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PRODUCT DETAIL

ThyroTop

Code 0155F
MA number 88/0201/25-S
Product Form: cps dur 1x38-7400 MBq (nádoba kryogénna plast.)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Mutual recognition procedure
MAH, country: Institute of Isotopes Co. Ltd. , Hungary
Therapeutic Class: 88 - RADIOPHARMACA
ATC:
V VARIOUS
V10 THERAPEUTIC RADIOPHARMACEUTICALS
V10X OTHER THERAPEUTIC RADIOPHARMACEUTICALS
V10XA Iodine (131I) compounds
V10XA01 Sodium iodide (131I)
Shelf life: 21 dní
Route of admin.: Oral use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 10a well-established use application
MA issued: 31.05.2025
Validity: 31.05.2030
Pediatric indication: Yes
Pediatric posology: Yes
Pediatric warnings: Yes
SPC: SPC_ThyroTop_cps dur_05.2025_REG.pdf  
PIL: PIL_ThyroTop_cps dur_05.2025_REG.pdf  
Safety feature No
Data update: 06.06.2025
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