Nippon Boehringer Ingelheim (NBI)

This sponsor has funded 22 studies across 1 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
8663 Finalised Non-EU RMP-only Post Marketing Surveillance in Japan on Drug Use of JARDIANCE® Tablets in Elderly Patients with type 2 Diabetes Mellitus (Japanese PMS, elderly... Yes No
9786 Finalised Non-EU RMP-only Post Marketing Surveillance in Japan on Long Term Drug Use of JARDIANCE® Tablets in Patients with type 2 Diabetes Mellitus (Japanese JARDIANCE PMS,... Yes No
9802 Finalised Non-EU RMP-only Specific Use-result Surveillance of Spiriva respimat in asthmatics (patients with severe persistent asthma) (Specific Use-result Surveillance in... Yes No
10891 Ongoing Non-EU RMP-only The special drug use-results survey (All-Case Surveillance) of Ofev® Capsules in patients with Idiopathic Pulmonary Fibrosis (IPF) in Japan No No
13462 Finalised Not included in RMP Comparison of the length of stay in patients hospitalized and initiated with dabigatran or warfarin for a concomitant Non-Valvular Atrial Fibrillation... No No
14273 Finalised Non-EU RMP-only Post-marketing surveillance (PMS) on long-term use of tiotropium+olodaterol fixed dose combination (Tio+Olo FDC) 5/5µg in patients with chronic... Yes No
15981 Finalised Non-EU RMP-only The drug use-results survey (All-Case Surveillance) on Prizbind® for Intravenous Solution 2.5 g in Japan (PMS for idarucizumab) No No
16392 Planned Not included in RMP Treatment Patterns of newly initiated oral anticoagulants on Japanese non-vascular atrial fibrillation patients using a Japanese claims database Yes No
17181 Finalised Non-EU RMP-only The special drug use-results survey on long-term use of telmisartan 80 mg/amlodipine 5 mg/hydrochlorothiazide 12.5 mg fixed dose combination tablets... Yes No
17761 Finalised Not included in RMP Clinical characteristics and practice patterns of type 2 diabetes mellitus (T2DM) patients treated with oral antidiabetic drugs (OAD) in Japan:... No No
19173 Finalised Non-EU RMP-only Specific Use-result Surveillance of Spiriva Respimat in asthmatics (patients with mild to moderate persistent asthma) (Specific Use-result... No No
19283 Finalised Non-EU RMP-only Post-Marketing Surveillance on the Use of Prazaxa® (Japanese Prazaxa PMS, second) No No
19696 Ongoing Not included in RMP Comparison of the medication adherence of patients treated with telmisartan/hydrochlorothiazide or telmisartan/amlodipine FDC versus double-pill... No No
20047 Ongoing Not included in RMP Comparative Effectiveness and Safety between Warfarin and Dabigatran Using Real World Claims data of Japanese Non-valvular Atrial Fibrillation... Yes No
20053 Planned Not included in RMP Medical Need of Non-vitamin K Oral Anti-coagulant Reversal in Japan: Epidemiological Assessment of Emergency Surgery, Trauma and Fracture, using Large... Yes No
26442 Finalised Non-EU RMP-only Post Marketing Surveillance in Japan on Long Term Drug Use of TRADIANCE® Combination Tablets AP and BP in Patients with type 2 Diabetes Mellitus... No No
32905 Ongoing Non-EU RMP-only Post-marketing Surveillance (PMS) on long term use of Ofev Capsules in Systemic Scleroderma associated Interstitial Lung Disease (SSc-ILD) in Japan... No No
36605 Ongoing Non-EU RMP-only Post-marketing Surveillance of Ofev Capsules in Chronic (PMS for PF-ILD) No No
40322 Planned Not included in RMP Japanese REal-world data for treatment of afatinib (GIotrif®) in first-line setting and Subsequent Therapies for patients with advanced EGFR... No No
40997 Finalised Not included in RMP Prevalence, Incidence and Patient Characteristics of Chronic Heart Failure (CHF) and the Predicted Subtypes HFrEF( Yes No
44340 Ongoing Non-EU RMP-only Post Marketing Surveillance on Long Term Drug Use of JARDIANCE® Tablets in Patients with chronic heart failure in Japan (PMS of JARDIANCE in CHF) No No
49953 Planned Non-EU RMP-only Post-marketing Surveillance of Spesolimab I.V. Infusion in improvement of Generalized Pustular Psoriasis (GPP) with acute symptoms in Japan (PMS for... No No

PAS by Risk Management Plan (RMP) requirement

Nippon Boehringer Ingelheim (NBI)

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.