TEMSIROLIMUS ACCORD
As listed in the register: TEMSIROLIMUS ACCORD 30 MG CONCENTRADO Y DISOLVENTE PARA SOLUCION PARA PERFUSION EFG
30 mg · concentrado y disolvente para solución para perfusión
- Prescription only
- Cancer treatments and immune-system medicines
- Active substance
- Temsirolimus
- Made by
- Accord Healthcare S.L.U.
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
Mediclarum has not yet retrieved and stored the official label for this product, so none of its text is shown here. Open the official leaflet
How it works
From the US prescribing label for the same active substance (Torisel). It describes the substance, not this exact product.
Temsirolimus is an inhibitor of mTOR (mammalian target of rapamycin).
Temsirolimus binds to an intracellular protein (FKBP-12), and the protein-drug complex inhibits the activity of mTOR that controls cell division.
No clinically significant effect is anticipated when 25 mg of temsirolimus is co-administered with agents that are metabolized by CYP2D6 or CYP3A.
After a single IV dose of [ 14 C]-temsirolimus approximately 82% of total radioactivity was eliminated within 14 days, with 4.6% and 78% of the administered radioactivity recovered in the urine and feces, respectively.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-12-26
Safety of the active substance
From the US prescribing label for the same active substance (Torisel). It describes the substance, not this exact product.
- TORISEL is contraindicated in patients with bilirubin >1.5×ULN [see Warnings and Precautions (5.2) ].
The most common (≥30%) adverse reactions observed with TORISEL are rash, asthenia, mucositis, nausea, edema, and anorexia.
Quoted from the US prescribing label for the same active substance. Your own pack’s leaflet is the authority for your product. DailyMed
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
European UnionNo exact match for this strength and form
France1 matching products
CanadaNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
Details
| Made by | Accord Healthcare S.L.U. |
|---|---|
| Active substance | Temsirolimus |
| Used in | Cancer treatments and immune-system medicines |
| Strength | 30 mg |
| Form | concentrado y disolvente para solución para perfusión |
| Classification | L01EG01 · Cancer treatments and immune-system medicines |
| Route | vía intravenosa |
| Marketed | No — authorised but not currently marketed, according to the register |
| Generic | Yes — a generic medicine, according to the register |
| Driving | The regulator flags that this medicine can affect the ability to drive. |
| Name in the register | TEMSIROLIMUS ACCORD 30 MG CONCENTRADO Y DISOLVENTE PARA SOLUCION PARA PERFUSION EFG |
| Nº Registro | 86058 |
Source: CIMA — Centro de Información online de Medicamentos · 2026-09-30 · not reviewed by a clinician
Fuente: Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), CIMA. Reuse terms: Aviso legal AEMPS.
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.