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Regional · European Union

EMA product information as a primary source — does this still hold?

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Solved by sleep_log in post #6
This follows post #3 rather than contradicting it. Date every claim. Positions in this subcategory have moved repeatedly and the archive keeps posts permanently.

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c.correiaTL214 Nov 2024#1

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 not reconcile and I would like a second pair of eyes before I decide which half is wrong.

Two sources, both reputable, giving figures that cannot both be right unless they are measuring different quantities. My suspicion is that they are, and I cannot see how.

5 likes 20mo
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s.grigorescuTL2Member14 Nov 2024#2

Taking the opening post at face value and following it one step further.

Regional stock held inside the union removes a customs question entirely for intra-union movement, which is a practical difference rather than a legal opinion.

0 likes 20mo
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r.weissTL214 Nov 2024#3

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

The reason EMA product information is hard to answer is that the obvious measurement and the relevant quantity are not the same thing, and substituting one for the other is silent.

28 likes 20mo
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i.aranda_esTL2Translator · ES14 Nov 2024 · edited#4
c.correia, post #1: 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 not reconcile and I would like a second pair of eyes before I decide which half is wrong. Two sources, both reputable, giving… Go to post

EMA product information: I would want to see the raw numbers rather than the summary before agreeing. Summaries lose exactly the information that would settle this.

14 likes in reply to #1 20mo
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i.ilungaTL214 Nov 2024#5

Agreed, and I will stop repeating the version of this I had been repeating.

5 likes 20mo
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sleep_logTL2Regular Solution14 Nov 2024#6

This follows post #3 rather than contradicting it.

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

7 likes 20mo
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l.vukovicTL214 Nov 2024#7
s.grigorescu, post #2: Taking the opening post at face value and following it one step further. Regional stock held inside the union removes a customs question entirely for intra-union movement, which is a practical difference rather than a legal opinion. Go to post

The claim about EMA product information upthread is stronger than its source supports. I have read the source. The source says "associated with" and the post says "causes".

0 likes in reply to #2 20mo
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weekly_pinTL2Regular14 Nov 2024#8
l.vukovic, post #7: The claim about EMA product information upthread is stronger than its source supports. I have read the source. The source says "associated with" and the post says "causes". Go to post

Reimbursement is decided nationally and varies substantially between member states for the same authorised product.

Someone should write this up properly, and it should probably not be me.

20 likes in reply to #7 20mo
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c.kuuselaTL214 Nov 2024#9

On EMA product information, I would rather understate and be corrected upward than overstate and be quoted. That is a house style here and it is a good one.

9 likes 20mo
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taper_fileTL3Regular14 Nov 2024#10

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.

2 likes 20mo
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b.demirTL214 Nov 2024#11

Parallel distribution is a real mechanism and produces packaging that looks unfamiliar for legitimate reasons.

The answer changed when I changed how I was measuring, which was informative.

0 likes 20mo
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s.bruunTL214 Nov 2024 · edited#12
r.weiss, post #3: Everything in the opening post holds. The case it does not cover is the one I have. The reason EMA product information is hard to answer is that the obvious measurement and the relevant quantity are not the same thing, and substituting one for the other is silent. Go to post

EMA product information is one of those subjects where the general answer and the answer for a specific case diverge, and the thread will go in circles until someone says which one is being asked for.

2 likes in reply to #3 20mo
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l.piresTL214 Nov 2024#13

Source for the EMA product information figure, since it was asked for. It is in the discussion rather than the abstract, which is why the version circulating is stronger than the paper is.

Reading the surrounding paragraph is worth the two minutes. The authors are more careful than their summarisers.

10 likes 20mo
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h.mensahTL214 Nov 2024#14
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m.onwukaTL215 Nov 2024#15
weekly_pin, post #8: Reimbursement is decided nationally and varies substantially between member states for the same authorised product. Someone should write this up properly, and it should probably not be me. Go to post

This follows post #12 rather than contradicting it.

The public assessment report published at authorisation is one of the best free technical documents available on any of these compounds and it is rarely cited here.

0 likes in reply to #8 20mo
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owen.bradyTL4 Moderator15 Nov 2024#16
s.bruun, post #12: EMA product information is one of those subjects where the general answer and the answer for a specific case diverge, and the thread will go in circles until someone says which one is being asked for. Go to post

Netherlands: CBG-MEB implements framework. GPs are first point of contact. Insurance coverage for weight management is conditional on structured lifestyle programme participation.

That is the version I use. It may not be the version that is correct.

5 likes in reply to #12 20mo
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g.rasmussenTL215 Nov 2024#17

For anyone finding this later: the short answer on EMA product information is that it depends on one thing, and the rest of the thread is people identifying which thing.

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mira.patelTL4 Admin15 Nov 2024#18

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.

29 likes 20mo
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j.erdoganTL215 Nov 2024#19
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np_gilmoreTL3Nurse practitioner15 Nov 2024#20

On post #18 — agreed on the reasoning, with one qualification.

Worth separating EMA product information as a question about the compound from EMA product information as a question about the documentation. They get answered by different people and only one of them is answerable here.

9 likes 20mo
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k.pereiraTL215 Nov 2024#21
sleep_log, post #6: This follows post #3 rather than contradicting it. Date every claim. Positions in this subcategory have moved repeatedly and the archive keeps posts permanently. Go to post

Language versions of the product information are all official and occasionally differ in emphasis. Where a detail matters, reading two is not paranoid.

1 like in reply to #6 20mo
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maintenance_modeTL3Regular15 Nov 2024#22

A request rather than an answer: could whoever has the primary source for EMA product information post it? I have seen the claim three times this month and each version had lost a qualifier.

0 likes 20mo
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g.radichTL215 Nov 2024#23

On post #20 — agreed on the reasoning, with one qualification.

Prescription status is harmonised at the level of the authorisation and the practical route to a prescription is not.

The variance between people here is larger than the effect being discussed.

16 likes 20mo
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two_year_lineTL3Regular15 Nov 2024#24

Thank you for taking the time. That was more work than a reply usually is.

6 likes 20mo
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s.kuuselaTL215 Nov 2024 · edited#25

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

I am reporting what happened, not recommending it.

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batchlogTL3Regular15 Nov 2024#26

I changed my mind about EMA product information after someone here asked me for the source and I could not produce one. That is worth saying out loud because it is the ordinary way it happens.

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j.iyerTL215 Nov 2024#27

Post #23 describes the usual case. This is about the unusual one.

Two claims get bundled together under EMA product information and they need separating. The descriptive one — this is what was observed — is usually well supported. The causal one — this is why — usually is not.

Almost every disagreement in threads like this one dissolves once you say which of the two you are making.

11 likes 20mo
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bias_varianceTL4Biostatistician15 Nov 2024#28
l.pires, post #13: Source for the EMA product information figure, since it was asked for. It is in the discussion rather than the abstract, which is why the version circulating is stronger than the paper is. Reading the surrounding paragraph is worth the two minutes. The authors are more careful than their summarisers. Go to post

Adding the measurement that post #27 says would settle it.

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

Noting that the question and the thing people usually mean by it are different.

3 likes in reply to #13 20mo
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id.almeidaTL215 Nov 2024#29

I read post #27 twice before replying, because I had assumed the opposite.

I would rather this thread reach "we do not know" about EMA product information than reach a confident answer that nobody can support when asked.

6 likes 20mo
BD
baseline_driftTL2Analytical chemist15 Nov 2024#30

Correcting a stale claim here is more valuable than adding a new one, because the stale claims are what people find first.

One more caveat and then I will stop qualifying: the sample selected itself.

1 like 20mo