PDF PART VI- Summary of the risk management plan - Lægemiddelstyrelsen

List of important risks and missing information Important identified risks  Use in pregnancy  Excess intake of drug Overdose  Use in patients with kidney dysfunction Use in

Important identified risks Hepatic dysfunction Malignant hyperthermia Perioperative hyperkalemia Cardiac arrhythmias Myocardial ischemia in patients with a history of coronary artery

9.2.1 Part VI – II.A: List of important risks and missing information Important risks of tacrolimus hard capsule and prolonged-release hard capsule are risks that need special risk

CONFIDENTIAL Page 26 of 31 08-Feb-2019 Final IPV-Al AJV DIR 39310-05 1.8.2 Risk Management System II.A List of important risks and missing information Important risks

Risk Management Plan Page 12/13 II.A List of important risks and missing information Important risks of Icatibant AdAlvo 30 mg/3 ml injektionsvæske, opløsning are risks that need

Risks associated with the medicine and activities to minimise or further characterise the risks Important risks of Lamotrigine 5/25/100 mg chewable/dispersible tablets, together with

Risk Management Plan Page 12/15 II.A List of important risks and missing information Important risks of Icatibant STADA 30 mg/3 ml injektionsvæske, opløsning are risks that need

Part VI: Summary of the risk management plan by product VI.1 Elements for summary tables in the EPAR VI.1.1 Summary table of Safety concerns Summary of safety concerns Important