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[Conolly]

Hello again,


According to https://www.gov.uk/government/collections/parallel-import-licences-lists-of-approved-products since 2014 there are 3 parallel import licences granted to Oestrogel, none to Oestrodose. The companies that have been granted the licences are G-Pharma Ltd in 2014, Ginova Ltd in 2016 and Quadrant Pharmaceuticals in 2018.


Quadrant Pharmaceuticals is a non trading company that is part of a group called Walkboost, along with Maxearn Ltd and Eaststone Ltd https://www.eaststone.co.uk/wp-content/uploads/2018/05/Walkboost-Group-Overview-August-2017.pdf


The most recent Oestrogel leaflet listed at MHRA website says:


'Manufactured by: Besins Manufacturing Belgium N.V., GrootBijgaardenstraat, 128-1620 Drogenbos, Belgium.Procured from within the EU. Product Licence Holder: QuadrantPharmaceuticals Ltd, Lynstock House, Lynstock Way, Lostock,Bolton, BL6 4SA. Repackaged by: Maxearn Ltd, Bolton, BL6 4SA.PL 20774/1551 Oestrogel Pump Pack Leaflet revision date: 11th January 2018'


I have sent them an email asking about Oestrodose.


Conolly X

[Conolly]

Hello again...


A great article on Parallel Imports
https://www.alscg.com/brexit-parallel-imports-end-era/


Conolly X

[Hurdity]

Yes there seem to be several parallel import companies based on the information given by women on here who use Oestrogel/Oestrodose.

The reason there isn't an import license granted to Oestrodose is I presume because the license is given for a parallel import of Oestrogel - the product labelled as such in Europe for the UK market ( amongst other countries maybe too?). There is no entry for Oestrodose in UK as it is not known by this name here so the license is given to import Oestrogel - and presumably it is cheaper for the import company to buy the estradiol gel packagaed as Oestrodose rather than maybe the more limited stocks of estradiol gel marketed as Oestrogel?

Not sure what you are asking Besins Connolly?

I asked them about the parallel import company and they didn't seem to have information - this is what they said:

There is only one formulation for manufacturing this product and the stabilities on the product, whether Oestrodose or Oestrogel, are all compliant. There was no significant difference in the past 20 years in stability studies for this product.

However, the stability studies are made on products not leaving the factory and stored in the
optimum conditions for the complete shelf-life period, although we have stability studies for the following conditions: 25℃ & 30℃ for 36 months and 40℃ for 6 months.
The product Oestrogel distributed in the UK is managed by Besins Healthcare from the
manufacturing facility to your distributor in the UK.

However, the product Oestrodose distributed in the UK is not monitored by Besins. Once the product leaves the distribution warehouse in France, we do not know what happens to the product when it is with the wholesaler in France and when it is shipped to the importer in the UK. Therefore, it is not possible for us to confirm that this is just a perception as there is a part of the time where the product has been out of our control and we do not know what conditions the product has been exposed to.

I would advise that you contact the importer of the product from France for further information on storage conditions of Oestrodose.

Their point was that if the product was stored in unfavourable conditions, this could account for apparent differences. I have mentioned this several times in the thread. Also that they did not hold contact details of the parallel importers as it went to a wholesaler first.

At this point I lose interest!

If you want to identify the whole supply chain and interrogate each parallel importer to ensure that all their stocks originate from Besins  and are always stored in favourable conditions - then good luck to you!

I am satisfied from my correspondence with Besins as well as accounts from a number of long-standing post-menopausal users of the gel, that at least for most of the time it is proper Oestrodose (Oestrogel). Whether on occasion a parallel importer gets it from somewhere else far afield and not manufactured in Belgium remains to be seen and I would suggest a good way to sort this out as suggested many times on here is to keep the packaging and batch numbers of any Oestrodose that differs in consistency from other Oestrodose/Oestrogel, or causes an allergic reaction and report to the MHRA or Besins themselves for analysis.

I would be interested to know what you have asked Besins Connolly, and their response, especially if it adds to what I have already established.

Hurdity x

[Conolly]

Bumping for Donna-paul


Conolly X

[Hurdity]

Copied from the other thread

Hello Hurdity,


Actually only in the UK Oestrodose is relabelled as Oestrogel. Oestrodose is only available in France and the Phillipines. All other EU countries have Oestrogel or Gynokadin (Germany) and Estrogel in the US.


I don't understand why Besins UK can't provide Oestrogel for the whole UK market. The only explanation for many parallel importers trading Oestrodose is because it's cheaper to buy it from France or the Phillipines.


The reason why the pump-pack is called Oestrodose in France is because Besins had already launched Oestrogel tube over there.


Conolly X

Just to reiterate – as reported in the first post on this thread, Besins Belgium have stated that they do not manufacture Oestrodose in the Phillipines and no such product from there reaches UK.  All the Oestrodose in UK is imported through parallel importers who purchase it from wholesalers supplied by Besins Belgium (the supply chain may be even longer than this?). The manufacturer of the Oestrodose you receive in UK will be given on the Patient information leaflet, and probably also the canister and the box and there will be a batch number.

I agree it is confusing to produce an identical product with two different names to the same country and it should ideally be called one or the other for whole of EU countries they supply!

Hurdity x

[Conolly]

Hello again,


Just to be clear... I never said Oestrodose is manufactured in the Philippines. I said that Oestrodose, as a brand name, is only available in France and the Philippines. I don't know how can you be so sure that parallel importers buy all Oestrodose from France. After all, if both are manufactered at the same plant (Drogenbos), it doesn't matter if they are imported from France or the Philippines.


Regarding the brand names, it's quite common to have the same product with different names around the world, it's just about international trademark registrations.


What I REALLY don't understand is why Besins UK can't provide Oestrogel for the whole UK market.


Conolly X


P.S. Oestrodose is also marketed in Tunisia and Lebanon by Besins.

[Hurdity]

UPDATE FOLLOWING RECENT DISCUSSION WITH DR LOUISE NEWSON

There has been continued speculation about the differences between Oestrogel and Oestrodose at various times and on various threads on this forum.

Just to recap – Besins manufacture both Oestrogel and Oestrodose at their plant in Belgium and they report that these are both the same product with different names, and have been tested extensively at different temperatures etc. Oestrogel is for the UK market and Oestrodose is for the French and other markets. The Oestrodose in the UK is imported via parallel import companies and repackaged (outer carton and pump pack, not the inner pouch containing the gel). Although stability studies (in terms of storage time and temperature) have been carried out using the Oestrodose/Oestrogel at Besins lab, they have stated they have no control over the product once it leaves their factory so cannot comment on storage conditions.

In view of the ongoing controversy surrounding this, and because she has been mentioned by forum members in the context of this debate at various times, I have been in discussion with Dr Louise Newson and she is happy for me to post her views on this forum.

She tells me that she has personally spoken to Besins several times about the gels, and that she has been given exactly the same information that I have – that the Oestrogel and Oestrodose that they manufacture there are identical in composition and just named differently.

 In addition she says the following:

“Many women do not notice the difference between the two types. However, I certainly have several women who have told me that their symptoms have returned with using the oestrodose instead of the oestrogel. I wonder whether the pump action is slightly different so they receive slightly less of the gel. It is for this reason that I only dispense oestrogel in my clinic. So as a general rule if women use the alternative preparation which they have obtained from their GP without any problems then I would not be concerned but if they experience symptoms then I would encourage them to go back to using oestrogel. They can use their NHS prescription www.theindependentpharmacy.co.uk who usually only dispense oestrogel.

I think women should know that most of them will be fine but if they notice a difference then they should get the original pump packs”

I raised the issue of the pump pack previously with Besins and they assured me that their pump pack delivered exactly the same amount. However as Louise points out there remains the possibility that the pump packs produced by some of the parallel importers are slightly different meaning some women might get less of the gel – and which some women may be more sensitive to?

The issue of itching is an entirely different matter and remains unresolved – there is no evidence to suggest there is a difference but as we have said several time before anyone experiencing a persistent allergic reaction only on the one product which resolves on changing and re-appears when Oestrodose is used – should report this to the MHRA, take a note of the batch number and also report to Besins because a compositional difference would imply fraud as the patient leaflets clearly state the ingredients, which are identical.

I hope this helps to clarify some of the issues raised. My intention in researching this was to help other women and reassure those who were concerned as well as to dispel rumours about the origins and composition of Besins Oestrodose which turned out to be unfounded.

Here's to a continued flush-free experience girls using whatever product you choose!

Hurdity x

[Ladybt28]

See itching Hurdity - Oestrogel has ethanol in it as part of the delivery mechanism which is where this sort evaporating alcohol consistency comes from.  Maybe it is the ethanol which some women don't get on well with on their skin.  Bit like skin cleansers and products that have alcohol type chemicals in them?  Does Oestrodose have the same?

[Hurdity]

Yes that's the whole point re the ingredients - they are exactly the same! They are not different products - that was the whole point of my writing to Besins to find out and then posting on this thread - to find this out. I completely get your point re the alcohol and women not getting on with or being allergic to some ingredients but there is as yet no explanation for anyone who experiences itching on one (Oestrodose) and not another (Oestrogel). For this to be attributable to one of the products - it would have to keep happening every time the product was switched, rather than just the once.

Hurdity x

[Ladybt28]

Sorry Hurdity - I must have missed the threads where itching was complained of with one product not the other - I thought the itching was a general gel issue and being discussed as such in amongst the thread and not as a product specific issue.  It doesn't affect me anyway I always get given a box which says oestrodose but has a bottle that says oestrogel which has been re-packaged in Doncaster.  I have never had "pure oestrodose" to compare it with.

[Hurdity]

No problem Ladybt!

Yes what you are getting is one and the same - what everyone else is getting - ie when you don't get the Oestrogel in the Oestrogel pack direct from Besins, you get Oestrodose from Besins made in the same plant, either repackaged or just re-labelled as Oestrogel in a variety of different ways depending on which company is importing it I think. So yes it's pure Oestrodose - which is pure Oestrogel because we don't call that product Oestrodose in UK hence it all has to be relabelled (As far as I know they all have to be relabelled as Oestrogel with the oestorgel pil  - as Oestrodose is not listed in the EMC).

As Conolly said a few posts back - why these companies have to call the same product by different names for different countries is beyond me - but must be something to do with the medicines regulator in each country or something to do with what appeals in different languages and cultures?? Who knows but it doesn't half cause confusion!!!

Hurdity x

[Kkay]

Thank you Hurdity and thank you Conolly for diving into this so deeply.

I live in India and sourcing my estradiol gel is always a great struggle.

I used Estrogel from 2004 to 2016. I used to buy it in France -  it came in a toothpaste-sized tube, not a pump. It controlled my symptoms more or less. A few times during that period I was given Oestrodose in a pump bottle (straight not with a neck) and I found it did not work as well although I cannot remember the exact symptoms now that reared their ugly heads. I made sure I was only given the tube not the pump after that.

France switched to Oestrodose, pumps sometime last year I think and the toothpaste -like Estrogel is no longer available to my knowledge. I did not do well on the pumps at all.

I am now using Oestraclin - made and sold in Spain over the counter - which is listed as the same as Estrogel, although not made by Besins. I am struggling with many symptoms, mainly brain fog, depression and cystitis- like urethral and bladder symptoms (which I am starting Vagifem for). Sorry if this is too detailed for this thread.

I do not know if my continued symptoms is due to the switch or simply increased needs of my body.

I think the investigations you have both done Hurdity and Conolly are brilliant. I don't believe Besin's replies entirely although I don't disbelieve them entirely either.

I am puzzled as to why some doctors seem to think the two preparations are different. Thank you Hurdity for checking with Dr. Louise. I wonder why Dr Stubbs only prescribes Estrogel? It might be good if one of his patients could ask what his evidence is for this. Also, I have seen the statement that oestrodose is weaker than estrogel in so many places - not on this site, but on many other websites - , and I simply don't know what the evidence for that is. Also, Dr Louise was quoted as saying that to someone on this thread (? I am very puzzled)

Thank you again for all the effort you have put into this and to everyone who replied with their experiences

[Hurdity]

Kkay - I appreciate your comments!

However there is more likely to be a difference between Oestralcin and Oestrogel/Oestrodose (which are the same even if different pump packs), because as you say Oestraclin is not made by Besins. It does however have the same ingredients and concentration of estradiol. Mary G swears by it so it must be good  . Although not the subject of this thread, however I would suggest though that anyone who is very sensitive to differences in these products as some users clearly are - should not use this substitute as it is not manufactured by Besins and could be subject to slight differences in the ingredients. Everyone else who is happy on any product would be fine!

Stellajane has answered your Q about private practitioners which I agree with. I have reported Louise Newson's reply to me verbatim in italics. Don't forget I did not write to her as a patient. She does not believe the products are different (because she also wrote or spoke to Besins herself), subject to possible caveat re potential slight difference in amount dispensed although Besins say their own packaged Oestrodose and Oestrogel pump packs dispense exactly the same amounts. She will no doubt respond to her patients as tactfully as possible and give them what they want. As for Dr Stubbs - do you mean John "the Prof" Studd? Who knows what he says to his patients at great expense (!) but it doesn't alter what I have reported from Besins and Dr Newson.

Not sure what it is about Besins you don't entirely believe? The patient information leaflets of all of these products should give the manufacturers as well as the importer. Once one goes into the realms of not accepting the statements from the companies about the origin of their products - well there is nothing further that can be done short of conducting your own detailed analysis of the product itself.

You will have read about one being weaker as hearsay and personal anecdotal evidence from forum and gel users. That is the evidence. There is no actual objective evidence. Third party reports of what someone may have said do not constitute evidence.  If you read this thread you will see that no-one is disputing that some gel users notice a difference but that does not mean that the products are different, and users' experiences are genuine. The various possible explanations for this have been given on the thread.

Anyway glad the Oestraclin is working for you Kkay . Long may that last!!!

Hurdity x

[Jeepers]

Hi all

I know the title of this thread is that they are exactly the same, but I just wanted to add my experience.

I was give oestrodose and  started using it about 2.5 weeks ago.  I have been feeling worse and worse.  Headaches, achy, hot flushes... anxiety ramping even higher.
So, I picked up my new prescription and they have given me one of each!  I switched back to oestrogen and hopefully things will improve (only on day 2).   I just think that maybe I wasn't absorbing the oestrodose, which is thin  and smells strongly of alcohol.

I spoke to a friend who used to work in a pharmacy and told me to take the unused oestrodose back and tell them that it is a parallel import, and that I cant take it, as I have a bad reaction, and they should change it (box is still sealed and my prescription definitely says oestrogel).

Jeeper xx

[Hurdity]

Hi Jeepers - sorry to hear about your problems. Just because it is a parallel import doesn't mean it's different. I explained all of that ( from my correspondence with Besins) at the beginning of,  and at intervals throughout the thread. Alcohol is the main ingredient of this estradiol gel (my testogel smells the same!).

If you have a reaction to the oestrogel packaged as Oestrodose then you must report it through the MHRA yellow card scheme and possibly also contact Besins with the batch number or whatever it is so that they can investigate that batch?

If you have only just started using gel then there are likely to be teething problems as your body adjusts, and also if you are peri-menopausal too. Hope you feel better soon

Hurdity x