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Approvals/Philippines FDA/Gadovist

Approved

STANDARD

Gadovist

Bayer AG🇵🇭 Food and Drug Administration - Philippines

Approval Date: Jul 14, 2025
Approval ID: e231bb12141a6c04
Company: Bayer AG
Type: Standard

Approval Details

Approval Id: e231bb12141a6c04
Drug Approval Philippines Name: Gadovist
Product Name: Gadovist
Registration Number: DR-XY38878
Brand Name: Gadovist
Generic Name: Gadobutrol
Dosage Form: Solution For Intravenous Injection
Dosage Strength: 1 mmol/mL (equivalent to 604.72 mg/mL)
Manufacturer: Bayer AG
Importer: Bayer Philippines, Inc.
Company Detail Path: /organization/bayer-ag
Issuance Date: 24 August 2023
Expiry Date: 24 August 2028
Pharmacologic Category: Paramagnetic Contrast Media
Classification: Prescription Drug (RX)

Active Ingredients

Approved

Quick Info

Agency

Philippines FDA

Country

🇵🇭

Approval Date

Jul 14, 2025

Approval ID

e231bb12141a6c04

Type

Standard

Back to Philippines FDA Approvals

Gadovist - Philippines FDA Drug Approval Details