(PDF/65.21 KB) (PDF/407.01 KB) (PDF/162.67 KB) The company also carried out a study that showed that it is ‘bioequivalent’ to the reference medicine. (PDF/56.41 KB) (PDF/469.26 KB) Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Cinacalcet Mylan, including the appropriate precautions to be followed by healthcare professionals and patients. (PDF/86.76 KB)
(PDF/157.46 KB) (PDF/442.47 KB) (PDF/485.87 KB) (PDF/166.09 KB) (PDF/88.51 KB) (PDF/142.73 KB) (PDF/464.59 KB) (PDF/52.67 KB)
The dose is then adjusted as needed, every 3 to 6 months, according to the iron levels in the blood.For more information about using Deferasirox Mylan, see the When the body cannot remove iron effectively, the excess iron can cause damage.
(PDF/158.92 KB) (PDF/51.49 KB) (PDF/429.24 KB) (PDF/129.01 KB) (PDF/48.21 KB) (PDF/139.46 KB) Side effects reported with Deferasirox Mylan are carefully evaluated and any necessary action taken to protect patients.Please note that the size of the above document can exceed 50 pages.You are therefore advised to be selective about which sections or pages you wish to print.This medicine is authorised for use in the European Union.
(PDF/159.22 KB) (PDF/89.35 KB) (PDF/93.16 KB) (PDF/66.81 KB) (PDF/156.8 KB) (PDF/53.26 KB) (PDF/47.77 KB) (PDF/425.68 KB) (PDF/50.14 KB) (PDF/143.89 KB)
(PDF/138.24 KB) (PDF/138.82 KB) (PDF/50.43 KB)
(PDF/54.19 KB) (PDF/52.67 KB) (PDF/49.54 KB) (PDF/162.68 KB)
(PDF/429.24 KB) (PDF/454.03 KB)
(PDF/68.32 KB) (PDF/48.39 KB)
(PDF/139.24 KB)
(PDF/48.21 KB) (PDF/442.47 KB) (PDF/162.36 KB) (PDF/139.19 KB)
(PDF/163.36 KB)
Therefore, the Agency’s view was that, as for Exjade, the benefits of Deferasirox Mylan outweigh the identified risks and it can be authorised for use in the EU.The company that markets Deferasirox Mylan must issue an education pack to healthcare professionals.
(PDF/396.75 KB) (PDF/425.35 KB) (PDF/87.8 KB)
(PDF/138.24 KB) (PDF/50.14 KB) (PDF/159.18 KB) (PDF/365.4 KB) (PDF/162.17 KB) (PDF/126.81 KB) (PDF/91.29 KB) (PDF/163.27 KB) A risk management plan has been developed to ensure that Cinacalcet Mylan is used as safely as possible. (PDF/142.73 KB)
(PDF/86.9 KB) (PDF/158 KB) In the UK we currently have more than 500 products, treating conditions ranging from respiratory diseases, severe allergic reactions, dermatology, cardiovascular and metabolic conditions, as well as psychiatric disorders.
(PDF/68.35 KB) (PDF/139.19 KB) (PDF/464.59 KB) (PDF/137.57 KB) A risk management plan has been developed to ensure that Tadalafil Mylan is used as safely as possible. (PDF/169.4 KB) (PDF/162.36 KB) (PDF/66.79 KB) (PDF/50.06 KB) (PDF/396.75 KB) (PDF/162.67 KB) (PDF/157.46 KB) (PDF/67.62 KB) (PDF/47.77 KB) Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Tadalafil Mylan, including the appropriate precautions to be followed by healthcare professionals and patients. (PDF/436.45 KB) (PDF/67.55 KB) (PDF/138.47 KB) (PDF/159.19 KB)