Code | 3352D | ||||||||||
MA number | EU/1/19/1407/001 | ||||||||||
Product Form: | tbl flm 60 (6x10)x1 mg | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU Orphan | ||||||||||
MAH, country: | Recordati Rare Diseases, France | ||||||||||
Therapeutic Class: | 34 - ANTIHORMONA | ||||||||||
ATC: |
|
||||||||||
Shelf life: | 36 | ||||||||||
Container: | blister Al/Al | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 8(3) application - new active substance |
MA issued: | 09.01.2020 |
Validity: | 09.01.2025 |
SmPC + PL: |
|
Safety feature | Yes |
Data update: | 24.01.2020 |