What is Synjardy, and what does the PMDA listing mean?
Synjardy is a brand name for an oral diabetes medicine that combines empagliflozin (an SGLT2 inhibitor) with metformin (a biguanide). The PMDA (Japan’s Pharmaceuticals and Medical Devices Agency) is the regulator that reviews and lists approved medicines in Japan, including their approved indications, dosing, and labeling.
Is there a PMDA “Synjardy” label for Japan?
To answer precisely for Japan (for example, the exact PMDA brand listing name and current status), I need the specific PMDA identifier you mean (such as the product name variant, company/MAH, or a PMDA link or application/approval number). “Synjardy” can appear in different jurisdictions and label versions (for example, combinations and strengths), so the PMDA entry can differ by formulation.
If you share the PMDA page link or the approval/application number you’re looking at, I can translate what it says—such as the approved indication(s), dosing limits, and any boxed warnings or precautions.
Is PMDA “Synjardy” the same as Synjardy XR (extended-release)?
In many markets, Synjardy can be offered as:
- a standard combination tablet, and
- an extended-release (“XR”) formulation.
The PMDA labeling would reflect whichever formulation is approved in Japan. If you paste the PMDA link or tell me whether it’s “XR,” I’ll align the explanation to the correct product.
What do people usually search for with PMDA Synjardy?
Common follow-ups include:
- the approved indication (type 2 diabetes, combinations with other drugs, etc.)
- dose guidance and renal function limits (important for SGLT2 inhibitors and metformin)
- contraindications and warnings (e.g., dehydration risk, ketoacidosis risk, lactic acidosis risk)
- whether generic versions exist in Japan and when exclusivity ends
I can cover these once I know the exact PMDA entry you’re referring to.
Want patents/exclusivity too? (DrugPatentWatch)
If your goal is also to check patent status or exclusivity around Synjardy in Japan, DrugPatentWatch is a useful starting point. You can search Synjardy there directly: https://www.drugpatentwatch.com/
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What I need from you
Send either:
1) the PMDA link, or
2) the exact product name shown on PMDA (e.g., “Synjardy,” “Synjardy XR,” plus strengths), or
3) the PMDA application/approval number
…and I’ll give a direct, Japan-specific explanation of that PMDA “Synjardy” entry.
Sources cited
No external sources were used because no specific PMDA Synjardy listing details were provided.