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Supply to the market of certain medicinal products containing the active substance ranitidine is prohibited

The State Medicines Control Agency (SMCA) made a decision to prohibit the supply to the market medicinal products containing the active substance ranitidine hydrochloride. This decision was made because of the presence of impurity N-nitrosodimethylamine (NDMA) in several batches of this active substance.


European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe on 23 September 2019 has suspended the Certificate of Compliance to European Pharmacopoeia (CEP) of ranitidine hydrochloride (manufacturer Saraca Laboratories Limited, India).
  
Taking into account the decision made by EDQM, other data received, and the recall of medicinal products containing ranitidine in Germany, Switzerland, Finland, Croatia, the Czech Republic, Hungary, Denmark, Canada, Italy, Spain, Poland, Portugal, Slovenia, Ireland, Finland and Singapore (in some of these countries recall was initiated by marketing authorisation holders themselves), supply to the Lithuanian market, including sale and release to the public of all medicinal products containing ranitidine hydrochloride as the active ingredient and manufactured by Saraca Laboratories Limited, India and Union Quimico Farmaceutica, SA (UQUIFA), Spain, is prohibited.

SMCA prohibits supplying to the market the following medicinal products:

- Ranitidinas  Sanitas 150 mg film coated tablets, N100 (marketing authorisation holder PharmaSwiss Česká republika s.r.o., Czech Republic); LT/1/97/3000/001;

- Ranitidine Accord 150 mg film coated tablets N30, N60, N100 (marketing authorisation holder Accord Healthcare B.V., the Netherlands); LT/1/12/3162/001 – 003;

- Ranigast 150 mg film coated tablets N10 (marketing authorisation holder Pharmaceutical Works POLPHARMA S.A., Poland); LT/1/97/1629/004;

- Ranitidine Accord 300 mg film coated tablets N10, N30, N60, N100 (marketing authorisation holder Accord Healthcare B.V., the Netherlands); LT/1/12/3162/004-007;

- Ranigast 150 mg film coated tablets N10 (holder of permit of parallel import  Actiofarma, UAB, Lithuania); LT/L//19/0939/001;

- Ranitidine 300 mg film coated tablets N10, N30, N60, N100 (holder of permit of parallel import PB & Т Project Ltd. filialas, Lithuania); LT/L/17/0520/001 – 004;

- Ranitidine Accord 150 mg film coated tablets N30, N60 (holder of permit of parallel import Actiofarma, UAB, Lithuania); LT/L//17/0512/001,003;

- Ranitidine Accord 300 mg film coated tablets N30 (holder of permit of parallel import Actiofarma, UAB, Lithuania); LT/L//17/0512/002;

- Ranitidine Accord 150 mg film coated tablets N60 (holder of permit of parallel import Actiofarma, UAB, Lithuania); LT/L//17/0515/001;

- Ranitidine Accord 300 mg film coated tablets N30 (holder of permit of parallel import PB & Т Project Ltd. filialas, Lithuania); LT/L//18/0783/001;

- Ranitidine Actiopharma 300 mg film coated tablets N30 (holder of permit of parallel import Actiofarma, UAB, Lithuania); LT/L//19/1019/001;

- Ranitidine Actiopharma 300 mg film coated tablets N30 (holder of permit of parallel import Actiofarma, UAB, Lithuania); LT/L//19/1005/001.

- Ranigast 75 mg film coated tablets N10 (marketing authorisation holder Pharmaceutical Works POLPHARMA S.A., Poland); LT/1/97/1629/001;

- Raniberl 150 mg film coated tablets N10 (marketing authorisation holder Berlin-Chemie AG (Menarini Group), Germany); LT/1/95/1234/001.

Prohibition of SMCA to supply mentioned medicinal products will be effective unless information is received or marketing authorisation holders of medicinal products, their representatives in Lithuania, and holders of parallel import permission will submit quality assurance documents that there is no NMDA impurity in batches of medicinal products distributed in the Republic of Lithuania.
 
Ranitidine medicines are used widely to reduce the production of stomach acid in patients with conditions such as heartburn (over-the-counter) and stomach ulcers (prescription only).
  
Patients who are presently taking above mentioned ranitidine containing medicinal products should consult their doctor or pharmacist regarding their further treatment. In Lithuania there are several other medicines used for the same approved therapeutic conditions as mentioned ranitidine that could be used as an alternative.
 
World Health Organisation (WHO) and International Agency for Research on Cancer classified NMDA and similar compounds, known as nitrosamines, as likely to cause cancer in humans. It is present in some foods and in water supplies but is not expected to cause harm when ingested in very low levels.
 
The SMCA continues to collect information on medicines containing mentioned active substance on the market, and actively cooperates with marketing authorisation holders of medicinal products, parallel import permission holders and the European Medicines Agency and, if needed, will take all necessary actions to protect patients' health.
  
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