ICH guideline E19 on a selective approach to safety data collection in specific late-stage pre-approval or post-approval clinical trials - Scientific guideline
Human medicines European public assessment report (EPAR): Aldurazyme, laronidase, Mucopolysaccharidosis I, Date of authorisation: 09/06/2003, Revision: 24, Status: Authorised
Human medicines European public assessment report (EPAR): Remsima, infliximab, Arthritis, Psoriatic;Spondylitis, Ankylosing;Colitis, Ulcerative;Psoriasis;Crohn Disease;Arthritis, Rheumatoid, Date of authorisation: 10/09/2013, Revision: 37, Status: Authorised
Timetable: Type II variation and worksharing application monthly assessment
Timetable: Type II variation and worksharing application alternative monthly assessment
Sweden - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021
Czechia - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021
European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) web based sales and and animal population data collection protocol
Opinion/decision on a Paediatric investigation plan (PIP): 3,6-diamino-2,5-bis{N-[(1R)-1-carboxy-2-hydroxyethyl]carbamoyl}pyrazine (MB-102), decision type: , therapeutic area: , PIP number: P/0457/2022
Opinion/decision on a Paediatric investigation plan (PIP): Enasidenib, decision type: , therapeutic area: , PIP number: P/0456/2022