What's new
Information from the previous month appears monthly in the newsletter “What'sNew” (link to registration page).
For the RSS feed with daily notifications of updates, use the link: RSS feed for “What'sNew”.
Meropenem (fixed dose combination products) New
Additional template
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12/06/2025
Further information can be found in the CMDh minutes from april 2025.
Meropenem New
PSUR-outcome
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12/06/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Hydrocortisone (systemic formulations....) New
PSUR-outcome
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06/06/2025
Hydrocortisone (systemic formulations except for products indicated in adrenal insufficiency in a modified release tablet formulation and except for centrally authorised products for adrenal insufficiency, paediatric use only). Further information…
Sertraline New
PRAC signal recommendation
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06/06/2025
Risk for Multiple acyl-coenzyme A dehydrogenase deficiency (MADD). Further information and amendments to the product information can be found on the EMA website.
Sulfamethoxazole, trimethoprim (cotrimoxazole) New
PRAC signal recommendation
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03/06/2025
Risk for Circulatory shock. Further information and amendments to the product information can be found on the EMA website.
Oxcarbazepine New
PSUR-outcome
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02/06/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Oxytetracycline hydrochloride, hydrocortisone acetate, polymyxin B sulfate (ear/eye drops/suspension/ointment) New
PRAC signal recommendation
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06/05/2025
Risk for hearing and vestibular disorders. Further information and amendments to the product information can be found on the EMA website.