Where I part company with post #9, and it is a narrow parting.
Reading this EMA product information thread as someone who came in with a fixed view: the third and seventh replies moved me and the confident ones did not.
Where I part company with post #9, and it is a narrow parting.
Reading this EMA product information thread as someone who came in with a fixed view: the third and seventh replies moved me and the confident ones did not.
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.
Taking post #26 at face value and following it one step further.
I have three months of notes on EMA product information and the honest summary is that the trend is real and the week-to-week numbers are noise. I nearly drew the opposite conclusion from the first fortnight.
Marking my uncertainty on EMA product information explicitly. I am confident about the direction, much less confident about the size, and not confident at all that it generalises past the case in the first post.
I keep a log for EMA product information specifically because my memory of it turned out to be systematically wrong in one direction. Six weeks of notes cost nothing and settled it.
On post #49 — agreed on the reasoning, with one qualification.
Language versions of the product information are all official and occasionally differ in emphasis. Where a detail matters, reading two is not paranoid.
I would put a moderate confidence on that and no more.
Post #53 describes the usual case. This is about the unusual one.
On EMA product information the community has more anecdote than the confidence in this thread implies, and I include my own contribution in that.
Building on post #57 rather than restating it.
Trying to state the EMA product information position in a way that someone who disagrees would recognise as fair, because I do not think the version in this thread passes that test.
Reporting rather than recommending, on EMA product information. What happened is above. Whether it should have is a different question and not one I am qualified to answer.
Read the full topic (75 posts)
| Topic | Participants | Replies | Views | Activity |
|---|---|---|---|---|
|
German, French and Dutch differences, compared
German, French and Dutch differences, compared — setting out what I have, and where I think it stops being reliable. Asking about german directly, because I have read four threads on it and each answered a…
|
2 | 12k | 10h | |
|
EMA product information as a primary source — does this still hold?
The question in the title: EMA product information as a primary source — does this still hold? I will give what I have already checked below so nobody repeats it. Something about EMA product information does…
|
+127 | 150 | 41k | 20mo |
|
Second pass at: Reimbursement variation across member states
On the subject in the title: Second pass at: Reimbursement variation across member states Working notes rather than a conclusion. The question about Reimbursement variation across member states that I…
|
+23 | 28 | 45k | 21mo |
|
Coming back to: Cross-border purchase rules within the EU
Cross-border purchase rules within the EU Writing it up because I had to work it out twice and would rather nobody else did. Cross-border purchase rules within — I have the observation and I do not trust my…
|
+12 | 16 | 2.8k | 11mo |
|
EU-wide position versus national implementation
EU-wide position versus national implementation Writing it up because I had to work it out twice and would rather nobody else did. Eu-wide position versus national implementation: what I expected, what I…
|
+22 | 29 | 356 | 11mo |
| Topic | Participants | Replies | Views | Activity |
|---|---|---|---|---|
|
[2026 update] An appeal that failed, and what I would do differently
Posting this under the heading it deserves: An appeal that failed, and what I would do differently Everything below is what sits behind that. Asking about appeal directly, because I have read four threads on…
|
+152 | 159 | 2.5k | 13mo |
|
Enforcement priorities versus written rules — does this still hold?
Enforcement priorities versus written rules — does this still hold? — that is the question, and I have not found it answered plainly anywhere I have looked. Asking what a regulator's document actually says,…
|
+36 | 40 | 37k | 11mo |
|
Prescription requirements and telehealth models — a second dataset
On the subject in the title: Prescription requirements and telehealth models — a second dataset Working notes rather than a conclusion. Posting a small dataset on Prescription requirements and telehealth…
|
+87 | 94 | 1.1k | 21d |
|
Reading a regulatory notice rather than an article about it
Posting this under the heading it deserves: Reading a regulatory notice rather than an article about it Everything below is what sits behind that. Posting a small dataset on reading a regulatory notice. It is…
|
2 | 2.9k | 5mo | |
|
[2026 update] EU-wide position versus national implementation
On the subject in the title: EU-wide position versus national implementation Working notes rather than a conclusion. A methods question rather than a substantive one, about eu-wide position versus national…
|
2 | 54k | 19mo |