Concept paper for the development of a guideline on the demonstration of therapeutic equivalence for nasal products
Concept paper for the development of a guideline on the demonstration of therapeutic equivalence for nasal products
Concept paper for the development of a guideline on the demonstration of therapeutic equivalence for nasal products
QRD statements for metered dose inhalers containing fluorinated greenhouse gases
Opinion/decision on a Paediatric investigation plan (PIP): Uptravi, Selexipag, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Other, PIP number: P/0417/2023
Opinion/decision on a Paediatric investigation plan (PIP): Giapreza, Angiotensin II (LJPC-501), decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Cardiovascular diseases, PIP number: P/0415/2023
Opinion/decision on a Paediatric investigation plan (PIP): Veyvondi, vonicog alfa, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Haematology-Hemostaseology, PIP number: P/0416/2023
Opinion/decision on a Paediatric investigation plan (PIP): Libtayo, Cemiplimab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: P/0414/2023
Opinion/decision on a Paediatric investigation plan (PIP): Zolgensma, Onasemnogene abeparvovec, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Neurology, PIP number: P/0412/2023
New fee regulation: General questions and answers - Annex I
New fee regulation: General questions and answers for all applicants
PSUSA/00001990/202402