PAS funded by this sponsor. EU PAS ID Status RMP requirementTitle Protocol uploaded Results uploaded 5171 Finalised Not included in RMP Characteristics of asthma patients at risk of failed Diskus use in primary care: a retrospective cohort study No No 7645 Ongoing Not included in RMP Comparative effectiveness and safety of Salbutamol Sterinebs® vs Ventolin Nebules® in COPD patients. No No 7678 Finalised Not included in RMP COMPARATIVE EFFECTIVENESS AND SAFETY OF BUDESONIDE STERINEBS® VS. PULMICORT RESPULES® IN A US POPULATION OF ASTHMA PATIENTS. Yes No 7744 Ongoing Not included in RMP The use of a spacer in the delivery of large (Fluticasone Propionate) and small particle (Qvar®) inhaled corticosteroid (ICS) in asthma (FP and Qvar... No No 7753 Finalised Not included in RMP Comparative effectiveness and safety of Ipramol (ipratropium/albuterol) SteriNebs® vs. DuoNeb® Yes No 8019 Finalised Unspecified Characterising patients at risk of failed Diskus use in primary care Yes No 8391 Finalised Unspecified Real-world effectiveness of extrafine vesrus standard particle inhaled corticosteroids: A comparative effectiveness analysis of extrafine (EF)... Yes No 8740 Finalised Unspecified State of the Union: Current asthma morbidity in the UK No No 8832 Finalised Unspecified A real-life historic study assessing metabolic and other adverse effects of small versus large particle inhaled corticosteroids in relation to their... No No 8840 Finalised Not included in RMP Dose response curves for patients prescribed small & large particle ICS formulation: an observational evaluation of the comparative effect of ICS dose... No No 9105 Ongoing Not included in RMP Real-world effectiveness of extra-fine formulations in Denmark No No 9651 Finalised Not included in RMP CRITIKAL Study Yes No 10402 Finalised EU RMP category 3 Pharmaco-epidemiologic study on occurrence of adverse events No Yes 10559 Finalised Unspecified Effectiveness of prescribing similar vs dissimilar devices for COPD management (phase 1) Yes No 10923 Finalised Not included in RMP Effectiveness of prescribing similar vs dissimilar devices for COPD management (phase 2) Yes No 11391 Finalised EU RMP category 1 Drug utilisation study (DUS) on flupirtine-containing products Retrospective drug utilisation study using patient-level databases to characterise... No Yes 11512 Finalised Not included in RMP The role of adherence to inhaled corticosteroids in the relationship between blood eosinophilia and asthma control No No 11571 Finalised EU RMP category 1 Post-Authorisation Safety Study (PASS) on Flupirtine-containing Medicinal Products - A retrospective, multicentre, non-interventional study to... No Yes 12030 Finalised EU RMP category 3 A Cross-sectional Study to Evaluate the Effectiveness of the Colobreathe Risk Minimisation Educational Programme Among Healthcare Professionals and... No No 12321 Planned Not included in RMP Training requirements to master inhaler devices available in real-life clinical practice (TMID) Yes No 12762 Finalised Not included in RMP Incidence of oral thrush in COPD patients prescribed ICS as part of ICS/LABA therapy Yes No 12984 Ongoing EU RMP category 3 Prescribing Patterns of Lipegfilgrastim (Lonquex®) in the European Union No No 13238 Finalised Not included in RMP Real-life effectiveness evaluation of budesonide/formoterol (BF) Spiromax for the management of asthma and COPD Yes Yes 16395 Finalised EU RMP category 3 An Open-label Observational Safety Study of Colobreathe® (colistimethate sodium dry powder for inhalation) Compared with Other Inhaled... No No 18976 Finalised EU RMP category 1 A retrospective longitudinal cohort study assessing the safety of Seasonique® use: A post-marketing authorization safety study (PASS) to assess the... Yes Yes 19909 Finalised EU RMP category 3 Risk of Melanoma Among Parkinson’s Disease Patients (TV1030-CNS-50024) No Yes 23021 Ongoing EU RMP category 3 Assessment of pregnancy outcomes in patients treated with reslizumab: Active pregnancy surveillance No No 34763 Ongoing EU RMP category 3 A Long-Term, Prospective, Observational Study to Evaluate the Safety, Including Cardiovascular Safety, of Fremanezumab in Patients with Migraine in... No No 35111 Planned Not included in RMP Pan European Prospective Observational Study of Fremanezumab effectiveness in patients with chronic or episodic migraine in the Real-World, PEARL... No No 36320 Ongoing EU RMP category 3 A Post-Authorisation Long-Term Retrospective Safety Cohort Study of Arsenic Trioxide in First Line Low- to Intermediate-Risk Acute Promyelocytic... No No 38434 Ongoing Not included in RMP Assessment of pregnancy outcomes in patients treated with Ajovy (fremanezumab): pregnancy database study No No 38442 Ongoing EU RMP category 3 Assessment of pregnancy outcomes in patients treated with Ajovy (fremanezumab): pregnancy registry (Teva migraine pregnancy registry) No No 41590 Finalised Not included in RMP A Randomized, Placebo-Controlled, Parallel-Design, Exploratory Study to Evaluate the Efficacy of fremanezumab in Subjects with Rosacea No No 43538 Ongoing EU RMP category 3 Assessment of Pregnancy Outcomes in Women Exposed to Modafinil/Armodafinil: Pregnancy Database Study No No 44465 Finalised Not included in RMP Real-world safety of Copaxone in Offsprings of Breastfeeding and treated RMS pAtients – COBRA study Yes Yes 44516 Finalised Not included in RMP Barriers to Care in Migraine in Germany No No 44606 Ongoing Not included in RMP Prospective observational study of Fremanezumab (Ajovy™) effectiveness in chronic and episodic migraine patients in clinical routine: FINESSE study No No 50402 Planned EU RMP category 3 A Long-Term Observational, Retrospective Cohort Study to Evaluate the Safety, Including Cardiovascular Safety, of Fremanezumab in Patients with... No No 103511 Ongoing Not included in RMP An Open-Label, Single-Dose Study to Assess the Pharmacokinetics and Target Engagement in Cerebral Spinal Fluid and Plasma Following a Single... No No 105202 Planned Not included in RMP Effectiveness and safety of rivaroxaban and amlodipine dual therapy compared to phenprocoumon and amlodipine dual therapy in non-valvular atrial... No No