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Product name Product type Date released
Expand APO-Tadalafil CMI 04 Aug 2020
 
APO-Tadalafil is used to treat:
erectile dysfunction, also known as impotence, in men. This is when a man cannot get, or maintain, a hard erect penis suitable for sexual activity. Following sexual stimulation, APO-Tadalafil works by helping the blood vessels in your penis to relax, allowing the flow of blood into your penis. The result of this is improved erectile function. APO-Tadalafil will only treat erectile dysfunction if you are sexually aroused. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.
urinary symptoms associated with a common condition called benign prostatic hyperplasia. This is when the prostate gland gets bigger with age. Symptoms include difficulty in starting to pass urine, a feeling of not completely emptying the bladder and a more frequent need to pass urine even at night. APO-Tadalafil improves blood flow to, and relaxes the muscles of, the prostate and bladder which may reduce symptoms of benign prostatic hyperplasia.
Your doctor may have prescribed you APO-Tadalafil to treat either, or both of these conditions.
Ask your doctor if you have any questions about why APO-Tadalafil has been prescribed for you.
Your doctor may have prescribed it for another reason. APO-Tadalafil is available only with a doctor's prescription.
APO-Tadalafil is not intended for use by women or by children under the age of 18 years.
The active ingredient in APO-Tadalafil tablets, tadalafil, belongs to a group of medicines called phosphodiesterase type 5 inhibitors.
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Expand APO-Tadalafil PI 03 Aug 2020
 
Expand Takhzyro PI 03 Aug 2020
 
Expand Fluoxetine APOTEX CMI 31 Jul 2020
 
The name of your medicine is Fluoxetine. It contains the active ingredient fluoxetine (as fluoxetine hydrochloride).
Fluoxetine belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). Serotonin is one of the chemicals in your brain which helps control your mood. Fluoxetine and other SSRIs are thought to help by increasing the amount of serotonin in your brain.
Fluoxetine is used to treat:
depression
obsessive compulsive disorder (OCD)
premenstrual dysphoric disorder (PDD)
Depression is longer lasting and/or more severe than the 'low moods' everyone has from time to time due to the stress of everyday life. It is thought to be caused by a chemical imbalance in parts of the brain. This imbalance affects your whole body and can cause emotional and physical symptoms such as feeling low in spirit, loss of interest in activities, being unable to enjoy life, poor appetite or overeating, disturbed sleep, often waking up early, loss of sex drive, lack of energy and feeling guilty over nothing. Fluoxetine corrects this chemical imbalance and may help relieve the symptoms of depression.
Check with your doctor if you need more information about obsessive compulsive disorder (OCD).
The symptoms of OCD vary from patient to patient.
This medicine is not expected to affect your ability to drive a car or operate machinery, but make sure you know how it affects you beforehand, as it can make some people dizzy or drowsy, and affect judgement, thinking and motor skills.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed this medicine for another reason.
There is not enough information to recommend the use of this medicine for children under the age of 18 years.
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Expand Fluoxetine APOTEX PI 31 Jul 2020
 
Expand Ventolin CFC-Free Inhaler (with counter) CMI 31 Jul 2020
 
The name of your medicine is VENTOLIN Inhaler. You may know it better as a 'puffer'.
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Expand Zempreon CFC-Free Inhaler PI 31 Jul 2020
 
Expand Zempreon CFC-Free Inhaler CMI 31 Jul 2020
 
The name of your medicine is ZEMPREON Inhaler. You may know it better as a 'puffer'.
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Expand Telnasal Allergy Spray PI 31 Jul 2020
 
Expand Telnasal Allergy Spray CMI 31 Jul 2020
 
Telnasal Allergy Spray contains the active ingredient mometasone furoate. This belongs to a family of medicines called corticosteroids, which are used to help reduce inflammation.
Allergic Rhinitis (hayfever): Telnasal Allergy Spray is sprayed into the nose to help relieve symptoms that may occur with hayfever or other year round allergies, including stuffiness (congestion) in the nose, discharge, itching and sneezing. This medicine may also be used to help prevent these symptoms two to four weeks before the beginning of the pollen season.
There is no evidence that this medicine is addictive.
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Expand Kozenis PI 28 Jul 2020
 
Expand Kozenis CMI 28 Jul 2020
 
KOZENIS contains a medicine called tafenoquine. Malaria is a serious disease spread by infected mosquitoes. KOZENIS is used to eliminate certain forms of malaria (specifically Plasmodium vivax) and help prevent it from coming back. It is given with another medicine (chloroquine) that treats the acute (blood) stage of malaria.
You must get medical advice on which anti-malarial medicines to take. You must ask your doctor or pharmacist if KOZENIS is suitable for the type of malaria to be treated.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
KOZENIS is unlikely to affect your ability to drive or use machines.
The safety and efficacy of tafenoquine have not been established in children and adolescents less than 16 years of age.
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Expand Lorviqua CMI 28 Jul 2020
 
LORVIQUA is used to treat a rare type of lung cancer that is caused by defects in a gene called anaplastic lymphoma kinase (ALK).
LORVIQUA blocks the action of an enzyme called ‘ALK tyrosine kinase’. Abnormal forms of this enzyme (due to the fault in the ALK gene) help encourage cancer cell growth.
LORVIQUA may slow down or stop the growth of your cancer. It may also help to shrink your cancer.
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.
LORVIQUA is available only with a doctor's prescription.
It is not addictive.
There is not enough information to recommend the use of this medicine for children.
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Expand Lorviqua PI 28 Jul 2020
 
Expand Temizole PI 23 Jul 2020
 
Expand Temizole CMI 23 Jul 2020
 
This medicine contains temozolomide as the active ingredient.
TEMIZOLE is used to treat:
patients with brain tumours
adult patients with advanced metastatic malignant melanoma
It belongs to a group of medicines called cytotoxic or chemotherapy medicines.
TEMIZOLE works by killing cancer cells and stopping cancer cells from growing and multiplying.
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.

Use in children

TEMIZOLE can be used to treat children aged 3 years and older, with specific forms of brain cancer (glioblastoma multiforme or anaplastic astrocytoma, showing reccurrence or progression after standard therapy).
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Expand Zeposia PI 22 Jul 2020
 
Expand Zeposia CMI 22 Jul 2020
 
Zeposia is used to treat adult patients with Relapsing forms of Multiple Sclerosis. Zeposia contains an active substance called ozanimod, which belongs to a group of medicines called sphingosine-1-phosphate (S1P) receptor modulators.
Multiple Sclerosis (MS) is a disease in which inflammation in the body attacks and destroys the protective coating around your nerves (called myelin). This stops the nerves from working properly. The symptoms of MS can vary from person to person. In relapsing MS, patients will experience relapse or flare-ups from time to time, followed by a period of recovery and stability, where symptoms may disappear or some symptoms may remain.
Zeposia can affect the ability of some white blood cells to move freely within the body and stops them from reaching the central nervous system (the brain, spine and optic nerve), where they can cause inflammation and damage. In doing so, Zeposia may help protect against attacks on the nerves, reduce inflammation and damage to the nerves’ protective coating and slow down the progression of disability.
Ask your doctor if you have any questions about how Zeposia works, or 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.
Safety and effectiveness of Zeposia in children younger than 18 years have not been established.
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Expand Libtayo CMI 21 Jul 2020
 
Libtayo is an anti-cancer medicine that contains the active substance cemiplimab, which is a monoclonal antibody.
Libtayo is used in adults to treat a type of skin cancer called advanced cutaneous squamous cell carcinoma, also known as CSCC.
Libtayo works by helping your immune system fight your cancer.
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Expand Dilaudid Oral Liquid CMI 21 Jul 2020
 
Do not use if you have ever had an allergic reaction to hydromorphone 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 DILAUDID? in the full CMI.
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