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Paclitaxel 300 mg/50 mL Concentrate For Solution For Infusion

NAFDAC Reg. No. A4-100143 · Drug

Registered with NAFDAC. Registration activeAs of 27 October 2026 · synced automatically from official sources.
Product
Paclitaxel 300 mg/50 mL Concentrate For Solution For Infusion
NAFDAC number
A4-100143
Active ingredient
Paclitaxel
Strength
300 mg/50 mL
Form
Concentrate for solution for infusion
Pack size
50 mL x 1's (in clear glass vial)
Manufacturer
Not listed
Applicant (holder)
Pfizer Specialties Ltd
Approved
2 Dec 2021
Status
Active View on NAFDAC ↗
Registration valid to
1 Dec 2026
WHO alerts
None found
Community reports
None
Times checked
0

What we found

  • Paclitaxel 300 mg/50 mL Concentrate For Solution For Infusion is on the NAFDAC register with an active registration (A4-100143). 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 Paclitaxel 300 mg/50 mL Concentrate For Solution For Infusion is used for

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

Boxed warning: Paclitaxel should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available. Anaphylaxis and severe hypersensitivity reactions characterized by dyspnea and hypotension requiring treatment, angioedema, and generalized urticaria have occurred in 2 to 4% of patients receiving paclitaxel in clinical trials. …
What it is used for

Paclitaxel Injection, USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, Paclitaxel Injection, USP is indicated in combination with cisplatin. Paclitaxel Injection, USP is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. …

Possible side effects

Pooled Analysis of Adverse Event Experiences from Single-Agent Studies Data in the following table are based on the experience of 812 patients (493 with ovarian carcinoma and 319 with breast carcinoma) enrolled in 10 studies who received single-agent Paclitaxel Injection. Two hundred and seventy-five patients were treated in 8, Phase 2 studies with paclitaxel doses ranging from 135 to 300 mg/m 2 administered over 24 hours (in 4 of these studies, G-CSF was administered as hematopoietic support). Three hundred and one patients were treated in the randomized Phase 3 ovarian carcinoma study which compared 2 doses (135 or 175 mg/m 2 ) and 2 schedules (3 or 24 hours) of paclitaxel. …

Do not use if

Paclitaxel is contraindicated in patients who have a history of hypersensitivity reactions to paclitaxel or other drugs formulated in polyoxyl 35 castor oil. Paclitaxel should not be used in patients with solid tumors who have baseline neutrophil counts of

Warnings

Anaphylaxis and severe hypersensitivity reactions characterized by dyspnea and hypotension requiring treatment, angioedema, and generalized urticaria have occurred in 2 to 4% of patients receiving paclitaxel in clinical trials. Fatal reactions have occurred in patients despite premedication. All patients should be pretreated with corticosteroids, diphenhydramine, and H 2 antagonists. (see DOSAGE AND ADMINISTRATION ). Patients who experience severe hypersensitivity reactions to paclitaxel should not be rechallenged with the drug. Bone marrow suppression (primarily neutropenia) is dose-dependent and is the dose-limiting toxicity. Neutrophil nadirs occurred at a median of 11 days. …

Pregnancy & breastfeeding

Pregnancy (See WARNINGS section).

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

Check your pack of Paclitaxel 300 mg/50 mL Concentrate For Solution For Infusion

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 Paclitaxel 300 mg/50 mL Concentrate For Solution For Infusion

What is in Paclitaxel 300 mg/50 mL Concentrate For Solution For Infusion?

Paclitaxel 300 mg/50 mL Concentrate For Solution For Infusion contains Paclitaxel (300 mg/50 mL), as concentrate for solution for infusion, according to its NAFDAC registration record.

Is Paclitaxel 300 mg/50 mL Concentrate For Solution For Infusion registered with NAFDAC?

Yes. Paclitaxel 300 mg/50 mL Concentrate For Solution For Infusion is listed on the NAFDAC register under registration number A4-100143, and its registration is active as of 27 October 2026.

Has Paclitaxel 300 mg/50 mL Concentrate For Solution For Infusion been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Paclitaxel 300 mg/50 mL Concentrate For Solution For Infusion in our automatically synced alert list.

How can I check that my pack of Paclitaxel 300 mg/50 mL Concentrate For Solution For Infusion is genuine?

Run a free authenticity scan with the NAFDAC number A4-100143, 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 Paclitaxel 300 mg/50 mL Concentrate For Solution For Infusion used for?

Paclitaxel Injection, USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, Paclitaxel Injection, USP is indicated in combination with cisplatin. Paclitaxel Injection, USP is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. … (Summarised from the official U.S. FDA label for paclitaxel. Always follow your doctor or pharmacist.)

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