Summary of Product Characteristics. (SmPC) The following wording should be included in the SmPC of the marketing authorisations of the products within the scope of this procedure (see annex I):
Summary of Product Characteristics. Cinacalcet (Mimpara®) Amgen Ltd. Last updated August 2017. Available xxxx://xxx.xxxxxxxxx.xxx.xx accessed 2/7/19
Summary of Product Characteristics. Cinacalcet (Mimpara®) Amgen Ltd. Last updated August 2017. Available xxxx://xxx.xxxxxxxxx.xxx.xx accessed 2/7/19 2. NICE TA 117 Cinacalcet for the treatment of secondary hyperparathyroidism in patients with end stage renal disease on maintenance dialysis therapy. January 2007 xxxx://xxx.xxxx.xxx.xx/guidance/ta117 3. NICE Guideline 132 Hyperparathyroidism (primary): diagnosis, assessment and initial management. 23 May 2019. xxxxx://xxx.xxxx.xxx.xx/guidance/NG132
Summary of Product Characteristics. Zemplar® AbbVie Ltd Last updated 28/11/19. Available via xxx.xxxxxxxxx.xxx.xx accessed 10/12/19
Summary of Product Characteristics. Azathioprine. Last updated 21.10.16. Available via xxx.xxxxxxxxx.xxx.xx accessed 14/8/2018
Summary of Product Characteristics. Leflunomide. Last updated 26.8.16. Available via xxx.xxxxxxxxx.xxx.xx accessed 14/8/172.
Summary of Product Characteristics. Prolia (denosumab). Amgen. Accessed November 2014.
Summary of Product Characteristics. Methotrexate 2.5 tablets. Last updated 15.4.16. Available via xxx.xxxxxxxxx.xxx.xx accessed 14/8/172.
Summary of Product Characteristics. Neoral. Last updated 22/07/2015. Available via xxx.xxxxxxxxx.xxx.xx accessed 06/09/18
Summary of Product Characteristics. Section 4.1 “Therapeutic indications” Testosterone replacement therapy for male hypogonadism, when testosterone deficiency has been confirmed by clinical features and biochemical tests. […]
