PSUSA/00002163/202407

Opinion/decision on a Paediatric investigation plan (PIP): Enerzair Breezhaler, Indacaterol (acetate),Mometasone (furoate),Glycopyrronium bromide, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Pneumology-allergology, PIP number: P/0493/2023

EMEA-001716-PIP07-22

Human medicines European public assessment report (EPAR): Karvea, irbesartan, Date of authorisation: 26/08/1997, Revision: 48, Status: Authorised

Opinion/decision on a Paediatric investigation plan (PIP): Skyrizi, Risankizumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Immunology-Rheumatology-Transplantation, PIP number: P/0492/2023

EMEA-001318-PIP01-12-M05

EMEA-003467-PIP01-23

Union list of critical medicines: eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) / Product Management System (PMS) entries (outdated)

Herbal medicinal product: Hyperici herba, Hypericum perforatum L.,Cimicifuga racemosa (L.) Nutt., D: Draft under discussion

Herbal medicinal product: Valerianae radix, Valeriana officinalis L., C: ongoing call for scientific data