National Drug Authority · Uganda
DEA-UG-2024-54413197
Tier 1 · Regulator-publishedUnclassifiedCancelamento do registoStatus · active
- Issuing authority
- National Drug Authority (NDA)
- Authority reference
- Not stated by the issuing authority
- Date issued
- 20 Feb 2024The circulars page states no date. The month shown is when the document was uploaded to the Authority's website, which is not the date the Authority acted; that date is inside the PDF.
- Recorded by us
- 2026-09-09 18:49:17 UTC
- Produto
- Ketoconazole oral tablets
- INN / active substance
- Ketoconazole
- Dosage form
- Not stated by the issuing authority
- Strength
- Not stated by the issuing authority
- Fabricante
- Not stated by the issuing authority
- Manufacturer country
- Not stated by the issuing authority
- MAH or importer
- Not stated by the issuing authority
- Números de lote
- Not published with the notice
- Prazos de validade
- Not published with the notice
- Action type
- Cancelamento do registo
- Classificação
- Not stated by the issuing authority
- Indicative severity
- Not assessed by Drug Eye Africa
- Defect category
- Sinal de segurança
- Product type
- Medicamento
- ATC code
- Not stated by the issuing authority
- Affected markets
- Uganda — no market beyond the issuing country was named on the notice
- Cross-border event
- Not linked to a cross-border event
- Texto do aviso
- The Authority concluded that the benefit-risk balance of oral Ketoconazole was negative because of high level of liver injury associated with the medicine and in view of the currently available alternative treatments, which are deemed safer. Oral ketoconazole is however also used in the treatment of Cushing's syndrome, and it has a positive benefit-risk balance for this indication, as there might not be satisfactory alternative treatments. In light of the above, the Authority resolved to withdraw the Marketing Authorisation for all oral Ketoconazole products with immediate effect, and to ensure continued access of patients with Cushing's syndrome to oral Ketoconazole, the medicine shall only be imported as special importations.Original language: en
- Estado
- Em vigor
- Superseded by
- Not superseded. This is the current version.
- Version
- 13
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- Taken and held by Drug Eye Africa, so the record survives the link above being moved or withdrawn.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
- 8aae26ade63beacdea233b303db34df5e1a69b1c5d134c78b5ecc715e3815c9cSHA-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 18:56:47 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-BW-2023-20632138 | 13 Mar 2023 | BW | Bedaquiline-containing regimenscardiac adverse events | none published | Safety communication | 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 (2024). DEA-UG-2024-54413197: Ketoconazole oral tablets — Cancelamento do registo, National Drug Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/ug/2024/dea-ug-2024-54413197Version 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.