Reduction of elevated intraocular pressure (IOP) in patients with open angle glaucoma and ocular hypertension in adults (including the elderly).
Reduction of elevated IOP in paediatric patients with elevated IOP and paediatric glaucoma.
Treatment of erectile dysfunction in adult males.
In order for tadalafil to be effective for the treatment of erectile dysfunction, sexual stimulation is required.
5 mg only: Treatment of the signs and symptoms of benign prostatic hyperplasia in adult males.
Tadalafil is not indicated for use by women.
Selexipag is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients with WHO functional class (FC) II–III, either as combination therapy in patients insufficiently controlled with an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 (PDE-5) inhibitor, or as monotherapy in patients who are not candidates for these therapies. Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease.
Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischemic attack (TIA); Age ≥ 75 years; heart failure (NYHA Class ≥ II); diabetes mellitus; hypertension. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults
DABIFIB 75/110/150 (Dabigatran Etexilate Capsules 75 mg /110 mg /150 mg) Treatment of venous thromboembolic events (VTE) and prevention of recurrent VTE in paediatric patients from birth to less than 18 years of age
PHYSIONEAL 40 is indicated whenever peritoneal dialysis is employed, including:
• Acute and chronic renal failure;
• Severe water retention;
• Severe electrolyte imbalance;
• Drug intoxication with dialysable substances, when a more adequate therapeutic alternative is not available.
PHYSIONEAL 40 bicarbonate/lactate based peritoneal dialysis solutions with a physiological pH are particularly indicated in patients in whom solutions based on lactate buffer only, with a low pH, cause abdominal inflow pain or discomfort.
Fulvestrant is indicated:
• as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women:
- not previously treated with endocrine therapy, or
- with disease relapse on or after adjuvant antioestrogen therapy, or disease progression on antioestrogen therapy.
• in combination with Palbociclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy.
In pre- or perimenopausal women, the combination treatment with Palbociclib should be combined with a luteinising hormone releasing hormone (LHRH) agonist
Breast cancer
Talazoparib is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2-negative locally advanced or metastatic breast cancer. Patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for endocrine-based therapy.
Prostate cancer
Talazoparib is indicated in combination with enzalutamide for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).
Registration
Generic(Multisource) Drug
TRASPOR
Amphotericin B
50 mg
Powder for concentrate for dispersion for infusion
Liposomal amphotericin is indicated in adults and children aged 1 month to 18 years old for:
• the treatment of severe systemic and/or deep mycoses;
• the treatment of visceral leishmaniasis in immunocompetent patients including both adults and children;
• the empirical treatment of presumed fungal infections in febrile neutropenic patients, where the fever has failed to respond to broad spectrum antibiotics and appropriate investigations have failed to define a bacterial or viral cause.
Infections successfully treated with liposomal amphotericin include: disseminated candidiasis, aspergillosis, mucormycosis, chronic mycetoma, cryptococcal meningitis and visceral leishmaniasis.
Liposomal amphotericin should not be used to treat the common clinically inapparent forms of fungal disease which show only positive skin or serologic tests.
Registration
New Drug
Sibnayal
Potassium citrate and potassium hydrogen carbonate
Letermovir is indicated for prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT).
Letermovir is indicated for prophylaxis of CMV disease in CMV-seronegative adults who have received a kidney transplant from a CMV-seropositive donor [D+/R-].
Consideration should be given to official guidance on the appropriate use of antiviral agents.
