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Drugs for MermaiHD Patient's Pridopidine can be made available to patients who have completed the
MermaiHD open-label phase. The practicalities around this expanded
access program has been outsourced by NeuroSearch to a company named
Idis.
Idis can be contacted via phone, fax or e-mail on the following numbers/addresses:
Telephone |
UK: | +44 (0) 1932 824 100 | |
France: | +33 (0) 1 55 27 39 32 | |
Germany: | +49 (0) 89 9700 7409 | | Italy: | +39 (0) 02 7254 6841 | | Spain: | +34 (0) 93 344 3224 | | Other: | +44 (0) 1932 824 123 |
Fax
| UK: | +44 (0) 1932 824 300 | | France: | +33 (0) 1 55 27 37 00 | | Germany: | +49 (0) 89 9700 7200 |
| Italy: | +39 (0) 02 7254 6430 |
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Spain: | +34 (0) 93 344 3216 |
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Other: | +44 (0) 1932 824 323 |
After you've contacted Idis with a request for pridopidine you will receive an information package including: - a description of the compassionate use program, which includes inclusion and exclusion criteria for treatment and procedures
- an access form which must be filled in and returned to Idis before any drug can be supplied
- summary of data and guidance for the treating physician (which is the same information as given in section 7 of the Investigator's Brochure)
- a template for informed consent (for you to translate into local language, if appropriate, and adapted to your local regulations)
- an adverse event form
Different EU countries have different regulatory procedures for
compassionate use, and Idis will be able to advise you in the process
for obtaining the necessary approvals. Once the approvals are in place,
and the signed access form has been received by Idis, drug will be
shipped from Idis to your hospital pharmacy for dispensing to the
patient. |
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