Injection containing apomorphine hydrochloride 10 mg in 1 mL

Injection

Apomine

PF

EMP

C4833 C4860

360

5

D

APO-BOSENTAN

GX

EMP

C4628 C6089 C6710 C6734 C6748 C6764 C6776

See Note 1

See Note 2

D

APO-BOSENTAN

GX

EMP

C6089 C6710 C6734 C6748 C6764 C6776

See Note 1

See Note 2

D

C6813

Parkinson disease

Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy.

Compliance with Authority Required procedures - Streamlined Authority Code 6813

Epoetin lambda

C6260

Anaemia associated with intrinsic renal disease

Patient must require transfusion; AND

Patient must have a haemoglobin level of less than 100 g per L; AND

Patient must have intrinsic renal disease, as assessed by a nephrologist.

Compliance with Authority Required procedures

C6294

Anaemia associated with intrinsic renal disease

Patient must require transfusion; AND

Patient must have a haemoglobin level of less than 100 g per L; AND

Patient must have intrinsic renal disease, as assessed by a nephrologist.

Compliance with Authority Required procedures - Streamlined Authority Code 6294

Paritaprevir with ritonavir with ombitasvir and dasabuvir and ribavirin

C6130

P6130

Chronic hepatitis C infection

Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND

Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND

The treatment must be limited to a maximum duration of 24 weeks.

Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age.

Compliance with Authority Required procedures

C6131

P6131

Chronic hepatitis C infection

Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND

Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND

The treatment must be limited to a maximum duration of 12 weeks.

Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age.

Compliance with Authority Required procedures

C5016

Treatment with peginterferon alfa has been associated with depression and suicide in some patients. Patients with a history of suicidal ideation or depressive illness should be warned of the risks. Psychiatric status during therapy should be monitored.

Chronic hepatitis B infection

Patient must not have cirrhosis, AND

Patient must not have previously received peginterferon alfa therapy for the treatment of hepatitis B, AND

Patient must have elevated HBV DNA levels greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, in conjunction with documented hepatitis B infection; OR

Patient must have elevated HBV DNA levels greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative, in conjunction with documented hepatitis B infection, AND

Patient must have evidence of chronic liver injury determined by confirmed elevated serum ALT or liver biopsy, AND

The treatment must be the sole PBS subsidised therapy for this condition.

Compliance with Written and Telephone Authority Required procedures

C5016

P5016

Chronic hepatitis C infection

Must be treated in an accredited treatment centre.

Patient must be aged 18 years or older; AND

Patient must not be pregnant or breastfeeding, and must be using an effective form of contraception if female and of child-bearing age.

Patient must have compensated liver disease; AND

Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND

Patient must have a contraindication to ribavirin; AND

The treatment must cease unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) show that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop; AND

The treatment must be limited to a maximum duration of 48 weeks.

Evidence of chronic hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records.

Compliance with Authority Required procedures