| Code | 2006E | ||||||||||
| MA number | 56/0243/22-S | ||||||||||
| Product Form: | imp sip 1x10,72 mg (striek.inj.napl.plast.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Zentiva, k.s., Czechia | ||||||||||
| Therapeutic Class: | 56 - HORMONA (LIEČIVA S HORMONÁLNOU AKTIVITOU) | ||||||||||
| ATC: |
|
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| Shelf life: | 48 | ||||||||||
| Route of admin.: | Subcutaneous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 19.09.2022 |
| Validity: | 19.09.2027 |
| Pediatric contraindication: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Toletate_imp sip_08_2024.pdf
|
| PIL: |
PIL_Toletate_imp sip_08_2024.pdf
|
| Safety feature | Yes |
| Data update: | 05.08.2024 |
