Code | 5869D | ||||||||||
MA number | 34/0255/20-S | ||||||||||
Product Form: | sol iru 1x5 ml/250 mg (striek.inj.skl.napl.+1ihla) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Vipharm S.A., Poland | ||||||||||
Therapeutic Class: | 34 - ANTIHORMONA | ||||||||||
ATC: |
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Shelf life: | 24 | ||||||||||
Container: | glass pre-filled syringe | ||||||||||
Route of admin.: | Intramuscular use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 27.11.2020 |
Validity: | 27.11.2025 |
Pediatric warnings: | Yes |
SPC: | SPC_Fulvestrant Vipharm_november 2020.docx |
PIL: | PIL_Fulvestrant Vipharm_november 2020.docx |
Safety feature | Yes |
Data update: | 01.12.2020 |