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PRODUCT DETAIL

Revestive 5 mg prášok a rozpúšťadlo na injekčný roztok

Code 2568A
MA number EU/1/12/787/001
Product Form: plv iol 28x5 mg+28x0,5 ml solv.(liek.inj.skl.+striek.inj.napl.skl.)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU Orphan
MAH, country: Takeda Pharmaceuticals International AG Ireland Branch, Ireland
Therapeutic Class: 87 - VARIA I
ATC:
A ALIMENTARY TRACT AND METABOLISM
A16 OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A16A OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A16AX Various alimentary tract and metabolism products
A16AX08 Teduglutide
Shelf life: 48
Container: glass vial
Route of admin.: Subcutaneous use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 30.08.2012
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 11.03.2019
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