[e-drug] Prescription status of cetirizine

[Vanda Zidoniene <VandaZidoniene@VVKT.LT>]

E-drug: Prescription status of cetirizine
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Dear E-Drugs colleagues,

We have registered Letizen ( Cetirizini dihydrochloridum)  from KRKA 
manufacturer.
And now we don't solve one problem: we have film coated tablet, 10 mg, 
packages of 7 and 10 units registered as OTC and the same product - 10 mg 
tablets in packages of 20 and 30 units - as prescription medicines.

I would like to ask  what legal status has this product in other countries 
if it is registered ?
Other products with cetirizine, Cirrus, Zyrtec, Cetirizine are registered 
as prescription drugs in Lithuania.

According to Lithuanian law we must take legal status according to original 
of SPC ( prepared by manufacturer), and we have two originals of this pr  
oduct.

We would be very grateful  if you'll send us information if you have.

Sincerely,
Vanda Zidoniene

_______________________
Vanda Zidoniene
The State medicines control agency
at the ministry of Health
The drug information centre
Traku 14, 2001 Vilnius, Lithuania
Tel. 370 2 62 78 60, 370 2 22 27 20
Fax 370 2  22 29 48
mob. 370 86 10540
E-mail: VandaZidoniene@VVKT.LT
http://vic.vvkt.lt

[Vanda, this was not so clear to me. It seems as if you regard Letizen as 
an original, and then one of the other is also an original? If this drug 
had been under patent, then one would be the original. Cetirizine is 
probably off patent and then they should all be multisource products. If 
one of them had been on the market before patent expiry, I suppose 
regulatory authorities would regard that as the original. In your case, I 
have a feeling all should have same status.
Further it is not clear to me how this new product could obtain OTC status 
for a couple of packages unless it has to do with package size (and/or 
strength), i.e. that your regulatory authority has decided to let the 
product be OTC in packages of 10 or less. We have many such products in 
Norway: some pain killers, antiallergy drugs and H2blockers. For 
cetirizine, a package of 7 is OTC in Norway. If this is what your 
regulatory has done, it means that the other products should obtain the 
same status of they make the same small packages. KM]

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