A description of medicines related safety issues evaluated through a referral procedure at the EU level after 2012.

Conclusions: PRAC recommended routine or additional RMMs for most referrals. Complete withdrawal of a drug or withdrawal of certain pharmaceutical forms or concentrations was advised only when the risk could not be managed by RMMs. PMID: 32186202 [PubMed - as supplied by publisher]
Source: Expert Opinion on Drug Safety - Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research