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Caelyx Injection

NAFDAC Reg. No. B4-8252 · Drug

Registered with NAFDAC. Registration activeAs of 27 October 2026 · synced automatically from official sources.
Product
Caelyx Injection
NAFDAC number
B4-8252
Active ingredient
Doxorubicin Hydrochloride
Strength
50 mg/25 mL
Form
Solution for injection
Pack size
1 x 1's (in vial)
Manufacturer
Not listed
Applicant (holder)
PharmaSymbiosis Limited
Approved
30 Nov 2023
Status
Active View on NAFDAC ↗
Registration valid to
29 Nov 2028
WHO alerts
None found
Community reports
None
Times checked
0

What we found

  • Caelyx Injection is on the NAFDAC register with an active registration (B4-8252). A valid number alone does not prove a pack is genuine — counterfeiters copy real numbers, so also check the expiry date, seal and print quality.

Generated automatically from the NAFDAC register, WHO alerts and community data as of today. This is not medical advice. Always follow your doctor or pharmacist.

What Caelyx Injection is used for

From the official U.S. FDA label for doxorubicin hydrochloride, the active ingredient registered with NAFDAC.

Boxed warning: CARDIOMYOPATHY, SECONDARY MALIGNANCIES, EXTRAVASATION AND TISSUE NECROSIS, and SEVERE MYELOSUPPRESSION Cardiomyopathy: Myocardial damage, including acute left ventricular failure, can occur with doxorubicin hydrochloride. The risk of cardiomyopathy is proportional to the cumulative exposure with incidence rates from 1% to 20% for cumulative doses ranging from 300 mg/m 2 to 500 mg/m 2 when doxorubicin hydrochloride is administered every 3 weeks. …
What it is used for

Doxorubicin hydrochloride for injection is an anthracycline topoisomerase inhibitor indicated: as a component of multiagent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer ( 1.1 ). for the treatment of: acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, metastatic breast cancer, metastatic Wilms’ tumor, metastatic neuroblastoma, metastatic soft tissue sarcoma, metastatic bone sarcomas, metastatic ovarian carcinoma, metastatic transitional cell bladder carcinoma, metastatic thyroid carcinoma, metastatic gastric carcinoma, metastatic bronchogenic carcinoma ( 1.2 ). …

Possible side effects

The following clinically significant adverse reactions are described elsewhere in the labeling. Cardiomyopathy and Arrhythmias [see Warnings and Precautions (5.1) ] Secondary Malignancies [see Warnings and Precautions (5.2) ] Extravasation and Tissue Necrosis [see Warnings and Precautions (5.3) ] Severe Myelosuppression [see Warnings and Precautions (5.4) ] Tumor Lysis Syndrome [see Warnings and Precautions (5.6) ] Radiation Sensitization and Radiation Recall [see Warnings and Precautions (5.7) ] The most common (> 10%) adverse reactions are alopecia, nausea and vomiting ( 6.1 ). …

Do not use if

Doxorubicin hydrochloride for injection is contraindicated in patients with: Severe myocardial insufficiency [see Warnings and Precautions (5.1) ] Recent (occurring within the past 4 to 6 weeks) myocardial infarction [see Warnings and Precautions (5.1) ] Severe persistent drug-induced myelosuppression [see Warnings and Precautions (5.4) ] Severe hepatic impairment (defined as Child Pugh Class C or serum bilirubin level greater than 5 mg/dL) [see Warnings and Precautions (5.5) ] Severe hypersensi …

Warnings

Radiation-Induced Toxicity: Can be increased by the administration of doxorubicin hydrochloride for injection. Radiation recall can occur in patients who receive doxorubicin hydrochloride for injection after prior radiation therapy ( 5.7 ). Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and on the use of effective contraception. Advise males with female partners of reproductive potential to use effective contraception. Advise males with pregnant partners to use condoms ( 5.8 , 8.1 , 8.3 ). …

Pregnancy & breastfeeding

8.1 Pregnancy Risk Summary Based on findings in animals and its mechanism of action, doxorubicin hydrochloride for injection can cause fetal harm when administered to a pregnant woman; avoid the use of doxorubicin hydrochloride for injection during the 1 st trimester. …

General information only, not dosing advice. Always follow the leaflet in your pack and your doctor or pharmacist.

Check your pack of Caelyx Injection

Add the expiry date on your pack for a full Trust Score.

3 free checks left today Official sources: NAFDAC Green Book & recalls · WHO · U.S. FDA · NLM RxNorm

About Caelyx Injection

What is in Caelyx Injection?

Caelyx Injection contains Doxorubicin Hydrochloride (50 mg/25 mL), as solution for injection, according to its NAFDAC registration record.

Is Caelyx Injection registered with NAFDAC?

Yes. Caelyx Injection is listed on the NAFDAC register under registration number B4-8252, and its registration is active as of 27 October 2026.

Has Caelyx Injection been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Caelyx Injection in our automatically synced alert list.

How can I check that my pack of Caelyx Injection is genuine?

Run a free authenticity scan with the NAFDAC number B4-8252, your pack's expiry date and batch number to get a Trust Score, compare the pack with the NAFDAC record (ingredient, strength, form, manufacturer), and buy only from licensed pharmacies.

What is Caelyx Injection used for?

Doxorubicin hydrochloride for injection is an anthracycline topoisomerase inhibitor indicated: as a component of multiagent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer ( 1.1 ). for the treatment of: acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, metastatic breast c (Summarised from the official U.S. FDA label for doxorubicin hydrochloride. Always follow your doctor or pharmacist.)

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