{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T14:49:59Z","timestamp":1790952599265,"version":"4.1.0"},"reference-count":24,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2022,11,1]],"date-time":"2022-11-01T00:00:00Z","timestamp":1667260800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2022,11,1]],"date-time":"2022-11-01T00:00:00Z","timestamp":1667260800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2022,11,1]],"date-time":"2022-11-01T00:00:00Z","timestamp":1667260800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-017"},{"start":{"date-parts":[[2022,11,1]],"date-time":"2022-11-01T00:00:00Z","timestamp":1667260800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-037"},{"start":{"date-parts":[[2022,11,1]],"date-time":"2022-11-01T00:00:00Z","timestamp":1667260800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-012"},{"start":{"date-parts":[[2022,11,1]],"date-time":"2022-11-01T00:00:00Z","timestamp":1667260800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-029"},{"start":{"date-parts":[[2022,11,1]],"date-time":"2022-11-01T00:00:00Z","timestamp":1667260800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-004"}],"content-domain":{"domain":["clinicalkey.com","clinicalkey.com.au","clinicalkey.es","clinicalkey.fr","clinicalkey.jp","msard-journal.com","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Multiple Sclerosis and Related Disorders"],"published-print":{"date-parts":[[2022,11]]},"DOI":"10.1016\/j.msard.2022.104184","type":"journal-article","created":{"date-parts":[[2022,9,14]],"date-time":"2022-09-14T13:06:05Z","timestamp":1663160765000},"page":"104184","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":15,"special_numbering":"C","title":["Fingolimod, teriflunomide and cladribine for the treatment of multiple sclerosis in women of childbearing age: description of drug utilization and exposed pregnancies in Germany"],"prefix":"10.1016","volume":"67","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2075-7978","authenticated-orcid":false,"given":"Katharina","family":"Platzbecker","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nadine","family":"Wentzell","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bianca","family":"Kollhorst","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ulrike","family":"Haug","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"issue":"12","key":"10.1016\/j.msard.2022.104184_bib0001","doi-asserted-by":"crossref","first-page":"1323","DOI":"10.1007\/s40264-021-01117-4","article-title":"Dispensing of potentially harmful prescription drugs in 1.8 million pregnant women in France: a nationwide study based on two risk classification systems","volume":"44","author":"Bloti\u00e8re","year":"2021","journal-title":"Drug Saf"},{"key":"10.1016\/j.msard.2022.104184_bib0002","unstructured":"Bundesinstitut f\u00fcr Arzneimittel und Medizinprodukte (BfArM), 2019. Rote-Hand-Brief zu Fingolimod (Gilenya): Neue Kontraindikation bei Anwendung w\u00e4hrend der Schwangerschaft und bei Frauen im geb\u00e4rf\u00e4higen Alter. https:\/\/www.bfarm.de\/SharedDocs\/Risikoinformationen\/Pharmakovigilanz\/DE\/RHB\/2019\/rhb-gilenya.html (Accessed June 16, 2022)."},{"issue":"4","key":"10.1016\/j.msard.2022.104184_bib0003","doi-asserted-by":"crossref","first-page":"481","DOI":"10.1002\/pds.5411","article-title":"Trends in the use of disease-modifying therapies among reproductive-aged women with multiple sclerosis in the United States from 2010 to 2019","volume":"31","author":"Duchesneau","year":"2022","journal-title":"Pharmacoepidemiol Drug Saf"},{"key":"10.1016\/j.msard.2022.104184_bib0004","unstructured":"European Medicines Agency (EMA), 2012. Assessment Report for Gilenya. https:\/\/www.ema.europa.eu\/en\/documents\/variation-report\/gilenya-h-c-2202-a20-0008-epar-assessment-report-article-20_en.pdf (Accessed December 14, 2021)."},{"key":"10.1016\/j.msard.2022.104184_bib0005","unstructured":"European Medicines Agency (EMA), 2013. Assessment Report Aubagio. https:\/\/www.ema.europa.eu\/en\/documents\/assessment-report\/aubagio-epar-public-assessment-report_en.pdf (Accessed December 14, 2021)."},{"key":"10.1016\/j.msard.2022.104184_bib0006","unstructured":"European Medicines Agency (EMA), 2017. Assessment Report Mavenclad. https:\/\/www.ema.europa.eu\/en\/documents\/assessment-report\/mavenclad-epar-public-assessment-report_en.pdf (Accessed December 14, 2021)."},{"key":"10.1016\/j.msard.2022.104184_bib0007","unstructured":"European Medicines Agency (EMA), 2019. Updated restrictions for gilenya: multiple sclerosis medicine not to be used in pregnancy. https:\/\/www.ema.europa.eu\/en\/documents\/press-release\/updated-restrictions-gilenya-multiple-sclerosis-medicine-not-be-used-pregnancy_en.pdf (Accessed December 14, 2021)."},{"key":"10.1016\/j.msard.2022.104184_bib0008","unstructured":"European Medicines Agency (EMA), 2021a. Aubagio: EPAR - product information. https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/aubagio-epar-product-information_en.pdf (Accessed December 1, 2021)."},{"key":"10.1016\/j.msard.2022.104184_bib0009","unstructured":"European Medicines Agency (EMA), 2021b. Gilenya: EPAR - product information. https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/gilenya-epar-product-information_en.pdf (Accessed December 14, 2021)."},{"key":"10.1016\/j.msard.2022.104184_bib0010","unstructured":"European Medicines Agency (EMA), 2022. Mavenclad: EPAR - product information. https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/mavenclad-epar-product-information_en.pdf (Accessed May 02, 2022)."},{"key":"10.1016\/j.msard.2022.104184_bib0011","unstructured":"European Registry of Congenital Anomalies and Twins (EUROCAT), 2018. EUROCAT Guide 1.4 and reference documents. https:\/\/eu-rd-platform.jrc.ec.europa.eu\/sites\/default\/files\/Full_Guide_1_4_version_28_DEC2018.pdf (Accessed May 25, 2022)."},{"key":"10.1016\/j.msard.2022.104184_bib0012","unstructured":"European Registry of Congenital Anomalies and Twins (EUROCAT), 2022. Prevalence charts and tables. https:\/\/eu-rd-platform.jrc.ec.europa.eu\/eurocat\/eurocat-data\/prevalence_en (Accessed June 16, 2022)."},{"issue":"3","key":"10.1016\/j.msard.2022.104184_bib0013","doi-asserted-by":"crossref","first-page":"258","DOI":"10.1002\/pds.2038","article-title":"Linkage of mother\u2013baby pairs in the German Pharmacoepidemiological Research Database","volume":"20","author":"Garbe","year":"2011","journal-title":"Pharmacoepidemiol Drug Saf"},{"issue":"7","key":"10.1016\/j.msard.2022.104184_bib0014","doi-asserted-by":"crossref","first-page":"635","DOI":"10.1007\/s40264-020-00948-x","article-title":"Pregnancy outcomes during the clinical development program of cladribine in multiple sclerosis: an integrated analysis of safety","volume":"43","author":"Giovannoni","year":"2020","journal-title":"Drug Saf"},{"key":"10.1016\/j.msard.2022.104184_bib0015","unstructured":"Grandt, D., Lappe, V., Schubert, I., 2021. BARMER Arzneimittelreport 2021 Arzneimitteltherapie in der Schwangerschaft und bei Frauen im geb\u00e4rf\u00e4higen Alter, Schriftenreihe zur Gesundheitsanalyse BARMER."},{"key":"10.1016\/j.msard.2022.104184_bib0016","series-title":"Databases For Pharmacoepidemiological Research","first-page":"119","article-title":"German Pharmacoepidemiological Research Database (GePaRD)","author":"Haug","year":"2021"},{"key":"10.1016\/j.msard.2022.104184_bib0017","unstructured":"Hemmer, B., 2021. Diagnose und Therapie der Multiplen Sklerose, Neuromyelitis-optica-Spektrum-Erkrankungen und MOG-IgG-assoziierten Erkrankungen, S2k-Leitlinie, 2021. https:\/\/dgn.org\/wp-content\/uploads\/2021\/04\/030050_LL_Multiple_Sklerose_2021.pdf (Accessed June 16, 2022)."},{"issue":"6","key":"10.1016\/j.msard.2022.104184_bib0018","doi-asserted-by":"crossref","first-page":"604","DOI":"10.1002\/pds.4409","article-title":"Utilization of drugs with pregnancy exposure registries during pregnancy","volume":"27","author":"Illoh","year":"2018","journal-title":"Pharmacoepidemiol Drug Saf"},{"key":"10.1016\/j.msard.2022.104184_bib0019","unstructured":"Leibniz Institute for Prevention Research and Epidemiology - BIPS (BIPS), 2020. The German Pharmacoepidemiological Research Database (GePaRD). https:\/\/www.bips-institut.de\/en\/research\/research-infrastructures\/gepard.html (Accessed April 12, 2022)."},{"issue":"4","key":"10.1016\/j.msard.2022.104184_bib0020","doi-asserted-by":"crossref","first-page":"556","DOI":"10.1002\/pds.4735","article-title":"Use and safety of disease-modifying therapy in pregnant women with multiple sclerosis","volume":"28","author":"MacDonald","year":"2019","journal-title":"Pharmacoepidemiol Drug Saf"},{"issue":"8","key":"10.1016\/j.msard.2022.104184_bib0021","doi-asserted-by":"crossref","first-page":"873","DOI":"10.1002\/pds.3467","article-title":"Evaluation of pregnancy outcome records in the German Pharmacoepidemiological Research Database (GePaRD)","volume":"22","author":"Mikolajczyk","year":"2013","journal-title":"Pharmacoepidemiol Drug Saf"},{"issue":"2","key":"10.1016\/j.msard.2022.104184_bib0022","first-page":"13","article-title":"Risiko Ven\u00f6ser Thromboembolien bei Einnahme von Kombinierten Hormonalen Kontrazeptiva","author":"Schink","year":"2021","journal-title":"Bulletin zur Arzneimittelsicherheit"},{"issue":"350","key":"10.1016\/j.msard.2022.104184_bib0023","article-title":"Estimating the beginning of pregnancy in German claims data: development of an algorithm with a focus on the expected delivery date","volume":"8","author":"Schink","year":"2020","journal-title":"Front Public Health"},{"issue":"9","key":"10.1016\/j.msard.2022.104184_bib0024","doi-asserted-by":"crossref","first-page":"1005","DOI":"10.1002\/pds.4588","article-title":"Optimizing an algorithm for the identification and classification of pregnancy outcomes in German claims data","volume":"27","author":"Wentzell","year":"2018","journal-title":"Pharmacoepidemiol Drug Saf"}],"container-title":["Multiple Sclerosis and Related Disorders"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S2211034822006897?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S2211034822006897?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2025,10,31]],"date-time":"2025-10-31T09:07:52Z","timestamp":1761901672000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S2211034822006897"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,11]]},"references-count":24,"alternative-id":["S2211034822006897"],"URL":"https:\/\/doi.org\/10.1016\/j.msard.2022.104184","relation":{},"ISSN":["2211-0348"],"issn-type":[{"value":"2211-0348","type":"print"}],"subject":[],"published":{"date-parts":[[2022,11]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Fingolimod, teriflunomide and cladribine for the treatment of multiple sclerosis in women of childbearing age: description of drug utilization and exposed pregnancies in Germany","name":"articletitle","label":"Article Title"},{"value":"Multiple Sclerosis and Related Disorders","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.msard.2022.104184","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2022 Elsevier B.V. All rights reserved.","name":"copyright","label":"Copyright"}],"article-number":"104184"}}