| Code | 15669 | ||||||||||
| MA number | 81/0383/96-S | ||||||||||
| Product Form: | sol inj 10x1 ml/250 µg (amp.skl.) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | National | ||||||||||
| MAH, country: | Pfizer Europe MA EEIG, Belgium | ||||||||||
| Therapeutic Class: | 81 - UTEROTONICA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 48 | ||||||||||
| Container: | glass ampoule | ||||||||||
| Route of admin.: | Intramuscular use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 14.05.1996 |
| Dokument: |
Prostin 15M_DHCP_final_signed_15 Nov 2011.pdf
|
| SPC: |
SPC_Prostin_15M_12_2021.pdf
|
| PIL: |
PIL_Prostin 15M_12_2021.pdf
|
| Safety feature | Yes |
| Data update: | 28.05.2018 |
