respiratory syncytial virus, glycoprotein f, recombinant, stabilised in the pre-fusion conformation, adjuvanted with as01e
As the list published 4 Feb 2026 has it, binding since 30 Jan 2026. Each entry binds six months after its own publication date (Article 107c(7) of Directive 2001/83/EC).
What the list says
- EU reference date
- 3 May 2023
- PSUR frequency
- 1 year
- Data lock point
- 2 May 2026
- Submission date
- 11 Jul 2026
- Next data lock point
- 2 May 2027
- Next submission date
- 11 Jul 2027
- Products covered
- Centrally authorised (CAP)
Are PSURs required for products referred to in Articles 10(1), 10a and 16a of Directive 2001/83/EC?
No — the list does not require PSURs for these products.
The list asks this as one question for Articles 10(1), 10a and 16a together, and does not answer it for Article 14 at all. A PSUR may in any case be required at the request of a competent authority or as a condition of the marketing authorisation.
Notes in the list
DLP was amended on 30/07/2025 PSUR frequency amended and DLP updated on 25/06/2025 DLP was amended on 18/12/2024
Changing
The list published 23 Sept 2026 changes this entry. Those values bind from 1 Jan 2027, six months after the change was published (Article 107c(7) of Directive 2001/83/EC). Until then, what is above applies.
| Field | Applies today | From the date above |
|---|---|---|
| Substance | respiratory syncytial virus, glycoprotein f, recombinant, stabilised in the pre-fusion conformation, adjuvanted with as01e | respiratory Syncytial Virus (RSV) vaccine (recombinant, adjuvanted) |
| Notes | DLP was amended on 30/07/2025 PSUR frequency amended and DLP updated on 25/06/2025 DLP was amended on 18/12/2024 | Active substance name was amended on 01/07/2026 DLP was amended on 30/07/2025 PSUR frequency amended and DLP updated on 25/06/2025 DLP was amended on 18/12/2024 |
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- Data lock point 2 May 2027Submission by 11 Jul 2027
- Data lock point 2 May 2028Submission by 11 Jul 2028
- Data lock point 2 May 2029Submission by 11 Jul 2029
Counted from the data lock point the list gives, on the cycle it states: the submission date is 70 days after the data lock point — 70 days for a cycle of twelve months or less, 90 days for a longer one, as GVP Module VII sets out.
In earlier versions of the list
EMA/630645/2012 Rev.164 · published 23 Sept 2026
respiratory Syncytial Virus (RSV) vaccine (recombinant, adjuvanted) — every 1 year, data lock point 2 May 2027
EMA/630645/2012 Rev.156 · published 4 Feb 2026
respiratory syncytial virus, glycoprotein f, recombinant, stabilised in the pre-fusion conformation, adjuvanted with as01e — every 1 year, data lock point 2 May 2027
Source: European Medicines Agency, list of EU reference dates and frequency of submission of periodic safety update reports, EMA/630645/2012 Rev.156, published 4 Feb 2026. Open the published file
Kreastel is a planning and oversight aid for pharmacovigilance obligations. It tracks dates like these for a marketing authorisation holder's own products.
Report a discrepancy — if this page and the published file disagree, the file is right and we want to know.