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: | |||
Responsible NRA: |
National Agency of Drug and Food Control Indonesia | ||
Country: |
Indonesia | ||
URL: |
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Effective date: | 13 November 2020 |
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Pharmaceutical Form: | Liquid: ready to use |
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Presentation: | Vial |
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Number of doses: | 50 doses |
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Route of administration: | Oral |
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Shelf-life: | 24 months |
at storage temperature: | -20°C |
Shell-life | 6 months | at storage temperature: | 2-8°C |
Vaccine Vial Monitor: | Type 2 |
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Secondary Packaging: | Carton holds ten 50 doses vials [Dimensions: 11.5 x 4.7 x 5.1 cm.] |
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Tertiary Packaging: | Box holds 147 cartons (1470 vials / 73500 doses total) [Dimensions: 65 x 51 x 60 cm] |
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Cold Chain Volume: | 0.55 |
cm3 (in secondary packaging) | |
Preservative: | None |
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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