EMA product information as a primary source — does this still hold? posts 31–60
This is a continuation of a long topic, addressed by post number rather than by page. Start at post 1 · go to the accepted answer.
The arithmetic in post #30 is right; the assumption feeding it is the part to check.
France: ANSM implements EU framework. Reimbursement has been narrower for weight management. Prescribing restrictions were applied during shortages, directing available product toward diabetes indications.
Two people can read the same figure differently here and both be reasonable.
Answering the question post #32 raises rather than the one it answers.
Summarising the EMA product information thread so far, since it is long and the answer is buried: the first reply has the method, the fourth has the correction to it, and the rest is people agreeing at length.
Confirming post #34 from a second method, which matters more than confirming it from a second person.
Practical answer on EMA product information, since the theoretical one is upthread: do the simplest check first, write down the result, and only then decide whether the complicated explanation is needed. It usually is not.
Shortage notifications are published both centrally and nationally and the two do not always agree, usually because they are describing different things.
Post #36 describes the usual case. This is about the unusual one.
Language versions of the product information are all official and occasionally differ in emphasis. Where a detail matters, reading two is not paranoid.
On balance I think that is right, and I would not bet much on it.
A device-and-compound combination has one authorisation and two supply chains, and the device is more often the limiting one.
I would rather be precise about what I do not know than vague about what I do.
Coming back to post #36, because the follow-up matters more than the original answer.
Two people in this thread mean different things by EMA product information and are disagreeing about the definition while believing they are disagreeing about the facts. Worth pausing to define it.
I would be cautious about generalising from the EMA product information example above. It is a good example. It is one example.
A definition problem is doing most of the work in this EMA product information discussion. Once the term is pinned down I suspect the disagreement mostly goes away and what is left is small.
Taking post #41 at face value and following it one step further.
What I would check first on EMA product information is whether the thing being measured moved or whether the way of measuring it moved. Those look identical in a graph.
Answering the question post #41 raises rather than the one it answers.
France: ANSM implements EU framework. Reimbursement has been narrower for weight management. Prescribing restrictions were applied during shortages, directing available product toward diabetes indications.
Written from notes rather than memory, which is why the numbers are specific.
Post #45 describes the usual case. This is about the unusual one.
Pharmacy practice: pharmacies in different EU countries differ in conservatism about irregular prescriptions. Some will decline a prescription they consider irregular; others will not. Local pharmacy culture matters.
Adding the measurement that post #49 says would settle it.
The documentation on EMA product information is better than this thread and I say that as someone who has posted in the thread.
Collapsed as off-topic by two members at trust level 3 or above
Post #48 is right about the mechanism and I think understates the practical bit.
An honest declaration on EMA product information: I have a prior here and it is strong enough that you should weight what I say downward. Stating it rather than hiding it.
Helpful, and easy to find again, which is half of what a good reply is.
Germany: BfArM implements EU framework. Statutory insurance (the majority) excludes "lifestyle medicines" including weight management. Private prescription is common. Private insurance sometimes covers it.
Posted with less confidence than the sentence structure implies.
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.
Post #53 answers the question as asked. The question underneath it is different.
Correcting a stale claim here is more valuable than adding a new one, because the stale claims are what people find first.
The uncertainty is in the assumption, not in the calculation.
Small methodological point on EMA product information: repeating a measurement is cheap and resolves most of what is being argued about here at no cost to anyone.
Reimbursement is decided nationally and varies substantially between member states for the same authorised product.
I would keep EMA product information and the decision it usually gets used for separate in this thread. They are related and they are not the same question, and merging them is why the last one went badly.
Adding a null result on EMA product information. I looked, carefully, and found nothing, and null results deserve posting precisely because they never are.