Botswana Medicines Regulatory Authority · Botswana
DEA-BW-2025-84824385
Tier 1 · Regulator-publishedUnclassifiedSafety communicationStatus · activeNot shown in search engines
- Issuing authority
- Botswana Medicines Regulatory Authority (BOMRA)
- Authority reference
- Not stated by the issuing authority
- Date issued
- 19 Feb 2025
- Recorded by us
- 2026-09-08 15:48:21 UTC
- Notice
- Tegretol Oral Suspension, limitation of use in neonates
- INN / active substance
- Not stated by the issuing authority
- Dosage form
- Not stated by the issuing authority
- Strength
- Not stated by the issuing authority
- Manufacturer
- Not stated by the issuing authority
- Manufacturer country
- Not stated by the issuing authority
- MAH or importer
- Not stated by the issuing authority
- Batch numbers
- Not published with the notice
- Expiry dates
- Not published with the notice
- Action type
- Safety communication
- Classification
- Not stated by the issuing authority
- Indicative severity
- Not assessed by Drug Eye Africa
- Defect category
- Not stated by the issuing authority
- Product type
- Medicine
- ATC code
- Not stated by the issuing authority
- Affected markets
- Botswana — no market beyond the issuing country was named on the notice
- Cross-border event
- Not linked to a cross-border event
- Notice text
- Not captured. The notice itself is linked below.
- Status
- Active
- Superseded by
- Not superseded. This is the current version.
- Version
- 33
Where this record came from, and what is held to show it.
- Copy of the source
- Taken and held by Drug Eye Africa, so the record survives the link above being moved or withdrawn. Not yet published at an address you can open.Ask us for it and check it against the fingerprint below.
- Fingerprint
- 3305b32f87c38e4fbf5fea4c3b0920691e7488be2df9cc04ccaffcb4e2aa0e00SHA-256 of the copy held. Any file that produces this number is that copy, byte for byte; any file that does not is a different document.
- Copy taken
- 2026-09-09 10:05:26 UTC
Cite this record
Drug Eye Africa (2025). DEA-BW-2025-84824385: Tegretol Oral Suspension, limitation of use in neonates — Safety communication, Botswana Medicines Regulatory Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/bw/2025/dea-bw-2025-84824385Version history
—No version history recorded for this record.
—Corrections appear here and in the site-wide log. Records are superseded, never deleted.
Verification
Tier 1 — Published by the issuing regulator on its own channel and captured by Drug Eye Africa, with the source document archived.
Indexing
This record is kept out of search engines, because the notice carries neither a batch number nor a stated reason. That lasts until the missing part is filled in. The record is held here in full in the meantime, and is found by searching this site.