№ lp_2_1_04712
Regulatory lay summary outlining the scientific assessment, authorisation basis, safety information, and risk management measures for a hybrid medicinal product evaluated under a national procedure.
Document type: Public Assessment Report (Lay Summary)
Procedure: National Procedure
Subject: Assessment and authorisation of a hybrid medicinal product
Reference authority: Medicines and Healthcare products Regulatory Agency (MHRA)
Content includes: Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL)
Regulatory framework: Hybrid medicine application
Safety reporting scheme: Yellow Card scheme
Risk management: Risk Management Plan (RMP)
Authorisation status: Marketing authorisation recommended or granted
Target audience: Patients and general public
Price: 8 / 10 USD
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