List of nationally authorised medicinal products - PSUSA/00002102/202105 (PDF/94.36 KB)

authorised medicinal products - PSUSA/00002102/202105 … authorised medicinal products - PSUSA/00002102/202105 EMA/683828/2021 14/01/2022 … nadifloxacin Procedure no.: PSUSA/00002102/202105 List of nationally …

Last updated: 14/01/2022
Active substance: nadifloxacin
Procedure number: PSUSA/00002102/202105
Regulatory outcome: Maintenance
List item

Acipimox : List of nationally authorised medicinal products - PSUSA/00000050/202105 (PDF/97.19 KB)

authorised medicinal products - PSUSA/00000050/202105 … authorised medicinal products - PSUSA/00000050/202105 EMA/35549/2022 19/01/2022 … acipimox Procedure no.: PSUSA/00000050/202105 List of nationally …

Last updated: 19/01/2022
Active substance: acipimox
Procedure number: PSUSA/00000050/202105
Regulatory outcome: Maintenance
List item

Clevidipine : List of nationally authorised medicines - PSUSA/00010288/202105 (PDF/119.38 KB)

nationally authorised medicines - PSUSA/00010288/202105 … nationally authorised medicines - PSUSA/00010288/202105 EMA/27992/2022 17/01/2022 … clevidipine Procedure no.: PSUSA/00010288/202105 List of nationally …

Last updated: 17/01/2022
Active substance: clevidipine
Procedure number: PSUSA/00010288/202105
Regulatory outcome: Maintenance
List item

Methoxyflurane: List of nationally authorised medicinal products - PSUSA/00010484/202105 (PDF/88.89 KB)

authorised medicinal products - PSUSA/00010484/202105 … authorised medicinal products - PSUSA/00010484/202105 EMA/772781/2021 05/01/2022 … methoxyflurane Procedure no.: PSUSA/00010484/202105 …

Last updated: 05/01/2022
Active substance: Methoxyflurane
Procedure number: PSUSA/00010484/202105
Regulatory outcome: Maintenance
List item

Flunarizine : List of nationally authorised medicinal products - PSUSA/00001416/202105 (PDF/137.69 KB)

authorised medicinal products - PSUSA/00001416/202105 … authorised medicinal products - PSUSA/00001416/202105 EMA/25628/2022 14/01/2022 … flunarizine Procedure no.: PSUSA/00001416/202105 List of nationally …

Last updated: 14/01/2022
Active substance: flunarizine
Procedure number: PSUSA/00001416/202105
Regulatory outcome: Maintenance
List item

Pholcodine : List of nationally authorised medicinal products - PSUSA/00002396/202105 (PDF/139.13 KB)

authorised medicinal products - PSUSA/00002396/202105 … authorised medicinal products - PSUSA/00002396/202105 EMA/156842/2022 14/03/2022 … pholcodine Procedure no.: PSUSA/00002396/202105 List of nationally …

Last updated: 14/03/2022
Active substance: pholcodine
Procedure number: PSUSA/00002396/202105
Regulatory outcome: Variation
List item

Pamidronate : List of nationally authorised medicinal products - PSUSA/00002269/202105 (PDF/158.17 KB)

authorised medicinal products - PSUSA/00002269/202105 … authorised medicinal products - PSUSA/00002269/202105 EMA/PRAC/14996/2022 16/03/202 … pamidronate Procedure No.: PSUSA/00002269/202105 EMA/PRAC/14996/2022 …

Last updated: 16/03/2022
Active substance: pamidronate
Procedure number: PSUSA/00002269/202105
Regulatory outcome: Maintenance
List item

Lanreotide : List of nationally authorised medicinal products - PSUSA/00001826/202105 (PDF/203.02 KB)

authorised medicinal products - PSUSA/00001826/202105 … authorised medicinal products - PSUSA/00001826/202105 EMA/24065/2022 14/01/2022 … lanreotide Procedure no.: PSUSA/00001826/202105 List of nationally …

Last updated: 14/01/2022
Active substance: lanreotide
Procedure number: PSUSA/00001826/202105
Regulatory outcome: Maintenance
List item

Remifentanil : List of nationally authorised medicinal products - PSUSA/00002617/202105 (PDF/176.78 KB)

authorised medicinal products - PSUSA/00002617/202105 … authorised medicinal products - PSUSA/00002617/202105 EMA/137844/2022 08/03/2022 … remifentanil Procedure no.: PSUSA/00002617/202105 List of nationally …

Last updated: 08/03/2022
Active substance: remifentanil
Procedure number: PSUSA/00002617/202105
Regulatory outcome: Variation
List item

Goserelin : List of nationally authorised medicinal products - PSUSA/00001562/202105 (PDF/167.1 KB)

authorised medicinal products - PSUSA/00001562/202105 … authorised medicinal products - PSUSA/00001562/202105 EMA/195107/2022 31/03/2022 … goserelin Procedure no.: PSUSA/00001562/202105 …

Last updated: 31/03/2022
Active substance: goserelin
Procedure number: PSUSA/00001562/202105
Regulatory outcome: Maintenance
List item

Lactulose : List of nationally authorised medicinal products - PSUSA/00001821/202105 (PDF/306.08 KB)

authorised medicinal products - PSUSA/00001821/202105 … authorised medicinal products - PSUSA/00001821/202105 EMA/156898/2022 14/03/2022 … lactulose Procedure no.: PSUSA/00001821/202105 List of nationally …

Last updated: 14/03/2022
Active substance: lactulose
Procedure number: PSUSA/00001821/202105
Regulatory outcome: Variation
List item

Benazepril / hydrochlorothiazide : List of nationally authorised medicinal products for variation - PSUSA/00000314/202105 (PDF/192.4 KB)

products for variation - PSUSA/00000314/202105 … products for variation - PSUSA/00000314/202105 PSUSA/00000314/202105 12/04/2022 … hydrochlorothiazide Procedure No.: PSUSA/00000314/202105 EMA/CHMP/4787/2022 …

Last updated: 12/04/2022
Active substance: benazepril, hydrochlorothiazide
Procedure number: PSUSA/00000314/202105
Regulatory outcome: Variation
List item

Olodaterol/tiotropium : List of nationally authorised medicinal products - PSUSA/00010489/202105 (PDF/322.6 KB)

authorised medicinal products - PSUSA/00010489/202105 … authorised medicinal products - PSUSA/00010489/202105 EMA/28179/2022 17/01/2022 … olodaterol/tiotropium Procedure no.: PSUSA/00010489/202105 List of nationally …

Last updated: 17/01/2022
Active substance: olodaterol, tiotropium
Procedure number: PSUSA/00010489/202105
Regulatory outcome: Maintenance
List item

Human hemin : List of nationally authorised medicinal products - PSUSA/00001629/202105 (PDF/152.46 KB)

authorised medicinal products - PSUSA/00001629/202105 … authorised medicinal products - PSUSA/00001629/202105 EMA/53411/2022 26/01/2022 … human hemin Procedure no.: PSUSA/00001629/202105 List of nationally …

Last updated: 26/01/2022
Active substance: human hemin
Procedure number: PSUSA/00001629/202105
Regulatory outcome: Maintenance
List item

5 fluorouracil / salicylic acid : List of nationally authorised medicinal products - PSUSA/00000008/202105 (PDF/212.49 KB)

authorised medicinal products - PSUSA/00000008/202105 … authorised medicinal products - PSUSA/00000008/202105 EMA/46876/2022 24/01/2022 … salicylic acid Procedure no.: PSUSA/00000008/202105 List of nationally …

Last updated: 24/01/2022
Active substance: 5 fluorouracil / salicylic acid
Procedure number: PSUSA/00000008/202105
Regulatory outcome: Maintenance
List item

Ranitidine : List of the nationally authorised medicinal products - PSUSA/00002610/202105 (PDF/178.67 KB)

authorised medicinal products - PSUSA/00002610/202105 … authorised medicinal products - PSUSA/00002610/202105 EMA/26959/2022 14/01/2022 … ranitidine Procedure No: PSUSA/00002610/202105 …

Last updated: 14/01/2022
Active substance: ranitidine
Procedure number: PSUSA/00002610/202105
Regulatory outcome: Maintenance
List item

Iodine (131i) iobenguane : List of nationally authorised medicinal products - PSUSA/00001764/202105 (PDF/277.29 KB)

authorised medicinal products - PSUSA/00001764/202105 … authorised medicinal products - PSUSA/00001764/202105 EMA/30003/2022 18/01/2022 … iobenguane Procedure no.: PSUSA/00001764/202105 List of nationally …

Last updated: 18/01/2022
Active substance: Iodine (131I) iobenguane
Procedure number: PSUSA/00001764/202105
Regulatory outcome: Maintenance
List item

Misoprostol (gynaecological indication - labour induction) : List of nationally authorised medicinal products - PSUSA/00010353/202105 (PDF/132.54 KB)

authorised medicinal products - PSUSA/00010353/202105 … authorised medicinal products - PSUSA/00010353/202105 EMA/PRAC/15035/2022 16/03/202 … induction) Procedure No.: PSUSA/00010353/202105 EMA/PRAC/15035/2022 …

Last updated: 16/03/2022
Active substance: misoprostol
Procedure number: PSUSA/00010353/202105
Regulatory outcome: Maintenance
List item

Bismuth subcitrate potassium / metronidazole / tetracycline : List of nationally authorised medicinal products - PSUSA/00010199/202105 (PDF/141.21 KB)

authorised medicinal products - PSUSA/00010199/202105 … authorised medicinal products - PSUSA/00010199/202105 EMA/382258/2015 14/01/2022 … tetracycline Procedure no.: PSUSA/00010199/202105 List of nationally …

Last updated: 14/01/2022
Active substance: Bismuth subcitrate potassium, Metronidazole, tetracycline
Procedure number: PSUSA/00010199/202105
Regulatory outcome: Maintenance
List item

Moxifloxacin (topical ophthalmic use) : List of nationally authorised medicinal products - PSUSA/00002094/202105 (PDF/168.34 KB)

authorised medicinal products - PSUSA/00002094/202105 … authorised medicinal products - PSUSA/00002094/202105 EMA/683961/2021 14/01/2022 … ophthalmic use) Procedure no.: PSUSA/00002094/202105 List of nationally …

Last updated: 14/01/2022
Active substance: moxifloxacin
Procedure number: PSUSA/00002094/202105
Regulatory outcome: Maintenance

2359 results

Loperamide, loperamide / simeticone : List of nationally authorised medicinal products - PSUSA/00010665/202105 (PDF/228.94 KB)

Loperamide, loperamide / simeticone : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010665/202105 (PDF/27.38 KB)

Loperamide, loperamide / simeticone: List of nationally authorised medicinal products - PSUSA/00010665/201805 (PDF/386.34 KB)

Loperamide, loperamide / simeticone: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010665/201805 (PDF/98.38 KB)

Ozenoxacin - List of nationally authorised medicinal products - PSUSA/00010651/202105 (PDF/95.21 KB)

Nadifloxacin : List of nationally authorised medicinal products - PSUSA/00002102/202105 (PDF/94.36 KB)

Acipimox : List of nationally authorised medicinal products - PSUSA/00000050/202105 (PDF/97.19 KB)

Clevidipine : List of nationally authorised medicines - PSUSA/00010288/202105 (PDF/119.38 KB)

Methoxyflurane: List of nationally authorised medicinal products - PSUSA/00010484/202105 (PDF/88.89 KB)

Flunarizine : List of nationally authorised medicinal products - PSUSA/00001416/202105 (PDF/137.69 KB)

Pholcodine : List of nationally authorised medicinal products - PSUSA/00002396/202105 (PDF/139.13 KB)

Pamidronate : List of nationally authorised medicinal products - PSUSA/00002269/202105 (PDF/158.17 KB)

Lanreotide : List of nationally authorised medicinal products - PSUSA/00001826/202105 (PDF/203.02 KB)

Remifentanil : List of nationally authorised medicinal products - PSUSA/00002617/202105 (PDF/176.78 KB)

Goserelin : List of nationally authorised medicinal products - PSUSA/00001562/202105 (PDF/167.1 KB)

Lactulose : List of nationally authorised medicinal products - PSUSA/00001821/202105 (PDF/306.08 KB)

Benazepril / hydrochlorothiazide : List of nationally authorised medicinal products for variation - PSUSA/00000314/202105 (PDF/192.4 KB)

Olodaterol/tiotropium : List of nationally authorised medicinal products - PSUSA/00010489/202105 (PDF/322.6 KB)

Human hemin : List of nationally authorised medicinal products - PSUSA/00001629/202105 (PDF/152.46 KB)

5 fluorouracil / salicylic acid : List of nationally authorised medicinal products - PSUSA/00000008/202105 (PDF/212.49 KB)

Ranitidine : List of the nationally authorised medicinal products - PSUSA/00002610/202105 (PDF/178.67 KB)

Iodine (131i) iobenguane : List of nationally authorised medicinal products - PSUSA/00001764/202105 (PDF/277.29 KB)

Misoprostol (gynaecological indication - labour induction) : List of nationally authorised medicinal products - PSUSA/00010353/202105 (PDF/132.54 KB)

Bismuth subcitrate potassium / metronidazole / tetracycline : List of nationally authorised medicinal products - PSUSA/00010199/202105 (PDF/141.21 KB)

Moxifloxacin (topical ophthalmic use) : List of nationally authorised medicinal products - PSUSA/00002094/202105 (PDF/168.34 KB)