PSUSA/00001088/202512 - periodic safety update report single assessment

About

Periodic safety update report single assessments (PSUSAs) are single assessments of related periodic safety update reports (PSURs) for active substances contained in medicines authorised in the European Union (EU). A PSUR is a pharmacovigilance report submitted regularly by a marketing-authorisation holder at defined time points following a medicine's authorisation.

Key facts

Active substance(s) in scope of the PSUSA procedure

caffeine / dimenhydrinate, dimenhydrinate

Procedure number

PSUSA/00001088/202512

Regulatory outcome

Variation

Documents

Caffeine / dimenhydrinate, dimenhydrinate : List of nationally authorised medicinal products - PSUSA/00001088/202512

Reference Number:

EMADOC-1700519818-3422143

English (EN) (221.8 KB - PDF)

First published:

28/08/2026

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Caffeine / dimenhydrinate, dimenhydrinate : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001088/202512

English (EN) (24.16 KB - PDF)

First published:

28/08/2026

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Other languages (22)

български (BG) (424.93 KB - PDF)

First published:

28/08/2026

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español (ES) (483.41 KB - PDF)

First published:

28/08/2026

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čeština (CS) (471.69 KB - PDF)

First published:

28/08/2026

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dansk (DA) (481.83 KB - PDF)

First published:

28/08/2026

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Deutsch (DE) (547.74 KB - PDF)

First published:

28/08/2026

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eesti (ET) (484.92 KB - PDF)

First published:

28/08/2026

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ελληνικά (EL) (484.11 KB - PDF)

First published:

28/08/2026

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français (FR) (485.07 KB - PDF)

First published:

28/08/2026

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hrvatski (HR) (486.58 KB - PDF)

First published:

28/08/2026

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italiano (IT) (471.66 KB - PDF)

First published:

28/08/2026

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latviešu (LV) (481.99 KB - PDF)

First published:

28/08/2026

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lietuvių (LT) (493.48 KB - PDF)

First published:

28/08/2026

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magyar (HU) (487.73 KB - PDF)

First published:

28/08/2026

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Malti (MT) (63.27 KB - PDF)

First published:

28/08/2026

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Nederlands (NL) (490.23 KB - PDF)

First published:

28/08/2026

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polski (PL) (520.58 KB - PDF)

First published:

28/08/2026

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português (PT) (32.57 KB - PDF)

First published:

28/08/2026

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română (RO) (476.53 KB - PDF)

First published:

28/08/2026

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slovenčina (SK) (496.53 KB - PDF)

First published:

28/08/2026

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slovenščina (SL) (505.77 KB - PDF)

First published:

28/08/2026

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suomi (FI) (473.04 KB - PDF)

First published:

28/08/2026

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svenska (SV) (482.06 KB - PDF)

First published:

28/08/2026

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