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Paracetamol (IV formulation) : List of nationally authorised medicinal products - PSUSA/00002311/202105 (PDF/581.9 KB)

authorised medicinal products - PSUSA/00002311/202105 … authorised medicinal products - PSUSA/00002311/202105 EMA/138000/2022 04/03/2022 … formulation) Procedure no.: PSUSA/00002311/202105 List of nationally …

Last updated: 04/03/2022
Active substance: paracetamol (IV formulation)
Procedure number: PSUSA/00002311/202105
Regulatory outcome: Variation
List item

Paracetamol (IV formulation) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002311/202105 (PDF/136.32 KB)

for the implementation - PSUSA/00002311/202105 … for the implementation - PSUSA/00002311/202105 Other languages: hu is it …

Last updated: 07/04/2022
Active substance: paracetamol (IV formulation)
Procedure number: PSUSA/00002311/202105
Regulatory outcome: Variation
Bulgarian
(PDF/192.3 KB)

Croatian
(PDF/195.36 KB)

Czech
(PDF/159.35 KB)

Danish
(PDF/162.18 KB)

Dutch
(PDF/140.68 KB)

Estonian
(PDF/92.08 KB)

Finnish
(PDF/136.2 KB)

French
(PDF/138.09 KB)

German
(PDF/143.47 KB)

Greek
(PDF/171.42 KB)

Hungarian
(PDF/219.74 KB)

Icelandic
(PDF/134.29 KB)

Italian
(PDF/182.7 KB)

Latvian
(PDF/125.25 KB)

Lithuanian
(PDF/120.98 KB)

Maltese
(PDF/120.5 KB)

Norwegian
(PDF/153.3 KB)

Polish
(PDF/204.5 KB)

Portuguese
(PDF/159.76 KB)

Romanian
(PDF/201.4 KB)

Slovak
(PDF/188.03 KB)

Slovenian
(PDF/230.38 KB)

Spanish
(PDF/154.91 KB)

Swedish
(PDF/172.08 KB)
List item

Paracetamol (IV formulation): List of nationally authorised medicinal products - PSUSA/00002311/201705 (PDF/381.89 KB)

authorised medicinal products - PSUSA/00002311/201705 … authorised medicinal products - PSUSA/00002311/201705 EMA/799933/2017 05/12/2017 … authorised medicinal products; PSUSA/00002311/201705 30 Churchill Place …

Last updated: 05/12/2017
Active substance: paracetamol
Procedure number: PSUSA/00002311/201705
Regulatory outcome: Maintenance
List item

Paracetamol (IV formulation): List of nationally authorised medicinal products - PSUSA/00002311/201605 (PDF/393.79 KB)

authorised medicinal products - PSUSA/00002311/201605 … authorised medicinal products - PSUSA/00002311/201605 EMA/819150/2016 07/12/2016 … authorised medicinal product - PSUSA/00002311/201605 30 Churchill Place …

Last updated: 07/12/2016
Active substance: paracetamol
Procedure number: PSUSA/00002311/201605
Regulatory outcome: Maintenance
List item

Paracetamol (IV formulation): List of nationally authorised medicinal products - PSUSA/00002311/201505 (PDF/149.67 KB)

authorised medicinal products - PSUSA/00002311/201505 … authorised medicinal products - PSUSA/00002311/201505 EMA/1461/2016 04/01/2016 … formulation) Procedure no.: PSUSA/00002311/201505 List of nationally …

Last updated: 17/10/2016
Active substance: paracetamol
Procedure number: PSUSA/00002311/201505
Regulatory outcome: Maintenance
List item

Paracetamol (IV formulation): List of nationally authorised medicinal products - PSUSA/00002311/201805 (PDF/434.16 KB)

authorised medicinal products - PSUSA/00002311/201805 … authorised medicinal products - PSUSA/00002311/201805 EMA/224487/2019Adopted 23/04 …

Last updated: 23/04/2019
Active substance: paracetamol
Procedure number: PSUSA/00002311/201805
Regulatory outcome: Variation
List item

Paracetamol (IV formulation): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00002311/201805 (PDF/29.77 KB)

for the implementation - PSUSA/00002311/201805 … for the implementation - PSUSA/00002311/201805 Other languages: bg cs da …

Last updated: 23/04/2019
Active substance: paracetamol
Procedure number: PSUSA/00002311/201805
Regulatory outcome: Variation
Bulgarian
(PDF/63.59 KB)

Croatian
(PDF/55.93 KB)

Czech
(PDF/107.92 KB)

Danish
(PDF/30.33 KB)

Dutch
(PDF/24.18 KB)

Estonian
(PDF/24.74 KB)

Finnish
(PDF/30.13 KB)

French
(PDF/23.93 KB)

German
(PDF/31.81 KB)

Greek
(PDF/52.87 KB)

Hungarian
(PDF/55.66 KB)

Icelandic
(PDF/30.61 KB)

Italian
(PDF/27.51 KB)

Latvian
(PDF/57.54 KB)

Lithuanian
(PDF/60.04 KB)

Maltese
(PDF/62.48 KB)

Norwegian
(PDF/24.9 KB)

Polish
(PDF/51.52 KB)

Portuguese
(PDF/24.35 KB)

Romanian
(PDF/49 KB)

Slovak
(PDF/48.67 KB)

Slovenian
(PDF/57.36 KB)

Swedish
(PDF/25.1 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
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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
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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

2355 results

Paracetamol (IV formulation) : List of nationally authorised medicinal products - PSUSA/00002311/202105 (PDF/581.9 KB)

Paracetamol (IV formulation) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002311/202105 (PDF/136.32 KB)

Paracetamol (IV formulation): List of nationally authorised medicinal products - PSUSA/00002311/201705 (PDF/381.89 KB)

Paracetamol (IV formulation): List of nationally authorised medicinal products - PSUSA/00002311/201605 (PDF/393.79 KB)

Paracetamol (IV formulation): List of nationally authorised medicinal products - PSUSA/00002311/201505 (PDF/149.67 KB)

Paracetamol (IV formulation): List of nationally authorised medicinal products - PSUSA/00002311/201805 (PDF/434.16 KB)

Paracetamol (IV formulation): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00002311/201805 (PDF/29.77 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)