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zameds

Norethisterone, oestradiol

Sold as Evorel conti, Activelle, Estalis

S4Read from the PI-PIL document and verified

Combination product

This product contains more than one active ingredient, so it has no single molecular structure.

Background

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Registration

Applicants
3
Registrations
4
Schedule source
SAHPRA documentation

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Adcock ingram limitedEvorel conti3,1 mg/3,2 mg310537S4PIPIL
Novo Nordisk (Pty) Ltd û (Rivonia)ActivelleNot stated330532Not determinedNone
Sandoz South Africa (Pty) LtdEstalis50/140, 50/250370456, 370457Not determinedNone

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Evorel conti

EACH PATCH CONTAINS: NORETHISTERONE ACETATE 11,2 mg, OESTRADIOL HEMIHYDRATE 3,2 mg

3,1 mg/3,2 mgTransdermal patch31053731/21.8.2/0537Approved 17 December 2021RegisteredS4PIPIL
Activelle

EACH TABLET CONTAINS NORETHISTERONE ACETATE 0,50 mg OESTRADIOL HEMIHYDRATE EQUIVALENT TO OESTRADIOL 1,0 mg

Not listed33053233/21.8.2/0532RegisteredNot determinedNone
Estalis 50/140

EACH PATCH CONTAINS NORETHISTERONE ACETATE 2,70 mg OESTRADIOL HEMIHYDRATE EQUIVALENT TO OESTRADIOL 0,620 mg

50/14037045637/21.8.2/0456RegisteredNot determinedNone
Estalis 50/250

EACH PATCH CONTAINS NORETHISTERONE ACETATE 4,80 mg OESTRADIOL HEMIHYDRATE EQUIVALENT TO OESTRADIOL 0,512 mg

50/25037045737/21.8.2/0457RegisteredNot determinedNone

Regulatory status

Where S4 sits on the scale

Prescription-only medicine.

Schedule 4 covers most ordinary prescription medicines. You need a prescription from an authorised prescriber, such as a doctor or dentist, and a pharmacist dispenses it. Its price, name, pack size and strength can still be told to the public, as long as nothing links it to what it treats.

Schedule S4, read from the product's PI-PIL leaflet.

Who may supply: A pharmacist dispensing against a written or verbal prescription from an authorised prescriber; a veterinarian, who may also prescribe, compound or dispense it directly; a medical practitioner or dentist, who may prescribe it and may compound or dispense it directly only if licensed under section 22C(1)(a); manufacturers and wholesalers may supply people who may lawfully possess it; and, for animal treatment, a person practising a para-veterinary profession, on a veterinarian's written or verbal instruction.

This is an informational summary of the Medicines and Related Substances Act 101 of 1965 and its 2017 General Regulations. It is not medical advice and not legal advice. Always check the medicine's label, which carries the schedule number inside a square border, or ask a pharmacist if you are unsure.

SAHPRA documents

Schedule verified from official documents

Schedule Verification

Evorel conti, Adcock ingram limited is scheduled S4 in its official SAHPRA documents, read with 90% confidence.

These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.

Research articles

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