Mundipharma

This sponsor has funded 15 studies across 16 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
3702 Ongoing EU RMP category 3 A prospective, multicentre, non-interventional study to collect further data on the safety and effectiveness of a new combination of formoterol and... No No
3889 Ongoing Not included in RMP The effect of asthma pre-treatment on the efficacy of flutiform® treatment with respect to asthma control in patients with asthma in daily clinical... No No
4072 Ongoing EU RMP category 3 A Non interventional post authorisation study to determine the safety and effectiveness of flutiform® (Affirm Study). (FLT9503 AFFIRM) No No
7072 Ongoing Not included in RMP Exploratory study identifying the benefits of pMDI versus Diskus for delivering fluticasone/salmeterol combination therapy in patients with chronic... Yes No
7690 Ongoing Not included in RMP The effect of flutiform® treatment on asthma control in patients with asthma in daily clinical practice; an observational study No No
9651 Finalised Not included in RMP CRITIKAL Study Yes No
10129 Finalised Not included in RMP Prevalence and Incidence of Problematic Prescription Opioid Use and Abuse in the United Kingdom and Germany (OXY9504) No No
11035 Finalised Unspecified Safety and efficacy of oxycodone/naloxone vs. oxycodone vs. morphine in the treatment of chronic low back pain - a 12-week prospective (optionally... No Yes
11234 Ongoing Unspecified NON-INTERVENTIONAL OBSERVATIONAL STUDY FOR THE EVALUATION OF TOLERABILITY AND EFFICACY OF THE WHO-STEP III OPIOIDS OXYCODONE/NALOXONE PR AND... No No
12275 Finalised Not included in RMP Real-life effectiveness evaluation of changing inhaler device for asthma treatment in Korea (Transfform) Yes No
12279 Finalised Not included in RMP Real-life effectiveness evaluation of asthma treatment in Korea Yes Yes
12330 Finalised EU RMP category 1 An observational evaluation of prescribing of fixed-dose combination inhaled corticosteroid / long-acting beta2-agonist (ICS/LABA): fluticasone... No Yes
14418 Ongoing Not included in RMP Real-Life evaluation of asthma control and exacerbation risk in patients treated with fluticasone propionate / formotérol fixed-dose association... No No
41097 Finalised Not included in RMP Incidence of tolerance, dependence, drug abuse and misuse of Targin in patients with Restless Legs Syndrome No No
41225 Ongoing EU RMP category 3 A multi-national, prospective mixed methods study of the effectiveness of naloxone (including intranasal Nyxoid) administration by lay people in... No No

PAS by Risk Management Plan (RMP) requirement

Mundipharma

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.