| Code | 0684E | ||||||||||
| MA number | 68/0134/22-S | ||||||||||
| Product Form: | sus iph 1x75 mg (striek.inj.napln.+2 ihly) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Egis Pharmaceuticals PLC, Hungary | ||||||||||
| Therapeutic Class: | 68 - ANTIPSYCHOTICA (NEUROLEPTICA) | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | 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: | 01.06.2022 |
| Validity: | 01.06.2027 |
| SPC: |
SPC_Egoropal_01_2024.pdf
|
| PIL: |
PIL_Egoropal_01_2024.pdf
|
| Safety feature | Yes |
| Data update: | 11.07.2023 |
