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Destruction of products
Scope of application For the destruction of: products held by holders of an end user licence (reference standards), medicinal products that were sold in a retail pharmacy and which, for various reasons, have been returned to the dispensary by the patient, products mentioned in Annex III of the Royal Decree of 6 September 2017, preparations mentioned in Annex Ic and IVc of the Royal Decree of 6 September 2017, substances mentioned in Annex V of the Royal Decree of 6 September 2017. no particular requirement has been set. Article 44 stipulates only that these products must be destroyed in accordance
Destruction of products
Scope of application For the destruction of: products held by holders of an end user licence (reference standards), medicinal products that were sold in a retail pharmacy and which, for various reasons, have been returned to the dispensary by the patient, products mentioned in Annex III of the Royal Decree of 6 September 2017, preparations mentioned in Annex Ic and IVc of the Royal Decree of 6 September 2017, substances mentioned in Annex V of the Royal Decree of 6 September 2017. no particular requirement has been set. Article 44 stipulates only that these products must be destroyed in accordance
Perjeta®
Active substance Pertuzumab Holder Roche Status Closed Indication in combination with Herceptin® (trastuzumab) and chemotherapy for the adjuvant treatment of adult patients with HER2 positive early breast cancer at high risk of recurrence defined as lymph node positive disease Public documents Approbation Information for the patient Informed consent Last update 09/07/2019
Symposium on working with and for the patient
The patient is one of the most important partners for the Federal Agency for Medicines and Health Products (FAMHP). In response to this, two symposia have already been organized regarding working with and for the patient.
Use of the OTC QRD template for medicines delivered on medical prescription or written request according to article 3 of the regent decree dated 6 February 1946
As of 1 January 2019, the holders of a marketing authorisation (MA) must use the OTC version of the QRD template for drugs delivered on medical prescription or written request according to article 3 of the regent decree dated 6 February 1946.
Xarelto
Active substance Rivaroxaban Holder Bayer Status Closed Indication Co-administered with acetylsalicylic acid (ASA), for the treatment of patients with coronary artery disease (CAD) at high risk of ischaemic events Public documents Approbation Information for the patient Informed consent Last update 21/08/2020
Medical Devices Division
Division/Coordination/Unit Medical Devices Division General e-mail address General phone number + 32 2 528 40 00 Key tasks
Safety report for ophthalmologists and patients for the ocular implant Raindrop Near Vision Inlay from the manufacturer Revision Optics
The FAMHP wants to notify ophthalmologists and patients of a safety report from the American government, the Food and Drug Administration (FDA) on the ocular implant Raindrop Near Vision Inlay from the manufacturer Revision Optics. At this time there is no information that the ocular implant was also distributed in Belgium.
Olorofim
Active substance F901318 Holder F2G Ltd Status closed Indication Treatment of invasive fungal infections due to Lomentospora prolificans, Scedosporium spp., Aspergillus spp., and other resistant fungi in patients lacking suitable alternative treatment. Public documents Approbation Information for the patient Informed consent Last update 23/06/2023