On 5 March 2012, orphan designation (EU/3/12/966) was granted by the European Commission to Nexus Oncology Ltd, United Kingdom, for (1-methyl-2-nitro-1H-imidazole-5-yl)methyl N,N'-bis(2-bromoethyl) diamidophosphate for the treatment of soft tissue sarcoma.
The Danish Health and Medicines Authority warns against taking the weight-loss products Slimex 15 and Slimex 15 New Formula that are sold on the internet. The weight-loss products contain sibutramine that may cause serious side effects.
If you are taking Slimex 15 or Slimex 15 New Formula, we advise you to stop taking the product immediately and to contact your doctor. Please return any unused products to the nearest pharmacy for destruction.
The weight-loss product Slimex 15 is available in the form of yellow or orange capsules, while Slimex 15 New Formula is available in the form of white tablets:
Slimex 15 (yellow capsule): Our analysis shows that the product contains sibutramine, but this does not appear from the package.
Slimex 15 (orange capsule): It appears from the package that the product contains sibutramine (”Sibutramine Hydrochloride Monohydrate”).
Slimex 15 New Formula (white tablet): Our analysis shows that the product contains sibutramine, but this does not appear from the package.
Risk of serious side effects
Sibutramine affects neurotransmitters in the brain, which suppresses appetite. The adverse reactions from sibutramine could turn out to be very serious and may show as a faster heart rate, hypertension, hot flush, constipation, nausea, trouble sleeping, headache, anxiety, perspiration and taste perversion. All medicines containing sibutramine were withdrawn from the market in the autumn of 2010 due to the risk of serious cardiovascular adverse reactions and brain haemorrhages.
We generally urge people to be careful when they buy medicines on the internet. We recommend that you contact your doctor before you buy any medicines on the Internet.
Photos of Slimex 15
Slimex 15 (Yellow capsule)
Slimex 15 (Orange capsule)
Slimex 15 New Formula (White tablet)
Via the Rapid Alert System from the German competent authority, the Agency for Medicinal Products and Medical Devices (HALMED) has received a notice on the suspected counterfeit batches of MabThera 100 mg concentrate for solution for infusion (batch: H0156B09, shelf-life: 05/2016) and MabThera 500 mg concentrate for solution for infusion (batch: H0721B04, shelf-life: 04/2016).
These batches reported as a suspected counterfeit have never been placed on the Croatian market.
More information is accessible under the link below.
An expert workshop "OTC medicines: the role of good classification in promoting medication safety and accessibility in Europe" organised by the Council of Europe’s European Directorate for the Quality of Medicines and Healthcare (EDQM) and the Agency for Medicinal Products and Medical Devices (HALMED) was held from 20 to 21 November 2014 in Zagreb. Nearly 100 participants from 19 countries in Europe, representing national and European competent drug authorities, ministries of health, healthcare professionals, patients’ organisations, the pharmaceutical industry and pharmaceutical wholesalers involved in classification of medicines as regard their supply.
Welcome speeches were held by Dr Susanne Keitel, PhD, the Director of EDQM, Dr Viola Macolić Šarinić, MD, PhD, the Head of HALMED and chair of the EDQM’s Committee of Experts on the Classification of Medicines as Regards their Supply (CD-P-PH/PHO).
The workshop was aimed at providing extended knowledge to participants and to familiarise them with the work of the Committee of Experts on the Classification of Medicines as regards their Supply (CD-P-PH/PHO), which annually issues recommendations to health authorities of European Pharmacopoeia member states for the classification of medicines and establishes good classification practices, and to collect feedback from the different stakeholders, including patient associations.
More information is accessible under the link below.
Roche d.o.o. in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and European Medicines agency (EMA) has sent a letter to healthcare professionals on the important information on stickers on vials as a precaution measure for safe use of Erivedge 150 mg hard capsules (vismodegib).
More information and the Dear Healthcare Professional Letter are accessible under the link below.
Roche d.o.o. in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and European Medicines agency (EMA) has sent a letter to healthcare professionals on the important safety information with regard to teratogenic effects of Erivedge 150 mg hard capsules (vismodegib) and introduction of the Pregnancy prevention programme for this medicine.
More information and the Dear Healthcare Professional letter is accessible under the link below.
In future, we will comment on medicinal product names applied for (names of human medicines applied for under the mutual recognition (MRP) and decentralised procedures (DCP)) on Day 50 for MRP and on Day 100 for DCP with Denmark as concerned member state, and on Day 70 with Denmark as reference member state. This takes place at request from the pharmaceutical industry.
Subject to approval of name
However, this procedure is subject to the final approval of a name, because in the period until a marketing authorisation has been granted for a medicinal product, other medicinal product names may have been approved that can be confused with the medicinal product name applied for. Consequently, companies should note that the longer the clock stop period for an application, the greater the probability that the medicinal product name applied for has already been approved for another medicinal product, since it is not possible to reserve a name during the procedure.
In addition, other circumstances may also arise, such as changed naming practice, with the result that the name cannot be approved.
Regarding medicinal product names applied for under the purely national procedure, we will continue to comment on the name applied for both on Day 0 and when we send our Day 110 letter.
As regards veterinary medicines, we will also comment on the name applied for on Day 54 (MRP) as well as on Day 100 (DCP).
We only evaluate proposals for medicinal product names based on an actual application.
You can read more about the practice for the naming of medicines on our website.
The combination of low-dose aspirins and anticoagulant medicines can cause severe bleeding. Consequently, we have published new material describing the risk of this combination to patients with heart flutters and doctors.
About 100,000 Danes suffer from heart flutters, and every year between 15,000 and 20,000 new patients are diagnosed with heart flutters. Heart flutters can be dangerous, because there is an increased risk of blood clots. One out of five blood clots in the brain is caused by heart flutters. The risk of heart flutters increases with age, and around one in ten people above 75 years suffers from heart flutters.
Combination causes an increased risk of bleeding
Most patients suffering from heart flutters benefit from treatment with anticoagulant medicines like Marevan® (warfarin) that reduces the risk of blood clots. Around every tenth patient with heart flutters also takes Hjertemagnyl®, a low-dose aspirin, in combination with Marevan®.
For patients who are being treated with Marevan®, treatment with Hjertemagnyl® does not offer further protection against blood clots. However, the risk of bleeding increases.
Consequently, we have published new material describing the risk of this combination and what patients should be particularly aware of; the material is aimed at patients with heart flutters and doctors (in Danish only). For example, the publication advises patients to inform their doctor of the medicines they take, including over-the-counter medicine.
Links to the material (in Danish only)
Video om hjerteflimmer og bivirkninger ved samtidig brug af acetylsalicylsyre og warfarin
Patientfolder:"Hjerteflimmer" om atrieflimren, antikoagulansbehandling med warfarin, interaktioner samt de nye antikoagulerende lægemidler
Patientfolder: Hjerteflimmer og Hjertemagnyl om den forhøjede blødningsrisiko, der er ved samtidig behandling med acetylsalicylsyre og warfarin
Informationsfolder til læger: Information om antikoagulansbehandling ved atrieflimren