EMA recommends eight drugs for approval from April meeting
The EMA's human medicines committee has adopted a positive opinion for eight medicines, recommending their marketing authorisation.
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The EMA's human medicines committee has adopted a positive opinion for eight medicines, recommending their marketing authorisation.
The marketing license for ingenol mebutate gel (Picato) has been suspended by the MHRA due to studies showing an increased risk of skin malignancies from the drug.
LEO Laboratories is recalling its Picato (ingenol mebutate) gels from pharmacies and wholesalers over a possible risk of skin malignancies; the products must be returned to suppliers for credit.
The EMA will assess the marketing authorisation for the medication to see whether it is a cause of skin cancer in patients.