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Didanosine: List of nationally authorised medicinal products - PSUSA/00001054/201810 (PDF/100.58 KB)

Last updated: 28/06/2019
Active substance: didanosine
Procedure number: PSUSA/00001054/201810
Regulatory outcome: Maintenance
List item

Iron isomaltoside : List of nationally authorised medicinal products - PSUSA/00010866/202101 (PDF/204.6 KB)

Last updated: 24/09/2021
Active substance: iron isomaltoside
Procedure number: PSUSA/00010866/202101
Regulatory outcome: Maintenance
List item

Tobramycin (nebuliser solution) : List of nationally authorised medicinal products - PSUSA/00009316/202012 (PDF/204.1 KB)

Last updated: 24/09/2021
Active substance: Tobramycin
Procedure number: PSUSA/00009316/202012
Regulatory outcome: Maintenance
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Influenza vaccine (split virion, inactivated) (non centrally authorised products) - List of nationally authorised medicinal products - PSUSA-00010298-202103 (PDF/477.74 KB)

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

Flumazenil : List of nationally authorised medicinal products - PSUSA/00001413/202112 (PDF/163.74 KB)

Last updated: 09/09/2022
Active substance: flumazenil
Procedure number: PSUSA/00001413/202112
Regulatory outcome: Maintenance
List item

Pilocarpine (ophthalmic formulation) : List of nationally authorised medicinal products - PSUSA/00002410/202108 (PDF/157.9 KB)

Last updated: 09/09/2022
Active substance: pilocarpine (ophthalmic formulation)
Procedure number: PSUSA/00002410/202108
Regulatory outcome: Maintenance
List item

Alverine / simeticone : List of nationally authorised medicinal products - PSUSA/00000125/202202 (PDF/151.49 KB)

Last updated: 29/09/2022
Active substance: alverine, simeticone
Procedure number: PSUSA/00000125/202202
Regulatory outcome: Maintenance
List item

Ivermectin (systemic use) : List of nationally authorised medicinal products - PSUSA/00010377/202204 (PDF/135.14 KB)

Last updated: 23/01/2023
Active substance: Ivermectin
Procedure number: PSUSA/00010377/202204
Regulatory outcome: Variation
List item

Ivermectin (systemic use) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010377/202204 (PDF/112.1 KB)

Last updated: 23/01/2023
Active substance: Ivermectin
Procedure number: PSUSA/00010377/202204
Regulatory outcome: Variation
Bulgarian
(PDF/131.31 KB)

Croatian
(PDF/137.49 KB)

Czech
(PDF/138.09 KB)

Danish
(PDF/104.48 KB)

Dutch
(PDF/115.18 KB)

Estonian
(PDF/121.41 KB)

Finnish
(PDF/110.09 KB)

French
(PDF/113.8 KB)

German
(PDF/117 KB)

Greek
(PDF/130.42 KB)

Hungarian
(PDF/136.75 KB)

Italian
(PDF/130.36 KB)

Latvian
(PDF/142.99 KB)

Lithuanian
(PDF/103.32 KB)

Maltese
(PDF/132.44 KB)

Polish
(PDF/110.92 KB)

Portuguese
(PDF/113.74 KB)

Romanian
(PDF/131.99 KB)

Slovak
(PDF/133.13 KB)

Slovenian
(PDF/127.69 KB)

Spanish
(PDF/113.13 KB)

Swedish
(PDF/112.77 KB)
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Vinorelbine : List of nationally authorised medicinal products - PSUSA/00003124/202204 (PDF/226.24 KB)

Last updated: 24/01/2023
Active substance: vinorelbine
Procedure number: PSUSA/00003124/202204
Regulatory outcome: Variation
List item

Lanreotide : List of nationally authorised medicinal products - PSUSA/00001826/202205 (PDF/206.91 KB)

Last updated: 24/01/2023
Active substance: lanreotide
Procedure number: PSUSA/00001826/202205
Regulatory outcome: Maintenance