ICH M14 guideline on general principles on plan, design and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines - Scientific guideline

ICH M14 guideline on general principles on planning, designing, analysing, and reporting of non-interventional studies that utilise real-world data for safety assessment of medicines Step 5

Nitrosamines EMEA-H-A5(3)-1490 - Questions and answers for marketing authorisation holders / applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products

Veterinary medicines European public assessment report (EPAR): Novem, meloxicam, Status: Authorised

Veterinary medicines European public assessment report (EPAR): Oncept IL-2, feline interleukin-2 recombinant canarypox virus (vCP1338 virus), Status: Authorised

Veterinary medicines European public assessment report (EPAR): Osurnia, terbinafine,florfenicol,betamethasone, Status: Authorised

Veterinary medicines European public assessment report (EPAR): Nobilis IB Primo QX, avian infectious bronchitis virus strain D388, Status: Authorised

Veterinary medicines European public assessment report (EPAR): Nobivac Bb, live vaccine against Bordetella bronchiseptica in cats, Status: Authorised

Veterinary medicines European public assessment report (EPAR): Novaquin, meloxicam, Status: Authorised

Veterinary medicines European public assessment report (EPAR): Porcilis Porcoli Diluvac Forte (previously Porcilis Porcoli), vaccine to provide passive immunity to the progeny against E. coli in pigs, Status: Authorised