Botswana Medicines Regulatory Authority · Botswana
DEA-BW-2023-10424004
Tier 1 · Regulator-publishedUnclassifiedSafety communicationStatus · active
- Issuing authority
- Botswana Medicines Regulatory Authority (BOMRA)
- Authority reference
- Not stated by the issuing authority
- Date issued
- 13 Mar 2023
- Recorded by us
- 2026-09-08 15:48:21 UTC
- Product
- Suspected Adverse Drug Reactions of Angiotensin 11 converting enzyme inhibitors reported to BoMRA
- 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
- Safety signal
- 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- Superseded by
- Not superseded.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
- 1
Where this record came from, and what is held to show it.
- Primary source
- https://www.bomra.co.bw/suspected-adverse-drug-reactions-of-angiotensin-11-converting-enzyme-inhibitors-reported-to-bomra/
- Copy of the source
- No copy was taken. If the link above stops working, this record has no fallback.
- Fingerprint
- No copy was taken, so there is nothing to fingerprint.
- Copy taken
- No copy was taken, so there is no time to record.
| Reference | Date | Ctry | Product | Batches | Action | Class | Source |
|---|---|---|---|---|---|---|---|
| DEA-BW-2024-39685589 | 28 Feb 2024 | BW | Safety Concern- Acute Interstitial Nephritis asscoiated with Proton Pump Inhibitorss | none published | Safety communication | Unclassified | Tier 1 · Regulator-published |
| DEA-BW-2023-20632138 | 13 Mar 2023 | BW | Bedaquiline-containing regimenscardiac adverse events | none published | Safety communication | Unclassified | Tier 1 · Regulator-published |
Cite this record
Drug Eye Africa (2023). DEA-BW-2023-10424004: Suspected Adverse Drug Reactions of Angiotensin 11 converting enzyme inhibitors reported to BoMRA — Safety communication, Botswana Medicines Regulatory Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/bw/2023/dea-bw-2023-10424004Version 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 indexable: it is dated, names a product, and carries either a batch number or a stated reason.