EMA product information as a primary source — does this still hold? posts 61–90

My position on EMA product information is current rather than settled. I have revised it once already and I expect to again, so treat it accordingly.

Where I part company with post #72, and it is a narrow parting.

The arithmetic on EMA product information is the easy part and it is where the errors are, which is an uncomfortable combination. Show your working and someone will catch it.

EMA is the regulator with national implementation. Licensed incretin analogues are prescription-only across the EU, with some variation in specific approvals by member state.

Not disagreeing with anyone above, just adding the bit I keep having to look up.

Post #77 answers the question as asked. The question underneath it is different.

Offering a way to settle EMA product information rather than another opinion about it. Two measurements, taken the same way, a fortnight apart. If the difference is within the noise, the question was not answerable at this precision.

France: ANSM implements EU framework. Reimbursement has been narrower for weight management. Prescribing restrictions were applied during shortages, directing available product toward diabetes indications.

Worth one more sentence than it usually gets.

EMA product information looks different depending on whether you are reading the primary literature or the summaries of it, and the difference is not in our favour.

Building on post #81 rather than restating it.

Where I would push back on the EMA product information consensus is the confidence, not the direction. The direction looks right. The confidence is borrowed.

Everything in post #81 holds. The case it does not cover is the one I have.

Nothing here is medical or legal advice, and this subcategory in particular attracts questions where that matters.

The short version is the first sentence; the rest is why.

Members outside the union should note that essentially none of this transfers, including the parts phrased generally.

I checked the source rather than the summary, and they differ.

Post #81 and I disagree about the size of the effect, not about the direction.

Two questions I would want answered before drawing anything from the EMA product information data above: how were the cases selected, and what happened to the ones that dropped out.

Taking post #85 at face value and following it one step further.

Careful with the language on EMA product information. "Not detected" and "not present" are different findings and the first is a statement about the method.

This is the answer, and the reason it is the answer is the more useful part.

Germany: BfArM implements EU framework. Statutory insurance (the majority) excludes "lifestyle medicines" including weight management. Private prescription is common. Private insurance sometimes covers it.

Date every claim. Positions in this subcategory have moved repeatedly and the archive keeps posts permanently.

This is the sort of thing that ought to be settled and apparently is not.

What I want from this EMA product information thread is the list of things that would need to be true for the claim to hold. If we can write that list, we can check it.