Contact Information for Reporting of Adverse Events

AVIBELA (levonorgestrel-releasing intrauterine system) 52 mg

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system or to the local partner. Patients are encouraged to call their healthcare provider if they have any concerns about Avibela and patients may also report any suspected adverse reactions via the national reporting system or to the local partner. Contact information for the national reporting systems and local partners can be found below.

Kenya

Imperial Managed Solutions East Africa Ltd.

Kutch Road, off Mombasa Road, Mlolongo, Kenya

Contact person: Robert Miano

Email: robert.miano@dpworld.com

Tel: +254717 977632

The Pharmacy and Poison Board

Lenana Road, Nairobi

Phone: (020) 2716905/6 ext 114

Email: pv@pharmacyboardkenya.org /pv@ppb.go.ke

Website: https://pv.pharmacyboardkenya.org/

Marie Stopes Kenya

Kindaruma Road, Kilimani

P.O. Box 59328-00200, Nairobi

Phone: 0800 720 005 / 254 (0) 57 252 3 218

Email: info@mariestopes.or.ke

Nigeria

Society for Family Health

Justice Ifeyinwa Nzeako House

8 Port Harcourt Crescent, Off Gimbiya Street

Area 11, Garki, Abuja

Phone: +234 092906736 / 092921823 / +234 092920235 / 092920236

Email: info@sfhnigeria.org

Assene-Laborex Limited

Plot 2&4, Block B, Amuwo Odofin Industrial Scheme, Apapa Oshodi, Expressway, Lagos

Panama

Dirección Nacional de Farmacia y Drogas

Email: fvigilancia@minsa.gob.pa

Uganda

United Healthcare Distributors Limited (UHD)

Plot 26 Nakasero Road

P.O. Box 34458

Kampala, Uganda

Phone: +256 705 672140

Email: pv@uhd-group.com

Uganda National Drug Authority (NDA)

WhatsApp: +256 740 002070

Email: druginfo@nda.or.ug

Botswana

Briomed (Pty) Ltd

Plot 26324, Block 9 Gaborone Botswana

Contact Person: Tendai Lovatt Mabhumbo

Email: regulatory2@briomed.co

Phone: +267 777 141 44

Botswana Medicine Regulatory Authority

Private Bag 2, Gaborone Station, Botswana

E-mail: reportmdae@bomra.co.bw

Tel No: (+267) 3731727

Fax No: (+267) 3186254

Toll-Free: 0800 600 216

Rwanda

Proline Healthcare and Services

Downtown Complex, KN3, P.O. BOX 391, Kigali, Rwanda

Contact Person: Zacharie Niyoyita

Tel:+250788884324

Email: niyozach@gmail.com

Rwanda Food and Drug Authority

32 KG 9 Ave, Kigali, Rwanda

Email: pv_sm@rwandafda.gov.rw

Guatemala

Guatemala Ministerio de Salud Pública y Asistencia Social

Email: monitoreodrcpfa@mspas.gob.gt or

autorizacionesdrcpfa@mspas.gob.gt

Nicaragua

Departamento de Farmacovigilancia de Nicaragua

Email: infmedica@minsa.gob.ni

Madagascar

PSI Madagascar

Immeuble ARBORETUM

Ex village des jeux ANKORONDRANO

ANTANANARIVO 101

Phone: + 261-20-22-629-84

Le Centre National de Pharmacovigilance de Madagascar - CNPV

Phone: +261 20 22 365 22 ext. 301

Zambia

Marie Stopes Zambia

Plot 120 Kudu Road, Kabulonga

P.O. Box 33730, Lusaka

Phone: +260 211 268 732

Email: fikansa.chanda@mariestopes.org.zm

Pharmaceutical Regulatory Authority National Pharmacovigilance Unit (NPVU)

P.O. Box 31890

Plot No. 6903, Tuleteka Road

Light Industrial Area, Lusaka

Phone: +260-1-220098 / 220109 / 22088

Email: pharmacy@coppernet.zm

Tanzania

DKT International Tanzania

Address: Plot No. 1006-A, Buzwagi Road, msasani peninsula /P.O. Box 23471, Dar es Salaam, TANZANIA

Phone: (+255) 879051141

Email: sufwe2018@gmail.com

Tanzania Medicines & Medical Devices Authority (TMDA)

P.O. BOX 77150, Dar es salaam

Phone: 22-2450512 / 2450751 / 0658-445222

Email: adr@tmda.go.tz

Toll-free number: 0800110084

Democratic Republic of Congo

DKT International RDC

372, Av. Colonel Mundjiba, concession Cotex Utex,

Commune de Ngaliema, Kinshasa - RDC

Contact person: Hyacinthe MUSANGU-BA-BWI

Tél: +243 81 37 32 520

Email: hyacinthe.musangu@dkt-rdc.org

Autorité Congolais de Règlementation Pharmaceutique

66, Boulevard du 30 juin, Immeuble 5 à Sec. 4ème niveau

Kinshasa/Gombe

Tél: +243 81 53 17 221/+243 82 18 20 109

Email: cibkaf@gmail.com/ mboyopierre@gmail.com

Malawi

Family Health Services

P.O. Box 30132, Lilongwe 3, Malawi

Contact person: Caroline Bakasa

Tel: +265 995 498 980

Email: cbakasa@psimalawi.org

National Pharmacovigilance Centre

Pharmacy and Medicines Regulatory Authority (PMRA)

Off Paul Kagame/Chilambula road, next to MRA domestic

Tel: +265 993 276 081 OR +265 885 471 377

Email: pvcenter@pmra.mw

Zimbabwe

Medicines Control Authority of Zimbabwe (MCAZ)

106 Baines Avenue

P.O. Box 10559

Harare, Zimbabwe

Website: https://e-pv.mcaz.co.zw/

Email: pvct@mcaz.co.zw

Phamacure Distributors

Dumisani K. Danda

+263 242 331 873/4

dumi@pharmacure.co.zw

Mozambique

Medifarma Limitada

Name: CLÉIDE MAHUMANA

Title: Technical director assistant

email: cleide.yara05@gmail.com

C: +258 846472245 / 833075390