What's new
Information from the previous month appears monthly in the newsletter “What'sNew” (link to registration page).
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Botulinum toxin a (except for centrally authorised products) New
PSUR-outcome
|
06/11/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Bupropion New
PSUR-outcome
|
05/11/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Niflumic acid New
PSUR-outcome
|
03/11/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Disodium hydrogen phosphate / sodium dihydrogen phosphate, phosphate sodium New
PSUR-outcome
|
03/11/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Testosterone (all formulations apart from topical use) New
PSUR-outcome
|
03/11/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Botulinum neurotoxin type a (150 kd) free from complexing proteins New
PSUR-outcome
|
31/10/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Dexketoprofen / Tramadol New
PSUR-outcome
|
30/10/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Ciclosporin (systemic use) New
PSUR-outcome
|
30/10/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
22/10/2025
Authorisation/registration applications 1. Where do I send my application to and in which form? 2. Method of payment? When do I have to transfer the fee? 3. When, how and in which form should I submit
Levofloxacin (intravenous and oral use) New
Additional template
|
22/07/2025
Further information can be found in the CMDh minutes from may 2025.