Riik: Lõuna-Aafrika Vabariik
keel: inglise
Allikas: South African Health Products Regulatory Authority (SAHPRA)
Cipla Medpro (Pty) Ltd
See ingredients
PESSARIES
EACH PASSARY CONTAINS PROGESTERONE 200 mg
Registered
1995-10-02
8 CUSTOMER PRODUCT NAME ITEM CODE OUR REF DATE PREVIOUS VERSION PHARMACODE NO MATERIAL FLAT SIZE FOLD SIZE VIEW PANEL FOLD DETAIL PACKING DETAILS COLOURS FRONT COLOURS BACK CUSTOMER PRODUCT NAME ITEM CODE OUR REF PROOF NO DATE PREVIOUS VERSION PHARMACODE NO MATERIAL FLAT SIZE FOLD SIZE VIEW PANEL FOLD DETAIL PACKING DETAILS COLOURS FRONT COLOURS BACK Actavis (UK) Ltd CYCLOGEST 200MG X 15S (SOUTH AFRICA) 50943832 SO50641 One 27/04/2018 n/a n/a 50gsm Opaque 210 x 148 148 x 27 PHARMACODE TO VIEW PARALLEL Shrinkwrapped in trays BLACK, P.GREEN BLACK, P.GREEN Actavis BST - Packing Technical BSTCutterGuideReq@actavis.com Dimensions: Component: Date Sent: Technologist: TECHNICALLY APPROVED Pharmacode: JDE No.: Cyclogest 200mg x 15’s (South Africa) 148x210 (Pre-Folded) 50943832 Leaflet for Sarong 5967 R.Wrey 12/12/17 148x210 Leaflet Pre-Folded Profile - Sarong (BST) Progesterone 200mg PIL - South Africa item no: AAAK4375 print proof no: 3 origination date: 11.04.18 originated by: dje revision date: 18.04.18 revised by: dje dimensions: 148 x 210 pharmacode: colours/plates: approved for print/date Non Printing Colours 1. Black 2. Teva PMS Green C 3. 4. 5. 6. 1. Profile 2. 3. date sent: N/A supplier: Actavis UK technically app. date: min pt size: 6pts TECHNICAL APPROVAL AAAK4375 CYCLOGEST ® _PROGESTERONE_ SCHEDULING STATUS: PROPRIETARY NAME AND DOSAGE FORM: CYCLOGEST® 200 MG (pessaries) COMPOSITION: Each pessary, suitable for vaginal insertion, contains 200 mg progesterone Ph.Eur. PHARMACOLOGICAL CLASSIFICATION: A 21.8.2 Progesterones with or without oestrogens PHARMACOLOGICAL ACTION: CYCLOGEST 200 MG (progesterone) is a natural progestogen. Progesterone released during the luteal phase of the menstrual cycle leads to the development of a secretory endometrium. Abrupt decline in the release of progesterone from the corpus luteum at the end of the cycle is the main determinant of the onset of menstruation. If the duration of the luteal phase is artificially lengthened, either by sustaining luteal function or by treatment Lugege kogu dokumenti