Polio Vaccine – Novel Oral (nOPV) Monovalent type 2
Novel Oral Poliomyelitis vaccine Type 2
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| Vaccine Type: | Polio Vaccine - Novel Oral (nOPV) Monovalent type 2 | ||
Commercial Name: | PT BioFarma (Persero) | ||
Country: | Indonesia | ||
| URL: | http://www.biofarma.co.id/ | ||
| Responsible NRA: | National Agency of Drug and Food Control Indonesia | ||
Country: | Indonesia | ||
URL: | http://www.pom.go.id/ | ||
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| Effective date: | 13 November 2020 | ||
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| Pharmaceutical Form: | Liquid: ready to use | ||
| Presentation: | Vial | ||
| Number of doses: | 50 doses | ||
| Route of administration: | Oral | ||
| Shelf-life: | 24 months | at storage temperature: | -20°C |
| Shell-life | 6 months | at storage temperature: | 2-8°C |
| Vaccine Vial Monitor: | Type 2 | ||
| Secondary Packaging: | Carton holds ten 50 doses vials [Dimensions: 11.5 x 4.7 x 5.1 cm.] | ||
| Tertiary Packaging: | Box holds 147 cartons (1470 vials / 73500 doses total) [Dimensions: 65 x 51 x 60 cm] | ||
| Cold Chain Volume: | 0.55 | cm3 (in secondary packaging) | |
| Preservative: | None | With concentration: | Not applicable |
| Handling of opened multi-dose vials: | WHO recommends that opened vials of this vaccine may be kept for use in subsequent immunization sessions (up to a maximum of 28 days) provided the conditions outlined in the WHO Policy Statement: The use of opened multi-dose vials of vaccine in subsequent immunization sessions are met. |
Recommendation and Product Insert
- Recommendation for an Emergency Use Listing (EUL) of Novel Oral Polio Vaccine Type 2 (nOPV2) submitted by PT BioFarma (Persero) (Published: 01 December 2020)
- Recommandation pour l'utilisation d'urgence (Procédure EUL) du nouveau Vaccin Antipoliomyélitique Oral de Type 2 (nVPO2) de PT Biofarma (Persero) (Traduction de la version anglaise publiée le 01 Décembre 2020)
- nOPV2 Product Information
