AL-S Pharma AG
AL-S Pharma AG holds 1 Swissmedic orphan drug status in Switzerland, covering 1 rare disease.
0 of its medicines are published with an authorisation number. Placing a medicine on the Swiss market requires an authorisation holder domiciled in Switzerland; the orphan drug status application does not, where a Swiss postal address suffices.
Medicines
No authorised medicine yet
No medicine with an authorisation number is published for this designation in Switzerland. The status can be granted before the authorisation application is filed.
Orphan designations
Swissmedic publishes one row per medicine and orphan indication: the indication in the wording of the decision, the date the status was granted and, where the status was withdrawn, the withdrawal date. The table below reproduces those rows unchanged and links every indication to the matching rare disease in the directory.
| Orphan indication | Disease | Status granted | Status withdrawn |
|---|---|---|---|
| Behandlung der amyotrophen Lateralsklerose (ALS) | Amyotrophic lateral sclerosis (ALS) | 23/01/2018 | Status active |
Reimbursement
Whether a medicine behind this entry is paid for by compulsory health insurance is decided only with the authorisation and the listing in the FOPH specialities list (SL). As long as no authorised medicine is published, only reimbursement in an individual case under Art. 71a-71d KVV applies, for instance after an individual import.
Frequently asked questions
How does a medicine obtain orphan drug status in Switzerland?
On application to Swissmedic. It requires a life-threatening or chronically debilitating disease affecting no more than 5 in 10,000 people in Switzerland, or an existing recognition in a country with comparable medicinal product control (Art. 4 para. 1 let. a decies TPA, Art. 4 TPLO).
What does the status actually give you?
The simplified authorisation procedure (Art. 14 para. 1 let. f TPA), priority assessment, a waiver of the flat-rate fee for the new authorisation application and, on request, 15 years of document protection (Art. 11b para. 4 TPA). There is no market exclusivity as in the EU.
How current is the data on AL-S Pharma AG?
Swissmedic publishes the list of medicinal products with orphan drug status under Art. 7 TPLO and updates it monthly. The date of the data set processed here is shown at the foot of every page.
Bring your orphan drug to Switzerland
You can enquire about orphan drug status, authorisation and reimbursement in Switzerland. Any specialist service and its scope are agreed separately with the external partner.
- Public Swissmedic data
- Four language versions