In compliance with Republic Act No. 10354, also known as “The Responsible Parenthood and Reproductive Health Act of 2012” and its IRR, the Food and Drug Administration (FDA) hereby invites all concerned to submit their petitions and any corresponding evidence on the mechanism of action of the following contraceptive products within ten (10) calendar days from the posting of this Advisory:
Generic Name | Dosage Strength and Form | Brand Name | Marketing Authorization Holder (MAH) |
1) Cyproterone acetate + Ethinylestradiol | 2mg / 35mcg Tablet | Ridne-35 | Hyphens Pharma Philippines Inc. |
2) Cyproterone acetate + Ethinylestradiol | 2mg / 35mcg Film-Coated Tablet | Ethidol-C | Ambica International Corporation |
3) Cyproterone acetate + Ethinylestradiol | 2mg / 35mcg Tablet | Estelle-35D | Zuellig Pharma Corporation |
4) Cyproterone acetate + Ethinylestradiol | 2mg / 35mcg Film-Coated Tablet | Safex | A.T.C. Health Care Int’l Corp. |
5) Cyproterone acetate + Ethinylestradiol | 2mg / 35mcg Tablet | Diane 35 | Bayer Philippines Inc. |
6) Cyproterone acetate + Ethinylestradiol | 2mg / 35mcg Tablet | Ariane | Innogen Pharmaceuticals, Inc. |
7) Cyproterone acetate + Ethinylestradiol | 2mg / 35mcg Tablet | Faye | AAA Pharma, Inc. |
8) Cyproterone acetate + Estradiol valerate | 2mg / 1mg Tablet | Climen 28 | Bayer Philippines Inc. |
9) Desogestrel | 75 mcg Tablet | Andrea | DKT Health, Inc. |
10) Desogestrel | 75 mcg Film-Coated Tablet | Desirett | Exeltis Philippines Inc. |
11) Desogestrel + Ethinylestradiol | 150mcg / 30mcg Tablet | Daisy-30 | S.M.H.P. Marketing & Consultancy |
12) Desogestrel + Ethinylestradiol | 150mcg / 30mcg Film-Coated Tablet | Mariona | Exeltis Philippines Inc. |
13) Dienogest | 2 mg Tablet | Vinca | Chemway Pharma, Inc. |
14) Drospirenone + Ethinylestradiol | 3mg / 20mcg Tablet | Gvez | Metro Drug, Inc. |
15) Drospirenone + Ethinylestradiol | 3mg / 30mcg Film-Coated Tablet | Gveza | Metro Drug, Inc. |
16) Drospirenone + Ethinylestradiol | 3mg / 30mcg Tablet | Erin | DKT Health, Inc. |
17) Estradiol + Drospirenone | 2mg / 1mg Tablet | Angeliq | Bayer Philippines, Inc. |
18) Levonorgestrel | 1.5 mg Film-Coated Tablet | Co-Pill | Ambica International Corporation |
19) Levonorgestrel | 1.5 mg Film-Coated Tablet | Gestrex | Next Chemical Enterprises |
20) Levonorgestrel | 750 mcg Tablet | Lenor-72 | Ambica International Corporation |
21) Levonorgestrel | 30 mcg Tablet | Safex | Golden Dale Pharma Corp. |
22) Levonorgestrel | 1.5 mg Tablet | Levonia One | Bonamis Pharmacy Philippines Corporation |
23) Levonorgestrel | 750 mcg Tablet | Contra 72 | Pharmastar Int’l Trading Corporation |
24) Levonorgestrel + Ethinylestradiol | 20mg/mL Tablet | Aecys | Fresenius Kabi Philippines Inc. |
25) Levonorgestrel + Ethinylestradiol | 150 mcg / 30 mcg Sugar-Coated Tablet | Zinnia P | S.M.H.P. Marketing & Consultancy |
26) Levonorgestrel + Ethinylestradiol | 250mcg / 50mcg Film-Coated Tablet | Florina-G | Ambica International Corporation |
27) Levonorgestrel + Ethinylestradiol | 150mcg / 30mcg Tablet | Besafe | AAA Pharma, Inc. |
28) Levonorgestrel + Ethinylestradiol | 150mcg / 30mcg Film-Coated Tablet | Meleva | Chemway Pharma, Inc. |
29) Levonorgestrel + Ethinylestradiol | 150mcg / 30mcg Film-Coated Tablet | Florina | Ambica International Corporation |
30) Levonorgestrel + Ethinylestradiol | 150mcg / 30mcg Tablet | Conchoice | Sun Pharma Philippines Inc. |
31) Levonorgestrel + Ethinylestradiol | 250mcg / 50mcg Tablet | Conchoice Plus | Sun Pharma Philippines Inc. |
32) Levonorgestrel + Ethinylestradiol + Ferrous fumarate | 125mcg / 30mcg; 75mcg Film-Coated Tablet | Safex-Combi | Golden Dale Pharma Corporation |
33) Levonorgestrel + Ethinylestradiol + Ferrous fumarate | 150mcg / 30mcg / 75mg Film-Coated Tablet | Helena Plus | Eon Pharmatek, Inc. |
34) Medroxyprogesterone acetate | 150 mg/mL Injection | Famy-Depo | S.M.H.P. Marketing & Consultancy |
35) Medroxyprogesterone acetate | 50 mg/mL Suspension for Injection (I.M.) | Contracep | Healol Pharma Corporation |
36) Medroxyprogesterone acetate | Sterile Aqueous Suspension for Injection | Depo-Provera | Pfizer, Inc. |
37) Medroxyprogesterone acetate | 104mg / 0.65mL Suspension for Injection | Sayana Press | Pfizer, Inc. |
38) Medroxyprogesterone acetate | 150 mg/mL Sterile Aqueous Suspension for Injection (I.M.) | Femme-3 | Amtol Pharma Imports Inc. |
39) Medroxyprogesterone acetate | 50 mg/mL (150mg / 3mL) Solution for Injection (I.M.) | Provestin | Phil Pharmawealth, Inc. |
40) Medroxyprogesterone acetate | 10 mg Tablet | Deporeva | QB International Trade |
41) Medroxyprogesterone acetate | 10 mg Tablet | Xygyn | Ambica International Corporation |
42) Medroxyprogesterone acetate | 150 mg/mL | Daisy-30 | S.M.H.P. Marketing & Consultancy |
43) Lynestrenol | 500 mcg Tablet | None | DKT Health, Inc. |
44) Norethisterone | 5 mg Tablet | None | Ambica International Corporation |
45) Norethisterone | 5 mg Tablet | Steron | Ambica International Corporation |
46) Norethisterone | 5 mg Tablet | NCnorm-P | Ambica International Corporation |
47) Norethisterone + Ethinylestradiol | 400mcg / 35mcg | None | Lloyd Laboratories, Inc. |
48) Norgestrel + Ethinylestradiol | 500mcg / 50mcg Film-Coated | Florina-N | Ambica International Corporation |
49) Intra Uterine Contraceptive Device, Code: TCu 380A | N/A | Eve’s | AAA Pharma, Inc. |
50) Intrauterine Contraceptive Device | N/A | Pregna | DKT Philippines, Inc. |
Documents and scientific evidence can be submitted to the Food and Drug Action Center (FDAC), Civic Drive, Filinvest City, Alabang, Muntinlupa on Mondays to Fridays, 8:00 am to 5:00 pm.