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Actilyse Powder

NAFDAC Reg. No. A6-0592 · Drug

Registered with NAFDAC. Registration activeAs of 28 October 2026 · synced automatically from official sources.
Product
Actilyse Powder
NAFDAC number
A6-0592
Active ingredient
Alteplase
Strength
50 mg
Form
Powder for injection
Pack size
1 x 1's
Manufacturer
Not listed
Applicant (holder)
Fensyl MHP Consulting Limited
Approved
20 Dec 2020
Status
Inactive View on NAFDAC ↗
Registration valid to
20 Dec 2025
WHO alerts
None found
Community reports
None
Times checked
0

What we found

  • Actilyse Powder is on the NAFDAC register with an active registration (A6-0592). 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 Actilyse Powder is used for

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

What it is used for

Cathflo ® Activase ® (Alteplase) is indicated for the restoration of function to central venous access devices as assessed by the ability to withdraw blood.

Possible side effects

The following adverse reactions are discussed in greater detail in Section PRECAUTIONS of the label: Bleeding Hypersensitivity In the clinical trials, the most serious adverse events reported after treatment were sepsis (see PRECAUTIONS, Infections ), gastrointestinal bleeding, and venous thrombosis. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …

Do not use if

Cathflo Activase should not be administered to patients with known hypersensitivity to Alteplase or any component of the formulation (see DESCRIPTION ).

Warnings

None.

Pregnancy & breastfeeding

Pregnancy Alteplase has been shown to have an embryocidal effect due to an increased postimplantation loss rate in rabbits when administered intravenously during organogenesis at a dose (3 mg/kg) approximately 50 times human exposure (based on AUC) at the dose for restoration of function to occluded CVADs. …

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

Check your pack of Actilyse Powder

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 Actilyse Powder

What is in Actilyse Powder?

Actilyse Powder contains Alteplase (50 mg), as powder for injection, according to its NAFDAC registration record.

Is Actilyse Powder registered with NAFDAC?

Yes. Actilyse Powder is listed on the NAFDAC register under registration number A6-0592, and its registration is active as of 28 October 2026.

Has Actilyse Powder been flagged as fake or recalled?

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

How can I check that my pack of Actilyse Powder is genuine?

Run a free authenticity scan with the NAFDAC number A6-0592, 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 Actilyse Powder used for?

Cathflo ® Activase ® (Alteplase) is indicated for the restoration of function to central venous access devices as assessed by the ability to withdraw blood. (Summarised from the official U.S. FDA label for alteplase. Always follow your doctor or pharmacist.)

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Reviews are personal experiences from PillVera users, not medical advice. Report side effects to your doctor and to NAFDAC.