Botswana Medicines Regulatory Authority · Botswana
DEA-BW-2023-20632138
Tier 1 · Regulator-publishedUnclassifiedCommunication de sécuritéStatus · 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
- Notice
- Bedaquiline-containing regimenscardiac adverse events
- INN / active substance
- Not stated by the issuing authority
- Dosage form
- Not stated by the issuing authority
- Strength
- Not stated by the issuing authority
- Fabricant
- Not stated by the issuing authority
- Manufacturer country
- Not stated by the issuing authority
- MAH or importer
- Not stated by the issuing authority
- Numéros de lot
- Not published with the notice
- Dates de péremption
- Not published with the notice
- Action type
- Communication de sécurité
- Classification
- Not stated by the issuing authority
- Indicative severity
- Not assessed by Drug Eye Africa
- Defect category
- Signal de sécurité
- Product type
- Médicament
- 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
- Texte de l’avis
- Not captured. The notice itself is linked below.
- Statut
- En vigueur
- Superseded by
- Not superseded. This is the current version.
- Version
- 9
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- Taken and held by Drug Eye Africa, so the record survives the link above being moved or withdrawn.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
- dcf5fc3b8162af53c04c4245e87a6d75f11f9ab5476d6b7308976f15750bb4bcSHA-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 10:05:05 UTC
| Reference | Date | Country | Product | Batches | Action | Class | Source |
|---|---|---|---|---|---|---|---|
| DEA-UG-2025-48246675 | 04 Dec 2025 | UG | Paracetamol-containing oral solid dosage forms | none published | Scheduling change | Unclassified | Tier 1 · Regulator-published |
| 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-UG-2024-54413197 | 20 Feb 2024 | UG | Ketoconazole oral tablets | none published | Deregistration | Unclassified | Tier 1 · Regulator-published |
| DEA-BW-2023-10424004 | 13 Mar 2023 | BW | Suspected Adverse Drug Reactions of Angiotensin 11 converting enzyme inhibitors reported to BoMRA | none published | Safety communication | Unclassified | Tier 1 · Regulator-published |
Cite this record
Drug Eye Africa (2023). DEA-BW-2023-20632138: Bedaquiline-containing regimenscardiac adverse events — Communication de sécurité, Botswana Medicines Regulatory Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/bw/2023/dea-bw-2023-20632138Version 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.