Miljöpåverkan
Hydrokortison
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Detaljerad miljöinformation
1.6. Environmental Risk AssessmentThe products subject to the present application do not contain any genetically modified organisms (GMO). Therefore only a part 1.6.1 is present.1.6.1. Non-GMOHydrocortisone tablets 1 mg, 2 mg, 5 mg. 10 mg and 20 mg, are products for which marketing authorization is applied for on basis of a well-established used application. The use of products with an immediate release character meant for oral administration containing hydrocortisone is known for decades. Medicinal products registered in the EU are known for the 10 mg and 20 mg strength. Lower strengths are known as “extemporaneous” or “magistral” products and are used for titration of the dose to an optimal dose for the individual patient. Strengths of 1 mg, 2 mg, 3 mg, 5 mg, 10 mg are known in the Netherlands (see Annex 1 to Module 1.7.1). The applicant herewith states that the applied products are intended to substitute for other, similar, products on the market. The products do not contain any component which results in additional hazard to the environment during storage, distribution, use and disposal. Based on the aforementioned and on the already existing use of the active substance hydrocortisone by marketing authorisation holders and pharmacists in the Netherlands as well by other companies across Europe, the approval of these Applications for Marketing Authorisation is deemed unlikely to increase the use of products containing hydrocortisone. The only foreseeable effect is a potential shift from extemporaneous use towards “licensed” use. Therefore it can be expected that the approval of these marketing authorisations will not cause any additional environmental risk. Hence the absence of an Environmental Risk Assessment report for the drug products Hydrocortison 1 mg, 2 mg, 5 mg, 10 mg and 20 mg, tablets, is justified. Oud-Beijerland, 4 February 2020
R.J. Liedorp
Information on the author is present in 1.4.1.