Sandoz

This sponsor has funded 10 studies across 11 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
2679 Finalised EU RMP category 3 SURVEILLANCE STUDY OF PHOTOCONTACT DERMATITIS LEADING TO HOSPITALIZATION IN EUROPE WITH A SPECIAL FOCUS ON TOPICAL KETOPROFEN AND OTHER TOPICAL... Yes No
7654 Finalised Unspecified ESTUDIO AUXOGROWTH - Estudio Exploratorio para la Utilización del Programa de Crecimiento AuxoLog en Pacientes con Déficit de Hormona de Crecimiento... Yes Yes
8398 Ongoing Not included in RMP Binocrit® in the management of preoperative anemia in patients scheduled to undergo major elective orthopedic surgery - a Prospective Observational... No No
10541 Ongoing EU RMP category 3 The Mycophenolate Pregnancy Registry Yes No
11057 Ongoing Not included in RMP Evaluation of the Correlation between fatigue and quality of life in patients with solid tumour, malignant lymphoma or multiple myeloma and treated... No No
11465 Ongoing Not included in RMP Modalities of G-CSF Zarzio® use in clinical practice in patients receiving cytotoxic chemotherapy regimens in which the rest period does not exceed 14... No No
11765 Finalised EU RMP category 1 Evaluation of the Effectiveness of Risk Minimisation Measures: A Joint PASS Survey among Health Care Professionals to Assess their Knowledge and... Yes Yes
12171 Ongoing EU RMP category 1 Retrospective Cohort Study on the Risk of Venous Thromboembolism with the use of combined oral contraceptives containing Chlormadinone... No No
12236 Finalised Not included in RMP Multicenter, open-label, non-interventional study to evaluate the impact on clinical effects, user-friendliness and patient's acceptance of Airflusal®... No No
24731 Finalised Not included in RMP Etude d’impact de la communication menée auprès des médecins prescripteurs d’Epitomax® et ses génériques en France No No

PAS by Risk Management Plan (RMP) requirement

Sandoz

The RMP for a medical product outlines strategies to identify, assess, and mitigate risks, including PAS for further evaluation.

Category 1 studies are imposed as condition of marketing authorisation.
Category 2 studies are imposed as specific obligation of marketing authorisation.
Category 3 studies are required under other circumstances.