Medicines tested by Semler are no longer sold in Denmark
On 22 July 2016, the European Medicines Agency (EMA) issued a press release and recommended that the national competent authorities suspend a number of medicines authorised on the basis of data from Semler Research Centre Private Ltd, Bangalore, India. The recommendation will now be sent to the European Commission for a legally binding decision valid throughout the EU.
In Denmark, the recommendation concerns four medicines in different strengths authorised for the Danish market. This matter was addressed by the media (Dagens Pharma) on 3 August 2016.
In April 2016, the Danish Medicines Agency entered into dialogue with the four pharmaceutical companies that are the marketing authorisation holders of the relevant medicines in Denmark. All of the four companies decided to withdraw the medicines from the market immediately.
The background for the recommendation is that inspections of Semler’s bioanalytical site identified several serious issues, including the handling of subjects’ clinical samples in bioequivalence studies. Semler does not manufacture medicines, but conducts clinical studies for pharmaceutical companies. Thus, Semler’s studies form the basis for the authorisation of the medicines which the EMA now recommends for suspension throughout the EU.
The medicines authorised in Denmark and recommended for suspension are:
- Atovaquone/Proguanil Orifarm, 250 mg/100 mg, film-coated tablet
- Atovaquone/Proguanil ratiopharm, 250 mg/100 mg, film-coated tablet
- Horisto, 62.5 mg/25 mg, film-coated tablet
- Horisto, 250 mg/100 mg, film-coated tablet
- Eletriptan Mylan, 40 mg, film-coated tablet
The medicines are used for the treatment of migraine and malaria.
There are no reports of lack of efficacy or any unexpected side effects from the medicines in questions.
In addition, Erlotinib Sandoz, 25 mg, 100 mg and 150 mg, is also on the EMA’s list of medicines in Denmark, however, this medicine is still under evaluation in Denmark and not yet authorised and marketed in Denmark.