See the DrugPatentWatch profile for Iluvien
What is Iluvien in Japan (PMDA) and what is it used for?
Iluvien is an intravitreal implant containing fluocinolone acetonide, used for the treatment of diabetic macular edema (DME). In Japan, the relevant regulatory reference for its approval status and labeling is the PMDA (Pharmaceuticals and Medical Devices Agency) database.
How to find Iluvien’s PMDA information (approval, labeling, and reviews)
To get the exact PMDA page(s) for Iluvien in Japan, you typically search PMDA by the product name (Iluvien) or the active ingredient name (fluocinolone acetonide) in the PMDA website search. The PMDA listing generally links to documents such as the official package insert (添付文書) and, depending on the product, review reports or related regulatory materials.
What PMDA documents usually include for Iluvien
When you open the PMDA entry for an approved product, the most commonly sought items include:
- the official package insert (for indications, dosing, contraindications, and safety information)
- regulatory approval details (manufacturer/applicant, approval date, and indication scope)
- any available public review summaries or related documents (if provided in the PMDA record)
Is Iluvien approved for the same indication in Japan as in other countries?
Japan-specific indication wording and restrictions come from the PMDA package insert. Even when the overall condition is the same (diabetic macular edema), practical details such as patient selection criteria and treatment timing can differ across jurisdictions, so the PMDA label is the right source to confirm Japan’s exact requirements.
If you mean “PMDA package insert,” where should you look?
The PMDA package insert is usually the most direct place to confirm:
- who can receive the implant
- recommended dosing and injection interval
- key warnings (ocular risks, steroid-related risks, etc.)
- monitoring advice and contraindications
Quick clarification so I can point you to the right PMDA record
Do you want:
1) the PMDA approval/labeling page for Iluvien in Japan, or
2) the PMDA package insert details (indication/dose/contraindications), or
3) whether Iluvien is currently approved or under review?
If you tell me which one, I can structure the answer around that exact PMDA topic.
Sources: None provided in your prompt.