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| EU PAS number, year, documents | EMA approval of drug | Study objective(s) | Populations | Country/region | Database | Medicine studied, indication | Primary care/hospital prescribing | Duration (years) | Interim reports | Comparator groups | Number of pregnant women in report |
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| 36014, 2020, protocol | 2018 | Exploratory: frequency of pregnancies, estimate rates of pregnancy outcomes | Patients prescribed drug class | Denmark, Sweden, Finland, Norway | Danish, Swedish, Finnish, and Norwegian national healthcare databases | Erenumab, migraine | Primary, secondary, inpatient, outpatient
Hospital treatment identified only in Denmark | 4 | Yearly after 2 years | Cohorts with same disease other treatments | Protocol |
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| 27574, 2020, protocol | 2018 | Primary objective: exposure to medicine during pregnancy | Pregnant patients with disease | US (submitted to EMA) | HealthCore Integrated Research Database (HIRD) | Galcanezumab, migraine | Primary care: outpatient prescription drug dispensing | 5 | Yearly | No | Protocol |
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| 17062, 2017, interim report | 2015 | Primary objective: characterise users (including pregnancy) | Patients prescribed the medicine | Belgium, Germany, Italy, Portugal, Spain, Switzerland, UK | Retrospective chart reviews | Edoxaban, anticoagulant | Hospitals and general practitioners, internal medicine, and specialists | 3 | After 1 year | No | 0 |
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| 9507, 2015 report | 2012 | Secondary objective: exposure to medicine during pregnancy | Patients prescribed the medicine | Spain, Germany, UK, Austria | Retrospective chart review | Fidaxomicin, Clostridium difficile | Primary care | 4 | No | No | 0 |
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| 13783, 2016, protocol and report | 2014 | Primary: frequency of use in different groups of patients (including pregnancy) | Patients prescribed the medicine | France, Germany, Spain, UK, Sweden | IMS Disease Analyzer, SIDIAP, NPR, SPDR, CPRD | Dulaglutide, T2DM | Primary care | 3 | Yearly | No | 0 |
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| 12839, 2016, protocol and report | 2013 | Primary: frequency of use in different groups of patients (including pregnancy) | Patients prescribed the medicine | UK, Spain, and Sweden | SIDIAP, CPRD, Sweden (NPR, PDR) | Linaclotide, irritable bowel syndrome | Primary care in UK and Spain, prescribed medicines in primary health care centers and outpatient specialists in Sweden | 5 | No | No | NR not mentioned in results |
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| 14445, 2016, protocol and report | 2014 | Secondary: frequency of use in different groups of patients (including pregnancy) | Patients prescribed the medicine | Germany, the Netherlands, Italy, England (UK) | BIPS, PHARMO, LHU, M-PEM | Dulaglutide, T2DM | Healthcare and administrative databases, for UK, primary care | NR | No | No | NR not mentioned in results |
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| 11841, 2015, protocol | 2014 | Primary: frequency of pregnancies, estimate rates of pregnancy outcomes | Patients with disease of childbearing age | UK | CPRD | Albiglutide, T2M | Primary care | 4 | Every 6 months | No | Protocol |
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| 4270, 2013, protocol and report | 2012 | Secondary objective frequency of pregnancy | Patients prescribed the medicine | US, Ireland, France, UK | ECFSPR Registry | Ivacaftor, cystic fibrosis | Specialists, inpatient and outpatient data | 5 | Yearly | Patients with disease not prescribed the medicine | 462 |
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| 4845, 2013, protocol and report | 2012 | Secondary objective frequency of pregnancy | Patients prescribed the medicine | UK, Denmark, Italy, the Netherlands, Spain | THIN, HSD, IPCI, Aarhus, SIDIAP | Glycopyrronium bromide, COPD | Outpatient (primary care) prescribing (specialists incomplete) | 4 | Yearly | No | 0 |
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| 3901, 2013, protocol and report | 2012 | Primary: frequency of pregnancy | Patients prescribed the medicines | France | SNIIR-AM | Bismuth subcitrate potassium, Helicobacter pylori | Nonhospital claims | 3 | Yearly | No | 1 |
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