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Actilyse - Philippines FDA Drug Approval Details

Approvals/Philippines FDA/Actilyse

Approved

STANDARD

Actilyse

-🇵🇭 Food and Drug Administration - Philippines

Approval Date: Feb 1, 2026
Approval ID: 91b1715827f7583c
Company: -
Type: Standard

Approval Details

Approval Id: 91b1715827f7583c
Drug Approval Philippines Name: Actilyse
Product Name: Actilyse
Registration Number: BR-1093
Brand Name: Actilyse
Generic Name: Alteplase
Dosage Form: Powder for Solution for Infusion (IV
Dosage Strength: 50 mg
Manufacturer: -
Issuance Date: N/A
Expiry Date: Boehringer Ingelheim (Philippines), Inc.
Pharmacologic Category: Each box contains: Ph. Eur. Type I colourless glass vial with bromobutyl rubber stopper and aluminium/ polypropylene, dark green flip-off seal + Type I glass vial (Sterile Water for Injection as diluent) x 50 mL
Classification: Prescription Drug (RX)

Approved

Quick Info

Agency

Philippines FDA

Country

🇵🇭

Approval Date

Feb 1, 2026

Approval ID

91b1715827f7583c

Type

Standard

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