The therapeutic effectiveness of Enterosgel has been demonstrated in:
Efficacy has been proven by clinical trials; the first was started in 1982. The International Date of Birth (the date of the first marketing authorisation) is 29.7.1994. The total number of clinical evaluation participants (including post-marketing evaluation) is more than 21,000 subjects. More than 395 scientific papers and publications have been produced. Of this number:
| Dissertations | 42 |
| Clinical reports | 57 |
| Scientific articles | 273 |
| Methodological guidelines | 23 |
Currently, 100,000,000 single doses of this medicinal product (6,000,000 initial packages) are administered annually in Europe. A marked favourable effect of the administration of Enterosgel in compliance with the instructions for use has been recorded in a large majority of the patients.
As to date, no unfavourable (unforeseen) side effects not stated in the instructions for use have been encountered, which has been confirmed also by the regular reports on the safety of medicinal products.
The risk associated with the use of Enterosgel has thus been assessed as insignificant (less than 1:1,000,000).