What's new
Information from the previous month appears monthly in the newsletter “What'sNew” (link to registration page).
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Hydromorphone New
PSUR-outcome
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15/09/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Phosphocreatine New
PSUR-outcome
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15/09/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Acetylsalicylic acid / Bisoprolol New
PSUR-outcome
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12/09/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Tapentadol New
PSUR-outcome
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09/09/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Nicotine (Amendments of the product information for oral and oromucosal formulations) New
PSUR-outcome
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08/09/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Domperidone New
PSUR-outcome
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25/08/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Levofloxacin (intravenous and oral use) New
Additional template
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22/07/2025
Further information can be found in the CMDh minutes from may 2025.
Mock-ups New
01/01/1970
Mock-ups New AT Guidance document – Mock-ups This guidance document summarizes the legal basics and the BASG requirements with regards to the mock-ups of human and veterinary medicinal products there