Article 57 product data

Human medicines European public assessment report (EPAR): Respreeza, alpha1-proteinase inhibitor (human), Genetic Diseases, Inborn;Lung Diseases, Date of authorisation: 20/08/2015, Revision: 12, Status: Authorised

Human medicines European public assessment report (EPAR): Olumiant, baricitinib, Arthritis, Rheumatoid, Date of authorisation: 13/02/2017, Revision: 17, Status: Authorised

Topiramate and topiramate/phentermine combination: New restrictions to prevent exposure during pregnancy

Human medicines European public assessment report (EPAR): Rezolsta, darunavir,cobicistat, HIV Infections, Date of authorisation: 19/11/2014, Revision: 16, Status: Authorised

Human medicines European public assessment report (EPAR): Ninlaro, ixazomib, Multiple Myeloma, Date of authorisation: 21/11/2016, Revision: 17, Status: Authorised

Human medicines European public assessment report (EPAR): Vanflyta, quizartinib, Leukemia, Myeloid, Date of authorisation: 06/11/2023, Status: Authorised

Appendix 1: Acceptable intakes established for N-nitrosamines

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