Note: the documents on this web site are PDF files. If you do not have a PDF reader, you can download one now.

Product name Product type Date released
Expand Ultomiris 100 mg/ml PI 23 Apr 2021
 
Expand Verzenio PI 23 Apr 2021
 
Expand Zactin Tabs PI 23 Apr 2021
 
Expand Somatuline Autogel CMI 23 Apr 2021
 
Somatuline Autogel is a prolonged release formulation of lanreotide. Lanreotide is an octapeptide, an analogue of a naturally occurring hormone, somatostatin. Lanreotide lowers the levels of hormones in the body such as GH (growth hormone) and IGF-1 (insulin-like growth factor-1).
read more
Expand Imatinib-Teva CMI 22 Apr 2021
 
Imatinib is used to treat adults and children/adolescents who have chronic myeloid leukaemia (CML) and acute lymphoblastic leukaemia with Philadelphia chromosome positive (Ph-positive ALL).
CML and ALL are types of leukaemia in which an abnormal chromosome produces an enzyme that leads to uncontrolled growth of white blood cells. Imatinib kills the abnormal cells while leaving normal cells alone.
Imatinib is also used to treat adults for:
myelodysplastic / myeloproliferative diseases (MDS/MPD).
These are a group of blood diseases in which some blood cells start growing out of control.
Hypereosinophilic syndrome (HES) and or chronic eosinophilic leukaemia (CEL).
These are blood diseases in which some blood cells, named "eosinophils", start growing out of control.
dermatofibrosarcoma protuberans (DFSP).
DFSP is a cancer of the tissue beneath the skin in which some cells start growing out of control.
Imatinib works by slowing the growth of abnormal cells. Imatinib kills the abnormal cells while leaving normal cells alone.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed it for another purpose.
Imatinib is only available with a doctor's prescription. It is not addictive.
There is not enough information to recommend the use of imatinib in children under 3 years of age for most uses.
For use in CML, there is no experience with the use of imatinib in children below 2 years of age.
For acute lymphoblastic leukaemia with Philadelphia chromosome positive (Ph-positive ALL), there is no experience with the use of imatinib in children below 1 year of age.
read more
Expand Imatinib-Teva PI 22 Apr 2021
 
Expand Zoton FasTabs PI 21 Apr 2021
 
Expand Atgam CMI 21 Apr 2021
 
Do not use if you have ever had an allergic reaction to Atgam/equine antithymocyte immunoglobulin or other horse proteins (equine gamma globulins) or any of the ingredients listed at the end of the CMI.
It is possible for products developed from horse or human blood to carry infectious diseases like viral hepatitis and AIDS.
Talk to your doctor if you have any other medical conditions, take any other medicines, or if you are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before treatment with Atgam? in the full CMI.
read more
Expand Entecavir Mylan PI 21 Apr 2021
 
Expand Actonel EC CMI 20 Apr 2021
 
Do not use if you have ever had an allergic reaction to Actonel EC or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use Actonel EC? in the full CMI.
read more
Expand Actonel PI 20 Apr 2021
 
Expand Actonel EC PI 20 Apr 2021
 
Expand Heparin Injection PI 20 Apr 2021
 
Expand Isoptin Injection CMI 20 Apr 2021
 
Isoptin Injection is used to:
treat unusual fast heart beat
treat high blood pressure, also called hypertension
treat poor blood flow to the heart
prevent certain heart problems occurring during surgery
Your doctor may have prescribed Isoptin Injection for another reason. Ask your doctor if you have any questions about why Isoptin Injection has been prescribed for you.
Isoptin Injection belongs to a group of medicines called calcium channel blockers or calcium antagonists. They work by widening blood vessels which lets more blood and oxygen reach the heart and at the same time lowers high blood pressure. Isoptin Injection also helps control fast heart rate.
Isoptin does not change the amount of calcium in your blood or bones. Calcium in your diet or in calcium supplements will not interfere with the way Isoptin Injection works.
Isoptin is available only with a doctor's prescription.
Isoptin Injection is not addictive.
read more
Expand Nupentin Capsules PI 20 Apr 2021
 
Expand Nupentin Capsules CMI 20 Apr 2021
 

What Nupentin does

Nupentin is used to control epilepsy. Epilepsy is a condition where you have repeated seizures (fits). There are many different types of seizures, ranging from mild to severe.
Nupentin is also used to treat neuropathic pain, a type of pain caused by damage to the nerves.
This medicine belongs to a group of medicines called anticonvulsants.

How Nupentin works

This medicine is thought to work by controlling brain chemicals which send signals to nerves to help control seizures or neuropathic pain.
Nupentin also has pain relieving effects.
Your doctor may have prescribed Nupentin in addition to other medicines that you may be taking. This may be necessary if your current treatment is no longer working as well.
Your doctor may have prescribed Nupentin for another reason.
Nupentin may lead to dependence on this medicine.
Ask your doctor if you have any questions about why Nupentin has been prescribed for you.
This medicine is available only with a doctor's prescription.

Use in children

There is not enough information to recommend the use of this medicine in children:
under the age of 3 years to control epilepsy, or
under the age of 18 years to treat neuropathic pain.
read more
Expand Lucrin Depot and Lucrin Depot Paediatric PDS injection CMI 19 Apr 2021
 
Check the list of ingredients at the end of the CMI. Do not use Lucrin if you have ever had an allergic reaction to any of them.
Talk to your doctor before you use this medicine if he/she is not aware that you have any other medical conditions, take any other medicines or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use Lucrin? in the full CMI.
read more
Expand Zircol 10 and Zircol 20 PI 19 Apr 2021
 
Expand Zircol 10 and Zircol 20 CMI 19 Apr 2021
 
The name of your medicine is ZIRCOL 10 or ZIRCOL 20, which is also known as lercanidipine.
ZIRCOL 10 and ZIRCOL 20 belong to a group of medicines called calcium channel blockers (of the dihydropyridine group).
ZIRCOL 10 and ZIRCOL 20 lower high blood pressure, which is also called hypertension. It works by relaxing some of the blood vessels in the body and reducing resistance to the flow of blood through the blood vessels.
Everyone has blood pressure. This pressure helps get your blood all around your body. Your blood pressure may be different at different times of the day, depending on how busy or worried you are. You have hypertension (high blood pressure) when your blood pressure stays higher than is needed, even when you are calm and relaxed.
There are usually no symptoms of hypertension. The only way of knowing that you have hypertension is to have your blood pressure checked on a regular basis. If high blood pressure is not treated it can lead to serious health problems. You may feel fine and have no symptoms, but eventually hypertension can cause stroke, heart disease and kidney failure. ZIRCOL 10 and ZIRCOL 20 help lower your blood pressure.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed it for another reason.
This medicine is available only with a doctor's prescription.
There is no evidence that this medicine is addictive.
read more
Expand Rydapt CMI 17 Apr 2021
 
RYDAPT contains the active ingredient midostaurin.
RYDAPT belongs to a group of medicines called protein kinase inhibitors. It is used to treat certain types of white blood cell disorders.
RYDAPT is used to treat:
acute myeloid leukemia (AML) in adults who have a defect in a gene called FLT3. AML is a type of cancer of white blood cells. White blood cells usually help the body to fight infections, and in the case of AML, the body produces too many abnormal white blood cells (named "myeloid" cells).
a disease called advanced systemic mastocystosis in adults. This is a disorder in which the body produces too many mast cells, a type of white blood cell. Symptoms are caused when too many mast cells get into organs like the liver, bone marrow and spleen, or release substances like histamine into the blood.
RYDAPT works by blocking the action of some enzymes (kinases) of the abnormal cells and stops their division and growth. At the start of the treatment in AML, RYDAPT is always used together with other chemotherapies.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed it for another reason.
This medicine is not addictive.
This medicine is available only with a doctor's prescription.
read more