Human medicines European public assessment report (EPAR): Exforge HCT, amlodipine besilate,valsartan,hydrochlorothiazide, Date of authorisation: 15/10/2009, Revision: 27, Status: Authorised

Human medicines European public assessment report (EPAR): Skytrofa (previously Lonapegsomatropin Ascendis Pharma), lonapegsomatropin, Date of authorisation: 11/01/2022, Revision: 5, Status: Authorised

Budesonide, gastro-resistant hard capsules with prolonged release properties, 3 mg, product-specific bioequivalence guidance

Budesonide, gastro-resistant hard capsules, 3 mg, gastro- resistant granules, 9 mg product-specific bioequivalence guidance

Budesonide, prolonged release tablets, 9 mg product- specific bioequivalence guidance

Opinion/decision on a Paediatric investigation plan (PIP): Vaxzevria (previously COVID-19 Vaccine AstraZeneca), COVID-19 vaccine (ChAdOx1-S [recombinant]) (AZD1222), decision type: W: decision granting a waiver in all age groups for all conditions or indications, therapeutic area: Vaccines, PIP number: P/0273/2024

Product-specific bioequivalence guidance

EMEA-003587-PIP01-24

EMEA-003360-PIP01-22

HMPC meeting report on European Union herbal monographs, guidelines and other activities - 20-22 January 2025