Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Bavarian Nordic A/S, Philip Heymans Allé 3, 2900 Hellerup, Denmark
Rabipur.
Powder and solvent for solution for injection in pre-filled syringe.
Rabies vaccine (inactivated).
| Pharmaceutical Form |
|---|
|
Powder and solvent for solution for injection in pre-filled syringe. The powder is white. The solvent is clear and colourless. |
After reconstitution, 1 vial (1.0 ml) contains:
Rabies virus* (Inactivated, strain Flury LEP) ≥2.5 IU
* produced on purified chick embryo cells (PCEC)
This vaccine contains residues of chicken proteins (e.g., ovalbumin), human serum albumin, and may contain traces of neomycin, chlortetracycline and amphotericin B. See section 4.4.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Rabies vaccine |
|
| List of Excipients |
|---|
|
Powder: Trometamol Solvent: Water for injection |
Package with:
1 vial (type I glass) of freeze-dried vaccine with stopper (chlorobutyl)
1 disposable pre-filled syringe (type I glass) of Sterile Diluent for reconstitution (1 mL) with plunger-stopper (bromobutyl) without needle and with a tip-cap (bromobutyl). 1 small orange needle for injection (25 gauge, 25 mm) and one long green needle for reconstitution (21 gauge, 40 mm)
Bavarian Nordic A/S, Philip Heymans Allé 3, 2900 Hellerup, Denmark
PL 40365/0004
Date of first authorisation: 06/04/2016
Date of latest renewal: 31/10/2019
| Drug | Countries | |
|---|---|---|
| RABIPUR | Austria, Spain, France, Croatia, Japan, Malta, Netherlands, New Zealand, Poland, Singapore, Tunisia, United Kingdom |
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